FibroBiologics, Inc 10-K for FY2023

FibroBiologics, Inc. (FBLG)

10-K 2024-02-29 For: 2023-12-31

Added on April 07, 2026

About this 10-K

FibroBiologics, Inc filed this 10-K on February 29, 2024, covering the fiscal year ended December 31, 2023 (FY2023).

Headline figures

Fiscal year ended December 31, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $16.49M; compared with a net loss of $5.12M a year earlier
Diluted EPS: -$0.68; compared with -$0.18 a year earlier

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Delaware		86-3329066
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

455 E. Medical Center Blvd, Suite 300 Houston, TX 77598		77598
(Address of principal executive offices)		(Zip Code)

	Large accelerated filer ☐		Accelerated filer ☐

	Non-accelerated filer ☒		Smaller reporting company ☒

	Emerging growth company ☒

	●	the timing, progress and results of preclinical studies and clinical trials for our current and future product candidates, 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 or likelihood of regulatory submissions, filings, and approvals, including final regulatory approval of our product candidates;

	●	our ability to develop and advance product candidates into, and successfully complete, clinical trials;

	●	our expectations regarding the size of the patient populations for our product candidates, if approved for commercial use;

	●	the implementation of our business model and our strategic plans for our business, product candidates and technology;

	●	our commercialization, marketing and manufacturing capabilities and strategy;

	●	the pricing and reimbursement of our product candidates, if approved;

	●	the rate and degree of market acceptance and clinical utility of our product candidates, in particular, and cell therapy, in general;

	●	our ability to establish or maintain collaborations or strategic relationships or obtain additional funding;

	●	our competitive position;

	●	the scope of protection we and/or our licensors are able to establish and maintain for intellectual property rights covering our product candidates;

	●	developments and projections relating to our competitors and our industry;

	●	our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

	●	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; and

	●	the impact of laws and regulations.

Item 1.	Business	1

Item 1A.	Risk Factors	26

Item 1B.	Unresolved Staff Comments	79

Item 1C.	Cybersecurity	79

Item 2.	Properties	79

Item 3.	Legal Proceedings	79

Item 4.	Mine Safety Disclosures	79

PART II

Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	80

Item 6.	Reserved	80

Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	80

Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	91

Item 8.	Financial Statements and Supplementary Data	91

Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	91

Item 9A.	Controls and Procedures	91

Item 9B.	Other Information	92

Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	92

PART III

Item 10.	Directors, Executive Officers and Corporate Governance	92

Item 11.	Executive Compensation	99

Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	106

Item 13.	Certain Relationships and Related Transactions, and Director Independence	108

Item 14.	Principal Accounting Fees and Services	109

PART IV

Item 15.	Exhibits, Financial Statement Schedules	110

	●	can be non-invasively harvested from a variety of skin donors from surgical procedures such as tummy tuck flaps;

	●	have a faster doubling time in culture than stem cells;

	●	possess superior immune modulatory activity compared with stem cells;

	●	exhibit enhanced ability to produce regenerative cytokines and growth factors compared with stem cells; and

	●	are more economical to isolate, culture and expand compared with stem cells because fibroblasts do not require the use of expensive tissue culture media.

Title of each class	Name of each exchange on which registered

	●	Attract and retain scientists with the skill sets required to conduct preclinical studies and identify the optimal paths forward to clinical trials.

	●	Prioritize our initial clinical development efforts on product candidates with the combination of significant unmet treatment needs, lower risk and market potential.

	●	Partner with Clinical Research Organizations, or CROs, with the relevant expertise and experience to successfully and timely execute clinical trials to generate reliable pivotal data that can be used to seek approvals.

	●	Invest in critical capabilities required to produce and supply fibroblasts for clinical trials and initial commercialization.

	●	Protect, expand and defend our intellectual property portfolio around fibroblasts.

	●	Expand development efforts in product candidates with longer development timelines, greater risk and significant unmet treatment needs as funding allows.

	●	Approximately $0.1 million to $0.2 million in capital expenditures for laboratory equipment to enable continued research and expand capabilities;

	●	Approximately $0.3 million to $0.4 million to acquire clinical skin samples;

	●	Approximately $0.2 million to $0.3 million for tissue and fibroblast cell characterization and optimization;

	●	Approximately $0.2 million to $0.4 million to develop a master cell bank;

	●	Approximately $0.1 million to $0.3 million to develop a working cell bank;

	●	Approximately $0.1 million to $0.3 million to develop processes for transfer to a CDMO;

	●	Approximately $0.1 million to submit an IND application for CYWC628 for a phase 1/2 clinical trial in wound healing;

	●	Approximately $0.2 million to $0.3 million to complete a preclinical animal study to determine mode of action for CYMS101 in MS prior to submitting an IND application for a phase 1/2 clinical trial in MS; and

	●	Approximately $0.1 million to initiate a preclinical animal study in CYTER915 for thymic involution reversal.

	●	absorbs shock;

	●	maintains motion; and

	●	keeps stability.

	(i)	Biomaterials, without additional cells, that are used to send signals to attract cells and promote regeneration;

	(ii)	Cells alone may be used, to form a tissue; and

	(iii)	Cells may be used with a biomaterial scaffold that acts as a frame for developing tissues.

	●	Biogen, Inc.: Strong presence in the global market coupled with a diverse portfolio of MS drugs;

	●	F. Hoffmann-La Roche Ltd (commonly known as Roche): Strong focus on research and development activities to develop novel medicine for MS treatment; and

	●	Novartis AG: Increased focus on investment in research and development of innovative molecules.

	●	diagnosis, treatment, prevention and palliation of spinal diseases, disorders or conditions;

	●	certain cancers;

	●	orthopedic diseases, disorders or conditions; and

	●	multiple sclerosis.

	●	completion of nonclinical or preclinical laboratory tests, animal studies and formulation studies in accordance with the FDA’s good laboratory practice, or GLP, requirements and other applicable regulations;

	●	submission to the FDA of an IND, which must become effective before human clinical trials may begin;

	●	approval by an IRB or ethics committee at each clinical site before each trial may be initiated;

	●	performance of adequate and well-controlled human clinical trials in accordance with GCP requirements to establish the safety and efficacy of the proposed drug for its intended use, or with respect to biologics, the safety, purity and potency of the product candidate for each proposed indication;

	●	submission to the FDA of an NDA or BLA after completion of all pivotal trials;

	●	a determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for review;

	●	satisfactory completion of an FDA advisory committee review, if applicable;

	●	satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity, and of selected clinical investigation sites to assess compliance with GCPs;

	●	a potential FDA audit of the preclinical and/or clinical trial sites that generated the data in support of the NDA or BLA; and

	●	the FDA’s review and approval of the NDA or BLA to permit commercial marketing of the product for particular indications for use in the United States.

	●	*Phase 1*: The product candidate is initially introduced into healthy human subjects or, in certain cases such as certain cancers, patients with the target disease or condition. These trials are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. In the case of some products for severe or life-threatening diseases, such as certain cancers, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

	●	*Phase 2*: The product candidate is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages, dose tolerance and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

	●	*Phase 3*: The product candidate is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for physician labelling. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA or BLA.

	●	restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

	●	fines, warning letters, or untitled letters;

	●	clinical holds on clinical trials;

	●	refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals;

	●	product seizure or detention, or refusal to permit the import or export of products;

	●	consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;

	●	mandated modification of promotional materials and labeling and the issuance of corrective information;

	●	the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or

	●	injunctions or the imposition of civil or criminal penalties.

	●	increased the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1% of the average manufacturer price;

	●	required collection of rebates for drugs paid by Medicaid managed care organizations;

	●	required manufacturers to participate in a coverage gap discount program, under which they must agree to offer 50% (increased to 70% pursuant to the Bipartisan Budget Act of 2018, effective as of January 1, 2019) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; and

	●	imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell “branded prescription drugs” to specified federal government programs.

	●	The successful development of biopharmaceutical products is highly uncertain.
	●	We have a limited operating history and none of our current product candidates have been approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability.
	●	We have incurred significant net losses since inception, expect to continue to incur significant net losses for the foreseeable future, and may never achieve or maintain profitability.
	●	We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts.
	●	The regulatory approval processes of the FDA, the European Medicines Agency, or the EMA, and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable.
	●	We may encounter substantial delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
	●	The outcome of preclinical studies or early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA, the EMA or other comparable foreign regulatory authorities.
	●	Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
	●	Our current or future product candidates may cause adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved products or investigational new drugs that may result in a safety profile that could inhibit regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences.
	●	Even if approved, our product candidates may not achieve adequate market acceptance.
	●	Our refrigerated product candidates require specific storage, handling and administration at the clinical sites.
	●	We intend to identify and develop novel cell therapy product candidates, which makes it difficult to predict the time, cost and potential success of product candidate development.
	●	Because cell therapy is novel and the regulatory landscape that governs any cell therapy product candidates we may develop is rigorous, complex, uncertain and subject to change, we cannot predict the time and cost of obtaining regulatory approval, if we receive it at all, for any product candidates we may develop.
	●	We may be unable to obtain U.S. or foreign regulatory approvals and, as a result, may be unable to commercialize our product candidates.
	●	Any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
	●	We have limited experience in designing clinical trials.
	●	Our long-term prospects depend in part upon discovering, developing and commercializing additional product candidates, which may fail in development or suffer delays that adversely affect their commercial viability.
	●	We have never commercialized a fibroblast cell-based therapy product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any product candidates on our own or together with suitable collaborators.
	●	We face significant competition.
	●	If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market our product candidates that obtain regulatory approval.
	●	In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.
	●	We are subject to risks related to our dependence on third parties (i) to conduct certain aspects of our preclinical studies and clinical trials and (ii) for certain portions of our manufacturing process.
	●	We are highly dependent on our Houston, Texas facility and any failure to maintain the use of this facility would have a material and adverse effect on our business.
	●	We are subject to extensive government regulations.
	●	Our business entails a significant risk of product liability.
	●	The FDA, the EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
	●	Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight.
	●	Our success depends on our ability to protect our intellectual property and our proprietary technologies, and we are subject to various risks relating to our intellectual property.
	●	The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain executive management and qualified board members.
	●	We are a “controlled company” within the meaning of the Nasdaq Stock Market Rules because our insiders beneficially own more than 50% of the voting power of our outstanding voting securities.
	●	We have 2,500 shares of Series C Preferred Stock with super voting rights.
	●	We have identified a material weakness in our internal controls over financial reporting due to lack of segregation of duties.
	●	An active trading market may not develop or continue to be liquid and the market price of our shares of common stock may be volatile.

	●	clinical trial results showing the product candidates to be less effective than expected (for example, a clinical trial could fail to meet its primary or key secondary endpoint(s)) or have an unacceptable safety or tolerability profile;
	●	failure to receive the necessary regulatory approvals or a delay in receiving such approvals, which, among other things, may be caused by patients who fail the trial screening process, slow enrollment in clinical trials, patients dropping out of trials, patients lost to follow-up, length of time to achieve trial endpoints, additional time requirements for data analysis or NDA preparation, discussions with the FDA, an FDA request for additional preclinical or clinical data or unexpected safety or manufacturing issues;
	●	preclinical study results showing the product candidate to be less effective than desired or to have harmful side effects;
	●	post-marketing approval requirements; or
	●	the proprietary rights of others and their competing products and technologies that may prevent our product candidates from being commercialized.

	●	advance the development of our lead product candidates through clinical development, and, if approved by the FDA, commercialization;
	●	advance our preclinical development programs into clinical development;
	●	incur manufacturing costs for cell production to supply our product candidates;
	●	seek regulatory approvals for any of our product candidates that successfully complete clinical trials;
	●	increase our research and development activities to identify and develop new product candidates;
	●	hire additional personnel;
	●	expand our operational, financial and management systems;
	●	meet the requirements and demands of being a public company;
	●	invest in further development to protect and expand our intellectual property;
	●	establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any product candidates for which we may obtain marketing approval and intend to commercialize; and
	●	expand our manufacturing and develop our commercialization efforts.

	●	the initiation, progress, timeline, cost and results of our clinical trials for our product candidates;
	●	the initiation, progress, timeline, cost and results of additional research and preclinical studies related to pipeline development and other research programs we initiate in the future;
	●	the cost and timing of manufacturing activities, including our planned manufacturing scale-up activities associated with our product candidates and other programs as we advance them through preclinical and clinical development through commercialization;
	●	the potential expansion of our current development programs to seek new indications;
	●	the outcome, timing and cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authorities;

	●	the cost of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights, in-licensed or otherwise;
	●	the effect of competing technological and market developments;
	●	the payment of licensing fees, potential royalty payments and potential milestone payments;
	●	the cost of general operating expenses;
	●	the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own; and
	●	the costs of operating as a public company.

	●	the FDA, the EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials;
	●	the FDA, the EMA or other comparable foreign regulatory authorities may determine that our product candidates are not safe and effective, only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use;
	●	the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval;
	●	the FDA, the EMA or other 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 product candidates may not be sufficient to support the submission of a Biologics License Application, or BLA, or other submission or to obtain regulatory approval in the United States or elsewhere;
	●	we may be unable to demonstrate to the FDA, the EMA or other comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable;
	●	the FDA, the EMA or other comparable foreign regulatory authorities may fail to approve our manufacturing processes, test procedures and specifications or facilities or those of third-party manufacturers with which we contract for clinical and commercial supplies; and
	●	the approval policies or regulations of the FDA, the EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

	●	the FDA, the EMA or other comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical trials;
	●	obtaining regulatory authorizations to commence a trial or reaching a consensus with regulatory authorities on trial design;
	●	any failure or delay in reaching an agreement with 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 from one or more independent institutional review boards, or IRBs;
	●	IRBs refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial;
	●	delays in enrollment due to travel or quarantine policies, or other factors related pandemics or other events outside our control;
	●	changes to clinical trial protocol;
	●	clinical sites deviating from trial protocol or dropping out of a trial;
	●	manufacturing sufficient quantities of a product candidate or obtaining sufficient quantities of combination therapies for use in clinical trials;
	●	subjects failing to enroll or remain in our trial at the rate we expect, or failing to return for post- treatment follow-up;
	●	subjects choosing an alternative treatment for the indication for which we are developing our product candidates, or participating in competing clinical trials;
	●	lack of adequate funding to continue the clinical trial;
	●	subjects experiencing severe or unexpected drug-related adverse effects;
	●	occurrence of serious adverse events in trials of the same class of agents conducted by other companies;
	●	selection of clinical endpoints that require prolonged periods of clinical observation or analysis of the resulting data;
	●	a facility manufacturing our product candidates or any of their components being ordered by the FDA, the EMA or comparable foreign regulatory authorities to temporarily or permanently shut down due to violations of cGMP regulations or other applicable requirements, or infections or cross-contaminations of product candidates in the manufacturing process;
	●	any changes to our manufacturing process that may be necessary or desired;
	●	third-party clinical investigators losing the licenses or permits necessary to perform our clinical trials, not performing our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, GCP or other regulatory requirements;
	●	third-party contractors not performing data collection or analysis in a timely or accurate manner; or
	●	third-party contractors becoming debarred or suspended or otherwise penalized by the FDA, the EMA or other government or regulatory authorities for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all of the data produced by such contractors in support of our marketing applications.

	●	be delayed in obtaining marketing approval, if at all;
	●	obtain approval for indications or patient populations that are not as broad as intended or desired;
	●	obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;
	●	be required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements;
	●	be subject to the addition of labeling statements, such as warnings or contraindications;
	●	be sued; or
	●	experience damage to our reputation.

	●	we may be forced to suspend marketing of that product, or decide to remove the product from the marketplace;
	●	regulatory authorities may withdraw or change their approvals of that product;
	●	regulatory authorities may require additional warnings on the label or limit access of that product to selective specialized centers with additional safety reporting and with requirements that patients be geographically close to these centers for all or part of their treatment;
	●	we may be required to create a medication guide outlining the risks of the product for patients, or to conduct post-marketing studies;
	●	we may be required to change the way the product is administered;
	●	we could be subject to fines, injunctions, or the imposition of criminal or civil penalties, or be sued and held liable for harm caused to subjects or patients; and
	●	the product may become less competitive, and our reputation may suffer.

	●	the efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments;
	●	the timing of market introduction of the product as well as competitive products;
	●	the clinical indications for which the product is approved;
	●	restrictions on the use of our product, such as boxed warnings or contraindications in labeling, or a REMS, if any, which may not be required of alternative treatments and competitor products;
	●	the potential and perceived advantages of products over alternative treatments;
	●	the cost of treatment in relation to alternative treatments;
	●	the availability of coverage and adequate reimbursement, as well as pricing, by third-party payors, including government authorities;
	●	relative convenience and ease of administration;

	●	the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
	●	the effectiveness of sales and marketing efforts;
	●	unfavorable publicity relating to our products or similar approved products or product candidates in development by third parties; and
	●	the approval of other new therapies for the same indications.

	●	generating sufficient data to support the initiation or continuation of clinical trials;
	●	obtaining regulatory permission to initiate clinical trials;
	●	contracting with the necessary parties to conduct clinical trials;
	●	successful enrollment of patients in, and the completion of, clinical trials on a timely basis;
	●	the timely manufacture of sufficient quantities of the product candidate and other key materials needed for use in clinical trials; and
	●	adverse events in the clinical trials.

	●	collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and may not perform their obligations as expected;
	●	collaborators may deemphasize or not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus, including as a result of a sale or disposition of a business unit or development function, or available funding or external factors such as an acquisition that diverts resources or creates competing priorities;
	●	collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
	●	collaborators could independently develop, or develop with third parties, products 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;
	●	a collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of our product candidates relative to other products;
	●	collaborators may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and intellectual property in such a way as to invite litigation or other intellectual property-related proceedings that could jeopardize or invalidate our proprietary information and intellectual property or expose us to potential litigation or other intellectual property-related proceedings;
	●	disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management attention and resources;
	●	collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates;
	●	collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all; and
	●	if a collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product candidate development or commercialization program could be delayed, diminished or terminated.

	●	inability to meet our product specifications and quality requirements consistently;
	●	inability to initiate or continue clinical trials of our product candidates under development;
	●	delays in submitting regulatory applications or receiving marketing approvals for our product candidates, if at all;
	●	inability to commercialize any product candidates that receive marketing approval on a timely basis;
	●	loss of the cooperation of future collaborators;

	●	subjecting third-party manufacturing facilities or our manufacturing facilities to additional inspections by regulatory authorities;
	●	requirements to cease development or to recall batches of our product candidates; and
	●	in the event of approval to market and commercialize our product candidates, an inability to meet commercial demands for our product candidates or any future product candidates.

	●	the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for the purchase, lease, order, arrangement, or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation. Violations are subject to civil fines and criminal penalties for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion from government healthcare programs. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act or federal civil money penalties;
	●	the federal civil and criminal false claims laws and civil monetary penalty laws, such as the federal False Claims Act, which impose criminal and civil penalties and authorize civil whistleblower or qui tam actions, against individuals or entities for, among other things: knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent; knowingly making, using or causing to be made or used, a false statement of record material to a false or fraudulent claim or obligation to pay or transmit money or property to the federal government or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal government. Manufacturers can be held liable under the federal False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The federal False Claims Act also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the federal False Claims Act and to share in any monetary recovery;

	●	the Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits, among other things, a person from knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false, fictitious, or fraudulent statements or representations in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
	●	HIPAA, as further amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, which impose certain requirements on certain covered healthcare providers, health plans and healthcare clearinghouses, as well as their respective business associates, independent contractors or agents of covered entities, that perform services for them that involve the use, creation, maintenance, receipt or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition, there are additional federal, state and non-U.S. laws which govern the privacy and security of health and other personal information in certain circumstances to which we may be subject and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts;
	●	federal government price reporting laws, which require manufacturers to calculate and report complex pricing metrics in an accurate and timely manner to government programs;
	●	federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;
	●	The ACA, including the provision commonly referred to as the Physician Payments Sunshine Act and its implementing regulations, which require applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the U.S. Centers for Medicare & Medicaid Services, or CMS, within the U.S. Department of Health and Human Services, information related to payments or other transfers of value made to physicians, nurse practitioners, certified nurse anesthetists, physician assistants, clinical nurse specialists, and certified nurse midwives as well as teaching hospitals and to disclose ownership and investment interests held by physicians and their immediate family members; and
	●	many state laws that govern the privacy of personal information in specified circumstances. For example, in California, the California Consumer Privacy Act, or the CCPA, which went into effect on January 1, 2020, establishes a new privacy framework for covered businesses by creating an expanded definition of personal information, establishing new data privacy rights for consumers in the State of California, imposing special rules on the sale of personal information, and creating a new and potentially severe statutory damages framework for violations of the CCPA and for businesses that fail to implement reasonable security procedures and practices to prevent data breaches. While clinical trial data and information governed by HIPAA are currently exempt from the CCPA, other personal information collection practices may be subject to the CCPA and possible changes to the CCPA may broaden its scope.

	●	delays in or the rejection of product approvals;
	●	restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials;
	●	restrictions on the products, manufacturers or manufacturing process;
	●	warning or untitled letters;
	●	civil and criminal penalties;
	●	injunctions;
	●	suspension or withdrawal of regulatory approvals;
	●	product seizures, detentions or import bans;
	●	voluntary or mandatory product recalls and publicity requirements;
	●	total or partial suspension of production; and
	●	imposition of restrictions on operations, including costly new manufacturing requirements.

	●	the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction;
	●	patent applications may not result in any patents being issued;
	●	patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage;
	●	the degree and range of protection any issued patents will afford us against competitors, including whether third parties will find ways to invalidate or otherwise circumvent our patents;
	●	whether others will apply for or obtain patents claiming aspects similar to those covered by our patents and patent applications;
	●	whether the patent applications that we own or in-license will result in issued patents with claims that cover our product candidates or uses thereof in the United States or in other foreign countries;
	●	our competitors, many of whom have substantially greater resources than we or our licensors do and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or block our ability to make, use and sell our product candidates;