Context Therapeutics Inc 10-K for FY2024
Context Therapeutics Inc. (CNTX)
10-K
2025-03-20
For: 2024-12-31
View Original
Added on
April 10, 2026
About this 10-K
Context Therapeutics Inc filed this 10-K on March 20, 2025, covering the fiscal year ended December 31, 2024 (FY2024).
Headline figures
Fiscal year ended December 31, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Net loss
- $26.73M
- compared with a net loss of $23.96M a year earlier
- Diluted EPS
- -$0.46
- compared with -$1.50 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
| ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
For the fiscal year ended December 31 , 2024
OR
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
Commission file number 001-40654
(Exact name of registrant as specified in its charter)
| (State of other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification Number) | ||||
(Address of principal executive offices, including zip)
(267 ) 225-7416
(Registrant’s telephone number, including area code)
| Securities registered pursuant to Section 12(b) of the Act: | ||||||||
| Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Which Registered | ||||||
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ | |||||||||||
| ☒ | Smaller reporting company | |||||||||||||
| Emerging growth company | ||||||||||||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
As of June 28, 2024 (the last business day of the registrant's most recently completed second fiscal quarter), the aggregate market value of the registrant's common stock held by non-affiliates was approximately $148.2 million based on the last reported sale price of the registrant's common stock on The Nasdaq Stock Market on June 28, 2024.
As of March 18, 2025, the registrant had 89,704,194 shares of common stock, $0.001 par value per share, outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s definitive Proxy Statement for its 2025 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K are incorporated by reference in Part III, Items 10-14 of this Annual Report on Form 10-K.
TABLE OF CONTENTS
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Unless the context otherwise requires, all references in this Form 10-K to "Context," the "Company," "we," "us," and "our" refer to Context Therapeutics Inc. and its subsidiaries.
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Trademark Notice
This Form 10-K contains references to our trademarks and to trademarks belonging to other entities. Context Therapeutics® is a registered trademark of Context in the United States. All other trademarks, trade names and service marks appearing in this Form 10-K are the property of their respective owners. We do not intend our use or
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display of other companies' trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
RISK FACTOR SUMMARY
The risk factors summarized below could materially harm our business, operating results and/or financial condition, impair our future prospects and/or cause the price of our common stock to decline. For more information, see “Item 1A. Risk Factors” in this Annual Report on Form 10-K for the year ended December 31, 2024. Material risks that may affect our business, operating results and financial condition include, but are not necessarily limited to, the following:
Risks Related to Our Business and Industry
•We have never been profitable and may never achieve or maintain profitability.
•We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.
•If we are unable to raise substantial additional capital on acceptable terms, or at all, we may be forced to delay, reduce or eliminate some or all of our research programs, product development activities and commercialization efforts.
•We may not be able to successfully integrate recent and future acquisitions.
•We have a limited operating history, which makes it difficult to evaluate our current business and future prospects and may increase the risk of your investment.
•We may expend our limited resources pursuing particular research programs or product candidates that may be less successful or profitable than other programs or product candidates.
•Fluctuating foreign exchange rates could increase our operating expenses and adversely affect our results of operations.
•Inflation could adversely affect our business and results of operations.
Risks Related to Our Product Candidates
•Our business is dependent on the successful development, regulatory approval and commercialization of our therapeutic product candidates, CTIM-76, CT-95 and CT-202, which are in the early stages of development.
•Results of preclinical studies, early clinical trials or analyses may not be indicative of results obtained in later trials.
•Interim “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
•Any product candidate may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require it to be taken off the market, require it to include safety warnings or otherwise limit its sales.
•We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties or delays enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
•The success of our business depends primarily upon our ability to identify, develop and commercialize products using our proprietary technologies.
Risks Related to Our Organization, Structure and Operations
•Our reliance on a central team consisting of a limited number of employees and consultants who provide various administrative, research and development, and other services across our organization presents operational challenges that may adversely affect our business.
•Our future success depends on our ability to retain our executive officers and other key executives and to attract, retain and motivate qualified personnel.
Risks Related to Our Reliance on Third Parties
•We expect to, and do, depend on collaborations with third parties for certain research, development and commercialization activities, and to rely on third parties to conduct, supervise and monitor our clinical trials and some aspects of our research and preclinical testing, as well as for the manufacturing process of
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product candidates. If any such collaborations or services by such third parties are not successful or not performed in a satisfactory manner, it may harm our business and prospects, and we may not be able to obtain regulatory approval or commercialize product candidates, or such approval or commercialization may be delayed, and our business may be substantially harmed.
•We may become involved in disagreements or disputes with our licensees, licensors and other counterparties relating to the development and/or commercialization of our current or past product candidates, which may be time consuming, costly and could harm our efforts to develop our current or future product candidates.
Risks Related to Government Regulation
•The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our current and any future product candidates.
•We expect that CTIM-76, CT-95 and CT-202 will be regulated as biological products, or biologics, and therefore they may be subject to competition from biosimilar applicants.
•The FDA may disagree with our regulatory plan and we may fail to obtain regulatory approval of any product candidate.
•Obtaining and maintaining regulatory approval of a product candidate in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of such product candidate in other jurisdictions.
•Even if we obtain regulatory approval of a product candidate, the product may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community.
•Coverage and reimbursement may be limited or unavailable in certain market segments for a product candidate, which could make it difficult for us to sell such product candidate, if approved, profitably.
Risks Related to Intellectual Property
•Patents and patent applications involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our business position.
•Third parties may assert claims against us alleging infringement of their patents and proprietary rights, or we may need to become involved in lawsuits to defend or enforce our patents, either of which could result in substantial costs or loss of productivity, delay or prevent the development and commercialization of our current and any future product candidates, prohibit our use of proprietary technology or sale of potential products or put our patents and other proprietary rights at risk.
•Our ability to compete effectively in our markets may decline if we do not adequately protect our proprietary rights, and our proprietary rights do not necessarily address all potential threats to our competitive advantages.
•If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
•We may not be able to protect our intellectual property rights throughout the world.
Risks Related to the Market for Our Common Stock
•Our common stock may be volatile or may decline regardless of our operating performance.
•We may not be able to regain and maintain compliance with the continued listing requirements of The Nasdaq Stock Market.
•We may issue debt and equity securities, which are senior to our common stock as to distributions and in liquidation, which could materially adversely affect the market price of our common stock.
•We may fail to maintain effective internal control over financial reporting and effective disclosure controls and procedures. If we fail to remediate any material weaknesses, we may not be able to report our financial results accurately or to prevent fraud, which could materially adversely affect the market price of our common stock.
•Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
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NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Form 10-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on our management’s beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts are forward-looking statements. The forward-looking statements are contained principally in, but not limited to, the sections entitled “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.” These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
•the ability of our preclinical studies and clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;
•the timing, progress and results of preclinical studies and clinical trials for CTIM-76, CT-95, CT-202 and other product candidates we may develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs;
•the timing, scope and likelihood of U.S. and foreign regulatory filings and approvals, including timing of Investigational New Drug (“IND”) applications and final U.S. Food and Drug Administration (“FDA”) approval, as well as similar applications and approvals in foreign jurisdictions, of CTIM-76, CT-95, CT-202 and any other future product candidates;
•our ability to develop and advance CTIM-76, CT-95, CT-202 and any other future product candidates, and successfully complete clinical studies;
•our manufacturing, commercialization, and marketing capabilities, implementations thereof, and strategy;
•our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus, sales strategy, and our ability to grow a sales team;
•our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering CTIM-76, CT-95, CT-202, and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights;
•any disagreements or disputes with our licensees, licensors and other counterparties relating to the development and/or commercialization of our current or past product candidates, which may be time consuming, costly and could harm our efforts to develop our current or future product candidates;
•the impact of economic uncertainties on our business and operations, including clinical trials, manufacturing suppliers, collaborators, use of contract research organizations and employees;
•the need to hire additional personnel and our ability to attract and retain such personnel;
•the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;
•our competitive position and the success of competing therapies that are or may become available;
•the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates;
•our ability to obtain and maintain regulatory approval of our product candidates;
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•our plans relating to the further development of our product candidates, including additional indications we may pursue;
•existing regulations and regulatory developments in the United States, Europe and other jurisdictions;
•our continued reliance on third parties to conduct and support clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials;
•our ability to obtain, and negotiate favorable terms of, collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;
•the pricing and reimbursement of CTIM-76, CT-95, CT-202 and other product candidates we may develop, if approved;
•the rate and degree of market acceptance and clinical utility of CTIM-76, CT-95, CT-202 and other product candidates we may develop;
•our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
•our current plans to seek additional capital in the future through equity and/or debt financings, partnerships, collaborations, licensing agreements or other strategic arrangements, or other sources and the availability of such future sources of capital;
•our financial performance;
•the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements;
•the impact of laws and regulations;
•our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act;
•our anticipated use of our existing cash and cash equivalents; and
•other risks and uncertainties, including those listed under the caption “Risk Factors”.
In some cases, you can identify forward-looking statements by terms such as “may,” “could,” “will,” “should,” “would,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “project” or “continue” or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the heading “Risk Factors” and elsewhere in this Form 10-K. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance. As a result, you should not place undue reliance on forward-looking statements.
This Form 10-K also contains certain data and information which we obtained from various government and private publications or third parties. Although we believe that the publications, information, data and reports are reliable, we have not independently verified the data. Statistical data in these publications includes projections that are based on a number of assumptions. If any one or more of the assumptions underlying the market data is later found to be incorrect, actual results may differ from the projections based on these assumptions. Scientific and clinical data presented herein are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification.
The forward-looking statements made in this Form 10-K relate only to events or information as of the date of the Form 10-K (or any earlier date indicated in such statement). Although we are a public company and have
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ongoing disclosure obligations under United States federal securities laws, we do not intend to update or otherwise revise the forward-looking statements in this Form 10-K, whether as a result of new information, future events or otherwise.
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MARKET, INDUSTRY AND OTHER DATA
This Annual Report on Form 10-K contains estimates, projections, market research and other information concerning our industry, our business, markets for our product candidates, the size of those markets, and the prevalence of certain medical conditions. Unless otherwise expressly stated, we obtain this information from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources as well as from our own internal estimates and research and from publications, research, surveys and studies conducted by third parties on our behalf. Information that is based on estimates, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are reflected in this information. As a result, you are cautioned not to give undue weight to such information.
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PART I.
Item 1. Business
Overview
We are a clinical-stage biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies (“bsAb”) for solid tumors. We are building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 (“CLDN6”) x CD3 TCE, CT-95, a Mesothelin (“MSLN”) x CD3 TCE, and CT-202, a Nectin cell adhesion protein 4 (“Nectin-4”) x CD3 TCE.
Our pipeline is shown below:
CTIM-76 is a CLDN6 x CD3 TCE that is intended to redirect T-cell-mediated lysis toward malignant cells expressing CLDN6. CLDN6 is a tight junction membrane protein target expressed in multiple solid tumors and absent from or expressed at low levels in healthy adult tissues. IND-enabling studies on CTIM-76 have been completed. On May 2, 2024, we announced the U.S. Food and Drug Administration (the “FDA”) cleared our IND application to support the initiation of a Phase 1 dose escalation and expansion trial of CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers. We dosed the first patient in our CTIM-76 Phase 1 trial in January 2025. We expect to share initial data for the CTIM-76 Phase 1 trial in the first half of 2026.
CT-95 is an MSLN x CD3 TCE that is intended to redirect T-cell-mediated lysis toward malignant cells expressing MSLN. MSLN is a membrane protein overexpressed in approximately 30% of cancers. We anticipate dosing the first patient in the CT-95 Phase 1 trial in the second quarter of 2025. We expect to share initial data for the CT-95 Phase 1 trial in the middle of 2026.
CT-202 is a Nectin-4 x CD3 TCE that targets Nectin-4, a cell surface protein that is highly and frequently overexpressed in a variety of solid tumors, including bladder, colorectal, lung and breast. Nectin-4 is a clinically validated target for cancer therapy using a traditional antibody-drug conjugate (“ADC”), but it is also associated with certain adverse events, including neuropathy and rash. CT-202 is a pH-dependent TCE that is designed to be preferentially active within the tumor microenvironment. We expect to file an IND application for CT-202 in the middle of 2026.
Beyond these product candidates, we continue to evaluate opportunities to expand our pipeline. We believe our team and capabilities position us to be a leader in developing novel therapies targeting solid tumors. We retain full worldwide development and commercialization rights to certain CTIM-76 patents in the field of bispecific antibodies, full worldwide development and commercialization rights to CT-95 patents, and full worldwide development and commercialization rights to certain CT-202 patents.
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Our Strategy
Our goal is to deliver safe and effective selective cancer therapies for patient populations with significant unmet medical needs. Key elements of our strategy include:
•Rapidly advance our CTIM-76 and CT-95 clinical programs through Phase 1 proof of concept. We are currently evaluating CTIM-76 in a Phase 1 clinical trial and plan to provide preliminary data in the first half of 2026. Additionally, we anticipate dosing the first patient in the CT-95 Phase 1 trial in the second quarter of 2025 and plan to provide preliminary data in the middle of 2026.
•Rapidly advance our third program, CT-202, through preclinical development. We are currently advancing our CT-202 program through Good Manufacturing Practices (“GMP”) manufacturing and IND enablement.
•Seek opportunities to expand our pipeline of selective cancer drug candidates and targets. We intend to continue to seek opportunities to expand our TCE pipeline for solid tumors. If we identify targets that we deem to have high potential to address unmet medical needs, we may develop, in-license or acquire assets with therapeutic potential against those identified selective cancer targets.
•Evaluate strategic opportunities to potentially accelerate development timelines and enhance the commercial potential of our product candidates globally. We intend to leverage our TCE expertise to advance a novel pipeline. We plan to commercialize our product candidates in key markets, either alone or with strategic partners, and seek to maximize the worldwide commercial potential of our programs.
Our Product Pipeline and Development
CLDN6xCD3 TCE program: CTIM-76
Our clinical product candidate, CTIM-76, is a CLDN6 x CD3 TCE that is intended to redirect T-cell-mediated lysis toward malignant cells expressing CLDN6. CLDN6 is a tight junction membrane protein target that has high prevalence across many solid tumors and is absent from or expressed at low levels in healthy adult tissues.
We believe CTIM-76 has the potential to be a differentiated CLDN6 product candidate, due in part to: (i) its high selectivity for CLDN6 over Claudin 3 (“CLDN3”), Claudin 4 (“CLDN4”), and Claudin 9 (“CLDN9”); and (ii) its potential ability to target tumors with low, medium or high levels of CLDN6 expression, which could potentially result in a broader target population and greater commercial opportunity compared with other approaches.
Structure and Mechanism of Action
CLDN6 is an oncofetal protein that is normally present at higher levels during embryonic development. In normal, adult tissue, CLDN6 is turned off or has very low levels of expression due to epigenetic silencing. CLDN6 is thought to be reactivated by some cancers to adopt a more embryonic phenotype through the process of dedifferentiation.
The structural complexity of CLDN6 and its similarity to other Claudin proteins expressed on healthy tissue, particularly CLDN3, CLDN4, and CLDN9, make selectivity a key development challenge that must be addressed by CLDN6-targeting assets in development.
The figure below indicates that CTIM-76 is a highly selective and potent CLDN6 x CD3 TCE.
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Market Opportunity
There is a significant global opportunity for the treatment of patients with tumors expressing CLDN6. CLDN6 is overexpressed in several cancers with significant unmet needs, including ovarian, non-small cell lung, colon, endometrial, breast, sarcoma and testicular, with expression being highest in ovarian, endometrial, and testicular adenocarcinomas.
Estimated incidence information for annual new cancer cases in the United States and CLDN6 expression rates for certain cancers with significant unmet needs are shown below. We estimate that greater than 50,000 patients per year in the United States have CLDN6- positive relapse/refractory (“R/R”) disease.
Initial indications of interest are based on: (i) CLDN6 prevalence; (ii) patient population size; (iii) observed clinical responses; and (iv) potential for accelerated development.
| Selected Cancer indications | Incidence (US Only) | R/R Incidence | CLDN6 Positive | CLDN6 Med/High | Patient Population Based on R/R Incidence | ||||||||||||
| Endometrial | 65,900 | 14,000 | 51%1 | 22%1 | 7,140 | ||||||||||||
| Ovarian | 19,900 | 12,800 | 44%1 | 25%1 | 5,632 | ||||||||||||
| Testicular | 9,910 | 400 | 94%1 | 90%1 | 376 | ||||||||||||
| Non-Small Cell Lung | 201,229 | 110,653 | 26%1 | 6%1 | 28,769 | ||||||||||||
| Colon | 152,810 | 53,010 | 40%2 | 0%2 | 21,204 | ||||||||||||
| Breast | 290,600 | 43,800 | 40%2 | 0%2 | 9,417 | ||||||||||||
| Sarcoma | 17,100 | 12,390 | 20%2 | 10%2 | 2,478 | ||||||||||||
| Gastric | 26,380 | 11,090 | 9%1 | 7%1 | 998 | ||||||||||||
1 Context internal data; 2 Mackensen, Nature Medicine, 2023. Incidences based on public estimates; R/R or last-line patient population approximated by annual mortality; CLDN6 target prevalence is based on IHC or RNAseq from published reports. Patient population derived from midpoint of CLDN6 positive population multiplied by R/R incident population.
Clinical Validation of the Target and Potential for Broader Patient Population
Based on clinical data reported for other therapeutic agents targeting CLDN6, including BioNTech (BNT211), TORL (TORL-1-23), and Daiichi Sankyo (DS9606a), in various phases of clinical development, including ADC and
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CAR T-cell approaches, we believe this target has been clinically validated. Whereas both ADC and CAR T-cell anti-CLDN6 approaches have required a substantial portion of tumor cells with high expression of CLDN6 for anti-tumor activity, we believe a T cell engager approach could potentially target tumors with varying levels of CLDN6 expression, including tumors with low levels of expression. Therefore, CTIM-76 could potentially capture a broader patient population and greater commercial opportunity.
Clinical Development Plan
We have an active IND for CTIM-76 with the FDA, and in January 2025, we announced that the first patient had been dosed in the Phase 1 clinical trial of CTIM-76, which is a dose escalation and expansion trial in patients with solid tumors likely to express CLDN6. In the dose escalation part of our Phase 1 trial, we expect to enroll patients with advanced unresectable or metastatic ovarian, endometrial or testicular cancer in increasing dose levels. The primary objective in dose escalation will be to evaluate the safety and tolerability of CTIM-76. In the expansion part of our Phase 1 trial, we plan to evaluate two doses in a single cancer type based upon dose escalation data. The primary objective in expansion will be to evaluate preliminary anti-tumor activity of CTIM-76 and to select a dose for future trials. CLDN6 expression will be required for enrollment in our Phase 1 trial for patients with ovarian and endometrial cancer. Due to high CLDN6 expression, prospective screening for testicular cancer will not be required.
Mesothelin x CD3 TCE program: CT-95
Our clinical product candidate, CT-95, is an MSLN x CD3 TCE that is intended to redirect T-cell-mediated lysis toward malignant cells expressing MSLN. MSLN is a membrane protein overexpressed in approximately 30% of cancers. One challenge in developing MSLN-targeted therapies has been the presence of MSLN fragments, also referred to as shed or soluble MSLN (“sMSLN”), found in both blood and the tumor microenvironment that can serve as a decoy or sink for MSLN-targeting antibodies. CT-95 is a fully humanized bispecific T cell engager that has a moderate affinity but high avidity for membrane-bound MSLN, minimizing the impact of the sMSLN.
We believe CT-95 has the potential to be a differentiated MSLN product candidate, due in part to: (i) its ability to bind to the membrane-proximal side of MSLN, which has been shown to increase potency compared to a historic program from Harpoon Therapeutics (HPN536), potentially driving improved outcomes for patients; (ii) avidity enhancement to improve CT-95 residence in the tumor microenvironment and minimize the risk of cytokine release syndrome; and (iii) its potential ability to target tumors with low, medium or high levels of MSLN expression, which could potentially result in a broader target population and greater commercial opportunity compared with non-TCE approaches.
On July 9, 2024, we entered into an asset purchase agreement (the “Asset Purchase Agreement”) pursuant to which we acquired CT-95 (formerly known as LNK-101), from Link (assignment for the benefit of creditors), LLC (“Link”), which succeeded to the assets of Link Immunotherapeutics Inc. The FDA previously cleared the IND application for CT-95.
Pursuant to the Asset Purchase Agreement, we purchased the assets of Link associated with CT-95, including patent rights, know-how, regulatory filings, and inventory of drug substance and drug product (the “Transferred Assets”), on an “as is” and “where is” basis. CT-95 patents are currently being prosecuted and/or maintained in the United States, Europe, Canada, Australia, Japan and Taiwan. We also assumed certain liabilities relating to the Transferred Assets. In consideration of the Transferred Assets, we made a one-time payment to Link of $3.75 million.
Structure and Mechanism of Action
MSLN is bound to tumor cells via a glycosylphosphatidylinositol (“GPI”) linker. Like many GPI-anchored proteins, MSLN can be cut into smaller fragments. The MSLN gene encodes a precursor that is cleaved into two products: a soluble N-terminal protein called megakaryocyte potentiating factor (MPF), and a membrane-bound fragment called full length mesothelin (“FL-MSLN”). FL-MSLN can then be further cleaved into even smaller sMSLN fragments. sMSLN serves as a competitive sink, preventing antibodies from binding to the tumor, which can lead to suboptimal drug exposure and efficacy.
CT-95 was designed to overcome the sMSLN sink through binding to membrane-proximal MSLN epitope and avidity enhancement. CT-95 exhibits moderate affinity for membrane-proximal MSLN but cooperative binding
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through bivalent binding of CT-95 to two MSLN epitopes results in high avidity binding of CT-95 to the tumor. This results in a potentially wide therapeutic window due to: (i) limited crosslinking by sMSLN, mitigating off-tumor T cell activation; and (ii) cooperative binding of MSLN on tumor surface to crosslink CD3, thereby activating T cells.
The figure below indicates that HPN-536 (Harpoon Therapeutics) binds to MSLN fragments in a dose proportional manner, limiting therapeutic exposure, whereas CT-95 does not lose potency in the same OVCAR-3 cell line model.
Market Opportunity
There is a significant global opportunity for the treatment of patients with tumors expressing MSLN. MSLN is overexpressed in several cancers with significant unmet needs, high grade serous ovarian, non-small cell lung, colon, esophageal, pancreatic carcinoma, endometrial, gastric, and mesothelioma, with expression being highest in high-grade serous ovarian cancer, pancreatic carcinoma, and mesothelioma.
Estimated incidence information for annual new cancer cases in the United States and MSLN expression rates for certain cancers with significant unmet needs are shown below. We estimate that greater than 100,000 patients per year in the United States have mesothelin-positive R/R disease.
Initial indications of interest are based on: (i) MSLN prevalence; (ii) patient population size; (iii) observed clinical responses; and (iv) potential for accelerated development.
| Selected Cancer indications | Incidence (US Only) | R/R Incidence | MSLN Positive | MSLN Med/High | Patient Population Based on R/R Incidence | ||||||||||||
| Non-Small Cell Lung | 201,229 | 110,653 | 55% | 36% | 60,859 | ||||||||||||
| Pancreatic | 66,440 | 51,750 | 80% | 61% | 41,400 | ||||||||||||
| Ovarian | 19,900 | 12,800 | 90% | 80% | 11,520 | ||||||||||||
| Mesothelioma | 3,000 | 2,500 | 70% | 60% | 1,750 | ||||||||||||
| Colon | 152,810 | 53,010 | 41% | 17% | 21,734 | ||||||||||||
| Esophageal | 22,370 | 16,130 | 41% | 26% | 6,613 | ||||||||||||
| Endometrial | 65,900 | 14,000 | 45% | 23% | 6,300 | ||||||||||||
| Gastric | 26,380 | 11,090 | 49% | 23% | 5,434 | ||||||||||||
| Breast (TNBC) | 62,054 | 15,500 | 30% | 18% | 4,650 | ||||||||||||
| Cervical | 13,820 | 4,360 | 42% | 21% | 1,831 | ||||||||||||
Incidences based on public estimates; R/R or last-line patient population approximated by annual mortality; MSLN target prevalence is based on Simon et al, Biomedicines, 2021. Patient population derived from MSLN positive population multiplied by R/R incident population.
Clinical Validation of the Target and Potential for Broader Patient Population
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Based on clinical data reported for other therapeutic agents targeting MSLN, including RemeGen Biosciences (RC88) and TCR2 Therapeutics (gavocabtagene autoleucel), in various phases of clinical development, including ADC and CAR T-cell approaches, we believe this target has been clinically validated. Whereas both ADC and CAR T-cell anti-MSLN approaches have required a substantial portion of tumor cells with high expression of MSLN for anti-tumor activity, we believe a T cell engager approach could potentially target tumors with varying levels of MSLN expression, including tumors with low levels of expression. Therefore, MSLN could potentially capture a broader patient population and greater commercial opportunity.
Clinical Development Plan
We have an active IND for CT-95 with the FDA. We anticipate dosing the first patient in the CT-95 Phase 1 trial in the second quarter of 2025, which is a dose escalation trial in patients with solid tumors likely to express MSLN. We expect to enroll patients with advanced unresectable or metastatic high grade serous ovarian cancer, pancreatic carcinoma, and mesothelioma. The primary objective in dose escalation will be to evaluate the safety and tolerability of CT-95. Expression of MSLN will not be required for enrollment in our Phase 1 trial; tumor tissue samples will be collected for retrospective biomarker assessment of MSLN expression by immunohistochemistry (“IHC”).
Nectin-4 x CD3 TCE program: CT-202
Our preclinical product candidate, CT-202, targets Nectin-4, which is highly and frequently overexpressed in a variety of cancers. Nectin-4 is a clinically-validated target for cancer therapy using a traditional antibody-drug conjugate, but it is also associated with certain adverse events, including neuropathy and rash. CT-202 is a pH-dependent TCE that is designed to be preferentially active within the acidic tumor microenvironment.
On September 23, 2024, we entered into a license agreement (the “BioAtla License Agreement”) with BioAtla, Inc. ("BioAtla"), pursuant to which we obtained an exclusive, worldwide license to develop, manufacture and commercialize two licensed antibodies (the “BioAtla Assets”), including BA3362 (renamed by the Company as CT-202), BioAtla’s Nectin-4 x CD3 TCE.
As partial consideration for the exclusive license under the BioAtla License Agreement, we made an upfront payment of $11.0 million, and BioAtla is eligible to receive up to $122.5 million in additional milestone payments based upon the achievement of specified pre-clinical, clinical, development and commercial milestones, as well as tiered mid-single digit to low double-digit royalties on future net sales for products containing the BioAtla Assets, subject to standard reductions.
We believe CT-202 has the potential to be a differentiated Nectin-4 product candidate, due in part to: (i) its ability to preferentially bind to Nectin-4 and CD3 in the low pH environment of tumor relative to pH neutral normal tissue, which has the potential to reduce the risk of dermatologic side effects associated with Nectin-4 expression in the skin; (ii) avidity enhancement to improve CT-202 residence in the tumor microenvironment and minimize the risk of cytokine release syndrome; and (iii) its potential ability to target tumors with low, medium or high levels of Nectin-4 expression, which could potentially result in a broader target population and greater commercial opportunity compared with non-TCE approaches.
Structure and Mechanism of Action
CT-202 incorporates logic gating through pH dependence and avidity enhancement which is intended to spare Nectin-4 in normal tissue. Because of its expression in healthy epidermal keratinocytes, sweat glands, and hair follicles, Nectin-4 targeted treatments are often associated with dermatological side effects. CT-202 incorporates pH dependent binding to both Nectin-4 and CD3 to minimize binding to healthy tissues and maximize binding and T cell activation within the tumor microenvironment.
CT-202 is avidity optimized to mitigate cytokine release syndrome risk. Cooperative Nectin-4 binding through bivalent binding to the tumor cell surface is intended to reduce T cell crosslinking in the absence of target. Steric hindrance of CD3 binding by Fc domain prevents T cell crosslinking by single CT-202 molecules.
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The figure below indicates our two-pronged approach for CT-202 to overcome Nectin-4 expression in the skin and to generate robust antitumor responses while minimizing the risk of cytokine release syndrome.
Market Opportunity
There is a significant global opportunity for the treatment of patients with tumors expressing Nectin-4. Nectin-4 is overexpressed in several cancers with significant unmet needs, including bladder (urothelial), non-small cell lung, pancreatic, head and neck, esophageal, colorectal, gastric, and triple negative breast cancer (“TNBC”), with expression being highest in bladder, colorectal, and TNBC.
Estimated incidence information for annual new cancer cases in the United States and Nectin-4 expression rates for certain cancers with significant unmet needs are shown below. We estimate that greater than 125,000 patients per year in the United States have Nectin-4- positive R/R disease. Initial indications of interest are based on: (i) Nectin-4 prevalence; (ii) patient population size; and (iii) observed clinical responses.
| Selected Cancer indications | Incidence (US Only) | R/R Incidence | Nectin-4 Positive | Nectin-4 Med/High | Patient Population Based on R/R Incidence | ||||||||||||
| Non-Small Cell Lung | 201,229 | 110,653 | 64%1 | 30%1 | 70,818 | ||||||||||||
| Colon | 152,810 | 53,010 | 87%1 | 78%1 | 46,119 | ||||||||||||
| Pancreatic | 66,440 | 51,750 | 71%1 | 37%1 | 36,743 | ||||||||||||
| Bladder (urothelial) | 83,190 | 20,000 | 83%1 | 60%1 | 16,600 | ||||||||||||
| Breast (TNBC) | 62,054 | 15,500 | 69%1 | 53%1 | 10,695 | ||||||||||||
| Head and Neck | 54,000 | 12,000 | 59%1 | 18%1 | 7,080 | ||||||||||||
| Esophageal | 22,370 | 16,130 | 55%1 | 24%2 | 8,872 | ||||||||||||
| Gastric | 26,890 | 12,000 | 71%3 | 60%3 | 8,520 | ||||||||||||
| Ovarian | 19,900 | 12,800 | 57%4 | 2%4 | 7,296 | ||||||||||||
Incidences based on public estimates; R/R or last-line patient population approximated by annual mortality; Patient population derived from Nectin-4 positive population multiplied by R/R incident population. 1 Challita, Can Res, 2016; 2 Zhang, Oncol Lett, 2018; 3 Derycke, Am J Clin Pathol, 2010; 4 Kobecki, Int J Mol Sci, 2023
Clinical Validation of the Target and Potential for Broader Patient Population
Based on clinical data reported for other therapeutic agents targeting Nectin-4, including Pfizer (Padcev®) and Bicycle (BT8009), including ADC approaches, we believe this target has been clinically validated. Padcev is
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currently approved for locally advanced or metastatic urothelial carcinoma, which is associated with high levels of Nectin-4 expression. Whereas ADC Nectin-4 approaches require a substantial portion of tumor cells with high expression of Nectin-4 for anti-tumor activity, we believe a TCE approach could potentially target tumors with varying levels of MSLN expression, including tumors with low levels of expression. Therefore, MSLN could potentially capture a broader patient population and greater commercial opportunity.
PR antagonist program: ONA-XR
Prior to the portfolio prioritization and capital allocation strategy announced on March 22, 2023, we were primarily focused on developing treatments for female cancers. Based upon the challenging market conditions for emerging companies, the increasingly competitive landscape for breast cancer treatments, recent study findings, and other factors, we decided to cease development and explore strategic options for ONA-XR. We wound down our ONA-XR clinical trials and development by the end of 2023.
Our collaboration and license agreements
Collaboration Agreement with Tyligand Bioscience
In March 2020, we entered into a process development agreement (the “Tyligand Process Development Agreement”) with Tyligand Bioscience (Shanghai) Limited (“Tyligand”) for the development, manufacturing, registration and future commercialization of ONA-XR. Upon completion of specific performance-based milestones under the Tyligand Process Development Agreement, in August 2021, we and Tyligand entered into a license agreement (the “Tyligand License Agreement”) whereby Tyligand was granted the exclusive right to ONA-XR and was solely responsible for the development and commercialization of ONA-XR in China, Hong Kong and Macau. We retained rights in the rest of the world to commercialize ONA-XR. In August 2024, we and Tyligand mutually agreed to terminate the Tyligand License Agreement, and any ongoing payment obligations we may have had to Tyligand under the Tyligand Process Development Agreement.
Collaboration and Licensing Agreement with Integral Molecular
In April 2021, we entered into a collaboration and licensing agreement with Integral Molecular, Inc. (“Integral”) (the “Integral License Agreement”) for the development of a CLDN6 bsAb for cancer therapy. Under the terms of the Integral License Agreement, we and Integral developed a CLDN6 bsAb that is intended to trigger the activation of T cells and eliminates cancer cells displaying CLDN6. We will conduct preclinical and all clinical development, as well as regulatory and commercial activities through exclusive worldwide rights to develop and commercialize the novel CLDN6 candidates. As a part of the Integral License Agreement, Integral was eligible to receive remaining development and regulatory milestone payments totaling approximately $55 million, sales milestone payments totaling up to $130 million, and tiered royalties of up to 12% of net sales of certain products developed under the Integral License Agreement.
On March 20, 2023, we amended the Integral License Agreement (the “First Amendment”) to remove the previously agreed to second milestone payment and to change the amount of the third milestone payment to increase such payment by the amount of the prior second milestone payment and to add payment for third-party research funding obtained and used by Integral in connection with the development of CTIM-76.
On February 29, 2024, we further amended the Integral License Agreement to reflect updated financial terms. In the course of our further due diligence review of CTIM-76, we determined that certain of the licensed rights under the Integral License Agreement may incorporate intellectual property rights currently held by a third party. Specifically, we are aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034 that potentially cover certain of the intellectual property included in CTIM-76. While we believe we will have reasonable defenses against any potential claim of infringement, we may not be successful in such efforts, and we also may not be able to obtain a license to such patent on commercially reasonable terms, or at all.
As part of Amendment 2 to the Integral License Agreement (the "Second Amendment"), Integral’s right to receive certain future payments was reduced as follows: aggregate development and regulatory milestone payments were reduced from $55 million to $15 million, aggregate sales milestone payments were reduced from $130 million to $12.5 million, and a tiered royalty of 8-12% that commenced at first commercial sale was reduced to a flat royalty rate of 6% on net sales beginning no sooner than February 1, 2034. The Second Amendment also narrowed the
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license grant from Integral to us to only cover CTIM-76, removed any further obligation of us to reimburse Integral for any independently obtained research funding Integral applied against CTIM-76 research, and included mutual releases by the parties.
The reduced development and regulatory milestones now reflect a payment due at each of: first patient’s first screening visit in a Phase 1b/2 or Phase 2 clinical trial for CTIM-76, first patient’s first screening visit in a Phase 3 clinical trial for CTIM-76, United States marketing approval for CTIM-76, European Union marketing approval for CTIM-76, United Kingdom marketing approval for CTIM-76, and Japan marketing approval for CTIM-76. The amended commercial milestones now also reflect a payment due upon the achievement of annual net sales of $500 million and annual net sales of $1 billion.
Asset Purchase Agreement with Link
On July 9, 2024, we entered into the Asset Purchase Agreement pursuant to which we acquired CT-95 (formerly known as LNK-101), from Link, which succeeded to the assets of Link Immunotherapeutics Inc. The FDA previously cleared the IND application for CT-95.
Pursuant to the Asset Purchase Agreement, we purchased all of the Transferred Assets on an “as is” and “where is” basis. CT-95 patents are currently being prosecuted and/or maintained in the United States, Europe, Canada, Australia, Japan and Taiwan. We also assumed certain liabilities relating to the Transferred Assets. In consideration of the purchase of the Transferred Assets, we made a one-time payment to Link of $3.75 million.
Collaboration and Licensing Agreement with BioAtla
On September 23, 2024, we entered into the BioAtla License Agreement with BioAtla, pursuant to which we obtained an exclusive, worldwide license to develop, manufacture and commercialize the BioAtla Assets, including BA3362 (renamed by the Company as CT-202), BioAtla’s Nectin-4 x CD3 TCE.
As partial consideration for the exclusive license under the BioAtla License Agreement, we made an upfront payment of $11.0 million, and BioAtla is eligible to receive up to $122.5 million in additional milestone payments based upon the achievement of specified pre-clinical, clinical, development and commercial milestones, as well as tiered mid-single digit to low double-digit royalties on future net sales for products containing the BioAtla Assets, subject to standard reductions.
Menarini Clinical Trial Collaboration and Supply Agreement
On August 1, 2022, we entered into a Clinical Trial Collaboration and Supply Agreement (the “Menarini Agreement”) with Berlin-Chemie AG - Menarini Group - (“Menarini”) related to ONA-XR. On March 21, 2023, we mutually terminated the Menarini Agreement, and the parties agreed to reasonably cooperate towards an orderly wind-down of the related clinical trial.
Commercialization
We retain full worldwide development and commercialization rights to certain CLDN6 patents in the field of bispecific antibodies, full worldwide development and commercialization rights to CT-95 patents, and full worldwide development and commercialization rights to certain CT-202 patents. We periodically evaluate out-license opportunities for our product candidates and seek to identify drug candidates for novel indications and/or patient subpopulations with an oncology focus that we might in-license. Our commercial plans and strategy for any of our programs may change as programs advance, markets change, and we receive more clinical data, and will depend on availability of current and future capital.
Sales and marketing
We currently have no sales, marketing, or commercial product distribution capabilities, and we may explore partnerships with larger pharmaceutical organizations that already have these capabilities. We intend to build the necessary infrastructure and capabilities over time for the United States, and potentially other regions, following further advancement of a product candidate.
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Manufacturing
We do not own or operate, and currently have no plans to establish, any manufacturing facilities. We rely, and expect to continue to rely, on third parties for the manufacture of our current and any future product candidates for preclinical and clinical testing, as well as for commercial manufacture if any product candidate obtains marketing approval. We also rely, and expect to continue to rely, on third parties to package, label, store and distribute our current and any future investigational product candidates, as well as for our commercial products if marketing approval is obtained. We believe that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment and personnel while also enabling us to focus our expertise and resources on the development of our current and any future product candidates.
To date, we have obtained active pharmaceutical ingredients (“API”) and drug product for our product candidates from several third-party contract manufacturers, including Lonza Sales AG (“Lonza Sales”) and Lonza AG (collectively, “Lonza”) and Just-Evotec Biologics, Inc. We continue to develop our supply chain for CTIM-76, CT-95 and CT-202, and intend to put in place additional framework agreements under which third-party contract manufacturers will generally provide us with necessary quantities of API and drug product on a project-by-project basis based on our development needs.
On November 7, 2022, we entered into a License Agreement (the “Lonza CTIM-76 License Agreement”) with Lonza Sales. Under the terms of the Lonza CTIM-76 License Agreement, to the extent incorporated into CTIM-76, Lonza granted us a non-exclusive license to use certain proprietary Lonza intellectual property and systems for us to develop, manufacture and commercially exploit CTIM-76.
We shall pay certain royalties and annual payments in respect of the manufacturing and sale of CTIM-76, which amounts shall be determined by the party manufacturing CTIM-76 and ranges from a potential annual payment of up to less than $500,000 and a royalty on net sales from 0% up to a low single digit percentage. The royalty payments and annual payments would be reduced in certain circumstances, including should the valid claims for any such patent rights not exist in the country in which CTIM-76 is being sold, and the royalty payments would expire upon the later of the expiration of the licensed patents in the country in which CTIM-76 is being sold, the expiration of the licensed patents in the country in which CTIM-76 is being manufactured, and 10 years from the first commercial sales of CTIM-76 in such country of sale.
The Lonza CTIM-76 License Agreement continues until terminated, and we or Lonza may terminate the Lonza CTIM-76 License Agreement for uncured material breaches or insolvency of the other party. We can unilaterally terminate the Lonza CTIM-76 License Agreement with prior written notice to Lonza, and Lonza can also unilaterally terminate the Lonza CTIM-76 License Agreement upon certain actions by us.
The Lonza CTIM-76 License Agreement also contains customary representations, warranties, indemnification and other obligations of us and Lonza.
As we advance our current and any future product candidates through development, we will consider our lack of redundant supply for the API and drug product for each product candidate to protect against any potential supply disruptions.
We generally expect to rely on third parties for the manufacture of any companion diagnostics we may develop.
Competition
The pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary products. While we believe that our technology, the experience of our executive and scientific team, research, clinical capabilities, development experience and scientific knowledge provide us with competitive advantages, we face increasing competition from many different sources, including pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private research institutions. Product candidates that we successfully develop and commercialize may compete with existing therapies and new therapies that may become available in the future.
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Many of our competitors, either alone or with their collaborators, have significantly greater financial resources, established presence in the market, expertise in research and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and reimbursement and marketing approved products than we do. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. Additional mergers and acquisitions may result in even more resources being concentrated in our competitors.
Our commercial potential could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market or make our development more complicated. The key competitive factors affecting the success of all of our programs are likely to be efficacy, safety and convenience.
For CTIM-76, our CLDN6 x CD3 TCE, we are aware of several companies developing T cell engagers against CLDN6. Several TCE candidates are currently in clinical development, including those of Chugai Pharmaceutical (SAIL66), Beigene (BGB-B455), NovaRock Biotherapeutics (NBL028), Third Arc Bio (ARC101), and Xencor (XmAb541). We may face further competition from companies pursuing the development of product candidates that target CLDN6 through other modalities, including Daiichi Sankyo (DS9606), BioNTech (BNT211, BNT142), and TORL (TORL-1-23).
For CT-95, our MSLN x CD3 TCE, we are aware of several companies developing T cell engagers against MSLN. Several TCE candidates are currently in clinical development, including those of Johnson & Johnson (JNJ-7903421), Zymeworks (ZW171), and Amgen (AMG-305). We may face further competition from companies pursuing the development of product candidates that target MSLN through other modalities, including Pfizer (HBM-9033), RemeGen Biosciences (RC88), Outpace Bio (OPB-101), and Navrogen (NAV001, NAV008).
For CT-202, our Nectin-4 x CD3 TCE, we are aware of several companies developing T cell engagers against Nectin-4. Several TCE candidates are currently in clinical development, including those of Bicycle Therapeutics (BT7480). We may face further competition from companies pursuing the development of product candidates that target Nectin-4 through other modalities, including Pifzer (Padcev®), Bicycle Therapeutics (BT8009), Eli Lilly (LY4052031, LY4101174), Corbus Pharmaceuticals (CRB-701), Bio-Thera (BAT8007), Mabwell (PMW2821), Adcentrx (ADRX-0706), Rondo Therapeutics (RNDO-564), Aktis Oncology (AKY-1189), and Shanghai Henlius Biotech (HLX-309).
Intellectual property
We strive to protect and enhance the proprietary technology, inventions and improvements that are commercially important to our business, including seeking, maintaining and defending our patent rights. We retain full worldwide development and commercialization rights to certain CLDN6 antibody patents in the field of bispecific antibodies, full worldwide development and commercialization rights to CT-95 patents, and full worldwide development and commercialization rights to certain CT-202 patents. Our policy is to seek to protect our proprietary position by, among other methods, filing patent applications in the United States and in jurisdictions outside of the United States directed to our proprietary technology, inventions, improvements and product candidates that are important to the development and implementation of our business. We also rely on trade secrets and know-how relating to our proprietary technology to protect our product candidates and continuing to innovate to develop, strengthen and maintain our proprietary position in the field of oncology. We also plan to rely on data exclusivity, market exclusivity and patent term extensions when available. Our commercial success will depend in part on our ability to obtain and maintain patent and other proprietary protection for our product candidates, technology, inventions and improvements; to preserve the confidentiality of our trade secrets; to defend and enforce our proprietary rights, including any patents that we may own or license in the future; and to operate without infringing on the valid and enforceable patents and other proprietary rights of third parties.
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As of March 1, 2025, the Integral Molecular, Inc. patent portfolio covering CTIM-76 and methods of use that we exclusively licensed pursuant to the Integral License Agreement includes two granted U.S. patents, three pending U.S. non-provisional applications, one pending International Patent Cooperation Treaty (“PCT”) application, granted patents in China, Eurasia, Japan, Saudi Arabia, Vietnam, and South Africa, and pending foreign applications in United Arab Emirates, Australia, Brazil, Canada, Chile, Europe, Hong Kong, Indonesia, Israel, India, South Korea, Mexico, New Zealand, Philippines, Singapore, Thailand, Taiwan and Ukraine. The U.S. patents are expected to expire in 2040 and 2043, subject to any extensions or disclaimers. We own two pending U.S. provisional applications covering CTIM-76 and methods of using it, which, if converted and issued, will expire in 2045, subject to any extensions or disclaimers.
As of March 1, 2025, we own the patent portfolio covering CT-95 and methods of use, which includes one U.S. patent, one pending U.S. non-provisional application, a pending U.S. provisional application, and pending foreign applications in Australia, Canada, Europe, Japan, and Taiwan. The U.S. patent is expected to expire in 2042, subject to any extensions or disclaimers.
As of March 1, 2025, the BioAtla patent portfolio covering CT-202 and methods of use that we exclusively licensed pursuant to the BioAtla License Agreement includes two pending U.S. non-provisional applications, a granted patent in Japan, and pending foreign applications in Australia, Canada, China, Europe, Hong Kong, Israel, India, Japan, South Korea, Macau, Mexico, Singapore, Thailand, and Taiwan. The issued patent and any patents that grant from the pending applications are expected to expire from 2039 to 2041, subject to any extensions or disclaimers.
We also possess substantial know-how and trade secrets relating to the development and commercialization of our product candidates, including related manufacturing processes and technology.
With respect to our current and any future product candidates and processes, we intend to develop and commercialize in the normal course of business, and we intend to pursue patent protection covering, when possible, compositions, methods of use, dosing and formulations. We may also pursue patent protection with respect to manufacturing and drug development processes and technologies.
Issued patents can provide protection for varying periods of time, depending upon the date of filing of the patent application, the date of patent issuance and the legal term of patents in the countries in which they are obtained. In general, patents issued for applications filed in the United States can provide exclusionary rights for 20 years from the earliest effective filing date. In addition, in certain instances, the term of an issued U.S. patent that covers or claims an FDA approved product can be extended to recapture a portion of the term effectively lost as a result of the FDA regulatory review period, which is called patent term extension. The restoration period cannot be longer than five years and the total patent term, including the restoration period, must not exceed 14 years following FDA approval. The term of patents outside of the United States varies in accordance with the laws of the foreign jurisdiction, but typically is also 20 years from the earliest effective filing date. However, the actual protection afforded by a patent varies on a product-by-product basis, from country-to-country and depends upon many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related extensions, the availability of legal remedies in a particular country and the validity and enforceability of the patent.
The patent positions of companies like ours are generally uncertain and involve complex legal and factual questions. No consistent policy regarding the scope of claims allowable in patents in the field of oncology has emerged in the United States. The relevant patent laws and their interpretation outside of the United States is also uncertain. Changes in either the patent laws or their interpretation in the United States and other countries may diminish our ability to protect our technology or product candidates and could affect the value of such intellectual property. In particular, our ability to stop third parties from making, using, selling, offering to sell or importing products that infringe our intellectual property will depend in part on our success in obtaining and enforcing patent claims that cover our product candidates, technology, inventions and improvements. We cannot guarantee that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications we may file in the future, nor can we be sure that any patents that may be granted to us in the future will be commercially useful in protecting our products, the methods of use or manufacture of those products. Moreover, even our issued patents may not guarantee us the right to commercialize our product candidates, if approved. Patent and other intellectual property rights in the pharmaceutical and biotechnology space are evolving and involve many risks and uncertainties. Third parties may have blocking patents that could be used to prevent us from
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commercializing our product candidates and practicing our proprietary product candidates, and our issued patents may be challenged, invalidated or circumvented, which could limit our ability to stop competitors from marketing related products or could limit the term of patent protection that otherwise may exist for our product candidates. Moreover, such third parties may obtain damages against us, which could require us to make commercially reasonable royalty payments, payments for lost profits, or other damages, costs and expenses. In addition, the scope of the rights granted under any issued patents may not provide us with protection or competitive advantages against competitors with similar products. Furthermore, our competitors may independently develop similar products that are outside the scope of the rights granted under any issued patents. For these reasons, we may face competition with respect to our product candidates. Moreover, because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that, before any particular product candidate can be commercialized, any patent protection for such product may expire or remain in force for only a short period following commercialization, thereby reducing the commercial advantage the patent provides.
Government Regulation
Regulatory Pathway
We expect that CTIM-76, CT-95 and CT-202 will each be classified and regulated by the FDA as a biologic. We expect that any small molecule product that we may develop will be classified and regulated by the FDA as a drug. A new drug application (“NDA”) is required to introduce a drug into interstate commerce. A biologics license application (“BLA”) is required to introduce a biologic product into interstate commerce. The specific requirements of NDAs and BLAs include applicant information, product information, manufacturing information, pre-clinical data, clinical data, and labelling. The most important, time-consuming, and expensive aspect of preparing for a BLA or NDA is conducting clinical trials to demonstrate safety and effectiveness. The requirements of such clinical trials heavily influence the eventual allowable product label claims. The FDA has a performance goal as defined in the Prescription Drug User Fee Act of 10 months for a standard submission and six months for priority review. It is not uncommon for NDAs and BLAs to require medical advisory board review prior to the FDA granting marketing approval. A facility inspection verifying the manufacturing systems is also usually performed prior to FDA approval.
We have in the past used and intend to continue to utilize the services of third-party experts to supplement internal regulatory planning and implementation.
Ongoing FDA Regulation
After the FDA permits a product to enter commercial distribution, numerous and pervasive regulatory requirements continue to apply to our business operations, products and technologies. These include:
•the FDA’s quality system regulation (“QSR”), which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures during all aspects of the manufacturing process;
•labeling and marketing regulations which require that promotion is truthful, not misleading, fairly balanced and provide adequate directions for use and that all claims are substantiated;
•advertising and promotion requirements, including FDA prohibitions against the promotion of products for uncleared, unapproved or off-label uses and FDA guidance on off-label dissemination of information and responding to unsolicited requests for information;
•restrictions on sale, distribution or use;
•product establishment, registration and listing requirements and reporting requirements;
•recall requirements, including a mandatory recall if there is a reasonable probability that a product would cause serious adverse health consequences or death;
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•an order of repair, replacement or refund; and
•post-market surveillance activities and regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data.
The FDA has broad post-market and regulatory enforcement powers. Manufacturers of biologic products and drug products are subject to unannounced inspections by the FDA and other state, local and foreign regulatory authorities to assess compliance with the QSR and other applicable regulations, and these inspections may include the manufacturing facilities of any suppliers.
Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions:
•warning letters, untitled letters, Form 483s, fines, injunctions, consent decrees and civil penalties;
•recall or seizure of products;
•operating restrictions, partial suspension or total shutdown of production;
•the FDA’s refusal of requests for approval of new products or indications for existing products;
•the FDA’s refusal to issue certificates to foreign governments needed to export products for sale in other countries;
•withdrawing approvals that have already been granted; and
•criminal prosecution.
Privacy and Security Laws
There are numerous U.S. federal and state laws and regulations related to the privacy and security of personal information, including health information. Among others, the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH), and their implementing regulations, (collectively referred to as “HIPAA”), establish privacy and security standards that limit the use and disclosure of protected health information (“PHI”) and require covered entities and business associates to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity and availability of individually identifiable health information in electronic form, among other requirements.
Violations of HIPAA may result in civil and criminal penalties. Companies subject to HIPAA must also comply with HIPAA’s breach notification rule which requires notification of affected patients and the U.S. Department of Health and Human Services (“HHS”), and in certain cases of media outlets, in the case of a breach of unsecured PHI. The regulations also require business associates of covered entities to notify the covered entity of breaches by the business associate. State attorneys general also have the right to prosecute HIPAA violations committed against residents of their states, and HIPAA standards have been used as the basis for the duty of care in state civil suits, such as those for negligence or recklessness in misusing personal information. In addition, HIPAA mandates that HHS conduct periodic compliance audits of HIPAA covered entities and their business associates for compliance.
Many states have laws that protect the privacy and security of sensitive and personal information, including health information, to which we are subject. These laws may be similar to or even more protective than HIPAA and other federal privacy laws. For example, California enacted the California Consumer Privacy Act (the “CCPA”), which creates individual privacy rights for California consumers and increases the privacy and security obligations of entities handling certain personal data. The CCPA went into effect on January 1, 2020, and the California Attorney General may bring enforcement actions for violations as of July 1, 2020. On January 1, 2023, California adopted the California Privacy Rights Act (“CPRA”), which amended the CCPA to enhance certain of the privacy protections for California consumers that were created by the CCPA. The enhancements include imposing additional compliance obligations for covered entities and removing certain exemptions previously available under the CCPA. While the California Attorney General retains civil enforcement authority, the CPRA also created the California
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Privacy Protection Agency to implement and enforce the law. Since the CCPA, many other states have passed or are considering passing similar state privacy laws.
We may be subject to other state and federal privacy laws, including laws that prohibit unfair privacy and security practices and deceptive statements about privacy and security, laws that place specific requirements on certain types of activities, such as data security and texting, and laws requiring holders of personal information to maintain safeguards and to take certain actions in response to a data breach.
European Union member states, the United Kingdom, Switzerland and other jurisdictions have also adopted data protection laws and regulations, which impose significant compliance obligations. The EU-wide General Data Protection Regulation (“GDPR”) became applicable on May 25, 2018, replacing the previous data protection laws issued by each EU Member State based on the Directive 95/46/EC. Unlike the Directive (which needed to be transposed at national level), the GDPR text is directly applicable in each EU member state, resulting in a more uniform application of data privacy laws across the EU. The GDPR imposes onerous accountability obligations, requiring data controllers and processors to maintain a record of their data processing and policies. It requires data controllers to be transparent and disclose to data subjects (in a concise, intelligible and easily accessible form) how their personal information is to be used, imposes limitations on retention of information, increases requirements pertaining to pseudonymized (i.e., key-coded) data, introduces mandatory data breach notification requirements and sets higher standards for data controllers to demonstrate that they have obtained valid consent for certain data processing activities. Fines for non-compliance with the GDPR are significant—the greater of EUR 20 million or 4% of global turnover. The GDPR provides that EU Member States may introduce further conditions, including limitations, to the processing of genetic, biometric or health data. In the UK, the UK General Data Protection Regulation (the “UK GDPR”) came into effect on January 1, 2021. Similar to the GDPR, the UK GDPR sets out the key principles, rights, and obligations for most processing of personal data in the UK. The Data Protection Act of 2018, which came into effect on May 25, 2018 and was amended on January 1, 2021, works alongside and supplements the UK GDPR.
U.S. Healthcare Reform
Changes in healthcare policy could increase our costs and subject us to additional regulatory requirements that may interrupt commercialization of our products. By way of example, the Patient Protection and Affordable Care Act (“PPACA”) substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacted the pharmaceutical, medical device and biologics industries, among others.
Since its enactment, there have been judicial and Congressional challenges to certain aspects of PPACA, and there may be additional amendments to PPACA in the future. For example, in 2017, Congress enacted the Tax Cuts and Jobs Act, which eliminated the tax-based shared responsibility payment imposed by PPACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.”
On August 16, 2022, the Inflation Reduction Act of 2022 (the “IRA”), was passed, which among other things, allows for the Centers for Medicare & Medicaid Services (“CMS”) to negotiate prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D, beginning with 10 high-cost drugs paid for by Medicare Part D starting in 2026, followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029 and beyond. The legislation subjects drug manufacturers to civil monetary penalties and a potential excise tax for failing to comply with the legislation by offering a price that is not equal to or less than the negotiated “maximum fair price” under the law or for taking price increases that exceed inflation. The legislation also caps Medicare beneficiaries’ annual out-of-pocket drug expenses at $2,000. The effect of the IRA on our business is not yet known.
There will continue to be proposals by legislators at both the federal and state levels, regulators and third-party payors to reduce costs while expanding individual healthcare benefits. Certain of these changes could impose additional limitations on the prices we will be able to charge and/or patients’ willingness to pay for our products. While in general it is too early to predict what effect, if any, any future healthcare reform legislation or policies will
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have on our business, current and future healthcare reform legislation and policies could have a material adverse effect on our business and prospects.
Pricing and Reimbursement
In the United States and markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend in part on the availability of reimbursement from third-party payors. Third-party payors include government health administrative authorities, managed care providers, private health insurers, and other organizations. These third-party payors are increasingly challenging the price and examining the cost-effectiveness of medical products and services. In addition, significant uncertainty exists as to the reimbursement status of newly approved healthcare products, and efforts are underway to reduce the cost of medical products and services overall. We may need to conduct expensive studies in order to demonstrate the cost-effectiveness of our products. Our current and any future product candidates may not be considered cost-effective. Decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. One third-party payor’s decision to cover a particular product or procedure using the product does not ensure that other payors will also provide coverage for the product. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate revenue level. Future legislation could limit payments for our current and any future product candidates.
The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost containment programs to limit the growth of government-paid health care costs, including price controls, restrictions on reimbursement and requirements for substitution of less costly products. Adoption of government controls and measures, and tightening of restrictive policies in jurisdictions with existing controls and measures, could limit payments for our products. The marketability of any products for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement. In addition, an increasing emphasis on managed care in the United States has increased and will continue to increase the pressure on medical product and service pricing.
Anti-Kickback and False Claims Laws
In the United States, the research, manufacturing, distribution, sale and promotion of pharmaceutical products and devices are subject to regulation by various federal, state and local authorities in addition to the FDA, including CMS, other divisions of HHS (e.g., the Office of Inspector General), the U.S. Department of Justice, state Attorneys General, and other federal, state and local government agencies. For example, sales, marketing and scientific/educational grant programs must comply with the Federal Food, Drug, and Cosmetic Act, the Anti-Kickback Statute, as amended, the False Claims Act, as amended, the privacy regulations promulgated under HIPAA, and similar state laws. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. All of these activities are also potentially subject to federal and state consumer protection and unfair competition laws.
As noted above, in the United States, we are subject to complex laws and regulations pertaining to healthcare “fraud and abuse,” including, but not limited to, the federal Anti-Kickback Statute, the federal False Claims Act, and other state and federal laws and regulations. The Anti-Kickback Statute makes it illegal for any person, including a biological product manufacturer (or a party acting on its behalf) to knowingly and willfully solicit, receive, offer, or pay any remuneration that is intended to induce the referral of business, including the purchase or order of an item for which payment may be made under a federal healthcare program, such as Medicare or Medicaid. Violations of this law are punishable by up to five years in prison, criminal fines, administrative civil money penalties, and exclusion from participation in federal healthcare programs. In addition, many states have adopted laws similar to the Anti-Kickback Statute. Some of these state prohibitions apply to the referral of patients for healthcare services reimbursed by any insurer, not just federal healthcare programs such as Medicare and Medicaid. Due to the breadth of these federal and state anti-kickback laws and the potential for additional legal or regulatory change in this area, it is possible that our sales and marketing practices and/or our relationships with physicians might be challenged under anti-kickback laws, which could harm us. Because we plan to commercialize products that could be reimbursed under a federal healthcare program and other governmental healthcare programs, we plan to develop a
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comprehensive compliance program that establishes internal controls to facilitate adherence to the rules and program requirements to which we are subject.
The federal False Claims Act prohibits anyone from, among other things, knowingly presenting, or causing to be presented, for payment to federal programs (including Medicare and Medicaid) claims for items or services, including pharmaceutical products, that are false or fraudulent. Although we would not submit claims directly to payers, manufacturers can be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting a product off-label. In addition, our activities relating to the reporting of wholesaler or estimated retail prices for our products, the reporting of prices used to calculate Medicaid rebate information and other information affecting federal, state, and third-party reimbursement for our products, and the sale and marketing of our products, are subject to scrutiny under this law. For example, pharmaceutical companies have been prosecuted under the federal False Claims Act in connection with their off-label promotion of drugs. Penalties for a False Claims Act violation include three times the actual damages sustained by the government, plus mandatory civil penalties for each separate false claim, the potential for exclusion from participation in federal healthcare programs, and, although the federal False Claims Act is a civil statute, conduct that results in a False Claims Act violation may also implicate various federal criminal statutes. If the government were to allege that we were, or convict us of, violating these false claims laws, we could be subject to a substantial fine and may suffer a decline in our stock price. In addition, private individuals have the ability to bring actions under the federal False Claims Act and certain states have enacted laws modeled after the federal False Claims Act.
There are also an increasing number of state laws that require manufacturers to make reports to states on pricing and marketing information. Many of these laws contain ambiguities as to what is required to comply with the laws. In addition, a provision of PPACA, referred to as the Sunshine Act, requires pharmaceutical product manufacturers to track and report to the federal government certain payments or other transfers of value made to physicians, registered nurses and teaching hospitals, among others, in the previous calendar year. These laws may affect our sales, marketing, and other promotional activities by imposing administrative and compliance burdens on us. In addition, given the lack of clarity with respect to these laws and their implementation, our reporting actions could be subject to the penalty provisions of the pertinent state and federal authorities.
Other Federal Healthcare Fraud and Abuse Laws
We may also be subject to other federal healthcare fraud and abuse laws, including provisions of HIPAA, which prohibit knowingly and recklessly executing a scheme or artifice to defraud any healthcare benefit program, including private payors, as well as knowingly and willfully falsifying, concealing or covering up a material fact by any trick, scheme or device or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. A violation of this statute is a felony and may result in fines, imprisonment or exclusion from government-sponsored programs. Similar to the federal Anti-Kickback Statute, a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation.
Foreign Corrupt Practices Act
The Foreign Corrupt Practices Act (the “FCPA”), prohibits U.S. businesses and their representatives from offering to pay, paying, promising to pay or authorizing the payment of money or anything of value to a foreign official in order to influence any act or decision of the foreign official in his or her official capacity or to secure any other improper advantage in order to obtain or retain business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring us to maintain books and records, which in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the corporation, including international subsidiaries, if any, and to devise and maintain a system of internal accounting controls sufficient to provide reasonable assurances regarding the reliability of financial reporting and the preparation of financial statements. The scope of the FCPA includes interactions with certain healthcare professionals in many countries.
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Human Capital
As of March 1, 2025, we had twelve full-time employees and no part-time employees. None of these employees are represented by labor unions or covered by collective bargaining agreements. We believe that our employee relations are good.
Culture is a critical element in the management of our organization. Our talented employees are focused on driving our business with the foundation for all our efforts being to advance medicines for solid tumors. Our goal is that each colleague feels a deep connection to what they do, loves coming to work, and is aligned to our mission.
Culture begins with our hiring process and continues throughout an employee’s time with Context. We support our colleagues with a comprehensive offering of competitive pay and benefits.
Facilities
Our principal office is located in Philadelphia, Pennsylvania, where we lease approximately 3,500 square feet of office space pursuant to a lease that expires on November 30, 2026, which lease renews at our option for two additional successive one-year periods should we provide the landlord with notice of extension at least 9 months before any such successive renewal. We believe our facility is adequate to meet our current needs, although we may seek to negotiate new leases or evaluate additional or alternate space for our operations. We believe appropriate alternative space will be readily available on commercially reasonable terms.
Legal Proceedings
From time to time we may be involved in disputes or litigation relating to claims arising out of our operations. We are not currently a party to any legal proceedings that could reasonably be expected to have a material adverse effect on our business, financial condition and results of operations.
Corporate Information
We were incorporated under the laws of the State of Delaware in April 2021. Our corporate office is located at 2001 Market Street, Suite 3915, Unit #15, Philadelphia, PA 19103. Our telephone number is (267) 225-7416. We maintain an Internet website at www.contexttherapeutics.com. The information contained on our website is not incorporated by reference into this Form 10-K.
We make available free of charge under the “Investors & News” — “Financials” — “SEC Filings” section of our website all of our filings with the SEC, including our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements and amendments to such documents, each of which is provided on our website as soon as reasonably practicable after we electronically file or furnish, as applicable, the information with the SEC.
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Item 1A. Risk Factors
Investing in our common stock involves a high degree of risk. You should consider carefully the risks and uncertainties described below, together with general economic and business risks and all of the other information contained in this Annual Report on Form 10-K, including the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes, before making a decision to invest in our common stock. Our business, results of operations, financial condition or prospects could also be harmed by risks and uncertainties that are not presently known to us or that we currently believe are not material. If any of the risks actually occur, our business, results of operations, financial condition and prospects could be materially and adversely affected. In that event, the market price of our common stock could decline, and you could lose all or part of your investment. This Annual Report on Form 10-K also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in the forward-looking statements as a result of specific factors, including the risks described below. See "Note Regarding Forward-Looking Statements."
Risks Related to Our Business and Industry
We have never been profitable and may never achieve or maintain profitability.
We have not commercialized any products and have yet to generate any revenue from product sales. The amount of our future net losses will depend, in part, on our expenses and our ability to generate revenues. Our current and any future product candidates will require substantial additional development time and resources before we may realize revenue from product sales, if at all. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase substantially if and as we:
•continue our current research and development programs, including conducting laboratory, preclinical and clinical studies for product candidates;
•continue and initiate clinical trials for product candidates;
•seek to identify, assess, acquire or develop additional research programs or product candidates;
•maintain, expand and protect our intellectual property portfolio;
•seek marketing approvals for any product candidates that may successfully complete development;
•establish a sales, marketing and distribution infrastructure to commercialize any products that may obtain marketing approval;
•further develop and refine the manufacturing process for our current and any future product candidates;
•change or add additional manufacturers or suppliers of pharmaceutical or biological materials or product candidates;
•acquire or in-license other technologies;
•seek to attract and retain new and existing personnel; and
•expand our facilities.
We recently began our clinical trial for CTIM-76 and no clinical studies have begun on CT-95 or CT-202. It will be several years, if ever, before we obtain regulatory approval for a therapeutic product candidate, at which time any revenues for such product candidate will depend upon many factors, including market conditions, costs and effectiveness of manufacturing, sales, marketing and distribution operations related to such product candidate, the scope of intellectual property protection for such product candidate, and the terms of any collaboration or other strategic arrangement we may have with respect to such product candidate and levels of reimbursement from third-party payors.
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If we are unable to develop and commercialize one or more product candidates either alone or with collaborators, including through the potential out-licensing of our product candidates, or if revenues from any product candidate that receives marketing approval or is commercialized are insufficient, we may not achieve profitability or sustain profitability, which would have an adverse effect on the value of our common stock, which would be materially adversely affected.
We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.
The continuation of our business is dependent upon raising additional capital. We will need additional funding to meet our operational needs and capital requirements for clinical trials, other research and development expenditures, and general and administrative expenses. We currently have no credit facility or committed sources of capital.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic transactions and/or marketing, distribution or licensing arrangements. There can be no assurances that our plans to obtain additional capital will be successful on the terms or timeline we expect, or at all. If these efforts are unsuccessful, we may be required to significantly curtail or discontinue operations or, if available, to obtain funds through financing transactions with unfavorable terms.
If we are unable to raise substantial additional capital on acceptable terms, or at all, we may be forced to delay, reduce or eliminate some or all of our research programs, product development activities and commercialization efforts.
The process of identifying product candidates and conducting preclinical and clinical trials is time consuming, expensive, uncertain and takes years to complete. Our operations have consumed substantial amounts of cash since inception. We expect our expenses to increase in connection with our ongoing activities, particularly as we identify, continue the research and development of, initiate clinical trials of, and seek marketing approval for, product candidates. Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:
•initiation, progress, timing, costs and results of preclinical studies and clinical trials, including patient enrollment in such trials, for CTIM-76, CT-95, CT-202 or any other future product candidates;
•clinical development plans we have established and may establish for CTIM-76, CT-95, CT-202 and any other future product candidates;
•obligation to make milestone, royalty and non-royalty sublicense receipt payments to third-party licensors, if any, under our licensing agreements;
•number and characteristics of product candidates that we discover or in-license and develop;
•outcome, timing and cost of regulatory review by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities to require that we perform more studies than those that we currently expect;
•costs of filing, prosecuting, defending and enforcing any patent claims and maintaining and enforcing other intellectual property rights;
•effects of competing technological and market developments;
•costs and timing of the implementation of commercial-scale manufacturing activities; and
•costs and timing of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval.
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Adequate additional financing may not be available to us on acceptable terms, or at all. If we are unable to obtain sufficient funding on a timely basis or on favorable terms, we may be required to significantly delay, reduce or eliminate one or more of our research or product development programs and/or commercialization efforts or we might have to obtain funds through arrangements, such as out-licensing our product candidates, with collaborative partners or others that may require us to relinquish rights to our technologies or product candidates that we otherwise would not relinquish. We may also be unable to expand our operations or otherwise capitalize on business opportunities as desired. Any of these events could materially adversely affect our financial condition and business prospects.
If we are not able to successfully integrate recent and future acquisitions, our management’s attention could be diverted, and efforts to integrate future acquisitions could consume significant resources.
Our recent obtainment of the rights to CT-202 and the acquisition of CT-95, and any other future acquisition that we may undertake, involve risks related to the integration of the acquired assets into the Company after the acquisition is completed. These risks include delays in development timelines, increased expenses, and assumption of undisclosed liabilities.
We have a limited operating history, which makes it difficult to evaluate our current business and future prospects and may increase the risk of your investment.
We are a biopharmaceutical company with a limited operating history. We were founded in 2015 and spent the first three years of our company’s history developing and refining our therapeutic approach, and only since then have we focused our efforts on advancing the development of product candidates.
Investment in biopharmaceutical product development is a highly speculative endeavor and entails substantial upfront capital expenditures. There is significant risk that any product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, obtain any required regulatory approvals or become commercially viable. Our product candidates and the therapeutic approach we are using are new and unproven. We had commenced Phase 2 human clinical trials for ONA-XR, but we ceased development of this product candidate and have only recently initiated clinical trials for one of our other product candidates, and we have not demonstrated an ability to successfully complete any clinical trials, obtain any required marketing approvals, manufacture products, conduct sales, marketing and distribution activities, or arrange for a third party to do any of the foregoing on our behalf.
Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a history of successfully developing and commercializing products. Our limited operating history, particularly in light of the rapidly evolving nature of the biopharmaceutical industries and the cancer therapeutics field, may make it difficult to evaluate our technology and business prospects or to predict our future performance.
We may expend our limited resources pursuing particular research programs or product candidates that may be less successful or profitable than other programs or product candidates.
Research programs to identify new product candidates require substantial technical, financial, and human resources. We may focus our efforts and resources on potential programs or product candidates that ultimately prove to be unsuccessful. The successful completion of a clinical trial with regard to any of our product candidates is not assured despite the expenditure of significant resources in pursuit of their development, and our spending on current and future research and development programs and product candidates may not yield any commercially viable products.
Additionally, if we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other strategic arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.
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Fluctuating foreign exchange rates could increase our operating expenses and adversely affect our results of operations.
We have vendors located outside of the United States that provide services relating to the development and manufacture of our product candidates, and as a result, we have had and expect to continue to have more significant foreign currency risks related to our operating expenses denominated in currencies other than the U.S. dollar. A weakening U.S. dollar could increase our operating expenses, which would adversely impact our results of operations and financial position.
Inflation could adversely affect our business and results of operations.
While inflation in the United States has been relatively low in recent years, the economy in the United States has encountered a material level of inflation since 2021. Although inflation eased somewhat in 2024, it has raised our costs for commodities, labor, materials, and services and other costs required to grow and operate our business, and failure to secure these on reasonable terms may adversely impact our financial condition. Additionally, increases in inflation, along with public health concerns, geopolitical developments, and global supply chain disruptions, have caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment, which may make it more difficult, costly, or dilutive for us to secure additional financing. A failure to adequately respond to these risks could have a material adverse impact on our financial condition, results of operations, or cash flows.
Our governing documents designate the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of state law actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents.
Our amended and restated certificate of incorporation provides that, unless we consent in writing to the selection of an alternative form, the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, the United States District Court for the District of Delaware) will be the sole and exclusive forum for: (1) any derivative action or proceeding brought on our behalf; (2) any action asserting a claim of breach of a fiduciary duty or other wrongdoing by any of our directors, officers, employees or agents to us or our stockholders; (3) any action asserting a claim against us arising pursuant to any provision of the General Corporation Law of the State of Delaware or our amended and restated certificate of incorporation or amended and restated bylaws; (4) any action to interpret, apply, enforce or determine the validity of our amended and restated certificate of incorporation or amended and restated bylaws; or (5) any action asserting a claim governed by the internal affairs doctrine. In addition, our amended and restated certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America shall, to the fullest extent permitted by law, be the sole and exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended (the “Securities Act”). Notwithstanding the foregoing, the exclusive forum provision shall not apply to claims seeking to enforce any liability or duty created by the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
This choice of forum provision may limit our stockholders’ ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, employees or agents, which may discourage such lawsuits against us and our directors, officers, employees and agents even though an action, if successful, might benefit our stockholders. Stockholders who do bring a claim in the Court of Chancery could face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near Delaware. The Court of Chancery may also reach different judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgments or results may be more favorable to us than to our stockholders. Alternatively, if a court were to find this provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could have a material adverse effect on our business, financial condition or results of operations.
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Risks Related to our Product Candidates
Our business is dependent on the successful development, regulatory approval and commercialization of our therapeutic product candidates, CTIM-76, CT-95 and CT-202, which are in the early stages of development.
We have no products approved for sale. The success of our business, including our ability to finance our Company and generate any revenue in the future, will primarily depend on the successful development, regulatory approval and commercialization of CTIM-76, CT-95 and CT-202, which may never occur.
In the future, we may also become dependent on other product candidates that we may develop or acquire; however, not all of our product candidates have been tested in humans and given our early stage of development, it may be many years, if at all, before we have demonstrated the safety and efficacy of a cancer treatment sufficient to warrant approval for commercialization.
We have not previously submitted an NDA or BLA to the FDA, or similar regulatory approval filings to comparable foreign authorities, for any product candidate, and we cannot be certain that our current or any future product candidates will be successful in clinical trials or receive regulatory approval. Further, any future product candidates may not receive regulatory approval even if they are successful in clinical trials. If we do not receive regulatory approvals for our current or future product candidates, we may not be able to continue our operations. Even if we successfully obtain regulatory approvals to market a product candidate, our revenue will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval and have commercial rights. If the markets or patient subsets that we are targeting are not as significant as we estimate, we may not generate significant revenues from sales of such products, if approved.
We plan to seek regulatory approval to commercialize our current and any future product candidates both in the United States and in selected foreign countries. While the scope of regulatory approval generally is similar in other countries, in order to obtain separate regulatory approval in other countries, we must comply with numerous and varying regulatory requirements of such countries regarding safety and efficacy. Other countries also have their own regulations governing, among other things, clinical trials and commercial sales, as well as pricing and distribution of our current and any future product candidates, and we may be required to expend significant resources to obtain regulatory approval and to comply with ongoing regulations in these jurisdictions.
The clinical and commercial success of our current and any future product candidates will depend on a number of factors, including the following:
•our ability to raise additional required capital on acceptable terms, or at all;
•our ability to complete IND and BLA-enabling studies and successfully submit an IND and BLA;
•timely completion of our preclinical studies and clinical trials, which may be slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors;
•whether we are required by the FDA or similar foreign regulatory agencies to conduct additional clinical trials or other studies beyond those planned to support approval of our product candidates;
•the results of our clinical trials;
•acceptance of our proposed indications and primary endpoint assessments relating to the proposed indications of our product candidates by the FDA and similar foreign regulatory authorities;
•our ability to consistently provide for manufacturing of our product candidates or future approved products, if any, on a timely basis;
•our ability, and the ability of any third parties with whom we contract, to remain in good standing with regulatory agencies and to develop, validate and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practices (“cGMPs”);
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•our ability to demonstrate to the satisfaction of the FDA and similar foreign regulatory authorities the safety, efficacy and acceptable risk-benefit profile of our product candidates;
•the prevalence, duration and severity of potential side effects or other safety issues experienced with our product candidates or future approved products, if any;
•the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities;
•achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to our product candidates or any future product candidates or future approved products, if any;
•the willingness of physicians, operators of hospitals and clinics and patients to utilize or adopt our product candidates or any future product candidates;
•our ability to successfully develop a commercial strategy and thereafter commercialize our current or any future product candidates in the United States and internationally, if approved for marketing, sale and distribution in such countries and territories, whether alone or in collaboration with others, including through the potential out-licensing of our product candidates;
•competition from other applicants’ products authorized for marketing before or after we receive regulatory authorization, if any, for our product candidates;
•the availability of coverage and adequate reimbursement from managed care plans, private insurers, government payors (such as Medicare and Medicaid) and other third-party payors for any of our product candidates that may be approved;
•the convenience of our treatment or dosing regimen;
•acceptance by physicians, payors and patients of the benefits, safety and efficacy of our current or any future product candidates, if approved, including relative to alternative and competing treatments;
•patient demand for our current or future product candidates, if approved;
•our ability to establish and enforce intellectual property rights in and to our product candidates; and
•our ability to avoid third-party patent interference, intellectual property challenges or intellectual property infringement claims.
These factors, many of which are beyond our control, could cause us to experience significant delays or an inability to obtain regulatory approvals or commercialize our current or future product candidates. Even if regulatory approvals are obtained, we may never be able to successfully commercialize any product candidates. Accordingly, we cannot provide assurances that we will be able to generate sufficient revenue through the sale of our product candidates or any future product candidates to continue our business or achieve profitability.
Our innovative therapy approach is based on novel ideas and technologies that are unproven and may not result in marketable products, which exposes us to unforeseen risks and makes it difficult for us to predict the time and cost of product development and potential for regulatory approval.
Our foundational science and product development approach are based on the selective targeting of solid-tumor cancers to elicit meaningful anticancer activity. We believe that this approach may offer an improved therapeutic effect by redirecting T-cell-mediated lysis toward malignant cells expressing the tumor antigens that are targeted (CLDN6, MSLN or Nectin-4). However, this approach to treating cancer is novel and the scientific research that forms the basis of our efforts to develop therapeutics that effectively inhibit membrane protein targets is both preliminary and limited.
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As such, we cannot assure you that even if we are able to develop cancer therapeutic candidates capable of redirecting T-cell-mediated lysis toward malignant cells, that such therapy would safely and effectively treat cancers. We may spend substantial funds attempting to develop this approach and never succeed in developing a marketable therapeutic.
Furthermore, no regulatory authority has granted approval for a T cell redirecting cancer therapy based on a selective targeting of CLDN6, MSLN or Nectin-4 positive cancers. As such, we believe the FDA has limited experience with evaluating our approach, which may increase the complexity, uncertainty and length of the regulatory approval process for our product candidates. We may never receive approval to market and commercialize any product candidate. Even if we obtain regulatory approval, the approval may be for targets, disease indications, lines of therapy or patient populations that are not as broad as we intended or desired or may require labeling that includes significant use or distribution restrictions or safety warnings.
Results of preclinical studies, early clinical trials or analyses may not be indicative of results obtained in later trials.
The results of preclinical studies, early clinical trials or analyses of a product candidate may not be predictive of the results of later-stage clinical trials. A product candidate in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. In addition, conclusions based on promising data from analyses of clinical results may be shown to be incorrect when implemented in prospective clinical trials. Even if our future clinical trials are completed as planned, we cannot be certain that their results will support the safety and efficacy sufficient to obtain regulatory approval.
Interim “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
From time to time, we may publish interim “top-line” or preliminary data from our clinical studies. Interim or preliminary data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or “top-line” data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.
Any product candidate may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require it to be taken off the market, require it to include safety warnings or otherwise limit its sales.
Serious adverse events or undesirable side effects caused by a product candidate could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. Results of any clinical trial we conduct could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. For example, certain patients treated with ONA-XR, our former product candidate, experienced adverse events that included, but were not limited to, fatigue, liver enzyme elevations and nausea.
If unacceptable side effects arise in the development of any product candidate, we, the FDA or the institutional review boards (“IRBs”) at the institutions in which our studies are conducted, or the data safety monitoring board, if constituted for our clinical trials, could recommend a suspension or termination of our clinical trials, or the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of a product candidate for any or all targeted indications. In addition, drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete a trial or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. We expect to have to train medical personnel using a product candidate to understand the side effect profiles for our clinical
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trials and upon any commercialization of any product candidate. Inadequate training in recognizing or managing the potential side effects of any product candidate could result in patient injury or death. Any of these occurrences may harm our business, financial condition and prospects significantly.
Additionally, if any product candidate receives marketing approval, and we or others later identify undesirable side effects caused by such product, a number of potentially significant negative consequences could result, including:
•regulatory authorities may withdraw approvals of such product;
•regulatory authorities may require additional warnings on the label, such as a “black box” warning or contraindication;
•additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof;
•we may be required to implement a Risk Evaluation and Mitigation Strategy (“REMS”), or create a medication guide outlining the risks of such side effects for distribution to patients;
•we could be sued and held liable for harm caused to patients;
•the product may become less competitive; and
•our reputation may suffer.
Any of these events could prevent us from achieving or maintaining market acceptance of a product candidate, if approved, and could significantly harm our business, results of operations and prospects.
We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties or delays enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
Successful and timely completion of clinical trials will require that we identify and enroll a specified number of patients for each of our clinical trials. We may not be able to initiate or continue clinical trials for our current or any future product candidates if we are unable to identify and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the United States. Subject enrollment, a significant factor in the timing of clinical trials, is affected by many factors, including the size and characteristics of the patient population, the proximity of patients to clinical sites, the eligibility and exclusion criteria for the trial, the design of the clinical trial, the ability to obtain and maintain informed consents, the risk that enrolled patients will not complete a clinical trial, our ability to recruit clinical trial investigators with the appropriate competencies and experience, and competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating as well as any product candidates under development. We will be required to identify and enroll a sufficient number of patients for each of our clinical trials and monitor such patients adequately during and after treatment. Potential patients for any planned clinical trials may not be adequately diagnosed or identified with the diseases that we are targeting, which could adversely impact the outcomes of our trials and could have safety concerns for the potential patients. Potential patients for any planned clinical trials may also not meet the entry criteria for such trials.
Additionally, other pharmaceutical companies targeting these same diseases are recruiting clinical trial patients from these patient populations, which may make it more difficult to fully enroll our clinical trials. The process of finding and recruiting patients may prove costly. The timing of our clinical trials depends, in part, on the speed at which we can recruit patients to participate in our trials, as well as completion of required follow-up periods. The eligibility criteria of our clinical trials, once established, may further limit the pool of available trial participants. If patients are unwilling or unable to participate in our trials for any reason, including the existence of concurrent clinical trials for similar target populations, the availability of approved or authorized therapies, or the fact that enrolling in our trials may prevent patients from taking a different product, or we otherwise have difficulty enrolling a sufficient number of patients, the timeline for recruiting patients, conducting trials, and obtaining regulatory approval of our product candidates may be delayed. Our inability to enroll a specified number of patients for any of
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our future clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether.
We cannot assure you that our assumptions used in determining expected clinical trial timelines are correct or that we will not experience delays or difficulties in enrollment, or be required by the FDA or other regulatory authorities to increase our enrollment, which would result in the delay of completion of such trials beyond our expected timelines.
The success of our business depends primarily upon our ability to identify, develop and commercialize products using our proprietary technologies.
We recently initiated clinical trials for CTIM-76, anticipate dosing the first patient in the CT-95 Phase 1 trial in the second quarter of 2025, and CT-202 is still in the IND validation process. We may be unsuccessful in advancing any product candidate during clinical development or otherwise into clinical development or in identifying and developing additional product candidates.
Our ability to identify and develop product candidates is subject to the numerous risks associated with preclinical, clinical and early stage biopharmaceutical development activities, including that:
•we may not be able to assemble sufficient resources to acquire or discover additional product candidates, including through the potential out-licensing of our product candidates;
•we may not be able to enter into collaborative arrangements to facilitate development of product candidates;
•competitors may develop alternatives that render our product candidates obsolete or less attractive;
•our product candidates may be covered by third parties’ patents or other exclusive rights;
•the regulatory pathway for a product candidate may be too complex, expensive or otherwise difficult to navigate successfully; or
•our product candidates may be shown to not be effective, have harmful side effects or otherwise pose risks not outweighed by such product candidate’s benefits or have other characteristics that may make the products impractical to manufacture, unlikely to receive any required marketing approval, unlikely to generate sufficient market demand or otherwise not achieve profitable commercialization.
Even if we do commence additional clinical trials of product candidates and continue to identify new product candidates, such product candidates may never be approved. Failure to successfully identify and develop new product candidates and obtain regulatory approvals for our products would have a material adverse effect on our business and financial condition and could cause us to cease operations.
If a product candidate does not achieve projected development milestones or commercialization in the announced or expected timeframes, the further development or commercialization of such product candidate may be delayed, and our business will be harmed.
We sometimes estimate, or may in the future estimate, the timing of the accomplishment of various scientific, clinical, manufacturing, regulatory and other product development objectives. These milestones may include our expectations regarding the commencement or completion of scientific studies or clinical trials, the submission of regulatory filings, the receipt of marketing approval or the realization of other commercialization objectives.
The achievement of many of these milestones may be outside of our control. All of these milestones are based on a variety of assumptions, including assumptions regarding capital resources, constraints and priorities, progress of and results from development activities and the receipt of key regulatory approvals or actions, any of which may cause the timing of achievement of the milestones to vary considerably from our estimates. For example, in 2024 we adjusted our guidance regarding the anticipated dosing of the first patient in the CTIM-76 Phase 1 trial.
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If we or our collaborators fail to achieve announced milestones in the expected timeframes, the commercialization of the affected product candidate may be delayed, our credibility may be undermined, our business and results of operations may be harmed, and the price of our common stock may decline.
Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any products that we develop alone or with collaborators.
We face an inherent risk of product liability and professional indemnity exposure related to the testing in clinical trials of our product candidates. We will face an even greater liability risk if we commercially sell any products that we or our collaborators may develop for human use.
Manufacturing defects, errors in product distribution or storage processes, improper administration or application and known or unknown side effects of product usage may result in liability claims against us or third parties with which we have relationships. These actions could include claims resulting from acts by our collaborators, licensees and subcontractors over which we have little or no control. For example, our liability could be sought by patients participating in clinical trials for potential therapeutic product candidates as a result of unexpected side effects, improper product administration or the deterioration of a patient’s condition, patient injury or even death.
Criminal or civil proceedings might be filed against us by patients, regulatory authorities, biopharmaceutical companies and any other third party using or marketing any product candidates or products that we develop alone or with collaborators. On occasion, large judgments have been awarded in class action lawsuits based on products that had unanticipated adverse effects. If we cannot successfully defend ourselves against claims that product candidates or products we develop alone or with collaborators caused harm, we could incur substantial liabilities.
Clinical development does not always fully characterize the safety and efficacy profile of a new medicine, and it is always possible that a drug or biologic, even after regulatory approval, may exhibit unforeseen side effects. If any product candidate were to cause adverse side effects during clinical trials or after approval, we may be exposed to substantial liabilities.
Product liability insurance coverage may not be adequate to cover all liabilities that we may incur. We anticipate that we will need to increase our insurance coverage when we expand our clinical trials and if we or our collaborators successfully commercialize any products.
Risks Related to Our Organization, Structure and Operations
Our reliance on a central team consisting of a limited number of employees and consultants who provide various administrative, research and development, and other services across our organization presents operational challenges that may adversely affect our business.
As of March 1, 2025, we had twelve full-time employees. We also have various consultants who we rely on for research and development, business development and other services. While we believe this structure enables us to reduce certain infrastructure costs, the small size of our centralized team may limit our ability to devote adequate personnel, time and resources to support the operations of our business, including our research and development activities, and the management of financial, accounting and reporting matters. If our centralized team fails to provide adequate administrative, research and development, or other services across our entire organization, our business, financial condition and results of operations could be harmed.
Our future success depends on our ability to retain our Chief Executive Officer, Chief Medical Officer, Chief Financial Officer, Chief Legal Officer, and other key executives and to attract, retain and motivate qualified personnel.
We are highly dependent on the research and development experience, technical skills, leadership and continued service of certain members of our management and scientific teams, including Martin Lehr, our Chief Executive Officer, Dr. Claudio Dansky Ullmann, our Chief Medical Officer, Jennifer Minai-Azary, our Chief Financial Officer, and Alex Levit, our Chief Legal Officer.
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Although we have formal employment agreements with all of our executive officers, these agreements do not prevent them from terminating their employment with us at any time. The loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives.
Recruiting and retaining qualified scientific, clinical, manufacturing and, if we retain commercialization responsibility for any product candidate we develop alone or with collaborators, sales and marketing personnel, will also be critical to our success. We may not be able to attract and retain these personnel on acceptable terms or at all given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategies. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us.
The inability to recruit, integrate, motivate and retain additional skilled and qualified personnel, or the loss of services of certain executives, key employees, consultants or advisors, may impede the progress of our research, development and commercialization objectives and have a material adverse effect on our business.
We will need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
We will need to significantly expand our organization, and our future financial performance, ability to develop and commercialize product candidates alone or with collaborators and ability to compete effectively will depend in part on our ability to effectively manage any future growth. We may have difficulty identifying, hiring and integrating new personnel.
Many of the biopharmaceutical companies that we compete against for qualified personnel and consultants have greater financial and other resources, different risk profiles and a longer history than we do. If we are unable to continue to attract and retain high-quality personnel and consultants, the rate and success at which we can identify and develop product candidates, enter into collaborative arrangements and otherwise operate our business will be limited.
Future growth would impose significant additional responsibilities on our management, including the need to identify, recruit, maintain, motivate and integrate additional employees, consultants and contractors. Management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing these growth activities. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expected expansion of our operations or recruit and train additional qualified personnel.
Moreover, the expected physical expansion of our operations may lead to significant costs and may divert our management and business development resources from other projects, such as the development of product candidates. If we are not able to effectively manage the expansion of our operations, it may result in weaknesses in our infrastructure, increase our expenses more than expected, give rise to operational mistakes, loss of business opportunities, loss of employees, consultants and contractors and reduced productivity.
Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.
We do not carry insurance for all categories of risk that our business may encounter. If we obtain marketing approval for any product candidates that we or our collaborators may develop, we intend to acquire insurance coverage to include the sale of commercial products, but we may be unable to obtain such insurance on commercially reasonable terms or in adequate amounts. We do not carry specific biological or hazardous waste insurance coverage, and our property, casualty and general liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination.
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Accordingly, in the event of contamination or injury, we could be held liable for damages or be penalized with fines in an amount exceeding our resources, and clinical trials or regulatory approvals for any product candidate could be suspended. As a public company it is more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified individuals to serve on our board of directors, our board committees or as our executive officers.
In the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses. We do not know if we will be able to maintain existing insurance with adequate levels of coverage, and any liability insurance coverage we acquire in the future may not be sufficient to reimburse us for any expenses or losses we may suffer. A successful liability claim or series of claims brought against us could require us to pay substantial amounts and cause our share price to decline and, if judgments exceed our insurance coverage, could adversely affect our results of operations and business, including preventing or limiting the development and commercialization of product candidates.
Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions, could adversely affect our current and projected business operations, financial condition and results of operations.
Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems. For example, on March 10, 2023, Silicon Valley Bank (“SVB”) was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (“FDIC”) as receiver. Subsequently, in March 2023, First Citizens BancShares acquired SVB.
Inflation and rapid increases in interest rates have led to a decline in the trading value of previously issued government securities with interest rates below current market interest rates. Although the U.S. Department of Treasury, FDIC and Federal Reserve Board announced a program in March 2023 to provide up to $25 billion of loans to financial institutions secured by certain of such government securities held by financial institutions to mitigate the risk of potential losses on the sale of such instruments, widespread demands for customer withdrawals or other liquidity needs of financial institutions for immediate liquidity may exceed the capacity of such a program. Additionally, there is no guarantee that the U.S. Department of Treasury, FDIC and Federal Reserve Board will provide access to uninsured funds in the future in the event of the closure of other banks or financial institutions, or that they would do so in a timely fashion.
In addition, a supplier or collaboration partner could be adversely affected by any of the liquidity risks that are described above. Any supplier or collaboration partner bankruptcy or insolvency, or the failure of any collaboration partner to make payments when due, or any breach or default by a supplier or collaboration partner, or the loss of any significant supplier or collaboration partner relationships, could result in material losses to us and may have a material adverse impact on our business.
Risks Related to Our Reliance on Third Parties
We expect to, and do, depend on collaborations with third parties for certain research, development and commercialization activities, and if any such collaborations are not successful, it may harm our business and prospects.
Working with collaborators poses several significant risks, including the following:
•limited availability of resource allocation and other developmental decisions made by our collaborators about the product candidates that we seek to develop with them may result in the delay or termination of research programs, studies or trials, repetition of or initiation of new studies or trials or provision of insufficient funding or resources for the completion of studies or trials or the successful marketing and distribution of any product candidates that may receive approval;
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•collaborators could independently develop, or develop with third parties, product candidates that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;
•collaborators may not properly obtain, maintain, enforce or defend our intellectual property or proprietary rights or may use our proprietary information in such a way that could jeopardize or invalidate our proprietary information or expose us to potential litigation; and
•disputes may arise between us and our collaborators that result in the delay or termination of the research, development or commercialization activities or that result in costly litigation or arbitration that diverts management attention and resources.
Our ability to generate revenues from these arrangements will depend on our collaborators’ abilities to successfully perform the functions assigned to them in these arrangements. If our collaborations, including those in which we may out-license our product candidates, do not result in the successful development and commercialization of product candidates, or if one of our collaborators terminates its agreement with us, we may not receive the expected deliverables or services from our collaborators, nor receive any future funding or milestone or royalty payments under the collaboration.
If we do not receive the funding or deliverables or services from our collaborators that we expect under these agreements, our development of product candidates could be delayed and we may need additional resources to develop such product candidates. In addition, if one of our collaborators terminates its agreement with us, we may find it more difficult to find a suitable replacement collaborator or attract new collaborators and may need to raise additional capital to pursue further development or commercialization of the applicable product candidates.
These events could delay development programs and negatively impact the perception of our company in business and financial communities. Failure to develop or maintain relationships with any current collaborators could result in the loss of opportunity to work with that collaborator or reputational damage that could impact our relationships with other collaborators in the relatively small industry communities in which we operate.
Moreover, all of the risks relating to product development, regulatory approval and commercialization described in this Form 10-K apply to the activities of our collaborators. If our existing collaboration agreements or any collaborative or strategic relationships we may establish in the future are not effective and successful, it may damage our reputation and business prospects, delay or prevent the development and commercialization of product candidates and inhibit or preclude our ability to realize any revenues.
We may become involved in disagreements or disputes with our licensees, licensors and other counterparties relating to the development and/or commercialization of our current or past product candidates, which may be time consuming, costly and could harm our efforts to develop our current or future product candidates.
We have entered into various agreements and licenses with licensees, licensors and other counterparties related to the development and/or commercialization of our current and past product candidates. These agreements and licenses impose a variety of obligations on us and the counterparties to such agreements and licenses. Disagreements and disputes between us and certain counterparties may arise, such as regarding each parties’ obligations under the respective agreement or license.
Any such disagreement or dispute could become time consuming, costly and could harm our efforts to develop current or future product candidates. Any disagreements or disputes with such parties that lead to litigation, arbitration or similar proceedings will result in us incurring significant legal expenses and potential significant legal liability and could jeopardize our ability to continue development of the related product candidate.
Further, any disagreements or disputes over our obligations or intellectual property that we have licensed or acquired may prevent or impair our ability to maintain our current arrangements on acceptable terms. If we fail to meet our obligations under these agreements or licenses, the respective counterparty may have the right to terminate the respective agreement or license and to re-obtain the related technology as well as aspects of any intellectual
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property controlled by us and developed during the period the agreement or license was in force that relates to the applicable technology. While we would expect to exercise our rights and remedies available to us in the event we fail to meet our obligations under such agreement or license in any material respect and otherwise seek to preserve our rights under the technology licensed to or acquired by us, we may not be able to do so in a timely manner, at an acceptable cost or at all. Any uncured breach under any agreement or license relating to a product candidate could result in our loss of rights and may lead to a complete termination of the respective agreement or license. Termination of one of these agreements or licenses for any reason could prevent us from completing a transaction to sell or out-license a product candidate.
Additionally, any disagreements or disputes over our counterparties’ obligations or intellectual property rights that we have licensed or acquired may prevent or impair our ability to develop any of our product candidates. If any counterparty fails to meet their obligations under these agreements or licenses or does not have the right to intellectual property rights that they may contractually claim to have, it could materially impact our development of such product candidate. While we may have the right to terminate the respective agreement or license and to maintain some or all of the related technology as well as some or all aspects of any intellectual property controlled by such counterparty, we may not be able to do so in a timely manner, at an acceptable cost or at all, and it may lead to litigation, arbitration or similar proceedings that may result in us incurring significant legal expenses and jeopardize our ability to continue development of the related product candidate. A dispute regarding, or termination of, one of these agreements or licenses for any reason also could prevent us from completing a transaction to sell or out-license a product candidate for which we have decided to discontinue development.
We have relied on and we expect to continue to rely on third parties to conduct, supervise and monitor our clinical trials and some aspects of our research and preclinical testing, and if those third parties do not successfully carry out their contractual duties, comply with regulatory requirements, or otherwise perform in a satisfactory manner, we may not be able to obtain regulatory approval or commercialize product candidates, or such approval or commercialization may be delayed, and our business may be substantially harmed.
We have relied on and we expect to continue to rely on medical institutions, clinical investigators, contract laboratories and other third parties, such as contract research organizations (“CROs”), to conduct preclinical studies and clinical trials for product candidates. Nevertheless, we are responsible for ensuring that each of our studies and trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, and our reliance on such third parties will not relieve us of our regulatory responsibilities. For example, we remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with regulations, commonly referred to as good clinical practices (“GCPs”), for conducting, monitoring, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected.
Although we have designed and intend to design future trials for product candidates either alone or with collaborators, third parties may conduct some parts of or all of the trials. As a result, many important aspects of our research and development programs, including their conduct and timing, will be outside of our direct control. Our reliance on third parties to conduct current and future studies and trials will also result in less direct control over the management of data developed through studies and trials than would be the case if we were relying entirely upon our own staff. Communicating with outside parties can also be challenging, potentially leading to mistakes and difficulties in coordinating activities. Such third parties may have staffing difficulties, fail to comply with contractual obligations, experience regulatory compliance issues, undergo changes in priorities, become financially distressed or form relationships with other entities, some of which may be our competitors.
We also face the risk of potential unauthorized disclosure or misappropriation of our intellectual property by CROs or other third parties, which may reduce our trade secret protection and allow our potential competitors to access and exploit our proprietary technology. For any violations of laws and regulations during the conduct of our preclinical studies and clinical trials, we could be subject to warning letters or enforcement action that may include civil penalties up to and including criminal prosecution.
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If we, our collaborators, our CROs or other third parties fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We also are required to register certain ongoing clinical trials and post the results of such completed clinical trials on a government-sponsored database, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.
If our CROs or other third parties do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for any other reasons, trials for a product candidate may be extended, delayed or terminated, and we or our collaborators may not be able to obtain regulatory approval for, or successfully commercialize, any product candidates. If we are required to repeat, extend the duration of or increase the size of any trials we conduct, it could significantly delay commercialization and require significantly greater expenditures.
As a result of any of these factors, our financial results and the commercial prospects for the affected product candidate would be harmed, our costs could increase and our ability to generate revenues could be delayed.
If we are unable to obtain sufficient quantities of raw materials and supplies, at acceptable prices and on a timely basis, it could harm our business.
We are dependent on third parties for the supply of various pharmaceutical and biological materials and the manufacture of product supplies that are necessary to produce our current and any future product candidates. The supply of these materials could be reduced or interrupted at any time. In such case, identifying and engaging an alternative supplier or manufacturer could result in delay, and we may not be able to find other acceptable suppliers or manufacturers on acceptable terms, or at all.
Changing suppliers or manufacturers may involve substantial costs and is likely to result in a delay in our desired clinical and commercial timelines. If we change suppliers or manufacturers for commercial production, applicable regulatory agencies may require us to conduct additional studies or trials. If key suppliers or manufacturers are lost, or if the supply of the materials is diminished or discontinued, we or our collaborators may not be able to develop, manufacture and market the affected product candidate in a timely and competitive manner, or at all. If any product candidate receives approval, we will likely need to seek alternative sources of supply of raw materials or manufactured product supplies and there can be no assurance that we will be able to establish such relationships to provide such supplies on commercially reasonable terms or at acceptable quality levels, if at all. If we are unable to identify and procure additional sources of supply that fit our required needs, we could face substantial delays or incur additional costs in procuring such materials.
We do, and may further, rely on third parties for the manufacturing process of our current and any future product candidates, and failure by those parties to adequately perform their obligations could harm our business.
We do not currently own any facility that may be used as our clinical-scale manufacturing and processing facility and do rely, and expect that we will continue to rely, on outside vendors, including vendors outside the United States, for at least a portion, if not all, of the manufacturing process of our current and any future product candidates that we or our collaborators develop.
The facilities used by our contract manufacturers to manufacture product candidates must be approved by the FDA or other foreign regulatory agencies pursuant to inspections conducted after we submit an application to the FDA or other foreign regulatory agencies. When we or our collaborators engage third parties for manufacturing services, we will not control the manufacturing process of, and will be completely dependent on, our contract manufacturing providers for compliance with cGMP requirements for manufacture of the product candidates.
We have not yet caused any product candidates to be manufactured or processed on a commercial scale and may not be able to do so. We will make changes as we work to optimize the manufacturing process, and we cannot be sure that even minor changes in the process will result in products that are safe and effective. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory
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requirements of the FDA or other regulatory authorities, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel.
If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market any of our or our collaborators’ potential products.
If we are not able to establish collaborations on commercially reasonable terms, we may have to alter our research, development and commercialization plans.
Our research and product development programs and the potential commercialization of our current and any future product candidates will require substantial additional cash to fund expenses, and we expect that we will continue to seek collaborative arrangements, including the potential out-licensing of some or all of our product candidates, for the development and potential commercialization of some or all of our current and any future product candidates or the development of ancillary technologies.
We face significant competition in establishing relationships with appropriate collaborators. In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators. Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include, among other things and as applicable for the type of potential product, an assessment of the opportunities and risks of our product candidates, the design or results of studies or trials, the likelihood of approval, if necessary, by the U.S. Department of Agriculture, the FDA or similar regulatory authorities outside the United States, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products and industry and market conditions generally.
Collaborations are complex and time-consuming to negotiate and document. We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we do enter into additional collaboration agreements, the negotiated terms may force us to relinquish rights that diminish our potential profitability from development and commercialization of the subject product candidate or others. Such collaborations may also impact our ability to control the nature, timing and cadence of developing and commercializing the product candidates subject to such collaborations. If we are unable to enter into additional collaboration agreements, we may have to curtail the research and development of the product candidate for which we are seeking to collaborate, reduce or delay research and development programs, delay potential commercialization timelines, reduce the scope of any sales or marketing activities or undertake research, development or commercialization activities at our own expense.
Risks Related to Government Regulation
The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our current and any future product candidates.
The research, testing, manufacturing, labeling, approval, selling, import, export, marketing, and distribution of drug products, including biologics and pharmaceuticals, are subject to extensive regulation by the FDA and other regulatory authorities in the United States. We expect the novel nature of our product candidates to create further challenges in obtaining regulatory approval. For example, the FDA has limited experience with commercial development of CLDN6, MSLN and Nectin-4 therapies for cancer. The FDA may also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to support licensure. The opinion of the Advisory Committee, although not binding, may have a significant impact on our ability to obtain licensure of product candidates based on the completed clinical trials, as the FDA often makes decisions consistent with the Advisory Committee’s recommendations. Accordingly, the regulatory approval pathway for our product candidates may be uncertain, complex, expensive and lengthy, and approval may not be obtained.
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We may also experience delays in completing planned clinical trials for a variety of reasons, including delays related to:
•obtaining regulatory authorization to begin a trial, if applicable;
•the availability of financial resources to commence and complete the planned trials;
•reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
•obtaining approval at each clinical trial site by an independent IRB;
•recruiting suitable patients to participate in a trial;
•having patients complete a trial, including having patients enrolled in clinical trials dropping out of the trial before the product candidate is manufactured and returned to the site, or return for post-treatment follow-up;
•clinical trial sites deviating from trial protocol or dropping out of a trial;
•addressing any patient safety concerns that arise during the course of a trial;
•adding new clinical trial sites; or
•manufacturing sufficient quantities of qualified materials under cGMPs and applying them on a patient by patient basis for use in clinical trials.
We could also encounter delays if physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of a product candidate in lieu of prescribing existing treatments that have established safety and efficacy profiles. Further, a clinical trial may be suspended or terminated by us, the IRBs for the institutions in which such trials are being conducted or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions, lack of adequate funding to continue the clinical trial, or based on a recommendation by the Data Safety Monitoring Committee. The FDA’s review of our data of our clinical trials may, depending on the data, also result in the delay, suspension or termination of one or more clinical trials, which would also delay or prevent the initiation of our other planned clinical trials. If we experience termination of, or delays in the completion of, any clinical trial of a product candidate, the commercial prospects for such product candidate will be harmed, and our ability to generate product revenue will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue.
Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may ultimately lead to the denial of regulatory approval of our current and any future product candidates.
We expect that CTIM-76, CT-95 and CT-202 will be regulated as biological products, or biologics, and therefore they may be subject to competition from biosimilar applicants.
The Biologics Price Competition and Innovation Act was enacted as part of PPACA to establish an abbreviated pathway for the approval of biosimilar and interchangeable biological products. The regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an approved biologic. Under the Biologics Price Competition and Innovation Act, an application for a biosimilar product cannot be approved by the FDA until 12 years after the reference product was approved under a BLA. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty.
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Regulatory decisions implementing the Biologics Price Competition and Innovation Act may have a material adverse effect on the future commercial prospects for our biological products.
We believe that CTIM-76, CT-95 and CT-202, if approved in the United States as biological products under BLAs, should qualify for the 12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise. Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of the reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.
The FDA may disagree with our regulatory plan and we may fail to obtain regulatory approval of any product candidate.
If and when our clinical trials for our current and any future product candidates are completed and, assuming positive data, we expect to advance to potential registrational trials. The general approach for FDA approval of a new biologic or drug is for the sponsor to provide dispositive data from two well-controlled, Phase 3 clinical studies of the relevant biologic or drug in the relevant patient population. Phase 3 clinical studies typically involve hundreds of patients, have significant costs and take years to complete. If the results from our clinical trials are sufficiently compelling, we intend to discuss with the FDA submission of a BLA for the relevant product candidate. However, we do not have any agreement or guidance from the FDA that our regulatory development plans will be sufficient for submission of a BLA for the relevant product candidate. For example, the FDA may require that we conduct a comparative trial against an approved therapy, which would significantly delay our development timelines and require substantially more resources. As well, in 2022 the Oncology Center of Excellence (OCE) of the FDA implemented Project Optimus to reform the dose optimization and dose selection paradigm in oncology drug development, which has impacted and could continue to impact our current and future clinical trials and significantly delay our development timelines and require substantially more resources.
The FDA may grant accelerated approval for a product candidate and, as a condition for accelerated approval, the FDA may require a sponsor of a drug or biologic receiving accelerated approval to perform post-marketing studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical endpoint, and the drug or biologic may be subject to withdrawal procedures by the FDA that are more accelerated than those available for regular approvals. We believe an accelerated approval strategy may be warranted given the limited alternatives for patients that our product candidates target, but the FDA may ultimately require a Phase 3 clinical trial prior to approval. In addition, the standard of care may change with the use of currently approved products or the approval of new products in the same indications that we are studying. This may result in the FDA or other regulatory agencies requesting additional studies to show that our product candidates are superior to the new products.
Our clinical trial results may also not support approval. In addition, our current and any future product candidates could fail to receive regulatory approval for many reasons, including the following:
•the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
•we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our current or any future product candidates are safe and effective for any of their proposed indications;
•the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval, including due to the heterogeneity of patient populations;
•we may be unable to demonstrate that our current and any future product candidates’ clinical and other benefits outweigh their safety risks;
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•the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
•the data collected from clinical trials of our current and any future product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;
•the FDA or comparable foreign regulatory authorities will review our manufacturing process and inspect our commercial manufacturing facility and may not approve our manufacturing process or facility; and
•the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
Obtaining and maintaining regulatory approval of a product candidate in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of such product candidate in other jurisdictions.
Obtaining and maintaining regulatory approval of a product candidate in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.
We may also submit marketing applications in other countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidates with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our current and any future product candidates will be harmed.
We will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with a product candidate.
Any regulatory approvals that we receive for a product candidate will require surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a REMS in order to approve a product candidate, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA or a comparable foreign regulatory authority approves a product candidate, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for that product candidate will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval. As such, we and our contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any BLA, other marketing applications and previous responses to inspectional observations. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control. In addition, the FDA could require us to conduct another study to obtain additional safety or biomarker information. Further, we will be required to comply with FDA promotion and advertising rules, which include, among others,
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standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved uses (known as “off-label use”), limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet and social media. Later discovery of previously unknown problems with a product candidate, including adverse events of unanticipated severity or frequency, or with our third-party suppliers or manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a risk evaluation and mitigation strategy program. Other potential consequences include, among other things:
•restrictions on the marketing or manufacturing of a product candidate, withdrawal of the product from the market or voluntary or mandatory product recalls;
•fines, warning letters or holds on clinical trials;
•refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;
•product seizure or detention, or refusal to permit the import or export of a product candidate; and
•injunctions or the imposition of civil or criminal penalties.
The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our current and any future product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.
Even if we obtain regulatory approval of a product candidate, the product may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community.
The use of T cell engaging bispecific antibodies as potential cancer treatments is a recent development and may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers and others in the medical community and we may not be able to convince them to use a product candidate for many reasons. Additional factors will influence whether a product candidate is accepted in the market, including:
•the clinical indications for which a product candidate is approved;
•physicians, hospitals, cancer treatment centers and patients considering a product candidate as safe and effective treatments;
•the potential and perceived advantages of a product candidate over alternative treatments;
•the prevalence and severity of any side effects;
•product labeling or product insert requirements of the FDA or other regulatory authorities;
•limitations or warnings contained in the labeling approved by the FDA or other regulatory authorities;
•the timing of market introduction of a product candidate as well as competitive products;
•the cost of treatment in relation to alternative treatments;
•the availability of coverage and adequate reimbursement by third-party payors and government authorities;
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•the willingness of patients to pay out-of-pocket in the absence of coverage and adequate reimbursement by third-party payors and government authorities;
•relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and
•the effectiveness of our sales and marketing efforts.
If a product candidate is approved but fails to achieve market acceptance among physicians, patients, hospitals, cancer treatment centers or others in the medical community, we will not be able to generate significant revenue. Even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or render our products obsolete.
Coverage and reimbursement may be limited or unavailable in certain market segments for a product candidate, which could make it difficult for us to sell such product candidate, if approved, profitably.
Successful sales of a product candidate, if approved, depend on the availability of coverage and adequate reimbursement from third-party payors, including governmental healthcare programs, such as Medicare and Medicaid, managed care organizations and commercial payors, among others. Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain regulatory approval. In addition, because our product candidates represent new approaches to the treatment of cancer, we cannot accurately estimate the potential revenue from our product candidates.
Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Obtaining coverage and adequate reimbursement from third-party payors is critical to new product acceptance.
Third-party payors decide which drugs and treatments they will cover and the amount of reimbursement. Reimbursement by a third-party payor may depend upon a number of factors, including, but not limited to, the third-party payor’s determination that use of a product is:
•a covered benefit under its health plan;
•safe, effective and medically necessary;
•appropriate for the specific patient;
•cost-effective; and
•neither experimental nor investigational.
Obtaining coverage and reimbursement of a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products. Even if we obtain coverage for a given product, if the resulting reimbursement rates are insufficient, hospitals may not approve our product for use in their facility or third-party payors may require co-payments that patients find unacceptably high. Patients are unlikely to use a product candidate unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of that product candidate. Separate reimbursement for the product itself may or may not be available. Instead, the hospital or administering physician may be reimbursed only for providing the treatment or procedure in which our product is used. Further, from time to time, CMS revises the reimbursement systems used to reimburse health care providers, including the Medicare Physician Fee Schedule and Outpatient Prospective Payment System, which may result in reduced Medicare payments. In some cases, private third-party payers rely on all or portions of Medicare payment systems to determine payment rates. Changes to government healthcare programs that reduce payments under these programs may negatively impact payments from private third-party payers, and reduce the willingness of physicians to use a product candidate.
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In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. Further, one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage for the product. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.
We intend to seek approval to market our current and any future product candidates in both the United States and in selected foreign jurisdictions. If we obtain approval in one or more foreign jurisdictions for a product candidate, we will be subject to rules and regulations in those jurisdictions. In some foreign countries, particularly those in Europe, the pricing of drugs and biologics is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after obtaining marketing approval of a product candidate. Some of these countries may require the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines, but monitor and control company profits. The downward pressure on health care costs has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.
The marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if government and other third-party payors fail to provide coverage and adequate reimbursement. We expect downward pressure on pharmaceutical pricing to continue. Further, coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
The advancement of healthcare reform may negatively impact our ability to sell our current and any future product candidates, if approved, profitably.
In the United States and other jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare. For example, in March 2010, PPACA was enacted, which substantially changed the way healthcare is financed by both governmental and private payors. Among the provisions of PPACA of importance to the pharmaceutical and biotechnology industries, which includes biologics, are the following:
•manufacturers and importers of certain biologics with annual sales of more than $5 million made to or covered by specified federal healthcare programs are required to pay an annual, nondeductible fee according to their market share of all such sales;
•an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% of the average manufacturer price for most branded drugs, biologics, and biosimilars and to 13.0% for generic drugs, and a cap of the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price;
•a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled, infused, instilled, implanted, or injected;
•extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
•expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;
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•expansion of the entities eligible for discounts under the Public Health program, commonly referred to as the “340B Program;”
•a requirement to annually report drug samples that manufacturers and distributors provide to physicians, also known as the “Physician Payments Sunshine Act;”
•a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
•establishment of a Center for Medicare Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending; and
•a licensure framework for follow-on biologic products.
Since its enactment, there have been judicial and Congressional challenges to certain aspects of PPACA, and there may be additional challenges and amendments to PPACA in the future. For example, in 2017, Congress enacted the Tax Cuts and Jobs Act, which repealed the tax-based shared responsibility payment imposed by PPACA on certain individuals who fail to maintain qualifying health coverage that is commonly referred to as the “individual mandate.”
In addition, other legislative changes have been proposed and adopted in the United States since PPACA was enacted which, among other things, have reduced Medicare payments to several types of providers, including hospitals and cancer treatment centers.
For example, on August 16, 2022, the IRA, was passed, which among other things, allows for CMS to negotiate prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D, beginning with 10 high-cost drugs paid for by Medicare Part D starting in 2026, followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029 and beyond. The legislation subjects drug manufacturers to civil monetary penalties and a potential excise tax for failing to comply with the legislation by offering a price that is not equal to or less than the negotiated “maximum fair price” under the law or for taking price increases that exceed inflation. The legislation also caps Medicare beneficiaries’ annual out-of-pocket drug expenses at $2,000. The effect of the IRA on our business and the healthcare industry in general is not yet known.
These new laws or any other similar laws introduced in the future, as well as regulatory actions that may be taken by CMS, may result in additional reductions in Medicare and other healthcare funding, which could negatively affect our customers and accordingly, our financial operations. Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. Additionally, individual states in the United States have passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing and costs. Similar developments have occurred outside of the United States, including in the European Union where healthcare budgetary constraints have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers.
To obtain reimbursement or pricing approval in some European Union member states, we may be required to conduct studies that compare the cost-effectiveness of a product candidate to other therapies that are considered the local standard of care. We cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation or administrative action in the United States or any other jurisdiction. If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties are not able to maintain regulatory compliance, a product candidate may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.
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Risks Related to Intellectual Property
Patents and patent applications involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our business position.
The patent positions of biopharmaceutical companies and other actors in our fields of business can be highly uncertain and typically involve complex scientific, legal and factual analyses. In particular, the interpretation and breadth of claims allowed in some patents covering biopharmaceutical compositions may be uncertain and difficult to determine, and are often affected materially by the facts and circumstances that pertain to the patented compositions and the related patent claims. The standards of the United States Patent and Trademark Office (the “USPTO”) and its foreign counterparts are sometimes uncertain and could change in the future.
Consequently, the issuance and scope of patents cannot be predicted with certainty. Patents, if issued, may be challenged, invalidated or designed around. U.S. patents and patent applications may also be subject to interference or derivation proceedings, and U.S. patents may be subject to reexamination, post-grant review and/or inter parties review proceedings in the USPTO.
International patents may also be subject to opposition or comparable proceedings in the corresponding international patent office, which could result in either loss of the patent or denial of the patent application, or loss or reduction in the scope of one or more of the claims of the patent or patent application. In addition, such interference, derivation, reexamination, post-grant review, inter partes review and opposition proceedings may be costly. Accordingly, rights under any issued patents may not provide us with sufficient protection against competitive products or processes.
Furthermore, even if not challenged, our patents and patent applications may not adequately protect our technology and product candidates or products that we develop alone or with collaborators or prevent others from designing their products to avoid being covered by our claims. If the breadth or strength of protection provided by the patents and patent applications that we hold with respect to our product candidates or potential products is threatened, it could dissuade companies from collaborating with us to develop, and could threaten our or their ability to successfully commercialize, such product candidates or potential products.
In addition, changes in, or different interpretations of, patent laws in the United States and other countries may permit others to use our discoveries or to develop and commercialize our technology and product candidates or products without providing any compensation to us, or may limit the scope of patent protection that we are able to obtain. The laws of some countries do not protect intellectual property rights to the same extent as U.S. laws, and those countries may lack adequate rules and procedures for defending our intellectual property rights.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications. We rely on our outside counsel and employ an outside firm to pay these fees due to USPTO and non-U.S. patent agencies. The USPTO and various non-U.S. governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. Although an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to enter the market, which would have a material adverse effect on our business.
If the patent applications we hold or have in-licensed with respect to our current and future research and development programs and product candidates fail to issue, if their validity, breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for our technology or any products and product candidates that we or our collaborators develop, it could dissuade companies from collaborating with us to develop product candidates, encourage competitors to develop competing products or technologies and threaten our or our collaborators’ ability to commercialize our current and any future product candidates. Any such outcome could have a material adverse effect on our business.
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Third parties may assert claims against us alleging infringement of their patents and proprietary rights, or we may need to become involved in lawsuits to defend or enforce our patents, either of which could result in substantial costs or loss of productivity, delay or prevent the development and commercialization of our current and any future product candidates, prohibit our use of proprietary technology or sale of potential products or put our patents and other proprietary rights at risk.
Our commercial success depends in part upon our ability to develop, manufacture, market and sell product candidates without alleged or actual infringement, misappropriation or other violation of the patents and proprietary rights of third parties. Litigation relating to infringement or misappropriation of patent and other intellectual property rights in the pharmaceutical and biotechnology field is common, including patent infringement lawsuits, and such interference, derivation, reexamination, post-grant review, inter parties review and opposition proceedings before the USPTO and corresponding international patent offices.
The various markets in which we plan to operate are subject to frequent and extensive litigation regarding patents and other intellectual property rights. In addition, many companies in intellectual property-dependent industries, including the biotechnology and pharmaceutical industries, have employed intellectual property litigation as a means to gain an advantage over their competitors.
Numerous United States, EU and other internationally issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we and our collaborators are developing product candidates. For example, we are aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034 that potentially cover certain parts of the intellectual property included in CTIM-76. As well, we are aware of a pending patent application in the United States and certain foreign jurisdictions that, if issued, would expire in 2042, and that potentially covers certain parts of the intellectual property included in CTIM-76. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our current and any future product candidates may be subject to claims of infringement of the intellectual property rights of third parties.
As a result of any patent infringement claims, or in order to avoid any potential infringement claims, we may choose to seek, or be required to seek, a license from a third party, which may require payment of substantial royalties or fees, or require us to grant a cross-license under our intellectual property rights.
These licenses may not be available on reasonable terms or at all. Even if a license can be obtained on reasonable terms, the rights may be nonexclusive, which would give our competitors access to the same intellectual property rights. If we are unable to enter into a license on acceptable terms, we or our collaborators could be prevented from commercializing one or more product candidates, forced to modify such product candidates, forced to cease some aspect of our business operations, or be required to pay substantial damages to a third party, which could harm our business significantly.
We or our collaborators might also be forced to redesign or modify our technology or product candidates so that we no longer infringe the third-party intellectual property rights, which may result in significant cost or delay to us, or which redesign or modification could be impossible or technically infeasible. Even if we were ultimately to prevail, any of these events could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.
Further, if a patent infringement suit is brought against us, our collaborators or our third-party service providers, our development, manufacturing or sales activities relating to the product or product candidate that is the subject of the suit may be delayed or terminated. In addition, defending such claims may cause us to incur substantial expenses and, if successful, could cause us to pay substantial damages if we are found to be infringing a third-party’s patent rights. We may not have sufficient resources to bring these actions to a successful conclusion.
These damages potentially include treble damages and attorneys’ fees if we are found to have infringed such rights willfully. Some claimants may have substantially greater resources than we do and may be able to sustain the costs of complex intellectual property litigation to a greater degree and for longer periods of time than we could. In addition, patent holding companies that focus solely on extracting royalties and settlements by enforcing patent rights may target us.
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We may in the future be subject to third-party claims and similar adversarial proceedings or litigation in other jurisdictions regarding our infringement of the patent rights of third parties. Even if such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, and the holders of any such patents may be able to block our or our collaborators’ ability to further develop or commercialize the applicable product candidate unless we obtain a license under the applicable patents, or until such patents expire or are finally determined to be invalid or unenforceable.
Similarly, if any third-party patents were held by a court of competent jurisdiction to cover aspects of our technologies, compositions, formulations, or methods of treatment, prevention or use, the holders of any such patents may be able to prohibit our use of those technologies, compositions, formulations, methods of treatment, prevention or use or other technologies, effectively blocking our or our collaborators’ ability to develop and commercialize the applicable product candidate until such patent expires or is finally determined to be invalid or unenforceable or unless we or our collaborators obtain a license.
Competitors may infringe our patents. In the event of infringement or unauthorized use, we may file one or more infringement lawsuits, which can be expensive and time-consuming. An adverse result in any such litigation proceedings could put one or more of our patents at risk of being invalidated, being found to be unenforceable, and/or being interpreted narrowly and could put our patent applications at risk of not issuing and/or could impact the validity or enforceability positions of our other patents. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.
Some of our competitors may be able to sustain the costs of complex intellectual property litigation more effectively than we can because they have substantially greater resources. In addition, intellectual property litigation, regardless of its outcome, may cause negative publicity, adversely impact prospective customers, cause product shipment delays or prohibit us from manufacturing, marketing or otherwise commercializing our products, services and technology.
Any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise additional funds or otherwise have a material adverse effect on our business, results of operation, financial condition or cash flows.
Our ability to compete effectively in our markets may decline if we do not adequately protect our proprietary rights, and our proprietary rights do not necessarily address all potential threats to our competitive advantages.
We rely on patent protection as well as trademark, trade secret and other intellectual property rights protection and contractual restrictions to protect CTIM-76, CT-95, CT-202 and any future product candidates. Our commercial success depends upon obtaining and maintaining proprietary rights to our intellectual property estate, including rights relating to CTIM-76, CT-95, CT-202 and any future product candidates, as well as successfully defending these rights against third-party challenges and successfully enforcing these rights to prevent third-party infringement. We will only be able to protect CTIM-76, CT-95, CT-202 and any future product candidates from unauthorized use by third parties to the extent that valid and enforceable patents or effectively protected trade secrets cover them.
Our ability to obtain and maintain patent protection for CTIM-76, CT-95, CT-202 and any future product candidates is uncertain due to a number of factors, including the following factors:
•we may not have been the first to invent the technology covered by our pending patent applications or issued patents;
•we may not be the first to file patent applications covering product candidates, including their compositions or methods of use, as patent applications in the United States and most other countries are confidential for a period of time after filing;
•others may identify prior art or other bases upon which to challenge and ultimately invalidate our patents or otherwise render them unenforceable;
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•our compositions and methods may not be patentable;
•our disclosures in patent applications may not be sufficient to meet the statutory requirements for patentability;
•any or all of our pending patent applications may not result in issued patents;
•others may independently develop identical, similar or alternative technologies, products or compositions, or methods of use thereof;
•others may design around our patent claims to produce competitive technologies or products that fall outside of the scope of our patents;
•we may fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection;
•we may not seek or obtain patent protection in countries and jurisdictions that may eventually provide us a significant business opportunity;
•we may decide not to maintain or pursue patents and patent applications that, at some point in time, may cover our products, potential products, or product candidates;
•any patents issued to us may not provide a basis for commercially viable products, may not provide any competitive advantages or may be successfully challenged by third parties;
•our representatives or their agents may fail to apply for or maintain patents in a timely fashion; and
•despite our efforts to enter into agreements with employees, consultants, collaborators, and advisors to confirm ownership and chain of title in patents and patent applications, an inventorship or ownership dispute could arise that may permit one or more third parties to practice our technologies or enforce our patent rights, including possible efforts to enforce patent rights against us.
Even if we have or obtain patents covering CTIM-76, CT-95, CT-202 and any future product candidates or compositions, others may have filed, and in the future may file, patent applications covering compositions, products or methods that are similar or identical to ours, which could materially affect our ability to successfully develop a product candidate or to successfully commercialize any approved products alone or with collaborators. In addition, because patent applications can take many years to issue, there may be currently pending applications unknown to us that may later result in issued patents that may cover CTIM-76, CT-95, CT-202 or any future product candidates or compositions. These patent applications may have priority over patent applications filed by us. For example, we are aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034 that potentially cover certain parts of the intellectual property included in CTIM-76. As well, we are aware of a pending patent application in the United States and certain foreign jurisdictions that, if issued, would expire in 2042, and that potentially covers certain parts of the intellectual property included in CTIM-76. While we believe we will have reasonable defenses against any potential claim of infringement, including challenging the validity of any such patents, we may not be successful in such efforts, and we also may not be able to obtain a license to such patents on commercially reasonable terms, or at all. If such patent is valid and not yet expired when, and if, we receive marketing approval for CTIM-76 we may need to seek a license to such patent, which may not be available on commercially reasonable terms or at all. Failure to receive a license to such patent, or other potentially relevant patents currently unknown to us, could delay the manufacture or commercialization of CTIM-76 or require us to incur additional payments and expenses, including legal fees, court issued damages or settlement costs.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products.
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In the United States, the natural expiration of a patent is generally 20 years after it is filed. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited.
Without patent protection for current or any future product candidates, we may be open to competition from generic or biosimilar versions of such potential products. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to those we or our collaborators may develop.
In addition, we also try to protect our trade secrets, know-how and other proprietary information through non-disclosure and confidentiality provisions in our agreements with parties who have access to them, such as our employees, consultants and research partners. Such agreements may not be enforceable or may not provide meaningful protection for our trade secrets, know-how and/or other proprietary information in the event of unauthorized uses or disclosure or other breaches of the provisions, and we may not be able to prevent such unauthorized uses or disclosure. Moreover, if a party having an agreement with us has an overlapping or conflicting obligation to a third party, our rights in and to certain intellectual property could be undermined. Monitoring unauthorized and inadvertent disclosure and uses is difficult, and we do not know whether the steps we have taken to prevent such disclosure and uses are, or will be, adequate. In addition, monitoring unauthorized disclosure and uses of our trade secrets is difficult, and we do not know whether the steps we have taken to prevent such disclosure and uses are, or will be, adequate. If we were to enforce a claim that a third party had illegally obtained and was using our trade secrets, it would be expensive and time-consuming, and the outcome would be unpredictable, and any remedy may be inadequate. In addition, courts outside the United States may be less willing to protect trade secrets.
We rely on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to protect our trade secrets and other proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover our trade secrets and proprietary information. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.
Because we rely on third parties to manufacture our product candidates, and because we collaborate with various organizations and academic institutions on the advancement of our current and potential product candidates, we must, at times, share trade secrets with them. We seek to protect our proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements, consulting agreements or other similar agreements with our manufacturers, collaborators, advisors, employees and consultants prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information, such as trade secrets. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, are used inappropriately to create new inventions or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have a material adverse effect on our business.
If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
We are a party to intellectual property license agreements that are important to our business and expect to enter into additional license agreements in the future. Our existing license agreements impose, and we expect that future license agreements will impose, various diligence, milestone payment, royalty and other obligations on us.
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Additionally, we may need to outsource and rely on third parties for many aspects of the development, sales and marketing of any products covered under our current and future license agreements. Delay or failure by these third parties could adversely affect the continuation of our license agreements with our licensors. If we fail to comply with any of our obligations under these agreements, or we are subject to a bankruptcy, our licensors may have the right to terminate the license, in which event we would not be able to market any products covered by the license.
In some cases, patent prosecution of our licensed technology is controlled solely by the licensor. If such licensor fails to obtain and maintain patent or other protection for the proprietary intellectual property we license from such licensor, we could lose our rights to such intellectual property or the exclusivity of such rights, and our competitors could market competing products using such intellectual property. In that event, we may be required to expend significant time and resources to develop or license replacement technology. Additionally, if such licensor fails to have patent rights that they otherwise may claim to have for the proprietary intellectual property we license from such licensor or they infringe the intellectual property rights of a third party, it could delay or materially impact our ability to commercialize our product candidates that rely on such intellectual property. In that event, we may be required to expend significant time and resources to develop or license replacement technology, to address any infringement claims that may be made by such third party, and to compensate a third party for any infringement.
If we are unable to develop or license replacement technology, we or our collaborators may be unable to develop or commercialize the affected product candidates, which could harm our business significantly. In other cases, we control the prosecution of patents resulting from licensed technology. In the event we breach any of our obligations related to such prosecution, we may incur significant liability to our licensing partners.
Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues and is complicated by the rapid pace of scientific discovery in our industry. Disputes may arise regarding intellectual property subject to a licensing agreement, including:
•the scope of rights granted under the license agreement and other interpretation-related issues;
•the extent to which our technology and processes infringe intellectual property of the licensor or a third party that is not subject to the licensing agreement;
•the extent to which the licensed intellectual property may infringe the intellectual property of a third party that is not subject to the licensing agreement, as well as the licensor’s potential breach of its related warranties or obligations in a licensing agreement;
•the sublicensing of patent and other rights under our collaborative development relationships;
•our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
•the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and
•the priority of invention of patented technology.
If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.
If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation with respect to our current and any future product candidates, thereby potentially extending the term of marketing exclusivity for such product candidates, our business may be harmed.
In the United States, a patent that covers an FDA-approved drug or biologic may be eligible for a term extension designed to restore the period of the patent term that is lost during the premarket regulatory review process conducted by the FDA. Depending upon the timing, duration and conditions of FDA marketing approval of our current and any future product candidates, one or more of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act,
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which permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process.
In the European Union, our current and any future product candidates may be eligible for term extensions based on similar legislation. In either jurisdiction, however, we may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements.
Even if we are granted such extension, the duration of such extension may be less than our request. If we are unable to obtain a patent term extension, or if the term of any such extension is less than our request, the period during which we can enforce our patent rights for that product will be in effect shortened and our competitors may obtain approval to market competing products sooner. The resulting reduction of years of revenue from applicable products could be substantial.
We may not be able to protect our intellectual property rights throughout the world.
Filing, prosecuting and defending patents on our current and any future product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
Changes in U.S. patent law, and the laws of other countries, could diminish the value of patents in general, thereby impairing our ability to protect our products.
The United States has enacted, and continues to consider, wide-ranging patent reform legislation. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, the USPTO, and the courts and regulatory agencies in other countries, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.
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Risks Related to the Market for Our Common Stock
Our common stock may be volatile or may decline regardless of our operating performance.
The market price for our common stock is likely to be volatile, in part because our shares have been traded publicly for only a few years. In addition, the market price of our common stock has and may continue to fluctuate significantly in response to several factors, most of which we cannot control, including:
•quarterly variations in our operating results compared to market expectations;
•adverse publicity about us, the industries we participate in or individual scandals;
•announcements of new offerings or significant price reductions by us or our competitors;
•stock price performance of our competitors;
•fluctuations in stock market prices and volumes;
•large purchases or sales causing stock price fluctuations due to low trading volumes;
•changes in senior management or key personnel;
•changes in financial estimates by securities analysts;
•the market’s reaction to our reduced disclosure as a result of being an “emerging growth company” under the JOBS Act;
•negative earnings or other announcements by us or our competitors;
•defaults on indebtedness, incurrence of additional indebtedness, or issuances of additional capital stock;
•global economic, legal and regulatory factors unrelated to our performance; and
•the other factors listed in this “Risk Factors” section.
Volatility in the market price of our common stock may prevent investors from being able to sell their shares at or above their purchase price. As a result, you may suffer a loss on your investment.
We may not be able to regain and maintain compliance with the continued listing requirements of The Nasdaq Stock Market.
Our common stock is listed on The Nasdaq Stock Market. In order to maintain that listing, we must satisfy minimum financial and other requirements including, without limitation, a requirement that our closing bid price be at least $1.00 per share. On February 27, 2025, we received a letter from Nasdaq stating that the we were not in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”) because our common stock failed to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days. This letter provides an initial 180 calendar day period, or until August 26, 2025, in which to regain compliance. We may request stockholder approval to undergo a reverse stock split in order to regain compliance with the $1.00 closing bid price requirement. If we do not regain compliance by August 26, 2025, we may be eligible for an additional 180-day grace period. If we fail to regain and maintain compliance with the Minimum Bid Price Rule or we fail to continue to meet all other applicable continued listing requirements for The Nasdaq Stock Market, our common stock may be delisted, which would adversely affect the market liquidity of our common stock and our ability to obtain financing to fund our operations.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the market price for the shares and trading volume could decline.
The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. If research analysts do not establish and maintain adequate
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research coverage or if one or more of the analysts who covers us downgrades our common stock or publishes inaccurate or unfavorable research about our business, the market price for our common stock would likely decline. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, we could lose visibility in the financial markets, which, in turn, could cause the market price or trading volume for our common stock to decline.
We do not expect to pay dividends in the foreseeable future, and you must rely on price appreciation of your shares for return on your investment.
We have paid no cash dividends on any class of our stock to date, and we do not anticipate paying cash dividends in the near term. For the foreseeable future, we intend to retain any earnings to finance the development and expansion of our business, and we do not anticipate paying any cash dividends on our stock. Accordingly, investors must be prepared to rely on sales of their shares after price appreciation to earn an investment return, which may never occur. Investors seeking cash dividends should not purchase our shares. Any determination to pay dividends in the future will be made at the discretion of our board of directors and will depend on our results of operations, financial condition, contractual restrictions, restrictions imposed by applicable law and other factors our board deems relevant.
We may issue debt and equity securities, which are senior to our common stock as to distributions and in liquidation, which could materially adversely affect the market price of our common stock.
In the future, we may attempt to increase our capital resources by entering into debt or debt-like financing that is secured by all or up to all of our assets, or issuing debt or equity securities, which could include issuances of commercial paper, medium-term notes, senior notes, subordinated notes or shares. In the event of our liquidation, our lenders and holders of our debt securities would receive a distribution of our available assets before distributions to our stockholders. In addition, any preferred stock, if issued by our company, may have a preference with respect to distributions and upon liquidation, which could further limit our ability to make distributions to our stockholders. Because our decision to incur debt and issue securities in our future offerings will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing or nature of our future offerings and debt financing.
Further, market conditions could require us to accept less favorable terms for the issuance of our securities in the future. Thus, you will bear the risk of our future offerings reducing the value of your common stock and diluting your interest in our company.
FINRA sales practice requirements may limit a stockholder’s ability to buy and sell our common stock.
The Financial Industry Regulatory Authority (“FINRA”) has adopted rules requiring that, in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending speculative or low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information. Under interpretations of these rules, FINRA has indicated its belief that there is a high probability that speculative or low-priced securities will not be suitable for at least some customers. If these FINRA requirements are applicable to us or our securities, they may make it more difficult for broker-dealers to recommend that at least some of their customers buy our common stock, which may limit the ability of our stockholders to buy and sell our common stock and could have an adverse effect on the market for and price of our common stock.
We are subject to ongoing public reporting requirements that are less rigorous than Exchange Act rules for companies that are not emerging growth companies and our stockholders could receive less information than they might expect to receive from more mature public companies.
We are required to publicly report on an ongoing basis as an “emerging growth company” (as defined in the JOBS Act) under the reporting rules set forth under the Exchange Act. For so long as we remain an emerging growth
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company, we may take advantage of certain exemptions from various reporting requirements that are applicable to other Exchange Act reporting companies that are not emerging growth companies, including but not limited to:
•not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act;
•being permitted to comply with reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and
•being exempt from the requirement to hold a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the benefits of this extended transition period. Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards.
We expect to take advantage of these reporting exemptions until we are no longer an emerging growth company. We will remain an emerging growth company until October 19, 2026, although if the market value of our common stock that is held by non-affiliates exceeds $700 million as of any June 30 before that time, we would cease to be an emerging growth company as of the following December 31.
Because we are subject to ongoing public reporting requirements that are less rigorous than Exchange Act rules for companies that are not emerging growth companies, our stockholders could receive less information than they might expect to receive from more mature public companies. We cannot determinate if investors find our common stock less attractive because we elect to rely on these exemptions, or if taking advantage of these exemptions has or will result in less active trading or more volatility in the price of our common stock.
If we fail to maintain effective internal control over financial reporting and effective disclosure controls and procedures, we may not be able to accurately report our financial results in a timely manner or prevent fraud, which may adversely affect investor confidence in our company.
We are subject to the reporting requirements of the Exchange Act, as well as the Sarbanes-Oxley Act and the rules and regulations of the stock market on which our common stock is listed. We are required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting. This assessment includes disclosure of any material weaknesses identified by our management in our internal control over financial reporting. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting in our first annual report required to be filed with the SEC following the date we are no longer an emerging growth company if we are not a non-accelerated filer at such time.
If we or our independent registered public accounting firm determines we have a material weakness in our internal control over financial reporting, investors could lose confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by the SEC or other regulatory authorities. Failure to remedy any material weakness or significant deficiency in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity and/or debt financings, partnerships and collaborations, licensing agreements or other strategic arrangements. To the extent that we raise additional capital or pay expenses through the sale or
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issuance of equity or convertible debt securities, your ownership interest will be diluted, and the terms of such securities may include liquidation or other preferences that adversely affect your rights as a common stockholder.
To the extent that we raise additional capital through debt financing, it would result in increased fixed payment obligations and a portion of our operating cash flows, if any, being dedicated to the payment of principal and interest on such indebtedness. In addition, debt financing may involve agreements that include restrictive covenants that impose operating restrictions, such as restrictions on the incurrence of additional debt, the making of certain capital expenditures or the declaration of dividends.
To the extent we raise additional capital through arrangements with collaborators or otherwise, we may be required to relinquish some of our technologies, research programs, product development activities, product candidates and/or future revenue streams, license our technologies and/or product candidates on unfavorable terms or otherwise agree to terms unfavorable to us. Furthermore, any capital raising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to advance research programs, product development activities or current or future product candidates.
General Risk Factors
We incur increased costs as a result of being a public company and in the administration of our organizational structure.
As a public company, we have incurred significant legal, accounting, insurance, and other expenses, including costs associated with public company reporting requirements. We also have incurred and will continue to incur costs associated with the Sarbanes-Oxley Act and related rules implemented by the SEC and ongoing periodic expenses in connection with the administration of our organizational structure. These laws and regulations could make it more difficult or costly for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. These laws and regulations could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as our executive officers. Furthermore, if we are unable to satisfy our obligations as a public company, we could be subject to delisting of our common stock, fines, sanctions and other regulatory action and potentially civil litigation.
We are subject to complex tax rules relating to our business, and any audits, investigations or tax proceedings could have a material adverse effect on our business, results of operations and financial condition.
We are subject to income and non-income taxes in the United States and Ireland, as well as the tax laws and regulations related to such matters. Tax accounting and compliance often involves complex issues, and judgment and interpretation is required in determining our provision for income taxes and other tax liabilities as well as the application of tax laws and regulations. We could become subject to income and non-income taxes in non-U.S. jurisdictions other than Ireland as well. In addition, many jurisdictions have detailed transfer pricing rules, which require that all transactions with related parties be priced using arm’s length pricing principles within the meaning of such rules. The application of such transfer pricing rules, as well as of withholding taxes, goods and services taxes, sales taxes and other taxes is not always clear and we may be subject to tax audits relating to such rules or taxes. We are also currently not subject to any tax audits.
However, various items cannot be accurately forecasted and future events may be treated as discrete to the period in which they occur. In addition, the Internal Revenue Service or other taxing authorities may disagree with our positions. Furthermore, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us (possibly with retroactive effect). If the Internal Revenue Service or any other tax authorities were successful in challenging our positions, or existing tax laws, statutes, rules, regulations or ordinances are so interpreted, changed or modified, we may be liable for additional tax and penalties and interest related thereto or other taxes, as applicable, in excess of any reserves established therefor, which may have a significant impact on our results and operations and future cash flow.
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Our business and operations would suffer in the event of system failures or security breaches.
Our computer systems, as well as those of third parties with which we have relationships, are vulnerable to damage from computer viruses, unauthorized access, natural and manmade disasters, terrorism, war and telecommunication and electrical failures. If we or a third party with which we have relationships were to experience a system failure, accident or security breach, such an event could cause interruptions in our or their operations, or it could result in delays and/or material disruptions of our research and development programs. For example, the loss of trial data from completed, ongoing or planned trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of or damage to data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability and the development of our current and any future product candidates could be delayed.
The U.S. federal and various state and foreign governments have enacted or proposed requirements regarding the collection, distribution, use, security and storage of personally identifiable information and other data relating to individuals, and U.S. federal and state consumer protection laws are being applied to enforce regulations related to the online collection, use and dissemination of data. In the ordinary course of our business, we and third parties with which we have relationships collect and store sensitive data, including intellectual property, clinical trial data, proprietary business information, personal data and personally identifiable information of our clinical trial subjects and employees, consultants and contractors, in data centers and on networks. The secure processing, maintenance and transmission of this information is critical to our operations. Despite our and our collaborators’ security measures, our information technology and infrastructure may be vulnerable to attacks by hackers or internal bad actors, breaches due to employee error, technical vulnerabilities, malfeasance or other disruptions, and any such breach could compromise our or their networks and the information stored there could be accessed, publicly disclosed, lost or stolen.
Any such access, disclosure, notifications, follow-up actions related to such a security breach or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information and significant costs, including regulatory penalties, fines and legal expenses, and such an event could disrupt our operations, cause us to incur remediation costs, damage our reputation and cause a loss of confidence in us and our collaborators’ ability to conduct clinical trials, which could adversely affect our reputation and delay our research and development programs.
We or third parties with whom we have relationships may be adversely affected by natural or manmade disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
Natural or manmade disasters could severely disrupt our operations and have a material adverse effect on our business, results of operations, financial condition and prospects. If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our facilities, that damaged our infrastructure or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time, and our research and development activities could be setback or delayed.
The disaster recovery and business continuity plan(s) we have in place may prove inadequate in the event of a serious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which could have a material adverse effect on our business, and such an event could disrupt our operations, cause us to incur remediation costs, damage our reputation and cause a loss of confidence in us and our or third parties’ ability to conduct clinical trials, which could adversely affect our reputation and delay our research and development programs.
We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
We may now and in the future employ individuals who were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or
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disclosed intellectual property, including trade secrets or other proprietary information, of any of our employees’ former employers or other third parties. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel, which could adversely impact our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees and consultants.
We could be subject to securities class action litigation.
In the past, securities class action litigation has often been brought against companies following a decline in the market price of their securities. This risk is especially relevant for us because biotechnology companies have experienced significant share price volatility in recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.
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Item 1B. Unresolved Staff Comments
None.
Item 1C. Cybersecurity
Risk Management and Strategy
We recognize the critical importance of developing, implementing, and maintaining robust cybersecurity measures to safeguard our information systems and protect the confidentiality, integrity, and availability of our data.
Managing Material Risks & Integrated Overall Risk Management
Risks from Cybersecurity Threats
Governance
Management’s Role Managing Risk
•Current cybersecurity landscape and emerging threats;
•Status of ongoing cybersecurity initiatives and strategies;
•Learnings from any cybersecurity events; and
•Compliance with regulatory requirements and industry standards.
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Monitor Cybersecurity Incidents
Item 2. Properties
Our corporate headquarters are located at 2001 Market Street, Suite 3915, Unit #15, Philadelphia, PA 19103, where we occupy approximately 3,500 square feet of office space pursuant to a lease that was set to expire on August 31, 2024 if we did not renew the lease for an additional year. In March 2024, we amended the lease to extend the expiration date to November 30, 2024. In July 2024, we further amended the lease, which now expires on November 30, 2026 and renews at our option for two additional successive one-year periods should we provide the landlord with notice of extension at least nine months before any such successive renewal.
Item 3. Legal Proceedings
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not presently a party to any material legal proceedings.
Item 4. Mine Safety Disclosures
None.
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PART II.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchase of Equity Securities
Market Information
Our common stock has been traded on The Nasdaq Stock Market under the symbol “CNTX” since October 20, 2021 following our initial public offering.
Stockholders
As of March 18, 2025, we had 89,704,194 shares of common stock outstanding held by 48 holders of record. The actual number of stockholders is greater than this number of record holders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees. This number of holders of record also does not include stockholders whose shares may be held in trust by other entities.
Dividends
We have not paid cash dividends on any class of our stock to date, and we do not anticipate paying any cash dividends in the near term. For the foreseeable future, we intend to retain any earnings to finance the development and expansion of our business, and we do not anticipate paying any cash dividends on our stock. Any determination to pay dividends in the future will be made at the discretion of our board of directors and will depend on our results of operations, financial condition, contractual restrictions, restrictions imposed by applicable law and other factors our board deems relevant.
Securities Authorized for Issuance under Equity Compensation Plans
Information required by Item 5 of Form 10-K regarding our equity compensation plans is incorporated herein by reference to Item 12 of Part III of this Annual Report on Form 10-K.
Item 6. [Reserved]
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Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes and other financial information included elsewhere in this Form 10-K. Some of the information contained in this discussion and analysis, including information with respect to our plans and strategy for our business, contains forward-looking statements that involve risks and uncertainties. You should review the section titled “Risk Factors” in this Form 10-K for a discussion of important factors that could cause actual results to differ materially from the results described below. Please also see the section entitled “Note Regarding Forward-Looking Statements.”
Overview
We are a clinical-stage biopharmaceutical company advancing TCE bispecific antibodies for solid tumors. We are building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a CLDN6 x CD3 TCE, CT-95, an MSLN x CD3 TCE, and CT-202, a Nectin-4 x CD3 TCE.
CTIM-76 is a CLDN6 x CD3 TCE that is intended to redirect T-cell-mediated lysis toward malignant cells expressing CLDN6. CLDN6 is a tight junction membrane protein target expressed in multiple solid tumors and absent from or expressed at low levels in healthy adult tissues. IND-enabling studies on CTIM-76 have been completed. On May 2, 2024, we announced the FDA cleared our IND application to support the initiation of a Phase 1 dose escalation and expansion trial of CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers. We dosed the first patient in our CTIM-76 Phase 1 trial in January 2025. We expect to share initial data for the CTIM-76 Phase 1 trial in the first half of 2026.
On September 23, 2024, we entered into the BioAtla License Agreement with BioAtla, pursuant to which we obtained an exclusive, worldwide license to develop, manufacture and commercialize the BioAtla Asset, including BA3362 (renamed by the Company as CT-202), BioAtla’s Nectin-4 x CD3 TCE.
As partial consideration for the exclusive license under the BioAtla License Agreement, we made an upfront payment of $11.0 million, and BioAtla is eligible to receive up to $122.5 million in additional milestone payments based upon the achievement of specified pre-clinical, clinical, development and commercial milestones, as well as tiered mid-single digit to low double-digit royalties on future net sales for products containing the BioAtla Assets, subject to standard reductions.
CT-202 is a Nectin-4 x CD3 TCE that targets Nectin-4, a cell surface protein that is highly and frequently overexpressed in a variety of solid tumors, including bladder, colorectal, lung and breast. Nectin-4 is a clinically validated target for cancer therapy using a traditional antibody-drug conjugate (“ADC”), but it is also associated with certain adverse events, including neuropathy and rash. CT-202 is a pH-dependent TCE that is designed to be preferentially active within the tumor microenvironment. We expect to file an IND application for CT-202 in the middle of 2026.
On July 9, 2024, we entered into the Asset Purchase Agreement pursuant to which we acquired CT-95 (formerly known as LNK-101), from Link, which succeeded to the assets of Link Immunotherapeutics Inc. The FDA previously cleared the IND application for CT-95.
Pursuant to the Asset Purchase Agreement, we purchased the Transferred Assets on an “as is” and “where is” basis. CT-95 patents are currently being prosecuted and/or maintained in the United States, Europe, Canada, Australia, Japan and Taiwan. We also assumed certain liabilities relating to the Transferred Assets. In consideration of the Transferred Assets, we made a one-time payment to Link of $3.75 million.
CT-95 is an MSLN x CD3 TCE that is intended to redirect T-cell-mediated lysis toward malignant cells expressing MSLN. MSLN is a membrane protein overexpressed in approximately 30% of cancers. We anticipate dosing the first patient in the CT-95 Phase 1 trial in the second quarter of 2025. We expect to share initial data for the CT-95 Phase 1 trial in the middle of 2026.
On December 2, 2024, we entered into the ATM Sales Agreement with Agent. Pursuant to the terms of the ATM Sales Agreement, we may offer and sell ATM Shares having an aggregate offering amount of up to $75.0
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million from time to time through the Agent. Sales of the ATM Shares may be made in sales deemed to be an “at-the-market offering” as defined in Rule 415 under the Securities Act. The Agent will be entitled to a commission from the Company of 3.0% of the gross proceeds from the sale of ATM Shares sold under the ATM Sales Agreement. On December 23, 2024, the Company sold 14,705,882 shares of its common stock under the ATM Sales Agreement for net proceeds of approximately $14.5 million.
On May 1, 2024, we entered into the Purchase Agreement for the Private Placement of (i) 59,032,259 PIPE Shares at a purchase price of $1.55 per PIPE Share and (ii) Pre-Funded Warrants to purchase 5,482,741 Warrant Shares at a purchase price of $1.549 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $0.001 per share of common stock, are immediately exercisable and remain exercisable until exercised in full. The aggregate gross proceeds for the Private Placement were approximately $100 million, before deducting offering expenses of $5.2 million, and the Private Placement closed on May 6, 2024.
On February 29, 2024, we amended the Integral License Agreement to reflect updated financial terms. In the course of our further due diligence review of CTIM-76, we determined that certain of the licensed rights under the Integral License Agreement may incorporate intellectual property rights currently held by a third party. Specifically, we are aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034 that potentially cover certain parts of the intellectual property included in CTIM-76. While we believe we will have reasonable defenses against any potential claim of infringement, we may not be successful in such efforts, and we also may not be able to obtain a license to such patent on commercially reasonable terms, or at all.
As part of the Second Amendment, Integral’s right to receive certain future payments was reduced as follows: aggregate development and regulatory milestone payments were reduced from $55 million to $15 million, aggregate sales milestone payments were reduced from $130 million to $12.5 million, and a tiered royalty of 8-12% that commenced at first commercial sale was reduced to a flat royalty rate of 6% on net sales beginning no sooner than February 1, 2034. The Second Amendment also narrowed the license grant from Integral to us to only cover CTIM-76, removed any further obligation of us to reimburse Integral for any independently obtained research funding Integral applied against CTIM-76 research, and included mutual releases by the parties.
The reduced development and regulatory milestones now reflect a payment due at each of: first patient’s first screening visit in a Phase 1b/2 or Phase 2 clinical trial for CTIM-76, first patient’s first screening visit in a Phase 3 clinical trial for CTIM-76, United States marketing approval for CTIM-76, European Union marketing approval for CTIM-76, United Kingdom marketing approval for CTIM-76, and Japan marketing approval for CTIM-76. The amended commercial milestones now also reflect a payment due upon the achievement of annual net sales of $500 million and annual net sales of $1 billion.
On March 22, 2023, we announced a portfolio prioritization and capital allocation strategy, including discontinuing the development of ONA-XR and focusing on the development of CTIM-76. Based upon the challenging market conditions for emerging companies, the increasingly competitive landscape for breast cancer treatments, recent study findings, and other factors, we decided to cease development and explore strategic options for ONA-XR. As a result, we no longer primarily focus on female cancers.
We were incorporated in April 2015 under the laws of the State of Delaware. Since inception, we have devoted substantially all of our resources to developing product and technology rights, conducting research and development, organizing and staffing our company, business planning and raising capital. We operate as one business segment and have incurred recurring losses, the majority of which are attributable to research and development activities, and negative cash flows from operations. We have funded our operations primarily through the sale of convertible debt, convertible preferred stock, common stock and warrants. Our net loss was $26.7 million for the year ended December 31, 2024. As of December 31, 2024, we had an accumulated deficit of $94.8 million.
We expect to have sufficient cash and cash equivalents to fund the estimated duration of the dose escalation portions of our CTIM-76 and CT-95 Phase 1 trials, the estimated expenses through IND filing for CT-202, as well as our operations into 2027.
Currently, our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, as well as general and administrative expenditures. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual
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commercialization of one or more of our current or any future product candidates. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance our current and any future product candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval. In addition, if we obtain regulatory approval for any product candidate, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. Furthermore, we have incurred and continue to incur significant costs associated with operating as a public company, including legal, accounting, investor relations and other expenses. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenses on other research and development activities.
We expect to continue to incur net operating losses for at least the next several years, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase. We expect our expenses and capital requirements will increase significantly in connection with our ongoing activities as we:
•continue nonclinical studies and initiate clinical trials for CTIM-76, CT-95, CT-202 and for any additional product candidates that we may pursue;
•continue to scale up external manufacturing capacity with the aim of securing sufficient quantities to meet our capacity requirements for clinical trials and potential commercialization;
•establish a sales, marketing and distribution infrastructure to commercialize any approved product candidate and related additional commercial manufacturing costs;
•develop, maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know how;
•acquire or in-license other product candidates and technologies, including related upfront, milestone and royalty payments;
•attract, hire and retain additional executive officers, clinical, scientific, quality control, and manufacturing management and administrative personnel;
•add clinical, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts;
•expand our operations in the United States and to other geographies; and
•incur additional legal, accounting, investor relations and other expenses associated with operating as a public company.
As of December 31, 2024, we had cash and cash equivalents of $94.4 million, which we expect will be sufficient to fund our operations into 2027. If the Company is unable to obtain additional financing, the lack of liquidity could have a material adverse effect on the Company’s future prospects.
We will need to raise substantial additional capital to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we plan to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic transactions and/or marketing, distribution or licensing arrangements. There are no assurances that we will be successful in obtaining an adequate level of financing as and when needed to finance our operations on terms acceptable to us, or at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to secure adequate additional funding, we may have to
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significantly delay, scale back or discontinue the development and commercialization of one or more product candidates or delay our pursuit of potential in-licenses or acquisitions.
Components of Our Results of Operations
Operating Expenses
Research and Development Expenses
Research and development expenses have consisted primarily of costs incurred in connection with the discovery and development of our product candidates. We expense research and development costs as incurred, including:
•expenses incurred to conduct the necessary discovery-stage laboratory work, preclinical studies and clinical trials required to obtain regulatory approval;
•personnel expenses, including salaries, benefits and share-based compensation expense for our employees and consultants engaged in research and development functions;
•costs of funding research performed by third parties, including pursuant to agreements with CROs that conduct our clinical trials, as well as investigative sites, consultants and CROs that conduct our preclinical and clinical studies;
•expenses incurred under agreements with contract manufacturing organizations, including manufacturing scale-up expenses, milestone-based payments, and the cost of acquiring and manufacturing preclinical study and clinical trial materials;
•fees paid to consultants who assist with research and development activities;
•license payments and acquisitions of acquired in-process research and development assets that have no alternative future use;
•expenses related to regulatory activities, including filing fees paid to regulatory agencies; and
•allocated expenses for facility costs, including rent, utilities and maintenance.
We track outsourced development costs and other external research and development costs to specific product candidates on a program-by-program basis. However, we do not track our internal research and development expenses on a program-by-program basis as they primarily relate to compensation, early research and other costs which are deployed across multiple projects under development.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect our research and development expenses to increase significantly over the next several years as we increase personnel costs, including share-based compensation, conduct our clinical trials, including later-stage clinical trials, for current and any future product candidates and prepare regulatory filings for our current and any future product candidates.
General and Administrative Expenses
General and administrative expenses have consisted primarily of personnel expenses, including salaries, benefits and share-based compensation expense, for employees and consultants in executive, finance and accounting, legal, operations support, information technology and business development functions. General and administrative expense also includes corporate facility costs not otherwise included in research and development expense, including rent, utilities and insurance, as well as legal fees related to intellectual property and corporate matters and fees for accounting and consulting services.
We expect that our general and administrative expenses will increase in the future to support our continued research and development activities, potential commercialization efforts and increased costs of operating as a public
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company. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, legal support and accountants, among other expenses. Additionally, we will continue to incur significant costs associated with being a public company, including expenses related to services associated with maintaining compliance with the requirements of Nasdaq and the Securities and Exchange Commission (the “SEC”), insurance and investor relations costs. If any of our current or future product candidates obtain U.S. regulatory approval, we expect that we would incur significantly increased expenses associated with building a sales and marketing team.
Interest Income
Interest income consists of interest earned on our cash and cash equivalents.
Other Expense
Other expense is primarily due to the recognition of foreign currency losses as a result of exchange rate fluctuations on transactions denominated in a currency other than our functional currency.
Results of Operations
Comparison of the Years Ended December 31, 2024 and 2023
The following table sets forth our results of operations for the years ended December 31, 2024 and 2023:
| Year ended December 31, | |||||||||||||||||||||||
| 2024 | 2023 | $ Change | % Change | ||||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development | $ | 22,701,335 | $ | 17,782,731 | $ | 4,918,604 | 28 | % | |||||||||||||||
| General and administrative | 7,222,565 | 7,289,885 | (67,320) | (1) | % | ||||||||||||||||||
| Loss from operations | (29,923,900) | (25,072,616) | (4,851,284) | 19 | % | ||||||||||||||||||
| Interest income | 3,200,224 | 1,163,975 | 2,036,249 | 175 | % | ||||||||||||||||||
| Other expense | (1,428) | (55,570) | 54,142 | (97) | % | ||||||||||||||||||
| Net loss | $ | (26,725,104) | $ | (23,964,211) | $ | (2,760,893) | 12 | % | |||||||||||||||
Research and Development Expenses
Research and development expenses increased by approximately $4.9 million for the year ended December 31, 2024 as compared to 2023. The following table summarizes our research and development expenses for the year ended December 31, 2024 as compared to 2023:
| Year ended December 31, | |||||||||||||||||||||||||||||
| 2024 | 2023 | $ Change | % Change | ||||||||||||||||||||||||||
| ONA-XR | $ | — | $ | 1,889,220 | $ | (1,889,220) | (100) | % | |||||||||||||||||||||
| CTIM-76 | 5,581,896 | 14,593,973 | (9,012,077) | (62) | % | ||||||||||||||||||||||||
| CT-95 | 4,871,254 | — | 4,871,254 | * | |||||||||||||||||||||||||
| CT-202 | 11,151,496 | — | 11,151,496 | * | |||||||||||||||||||||||||
| Personnel-related costs | 1,032,516 | 1,218,914 | (186,398) | (15) | % | ||||||||||||||||||||||||
| Other research and development | 64,173 | 80,624 | (16,451) | (20) | % | ||||||||||||||||||||||||
| $ | 22,701,335 | $ | 17,782,731 | $ | 4,918,604 | 28 | % | ||||||||||||||||||||||
* Percentage not meaningful
The decrease in ONA-XR expenses of $1.9 million was due to the decision in March 2023 to discontinue development of ONA-XR and focus on the development of CTIM-76. CTIM-76 expenditures decreased by $9.0 million, primarily due to decreases of $6.1 million in contract manufacturing costs mainly due to the completion of manufacturing activities in early 2024 and $5.0 million in preclinical costs as a result of the completion of IND-
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enabling studies in early 2024. These decreases were partially offset by an increase of $2.0 million in clinical costs as a result of initiating our Phase 1 clinical trial. CT-95 expense of $4.9 million primarily represents consideration paid of $3.75 million to acquire the asset from Link in July 2024 and approximately $1.1 million in other expenses, the majority of which were $0.6 million of clinical start up costs. CT-202 expense of $11.2 million primarily represents the $11.0 million consideration paid under the BioAtla License Agreement entered into in September 2024. Personnel-related costs, which include salaries, benefits and stock-based compensation expense, decreased by approximately $0.2 million, primarily due to lower average headcount over the prior year period.
General and Administrative Expenses
General and administrative expenses decreased by $0.1 million from $7.3 million for the year ended December 31, 2023 to $7.2 million for the year ended December 31, 2024. The decrease was primarily driven by a decrease in insurance expense of $0.2 million and salaries, benefits and stock-based compensation expense of $0.1 million. These decreases were partially offset by an increase in other administrative costs of $0.2 million.
Interest Income
Interest income increased by approximately $2.0 million for the year ended December 31, 2024 as compared to 2023, primarily due to higher interest income earned on cash and cash equivalent balances due to the Private Placement and other sales of common stock.
Other Expense
Other expense decreased by approximately $0.1 million for the year ended December 31, 2024 as compared to 2023 primarily due to lower foreign currency losses as a result of exchange rate fluctuations on transactions denominated in a currency other than our functional currency.
Liquidity and Capital Resources
Overview
Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. Since our inception through December 31, 2024, we have funded our operations through the sale of convertible debt, convertible preferred stock, common stock and warrants. As of December 31, 2024, we had $94.4 million in cash and cash equivalents and an accumulated deficit of $94.8 million.
We expect our cash and cash equivalents at December 31, 2024 to fund the estimated duration of the dose escalation portions of our CTIM-76 and CT-95 Phase 1 trials, the estimated expenses through IND filing for CT-202, as well as our operations into 2027. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect.
Funding Requirements
Our primary use of cash is to fund operating expenses, which consist of research and development expenditures and various general and administrative expenses. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid expenses.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:
•the scope, timing, progress and results of discovery, preclinical development, laboratory testing and clinical trials for our current and any future product candidates that we may pursue;
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•the costs of manufacturing our current and any future product candidates for clinical trials and in preparation for regulatory approval and commercialization;
•the extent to which we enter into collaborations or other arrangements with additional third parties in order to further develop our current and any future product candidates that we may pursue;
•the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
•the costs and fees associated with the discovery, acquisition or in-license of additional product candidates or technologies;
•expenses needed to attract and retain skilled personnel;
•costs associated with being a public company;
•the costs required to scale up our clinical, regulatory and manufacturing capabilities;
•the costs of future commercialization activities, if any, including establishing sales, marketing, manufacturing and distribution capabilities, for our current and any future product candidates for which we receive regulatory approval; and
•revenue, if any, received from commercial sales of our current and any future product candidates, should any of our product candidates receive regulatory approval.
We will need additional funds to meet our operational needs and capital requirements for clinical trials, other research and development expenditures, and general and administrative expenses. We currently have no credit facility or committed sources of capital.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic transactions and/or marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic transactions or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Cash Flows
The following table shows a summary of our cash flows for the periods indicated:
| Year ended December 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| Cash used in operating activities | $ | (14,556,434) | $ | (21,047,618) | |||||||
| Cash used in investing activities | (14,757,316) | — | |||||||||
| Cash provided by financing activities | 109,293,747 | — | |||||||||
| Net increase (decrease) in cash and cash equivalents | $ | 79,979,997 | $ | (21,047,618) | |||||||
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Comparison of the Years Ended December 31, 2024 and 2023
Operating Activities
During the year ended December 31, 2024, we used $14.6 million of cash in operating activities. Cash used in operating activities reflected our net loss of $26.7 million and a net change in our operating assets and liabilities of $3.5 million, partially offset by in-process research and development charges of $14.8 million and non-cash share-based compensation of $0.8 million. The primary uses of cash were to fund our operations related to the development of our product candidates.
During the year ended December 31, 2023, we used $21.0 million of cash in operating activities. Cash used in operating activities reflected our net loss of $24.0 million, partially offset by non-cash share-based compensation of $1.1 million and a net change in our operating assets and liabilities of $1.8 million. The primary uses of cash were to fund our operations related to the development of our current and former product candidates.
Investing Activities
During the year ended December 31, 2024, cash used in investing activities was primarily attributable to a payment of $11.0 million under the BioAtla License Agreement for the development of CT-202 and a one-time payment of $3.75 million made to Link to acquire the assets associated with CT-95.
We did not have cash flows from investing activities during the year ended December 31, 2023.
Financing Activities
During the year ended December 31, 2024, financing activities provided $109.3 million, consisting of net proceeds of $94.8 million from the sale of common stock and Pre-Funded Warrants in the Private Placement, as well as net proceeds of $14.5 million from the sale of common stock under our ATM Sales Agreement.
We did not have cash flows from financing activities during the year ended December 31, 2023.
Off-Balance Sheet Arrangements
During the periods presented, we did not have, nor do we currently have, any relationships with unconsolidated entities or financial partnerships, including entities sometimes referred to as structured finance or special purpose entities that were established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. We do not engage in off-balance sheet financing arrangements. In addition, we do not engage in trading activities involving non-exchange traded contracts. We therefore believe that we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in these relationships.
Critical Accounting Policies and Estimates
This management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to prepaid/accrued research and development expenses and share-based compensation. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in Note 3 to our audited consolidated financial statements included elsewhere in this Form 10-K, we believe the following accounting policies are the most critical to the judgments and estimates used in the preparation of our consolidated financial statements.
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Research and Development Expenses
Research and development costs are expensed as incurred. Research and development costs include external costs of outside vendors engaged to conduct clinical studies and other research and development activities, acquired IPR&D, salaries, share-based compensation, and other operational costs related to our research and development activities.
Costs for certain development activities, such as the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, are estimated based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to us by our vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued research and development expense, as the case may be. The estimates are adjusted to reflect the best information available at the time of the financial statement issuance. Although we do not expect our estimates to be materially different from amounts actually incurred, our estimate of the status and timing of services performed relative to the actual status and timing of services performed may vary.
Nonrefundable advance payments for goods and services, including fees for clinical trial expenses, process development or manufacturing and distribution of clinical supplies that will be used in future research and development activities, are deferred and recognized as expense in the period that the related goods are consumed or services are performed.
Share-Based Compensation
We measure compensation expense for all share-based awards based on the estimated fair value of the share-based awards on the grant date. We use the Black-Scholes option pricing model to value our share-based awards. We recognize compensation expense on a straight-line basis over the requisite service period, which is generally the vesting period of the award. We have not issued awards for which vesting is subject to market or performance conditions.
The Black-Scholes option-pricing model requires the use of subjective assumptions that include the expected stock price volatility and the fair value of the underlying common stock on the date of grant. See Note 7 to our audited consolidated financial statements included elsewhere in this Form 10-K for information concerning certain of the specific assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our awards granted.
Recent Accounting Pronouncements
See Note 3 to our audited consolidated financial statements found elsewhere in this Form 10-K for a description of recent accounting pronouncements applicable to our consolidated financial statements.
Emerging Growth Company and Smaller Reporting Company Status
In April 2012, the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this exemption from complying with new or revised accounting standards and, therefore, will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
Other exemptions and reduced reporting requirements under the JOBS Act include, without limitation, the requirements for providing an auditor’s attestation report on our system of internal control over financial reporting
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pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation, and less extensive disclosure about our executive compensation arrangements. We will remain an emerging growth company until the earlier to occur of (a) the last day of the fiscal year (i) following October 19, 2026, (ii) in which we have total annual gross revenues of at least $1.235 billion or (iii) in which we are deemed to be a “large accelerated filer” under the rules of the SEC, which means that we have been required to file annual and quarterly reports under the Exchange Act for a period of at least 12 months and have filed at least one annual report pursuant to the Exchange Act and (b) either (i) the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, or (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700.0 million and our annual revenue is less than $100.0 million during the most recently completed fiscal year. We will continue to be a smaller reporting company while either (i) the market value of our stock held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Not required for smaller reporting companies.
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Item 8. Financial Statements and Supplementary Data
Context Therapeutics Inc.
Index To Consolidated Financial Statements
| Page | |||||
Report of Independent Registered Public Accounting Firm (PCAOB ID | |||||
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Stockholders of
Context Therapeutics Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Context Therapeutics Inc. and Subsidiaries (the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements of operations, changes in stockholders’ equity, and cash flows for the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023 and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free from material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ CohnReznick LLP
We have served as the Company’s auditor since January 2021.
March 20, 2025
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Context Therapeutics Inc.
Consolidated Balance Sheets
December 31, | |||||||||||
| 2024 | 2023 | ||||||||||
Assets | |||||||||||
Current assets: | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
| Prepaid expenses and other current assets | |||||||||||
| Total current assets | |||||||||||
| Operating lease right-of-use asset | |||||||||||
| Property and equipment, net | |||||||||||
Total assets | $ | $ | |||||||||
| Liabilities and Stockholders' Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | $ | |||||||||
| Accrued expenses and other current liabilities | |||||||||||
| Operating lease liability - current | |||||||||||
| Total current liabilities | |||||||||||
| Operating lease liabilities - non-current | |||||||||||
| Total liabilities | |||||||||||
| Commitments and contingencies (Note 8) | |||||||||||
| Stockholders' equity: | |||||||||||
Preferred stock, $ | |||||||||||
Common stock—$ | |||||||||||
| Additional paid-in capital | |||||||||||
| Accumulated deficit | ( | ( | |||||||||
| Total stockholders' equity | |||||||||||
| Total liabilities and stockholders' equity | $ | $ | |||||||||
The accompanying notes are an integral part of these consolidated financial statements.
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Context Therapeutics Inc.
Consolidated Statements of Operations
Year ended December 31, | |||||||||||
| 2024 | 2023 | ||||||||||
Operating expenses: | |||||||||||
| Research and development | $ | $ | |||||||||
| General and administrative | |||||||||||
| Loss from operations | ( | ( | |||||||||
| Interest income | |||||||||||
| Other expense | ( | ( | |||||||||
| Net loss | $ | ( | $ | ( | |||||||
| Net loss per common share, basic and diluted | $ | ( | $ | ( | |||||||
| Weighted average shares outstanding, basic and diluted | |||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
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Context Therapeutics Inc.
Consolidated Statements of Changes in Stockholders’ Equity
| Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total Stockholders’ Equity | ||||||||||||||||||||||||||
| Shares | Amount | ||||||||||||||||||||||||||||
| Balance at January 1, 2023 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||
| Share-based compensation expense | — | — | — | ||||||||||||||||||||||||||
| Net loss | — | — | — | ( | ( | ||||||||||||||||||||||||
| Balance at December 31, 2023 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||
| Share-based compensation expense | — | — | — | ||||||||||||||||||||||||||
Sale of common stock and prefunded warrants in private placement, net of offering costs of $ | — | ||||||||||||||||||||||||||||
Sale of common stock from ATM facility, net of offering costs of $ | — | ||||||||||||||||||||||||||||
| Net loss | — | — | — | ( | ( | ||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
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Context Therapeutics Inc.
Consolidated Statements of Cash Flows
Year ended December 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| Cash flows from operating activities: | |||||||||||
| Net loss | $ | ( | $ | ( | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Acquired in-process research and development charge | |||||||||||
| Share-based compensation expense | |||||||||||
| Depreciation and amortization expense | |||||||||||
| Reduction in the carrying amount of operating lease right-of-use asset | |||||||||||
| Changes in operating assets and liabilities: | |||||||||||
| Prepaid expenses and other current assets | ( | ||||||||||
| Other assets | |||||||||||
| Accounts payable | ( | ||||||||||
| Accrued expenses and other current liabilities | ( | ( | |||||||||
| Operating lease liability | ( | ( | |||||||||
| Cash used in operating activities | ( | ( | |||||||||
| Cash flows from investing activities: | |||||||||||
| Acquired in-process research and development | ( | ||||||||||
| Purchase of property and equipment | ( | ||||||||||
| Cash used in investing activities | ( | ||||||||||
| Cash flows from financing activities: | |||||||||||
| Proceeds from the sale of common stock and prefunded warrants in private placement, net | |||||||||||
| Proceeds from the sale of common stock from ATM facility, net | |||||||||||
| Cash provided by financing activities | |||||||||||
| Net increase (decrease) in cash and cash equivalents | ( | ||||||||||
| Cash and cash equivalents at beginning of year | |||||||||||
| Cash and cash equivalents at end of year | $ | $ | |||||||||
| Supplemental disclosure of non-cash activities: | |||||||||||
| Unpaid offering costs in accounts payable | $ | $ | |||||||||
| Right-of-use asset acquired under operating lease | $ | $ | |||||||||
The accompanying notes are an integral part of these consolidated financial statements.
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CONTEXT THERAPEUTICS INC.
Notes to Consolidated Financial Statements
(1) Organization and Description of Business
Context Therapeutics Inc. (the “Company”) is a clinical-stage biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies (“bsAb”) for solid tumors. The Company’s product candidates include CTIM-76, a Claudin 6 (“CLDN6”) x CD3 TCE, CT-95, a Mesothelin (“MSLN”) x CD3 TCE, and CT-202, a Nectin cell adhesion protein 4 (“Nectin-4”) x CD3 TCE.
The Company had also been developing onapristone extended release (“ONA-XR”). However, in March 2023, the Company announced its plan to discontinue the development of this product candidate and focus its efforts on the development of CTIM-76. All close-out costs associated with the ONA-XR program were recognized in research and development expense in 2023. The Company does not expect to incur future expenses related to this program.
(2) Risks and Liquidity
The Company has incurred losses and negative cash flows from operations since inception and had an accumulated deficit of $94.8 million as of December 31, 2024. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant revenues from its current or any future product candidates. The Company believes its cash and cash equivalents of $94.4 million as of December 31, 2024 are sufficient to fund its projected operations for a period of at least 12 months from the issuance date of these consolidated financial statements. Substantial additional funding will be needed by the Company to fund its operations and to commercially develop its current and any future product candidates.
Management plans to seek additional capital in the future through a combination of equity offerings, debt financings, collaborations, strategic transactions and/or marketing, distribution or licensing arrangements to carry out the Company’s planned development activities. If additional capital is not available when required, the Company may need to delay or curtail its operations until such funding is received. There is no assurance that such financing will be available when needed or on acceptable terms. Various internal and external factors will affect whether and when the Company’s current or any future product candidates become approved for marketing and successful commercialization. The regulatory approval and market acceptance of the Company’s current and any future product candidates, length of time and cost of developing and commercializing these product candidates and/or failure of them at any stage of the approval process will materially affect the Company’s financial condition and future operations.
(3) Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).
The consolidated financial statements include the accounts of the Company, Context Therapeutics LLC, Context Biopharma, Inc. and Context Ireland Ltd., the Company’s wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
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Emerging Growth Company Status
Use of Estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
Concentrations of Credit Risk
Segment Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources in assessing performance. The Company has one reportable segment which consists of the development of clinical and preclinical product candidates for the advancement of therapies to treat solid tumors. The Company’s chief operating decision maker (“CODM”) is the chief executive officer.
The accounting policies of the Company’s segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for the Company’s segment based on net loss, which is reported on the income statement as net loss. The measure of segment assets is reported on the balance sheet as total assets.
To date, the Company has not generated any product revenue. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval. As such, the CODM uses cash forecast models in deciding how to deploy capital at the Company. Such cash forecast models are reviewed to assess the entity-wide operating results and performance. Net loss is used to monitor budget versus actual results. Monitoring budgeted versus actual results is used in assessing performance of the segment, along with cash forecast models. The CODM is regularly provided with net loss and consolidated assets, which are reported on the consolidated statements of operations and consolidated balance sheets, respectively.
The table below summarizes the significant expense categories regularly reviewed by the CODM for the years ended December 31, 2024 and 2023:
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Year ended December 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| Operating Expenses: | |||||||||||
| ONA-XR | $ | $ | |||||||||
| CTIM-76 | |||||||||||
| CT-95 | |||||||||||
| CT-202 | |||||||||||
| Personnel-related costs | |||||||||||
| Professional fees | |||||||||||
| Share-based compensation | |||||||||||
| Interest income | ( | ( | |||||||||
| Other segment items (a) | |||||||||||
| Segment and Net Loss | $ | $ | |||||||||
(a)Other segment items included in Segment loss mainly includes board fees, insurance, facilities and information technology costs.
Fair Value of Financial Instruments
The carrying amounts of the Company’s financial instruments, which include cash and cash equivalents and accounts payable, approximate their fair values given their short-term nature.
Cash and Cash Equivalents
Deferred Offering Costs
Property and Equipment
Leases
The Company determines if an arrangement is a lease at inception. Balances recognized related to operating leases are included in operating lease right-of-use assets and operating lease liabilities in the consolidated balance
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sheets. Operating lease right-of-use assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. The Company recognizes rent expense on a straight-line basis over the lease period and accrues for rent expense incurred but not yet paid.
Acquired In-Process Research and Development Costs
Research and Development Costs
Research and development costs are expensed as incurred. Research and development costs include external costs of outside vendors engaged to conduct clinical studies and other research and development activities, acquired IPR&D, salaries, share-based compensation, and other operational costs related to the Company’s research and development activities.
Costs for certain development activities, such as the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, are estimated based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued research and development expense, as the case may be. The estimates are adjusted to reflect the best information available at the time of the financial statement issuance. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company's estimate of the status and timing of services performed relative to the actual status and timing of services performed may vary.
Patent Costs
Costs related to filing and pursuing patent applications are recorded as general and administrative expense and expensed as incurred since recoverability of such expenditures is uncertain.
Share-Based Compensation
The Company measures and recognizes share-based compensation expense for both employee and non-employee awards based on the grant date fair value of the awards. The Company recognizes share-based compensation expense on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. The Company recognizes forfeitures as they occur.
The Company classifies share-based compensation expense in its consolidated statements of operations in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified.
The Company estimates the fair value of employee and non-employee stock awards as of the date of grant using the Black-Scholes option pricing model. The Company lacks Company-specific historical and implied volatility
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Income Taxes
Income taxes are recorded in accordance with ASC Topic 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. To date, the Company has not taken any uncertain tax position or recorded any reserves, interest or penalties.
Net Loss Per Share
The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares of common stock outstanding, as they would be anti-dilutive:
| December 31, | ||||||||||||||
| 2024 | 2023 | |||||||||||||
| Stock options | ||||||||||||||
| Warrants | ||||||||||||||
Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires disclosure of incremental segment information on an annual and interim basis. This ASU was effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024 on a retrospective basis. The Company adopted this standard for the Company’s year-ended 2024 annual reporting period. See above for additional disclosures added upon adoption.
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In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which expands the disclosures required for income taxes. This ASU is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The amendment should be applied on a prospective basis while retrospective application is permitted. The Company is currently evaluating the impact of ASU 2023-09 on its consolidated financial statements and related disclosures.
Recently Issued but Not yet Adopted Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses. ASU 2024-03 requires additional disclosure of specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted. The requirements will be applied prospectively with the option for retrospective application. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its disclosures.
(4) Fair Value Measurements
The Company utilizes a valuation hierarchy that prioritizes fair value measurements based on the types of inputs used for the various valuation techniques related to its financial assets and financial liabilities. The three levels of inputs used to measure fair value are described as follows:
Level 1 – Observable inputs such as quoted prices in active markets.
Level 2 – Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly.
Level 3 – Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions.
In accordance with the fair value hierarchy described above, the following table sets forth the Company’s assets and liabilities measured at fair value on a recurring basis:
| December 31, 2024 | |||||||||||||||||||||||
Total | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | ||||||||||||||||||||
Financial assets | |||||||||||||||||||||||
Cash equivalents (Money Market Accounts) | $ | $ | $ | $ | |||||||||||||||||||
| December 31, 2023 | |||||||||||||||||||||||
Total | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | ||||||||||||||||||||
Financial assets | |||||||||||||||||||||||
Cash equivalents (Money Market Accounts) | $ | $ | $ | $ | |||||||||||||||||||
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(5) Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:
| December 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| Compensation and benefits | $ | $ | |||||||||
| Research and development costs | |||||||||||
| Professional fees | |||||||||||
| Other | |||||||||||
| Total | $ | $ | |||||||||
(6) Stockholders’ Equity
Increase to Authorized Shares
On September 17, 2024, the Company held a Special Meeting of Stockholders (the “Special Meeting”). At the Special Meeting, the Company’s stockholders approved, among other things, an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 100,000,000 to 200,000,000 .
Private Placement
On May 1, 2024, the Company entered into a securities purchase agreement (the “Purchase Agreement”) for the private placement (the “Private Placement”) of (i) 59,032,259 shares (the “PIPE Shares”) of the Company’s common stock at a purchase price of $1.55 per PIPE Share, and (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase 5,482,741 shares of common stock at a purchase price of $1.549 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $0.001 per share of common stock, are immediately exercisable and remain exercisable until exercised in full. As of December 31, 2024, the Pre-Funded Warrants had not been exercised. The aggregate gross proceeds for the Private Placement were approximately $100 million, before deducting offering expenses of approximately $5.2 million, and the Private Placement closed on May 6, 2024.
At-the-Market Facility
On December 2, 2024, the Company entered into a Sales Agreement (the “ATM Sales Agreement”) with Leerink Partners LLC (the “Agent”). Pursuant to the terms of the ATM Sales Agreement, the Company may offer and sell shares of the Company’s common stock, $0.001 par value per share (the “ATM Shares”), having an aggregate offering amount of up to $75.0 million from time to time through the Agent. Sales of the ATM Shares may be made in sales deemed to be an “at-the-market offering” as defined in Rule 415 under the Securities Act of 1933, as amended. On December 23, 2024, the Company sold 14,705,882 shares of its common stock under the ATM Sales Agreement for net proceeds of approximately $14.5 million.
Warrants for Common Stock
| Outstanding | Exercise price | Expiration dates | |||||||||||||||
| Issued in connection with 2021 initial public offering | $ | October 2026 | |||||||||||||||
| Issued in connection with 2021 private placement | $ | June 2027 | |||||||||||||||
| Issued in 2022 for consulting services | $ | December 2027 | |||||||||||||||
| Issued in connection with 2024 private placement | $ | No expiration | |||||||||||||||
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(7) Share-based Compensation
In April 2021, the Company adopted the 2021 Long-Term Performance Incentive Plan (“2021 Incentive Plan”). Under the 2021 Incentive Plan, the Company can grant stock options, stock appreciation rights, restricted stock, restricted stock units (“RSUs”) and stock grants. The 2021 Incentive Plan allows for the issuance of up to 1,266,092 shares of common stock (the “Share Limit”). The Share Limit automatically increases on January 1st of each year, during the term of the 2021 Incentive Plan, commencing on January 1 of the year following the year in which the effective date occurs, in an amount equal to four percent (4 %) of the total number of shares of the Company’s common stock outstanding on December 31st of the preceding calendar year; provided that the board of directors may determine that there will be no such increase or a smaller increase for any particular year. As of December 31, 2024, 209,115 shares remained available for future grants.
In addition, from time to time, the Company makes inducement grants of stock options to new hires, which awards are made pursuant to the Nasdaq’s inducement grant exception to the shareholder approval requirement for grants of equity compensation. During the year ended December 31, 2024, the Company granted inducement stock options covering 317,407 shares of the Company’s common stock to new employees.
Share-based awards generally vest over a period of one year to four years , and share-based awards that lapse or are forfeited are available to be granted again. The contractual life of all share-based awards is 10 years. The expiration dates of the outstanding share-based awards range from January 2028 to October 2034.
The Company measures share-based awards at their grant-date fair value and records compensation expense on a straight-line basis over the service period of the awards. Share-based compensation is allocated to employees and consultants based on their respective departments. All board of directors’ compensation is charged to general and administrative expense.
Share-based compensation expense related to the issuance of stock options was as follows for the years ended December 31, 2024 and 2023:
| Year ended December 31, | ||||||||||||||
| 2024 | 2023 | |||||||||||||
| Research and development | $ | $ | ||||||||||||
| General and administrative | ||||||||||||||
| $ | $ | |||||||||||||
The weighted average assumptions used in the Black-Scholes option pricing model to determine the fair value of stock option awards granted during 2024 and 2023 were as follows:
| 2024 | 2023 | ||||||||||
| Expected stock price volatility | |||||||||||
| Expected term (in years) | |||||||||||
| Risk-free interest rate | |||||||||||
| Expected dividend yield | |||||||||||
As the Company began trading publicly in October 2021, there is a lack of Company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies. Additionally, due to an insufficient history with respect to stock option activity and post-vesting cancellations, the expected term assumption for employee grants is based on a permitted simplified method, which is based on the vesting period and contractual term for each tranche of awards. The mid-point between the weighted-average vesting term and the expiration date is used as the expected term under this method. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect for time periods approximately equal to the expected term of the award. Expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
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The following table summarizes the share-based award activity for the periods presented:
Number of Shares | Weighted Average Exercise Price Per Share | Weighted Average Remaining Contractual Term (years) | Aggregate Intrinsic Value | ||||||||||||||||||||
| Outstanding at January 1, 2024 | $ | $ | |||||||||||||||||||||
| Granted | $ | ||||||||||||||||||||||
| Forfeited | ( | $ | |||||||||||||||||||||
| Outstanding at December 31, 2024 | $ | $ | |||||||||||||||||||||
| Vested and exercisable at December 31, 2024 | $ | $ | |||||||||||||||||||||
| Vested and expected to vest at December 31, 2024 | $ | $ | |||||||||||||||||||||
(8) Commitments and Contingencies
Collaboration Agreement with Tyligand Bioscience
In March 2020, the Company entered into a process development agreement (the “Tyligand Process Development Agreement”) with Tyligand Bioscience (Shanghai) Limited (“Tyligand”) for the development, manufacturing, registration and future commercialization of onapristone extended release (“ONA-XR”). Upon completion of specific performance-based milestones under the Tyligand Process Development Agreement, in August 2021, the Company and Tyligand entered into a license agreement (the “Tyligand License Agreement”) whereby Tyligand was granted the exclusive right to ONA-XR and was solely responsible for the development and commercialization of ONA-XR in China, Hong Kong and Macau. The Company retained rights in the rest of the world to commercialize ONA-XR. In August 2024, the Company and Tyligand mutually agreed to terminate the Tyligand License Agreement, and any ongoing payment obligations the Company may have had to Tyligand under the Tyligand Process Development Agreement.
Collaboration and Licensing Agreement with Integral Molecular
In April 2021, the Company entered into a collaboration and licensing agreement with Integral Molecular, Inc. (“Integral”) (the “Integral License Agreement”) for the development of a CLDN6 bsAb for cancer therapy. Under the terms of the Integral License Agreement, Integral and the Company developed a CLDN6 bsAb that is intended to trigger the activation of T cells and eliminate cancer cells displaying CLDN6. The Company will conduct preclinical and all clinical development, as well as regulatory and commercial activities through exclusive worldwide rights to develop and commercialize the novel CLDN6 candidates. The payment for the initial upfront license fee as well as subsequent payments for milestones achieved were expensed to acquired in-process research and development. As a part of the Integral License Agreement, Integral was eligible to receive remaining development and regulatory milestone payments totaling approximately $55.0 million, sales milestone payments totaling up to $130.0 million, and tiered royalties of up to 12 % of net sales of certain products developed under the Integral License Agreement.
On March 20, 2023, the Company amended the Integral License Agreement (the “First Amendment”) to remove the previously agreed to second milestone payment and to change the amount of the third milestone payment to increase such payment by the amount of the prior second milestone payment and to add payment for third-party research funding obtained and used by Integral in connection with the development of CTIM-76.
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On February 29, 2024, the Company further amended the Integral License Agreement (the "Second Amendment") to reflect updated financial terms. Integral’s right to receive certain future payments was reduced as follows: aggregate development and regulatory milestone payments were reduced from $55 million to $15 million, aggregate sales milestone payments were reduced from $130 million to $12.5 million, and a tiered royalty of 8 -12 % that commenced at first commercial sale was reduced to a flat royalty rate of 6 % on net sales beginning no sooner than February 1, 2034. The Second Amendment also narrowed the license grant from Integral to the Company to only cover CTIM-76, removed any further obligation to reimburse Integral for any independently obtained research funding Integral applied against CTIM-76 research, and included mutual releases by the parties.
Asset Purchase Agreement
On July 9, 2024, the Company entered into an asset purchase agreement (the “Asset Purchase Agreement”) pursuant to which the Company acquired CT-95 (formerly known as LNK-101), an MSLN x CD3 T cell engaging bispecific antibody, from Link (assignment for the benefit of creditors), LLC (“Link”), which succeeded to the assets of Link Immunotherapeutics Inc.
Pursuant to the Asset Purchase Agreement, the Company purchased all of the assets from Link associated with CT-95, including patent rights, know-how, regulatory filings, and inventory of drug substance and drug product (the “Transferred Assets”), on an “as is” and “where is” basis. CT-95 patents are currently being prosecuted and/or maintained in the United States, Europe, Canada, Australia, Taiwan and Japan. The Company also assumed certain liabilities relating to the Transferred Assets. In consideration of the purchase of the Transferred Assets, the Company made a one-time payment to Link of $3.75 million and is not obligated to make any other payments. This transaction qualified as an asset purchase as prescribed by ASC 805-50 and the assets purchased were determined to have no alternative future use under the accounting definition, and therefore the Company expensed the one time payment as a component of research and development expense in the consolidated statements of operations for the year ended December 31, 2024.
Collaboration and Licensing Agreement with BioAtla
On September 23, 2024, the Company entered into a license agreement (the “BioAtla License Agreement”) with BioAtla, Inc. ("BioAtla"), pursuant to which the Company obtained an exclusive, worldwide license to develop, manufacture and commercialize two licensed antibodies (the “BioAtla Assets”), including BA3362 (renamed by the Company as CT-202), BioAtla’s Nectin-4 x CD3 T cell engaging bispecific antibody.
As partial consideration for the exclusive license under the BioAtla License Agreement, the Company made an upfront payment of $11.0 million for the IPR&D asset, which was determined to have no alternative future use under the accounting definition. Therefore, the upfront payment was expensed as a component of research and development expense in the consolidated statements of operations for the year ended December 31, 2024. The Company may be obligated to pay up to $122.5 million in additional milestone payments based upon the achievement of specified pre-clinical, clinical, development and commercial milestones, as well as tiered mid-single digit to low double-digit royalties on future net sales for products containing the BioAtla Assets, subject to standard reductions. The BioAtla License Agreement will continue on a country-by-country, product-by-product basis until the expiration of the royalty term as defined in the BioAtla License Agreement, unless earlier terminated.
Research and Development Arrangements
In the course of normal business operations, the Company enters into agreements with investigative sites and contract research organizations to assist in the performance of research and development activities and contract manufacturers to assist with chemistry, manufacturing, and controls-related expenses. Expenditures to contract research organizations represent a significant cost in clinical development for the Company. The Company could also enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may require upfront payments and long-term commitments of cash.
Operating Leases
In February 2022, the Company commenced a noncancellable operating sublease for corporate office space in Philadelphia, Pennsylvania. In March 2023, the Company entered into a direct lease for this same office space that
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commenced on August 1, 2023. In March 2024, the Company amended the lease to extend the expiration date to November 30, 2024. In July 2024, the Company further amended the lease, which is now set to expire on November 30, 2026, thus making the arrangement no longer qualify for the short-term lease exception under ASC 842. The Company also retains the right to renew the lease for up to two consecutive 12-month terms upon at least nine months advance notice to the landlord before any such successive renewal. These renewal options were not contemplated in the Company's calculation of its right of use asset and lease liability.
As of December 31, 2024, the operating lease right-of-use asset and the operating lease liabilities were each approximately $0.2 11 %. As of December 31, 2024, the remaining term of the Company’s noncancellable operating lease was 1.92 years. Future minimum lease payments under the lease are $0.2 million at December 31, 2024.
The Company recognizes rent expense on a straight-line basis over the lease period and accrues for rent expense incurred but not yet paid. Rent expense related to the Company’s operating lease was approximately $125,000 and $94,000 for the years ended December 31, 2024 and 2023, respectively.
Employee Benefit Plans
The Company established a defined contribution 401(k) plan in which employees may contribute up to 100 % of their salary and bonus, subject to statutory maximum contribution amounts. The Company contributes a safe harbor minimum contribution equivalent to 3 % of employees’ compensation. The Company generally assumes all administrative costs of the plan. For the years ended December 31, 2024 and 2023, the Company provided contributions of approximately $60,000 and $66,000 , respectively.
Litigation
Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. The Company believes no matters existed at either December 31, 2024 or 2023 that will have a material impact to the Company’s financial position, results of operations or cash flows.
Indemnification
In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has never incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company has also entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted by applicable law. The Company currently has directors and officers insurance. The Company is not aware of any claims under indemnification arrangements, and it has not accrued any liabilities related to such obligations in its consolidated financial statements as of December 31, 2024 and 2023.
(9) Income Taxes
The Company is a corporation and is subject to federal, state and local corporate income taxes which have been provided for in the consolidated financial statements based upon ASC 740. Context BioPharma, Inc. has always been subject to corporate income taxes.
The Company had no
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each period due to its uncertainty of realizing a benefit from those items. All of the Company’s losses before income taxes were generated in the United States.
The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets and liabilities were as follows:
December 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| Deferred tax assets: | |||||||||||
| Net operating loss carryforwards | $ | $ | |||||||||
| Research and development credits | |||||||||||
| Capitalized research and development Section 174 expense | |||||||||||
| Share-based compensation | |||||||||||
| Amortization | |||||||||||
| Other accruals | |||||||||||
| Gross deferred tax assets | |||||||||||
| Deferred tax liabilities: | |||||||||||
| Prepaid expenses | ( | ( | |||||||||
| Property and equipment | ( | ( | |||||||||
| Net deferred tax assets | |||||||||||
| Less: valuation allowance | ( | ( | |||||||||
| $ | $ | ||||||||||
In assessing the need for a valuation allowance, management must determine that there will be sufficient taxable income to allow for the realization of deferred tax assets. Based upon the historical and anticipated future losses, management has determined that the deferred tax assets do not meet the more likely than not threshold for realizability. Accordingly, a full valuation allowance has been recorded against the Company’s net deferred tax assets as of December 31, 2024 and 2023. The valuation allowance increased by $8.2 million and $7.4 million during the years ended December 31, 2024 and 2023, respectively.
A reconciliation of the federal income tax rate to the Company’s effective tax rate is as follows:
Year ended December 31, | |||||||||||
| 2024 | 2023 | ||||||||||
Federal income tax benefit at statutory rate | % | % | |||||||||
State income tax, net of federal benefit | |||||||||||
Research and development credit | |||||||||||
Change in valuation allowance | ( | ( | |||||||||
| Effective income tax rate | % | % | |||||||||
The following table summarizes carryforwards of federal, state and local net operating losses (“NOL”) and research tax credits:
December 31, | |||||||||||
| 2024 | 2023 | ||||||||||
NOL carryforwards—Federal | $ | $ | |||||||||
NOL carryforwards—State | |||||||||||
NOL carryforwards—Local | |||||||||||
Research tax credits—Federal | |||||||||||
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The NOL carryforwards begin expiring in 2037 for federal and state income tax purposes; however, all federal NOL carryforwards generated subsequent to January 1, 2018 are able to be carried forward indefinitely. Local NOL carryforwards expire after three years with the 2022 NOL set to expire in 2025. As of December 31, 2024 and 2023, the Company had federal research and development tax credit carryforwards of $1.8 million and $1.2 million, respectively, that will begin to expire in 2037, unless previously utilized.
The NOL and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code, respectively, as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. To date, the Company has not performed an analysis to determine whether or not ownership changes have occurred since inception. State and local NOLs may also be limited.
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Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures, (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act) that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and is accumulated and communicated to management, including the principal executive officer (our Chief Executive Officer) and principal financial officer (our Chief Financial Officer), to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Our management has evaluated, with the participation of our Chief Executive Officer and Chief Financial Officer, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Annual Report on Form 10-K. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of December 31, 2024, our disclosure controls and procedures were effective.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act. Internal control over financial reporting is a process designed under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and includes those policies and procedures that: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. GAAP, and that receipts and expenditures of our Company are being made only in accordance with authorizations of management and directors of the Company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Company’s assets that could have a material effect on the financial statements.
As of December 31, 2024, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, assessed the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013). Based on this assessment, our management concluded that, as of December 31, 2024, our internal control over financial reporting was effective based on those criteria.
Attestation Report of the Registered Public Accounting Firm
This Annual Report does not include an attestation report of our independent registered public accounting firm regarding internal control over financial reporting due to an exemption provided by the JOBS Act for emerging growth companies.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended December 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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Item 9B. Other Information
During the three months ended December 31, 2024, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act)adopted terminated
During the three months ended December 31, 2024, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act)
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
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PART III.
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this item is incorporated by reference to our Proxy Statement for our 2025 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2024, under the captions “Information regarding Committees of the Board of Directors,” “Information regarding the Board of Directors and Corporate Governance,” “Executive Officers” and “Delinquent Section 16(a) Reports.”
Item 11. Executive Compensation
The information required by this item is incorporated by reference to our Proxy Statement for our 2025 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2024, under the captions “Executive Compensation” and “Director Compensation.”
.
Item 12. Security Ownership of Certain Beneficial Owner and Management and Related Stockholder Matters
The information required by this item is incorporated by reference to our Proxy Statement for our 2025 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2024, under the captions “Equity Compensation Plan Information” and “Security Ownership of Certain Beneficial Owners and Management.”
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item is incorporated by reference to our Proxy Statement for our 2025 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2024, under the captions “Transactions with Related Persons” and “Director Compensation.”
Item 14. Principal Accountant Fees and Services
The information required by this item is incorporated by reference to our Proxy Statement for our 2025 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2024, under the caption “Proposal 1–Ratification of Selection of Independent Registered Public Accounting Firm.”
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PART IV.
Item 15. Exhibits and Financial Statement Schedules
We have filed the following documents as part of this Annual Report:
(a)(1) Financial Statements
The financial statements are included in Item 8. “Financial Statements and Supplementary Data.”
(a)(2) Financial Statement Schedules
All schedules are omitted as information required is inapplicable or the information is presented in the financial statements and the related notes.
(a)(3) The exhibits listed under Item 15(b), which are incorporated herein by reference, are filed or furnished as part of this report or are incorporated into this report by reference.
(b) Exhibits.
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| Exhibit No. | Description of Exhibit | ||||||||||
10.6† | |||||||||||
10.7† | |||||||||||
10.8† | |||||||||||
10.9† | |||||||||||
10.10† | |||||||||||
10.11 | |||||||||||
10.12 | |||||||||||
10.13† | |||||||||||
10.14# | |||||||||||
10.15*# | |||||||||||
10.16# | |||||||||||
10.17 | |||||||||||
10.18 | |||||||||||
10.19*# | |||||||||||
10.20# | |||||||||||
10.21† | |||||||||||
10.22† | |||||||||||
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| Exhibit No. | Description of Exhibit | ||||||||||
10.23† | |||||||||||
10.24# | |||||||||||
10.25 | |||||||||||
19* | |||||||||||
| 21.1 | |||||||||||
| 23.1* | |||||||||||
| 31.1* | |||||||||||
| 31.2* | |||||||||||
| 32.1*+ | |||||||||||
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| 101 | The following financial statements from Context Therapeutics Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, formatted in Inline XBRL (eXtensible Business Reporting Language): (i) Consolidated Balance Sheets; (ii) Consolidated Statements of Operations; (iii) Consolidated Statements of Changes in Stockholders’ Equity; (iv) Consolidated Statements of Cash Flows; (v) Notes to the Consolidated Financial Statements and (vi) information regarding trading arrangements set forth in Part II, Item 9B. | ||||||||||
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | ||||||||||
________________
*Filed herewith
†Executive Compensation Plan or Agreement
# Certain information has been excluded from the exhibit because it both (i) is not material and (ii) is the type that the registrant treats as private or confidential.
+ This certification is being furnished pursuant to 18 U.S.C. Section 1350 and is not being filed for purposes of Section 18 of the Exchange Act, and is not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof.
+ This certification is being furnished pursuant to 18 U.S.C. Section 1350 and is not being filed for purposes of Section 18 of the Exchange Act, and is not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof.
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Item 16. Form 10-K Summary
Not applicable.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| CONTEXT THERAPEUTICS INC. | ||||||||
| By: | /s/ Martin Lehr | |||||||
Martin Lehr | ||||||||
| March 20, 2025 | Chief Executive Officer | |||||||
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
SIGNATURE | TITLE | DATE | ||||||||||||
/s/ Martin Lehr | Chief Executive Officer and Director (Principal Executive Officer) | March 20, 2025 | ||||||||||||
| Martin Lehr | ||||||||||||||
/s/ Jennifer Minai-Azary | Chief Financial Officer (Principal Financial and Accounting Officer) | March 20, 2025 | ||||||||||||
| Jennifer Minai-Azary | ||||||||||||||
/s/ Andy Pasternak | Chairman of the Board and Director | March 20, 2025 | ||||||||||||
Andy Pasternak | ||||||||||||||
| /s/ Philip Kantoff | Director | March 20, 2025 | ||||||||||||
Philip Kantoff | ||||||||||||||
/s/ Karen Smith | Director | March 20, 2025 | ||||||||||||
Karen Smith | ||||||||||||||
| /s/ Jennifer Evans Stacey | Director | March 20, 2025 | ||||||||||||
Jennifer Evans Stacey | ||||||||||||||
/s/ Luke Walker | Director | March 20, 2025 | ||||||||||||
Luke Walker | ||||||||||||||
| /s/ Linda West | Director | March 20, 2025 | ||||||||||||
Linda West | ||||||||||||||
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Exhibit 4.4
Description of the Registrant’s Securities Registered Under
Section 12 of the Securities Exchange Act of 1934
As of December 31, 2024, Context Therapeutics Inc. (the “Company,” “we,” “our” and “us”) maintained one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), our common stock, par value $0.001 per share.
The following is a description of the material terms of our common stock. The description is qualified in its entirety by reference to our Amended and Restated Certificate of Incorporation (our “certificate of incorporation”), our Amended and Restated Bylaws (our “bylaws”) and the applicable provisions of the Delaware General Corporation Law, as amended (the “DGCL”). Our certificate of incorporation and our bylaws are incorporated by reference as exhibits to the Annual Report on Form 10-K for the year ended December 31, 2024.
General
Our authorized capital stock consists of:
•200,000,000 shares of common stock, par value $0.001 per share; and
•10,000,000 shares of preferred stock, par value $0.001 per share.
Voting Rights
Each holder of our common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders, including the election of directors. Our stockholders do not have cumulative voting rights in the election of directors. Accordingly, holders of a majority of the voting shares are able to elect all of the directors.
Dividends
Subject to preferences that may be applicable to any then outstanding preferred stock, holders of our common stock are entitled to receive dividends, if any, as may be declared from time to time by our board of directors out of legally available funds.
Liquidation
In the event of our liquidation, dissolution or winding up, holders of our common stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of our debts and other liabilities and the satisfaction of any liquidation preference granted to the holders of any then outstanding shares of preferred stock.
Rights and Preferences
Holders of our common stock have no preemptive, conversion, subscription or other rights, and there are no redemption or sinking fund provisions applicable to our common stock. The rights, preferences and privileges of the holders of our common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of our preferred stock that we may designate in the future.
Listing
Our common stock is listed on The Nasdaq Capital Market under the symbol “CNTX.”
Transfer Agent
The transfer agent and registrar for our common stock is Equiniti Trust Company, LLC.
Anti-takeover effects of provisions of our certificate of incorporation, our bylaws and the DGCL
Some provisions of the DGCL, our certificate of incorporation and our bylaws contain provisions that could make the following transactions more difficult: acquisition of us by means of a tender offer; acquisition of us by means of a proxy contest or otherwise; or removal of our incumbent officers and directors. It is possible that these provisions could make it more difficult to accomplish or could deter transactions that stockholders may otherwise consider to be in their best interests or in our best interests, including transactions that might result in a premium over the market price for our shares.
These provisions, summarized below, are expected to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to encourage persons seeking to acquire control of us to first negotiate with our board of directors. We believe that the benefits of increased protection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure us outweigh the disadvantages of discouraging these proposals because negotiation of these proposals could result in an improvement of their terms.
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Delaware anti-takeover statute
We are subject to Section 203 of the DGCL, which prohibits persons deemed “interested stockholders” from engaging in a “business combination” with a publicly-held Delaware corporation for three years following the date these persons become interested stockholders unless the business combination is, or the transaction in which the person became an interested stockholder was, approved in a prescribed manner or another prescribed exception applies. Generally, an “interested stockholder” is a person who, together with affiliates and associates, owns, or within three years prior to the determination of interested stockholder status did own, 15% or more of a corporation’s voting stock. Generally, a “business combination” includes a merger, asset or stock sale, or other transaction resulting in a financial benefit to the interested stockholder. The existence of this provision may have an anti-takeover effect with respect to transactions not approved in advance by the board of directors, such as discouraging takeover attempts that might result in a premium over the market price of our common stock.
No Written Consent of Stockholders
Our certificate of incorporation provides that all stockholder actions are required to be taken by a vote of the stockholders at an annual or special meeting, and that stockholders may not take any action by written consent in lieu of a meeting. This limit may lengthen the amount of time required to take stockholder actions and would prevent the amendment of our bylaws or removal of directors by our stockholders without holding a meeting of stockholders.
Meetings of Stockholders
Our bylaws provide that a special meeting of stockholders may be called only by our chairman of the board of directors, Chief Executive Officer or by a resolution adopted by a majority of our board of directors, and only those matters set forth in the notice of the special meeting may be considered or acted upon at a special meeting of stockholders. Our bylaws also limit the business that may be conducted at an annual meeting of stockholders to those matters properly brought before the meeting.
Advance Notice Requirements
Our bylaws establish advance notice procedures with regard to stockholder proposals relating to the nomination of candidates for election as directors or new business to be brought before meetings of our stockholders. These procedures provide that notice of stockholder proposals must be timely given in writing to our corporate secretary prior to the meeting at which the action is to be taken. Generally, to be timely, notice must be received at our principal executive offices not less than 90 days nor more than 120 days prior to the first anniversary date of the annual meeting for the preceding year. In addition, to comply with the universal proxy rules, stockholders who intend to solicit proxies in support of director nominees other than our nominees must provide notice that sets forth the information required by Rule 14a-19 under the Exchange Act, generally no later than 60 days prior to the first anniversary of the date of the preceding year’s annual meeting. Our bylaws specify the requirements as to form and content of all stockholders’ notices. These requirements may preclude stockholders from bringing matters before the stockholders at an annual or special meeting.
Amendment to Our Certificate of Incorporation
Any amendment of our certificate of incorporation must first be approved by a majority of our board of directors, and if required by law or our certificate of incorporation, must thereafter be approved by a majority of the outstanding shares entitled to vote on the amendment.
Undesignated Preferred Stock
Our certificate of incorporation provides for 10,000,000 authorized shares of preferred stock. The existence of authorized but unissued shares of preferred stock may enable our board of directors to discourage an attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise. For example, if in the due exercise of its fiduciary obligations, our board of directors were to determine that a takeover proposal is not in the best interests of our stockholders, our board of directors could cause shares of preferred stock to be issued without stockholder approval in one or more offerings or other transactions that might dilute the voting or other rights of the proposed acquirer or insurgent stockholder or stockholder group. In this regard, our certificate of incorporation grants our board of directors broad power to establish the rights and preferences of authorized and unissued shares of preferred stock. The issuance of shares of preferred stock could decrease the amount of earnings and assets available for distribution to holders of shares of common stock. The issuance may also adversely affect the rights and powers, including voting rights, of these holders and may have the effect of delaying, deterring or preventing a change in control of us.
Director terms; election and removal of directors; filling vacancies
Our directors serve for a three-year term. Because our stockholders do not have cumulative voting rights, our stockholders holding a majority of the shares of common stock outstanding will be able to elect all of our directors. Our certificate of incorporation provides for the removal of any of our directors only for cause. Furthermore, any
2
vacancy on our board of directors, however occurring, including a vacancy resulting from an increase in the size of the board of directors, may only be filled by the affirmative vote of a majority of the remaining directors then in office. This system of electing and removing directors and filling vacancies may tend to discourage a third party from making a tender offer or otherwise attempting to obtain control of us, because it generally makes it more difficult for stockholders to replace a majority of the directors.
Choice of Forum
Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, the United States District Court for the District of Delaware) will be the sole and exclusive forum for: (1) any derivative action or proceeding brought on our behalf; (2) any action asserting a claim of breach of a fiduciary duty or other wrongdoing by any of our directors, officers, employees or agents to us or our stockholders; (3) any action asserting a claim against us arising pursuant to any provision of the DGCL or our certificate of incorporation or bylaws; (4) any action to interpret, apply, enforce or determine the validity of our certificate of incorporation or bylaws; or (5) any action asserting a claim governed by the internal affairs doctrine. In addition, our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America shall, to the fullest extent permitted by law, be the sole and exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended (the “Securities Act”). Notwithstanding the foregoing, the exclusive forum provision shall not apply to claims seeking to enforce any liability or duty created by the Exchange Act. Our certificate of incorporation also provides that any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock will be deemed to have notice of and to have consented to these choice of forum provisions. It is possible that a court of law could rule that the choice of forum provisions contained in our certificate of incorporation are inapplicable or unenforceable if they are challenged in a proceeding or otherwise. Although we believe these provisions benefit us by providing increased consistency in the application of Delaware law and the Securities Act for the specified types of actions and proceedings, the provisions may have the effect of discouraging lawsuits against us or our directors and officers.
3
Exhibit 10.15
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
CONFIDENTIAL
EXECUTION VERSION
FIRST AMENDMENT TO DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT
This First Amendment to Development and Manufacturing Services Agreement (this “First Amendment”) dated as of January 9, 2025 (the “First Amendment Effective Date”) is made by and among Lonza Sales AG, of Muenchensteinerstrasse 38, CH-4002 Basel, Switzerland (“Lonza Sales AG”), Lonza AG, of Muenchensteinerstrasse 38, CH-4002 Basel, Switzerland (“Lonza AG”, together with Lonza Sales AG, “Lonza”) and Context Therapeutics Inc., of 2001 Market Street, Suite 3915, Unit 15, Philadelphia, PA 19103 (“Customer”). Lonza and Customer are each referred to as a “Party”, and collectively the “Parties”. Any capitalized term used but not defined herein shall have the meaning ascribed to it in the DMSA (as defined below).
WHEREAS, the Parties entered into that certain Development and Manufacturing Services Agreement, dated as of November 7, 2022 (the “DMSA”), pursuant to which Lonza performs certain Services to Customer;
WHEREAS, simultaneously with execution of the DMSA, Lonza Sales AG and Customer entered into that certain Licence Agreement, dated as of November 7, 2022 (the “License Agreement”), pursuant to which Lonza grants to Customer certain licenses under Intellectual Property Rights (as defined in the License Agreement);
WHEREAS, as permitted by the DMSA, [***];
WHEREAS, Lonza desires to obtain, and Customer has agreed to grant to Lonza and its Affiliates, a limited license under Limited License Customer Patent Rights (as defined below); and
WHEREAS, the Parties wish now to amend the DMSA as provided for herein.
NOW, THEREFORE, in consideration of the foregoing, the mutual covenants contained herein and other valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
1.Amendments to Clause 1.
a.A new definition of “Cover” is hereby added to Clause 1 of the DMSA as follows:
“Cover” or “Covered” mean, with respect to a Valid Claim and a pharmaceutical composition comprising an antibody construct, that, but for the license and other rights granted pursuant to Clause 10.9.1 hereof, such Valid Claim would be infringed by the manufacture, use, sale, offer for sale, exportation or importation of such pharmaceutical composition.
b.A new definition of “Limited License Customer Patent Rights” is hereby added to Clause 1 of the DMSA as follows:
Exhibit 10.15
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
CONFIDENTIAL
EXECUTION VERSION
“Limited License Customer Patent Rights” means [***].
c.A new definition of “Limited License Product” is hereby added to Clause 1 of the DMSA as follows:
“Limited License Product” means any pharmaceutical composition comprising an antibody construct that:
[***].
d.A new definition of “Valid Claim” is hereby added to Clause 1 of the DMSA:
“Valid Claim” means a claim within a patent or patent application (including any re-issued and unexpired claims) which:
[***].
2.New Clause 10.9. A new Clause 10.9 shall be added to the DMSA as follows:
“10.9 Limited License Grant to Lonza.
10.9.1 Lonza hereby acknowledges that, as of the First Amendment Effective Date, Customer is in compliance with this Agreement with respect to [***]. In consideration for such acknowledgement by Lonza, subject to the terms and conditions of this Agreement, during the period commencing as of the First Amendment Effective Date and ending on the date of expiration or termination of the last Valid Claim of the Limited License Customer Patent Rights, Customer hereby grants to Lonza and its Affiliates a non-exclusive, worldwide, royalty-free, fully paid-up license under the Limited License Customer Patent Rights (with the right to sublicense, subject to Clause 10.9.3 below) solely to develop, have developed, manufacture, have manufactured, market, have marketed, sell, have sold, offer for sale, distribute, import and export Limited License Products worldwide.
10.9.2 Lonza hereby covenants and agrees it shall not, and shall not permit any of its Affiliates or sublicensees, to practice any Limited License Customer Patent Right licensed to it by Customer outside the scope of the license granted to it under Clause 10.9.1 of this Agreement.
10.9.3 Subject to the provisions of this Clause 10.9.3 and the terms and conditions of this Agreement, Lonza shall be entitled to grant a sublicence to the rights (including the right to grant additional tiers of sublicences) granted by Clause 10.9.1 (each, including any further grants through subsequent tiers, a “Limited License Sublicense”) to any one or more Third Parties (each, including any further grants through subsequent tiers, a “Limited License Sublicensee”) provided always:
Exhibit 10.15
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
CONFIDENTIAL
EXECUTION VERSION
(a) Lonza shall ensure such Limited License Sublicensee’s exercise of the Limited License Sublicense is not outside the scope of the license granted to Lonza under Clause 10.9.1 of this Agreement; and
(b) Each Limited License Sublicensee shall not, by virtue of this Agreement, grant any right or license, either express or implied, to the Limited License Customer Patent Rights other than to develop, market, sell, offer for sale, distribute, import and export Limited License Products worldwide. Lonza agrees to ensure that Limited License Sublicensee shall not assign, transfer or otherwise make over the benefit or the burden of the rights granted to it pursuant to the Limited License Sublicense.
10.9.4 Lonza shall ensure any Limited License Sublicense granted by Lonza or a Limited License Sublicensee is granted consistent with the scope of the license granted pursuant to Clause 10.9.1 and shall ensure the strict adherence by each Limited License Sublicensee hereunder to the terms and conditions of this Agreement. Lonza shall be responsible and liable for the acts or omissions of each Limited License Sublicensee herein and Lonza shall indemnify Customer against all costs, expenses, claims, loss or damage incurred or suffered by Customer, or for which Customer may become liable arising out of any act or omission of any Limited License Sublicensee, including any product liability claim relating to Limited License Product manufactured, supplied or put into use by the Limited License Sublicensee, except in all instances if directly related to the gross negligence or willful misconduct of Customer.
10.9.5 The license granted by Customer to Lonza pursuant to Clause 10.9.1 may be terminated by Customer at any time with immediate notice and upon written notice to Lonza, to the extent Lonza or any of its Affiliates or Limited License Sublicensees commits a material breach of Clause 10.9.1 or Clause 10.9.2. In such case, Clause 10.9.1 shall terminate and all Limited License Sublicenses granted shall terminate with effect from the date of termination.”
3.New Clause 12.1.3. A new Clause 12.1.3 shall be added to the DMSA as follows:
“12.1.3 any material breach by Lonza of Section 10.9.2 and any development, manufacturing, marketing, selling, offering for sale, distributing, importing and exporting of Limited License Products worldwide by or on behalf of Lonza, its Affiliates or Limited License Sublicensees;”
4.Amendment to Clause 12.5. The first sentence of Clause 12.5 shall be deleted in its entirety and replaced with the following:
Exhibit 10.15
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
CONFIDENTIAL
EXECUTION VERSION
“Subject always to Clause 12.6 [***], the aggregate liability of Lonza and its Affiliates under or in relation to this Agreement and the Project Plans (whether in contract, tort, negligence, breach of statutory duty, under indemnity, or otherwise howsoever arising) shall not exceed, in the aggregate, an amount equal to [***] under this Agreement by Customer to Lonza, [***].”
5.Integration. Except as expressly set forth herein, all provisions of the DMSA shall remain unchanged and in full force and effect. To the extent there are any inconsistencies between this First Amendment and the DMSA, the terms of this First Amendment shall control.
6.Counterpart. This First Amendment may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument. This First Amendment may be executed by facsimile or electronic (e.g., .pdf) signatures and such signatures shall be deemed to bind each party hereto as if they were original signatures.
[Signature Page Follows]
Exhibit 10.15
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
CONFIDENTIAL
EXECUTION VERSION
IN WITNESS WHEREOF, the Parties have caused this First Amendment to be executed by their duly authorized representatives as of the Effective Date.
LONZA AG By: /s/ Albert Pereda Name: Albert Pereda Title: Associate General Counsel (Rev. TH) LONZA AG By: /s/ Thomas Haefele Name: Thomas Haefele Title: Senior Director, IP Division Head Small Molecules | LONZA SALES AG By: /s/ Albert Pereda Name: Albert Pereda Title: Associate General Counsel (Rev. TH) LONZA SALES AG By: /s/ Thomas Haefele Name: Thomas Haefele Title: Senior Director, IP Division Head Small Molecules | ||||
CONTEXT THERAPEUTICS INC. By: /s/ Martin Lehr Name: Martin Lehr Title: CEO | |||||
Exhibit 10.19
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
MASTER SERVICES AGREEMENT
TABLE OF CONTENTS
2. SCOPE OF THE AGREEMENT 11
2.1. Scope of Agreement 11
2.2. Statements of Work 11
2.2.1. Current Statement of Work 11
2.3. Change Orders 12
2.4. Nature of Services 12
2.5. Audit 12
2.6. Restriction on Subcontracting 12
2.7. Conduct of Services 13
2.8. Limitation on Activities Outside of Statement of Work 13
2.9. Materials and Equipment 13
2.10. Amendments/Changes 13
2.11. Meetings; Communications; Updates by Just 14
2.12. Responsibilities of Client 14
3. DISPOSITION; DELIVERY; COMPENSATION 14
3.1. Product Quantity and Quality 14
3.2. Quality Assurance; Certificates 15
3.3. Inspection; Disposition 15
3.4. Disposition 15
3.4.1. Latent Defect 16
3.4.2. Non-Conforming Product 16
3.5. Remedies for Non-Conforming Product 16
3.6. Delivery of Product 17
3.7. Retention Samples; Storage 17
3.8. Payments 17
3.9. Taxes 18
3.10. Records 18
4. REPORTS 18
4.1. Progress Reports 18
4.2. Final Reports 18
5. RECORDS; REGULATORY MATTERS 18
5.1. Record-Keeping 18
5.2. Submissions to Regulatory Authorities; Documentation 19
5.3. Obligations of Just 19
5.4. Communications with Regulatory Authorities 19
5.5. Regulatory Inspections 19
5.6. Compliance 20
5.7. Inspection; Right of Access 20
6. INTELLECTUAL PROPERTY AND DELIVERABLES 20
6.1. Ownership of Intellectual Property 20
Just - Evotec Biologics, Inc. Proprietary and Confidential 2
6.2. Improvement on Background Intellectual Property 21
6.3. Deliverables; Ownership and Non-Exclusive License 21
6.4. License to Just 22
6.5. Project Data 22
6.6. No Restriction on Services Provision for Third Parties 22
7. CONFIDENTIALITY; USE OF NAMES 23
7.1. Confidential Information 23
7.2. Permitted Disclosures 23
7.3. Remedies 24
7.4. Use of Names 24
7.5. Press Release 24
8. REPRESENTATIONS, WARRANTIES AND COVENANTS 24
8.1. Just Representations and Warranties 24
8.2. Client Representations and Warranties 25
8.3. Mutual Representations and Warranties 26
9. TERM; TERMINATION 26
9.1. Term 26
9.2. Termination for Cause 26
9.3. Termination by Mutual Consent; Termination by Client 26
9.4. Effects of Termination or Expiration 27
9.4.1. Payment 27
9.4.2. Delivery of Product 27
9.4.3. Technology Transfer 27
9.5. Cancellation or Rescheduling of Services 27
9.5.1. Cancelling or Rescheduling of J.MD Services and JP3 Services 27
9.5.2. Cancelling or Rescheduling of cGMP Production Run 28
9.5.3. Duty to Mitigate. 29
9.6. Survival 29
10. DISCLAIMERS OF CERTAIN WARRANTIES; LIMITATIONS OF LIABILITY 29
10.1. Disclaimer of Certain Warranties 29
10.2. Limitations of Liability 29
11. INDEMNIFICATION 30
11.1. Indemnification by Client 30
11.2. Indemnification by Just 30
11.3. Defense and Resolution of Claim 30
12. INSURANCE 31
12.1. Insurance 31
13. GENERAL PROVISIONS 31
13.1. Amendments 31
13.2. Assignment 31
13.3. Counterparts 32
Just - Evotec Biologics, Inc. Proprietary and Confidential 3
13.4. Dispute Resolution 32
13.5. Entire Agreement 32
13.6. Force Majeure 32
13.7. Governing Law 32
13.8. Headings 32
13.9. No Agency or Joint Venture 32
13.10. No Third Party Beneficiaries 33
13.11. Notices 33
13.12. Severability 33
13.13. Waiver 33
Exhibit A: Statement of Work No. 1
Just - Evotec Biologics, Inc. Proprietary and Confidential 4
MASTER SERVICES AGREEMENT
This Master Services Agreement is made effective as of October 8, 2021 (the “Effective Date”) by and between Link Immunotherapeutics, Inc., a Delaware corporation, with its principal place of business at 1616 Eastlake Avenue E, Unit 208, Seattle, WA 98102 (“Client”) and Just - Evotec Biologics, Inc., a Delaware corporation, with its principal place of business at 401 Terry Avenue North, Seattle, WA 98109 (“Just”).
RECITALS
WHEREAS, Client is a biotechnology company in the business of, among other things, developing and commercializing therapeutic biological and pharmaceutical products;
WHEREAS, Just has a mission to design and apply innovative technologies to dramatically expand global access to biotherapeutics;
WHEREAS, inter alia, Just provides services including molecular design and optimization and contract development and manufacturing services including process development, process scale-up, production, quality assurance, regulatory support, analytical development and quality control analysis of intermediates and active pharmaceutical ingredients to pharmaceutical and biotechnology companies;
WHEREAS, Client wishes to contract with Just for the provision of services and Just is willing and able to provide the services on the terms and conditions herein;
WHEREAS, Client and Just now therefore agree to establish a contractual relationship for the performance of services under this Agreement for which Client and Just will execute one or more Statements of Work (defined below) describing the responsibilities and obligations specific to the applicable services, as set forth in each Statement of Work; and
WHEREAS, Client and Just have agreed to the terms and conditions for the first Statement of Work under this Agreement for the Project (defined below) titled “[***]”;
NOW, THEREFORE, in consideration of the premises and the representations, warranties, and covenants set forth in this Agreement and for other good and valuable consideration, the receipt and sufficiency of which are acknowledged, Client and Just agree as follows:
1.DEFINITIONS
Unless specifically set forth to the contrary in this Agreement, the following terms, whether used in the singular or plural, shall have the respective meanings set forth in this Article 1:
1.1.“Affiliate” shall mean, with respect to a Party, any corporation or other entity that controls, is controlled by, or is under common control with the Party specified. A corporation or other entity shall be regarded as in control of another corporation or entity if it owns or controls, directly or indirectly, fifty percent (50%) or more of the voting power of the other corporation or entity or otherwise has the power to control its general activities.
1.2.“Agreement” means this Master Service Agreement including Statements of Work executed between Client and Just.
Just - Evotec Biologics, Inc. Proprietary and Confidential 5
1.3.“Applicable Laws” shall mean (a) all laws, rules, regulations, ordinances, directives, and guidance (i) of the United States and the jurisdiction(s) in which the Services under a Statement of Work will be performed and (ii) which are applicable to manufacturing and supply of Deliverables and to the obligations of Just, or Client, as the context requires, under this Agreement, including the U.S. Federal Food, Drug and Cosmetic Act, 21 USC §301 et seq. and regulations promulgated thereunder, and cGMP; and (b) all applicable codes of ethics, principles, and industry standards of the United States and the jurisdiction(s) in which the given activities will be performed, as any of the foregoing may be amended from time to time. The term “Applicable Laws” shall include then-current standards of the FDA, any equivalent Regulatory Authority with jurisdiction over Product and the ICH for the manufacture and testing of pharmaceutical products to be used in the conduct of human clinical trials.
1.4.“Authorized Person” shall have the meaning as set forth in Section 7.1.
1.5.“Background Intellectual Property” means Intellectual Property that is or becomes Controlled by a Party and that exists on or before the Effective Date or is developed, conceived, created, or otherwise Controlled by a Party during the Term, but not resulting from performance of the Services or other activities under this Agreement.
1.6.“Batch” shall mean a specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a Batch may correspond to a defined fraction of the production. The Batch size may be defined either by a fixed quantity or by the amount produced in a fixed time interval. As used herein, the term “Batch” may refer to Product.
1.7.“Batch Records” shall mean records of the procedures followed by Just with respect to Processing the Product (as applicable). A Batch Record includes master manufacturing formula, a listing of raw materials and corresponding specifications, packaging and storage instructions, testing requirements and exception documentation, such as deviations, failures, out-of-specification investigation reports, non-conforming material reports and additional documentation which may have been generated and/or processed as part of the production record of the Batch.
1.8.“Certificate of Analysis” shall mean, for each Batch produced, a document showing acceptance criteria and/or Specifications for such Batch, a compilation of the analytical test methods applied, specifications for each test, and test results for a particular intermediate or finished end product lot.
1.9.“Certificate of Compliance” shall mean, for each Batch, a document confirming that an intermediate or end product has been manufactured in compliance with cGMP, cGLP, or other relevant and applicable quality standard and that quality records associated with such Batch have been reviewed and approved by Quality Assurance at Just.
1.10.“cGLP” shall mean current Good Laboratory Practices.
1.11.“cGMP” shall mean current Good Manufacturing Practices. For purposes of this Agreement, the following guidance and regulations will be applied: applicable FDA regulations on cGMP and ICHQ7 – as incorporated in 21 CFR Parts 610 - 680, as the same may be amended from time to time.
1.12.“Change Order” shall have the meaning set forth in Section 2.3.
1.13.
1.14.“cGMP Production Run” shall mean a cGMP production run and associated process development activities.
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1.15.“Client Indemnitee” and “Client Indemnitees” shall have the meaning set forth in Section 11.1.
1.16.“Client IP” shall have the meaning set forth in Section 6.1.
1.17.“Client Materials” shall mean the materials to be provided to Just by Client for the performance of the Services including, but not limited to, [***] (including [***]), [***] cell line or other similar biologic materials.
1.18.“Client Property” shall mean any property or process owned or controlled by or licensed to Client as of the Effective Date or thereafter, as well as any other property or process developed for Client, or disclosed or delivered by or on behalf of Client, in connection with this Agreement. Client Property includes any Deliverables, Client Materials, and Client’s Confidential Information.
1.19.“Clinical Trial” shall mean a prospective biomedical research study of human subjects that is designed to answer specific questions about biomedical interventions.
1.20.“CMO” means an entity acting in a contract manufacturing capacity by providing services for Just’s and/or Client’s benefit.
1.21.“Commercially Reasonable Efforts” means, with respect to the performance of obligations or tasks by a Party under this Agreement, the use of diligent, good faith efforts and resources by such Party as commonly practiced in the pharmaceutical industry for the development or manufacture of products at a similar stage of development as the applicable Product(s) under this Agreement.
1.22.“Confidential Information” shall mean all confidential information, including any data, research, development, manufacturing, marketing, financial, personnel, business, and other nonpublic, proprietary, or technical information, disclosed by or on behalf of a Party (in such capacity, the “Disclosing Party”) and/or its Affiliates to the other Party (in such capacity, the “Recipient”) and/or its Affiliates, directly or indirectly, in writing (or in any other tangible medium), orally, or by inspection of tangible objects (including documents, prototypes, samples, facilities, and equipment) under this Agreement during the Term. Such information will be considered Confidential Information if (i) such information is identified, in writing or orally, as Confidential Information, or otherwise marked as “Confidential” or “Proprietary” or with a similar designation, at the time of initial disclosure or within a reasonable time thereafter, or (ii) under the circumstances surrounding the disclosure, the Recipient reasonably should have known that such information was confidential or proprietary to the Disclosing Party. The terms of this Agreement shall be the Confidential Information of both Parties. Confidential Information includes, without limitation, any know-how, knowledge, techniques, methods, formula, expertise, trade secrets, documents, or technical information of any type or nature, tangible or intangible, as well as processes, operations, technologies, and forecasts disclosed, supplied, made available, or provided by the Disclosing Party to the Recipient in connection with or relating to this Agreement or a Statement of Work, except any portion of such information that:
(a) is or becomes generally available to the public or within the industry to which such information relates, other than as a result of a breach of this Agreement; or
Just - Evotec Biologics, Inc. Proprietary and Confidential 7
(b) is known by Recipient without obligation of confidentiality at the time of receipt of the Disclosing Party’s information, as evidenced by Recipient’s contemporaneous written records; or
(c) is provided to Recipient on a non-confidential basis by a Third Party who has the legal right to make such disclosure; or
(d) was or is independently developed by or for Recipient without access to or use of the information of the Disclosing Party, as evidenced by Recipient’s contemporaneous written records.
1.23.“Controlled” or “Controls” means possession of the right, whether directly or indirectly, and whether by ownership, license, or otherwise (other than by operation of a license under this Agreement), to assign or grant a license, sublicense, or other right or to transfer or provide access to or under, any material, information, or intellectual property right as provided for herein without violating the terms of any agreement with any Third Party, knowingly infringing upon the intellectual property rights of a Third Party, or misappropriating the proprietary information of a Third Party.
1.24.“Damages” shall have the meaning set forth in Section 11.1.
1.25.“Deliverables” shall mean those deliverables to be developed by Just and provided by Just to Client under a Statement of Work (e.g., Product, [***]) as more fully described in the Payment and Deliverable Schedule and/or in the Scope of Services pursuant to a Statement of Work.
1.26.“Development-Stage Product” shall mean Product for which the manufacturing process has not been standardized, (i) so that each Batch of such Product does not consistently meet the acceptance criteria of its Specifications, if there are Specifications for the Product, or (ii) because there is no Specification and the manufacturing process is subject to adjustment during the Statement of Work performance period. For the avoidance of doubt, this definition shall not be applicable unless a Product is expressly indicated to be a Development-Stage Product in a Statement of Work.
1.27.“Disposition,” with a correlative meaning for “Dispositioned”, shall mean a process by which Quality Assurance releases or rejects materials, including pre-bulk, drug substance, drug product, components, or labeling materials, as the context requires. Material may be Dispositioned as released, conditionally released, released for specific purposes (for example, non-clinical use only), rejected, or retired.
1.28.“DMF” shall mean the Drug Master File as further defined in Section 5.3.
1.29.“Facility” shall mean the Just facility(ies) defined in a Statement of Work which is/are used for Services under this Agreement.
1.30.“FDA” shall mean the United States Food and Drug Administration and any successor agency thereto.
1.31.“Final Report” shall have the meaning set forth in Section 4.2.
1.32.“Force Majeure Event” shall have the meaning set forth in Section 13.1.
1.33.“ICH” shall mean the International Council for Harmonization and any successor entity thereto.
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1.34.“Improvement IP” shall have the meaning set forth in Section 6.2.
1.35.“Indemnitee” shall have the meaning set forth in Section 11.3.
1.36.“Indemnitor” shall have the meaning set forth in Section 11.3.
1.37.“Intellectual Property” shall mean all intellectual property (whether or not patented or patentable), including patents, patent applications, trade secrets, copyrights, trademarks, designs, concepts, technical information, manuals, standard operating procedures, instructions, know-how, or specifications.
1.38.“Invention” shall mean any invention or discovery, including without limitation know-how, whether patentable or not under the patent laws of the United States (Title 35 United States Code Section 101 et seq.) that is conceived or made solely by employees and/or agents of a Party or jointly by employees and/or agents of multiple Parties in the performance of the Services.
1.39.“J.MD Services” shall mean services related to molecular design.
1.40.“JP3 Services” shall mean services related to process and product design.
1.41.“Just Indemnitee” and “Just Indemnitees” shall have the meaning set forth in Section 11.1.
1.42.“Latent Defect” shall mean any defect in any Batch or other delivered quantity of Product resulting in a failure to comply with Standards that results in Product that does not meet the Specifications for such Product, with such defect identified after such Product was released through Disposition and such defect being identified by either Just or Client. For clarity, Latent Defect shall not include any defect to the extent resulting from any activities beyond the action, omission or control of Just, its employees, approved subcontractors, agents, or other representatives.
1.43.“Materials” shall mean the materials to be provided and/or obtained by Just for Processing Product including but not be limited to raw materials, ingredients, cell banks, intermediates, and packaging and shipping materials.
1.44.“mAb” shall mean a monoclonal antibody provided, developed or Processed under a Statement of Work.
1.45.“New Product Introduction Period” shall mean in the context of a cGMP Production Run requested by Client pursuant to a Statement of Work, the [***]-month period immediately prior to such contemplated date for the cGMP Production Run commencing with Client’s commitment to reserving such cGMP Production Run as set forth in the applicable Statement of Work and ending upon the commencement of such cGMP Production Run unless the Parties shall otherwise agree in writing.
1.46.“Non-Conforming Batch” shall have the meaning set forth in Section 3.4.
1.47.“Party” shall mean Client or Just individually, as the context requires, and “Parties” shall mean Client and Just jointly.
1.48.“Payment and Deliverable Schedule” shall mean the schedule of payments and Deliverables as set forth in a Statement of Work.
1.49.“Phase 1 Clinical Trial” means any Clinical Trial conducted on sufficient numbers of human subjects to establish that a pharmaceutical product is reasonably safe for continued testing and to support its continued testing in Phase 2 Clinical Trials. “Phase 1 Clinical Trial” shall
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include without limitation any clinical trial that would or does satisfy the requirements of 21 C.F.R. § 312.21(a), whether or not it is designated a Phase 1 Clinical Trial.
1.50.“Phase 2 Clinical Trial” means any Clinical Trial conducted on sufficient numbers of human subjects that have the targeted disease of interest to investigate the safety and efficacy of a pharmaceutical product for its intended use and to define warnings, precautions, and adverse reactions that may be associated with such pharmaceutical product in the dosage range to be prescribed. “Phase 2 Clinical Trial” shall include without limitation any clinical trial that would or does satisfy the requirements of 21 C.F.R. § 312.21(b), whether or not it is designated a Phase 2 Clinical Trial.
1.51.“Phase 3 Clinical Trial” means any Clinical Trial intended as a pivotal study for purposes of seeking Regulatory Approval that is conducted on sufficient numbers of human subjects to establish that a pharmaceutical product is safe and efficacious for its intended use, to define warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, and to support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product. “Phase 3 Clinical Trial” shall include without limitation any clinical trial that would or does satisfy the requirements of 21 C.F.R. § 312.21(c), whether or not it is designated a Phase 3 Clinical Trial.
1.52.“Process” or “Processing” shall mean the act of developing, manufacturing, handling, storing, analyzing, testing, filling, finishing, packaging, inspecting, labeling, and preparing for shipment of Product (as applicable) by Just pursuant to this Agreement and shall include development and optimization of the processes by which the Product is made.
1.53.“Product” shall mean any mAb or other biologic Processed by Just for delivery to Client pursuant to a Statement of Work.
1.54.“Progress Report” shall have the meaning set forth in Section 4.1.
1.55.“Project” shall mean a project set forth in a Statement of Work.
1.56.“Project Data” shall mean all information, documents, records, raw data, specimens, and other work product that relate to or describe the activities and work performed in connection with a Statement of Work, including the Processing of Product and the tangible materials that are the cell lines and Products produced pursuant to a Statement of Work. The term “Project Data” shall include the foregoing and all documents and records pertaining to Processing of Product, release Specifications, Project-specific analytical test methods, analytical test results, list of equipment used in the Processing of Product, signed title pages of approved qualification and calibration reports for such equipment, and process control and performance, process trend and variability data, and all other documents, reports, and data prepared, developed, or generated by Just in connection with the Services. The term “Project Data” shall expressly exclude, however, information that is the Confidential Information of Just specifically related to its Background Intellectual Property, Improvement IP, or manufacturing processes.
1.57.“Project Representative” shall have the meaning set forth in Section 2.11.
1.58.“QA Release” shall mean release by Just Quality Assurance of a Batch of Product that has been produced in satisfaction of cGMP and that may be used in a Clinical Trial after release of such Batch.
1.59.“Quality Agreement” shall mean, as designated by the Parties as applicable to the scope of Services and Deliverables pursuant to a given Statement of Work, an independent quality agreement entered into or to be entered into by and between Just and Client, which sets forth certain quality responsibilities of the Parties (e.g., for phase-appropriate compliance with cGMP) as they relate to the Processing, Disposition, and delivery of Product(s) for pre-clinical, Phase 1
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Clinical Trial, Phase 2 Clinical Trial, or Phase 3 Clinical Trial, or commercial supply activities under a Statement of Work.
1.60.“Quality Assurance” shall mean a unit, department, group, or contractor that has the responsibility and authority to approve or reject all Deliverables (e.g. Product, mAb, or other biologic, components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products) and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.
1.61.“Quality Control” shall mean the testing laboratory and the performance of tests or other analyses by it to determine whether a Deliverable conforms to Specifications.
1.62.“Regulatory Authority” shall mean any governmental regulatory agency or authority that is responsible for regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging, or use of Product. The term “Regulatory Authority” shall include the FDA and any regulatory agency or authority with jurisdiction over clinical studies of the Product.
1.63.“Reporting Schedule” shall mean the schedule of reports as set forth in a Scope of Services and/or Statement of Work.
1.64.“Scope of Services” shall mean the description of the Services to be performed as more specifically described in individual Statements of Work.
1.65.“Services” shall mean the services performed under this Agreement and more specifically described in individual Statements of Work.
1.66.“Services Cost” shall mean the total cost of Services and breakdown of such cost set forth in a Statement of Work.
1.67.“SOPs” shall mean standard operating procedures.
1.68.“Specifications” shall mean, with respect to a Deliverable, a list of tests, references to analytical procedures, and appropriate acceptance criteria and standards, or other criteria or requirements for the test described or specifications of the Deliverable. The Specifications establish the set of criteria to which a Deliverable should conform to be considered acceptable under this Agreement. The Specifications (including release Specifications) for any Deliverable will be included in its associated Statement of Work or the Quality Agreement, and/or agreed to by the Parties in writing, which is incorporated herein by reference and is made a part of this Agreement and may be amended from time to time in writing by the Parties.
1.69.“Standards” shall have the meaning set forth in Section 2.7.
1.70.“Statement of Work” shall have the meaning set forth in Section 2.2. Statement of Work No. 1 is attached hereto as Exhibit A and made a part of this Agreement.
1.71.“Technology Transfer” shall have the meaning set forth in Section 9.4.3.
1.72.“Term” shall have the meaning set forth in Section 9.1.
1.73.“Third Party” shall mean any individual or entity other than Client or Just or Affiliates of either Party.
2.SCOPE OF THE AGREEMENT
2.1.Scope of Agreement
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As a “Master Services Agreement”, this Agreement allows the Parties to contract for Services through the issuance of multiple Statements of Work, as described in Section 2.2, without having to re-negotiate the basic terms and conditions contained herein for each such Statement of Work. This Agreement covers the provision of Services by Just. Accordingly, this Agreement represents the legal mechanism by which the Parties can efficiently contract with each other for a broad range of Services to be performed under this Agreement including services such as development and manufacturing services and project management services.
2.2.Statements of Work
The specific details of each Service under this Agreement shall be separately negotiated and specified in writing on terms and in a form acceptable to the Parties and numbered consecutively No. 1, No. 2, No. 3, etc. (each such writing, a “Statement of Work”). Each Statement of Work shall include appendices (as appropriate) setting forth the Scope of Services, Services Costs, Specifications, Deliverables, and Payment and Deliverable Schedule and may include such other agreed upon technical and financial details. Such appendices, as applicable, will be appended to the Statement of Work and made a part thereto. Each Statement of Work shall be subject to all of the terms and conditions of this Agreement, in addition to the specific details set forth in the Statement of Work. To the extent any terms or provisions of a Statement of Work conflict with the terms and provisions of this Agreement excluding such Statement of Work, the terms and provisions of this Agreement excluding such Statement of Work shall control, except to the extent the Statement of Work expressly and specifically states an intent to supersede the Agreement on a specific matter or provision. Once executed by both Parties, a Statement of Work and attachments thereto shall be deemed to be incorporated herein by reference. The Parties recognize that certain provisions of this Agreement will only be applicable based upon the specific nature of the Deliverables that are the subject of a specific Statement of Work.
2.2.1.Current Statement of Work
As of the Effective Date, the Parties have agreed to the terms and conditions for the first Statement of Work (Statement of Work No. 1) for the Project titled “[***]” under this Agreement as set forth in Exhibit A. All references under this Agreement to Quality Agreement shall be to the relevant agreement setting forth quality responsibilities of the Parties as relevant to the applicable Statement of Work(s) and Deliverables.
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2.3.Change Orders
Any (a) change in the details of an executed Statement of Work or (b) change in the assumptions upon which an executed Statement of Work is based (including, but not limited to, changes in an agreed starting date for Services or suspension of the Services by Parties) may require changes in the tasks, responsibilities, duties, Services Cost, Payment and Deliverable Schedule, timelines and/or other matters, and shall require a written amendment to such Statement of Work signed by the Parties (a “Change Order”). Each Change Order shall detail the requested changes to the applicable task, responsibility, duty, Services Cost, Payment Schedule, timeline, or other matter. The Change Order will become effective upon the execution of the Change Order by the Parties and will include a specified period of time (as agreed upon by the Parties) within which Just will implement the changes. The Parties agree to act in good faith and promptly when considering a Change Order requested by the other Parties, subject to Section 2.10. Just will not give effect to changes in the Scope of Services until such time the Parties agree to and execute the corresponding Change Order.
2.4.Nature of Services
The Services covered under this Agreement may include general consulting, molecular design and optimization and manufacturing and process development services in the fields of chemistry, biology, preclinical research, biologics, formulation development, clinical material supply, analysis, stability studies, toxicology, process development, drug metabolism, pharmacokinetics, bioanalysis, regulatory, project management, and other related Services as agreed to by the Parties and set forth in the relevant Statement(s) of Work.
2.5.Audit
During the Term and for [***] years thereafter, Client or its authorized representatives may visit the facilities of Just or its subcontractors where the Services are being performed, during normal business hours, for the purposes of audit. Client will pay for its own expenses during such audit visit except for any for cause audit. The detailed scope of audit shall be communicated to Just at least [***] calendar days prior to the requested date of audit and the Parties shall work in good faith to schedule a mutually agreeable date for such audit to occur within [***] business days following the requested date for such audit. Any such audit shall be conducted in a reasonable manner to confirm compliance under the Agreement and applicable Statement of Work and in a manner to avoid material disruption to Just’s activities.
2.6.Restriction on Subcontracting
Just shall not subcontract any part of Services, or otherwise delegate any of its obligations or responsibilities under this Agreement without, in each instance and for each Statement of Work, obtaining the prior written approval of Client, which approval may be granted or withheld at the sole discretion of Client. If Just obtains such prior written approval to delegate any of its obligations or responsibilities under this Agreement to a subcontractor, Just shall enter into a written subcontract agreement with each such approved subcontractor. Any attempted subcontracting or delegation of duties by Just without the prior written approval of Client shall be null and void. Any such unapproved attempted subcontracting or delegation of responsibilities by Just shall be a material breach of this Agreement for which Client may immediately terminate this Agreement. Any approved subcontractor of Just shall be subject to all of the terms and conditions applicable to Just under this Agreement and Statements of Work. No approved subcontractor of Just may further subcontract or delegate any responsibilities under this Agreement
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without the prior written consent of Client, which consent may be granted or withheld at the sole discretion of Client. Approval of a subcontractor shall not relieve Just of its obligations under this Agreement, and Just shall remain primarily liable and shall be responsible for its subcontractor’s performance of this Agreement. Client shall have the right to audit and inspect all approved subcontractors with whom Just has entered into agreements regarding the performance of Services. Such audit and inspection rights of Client shall be substantially similar to the rights of Client to audit and inspect Just under this Agreement. Just shall ensure that all of its agreements with its approved subcontractors include such audit and inspection rights by Client and provisions to maintain the confidentiality of Confidential Information of Client. The Parties shall include the list of approved subcontractors in the Statement of Work and/or the Scope of Services for such Statement of Work. Client shall have the right to retract approval of a subcontractor before initiation of the Statement of Work and upon [***] days’ prior written notice to Just.
2.7.Conduct of Services
Just shall, and shall cause all authorized and approved subcontractors to, perform Services: (a) in a professional and good scientific manner, meeting the standards of diligence, safety, and skill customary in the field; (b) in compliance with all Applicable Laws (including cGMP if applicable to such Services as set forth in the applicable Statement of Work); and (c) in compliance with this Agreement (including the Specifications as provided in a Statement of Work) (the “Standards”). Without limiting the foregoing, Just shall use its Commercially Reasonable Efforts to complete the objectives and activities set forth in a Statement of Work and to achieve the milestones and meet the timelines and schedules set forth in a Statement of Work. Just will promptly notify Client in writing of any material deviations from Applicable Laws. All Services shall be subject to all of the terms and conditions of this Agreement in addition to the specific details set forth in a Statement of Work. A Statement of Work shall clearly define Services and the responsibilities of the Parties with respect to a Statement of Work. In the event of a conflict between or among any of the standards set forth in this Section 2.7, Just shall comply with the standards established by FDA and ICH, unless the Parties otherwise mutually agree in writing. However, Client acknowledges that certain Services may involve Development-Stage Product and development activities for which the results of Processing and other activities under this Agreement are uncertain and subject to variability. Just and its approved subcontractor will use Commercially Reasonable Efforts to perform the Services for Development-Stage Product in accordance with the Standards but Just shall have no liability for the Services not achieving the desired milestones, Specifications, or timelines. If by exercising Commercially Reasonable Efforts with respect to a Project, Just is not able to achieve the desired milestones, Specifications, or timelines, then Just shall promptly notify Client of such event(s) and the Parties will discuss in good faith the appropriate remedies for such events.
2.8.Limitation on Activities Outside of Statement of Work
Subject to Section 6.5, Just shall not use Deliverables for any purposes other than Services without the prior written consent of Client, which consent may be granted or withheld at the sole discretion of Client.
2.9.Materials and Equipment
Unless otherwise agreed by the Parties in writing or otherwise expressly specified in a Statement of Work or Services Cost, Just shall supply all Materials and equipment needed for Services in accordance with this Agreement and a Statement of Work at its sole cost and expense.
2.10.Amendments/Changes
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If a Party seeks a change to the Specifications or a Statement of Work because, for example, (a) an assumption is proven to be incorrect, or (b) there is a change in Applicable Laws that would necessitate a change in the Specifications, Processing, Statement of Work, Deliverables, or the means or methods of performance of Services, the Parties will meet and confer in good faith to determine whether and what changes should be made thereto. No change in the Specifications, Statement of Work, Product-specific or mAb-specific manufacturing processes, test methods, or other documentation or procedures relating to Processing of Product, mAbs, or provision of Services shall be implemented by Just, whether requested by Just, initiated by Client, or requested or required by any Regulatory Authority, unless and until the Parties have executed a written agreement documenting such change through a Change Order, including the implementation date of such change and any increase or decrease in the Services Cost (and change to the Payment and Deliverable Schedule) to reflect adjusted costs, expenses, fees, or savings associated with such change, provided that, if any such change is required by any Regulatory Authority, Just shall use Commercially Reasonable Efforts to execute and implement such change through a Change Order, pending agreement by the Parties on any reasonable adjustment to Services Costs. Notwithstanding anything to the contrary in this Agreement, each Party agrees to use Commercially Reasonable Efforts to manage and control costs so as to prevent the need to request an increase in the Services Cost for a Statement of Work. Any real or anticipated costs beyond those covered in the relevant Services Cost requires prior written approval by Client.
2.11.Meetings; Communications; Updates by Just
The Parties shall hold Project team meetings via teleconference, videoconference, or in person on a regular and periodic basis after issuance of a Statement of Work. Each Party shall appoint a Project representative for each Statement of Work, as identified in each Statement of Work (each, a “Project Representative”) who will have primary responsibility for day-to-day interactions with the other Party’s Project Representative concerning a Statement of Work, Services, and other information pertinent to this Agreement. Unless otherwise mutually agreed by the Parties in writing, all communications between Just and Client regarding a Statement of Work and the activities of the Parties in connection with this Agreement (including Services) shall be addressed to or routed directly through (as appropriate) the respective Project Representatives of each Party. Just shall provide, at a minimum, [***] updates to Client, describing Services during the preceding [***] in reasonable detail, and the detailed results obtained during such [***]; provided that, during the time period of Just’s Product manufacturing campaigns, Just shall provide, at a minimum, [***] updates to Client. These updates may be delivered by Just in writing, or orally, by telephone or videoconference, in each case, followed by a summary in writing, in accordance with instructions from Client, on a [***]-to-[***] or [***]-to-[***] basis (as applicable).
2.12.Responsibilities of Client
Unless otherwise agreed by the Parties in writing or otherwise expressly set forth in a Statement of Work, Client will: (a) provide requirements for a Statement of Work and Services; (b) to the extent applicable, provide Just with information necessary to perform Services and to estimate costs for the Services; (c) prepare or review (as applicable) and approve all Specifications; and (d) perform all obligations and provide all Client Materials and other deliverables expressly allocated to Client in the Statement of Work. Just acknowledges and agrees that Client may enter into agreements with one or more Third Parties for activities and testing related to Deliverables. A Statement of Work may set forth such Client contractors as of the Effective Date, but Client may engage other contractors in this regard during the Term.
3.DISPOSITION; DELIVERY; COMPENSATION
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3.1.Product Quantity and Quality
Pursuant to a Statement of Work, Just shall perform Services in accordance with the Standards to Process and deliver to Client, or to a designated recipient of Client, the quantity and quality of Deliverables as specified in a Statement of Work. The Parties acknowledge and agree that the quantity of Product Processed pursuant to a Statement of Work is not guaranteed and may be within plus or minus [***] percent ([***]%) of the quantity to be delivered pursuant to such Statement of Work. As used in this Agreement, the term “by Client” shall mean “by or on behalf of Client”.
3.2.Quality Assurance; Certificates
Just’s Quality Assurance shall monitor Just’s activities under this Agreement to ensure that each Batch is Processed in accordance with Applicable Laws, including cGMP (if applicable) and conforms to the Specifications. All Quality Control test results and copies thereof shall be provided to Client. To the extent any terms or conditions of a Quality Agreement conflict with the terms and conditions of this Agreement with respect to product quality matters, the terms and conditions of the Quality Agreement shall control and the terms and conditions of this Agreement shall control with respect to non-product quality matters. Any QA Release of Product performed by or on behalf of Just (including tests to confirm that each Batch meets the Specifications) may be relied upon by Client when deciding how a Batch of Product will be used. Client (or a Third Party designated by Client) shall be solely responsible for deciding how any Batch of Product will be used. If Client notifies or has notified Just that a Batch of Product will go through QA Release, then Client shall conduct a technical review of all relevant documents and after such review shall timely notify Just of its approval prior to the QA Release. Client (in its sole discretion) shall determine the form and substance of any release testing information that is submitted to a Regulatory Authority. Prior to any release testing of a Batch by Client, Just shall provide to Client or/and to a designated Third Party a Quality Control reviewed and signed Certificate of Analysis with respect to such Batch and a reviewed and signed Certificate of Compliance within [***] days after Disposition by Just. Just shall provide Client with copies of Batch Records for each Batch within [***] days after Disposition of such Batch, unless otherwise set forth in the relevant Quality Agreement. If Client, or a Third Party laboratory selected by Client, performs an assay needed for release of Product to satisfy cGMP, then Client, and not Just, shall be responsible for the results of such assay. If Client desires to perform Third Party testing of a Batch, then Client will first consult with Just to confirm similarity of testing methodology (e.g. assays, etc.). The Parties acknowledge that Just’s SOPs shall provide a reasonable basis for compliance with the quality standards set forth herein and shall be interpreted in good faith.
3.3.Inspection; Disposition
Just will perform inspection and Disposition of all Materials and all Product Processed pursuant to this Agreement; provided that Client shall be solely responsible for deciding whether to release Materials and Product for clinical use. Client may, in conjunction with Just, perform inspection and Disposition of all Product Processed pursuant to this Agreement. Such inspection and Disposition by Client may take place on-site at Just’s Facility or at another location agreed upon by the Parties (for example, if Batch Records are made available to Client at a location other than Just’s Facility).
3.4.Disposition
Client shall have [***] days from the later of (a) the date that Just notifies Client that documentation for Disposition of each Batch of Product (as applicable) is available at Just’s
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Facility or another location (as described in Section 3.3 above) or (b) the date of receipt by Client of such Batch-related documentation in which to access and review Batch-related documentation, and to evaluate such Batch of Product. Client, shall have the right to reject any Batch of Product as nonconforming if (w) Just fails to timely provide an accurate Certificate of Analysis and/or Certificate of Compliance for such Batch, (x) such Batch of Product does not meet the Specifications because of Just’s failure to comply with the Standards or, (y) such Batch of Product was not Processed in accordance with Applicable Laws, including cGMP, if applicable to such Batch (each of (w-y), a “Non-Conforming Batch”). If Client, or its designee does not notify Just in writing of the rejection of such Batch of Product as a Non-Conforming Batch within such [***] day period, then Client shall have no further right to reject such Batch of Product as a Non-Conforming Batch, except for any Batch of Product deemed a Non-Conforming Batch for a Latent Defect pursuant to Section 3.4.2.
3.4.1.Latent Defect
If, after the release of a Batch of Product by Just, either Party discovers a Latent Defect, then such Party shall notify the other Party within [***] business days after such discovery of the Latent Defect, and upon such notice, such Batch of Product shall be deemed a Non-Conforming Batch.
3.4.2.Non-Conforming Product
If Client rejects a Batch of Product as a Non-Conforming Batch in accordance with Section 3.4.1, or if a Batch of Product having a Latent Defect is deemed a Non-Conforming Batch under Section 3.4.2, then Just shall have the right within [***] days thereafter to sample and re-test such Batch of Product. If Just: (a) agrees that such Batch of Product is a Non-Conforming Batch, then the terms of Section 3.5 shall apply; or (b) disagrees with the determination of Client that such Batch of Product is a Non-Conforming Batch, Just shall so notify Client, in writing within such [***] day period. If Just disagrees with the determination by Client that such Batch of Product is a Non-Conforming Batch, then Just and Client, shall cause an outside testing laboratory or consultant agreeable to both of them to perform comparative tests and/or analyses on samples of the alleged Non-Conforming Batch of Product. The testing laboratory’s or consultant’s results shall be in a written report and shall be final and binding with respect to disputes over whether such batch of Product is a Non-Conforming Batch, save for manifest error on the face of the report. Unless otherwise agreed to by Just and Client, in writing, the costs associated with such testing and review shall be borne by the Party [***]. The outside testing laboratory or consultant shall be required to enter into written undertakings of confidentiality no less stringent than those set forth herein. Just shall furnish the outside testing laboratory such instructions regarding the storage, handling, and potential hazards of any samples of such Batch of Product as are provided to or developed by Just for or on behalf of Client. If a Batch of Product is determined to be a Non-Conforming Batch, then Quality Assurance of Just shall conduct a failure investigation to determine the root cause of such event to the satisfaction of Client. Notwithstanding the foregoing, Just shall not be responsible for any Product defects or delays resulting from incompatibility or instability of the production strain with the manufacturing process agreed upon by the Parties.
3.5.Remedies for Non-Conforming Product
If Just agrees that a Batch of Product is a Non-Conforming Batch, or if the outside testing laboratory or consultant determines that such Product is a Non-Conforming Batch, then Just will Process another Batch
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in accordance with the Standards at Just’s sole cost and expense to begin within [***] days of such determination and to be completed [***]. If such additional Batch is again deemed to be a Non-Conforming Batch, then the Parties shall discuss (in good faith) an appropriate equitable remedy for such non-conformance. Upon Just’s instructions, Client shall destroy or return, at Just’s cost, the Non-Conforming Batch(es) of Product.
3.6.Delivery of Product
Each Batch shall be delivered by Just FCA (Incoterms 2020) Just’s facility; provided that Just shall clear such Batch for export if applicable, and that at Client’s request, Just will arrange for shipment of the Batch and add the shipping, and related insurance charges to its invoice (such charges to be [***]), unless such charges have already been set forth in the Services Cost for the applicable Statement of Work. Notwithstanding the foregoing, Client shall be solely responsible for all import formalities and related costs and duties provided, however, that Just will reasonably cooperate with Client’s efforts at compliance with such formalities.
3.7.Retention Samples; Storage
In accordance with its quality system requirements and Applicable Laws, Just shall retain samples of each Batch of Product at the Facility at no cost to Client until the date that is [***] after completion of Processing of each such Batch (or for such longer period as may be required by applicable Regulatory Authorities or Applicable Laws). Thereafter, if requested by Client, then Just shall make arrangements for contracted storage of such Product samples, as agreed upon by Client, at the cost and expense to be borne by Client. At any time following such [***] (or longer) period, if Just decides that it will no longer store such samples, then it shall provide no less than [***] days written notice to Client during which notice period Client may instruct Just to either ship such samples to Client, a designee of Client, or destroy such samples. Just shall comply with such instructions from Client provided, however, that Client shall reimburse Just for its reasonable out-of-pocket costs incurred in shipping or destroying such samples. If Client requires Just to destroy such samples, then Just shall promptly provide Client with an affidavit attesting that such destruction has been completed.
3.8.Payments
In consideration of Just’s performance of Services and delivery of Deliverables in each case in accordance with this Agreement and each applicable Statement of Work, Client shall pay Just for Services in accordance with the applicable due date set forth in the Payment and Deliverable Schedule in the Statement of Work and if no due date is specified, then within [***] days after Client’s receipt of an invoice for such appropriately completed Services and conforming Deliverables from Just. Such Payment and Deliverable Schedule may include payment by a certain due date upon completion of a milestone and/or receipt of a deliverable or submission of an invoice by Just upon completion of specific Services or a combination of approaches. Client will make payments under this Agreement and each Statement of Work only after receipt of an invoice for the amount to be paid. The Services Cost set forth in a Statement of Work reflects the maximum cost of performing the Services for such Statement of Work, and Client shall not be obligated or expected to pay any additional amounts in connection with the Services unless a Change Order is issued relative to such Statement of Work.
Each such invoice shall set forth the following information: (i) the applicable Statement of Work number under which the Services were performed, (ii) the amount due, (iii) the calculation of such amount due,
and (iv) any applicable supporting documentation. The Statement of Work number is required for
and (iv) any applicable supporting documentation. The Statement of Work number is required for
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payment under an invoice. All invoices shall be directed to the person indicated in the applicable Statement of Work for payment by Client. Client shall have the right (acting in good faith) to require, as a condition to making payment, reasonable additional information from Just for the purposes of determining the sufficiency of the Services and the amount, and Just shall respond to such request promptly and reasonably. Client may dispute any invoiced amount by providing written notice to Just. Client is not obligated to pay any invoiced amount that is the subject of a good faith dispute until such dispute is resolved, provided that Client pays any undisputed invoiced amount. Once an invoice dispute is resolved, if the resolution is in Just’s favor, the disputed amount shall be paid within [***] days of the resolution of such dispute. Overdue undisputed invoiced amounts shall accrue interest at the rate of [***] percent ([***]%) per month beginning [***] days after the due date until the date the balance is paid in full.
3.9.Taxes
Just is liable for and shall pay when due all taxes, levies, duties, fees, and assessments imposed in connection with this Agreement. Just acknowledges that Services Costs as set forth in a Statement of Work are inclusive of all applicable employment-related, consumer, use, VAT, excise, sales, and other similar taxes.
3.10.Records
Just will maintain and make available to Client and its auditors sufficient books and records for a minimum of [***] years after the Term solely to verify Just’s compliance with the terms and conditions of this Agreement.
4.REPORTS
4.1.Progress Reports
Just shall submit to Client a written technical progress report in English (a “Progress Report”) within [***] days after completion of each stage as specified in the Scope of Services. Each Progress Report will include such Project Data as set forth in the Statement of Work or as Client may request from time to time.
4.2.Final Reports
Just shall submit to Client a final written report in English (“Final Report”) within [***] days after completion of the Services as set forth in a Statement of Work or, if this Agreement is terminated prior to completion of the Services under a Statement of Work, then within [***] days after such early termination. The Final Report shall contain a complete written description of the activities under the Statement of Work and all Project Data resulting therefrom, including all related documentation to the extent not previously provided.
5.RECORDS; REGULATORY MATTERS
5.1.Record-Keeping
Except as otherwise expressly set forth in this Agreement, all documentation related to Product, Processing, and Batches shall be provided to Client (or to a Third Party designated by Client to act on behalf of Client) in the English language. For avoidance of doubt, any documentation that Just is required
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to produce under this Agreement and is needed for regulatory submissions by Client or that is required to be held by Client in files by a Regulatory Authority must be provided by Just in the English language. Just shall maintain complete, true, and accurate books, records, test and laboratory data, reports, and all other information relating to Services, including the Project Data and technical records pertaining to the methods, facilities, and equipment used for Processing of Product, in accordance with Applicable Laws and as is reasonably necessary to support regulatory filings by Client with respect to Product. Just shall store all such records and information for a period of at least [***] years from the relevant Product manufacturing date or longer if required under Applicable Laws, after which date Just may dispose of such records in accordance with express written instructions for disposal from Client. In the absence of such instructions, Just shall notify Client, in writing of its intent to dispose of such records and request instructions as to their disposal.
If Client, does not respond to such notice within [***] days after receipt thereof, or in any event prior to the later destruction of such records, Just may destroy such records at its discretion and expense. All such records shall be made reasonably available to Client for audit and for copying if Client is required to submit any such Records under Applicable Law.
5.2.Submissions to Regulatory Authorities; Documentation
Client or Client’s designated subcontractor shall be solely responsible for preparation and submission of applications to Regulatory Authorities regarding Product. Client will advise Just of document requirements in support of such applications by Client. Just and Client, as applicable, will agree to the cost for Just to prepare and provide such document requirements through a Statement of Work. Just will use its Commercially Reasonable Efforts to provide documents and additional information needed for such applications, and to cooperate with and assist Client in preparation and submission of such applications to the FDA (and other Regulatory Authorities, as appropriate). All such applications to Regulatory Authorities and related filings by Client shall be the sole and exclusive property of Client.
5.3.Obligations of Just
Just shall be solely responsible for all permits and licenses required by Regulatory Authorities for the Facility for Processing under this Agreement, and if expressly required under a Statement of Work filing and maintaining a drug master file (“DMF”). Just hereby grants to Client the right to reference such DMF in support of regulatory filings related to the subject matter of this Agreement, and upon the request of Client, Just shall authorize, and hereby authorizes, Regulatory Authorities to permit such DMF to be incorporated by reference in such regulatory filings of Client. Upon request by Client, Just shall make complete copies of all records maintained as provided in Section 5.1 available for inspection by authorized representatives of the FDA and other Regulatory Authorities and for review by Client in accordance with Section 5.7. At the request of Client and in addition to the obligations of Just under Section 5.2, Just shall prepare all sections of regulatory filings by Client that pertain to Services hereunder (including Processing) as described and set forth in a Statement of Work with associated Services Costs.
5.4.Communications with Regulatory Authorities
Client shall be solely responsible for all contacts and communications with any Regulatory Authority with respect to all matters relating to Products. At the request of Client, Just shall make appropriate personnel reasonably available for meetings with Regulatory Authorities related to the Processing of Products. Just shall have no contact or communication with any Regulatory Authority regarding Products, or regarding Processing activities related to Products, without the prior written consent of Client, which consent may
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be granted or withheld at the sole discretion of Client, except as provided in Section 5.5 or as required by Applicable Laws or a Regulatory Authority. Just shall notify Client, immediately, and in no event later than [***] business days, after receiving any contact or communication from any Regulatory Authority that in any way relates to Materials, Products, or to Processing activities.
5.5.Regulatory Inspections
Just shall advise Client no later than the next day that is not a Saturday, Sunday, or federal or state holiday if an authorized agent of any Regulatory Authority or any other regulatory body plans to visit the Facility for Product-specific concerns and/or makes an inquiry regarding Processing of Product or regarding any part of the Facility that is used in Processing of Product. Client shall have the right to be present at any visit relating to Product and to review in advance and comment on any response to the communication or investigation submitted by Just. Just shall cooperate fully with such Regulatory Authority and with Client in providing the information needed for any such communication. Just shall provide to Client copies of any Form 483 or equivalent document delivered by such Regulatory Authority or regulatory body as a result of such visit. If an authorized agent of any Regulatory Authority or any other regulatory body visits the Facility in connection with another product or another part of the Facility and such visit results in a finding or other action that could materially and adversely affect Just’s performance of the Services, then Just shall notify Client within [***] business days after Just receives information about such finding or other action and shall provide Client with information and correspondence concerning Just’s response to such finding or action.
5.6.Compliance
Just shall comply in all material respects with all regulatory requirements with respect to Product that are imposed upon Just (as the provider of Services hereunder) by Applicable Laws from time to time, including those relating to environmental, health, and safety matters. Client shall comply in all material respects with all regulatory requirements with respect to Product that is used in pre-clinical or clinical studies that are imposed upon Client by Applicable Laws.
5.7.Inspection; Right of Access
Just shall permit Client personnel and representative(s), and shall ensure that Client personnel and representative(s) shall be entitled, (a) to inspect, observe, and audit the Processing of Product, the Facility, and other locations at which Product is Processed, (b) to examine the condition of the Materials and Product stored at the Facility, and (c) to examine all Project Data and all other documentation related to this Agreement and Just’s trade secrets and other Confidential Information related to its manufacturing processes to the extent relevant to the Processing of Product and/or the Services. Client personnel and/or representatives shall be entitled to observe the Processing of Product at any time upon reasonable notice and for reasonable duration during regular business hours (including during any shift that is engaged in Processing of Product). Client shall be entitled to conduct an audit hereunder once in any [***] month period during the Term, upon reasonable notice during regular business hours for a period not to exceed [***]; provided, however, that Client shall be entitled to conduct audits following issuance of Form 483 or similar reports delivered by Regulatory Authorities to Just pertaining to the Processing of Product or the occurrence of other events which are likely to materially and adversely affect the Processing of Product as frequently as requested by Client at reasonable times and for reasonable duration (which may exceed [***] days) until Just has corrected such deficiencies. Upon request, Client may conduct additional audits, provided that Client shall reimburse Just for reasonable time and expenses incurred by Just in connection with such audits. Excluding Just’s Confidential Information and Just’s Intellectual
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Property, Background Intellectual Property, and Improvement IP included or referenced in the information obtained by Client, all information obtained by Client in any such inspection (including Project Data, and all findings and results obtained by Client during such inspection), shall be solely owned by Client. During audits by Client of the Facility, Client shall have the right to confirm Just’s audits of Just’s approved subcontractors and suppliers for any Product Processed under this Agreement.
6.INTELLECTUAL PROPERTY AND DELIVERABLES
6.1.Ownership of Intellectual Property
Except as expressly set forth in this Agreement or as the Parties may otherwise agree in writing, each Party owns, and shall continue to own, its Background Intellectual Property, without conferring any interests therein on the other Party. Subject to Section 6.2, except as expressly set forth in this Agreement or as the Parties may otherwise agree in writing, all right, title, and interest in and to any and all Intellectual Property conceived, reduced to practice, generated, or made by any Party, individually or jointly with another party arising from the performance of the Services under a Statement of Work that is specifically directed to a Deliverable and which does not constitute Improvement IP (defined below) shall belong solely to Client (“Client IP”). Just shall and hereby does assign all right, title, and interest in and to such Client IP to Client. Just shall promptly notify and disclose to Client in writing all such Client IP. Just shall, upon the request of Client, execute such documents, including any and all applications, assignments, or other instruments, give any testimony, and take such other actions as Client deems necessary to apply for, secure, and maintain patent or other proprietary protection in the United States or any other country with respect to such Client IP, provided that Client shall compensate Just for its reasonable out-of-pocket costs and expenses associated with such actions.
6.2.Improvement on Background Intellectual Property
If an improvement is made that is specifically directed to Just’s Background Intellectual Property in performance of the Services under a Statement of Work (“Improvement IP”), then Just shall solely own such Improvement IP. Client shall and hereby does assign all of its right, title, and interest in and to such Improvement IP to Just. Client shall, upon the request of Just, execute such documents, including any and all applications, assignments, or other instruments, and take such other reasonable actions as Just reasonably deems necessary to apply for, secure, and maintain patent or other proprietary protection in the United States or any other country with respect to Client’s assignment of rights in such Improvement IP, provided that Just shall compensate Client for its reasonable out-of-pocket costs and expenses associated with such actions.
6.3.Deliverables; Ownership and Non-Exclusive License
(a) As between the Parties and subject to Sections 6.3(b) and 6.3(c), Client shall solely own all right, title, and interest in and to Deliverables. Subject to Sections 6.3(b) and 6.3(c), Client also has the right to transfer Deliverables to other manufacturing facilities, in which case Just will facilitate such transfer and will provide reasonable Technology Transfer services (at Client’s cost) in good faith.
(b) Subject to Section 6.3(c), Just hereby grants to Client and its Affiliates, a worldwide, perpetual, irrevocable, non-terminable, fully paid-up, royalty-free, non-exclusive license, with a right to sublicense, to use or exploit Just’s Intellectual Property (including Just’s Background Intellectual Property) and the Improvement IP solely to the extent embodied in the Deliverables (including [***] or [***]) and solely to the extent required to use or exploit such Deliverables (including using such [***] or [***] solely for the
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manufacturing of Product) (“Non-Exclusive License with Respect to Deliverables”). Except for the Non-Exclusive License with Respect to Deliverables, (i) Just grants no other license, express or implied, to Client to use or exploit Just’s Intellectual Property (including Just’s Background Intellectual Property or Improvement IP) for any other purpose or for any other product and (ii) no permitted (under this Section 6.3) Third Party sublicensee of Client shall have the right to practice or exploit Just’s Intellectual Property (including Just’s Background Intellectual Property or Improvement IP) for any purpose or product other than using such cell lines for the manufacturing of Product for Client.
(c) Client acknowledges that its rights under the Non-Exclusive License With Respect to Deliverables are dependent upon Just – Evotec’s ability to grant such rights based upon the actual Deliverables provided to Client, the scope of certain intellectual property rights owned or controlled by a Third Party(ies) and in-licensed by Just - Evotec through agreements between Just - Evotec and such Third Party(ies), Client’s classification as to the type of recipient to whom Deliverables are to be provided, and Client’s intended use of or activities with respect to such Deliverables. Accordingly, the Non-Exclusive License with espect to Deliverables is subject to, as applicable, the restrictions or limitations set forth in Section 6.3(c)(i) (below).
Client shall be responsible for any license fee financial obligations imposed by such Third Party license agreements by virtue of Client’s practice of the Non-Exclusive License Right With Respect to applicable Deliverables:
(i) [***] Technology. Where by agreement of the Parties Deliverables incorporate or are produced using [***] technology, the Non-Exclusive License with Respect to Deliverables shall be limited by and subject to the restrictions and obligations set forth in that certain Non-Exclusive License Agreement (effective [***]) (“[***] Agreement”) by and between Just and [***]. A redacted copy of the [***]Agreement will be provided to Client upon request. Just hereby represents to Client that:
(a) the redacted portions of the [***] Agreement do not: (i) affect the Non-Exclusive License With Respect to Deliverables and will not result in any obligations of Client under the [***] Agreement (including any payment obligations) other than as set forth in the non-redacted portions of the [***] Agreement including with respect, but not limited, to the [***] fee(s) and applicable late payment fees as set forth in the [***] under the [***] Agreement; or (ii) conflict with the terms of this Agreement;
(b) as of the Effective Date, the [***] Agreement is in full force and effect, and it has not received any notice of default or termination, and, to its knowledge, it has not conducted any activities that would result in the default or termination of the [***] Agreement; and
(c) other than the [***] fee(s) and applicable late payment fees as set forth in the [***] under the [***] Agreement, Client has no obligation to make any payment to [***] under the [***] Agreement for the practice of the Non-Exclusive License With Respect to Deliverables.
6.4.License to Just
During the term of an applicable Statement of Work, Client hereby grants to Just a royalty-free, non-exclusive license, with the right to sublicense to Just’s Affiliates and subcontractors, to use and practice Client IP and Client Background Intellectual Property Controlled by Client and solely as necessary for performance of the Services under such Statement of Work. Except for the license set forth in the
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foregoing sentence or as otherwise expressly set forth in this Agreement, Client grants no license, express or implied, to Just to use or practice any of the Intellectual Property of Client for any purpose.
6.5.Project Data
All Project Data generated or obtained by Just or by Client, whether obtained solely by one Party or jointly by both Parties, in connection with this Agreement shall be solely owned by Client and shall be deemed to be the Confidential Information of Client. Upon completion of a Statement of Work or the earlier request of Client, Just shall send to Client, complete copies of all Project Data. The Project Data shall be prepared, documented, and communicated by Just in a manner consistent with the Specifications and a Statement of Work or as otherwise instructed by Client. Notwithstanding anything to the contrary in this Agreement, Client hereby expressly agrees that Just [***].
6.6.No Restriction on Services Provision for Third Parties
Subject only to the restrictions on Just’s use of Project Data under Section 6.5, nothing in this Agreement prevents Just from carrying out services for any other person or entity, including any services that use products or processes that are similar to the Client Materials and the Processes used to perform the Services under this Agreement, provided that such services will not use any of Client’s Confidential Information, Client’s Background Intellectual Property or Client IP and will not conflict with the provision of Services to Client under this Agreement.
7.CONFIDENTIALITY; USE OF NAMES
7.1.Confidential Information
(a) The Disclosing Party has and shall retain sole and exclusive rights of ownership in all Confidential Information disclosed or owned by such Party. Recipient will use any Confidential Information solely for the purposes of performing its obligations under this Agreement, unless otherwise agreed by the Parties in writing. Recipient will not disclose any Confidential Information to Third Parties except to Recipient’s and its Affiliate’s employees, professional advisors (e.g., attorneys, accountants, and consultants), agents, current and potential investors, grantors, licensees, collaboration partners or acquirers (each, an “Authorized Person”) who reasonably require disclosure of such Confidential Information to achieve the purposes of this Agreement and who are bound to the Recipient by obligations of confidentiality and non-use no less stringent than those set forth herein, except that, with respect to Authorized Persons who are current and potential investors, the relevant time period of confidentiality and non-use obligations may be less than the time period of such obligations set forth herein to the extent customary and reasonable) without the prior written consent of the Disclosing Party. Each Party will maintain and follow reasonable procedures to prevent unauthorized disclosure or use of the other Party’s Confidential Information and to prevent it from becoming disclosed or being accessed by unauthorized persons. Each Recipient may disclose to Authorized Persons only such Confidential Information as is necessary for each such Authorized Person to perform its responsibilities under this Agreement.
(b) Recipient will immediately advise the Disclosing Party of any disclosure, loss, or use of Confidential Information in violation of this Agreement. Recipient shall be liable for any breach of this Agreement by its Authorized Persons.
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(c) Upon request of the Disclosing Party, all Confidential Information in the possession of Recipient (which Recipient is not otherwise entitled to retain pursuant to a license granted under this Agreement), whether in written, graphic, electronic, or other tangible form, and all copies thereof shall be returned to the Disclosing Party or destroyed, upon written request of the Disclosing Party provided, however, that one (1) copy thereof may be retained by the Recipient for record-keeping and for purposes of exercising its right hereunder. Disclosures by a Disclosing Party’s Affiliate shall be deemed disclosures by that Disclosing Party, and disclosures to a Recipient’s Affiliate shall be deemed disclosures to that Recipient. Further, notwithstanding the foregoing, Recipient will not be required to destroy or delete copies of the Confidential Information embedded in its electronic storage systems through routine backup processes, including deleted files and metadata that are generally inaccessible, all subject to Recipient’s ongoing obligations of confidentiality and non-use hereunder.
7.2.Permitted Disclosures
Notwithstanding any other provision in this Agreement, a Recipient may disclose Confidential Information to comply with Applicable Laws, requirements of any Regulatory Authority or other regulatory agency, or court order. Prior to making any such permitted disclosures, however, the compelled Party shall give reasonable advance notice to the other Party with as much detail as possible in relation to the disclosure. Each Party shall reasonably cooperate fully and in a timely manner with the other Party with respect to all such permitted disclosures, including determining what information should be released and requests for confidential treatment of Confidential Information of either Party included in any such disclosure; provided that in no event shall a Party be required to delay any filing or release unreasonably hereunder.
7.3.Remedies
Because of the unique nature of the Confidential Information, Recipient acknowledges and agrees that the Disclosing Party may suffer irreparable injury if the Recipient fails to comply with the obligations set forth in this Article 7, and that monetary damages may be inadequate to compensate the Disclosing Party for such breach. Accordingly, the Disclosing Party will be entitled, in addition to any other remedies available to it at law, in equity or otherwise, without the requirement to post a bond, to seek injunctive relief and/or specific performance to enforce the terms, or prevent or remedy the violation, of this Article 7. This provision shall not constitute a waiver by either Party of any rights to damages or other remedies which it may have pursuant to this Agreement or otherwise.
7.4.Use of Names
Except as required by Applicable Laws and/or as required or expressly authorized under this Article 7, neither Party shall use the name or logo of the other Party or the name of any Affiliate of the other Party, or of any employee or agent of the other Party or its Affiliates, for any public purpose, including in any publication, presentation, publicity, press release, promotion, or advertisement, without the prior written consent of the other Party. Neither Party shall use the name or logo of the other Party or their respective Affiliates, for any public purpose, including in any publication, presentation, publicity, press release, promotion, or advertisement, without the prior written consent of the other Party.
7.5.Press Release
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The Parties agree to cooperate (in good faith) on the content and timing of a mutually agreeable press release announcing the entry into this Agreement.
8.REPRESENTATIONS, WARRANTIES AND COVENANTS
8.1.Just Representations and Warranties
Just represents and warrants or covenants (as the context requires) to Client that:
(a) Just will assign to the performance of Services, professional personnel qualified to perform the activities set forth in a Statement of Work and otherwise in connection with this Agreement in a manner consistent with the technical requirements of a Statement of Work;
(b) Just has no other commitments of its resources that will interfere with its ability to fulfill its obligations under this Agreement;
(c) neither Just nor, to Just’s knowledge, any person employed or used by Just has been debarred under §306(a) or §306(b) of the Federal Food, Drug and Cosmetic Act (codified at 21 USC §335(a) and (b)) and that no debarred person will in the future be knowingly employed or used by Just to perform any Services or any other activities in connection with this Agreement. Neither Just nor to Just’s knowledge any person employed or used by Just has a conviction on their record for which a person can be debarred as described in §306(a) or §306(b) of the Federal Food, Drug and Cosmetic Act. Just further represents and warrants that should Just or any person employed by Just be convicted in the future, of any act for which a person can be debarred as described in §306(a) or §306(b) of the Federal Food, Drug and Cosmetic Act, Just shall immediately notify Client of such conviction;
(d) Just will conduct Services in conformity with Applicable Laws including cGMP, when appropriate, the procedures and parameters set forth in a Statement of Work, the related instructions of Client, and generally accepted professional standards, and in the event of a conflict among any of these requirements, it will conduct Services in conformity with the most stringent requirement;
(e) each Certificate of Analysis will reflect the results of the tests conducted on the Batch of Product to which it relates, each Certificate of Compliance will be accurate and true, and the Batch Records will accurately reflect in all material respects the processes and procedures followed by Just in Processing Product;
(f) the Product shall not have been and shall not be misused, contaminated, tampered with, or otherwise altered, mishandled, or subjected to negligence while in the custody and control of Just;
(g) to Just’s knowledge, the use of Just Background Intellectual Property for the Processing of Product does not infringe or misappropriate any Third Party intellectual property right or otherwise conflict with the rights of any Third Party, and Just will not knowingly infringe or misappropriate any Third Party intellectual property right or otherwise conflict with the rights of any Third Party in the Processing of Product;
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(h) the execution and delivery by Just of this Agreement require no governmental or regulatory approvals to be obtained on the part of Just, or, if required, Just has obtained such approvals;
(i) Just will not transfer to any Third Party any Product Processed for Client, other than (i) for the purpose of tests at any outside testing laboratory or consultant, as provided under Section 3.4.2, (ii) to a designee of Client, or (iii) to any subcontractor in accordance with Section 2.6;
(j) Just has obtained (or will obtain prior to Processing Product) and will maintain, and will remain in compliance with, during the Term, all permits, licenses, and other authorizations which are required under Applicable Laws for the performance of its obligations under this Agreement; and
8.2.Client Representations and Warranties
Client represents and warrants or covenants (as the context requires) to Just that:
(a) Client has the right to disclose all Confidential Information and Intellectual Property that it discloses or licenses to Just and to supply to Just the Client Materials and deliverables required to be supplied to Just in accordance with each Statement of Work; and
(b) Client does not have actual knowledge that Just’s use or practice of Client’s Confidential Information, Client’s Intellectual Property (pursuant to Section 6.4 hereof), Client Materials, supplied by or on behalf of Client under a Statement of Work, when used by Just to provide the Services under and in accordance with such Statement of Work, infringes or misappropriates any patent, copyright, trademark, trade secret, or other proprietary right of any Third Party or otherwise conflict with the rights of any Third Party.
8.3.Mutual Representations and Warranties
Each Party hereby represents and warrants to the other Party that: (a) it has the full power, right, and authority to execute and deliver this Agreement; (b) the person executing this Agreement is authorized to execute this Agreement; (c) this Agreement is legal and valid and the obligations binding upon such Party are enforceable by their terms; and (d) the execution, delivery, and performance of this Agreement does not breach any written agreement to which such Party may be bound, nor violate any law or regulation of any court, governmental body, or administrative or other agency having jurisdiction over it.
9.TERM; TERMINATION
9.1.Term
The term (“Term”) of this Agreement shall commence as of the Effective Date and shall expire five (5) years after the Effective Date, unless earlier terminated by a Party in accordance with this Agreement. The Parties may extend the Term, upon mutual agreement, in a written amendment prior to the expiration of the then-current Term.
9.2.Termination for Cause
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A Party shall have the right to terminate this Agreement or any Statement of Work, at such Party’s option, upon the occurrence of any of the following events: (a) if another Party commits a material breach of a material provision of this Agreement (including a material breach of a material obligation under a Statement of Work), which (in the case of a breach capable of remedy) is not remedied within [***] days after the receipt by the breaching Party of written notice from the non-breaching Party that identifies the breach and requires its remedy; or (b) upon the filing or institution of bankruptcy, reorganization, liquidation, or receivership proceedings by or against the other Party (and if such proceedings are by or against Just, Just shall provide written notice of such proceedings to Client within [***] business days after such filing or institution, so that Client may take possession of its property, including Product); provided, however, that in the event of any involuntary bankruptcy or receivership proceeding, such right to terminate shall only become effective if the proceeding is not dismissed within [***] days after the filing thereof; or (c) if the other Party ceases for any reason to carry on its business (except for assignment pursuant to Section 13.2), or makes an assignment for the benefit of its creditors, or is the subject of any proposal for a voluntary arrangement. In addition, Just shall promptly notify Client in writing if Just receives notice of the debarment or threatened debarment of any individual or entity utilized by Just in connection with Services or this Agreement, and Client shall have the right to immediately terminate this Agreement upon written notice to Just without further cost or liability, except for payments of accrued and unpaid obligations accrued before the date of termination.
9.3.Termination by Mutual Consent; Termination by Client
The Parties may terminate this Agreement at any time by mutual written consent. In addition, Client may terminate any Statement of Work upon [***] days’ prior written notice for any reason. For the sake of clarity, termination of a Statement of Work shall not automatically terminate this Agreement.
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9.4.Effects of Termination or Expiration
9.4.1.Payment
Expiration or termination of this Agreement for any reason shall not relieve Client of its respective payment obligations under this Agreement for Services performed prior to such expiration or termination.
9.4.2.Delivery of Product
Upon expiration or earlier termination of this Agreement or a Statement of Work for any reason and after Client has paid all undisputed invoices for Services and Deliverables appropriately completed by Just as described in Sections 3.8 and 3.9, Just shall promptly deliver to Client or its designee all Deliverables, including all Project Data and Product, and any other Client Property (other than samples retained under Section 3.7) but no later than the later of (a) [***] business days after the date of such expiration or early termination or (b) [***] days after Just’s receipt of payment of all of such invoices.
9.4.3.Technology Transfer
(a) In the event of termination of this Agreement by Client for an uncured breach by Just by operation of Section 9.2, Just agrees to use Commercially Reasonable Efforts to provide reasonable technology transfer assistance related specifically to Processing of Product (“Technology Transfer”) to Client or its designee at Just’s own reasonable expense and cost. A Technology Transfer will include at least the following activities by Just: (a) provide all pertinent know-how, technical data, and other information and documentation necessary or useful to Process Product in accordance with this Agreement and to support regulatory filings for Product (including analytical testing methods, protocols, process descriptions, Batch Records, Project Data, and other process and manufacturing data and documentation); (b) provide reasonable assistance, training and cooperation at manufacturing site(s) to be agreed upon by Client and Just, in order to enable Client or its designee to Process Product; and (c) provide Client or its designee with access to Just employees with expertise in manufacturing to answer questions related to such Technology Transfer. Nothing in this Section 9.4.3 affects Just’s obligations to prepare and provide all Batch Records and Project Data to Client in accordance with the terms of this Agreement, regardless of whether Technology Transfer is requested.
(b) In the event of expiration or termination of this Agreement for any reason (other than an uncured breach by Just by operation of Section 9.2) or upon Client’s request, Just agrees to negotiate with Client (in good faith) for the provision by Just of Technology Transfer, provided such Technology Transfer will be solely at Client’s expense and cost.
9.5.Cancellation or Rescheduling of Services
Unless otherwise set forth in a Statement of Work, Client agrees that the following consequences will be triggered upon the cancellation or re-scheduling by Client of Services covered by such Statement of Work by Client:
9.5.1.Cancelling or Rescheduling of J.MD Services and JP3 Services
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(a) Upfront Fee. Client shall pay any upfront fee due within [***] days after execution of this Agreement (“Upfront Fee”) as required or otherwise designated under the applicable Statement of Work.
(b) [***] or More Days Prior. If Client cancels or reschedules J.MD Services or JP3 Services [***] or more days prior to the scheduled initiation date of the applicable J.MD Services or JP3 Services, then Client shall [***] Just for costs related to [***] incurred by Just for such cancelled or rescheduled Services.
(c) [***] Days Prior. If Client cancels or reschedules J.MD Services or JP3 Services [***] days prior to the scheduled initiation date of J.MD Services or JP3 Services, then (i) Client shall forfeit [***] of the applicable Upfront Fee and (ii) [***] Just for costs related to [***] incurred by Just for such cancelled or rescheduled Services.
(d) Less than [***] Days Prior. If Client cancels or reschedules J.MD Services or JP3 Services less than [***] days prior to the scheduled initiation date of J.MD Services or JP3 Services, then (i) Client shall forfeit [***] of the applicable Upfront Fee for such cancelled or rescheduled Services.
9.5.2.Cancelling or Rescheduling of cGMP Production Run
(a) Reservation Fee. Client shall pay any upfront or reservation fee(s) (“Upfront or Reservation Fee(s)”) as required or otherwise designated under the applicable Statement of Work.
(b) Greater than [***] Days Prior. If Client cancels or reschedules a cGMP Production Run greater than [***] days prior to the scheduled initiation date of the applicable cGMP Production Run, then Client shall [***] Just for costs related to [***] incurred by Just for such cancelled or rescheduled cGMP Production Run.
(c) [***] Days to [***] Days Prior. If Client cancels or reschedules [***] to [***] days prior to the scheduled initiation date of a cGMP Production Run, then (i) Client shall forfeit [***] of the applicable Upfront or Reservation Fee and (ii) [***] Just for costs related to [***] incurred by Just for such cancelled or rescheduled cGMP Production Run.
(d) [***] Days to [***] Days Prior. If Client cancels or reschedules [***] to [***] days prior to the scheduled initiation date of a cGMP Production Run, then (i) Client shall forfeit [***] of the applicable Upfront or Reservation Fee and (ii) [***] Just for costs related to [***] incurred by Just for such cancelled or rescheduled cGMP Production Run.
(e) Less than [***] Days Prior. If Client cancels or reschedules a cGMP Production Run less than [***] days prior to the scheduled initiation date of a cGMP Production Run, then (i) Client shall forfeit [***] of the applicable Upfront or Reservation Fee for such cancelled or rescheduled cGMP Production Run.
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(f) Raw Materials. Raw materials will be purchased at the beginning of the New Product Introduction Period. Client will not receive a refund for raw materials ordered by and billed to Just. Upon Client’s request, raw materials purchased by Just and not used by Just can be sent to Client at Client’s expense for shipping and handling. Raw materials that can be used by Just can be credited against Client’s payment obligations under the applicable Statement of Work less a restock fee of [***] percent ([***]%).
9.5.3.Duty to Mitigate.
Notwithstanding the foregoing, Just (i) acknowledges that Client’s payment of fees for cancellation or rescheduling under this Section 9.5 is intended to compensate Just if Just is unable through Commercially Reasonable Efforts to find a replacement customer for Client’s cancelled or rescheduled Services and (ii) agrees that to the extent Just is able to find a replacement customer for Client’s cancelled or rescheduled services, then the amounts under this Section 9.5 (or a prorated portion based upon the capacity assumed by such replacement customer) will not apply and will not be due and payable by Client.
9.6.Survival
A Recipient’s obligations of confidentiality and non-use with respect to Confidential Information shall survive the Term for a period of [***] years. Also, the following Articles and Sections shall survive expiration or termination of this Agreement: Sections 2.5, 2.8, 3.4, 3.7, 3.9, 3.10, and 4.2, Articles 5 and 6, Sections 7.1, 7.2, 7.3, 7.4, 8.1, and 9.4, Articles 10, 11, 12, and 13 and this Section 9.6; in each case for the timeframe specified therein or, if no timeframe is so specified, then in perpetuity. Expiration or termination of this Agreement shall not relieve the Parties of any causes of action or obligations accruing prior to such expiration or termination.
10.DISCLAIMERS OF CERTAIN WARRANTIES; LIMITATIONS OF LIABILITY
10.1.Disclaimer of Certain Warranties
EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH PARTY DISCLAIMS ALL REPRESENTATIONS, AND WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
10.2.Limitations of Liability
EXCEPT FOR INDEMNIFICATION OBLIGATIONS, BREACH OF CONFIDENTIALITY OBLIGATIONS, OR A PARTY’S GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT, UNDER NO CIRCUMSTANCES SHALL ANY PARTY, ANY OF ITS AFFILIATES, OR ANY OF THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, REPRESENTATIVES, AGENTS, LICENSORS, OR PARTNERS BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL, EXEMPLARY, CONSEQUENTIAL, OR PUNITIVE DAMAGES OR LIABILITIES (INCLUDING TO THE EXTENT SUCH DAMAGES OR LIABILITIES INCLUDE LOSS OF PROFITS, BUSINESS USE, OR OTHER ECONOMIC ADVANTAGE) ARISING OUT OF OR IN ANY WAY RELATED TO THIS AGREEMENT (INCLUDING PERFORMANCE OR FAILURE TO PERFORM HEREUNDER), EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY THEREOF, AND REGARDLESS OF THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT, OR OTHERWISE).
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11.INDEMNIFICATION
11.1.Indemnification by Client
Client shall indemnify, defend, and hold harmless Just and its Affiliates and their directors, officers, employees, and agents (each, an “Just Indemnitee” and collectively, the “Just Indemnitees”) from and against any and all liabilities, obligations, penalties, claims, judgments, demands, suits, reasonable costs and expenses (including reasonable attorneys’ fees) (any or all of the foregoing, “Damages”) arising out of or occurring as a result of a claim or demand made by a Third Party against a Just Indemnitee arising out of property damage, bodily injury (including, but not limited to, sickness, disease, death, mental anguish or emotional distress), or personal injury (including death), resulting from: (a) a breach by Client of any of Client’s obligations or covenants under this Agreement; (b) negligence or willful misconduct of Client in performing its obligations under this Agreement; (c) any of Client representations and warranties set forth in this Agreement being untrue in any material respect when made; or (d) the conduct of any clinical trials for which Client is the sponsor utilizing any Product manufactured by Just pursuant to this Agreement, in each case (a) to (c), except to the extent of any Damages for which Just is required to indemnify a Client Indemnitee pursuant to Section 11.2.
11.2.Indemnification by Just
Just shall indemnify, defend, and hold harmless Client and its Affiliates and their respective directors, officers, employees, donors, and agents (each, a “Client Indemnitee” and collectively, the “Client Indemnitees”), from and against any and all Damages arising out of or occurring as a result of any claim or demand made by a Third Party against a Client Indemnitee in connection with: (a) Processing of a Product; (b) a breach by Just of any of its obligations or covenants under this Agreement; (c) negligence or willful misconduct of Just in performing its obligations under this Agreement; (d) any of Just representations and warranties set forth in this Agreement being untrue in any material respect when made; (e) Just’s purchase, transportation, storage, use, handling, or disposal of any hazardous substances in connection with performance of its obligations under this Agreement; or (f) any claim alleging that the Just Background Intellectual Property used in Processing of Product or provision of Services, infringes or misappropriates the patent or other proprietary rights of any Third Party, in each case (a) to (f), except to the extent of any Damages for which Client is required to indemnify a Just Indemnitee pursuant to Section 11.1.
11.3.Defense and Resolution of Claim
Each Party’s agreement to indemnify, defend, and hold the other harmless is conditioned on the indemnified Party (“Indemnitee”): (a) providing written notice to the indemnifying Party (“Indemnitor”) of any claim, demand, or action arising out of the indemnified activities as soon as practicable after an officer of the Indemnitee has knowledge of such claim, demand, or action, provided that, failure or delay to provide such notice by the Indemnitee shall not relieve the Indemnitor of its obligations hereunder unless the failure or delay materially impairs the Indemnitor’s ability to defend against the Third Party claim or demand; (b) permitting the Indemnitor to assume full responsibility and costs to investigate, prepare for, and defend against any such claim or demand with counsel of the Indemnitor’s choice; (c) assisting the Indemnitor, at the Indemnitor’s reasonable expense, in the investigation of, preparation for, and defense of any such claim or demand; and (d) not compromising or settling such claim or demand without the Indemnitor’s written consent said consent shall not be unreasonably delayed or denied. Indemnitor shall not settle or compromise any claim without the other
Just - Evotec Biologics, Inc. Proprietary and Confidential 32
Party’s prior written approval, which will not be unreasonably withheld, delayed or conditioned. The Indemnitee shall have the right to be represented by its own counsel at its own cost in such matters.
12.INSURANCE
12.1.Insurance
(a) Within [***] days following the Effective Date, if not already in force as of the Effective Date, Just shall, at its own cost and expense, obtain and maintain in full force and effect during the Term, or for the remainder of the Term if not already in force as of the Effective Date, the following: (i) Commercial General Liability Insurance with a per occurrence limit of [***] Dollars ($[***]) and an annual aggregate limit of [***] Dollars ($[***]); (ii) Products and Completed Operations Liability Insurance with a per occurrence limit of not less than [***] Dollars ($[***]) and an annual aggregate limit of [***] Dollars ($[***]); (iii) Workers’ Compensation Insurance with statutory amounts and Employers Liability Insurance with limits of not less than [***] Dollars ($[***]) per accident; and (iv) Auto Liability insurance for owned, hired and non-owned vehicles in a minimum amount of [***] Dollars ($[***]) combined single limit. Just shall, at its own cost and expense, obtain and maintain in full force and effect during the Term, All Risk Property Insurance, including transit coverage, in an amount equal to the full replacement value of its property while in, or in transit to, or from, its facilities.
(b) Just may self-insure all or any portion of the required insurance as long as, together with its Affiliates, its US GAAP net worth is greater than [***] Dollars ($[***]) or its annual EBITDA (earnings before interest, taxes, depreciation and amortization) is greater than [***] Dollars ($[***]). If any required insurance policy is written on a claims made basis, then such policy shall be maintained throughout the Term and for a period of at least [***] years thereafter. Waivers of subrogation and additional insured status obligations will operate the same whether insurance is carried through third parties or self-insured. Upon Client’s written request from time to time, Just shall promptly furnish to Client a certificate of insurance or other evidence of the required insurance or qualification to self-insurance in accordance with the requirements of this Section 12.1. Each insurance policy that is required under this Agreement shall be obtained from an insurance carrier with an A.M. Best or equivalent rating of at least A- VII or an S&P rating of A.
(c) At the written request of Just, Client will provide certificates evidencing its General Liability Insurance and Products Liability and Completed Operations Insurance coverages.
13.GENERAL PROVISIONS
13.1.Amendments
No amendments or modifications to this Agreement shall be effective unless and until made in writing and signed and delivered by both Parties.
13.2.Assignment
A Party shall not assign its rights, or delegate its obligations, under this Agreement, in whole or in part, without the prior written consent of the other Party, except that such consent is not required if such assignment is made to an Affiliate of the assigning Party or to the successor to all or substantially all of the business or assets of the assigning Party to which this Agreement relates (whether by merger, sale of stock, sale of assets or other transaction); provided that the assigning Party shall remain jointly and
Just - Evotec Biologics, Inc. Proprietary and Confidential 33
severally liable with any such Affiliate assignee for the performance of its assigned obligations hereunder. Any attempted assignment in violation hereof shall be void. Subject to the foregoing restrictions, this Agreement shall be binding on the Parties and their respective successors and permitted assigns.
13.3.Counterparts
This Agreement may be executed in counterparts, whether by hand or electronically or digitally, each of which shall be deemed an original, and all of which, taken together, shall constitute one and the same instrument.
13.4.Dispute Resolution
The Parties agree to try to reconcile (in good faith) any controversy or claim arising out of or relating to any provision of the Agreement or any breach thereof, failing which a Party may seek any remedy available to it at law or equity.
13.5.Entire Agreement
This Agreement reflects the entire understanding and agreement between the Parties with respect to the subject matter hereof and supersedes any or all prior or contemporaneous (oral or written) communications, understandings, representations, and agreements, express or implied, between the Parties with respect to the subject matter hereof.
13.6.Force Majeure
A Party shall be excused from performing its obligations under this Agreement (other than payment obligations) if its performance is delayed or prevented by any event beyond such Party’s reasonable control including, without limitation, acts of God, fire, explosion, weather, disease, war, insurrection, civil strife, riots, government action, earthquake, terrorism, or power failure (each, a “Force Majeure Event”); provided that such performance shall be excused only to the extent of and during such disability and the affected Party shall use Commercially Reasonable Efforts to resume performance as soon as reasonably practicable and provided that such event was not caused by such Party’s negligence or willful misconduct. Any time specified for completion of performance in a Statement of Work and falling during or subsequent to the occurrence of any or all such Force Majeure Events shall be automatically extended for a commercially reasonable period of time to enable the non-performing Party to recover from such Force Majeure Event. Just shall, within [***] business days, notify Client if, by reason of any Force Majeure Event, Just is unable to meet any such time for performance specified in a Statement of Work. If Just is delayed due to a Force Majeure Event for more than [***] business days, Client shall have the right to engage a Third Party to perform the Services under the delayed Statement of Work without any breach of this Agreement and without any liability to Just.
13.7.Governing Law
This Agreement shall be governed by and construed and enforced in accordance with the laws of the State of Delaware without reference to provisions of conflicts of laws.
13.8.Headings
All captions and headings in this Agreement are for convenience only and shall not be considered as substantive parts of this Agreement or determinative in the interpretation of this Agreement.
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13.9.No Agency or Joint Venture
It is agreed and understood by the Parties hereto that each of Client and Just, in its performance of its obligations and responsibilities under this Agreement, is an independent contractor. Nothing in this Agreement shall be deemed to create an agency or partnership relationship or joint venture among the Parties.
13.10.No Third Party Beneficiaries
Subject to Section 6.3, this Agreement shall not be deemed to create any rights in any Third Party, including subcontractors or to create any obligations of a Party to any such Third Party.
13.11.Notices
All notices pursuant to this Agreement must be in writing in the English language and shall be: (a) delivered personally; (b) sent by registered mail, return receipt requested, postage prepaid; or (c) sent by an internationally-recognized courier service guaranteeing next-day delivery, charges prepaid to the address of the other Party set forth below. Notification of change of address shall be given in writing.
If to Client:
Link Immunotherapeutics, Inc.
[***]
Attention: [***]
[***]
If to Just:
Just – Evotec Biologics, Inc.
[***]
Attention: [***]
[***]
13.12.Severability
The provisions of this Agreement are severable. If any provision(s) of this Agreement shall be held invalid, illegal, or unenforceable in an arbitration or by a court of competent jurisdiction, this Agreement shall continue in full force and effect without said provision(s), consistent with the intent of the Parties at the time of its execution. If deletion of such provision materially alters the basis of this Agreement, then the Parties shall negotiate an alternative provision in good faith.
13.13.Waiver
No waiver of any breach or default hereunder shall be considered valid unless in a writing signed by both Parties, and no such waiver shall be deemed a waiver of any subsequent breach or default of the same or similar nature. The failure of a Party to enforce any rights granted hereunder or to take action against another Party in the event of any breach hereunder shall not be deemed a waiver by that Party as to subsequent enforcement of rights or subsequent actions in the event of future breaches.
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IN WITNESS THEREOF, the Parties have executed this Master Services Agreement through their authorized representatives.
Link Immunotherapeutics, Inc. By: /s/ David Meininger Name: David Meininger Title: CEO Date: October 8, 2021 | Just - Evotec Biologics, Inc. By: /s/ Linda Zuckerman Name: Linda Zuckerman Title: SVP Business Development Date: October 8, 2021 By: /s/ Mike Vandiver Name: Mike Vandiver Title: Senior Vice President, Biotherapeutic Operations Date: October 10, 2021 | ||||
Exhibit 19
CONTEXT THERAPEUTICS INC.
INSIDER TRADING POLICY
Purpose
This Insider Trading Policy (the “Policy”) provides guidelines with respect to transactions in the securities of Context Therapeutics Inc. (together with its subsidiaries, the “Company”) and the handling of confidential information about the Company and the companies with which the Company does business. The Company’s Board of Directors (the “Board”) has adopted this Policy to promote compliance with Unites States federal and state and applicable foreign securities laws that prohibit certain persons who are aware of material nonpublic information about a company from: (i) trading in securities of that company; or (ii) providing material nonpublic information to other persons who may trade on the basis of that information.
This Policy is divided into two parts: the first part prohibits trading in certain circumstances and applies to all persons described below and the second part imposes special additional trading restrictions and applies to all persons listed in Appendix A as well as any other person designated by the Trading Compliance Officer (as defined below) as being subject to those additional procedures, as well as the Family Members and Controlled Entities of those persons (collectively, the “Covered Persons”). If you are a Covered Person or otherwise designated by the Trading Compliance Officer, you will be notified by the Trading Compliance Officer.
PART I
Persons Subject to the Policy
This Policy applies to all officers of the Company, all members of the Board and all employees of the Company. The Company may also determine that other persons should be subject to this Policy, such as contractors or consultants who have access to material nonpublic information. This Policy also applies to family members, other members of a person’s household and entities controlled by a person covered by this Policy, as described below.
Transactions Subject to the Policy
This Policy applies to transactions in the Company’s securities (collectively referred to in this Policy as “Company Securities”), including the Company’s common stock, options to purchase common stock, or any other type of securities that the Company may issue, including (but not limited to) preferred stock, bonds, convertible debentures and warrants and other derivative securities, as well as derivative securities that are not issued by the Company, such as exchange-traded put or call options or swaps relating to the Company’s Securities.
Individual Responsibility
Persons subject to this Policy have ethical and legal obligations to maintain the confidentiality of information about the Company and to not engage in transactions in Company Securities while in possession of material nonpublic information. Each individual is responsible for making sure that he or she complies with this Policy, and that any family member, household member or entity whose transactions are subject to this Policy, as discussed below, also comply with this Policy. In all cases, the responsibility for determining whether an individual is in possession of material nonpublic information rests with that individual, and any action on the part of the Company, the Trading Compliance Officer or any other employee or director pursuant to this Policy (or otherwise) does not in any way constitute legal advice or insulate an individual from liability under applicable securities laws. You could be subject to severe legal penalties and disciplinary action by the Company for any conduct prohibited by this Policy or applicable securities laws, as described below in more detail under the heading “Consequences of Violations.”
Administration of the Policy
The Company has tasked the Chief Legal Officer or his or her designee (the “Trading Compliance Officer”) with administering this Policy, including:
(i)assisting with implementation and enforcement of this Policy;
(ii)circulating this Policy to all employees and directors and ensuring that this Policy is amended as necessary to remain up-to-date with insider trading laws;
(iii)pre-clearing all trading in Company Securities by all Covered Persons in accordance with the procedures set forth under the heading “Additional Procedures; Pre-Clearance Procedures;” and
(iv)providing approval of any Rule 10b5-1 plans, as described under the heading “Rule 10b5-1 Plans,” and any prohibited transactions, as described under the heading “Special and Prohibited Transactions.”
Statement of Policy
It is the policy of the Company that no director, officer or other employee of the Company who is aware of material nonpublic information relating to the Company may, directly or indirectly through family members or other persons or entities:
(i)engage in transactions in Company Securities, except as otherwise specified in this Policy under the headings “Transactions Under Company Plans and Certain Other Exceptions,” “Transactions Not Involving a Purchase or Sale” and “Rule 10b5-1 Plans;”
(ii)recommend the purchase or sale of any Company Securities;
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(iii)disclose (“tip”) material nonpublic information to persons within the Company whose jobs do not require them to have that information, or outside of the Company to other persons, including, but not limited to, family, friends, business associates, investors and expert consulting firms, unless any such disclosure is made in accordance with the Company’s policies regarding the protection or authorized external disclosure of information regarding the Company; or
(iv)assist anyone engaged in the above activities.
In addition, no director, officer or other employee of the Company may trade securities of another company at any time when the individual has material nonpublic information about that company, including, without limitation, any of our customers, when that information was obtained as a result of the individual’s employment or relationship to the Company.
There are no exceptions to this Policy, except as specifically noted herein. Transactions that may be necessary or justifiable for independent reasons (such as the need to raise money for an emergency expenditure), or small transactions, are not excepted from this Policy. The securities laws do not recognize any mitigating circumstances, and, in any event, even the appearance of an improper transaction must be avoided to preserve the Company’s reputation for adhering to the highest standards of conduct.
Definition of Material Nonpublic Information
Material Information
Information is considered “material” if it is likely that a reasonable investor would consider it important in making a decision to buy, sell or hold a security. Any information that could be expected to affect the Company’s stock price, whether it is positive or negative, should be considered material. There is no bright-line standard for assessing materiality; rather, materiality is based on an assessment of all of the facts and circumstances, and is often evaluated by enforcement authorities with the benefit of hindsight. While it is not possible to define all categories of material information, some examples of information that ordinarily would be regarded as material are:
•current or expected operating or financial performance, including quarterly and annual results;
•guidance on earnings estimates (and changing or confirming such guidance on a later date or other significant variances in results from previous guidance) or other projections of future financial performance;
•mergers, acquisitions, dispositions, joint ventures and other strategic transactions;
•financings and other events regarding the Company’s securities (e.g., defaults on securities, calls of securities for redemption, stock repurchase plans, stock splits, public
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or private sales of securities, changes in dividends or dividend rates, and changes to the rights of securityholders);
•new products or technologies or significant developments with respect to existing products or technologies, including information concerning preclinical and clinical trials and their results;
•significant actions by regulatory agencies or significant communications to or from regulatory agencies;
•information regarding the Company’s patents or other intellectual property rights;
•developments regarding accounts or suppliers, including the acquisition or loss of an important contract;
•changes in management or the Board;
•significant write-offs;
•significant changes in executive compensation policy;
•change in or dispute with the Company’s independent registered public accounting firm or notification that the Company may no longer rely on such firm’s report;
•significant pending or threatened litigation or governmental investigations or significant developments with respect to litigation or governmental investigations;
•a significant disruption in the Company’s operations, or loss, potential loss, breach or unauthorized access of the Company’s property or assets, including information technology infrastructure and cybersecurity and privacy incidents or events; and
•impending bankruptcy, corporate restructuring or receivership.
Information that something is likely to happen or even just that it may happen can be material. Courts often resolve close cases in favor of finding the information to be material. You should keep in mind that U.S. Securities and Exchange Commission (the “SEC”) rules and regulations provide that the mere fact that a person is aware of the information is a bar to trading. It is no excuse that your reasons for trading were not based on the information.
When in doubt about whether particular non-public information is material, presume it is material. If you are unsure whether information is material, you should consult the Trading Compliance Officer before making any decision to disclose such information (other than to persons who need to know it and who have entered in an agreement (or are otherwise bound) to
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maintain the confidentiality of such information) or to trade in or recommend securities to which that information relates.
When Information is Considered Public
Insider trading prohibitions come into play only when you possess information that is material and “nonpublic.” The fact that information has been disclosed to a few members of the public does not make it public for insider trading purposes. To be “public” the information must have been disseminated in a manner designed to reach investors generally, and the investors must be given the opportunity to absorb the information. Generally, you should assume that information has NOT been widely disseminated unless it has been disclosed by the Company in a press release distributed through a widely disseminated news or wire service or it has been disclosed by the Company in a publicly available filing made with the SEC.
Further, the information disseminated must be some form of “official” announcement or disclosure, which, in the case of information about the Company, must be made by the Company. In other words, the fact that rumors, speculation, or statements attributed to unidentified sources are public is insufficient to be considered widely disseminated even when the information is accurate.
Once information is widely disseminated, it is still necessary to afford the investing public with sufficient time to absorb the information. As a general rule, information should not be considered fully absorbed by the marketplace until at least one full trading session has elapsed on the Nasdaq Stock Market (“Nasdaq”) after the information was publicly disclosed. If, for example, the Company were to make an announcement after the market opened on a Monday, you should not trade in Company Securities until Wednesday. Depending on the particular circumstances, the Company may determine that a longer or shorter period should apply to the release of specific material nonpublic information.
As with questions of materiality, if you are not sure whether information is considered public, you should either consult with the Trading Compliance Officer or assume that the information is “non-public” and treat it as confidential.
Transactions by Family Members and Others
This Policy applies to your family members who reside with you (including a spouse, a child, a child away at college, stepchildren, grandchildren, parents, stepparents, grandparents, siblings and in-laws), anyone else who lives in your household, and any family members who do not live in your household but whose transactions in Company Securities are directed by you or are subject to your influence or control, such as parents or children who consult with you before they trade in Company Securities (collectively referred to as “Family Members”). You are responsible for the transactions of these other persons and therefore should make them aware of the need to confer with you before they trade in Company Securities, and you should treat all such transactions for the purposes of this Policy and applicable securities laws as if the transactions were for your own account. This Policy does not, however, apply to personal
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securities transactions of Family Members where the purchase or sale decision is made by a third party not controlled by, influenced by or related to you or your Family Members (for example, by an independent trustee of a trust).
Transactions by Entities that You Influence or Control
This Policy applies to any entities that you influence or control, including any corporations, partnerships or trusts (collectively referred to as “Controlled Entities”). You are responsible for the transactions of your Controlled Entities and therefore should make them aware of the need to confer with you before they trade in Company Securities, and you should treat all such transactions for the purposes of this Policy and applicable securities laws as if the transactions were for your own account.
Transactions Under Company Plans and Certain Other Exceptions
This Policy does not apply in the case of the following transactions, except as specifically noted:
Stock Option Exercises. This Policy does not apply to the exercise of an employee stock option (including any net-settled stock option exercise) acquired pursuant to the Company’s plans. This Policy also does not apply to the withholding of shares subject to an option to satisfy tax withholding requirements. This Policy does apply, however, to any market sale of stock acquired upon such exercise, including as part of a broker-assisted cashless exercise of an option, or any other market sale for the purpose of generating the cash needed to pay the exercise price of an option.
Restricted Stock and Restricted Stock Unit Awards. This Policy does not apply to the vesting of restricted stock or restricted stock units, or the exercise of a tax withholding right pursuant to which you elect to have the Company withhold shares of stock to satisfy tax withholding requirements upon the vesting of any restricted stock. This Policy also does not apply to the withholding (whether mandated by the Company or pursuant to a tax withholding right) of shares of restricted stock or shares underlying restricted stock units to satisfy tax withholding requirements. The Policy does apply, however, to any market sale of shares acquired upon vesting of these awards.
Deferred Compensation Plans. This Policy does not apply to the election by participants in the Company’s deferred compensation plans to allocate their deferred compensation to common stock equivalents, provided that such election is made in advance in accordance with the terms of such plans.
Other Plan Transactions. To the extent the Company offers its securities as an investment option in an employee stock purchase plan, this Policy does not apply to the purchase of stock through the Company’s employee stock purchase plan. The Policy does apply, however, to the sale of any such stock and changing instructions regarding the level of withholding contributions which are used to purchase stock.
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To the extent the Company offers a dividend reinvestment plan (“DRIP”), this Policy does not apply to the purchase of stock through the DRIP resulting from reinvestment of dividends paid on the Company’s securities. The Policy does apply, however, to (i) a voluntary purchase of the Company’s securities that results from additional contributions a participant chooses to make to the DRIP, and to a participant’s election to participate, cease participation or otherwise alter his or her participation in the DRIP, and (ii) a participant’s sale of any of the Company’s securities purchased pursuant to the DRIP.
Certain Other Exceptions. The trading restrictions in this Policy do not apply to:
•Transfers of shares to an entity that does not divest the transferor of beneficial ownership of the shares (for example, to an inter vivos trust of which you are the sole beneficiary during your lifetime or a grantor trust of which you are one of the trustees); and
•Sales of Company Securities as a selling stockholder in a registered public offering in accordance with applicable securities laws.
Special and Prohibited Transactions
The Company has determined that there is a heightened legal risk and/or the appearance of improper or inappropriate conduct if the persons subject to this Policy engage in certain types of transactions. It therefore is the Company’s policy that any persons covered by this Policy may not engage in any of the following transactions, or should otherwise consider the Company’s preferences as described below:
Short Sales. Short sales of Company Securities (i.e., the sale of a security that the seller does not own) may evidence an expectation on the part of the seller that the securities will decline in value, and therefore have the potential to signal to the market that the seller lacks confidence in the Company’s prospects. In addition, short sales may reduce a seller’s incentive to seek to improve the Company’s performance. For these reasons, short sales of Company Securities are prohibited. In addition, Section 16(c) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), prohibits directors and certain officers from engaging in short sales. (Short sales arising from certain types of hedging transactions are governed by the paragraph below captioned “Hedging Transactions.”)
Publicly-Traded Options. Given the relatively short term of publicly-traded options, transactions in options may create the appearance that a director, officer or employee is trading based on material nonpublic information and focus a director’s, officer’s or other employee’s attention on short-term performance at the expense of the Company’s long-term objectives.
Accordingly, transactions in put options, call options or other derivative securities, on an exchange or in any other organized market, are prohibited by this Policy. (Option positions
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arising from certain types of hedging transactions are governed by the paragraph below captioned “Hedging Transactions.”)
Hedging Transactions. Hedging or monetization transactions can be accomplished through a number of possible mechanisms, including through the use of financial instruments such as prepaid variable forwards, equity swaps, collars and exchange funds. Such hedging transactions may permit a director, officer or employee to continue to own Company Securities obtained through employee benefit plans or otherwise, but without the full risks and rewards of ownership. When that occurs, the director, officer or employee may no longer have the same objectives as the Company’s other stockholders. Therefore, directors, officers and employees are prohibited from engaging in hedging or monetization transactions. The prohibition on hedging and monetization transactions does not preclude directors, officers and employees from engaging in general portfolio diversification or investing in broad-based index funds.
Margin Accounts. Securities held in a margin account as collateral for a margin loan may be sold by the broker without the customer’s consent if the customer fails to meet a margin call. Because a margin sale may occur at a time when the pledgor is aware of material nonpublic information or otherwise is not permitted to trade in Company Securities, directors, officers and employees wishing to hold Company Securities in a margin account must first obtain pre-clearance in accordance with the procedures outlined below in Part II under “Pre-Clearance Procedures” to do so. Notwithstanding these procedures, any request for pre-clearance must be submitted at least two weeks prior to setting up the account.
Pledged Securities. Securities pledged (or hypothecated) as collateral for a loan may be sold in foreclosure without the pledgor’s consent if the borrower defaults on the loan. Because a foreclosure sale may occur at a time when the pledgor is aware of material nonpublic information or otherwise is not permitted to trade in Company Securities, directors, officers and employees wishing to enter into such an arrangement must first submit the proposed transaction for pre-clearance in accordance with the procedures outlined below in Part II under “Pre-Clearance Procedures.” Notwithstanding these procedures, any such request for pre-clearance must be submitted to the Trading Compliance Officer at least two weeks prior to the proposed execution of documents evidencing the proposed transaction and must set forth a justification for the proposed transaction. (Pledges of Company Securities arising from certain types of hedging transactions are governed by the paragraph above captioned “Hedging Transactions.”)
Standing and Limit Orders. Standing and limit orders (except standing and limit orders under approved Rule 10b5-1 Plans, as described below) create heightened risks for insider trading violations similar to the use of margin accounts. There is no control over the timing of purchases or sales that result from standing instructions to a broker, and as a result the broker could execute a transaction when a director, officer or other employee is in possession of material nonpublic information. The Company therefore discourages placing standing or limit orders on Company Securities. If a person subject to this Policy determines that he or she must use a standing order or limit order, the order should be limited to two trading days and should otherwise comply with the restrictions and procedures outlined below under the heading “Additional Procedures.”
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Mutual Funds and ETFs. Investments in mutual fund(s) or exchange traded fund(s) that invest in a broad index or sector that also invest in Company Securities, are not prohibited, although the purchase, sale or hedging of mutual fund or ETF shares based on material nonpublic information about the Company would violate this Policy and implicate the securities laws.
However, the SEC and other regulators have taken steps to stop market timing practices and punish people who have broken the insider trading laws through market timing. In light of this close scrutiny, frequent and excessive trading in mutual fund(s) and ETFs that invest in Company Securities is prohibited, and short-term trading in-and-out of such funds and Company Securities generally, especially during periods surrounding the Company’s scheduled release of financial results, is strongly discouraged.
PART II
Additional Procedures
The Company has established additional procedures to assist the Company in the administration of this Policy, to facilitate compliance with laws prohibiting insider trading while in possession of material nonpublic information, and to avoid the appearance of any impropriety. These additional procedures are applicable only to those individuals described below.
Pre-Clearance Procedures. Covered Persons, and any other person designated by the Trading Compliance Officer as being subject to these procedures, may not engage in any transaction in Company Securities, including hedging or pledging transactions, other than exceptions explicitly provided for under this Policy, without first obtaining pre-clearance of the transaction from the Trading Compliance Officer. To obtain clearance for a transaction, submit via email the information contained in the Request for Clearance to Trade as set forth on Appendix B attached hereto. Transactions by the Trading Compliance Officer or his or her Family Members or Controlled Entities must be pre-cleared by the Chief Financial Officer. A request for pre-clearance should be submitted in writing or by electronic transmission to the Trading Compliance Officer at least two business days in advance of the proposed transaction, unless a longer period is otherwise explicitly required under this Policy. In evaluating each proposed transaction, the Trading Compliance Officer (or such person’s designee) will consult as necessary with counsel and senior management before clearing any proposed trade. Approval will generally be granted only during a Window Period (as defined below) and must be in writing or otherwise evidenced by electronic transmission. The Trading Compliance Officer is under no obligation to approve a transaction submitted for pre-clearance, and may determine not to permit the transaction. Unless revoked, a grant of permission will normally remain valid until the close of trading two business days following the day on which it was granted. If the transaction does not occur during the two-day period, pre-clearance of the transaction must be re-requested. If a person seeks pre-clearance and permission to engage in the transaction is denied or is otherwise not provided, then he or she should refrain from initiating any transaction in Company Securities, and should not inform any other person of the restriction.
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When a request for pre-clearance is made, the requestor should carefully consider whether he or she may be aware of any material nonpublic information about the Company, and should describe fully those circumstances to the Trading Compliance Officer. The Trading Compliance Officer will generally require a representation from the requestor that he or she is not aware of any material, nonpublic information. If the requestor is a director or officer (as defined in Rule 16a-1 under the Exchange Act) (collectively, “Section 16 Persons”), the requestor should also indicate whether he or she has effected any non-exempt “opposite-way” transactions (i.e., “short-swing” transactions, which may result in a Section 16 Person having to disgorge to the Company any profits realized) within the past six months, and should be prepared to report the proposed transaction on an appropriate Form 4 or Form 5, if required. The requestor should also be prepared to comply with SEC Rule 144 and file a Form 144, if necessary, at the time of any sale.
The timely reporting of transactions by Section 16 Persons requires tight interface with brokers handling transactions. A knowledgeable, alert broker can also serve as a gatekeeper, helping to ensure compliance with our pre-clearance procedures and helping prevent inadvertent violations. Therefore, in order to facilitate timely compliance by the directors and executive officers of the Company with the requirements of Section 16 of the Exchange Act, brokers of Section 16 Persons need to comply with the following requirements:
(i)not to enter any order (except for orders under pre-approved Rule 10b5-1 plans) without first verifying with the Company that your transaction was pre-cleared and complying with the brokerage firm’s compliance procedures (e.g., Rule 144); and
(ii)to report before the close of business on the day of the execution of the transaction to the Company by telephone and in writing via e-mail to the Chief Legal Officer or his or her designee, the complete (i.e., date, type of transaction, number of shares and price) details of every transaction involving the Company’s equity securities, including gifts, transfers, pledges and all 10b5-1 transactions.
Because it is the legal obligation of the trading person to cause any filings on Form 3, Form 4, Form 5 or Form 144 (or as may otherwise be required) to be made, you are strongly encouraged to confirm following any transaction that your broker has immediately telephoned and e-mailed the required information to the Company.
Quarterly Trading Restrictions. Covered Persons, as well as any other person designated by the Trading Compliance Officer as subject to this restriction, as well as their Family Members or Controlled Entities, may not conduct any transactions involving the Company’s Securities (other than Exceptions) during a “Blackout Period” beginning two weeks before the end of each fiscal quarter and ending after one full trading session on Nasdaq has elapsed since the public release of the Company’s earnings results for that quarter. In other words, these persons may only conduct transactions in Company Securities during the “Window Period” beginning after at least one full trading session on Nasdaq has elapsed following the public release of the
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Company’s quarterly earnings and ending two weeks before the close of the then-current fiscal quarter.
In order to assist Covered Persons in complying with this Policy, the Company will deliver an e-mail (or other communication) notifying all Covered Persons when the Blackout Period begins and when the Window Period opens. The Company’s delivery or nondelivery of these e-mails (or other communication) does not relieve Covered Persons from their obligation to only trade in Company Securities in full compliance with this Policy.
Event-Specific Trading Restriction Periods. From time to time, an event may occur that is material to the Company and is known by only a few directors, officers and/or employees. So long as the event remains material and nonpublic, the persons designated by the Trading Compliance Officer may not trade Company Securities. In addition, the Company’s financial results may be sufficiently material in a particular fiscal quarter that, in the judgment of the Trading Compliance Officer, designated persons should refrain from trading in Company Securities even sooner than the typical start of the Blackout Period described above. In that situation, the Trading Compliance Officer may notify these persons that they should not trade in the Company’s Securities, without disclosing the reason for the restriction. The existence of an event-specific trading restriction period or extension of a Blackout Period will not be announced to the Company as a whole, and should not be communicated to any other person. Even if the Trading Compliance Officer has not designated you as a person who should not trade due to an event-specific restriction, you should not trade while aware of material nonpublic information. Exceptions will not be granted during an event-specific trading restriction period.
Exceptions. The quarterly trading restrictions and event-driven trading restrictions do not apply to those transactions to which this Policy does not apply (collectively, “Exceptions”), as described herein under the headings “Transactions Under Company Plans and Certain Other Exceptions” and “Transactions Not Involving a Purchase or Sale.” Further, the requirement for pre-clearance, the quarterly trading restrictions and event-driven trading restrictions do not apply to transactions conducted pursuant to approved Rule 10b5-1 plans, described under the heading “Rule 10b5-1 Plans.”
Rule 10b5-1 Plans
A 10b5-1 trading plan is a binding, written contract between you and your broker that specifies the price, amount, and date of trades to be executed in your account in the future, or provides a formula or mechanism that your broker will follow. These trading restrictions do not apply to transactions under a pre-existing written plan, contract, instruction, or arrangement under SEC Rule 10b5-1 (an “Approved 10b5-1 Plan”) that:
(i)has been approved in writing in advance by the Trading Compliance Officer;
(ii)was entered into (or modified) in good faith, not as part of a plan or scheme to evade the prohibitions of the insider trading rules and during a time when the person covered by this Policy is not aware of material nonpublic information; and
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(iii)gives a third party the discretionary authority to execute such purchases and sales, outside the influence and control of the person covered by this Policy, so long as such third party does not possess any material nonpublic information about the Company; or explicitly specifies the security or securities to be purchased or sold, the number of shares, the prices and/or dates of transactions, or other formula(s) describing such transactions.
All Approved 10b5-1 Plans will be subject to a “cooling off” period for at least the minimum period required under, and must comply with all other applicable provisions of, SEC Rule 10b5-1(c). Additionally, any amendment must include a new cooling off period between such amendment and its effectiveness.
The rules regarding 10b5-1 trading plans are complex and you must fully comply with them. You must consult with the Trading Compliance Officer prior to entering into any 10b5-1 trading plan and should consult with your legal advisor before proceeding.
Notification of Gift Transactions
Covered Persons must first notify the Trading Compliance Officer in writing or by electronic transmission at least two business days in advance of any proposed gifts of Company Securities.
Post-Termination Transactions
This Policy continues to apply to transactions in Company Securities even after termination of service to the Company. If an individual is in possession of material nonpublic information when his or her service terminates, that individual may not trade in Company Securities until the earlier of (A) when that information has become public or is no longer material or (B) three months, or for all Covered Persons, until the opening of the first Window Period, after termination of employment or other relationship with the Company, except that, unless notified otherwise by the Company, the pre-clearance requirements set forth above under “Pre-Clearance Procedures” continue to apply to Section 16 Persons for six months after the termination of their status as a Covered Person.
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GENERAL
Consequences of Violations
The purchase or sale of securities while aware of material nonpublic information, or the disclosure of material nonpublic information to others who then trade in Company Securities, is prohibited by U.S. federal and state laws, as well as the laws of foreign jurisdictions. Trading in securities during the “Window Period” and outside of any trading suspension periods should not be considered a “safe harbor.” Insider trading violations are pursued vigorously by the SEC, U.S. Attorneys and state enforcement authorities. A person who violates insider trading laws by engaging in transactions in a company’s securities when he or she is aware of material nonpublic information can be sentenced to a substantial jail term and required to pay a criminal penalty of several times the amount of profits gained or losses avoided.
In addition, a person who tips others may also be liable for transactions by the tippees to whom he or she has disclosed material nonpublic information. Tippers can be subject to the same penalties and sanctions as the tippees, and the SEC has imposed large penalties even when the tipper did not profit from the transaction.
The SEC can also seek substantial civil penalties from any person who, at the time of an insider trading violation, “directly or indirectly controlled the person who committed such violation,” which would apply to the Company and/or management and supervisory personnel. These control persons may be held liable for up to the greater of $1 million or three times the amount of the profits gained or losses avoided. Even for violations that result in a small or no profit, the SEC can seek penalties from a company and/or its management and supervisory personnel as control persons.
In addition, an individual’s failure to comply with this Policy may subject the individual to Company-imposed sanctions, including dismissal for cause, whether or not the employee’s failure to comply results in a violation of law. Needless to say, a violation of law, or even an SEC investigation that does not result in prosecution, can tarnish a person’s reputation and irreparably damage a career.
Legal Effect of this Policy
This Policy, and the procedures that implement this Policy, are not intended to serve as precise recitations of the legal prohibitions against insider trading and tipping which are highly complex, fact specific and evolving. Certain of the procedures are designed to prevent even the appearance of impropriety and in some respects may be more restrictive than the applicable laws. Therefore, these procedures are not intended to serve as a basis for establishing civil or criminal liability that would not otherwise exist.
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Company Assistance
Any person who has a question about this Policy or its application to any proposed transaction may obtain additional guidance from the Trading Compliance Officer, who can be reached by e-mail at [***].
Certification
All persons subject to this Policy must certify their understanding of, and intent to comply with, this Policy.
Adopted: May 30, 2023
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Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the Registration Statements on Form S-3 (No. 333-283037, 333-279693, 333-268266 and 333-261599) and Form S-8 (No. 333-278127, 333-270759, 333-263789, 333-260385) of our report dated March 20, 2025, with respect to the consolidated financial statements of Context Therapeutics Inc. and Subsidiaries included in this Annual Report on Form 10-K of Context Therapeutics Inc. for the year ended December 31, 2024.
/s/ CohnReznick LLP
Parsippany, New Jersey
March 20, 2025
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
I, Martin Lehr, certify that:
1.I have reviewed this Annual Report on Form 10-K of Context Therapeutics Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
| Date: March 20, 2025 | By: | /s/ Martin Lehr | ||||||||||||
| Martin Lehr | ||||||||||||||
| Chief Executive Officer | ||||||||||||||
| (Principal Executive Officer) | ||||||||||||||
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL
OFFICER PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002
I, Jennifer Minai-Azary, certify that:
1.I have reviewed this Annual Report on Form 10-K of Context Therapeutics Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
| Date: March 20, 2025 | By: | /s/ Jennifer Minai-Azary | ||||||||||||
| Jennifer Minai-Azary | ||||||||||||||
| Chief Financial Officer | ||||||||||||||
| (Principal Financial Officer) | ||||||||||||||
EXHIBIT 32.1
CERTIFICATIONS PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350, as adopted), Martin Lehr, Chief Executive Officer (Principal Executive Officer) of Context Therapeutics Inc. (the “Company”), and Jennifer Minai-Azary, Chief Financial Officer (Principal Financial Officer) of the Company, each hereby certifies that, to the best of his or her knowledge:
(1) The Company’s Annual Report on Form 10-K for the year ended December 31, 2024 (the “Annual Report”), and to which this Certification is attached as Exhibit 32.1, fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended, and
(2) The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the periods presented therein.
| /s/ Martin Lehr | |||||
| Date: March 20, 2025 | Martin Lehr | ||||
| Chief Executive Officer (Principal Executive Officer) | |||||
| /s/ Jennifer Minai-Azary | |||||
| Date: March 20, 2025 | Jennifer Minai-Azary | ||||
| Chief Financial Officer (Principal Financial Officer) | |||||
This certification accompanies the Annual Report on Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Context Therapeutics Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.