vTv Therapeutics (VTVT) risk factors, FY2024 10-K

Other

1. 01Summary of Principal Risk Factors
2. 02Our Financial Position and Need for Additional Capital
3. 03The Development and Regulatory Approval of Our Drug Candidates

Risks Relating to Employee Matters and Managing Growth

1. 04Other Risks Relating to Our Business
2. 45We may need to expand our operations and increase the size of our company, and we may experience difficulties in managing growth
3. 46We may not be able to manage our business effectively if we are unable to attract and retain key personnel
4. 47Our employees, independent contractors, principal investigators, CROs, consultants and collaborators may engage in misconduct or other improper activities, including noncompliance with legal, compliance or regulatory standards and requirements
5. 48We may use our financial and human resources to pursue a particular research program or drug candidate and fail to capitalize on programs or drug candidates that may be more profitable or for which there is a greater likelihood of success
6. 49We may be subject to litigation or government investigations for a variety of claims, which could adversely affect our operating results, harm our reputation or otherwise negatively impact our business
7. 50If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of any future products we develop
8. 51Our insurance policies are expensive and protect us only from some business risks, which will leave us exposed to significant uninsured liabilities
9. 52The market for our proposed products is rapidly changing and competitive, and new drugs and new treatments that may be developed by others could impair our ability to maintain and grow our businesses and remain competitive
10. 53Our business and operations would suffer in the event of computer system failures, cyber-attacks or a deficiency in our cybersecurity

Risks Relating to Our Financial Position and Need for Additional Capital

1. 05We have incurred significant losses since inception and anticipate that we will incur continued losses for the foreseeable future. We may never achieve or maintain profitability
2. 06Currently, we have no products approved for commercial sale, and to date we have not generated any revenue from product sales. As a result, our ability to generate revenue from products, curtail our losses and reach profitability is unproven, and we may never generate substantial product revenue
3. 07We will need additional capital to complete the development and commercialization of cadisegliatin (TTP399) and our other drug candidates. If we are unable to raise sufficient capital for these purposes, we would be forced to delay, reduce or eliminate our product development programs
4. 08Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or drug candidates
5. 09We have a limited operating history, and we expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance

Risks Relating to the Development, Regulatory Approval, and Commercialization of Our Drug Candidates

1. 10Our development efforts are focused on the continued development of cadisegliatin (TTP399). There can be no assurance that we will be able to implement our business strategy successfully
2. 11This lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market our drug candidates, which would significantly harm our business, results of operations and prospects
3. 12Changes in law could have a negative impact on the approval of our drug candidates
4. 13Delays in the commencement, enrollment and completion of our clinical trials could result in increased costs to us and delay or limit our ability to obtain regulatory approval for our drug candidates
5. 14We have never submitted an NDA before and may be unable to do so for cadisegliatin (TTP399) and our other drug candidates we are developing
6. 15Our drug candidates may cause serious adverse events or undesirable side effects which may delay or prevent marketing approval, or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales
7. 16If any of our drug candidates for which we receive regulatory approval do not achieve broad market acceptance, the revenues that are generated from their sales will be limited
8. 17If, in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our drug candidates, we may not be successful in commercializing our drug candidates if and when they are approved
9. 18Even if our drug candidates receive regulatory approval, we will still be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense, and we may still face future development and regulatory difficulties
10. 19We expect that our existing and future drug candidates will face competition, and most of our competitors have significantly greater resources than we do
11. 20Teplizumab (Tzield) is a FDA approved immune agent to delay the onset of stage 3 T1D disease progression in adult and pediatric patients
12. 21Medical device technology such as continuous glucose monitors, Smart Connected Insulin Pens systems and automated insulin delivery systems continue to evolve to address glycemic control and the reduction of hypoglycemia
13. 22Current and future legislation may increase the difficulty and cost for us and any future collaborators to obtain marketing approval of our other drug candidates and affect the prices we, or they, may obtain
14. 23Our current and future relationships with healthcare professionals, principal investigators, consultants, customers (actual and potential) and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable healthcare laws and regulations

Risks Relating to Our Dependence on Third Parties

1. 24We may not succeed in establishing and maintaining collaborative relationships, which may significantly limit our ability to develop and commercialize our drug candidates successfully, if at all
2. 25We rely on third parties to conduct, supervise and monitor certain of our clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business
3. 26if our CROs fail to comply with these regulations or fail to recruit a sufficient number of patients, our clinical trials may be delayed or we may be required to repeat such clinical trials, which would delay the regulatory approval process
4. 27We intend to rely on third-party manufacturers to produce our drug candidates. If we experience problems with any of these suppliers, the manufacturing of our drug candidates or products could be delayed

Risks Relating to Our Intellectual Property

1. 28secrets. Any non-confidential disclosure to or misappropriation by third parties of our confidential or proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in our market
2. 29that we infringe their intellectual property. Furthermore, some of our competitors have substantially greater intellectual property portfolios, and resources, than we do
3. 30If we are unable to prevent disclosure of our trade secrets or other confidential information to third parties, our competitive position may be impaired
4. 31Obtaining 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
5. 32Changes to the patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products candidates and future products
6. 33If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected
7. 34If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation could harm our business
8. 35We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful
9. 36Our patent rights may prove to be an inadequate barrier to competition
10. 37We may not be able to enforce all of our intellectual property rights throughout the world
11. 38Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
12. 39If we do not obtain patent term extensions for our drug candidates, the length of our patent exclusivity will be shorter which may harm our business materially
13. 40If 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
14. 41If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected, harming our business and competitive position
15. 42We may be subject to claims that we or our employees, independent contractors, or consultants have wrongfully used or disclosed alleged confidential information or trade secrets
16. 43We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees, independent contractors, or consultants have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers
17. 44The patent protection and patent prosecution for some of our product candidates may be dependent on third parties

Risks Related to our Common Stock

1. 54If we are unable to maintain listing of our Class A common stock on the Nasdaq Capital Market or another national stock exchange, it may be more difficult for our stockholders to sell their Class A common stock
2. 55Our directors who have relationships with the Significant Investors may have conflicts of interest with respect to matters involving our company
3. 56We do not anticipate paying cash dividends on our Class A common stock, and accordingly, stockholders must rely on stock appreciation for any return on their investment
4. 57Our share price may be volatile, which could subject us to securities class action litigation and result in substantial losses for our stockholders
5. 58The trading market for our Class A common stock will be influenced by the research and reports that equity research analysts publish about us and our business
6. 59A substantial portion of our total outstanding shares may be sold into the market at any time. This could cause the market price of our Class A common stock to drop significantly, even if our business is doing well
7. 60We also have issued warrants to MacAndrews to purchase 40,639 shares of our Class A common stock
8. 61Additionally, we entered into the Securities Purchase Agreement and the Registration Rights Agreement with the Private Placement Investors providing certain governance and registration rights
9. 62Future sales and issuances of our Class A common stock or rights to purchase Class A common stock, including pursuant to our equity incentive plans or the exercise of outstanding warrants, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall
10. 63We incur significant costs and devote substantial management time as a result of operating as a public company and additional resources would be required if we lose our “smaller reporting company” and “non-accelerated filer” status
11. 64Provisions in our Certificate of Incorporation and By-laws and investor agreements, and provisions of Delaware law may delay or prevent our acquisition by a third party, which might diminish the value of our common stock
12. 65We will be required to pay M&F TTP Holdings Two LLC (“M&F”) for certain tax benefits we may claim. In certain circumstances, payments under the Tax Receivable Agreement may be accelerated and/or significantly exceed the actual tax benefits we realize
13. 66The only asset of the Company is its interest in vTv LLC, and accordingly it will depend on distributions from vTv LLC to pay taxes and expenses, including payments under the Tax Receivable Agreement. vTv LLC’s ability to make such distributions may be subject to various limitations and restrictions
14. 67Our organizational structure confers certain benefits upon M&F and certain of its successors and assigns that will not benefit Class A common stockholders to the same extent as it will benefit M&F