Tevogen (TVGN) risk factors, FY2024 10-K

Risks Related to Our Financial Position and Need for Additional Capital

1. 01We have a limited operating history and no products approved for commercial sale and have never generated revenue from product sales. We have a history of significant losses, expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability
2. 02We are relying in part on an additional $8.0 million of grant funding that we have not yet received to meet our liquidity needs
3. 03Until we can generate sufficient product and royalty revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, and licensing arrangements

Risks Related to Development, Regulatory Review, and Product Approval

1. 04We cannot be sure that the manufacturing processes used in connection with our T cell immunotherapy product candidates will yield a sufficient supply of satisfactory products that are safe, pure, and potent, scalable, or profitable
2. 05If we are unable to successfully develop, receive regulatory approval for, and commercialize our product candidates, our business will be harmed
3. 06We may encounter substantial delays and disruptions in completing the development of our product candidates that could impair our ability to successfully commercialize our product candidates and may harm our business and results of operations
4. 07The FDA regulatory approval process is lengthy and time-consuming and may lead to significant delays in the clinical development and regulatory approval of our product candidates
5. 08We may seek RMAT designation from FDA for TVGN 489 for the treatment of COVID-19, or for our other product candidates. FDA may find that TVGN 489 or our other product candidates do not meet the criteria for RMAT designation or may otherwise deny our requests for RMAT designation
6. 09Our business is highly dependent on our first product candidate, TVGN 489, and we must conduct clinical testing before we can obtain regulatory approval and begin commercialization of any of our product candidates
7. 10Interim and preliminary results 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, validation, and verification procedures that could result in material changes in the final data
8. 11The results of earlier preclinical and clinical trials may not be predictive of future clinical trial results. Initial positive results in any of our clinical trials may not be indicative of results obtained when the trial is completed
9. 12Because the number of patients in our proof-of-concept clinical trial of TVGN 489 was small, the results from this trial may be less reliable than results achieved in larger clinical trials
10. 13Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay
11. 14Our approach to the discovery and development of product candidates using our ExacTcell technology is unproven and may not result in marketable products
12. 15If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise be adversely affected
13. 16We 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
14. 17If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our products may be delayed
15. 18We may develop future product candidates in combination with other therapies, which exposes us to additional regulatory risks
16. 19The use artificial intelligence in our business may require us to spend material resources and presents risks that could adversely impact our business, including by posing security and other risks to our confidential and/or proprietary information

Risks Related to Business Development and Commercialization

1. 20Our commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among physicians, patients, healthcare payors and the medical community, including hospitals and outpatient clinics
2. 21We expect the product candidates we develop will be regulated biologics and therefore they may be subject to biosimilar competition
3. 22In addition, the approval of a biologic product that is a biosimilar to one of our products could have a material adverse impact on our business as it may be significantly less costly to bring to market and may be priced significantly lower than our products
4. 23Even if our product candidates receive regulatory approval, we will still face extensive ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense, and our products may still face future development and regulatory difficulties
5. 24The occurrence of any of the foregoing may inhibit our ability to successfully commercialize our products
6. 25If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate any revenue
7. 26Data protection, privacy and similar laws restrict access, use, and disclosure of information, and failure to comply with or adapt to changes in these laws could materially and adversely harm our business
8. 27Increasing use of AI could give rise to liability, breaches of data security and privacy laws, or reputational damage
9. 28Our internal computer systems, or those used by our contractors or consultants, may fail, or suffer security breaches
10. 29Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates, if approved, profitably
11. 30The advancement of healthcare reform may negatively impact our ability to sell our product candidates, if approved, profitably
12. 31We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties
13. 32If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business

Risks Related to Manufacturing and Reliance on Third Parties

1. 33The manufacture of cell therapies is subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our product candidates
2. 34Our efforts to establish manufacturing capabilities, either on our own or through a contract relationship, will involve significant time and expense and may not be successful
3. 35We depend on third-party suppliers for key materials used in our manufacturing processes, and the loss of these third-party suppliers or their inability to supply us with adequate materials could harm our business
4. 36We may depend on third-party collaborators for the development and commercialization of certain of our current and future product candidates. If our collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates
5. 37We may have to alter our development and commercialization plans if we seek to establish collaborations and are not able to establish them on commercially reasonable terms

Risks Related to Intellectual Property

1. 38If we are unable to obtain and maintain adequate patent protection for our product candidates or ExacTcell, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our product candidates may be adversely affected
2. 39Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
3. 40We may not be able to protect our intellectual property rights throughout the world
4. 41Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
5. 42We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming, and unsuccessful
6. 43Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court. We may not be able to protect our trade secrets in court
7. 44Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business and financial condition
8. 45Others may claim an ownership interest in our intellectual property and our product candidates, which could expose us to litigation and have a significant adverse effect on our prospects
9. 46If we are unable to protect the confidentiality of our proprietary information, the value of our technology and products could be adversely affected
10. 47We may be subject to claims asserting that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers
11. 48If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
12. 49Intellectual property rights do not necessarily address all potential threats

Risks Related to Our Business

1. 50We are highly dependent on our key personnel, and if we are not successful in attracting, motivating, and retaining highly qualified personnel, we may not be able to successfully implement our business strategy
2. 51We may face substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than we do
3. 52We will need to grow the size of our organization, and we may experience difficulties in managing this growth
4. 53Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our product candidates
5. 54Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations

Risks Related to Being a Public Company and Ownership of Securities

1. 55The price of our Common Stock and Warrants may fluctuate significantly and you could lose all or part of your investment as a result
2. 56We have previously failed to timely file certain periodic reports with the SEC. Potential future delays in the filing of our reports with the SEC pose significant risks to our business, and could materially and adversely affect our financial condition and results of operations
3. 57We incur increased costs as a result of operating as a public company, and our management devotes substantial time to compliance initiatives and corporate governance practices
4. 58We may issue additional shares of our Common Stock or other equity securities without your approval, which would dilute your ownership interests and may depress the market price of your shares
5. 59We are an “emerging growth company” and a “smaller reporting company”, and certain exemptions from disclosure requirements available to us could make our securities less attractive to investors and may make it more difficult to compare our performance to the performance of other public companies
6. 60Our management team has limited experience managing a public company
7. 61Our business and operations could be negatively affected we become subject to any securities litigation or stockholder activism, which could cause us to incur significant expense, hinder execution of business and growth strategy and impact its stock price
8. 62We may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on its financial condition, results of operations and the share price of our securities, which could cause you to lose some or all of your investment
9. 63A significant portion of our total outstanding shares may be sold into the market in the near future. This could cause the market price of our Common Stock to drop significantly, even if our business is doing well
10. 64Our directors, executive officers, and principal stockholders, and Dr. Ryan Saadi in particular, have substantial control over our Company, which could limit your ability to influence the outcome of key transactions, including a change of control
11. 65We may redeem a warrant holder’s unexpired warrants prior to their exercise at a time that may be disadvantageous to such warrant holder, thereby making its warrants worthless