TVGN 10-K

Tevogen Inc. (TVGN)

10-K 2024-04-29 For: 2023-12-31

View Original

Added on April 10, 2026

Search and read filings like this one from Claude or ChatGPT with the SEC filings MCP server →

Large accelerated filer	☐	Accelerated filer	☐	Non-accelerated filer	☒
Smaller reporting company	☒	Emerging growth company	☒

		Page
	PART I
Item 1	Business	7
Item 1A	Risk Factors	37
Item 1B	Unresolved Staff Comments	77
Item 1C	Cybersecurity	77
Item 2	Properties	78
Item 3	Legal Proceedings	78
Item 4	Mine Safety Disclosures	78

	PART II
Item 5	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	79
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	85
Item 8	Financial Statements and Supplementary Data	85
Item 9	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	85
Item 9A	Controls and Procedures	86
Item 9B	Other Information	86
Item 9C	Disclosure Regarding Foreign Jurisdictions that Prevent Inspection	86

	PART III
Item 10	Directors, Executive Officers, and Corporate Governance	87
Item 11	Executive Compensation	93
Item 12	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	103
Item 13	Certain Relationships and Related Transactions, and Director Independence	104
Item 14	Principal Accounting Fees and Services	109

	PART IV
Item 15	Exhibits and Financial Statement Schedule	110
Item 16	Form 10-K Summary	110

	●	the development of, potential benefits of, and patient access to our product candidates for the treatment of infectious diseases, cancer, and neurological disorders, including TVGN 489 for the treatment of COVID-19 and Long COVID;
	●	our ability to develop additional product candidates, including through the use of our ExacTcell platform;
	●	the anticipated benefits of ExacTcell;
	●	our expectations regarding our future clinical trials;
	●	our manufacturing plans;
	●	our ability to generate revenue in the future;
	●	our ability to manage, grow, and diversify our business and execute our business initiatives and strategy;
	●	expectations regarding the healthcare and biopharmaceutical industries;
	●	the potential liquidity and trading of our securities; and
	●	the future business, operations, and financial performance of our company.

	●	We have a limited operating history, no products approved for commercial sale, have never generated revenue from product sales, and have a history of significant losses.
	●	There is substantial doubt about the ability to continue as a going concern due to cash on hand.
	●	We will require substantial additional financing to pursue our business objectives.

	●	Regulation of cellular therapy product candidates is rigorous, complex, uncertain, and subject to change.
	●	We have limited experience designing and implementing preclinical and clinical trials, which are complex, expensive, time-consuming, difficult to design and implement, and involve uncertain outcomes.
	●	We may be unable to develop, receive regulatory approval for, and commercialize our product candidates.
	●	We may encounter substantial delays and disruptions in the development of our product candidates.
	●	The FDA regulatory approval process is lengthy and time-consuming.
	●	We may never receive regenerative medicine advanced therapy designation for any product candidate, and this designation may not lead to a faster development or regulatory review or approval process.
	●	Our business is highly dependent on our first product candidate, TVGN 489.
	●	Results from our clinical trials may change and are subject to audit, validation, and verification procedures.
	●	Initial results and results of earlier trials may not be predictive of future results.
	●	Our TVGN 489 proof-of-concept clinical trial results may be less reliable than results in larger clinical trials.
	●	Changes in product candidate manufacturing or formulation may result in additional costs or delay.
	●	ExacTcell is unproven and may not result in marketable products.
	●	We may fail to demonstrate the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects may be identified during development.
	●	We may encounter difficulties enrolling patients in our clinical trials.
	●	We may be required to suspend, repeat, or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive, or the trials are not well designed.
	●	We may not achieve our projected development goals in the time frames we announce and expect.
	●	Disruptions at government agencies could hinder or prevent product development and commercialization.
	●	Development of product candidates in combination with other therapies presents additional regulatory risks.

	●	Our commercial success depends upon attaining significant market acceptance of our product candidates.
	●	Regulated biologics may be subject to biosimilar competition.
	●	The incidence and prevalence of target patient populations are based on estimates and third-party sources.
	●	We will face extensive ongoing regulatory requirements and regulatory review after regulatory approval.
	●	We may be unable to establish sales and marketing capabilities.
	●	Failure to comply with or adapt to changes in data protection, privacy, and similar laws could materially and adversely harm our business.
	●	Computer systems may fail or suffer security breaches.
	●	Coverage and reimbursement may be limited or unavailable in certain market segments.
	●	Healthcare reform may negatively impact our ability to sell our product candidates profitably.
	●	We could violate healthcare fraud and abuse, false claims, and health information privacy and security laws.
	●	We could fail to comply with environmental, health and safety laws and regulations.

	●	The manufacture of cell therapies is subject to a multitude of manufacturing risks.
	●	Our efforts to establish manufacturing capabilities will involve time and expense and may not be successful.
	●	The loss of suppliers or their inability to supply us with adequate materials could harm our business.
	●	We may not obtain marketing approval for or successfully commercialize product candidates as a result of failures by third parties.
	●	We may not be able to establish collaborations on commercially reasonable terms.

	●	We may be unable to obtain and maintain sufficient patent protection for our product candidates or ExacTcell.
	●	Our patent protection could be reduced or eliminated for non-compliance with patent agency requirements.
	●	We may not be able to protect our intellectual property rights throughout the world.
	●	Changes in patent law could diminish the value of patents in general.
	●	We may become involved in lawsuits to protect or enforce our intellectual property.
	●	Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court.
	●	Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights.
	●	Others may claim an ownership interest in our intellectual property and our product candidates.
	●	We may be unable to protect the confidentiality of our proprietary information.
	●	We may be subject to claims asserting that our agents have wrongfully used or disclosed alleged trade secrets.
	●	Our trademarks and trade names may be inadequately protected.
	●	Intellectual property rights do not necessarily address all potential threats.

	●	We are highly dependent on our key personnel.
	●	We may face substantial competition.
	●	We will need to grow the size of our organization.
	●	Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization.
	●	We may be limited in our ability to use our net operating loss carryforwards.

	●	The price of our Common Stock and Warrants may fluctuate significantly.
	●	Sales of a substantial number of our securities by existing securityholders could cause their price to fall.
	●	We may not have the funds necessary to satisfy our future obligations under the terms of our Preferred Stock.
	●	Failure to meet Nasdaq continued listing requirements could result in delisting of our securities.
	●	We incur increased costs due to operating as a public company, and our management devotes substantial time to compliance initiatives and corporate governance practices.
	●	We may issue additional shares of our Common Stock or other equity securities without your approval.
	●	We have no current plans to pay regular cash dividends on our Common Stock.
	●	We are an “emerging growth company” and a “smaller reporting company”.
	●	Our management team has limited experience managing a public company.
	●	Analysts may not publish research about us or may change their recommendation regarding our Common Stock.
	●	We could become subject to securities litigation or stockholder activism.
	●	We may be required to take write-downs or write-offs, restructuring and impairment or other charges.
	●	We could fail to maintain proper and effective internal control over financial reporting.
	●	Certain individuals have substantial control over us.
	●	We may redeem warrants at a time that is disadvantageous to warrant holders.
	●	A warrant holder exercising warrants on a “cashless basis” will receive fewer shares of Common Stock from such exercise than through a cash exercise.
	●	Our public warrants may never be in the money and they may expire worthless.

¹	Phase 1 clinical trials are designed in part to generate proof of concept data and safety-related data on tolerability and side effects.

²	A pivotal trial is a trial designed to generate data sufficient to support the filing of an application for regulatory approval. A pivotal trial may not necessarily be denoted as a Phase 3 clinical trial, and instead may be a Phase 2 or Phase 2/3 clinical trial. We believe that Phase 2, Phase 2/3, or Phase 3 clinical trials may serve as pivotal trials for TVGN 489.

³	Our completed Phase 1 clinical trial of TVGN 489 was specifically conducted in ambulatory, high-risk adult patients with acute cases of COVID-19.

⁴	We believe that the data from our completed Phase 1 clinical trial should be sufficient to serve as the basis for one or more later stage, potentially pivotal trials in acute COVID-19 patients with B-cell cancer immune suppression, other B cell immune suppressed acute COVID-19 patients without a B cell cancer indication, and for Long COVID prevention and treatment. We cannot be certain whether we will be permitted to move from a Phase 1 trial directly to a pivotal trial covering any specific target population until FDA reviews and concurs with or rejects our proposed plans, and FDA may require us to conduct further trials to generate additional safety and efficacy data prior to approval.

⁵	Data collected in the completed Phase 1 trial of TVGN 489 includes and in all future trials of TVGN 489 is expected to include information regarding the incidence of Long COVID in patients treated with TVGN 489 versus untreated patients or those treated with alternate approaches.

	●	*Advancing the clinical development of TVGN 489 for the treatment of COVID-19 and Long COVID*. We completed a Phase 1 proof-of-concept trial of TVGN 489 for the treatment of high-risk ambulatory adult COVID-19 patients in January 2023 and hope to launch a pivotal trial in COVID-19 patients with B cell malignancies as soon as late 2024. TVGN 489 is also in development for other highly vulnerable COVID-19 patients and sufferers of Long COVID. We will undertake a Long COVID genetic predisposition trial early in the second quarter of 2024 in part to generate information needed to expeditiously conduct a Long Covid treatment trial that we expect to be launched in approximately the first quarter of 2025.

	●	*Leveraging our ExacTcell platform to develop therapies for additional indications*. In addition to TVGN 489, we are leveraging our ExacTcell platform to advance product candidates in virology, oncology, and neurology. Preclinical investigation is underway with product candidates for the treatment of Epstein-Barr virus-associated lymphomas, multiple sclerosis, and several other viral and cancer targets.

	●	*Developing manufacturing capabilities, including through acquisitions*. We will need to develop manufacturing capabilities for clinical and, if approved, commercial supply of our cell therapy products. Our efforts to develop manufacturing capability are currently focused on acquiring existing manufacturing facilities or constructing one or more new manufacturing facilities, including through collaboration with a potential facility development partner, and we have identified a potential clinical manufacturing facility for use.

	●	*Forming strategic alliances and collaborating with partners to augment our capabilities*. We may pursue strategic alliances with other biopharmaceutical companies with well-established presences in the specialties we aim to target for our indications. This may include co-marketing, co-promotion, and co-development relationships, or a partnership with a diagnostics company to help improve availability of rapid HLA testing. We also intend to explore options to work with partners to augment the study and treatment of patients and the impact of our product candidates, including medical professionals, healthcare professional networks, pharmacy benefit managers, insurance companies, and artificial intelligence companies.

	●	completion of non-clinical laboratory tests and studies performed in accordance with FDA’s good laboratory practice (“GLP”) regulations;

	●	manufacture, labeling and distribution of investigational drugs in compliance with FDA’s current good manufacturing practice (“cGMP”) requirements;

	●	submission to FDA of an IND, which must become effective before clinical trials may begin and must be updated annually and when significant changes are made;

	●	approval by an independent institutional review board (“IRB”) for each clinical site before each clinical trial may be initiated;

	●	performance of adequate and well-controlled human clinical trials in accordance with FDA’s Good Clinical Practices (“GCP”) to establish the safety, purity, and potency of the proposed biological product candidate for its intended purpose;

	●	after completion of all pivotal clinical trials, preparation of and submission to FDA of a Biologics License Application (“BLA”) requesting marketing approval, which includes providing sufficient evidence to establish the efficacy, safety, purity, and potency of the proposed biological product for its intended use, including from results of nonclinical testing and clinical trials;

	●	satisfactory completion of an FDA advisory committee review, when appropriate, as may be requested by FDA to assist with its review;

	●	satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the proposed product, or certain components thereof, are produced to assess compliance with cGMP and data integrity requirements to assure that the facilities, methods, and controls are adequate to preserve the biological product’s identity, strength, quality, and purity and, if applicable, FDA’s good tissue practice (“GTP”) requirements for human cellular and tissue products;

	●	satisfactory completion of FDA inspections of selected clinical investigation sites to assure compliance with GCP requirements and the integrity of the clinical data;

	●	satisfactory completion of an FDA sponsor GCP inspection, often conducted at the applicant’s headquarters facility;

	●	payment of user fees (unless there is a waiver, exemption, or reduction) under the Prescription Drug User Fee Act (“PDUFA”) for the relevant year;

	●	FDA’s review and approval of the BLA to permit commercial marketing of the licensed biologic for particular indications for use in the United States;

	●	compliance with post-approval requirements, including the potential requirements to implement a Risk Evaluation and Mitigation Strategy (“REMS”), to report adverse events and biological product deviations, and to complete any post-approval studies; and

	●	completion of any post-approval clinical studies required by FDA, such as confirmatory trials or pediatric studies.

	●	Phase 1: The investigational product is initially introduced into a small group of healthy human subjects or 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 and the side effects associated with increasing doses. These trials may also yield early evidence of effectiveness.

	●	Phase 2: The investigational product is administered to a slightly larger patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages, 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 investigational product 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 generate sufficient data to statistically demonstrate the efficacy and safety of the product, to establish the overall risk/benefit ratio of the investigational product, and to provide an adequate basis for product approval by FDA.

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

	●	fines, warning or untitled letters, or holds on post-approval clinical studies;

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

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

	●	permanent injunctions and consent decrees, including the imposition of civil or criminal penalties.

	●	continue to advance the development of TVGN 489 and our preclinical product candidates;
	●	leverage our ExacTcell platform to advance additional product candidates into preclinical and clinical development;
	●	seek regulatory approvals for any product candidates that successfully complete clinical trials and potential commercialization;
	●	develop and expand our cGMP manufacturing capacity, including to provide drug supply for future clinical trials;
	●	hire additional clinical, quality control, regulatory, scientific, and administrative personnel;
	●	expand our operational, financial, and management systems and increase personnel, including to support our clinical development, manufacturing, and commercialization efforts and our operations as a public company;
	●	maintain, expand, and protect our intellectual property portfolio;
	●	establish a marketing, sales, distribution, and medical affairs infrastructure to commercialize any products for which we may obtain marketing approval and commercialize, whether on our own or jointly with a partner;
	●	acquire or in-license other technologies or engage in strategic partnerships; and
	●	incur additional legal, accounting, or other expenses in operating our business.

	●	completing preclinical studies and clinical trials of our product candidates;
	●	seeking and obtaining marketing approvals for any product candidates that we or our collaborators develop;
	●	receiving authorization of INDs for future product candidates;
	●	identifying and developing new product candidates;

	●	manufacturing cGMP supply of our product candidates for clinical trials and, if approved, commercial sales;
	●	launching and commercializing products for which we obtain marketing approval by establishing a marketing, sales, distribution, and medical affairs infrastructure or, alternatively, collaborating with a commercialization partner;
	●	achieving coverage and adequate reimbursement by hospitals and third-party payors, including governmental authorities, such as Medicare and Medicaid, private insurers, and managed care organizations, for product candidates, if approved, that we or our collaborators develop;
	●	obtaining market acceptance of product candidates, if approved, that we develop as viable treatment options;
	●	addressing any competing technological and market developments;
	●	negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter and performing our obligations under such arrangements;
	●	maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how;
	●	defending against third-party interference or infringement claims, if any; and
	●	attracting, hiring, and retaining qualified personnel.

	●	the scope, progress, timing, results, and costs of researching and developing TVGN 489 and our other product candidates, including product candidates developed with our ExacTcell platform, and of conducting preclinical studies and clinical trials;
	●	the timing of, and the costs involved in, obtaining marketing approval for TVGN 489 and any future product candidates we develop, if clinical trials are successful;
	●	the costs of manufacturing TVGN 489 and any future product candidates for preclinical studies and clinical trials and in preparation for marketing approval and commercialization;
	●	the costs of commercialization activities, including marketing, sales, and distribution costs, for TVGN 489 and any future product candidates we develop if any of these product candidates are approved for sale;
	●	our ability to establish and maintain strategic collaborations, licensing, or other arrangements on favorable terms, if at all;
	●	the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending, and enforcing patent claims, including litigation costs and the outcome of any such litigation;
	●	the timing, receipt, and amount of sales of, or royalties on, our future products, if any; and
	●	the emergence of competing therapies and other developments in the markets we intend to address.

	●	obtaining regulatory approval from FDA, which has relatively limited experience with regulating the development and commercialization of T cell immunotherapies;
	●	developing and deploying consistent and reliable processes for procuring blood from consenting third-party donors, isolating T cells from the blood of such donors, activating the isolated T cells against specific antigens, characterizing and storing the resulting activated T cells for future therapeutic use, selecting and delivering a sufficient supply and breadth of appropriate human leukocyte antigen-matched (“HLA-matched”) cells from among the available T cell lines, and finally infusing these activated T cells into patients to eliminate virus-infected cells in the patient and induce anti-disease benefit;
	●	relying on healthcare provider site availability and accessibility to patients for receipt of T cell infusions;
	●	utilizing these product candidates in combination with other therapies currently used to treat patients in our target population, which may increase the risk of adverse side effects;
	●	educating medical personnel regarding the potential side effect profile of each of our product candidates, particularly those that may be unique to our allogeneic T cell therapy product candidates;
	●	understanding and addressing variability in the quality of a donor’s T cells, which could ultimately affect our ability to manufacture product in a reliable and consistent manner;
	●	developing processes for the safe administration of these products, including long-term follow-up and registries, as applicable, for all patients who receive these product candidates;
	●	manufacturing our product candidates to our specifications and in a timely manner to support our clinical trials and, if approved, commercialization;
	●	sourcing clinical and, if approved by FDA, commercial supplies for the materials used to manufacture and process these product candidates that are free from viruses and other pathogens that may increase the risk of adverse side effects;
	●	developing a manufacturing process and distribution network that can provide a stable supply with a cost of goods that allows for an attractive return on investment;
	●	establishing sales and marketing capabilities ahead of and after obtaining any regulatory approval to gain market acceptance, and obtaining adequate coverage, reimbursement and pricing by third-party payors and government authorities; and
	●	developing therapies for types of diseases beyond those initially addressed by our current product candidates.

	●	timely and successful completion of preclinical studies and clinical trials;
	●	effective INDs submitted to FDA that allow commencement of our clinical trials for our product candidates;
	●	sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials;
	●	successful development of, or making arrangements with third-party manufacturers for, our commercial manufacturing processes for our clinical trials and any of our product candidates that receive regulatory approval at an acceptable cost and on a timely basis;
	●	receipt of timely marketing approvals from FDA;
	●	launching commercial sales of products, if approved;
	●	acceptance of the benefits and use of our products, if approved, by patients, the medical community, and third-party payors, for their approved indications;
	●	the prevalence and severity of adverse events or other safety issues experienced with our product candidates;
	●	the availability, perceived advantages, cost, safety, and efficacy of alternative therapies for any product candidate, and any indications for such product candidate, that we develop;
	●	our ability to produce any product candidates we develop on a commercial scale;
	●	obtaining and maintaining patent, trademark and trade secret protection and regulatory exclusivity for our product candidates and otherwise protecting our rights in our intellectual property portfolio;
	●	maintaining compliance with regulatory requirements, including cGMP requirements;
	●	obtaining and maintaining coverage and adequate reimbursement by third-party payors, including government payors, for our products, if approved by FDA;
	●	maintaining a continued acceptable safety, tolerability and efficacy profile of the products following approval; and
	●	maintaining and growing an organization of scientists and functional experts who can develop and commercialize our products and technology.

	●	the extensive research and development required because our product candidates are based on new technologies;
	●	the availability of financial resources to commence and complete the planned trials;
	●	reaching agreement on acceptable terms with prospective clinical research organizations (“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;
	●	FDA or independent institutional review boards (“IRBs”) may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
	●	recruiting suitable patients to participate in a trial or sufficient patients to complete a trial;
	●	having patients complete a trial or return for post-treatment follow-up;
	●	clinical trial sites deviating from trial protocol or dropping out of a trial, which may require that we add new clinical trial sites or investigators;
	●	manufacturing the necessary product for use in the clinical trials;
	●	clinical trials of any product candidate may fail to show safety, purity, or potency, or may produce negative or inconclusive results, which may cause us to decide, or regulators to require us, to conduct additional nonclinical trials or clinical trials or which may cause us to decide to abandon product candidate development programs;
	●	any of our product candidates could cause undesirable side effects that could result in significant negative consequences, including the inability to enter clinical development or receive regulatory approval; and/or
	●	competition from other clinical trial programs for similar indications and clinical trial patients.

	●	FDA may disagree with the design or implementation of our clinical trials;
	●	we may be unable to demonstrate to the satisfaction of FDA that a product candidate is safe, pure, and potent for its proposed indication;
	●	the results of clinical trials may not meet the level of statistical significance required by FDA for approval;
	●	we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
	●	FDA may disagree with our interpretation of data from clinical trials or preclinical studies;
	●	the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a BLA to FDA to obtain regulatory approval in the United States; and
	●	FDA may find deficiencies with or fail to approve our manufacturing processes or facility or the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies.

	●	FDA may withdraw approvals of such product;
	●	FDA may require additional warnings on the labels such as a “black box” warning or a contraindication;
	●	we may be required to create a medication guide outlining the risks of such side effects for distribution to patients or other requirements subject to a REMS;
	●	we could be sued and held liable for harm caused to patients;
	●	we may not be able to achieve or maintain third-party payor coverage and adequate reimbursement;
	●	we may be required to recall a product or change the way such product is administered to patients;
	●	additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof; and
	●	our reputation and physician or patient acceptance of our products may suffer.

	●	the patient eligibility criteria defined in the protocol;
	●	the nature and size of the patient population required for analysis of the trial’s primary endpoints and the process for identifying patients;
	●	the number and location of participating clinical sites or patients;
	●	the design of the trial;
	●	our ability to recruit clinical trial investigators with the appropriate competencies and experience;
	●	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;
	●	the availability of competing commercially available therapies and other competing drug candidates’ clinical trials;
	●	our ability to obtain and maintain patient informed consents for participation in our clinical trials;
	●	the risk that patients enrolled in clinical trials will drop out of the trials before completion; and/or
	●	factors outside of our control, including as a result of business interruptions resulting from natural disasters and public health emergencies, such as the coronavirus.

	●	deficiencies in the conduct of the clinical trials, including failure to conduct the clinical trial in accordance with regulatory requirements or study protocols;
	●	deficiencies in the clinical trial operations or trial sites;
	●	unforeseen adverse side effects or the emergence of undue risks to study subjects;
	●	deficiencies in the trial design necessary to demonstrate efficacy;
	●	the product candidate may not appear to offer benefits over current therapies; or
	●	the quality or stability of the product candidate may fall below acceptable standards.

	●	the efficacy and safety of the product candidates as demonstrated in clinical trials;
	●	the clinical indications and patient populations for which the product candidate is approved;
	●	acceptance by physicians and patients of the drug as a safe and effective treatment;
	●	the administrative and logistical burden of treating patients, including the availability and accessibility of healthcare provider sites for administering infusions to patients;
	●	the adoption of novel cellular therapies by physicians, hospitals, and third-party payors;
	●	the potential and perceived advantages of product candidates over alternative treatments;
	●	the safety of product candidates seen in a broader patient group, including its use outside the approved indications should physicians choose to prescribe for such uses;
	●	any restrictions on use together with other medications;
	●	the prevalence and severity of any side effects;
	●	FDA’s product labeling or package insert requirements;
	●	the timing of market introduction of our products as well as competitive products;
	●	the development of manufacturing and distribution processes for our product candidates;
	●	the cost of treatment in relation to alternative treatments;
	●	the availability of coverage and adequate reimbursement from, and our ability to negotiate pricing with, third-party payors, providers, and government authorities;
	●	relative convenience and ease of administration; and
	●	the effectiveness of our sales and marketing efforts.

	●	issue warning letters or untitled letters;
	●	mandate modifications to promotional materials or require us to provide corrective information to healthcare practitioners, or require other restrictions on the labeling or marketing of such products;

	●	require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance;
	●	seek an injunction or impose civil or criminal penalties or monetary fines;
	●	suspend, withdraw, or modify regulatory approval;
	●	suspend or modify any ongoing clinical trials;
	●	refuse to approve pending applications or supplements to applications filed by us;
	●	suspend or impose restrictions on operations, including costly new manufacturing requirements; or
	●	seize or detain products, refuse to permit the import or export of products, or require us to initiate a product recall.

	●	the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs;

	●	the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds, or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government;

	●	HIPAA, which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters;

	●	HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and its implementing regulations, which imposes specified requirements relating to the privacy, security, and transmission of individually identifiable health information;

	●	the U.S. federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the CMS information related to direct or indirect payments and other transfers of value to physicians and teaching hospitals (and certain other practitioners), as well as ownership and investment interests held in the company by physicians and their immediate family members; and

	●	collaborators may have significant discretion in determining the efforts and resources that they will apply to these collaborations;

	●	collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;

	●	collaborators may not properly enforce, maintain, or defend our intellectual property rights or may use our proprietary information in a way that gives rise to actual or threatened litigation or that could jeopardize or invalidate our intellectual property or proprietary information, exposing us to potential litigation or other intellectual property proceedings;

	●	collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;

	●	disputes may arise between a collaborator and us that cause the delay or termination of the research, development, or commercialization of the product candidate, or that result in costly litigation or arbitration that diverts management attention and resources;

	●	collaborators with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such products;

	●	if a present or future collaborator were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program under such collaboration could be delayed, diminished, or terminated; and

	●	collaboration agreements may restrict our right to independently pursue new product candidates.

	●	others may be able to make products that are similar to our product candidates but that are not covered by the claims of the patents that we own or may own in the future;
	●	we, or any partners or collaborators, might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own or may own in the future;
	●	we, or any partners or collaborators, might not have been the first to file patent applications covering certain of our or their inventions;
	●	others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights;
	●	it is possible that our pending patent applications or those that we may own in the future will not lead to issued patents;
	●	issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;

	●	our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
	●	we may not develop additional proprietary technologies that are patentable;
	●	the patents of others may have an adverse effect on our business; and
	●	we may choose not to file a patent for certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

	●	identifying, recruiting, integrating, maintaining, and motivating additional employees;

	●	managing our internal development efforts effectively, including the clinical and FDA review process for TVGN 489 and any future product candidates we develop, while complying with our contractual obligations to contractors and other third parties; and

	●	improving our operational, financial and management controls, reporting systems and procedures.