Processa Pharmaceuticals (PCSA) risk factors, FY2025 10-K

Risks Related to Our Financial Position and Need for Additional Capital

1. 01We need to raise additional capital to fund our operations21% rewritten
2. 02We have limited cash resources and will require additional financing
3. 03We will need to raise additional capital to complete the development efforts for NGC-Cap and/or NGC-Iri. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations
4. 04Our financial statements contain a statement regarding a substantial doubt about our ability to continue as a going concern
5. 05Our ability to use our net operating loss carryforwards and other tax attributes may be limited

Risks Relating to Clinical Development and Commercialization of Our Product Candidates

1. 06Our licenses are subject to termination by the licensor in certain circumstances and any termination of a license agreement would result in a loss of important rights and have a material adverse impact on our business and prospects
2. 07We currently do not have, and may never develop, any FDA-approved, licensed or commercialized products
3. 08We must successfully complete clinical trials for our product candidates before we can apply for marketing approval
4. 09We are not permitted to market our product candidates as prescription pharmaceutical products in the United States until we receive approval of an NDA from the FDA, or in any foreign countries until we receive the requisite approval from such countries
5. 10Furthermore, we may not have the financial resources to continue development of, or to enter into collaborations for, a product candidate if we experience any problems or other unforeseen events that delay or prevent regulatory approval of, or our ability to commercialize, product candidates
6. 11Disruptions at the FDA and other government agencies could hinder new or modified products from being developed, approved, or commercialized in a timely manner or at all, which could negatively impact our business80% rewritten
7. 12Even if we receive regulatory approval for any of our product candidates, we may not be able to successfully license or commercialize the product and the revenue that we generate from its sales, if any, may be limited
8. 13Even if we obtain marketing approval for any of our product candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expenses
9. 14Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions
10. 15Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain24% rewritten
11. 16We could face competition from other biotechnology and pharmaceutical companies, and our operating results would suffer if we fail to innovate and compete effectively
12. 17Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results
13. 18Even though we may apply for orphan drug designation for a product candidate, we may not be able to obtain orphan drug marketing exclusivity
14. 19Although we may pursue expedited regulatory approval pathways for a product candidate, it may not qualify for expedited development or, if it does qualify for expedited development, it may not actually lead to a faster development, regulatory review or approval process
15. 20Third-party coverage and reimbursement, health care cost containment initiatives and treatment guidelines may constrain our future revenues
16. 21Legal, regulatory and legislative changes with respect to reimbursement, pricing and contracting may adversely affect our business and future prospects
17. 22We may face product liability exposure, and if successful claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate
18. 23We may choose not to continue developing or commercializing any of our product candidates at any time during development or after approval, which would reduce or eliminate our potential return on investment for those product candidates
19. 24Changes in U.S. and international trade policies, particularly with respect to China, Europe and India may adversely impact our business and operating results28% rewritten
20. 25Investments in Digital Assets are substantially speculative and have a significant risk of resulting in a loss compared to other forms of investmentNew
21. 26Digital Assets have historically experienced, and are expected to continue to experience, high price volatility which may influence our financial results and the market price of our common stockNew
22. 27We may be unable to successfully implement our Digital Asset StrategyNew
23. 28Our Digital Asset holdings will be less liquid than existing cash and cash equivalents and may not be able to serve as a source of liquidity to the same extent as cash and cash equivalentsNew
24. 29If we or our third-party service providers experience a security breach or cyberattack and unauthorized parties obtain access to our Digital Assets, we may lose some or all of our Digital Assets and our financial condition and results of operations could be materially adversely affectedNew
25. 30We face risks relating to the custody of our Digital Assets, including the loss or destruction of private keys required to access our Digital Assets, and cyberattacks or other data loss relating to our Digital AssetsNew
26. 31Our custodially-held Digital Assets may become part of the custodian’s insolvency estate if one or more of our custodians enters bankruptcy, receivership or similar insolvency proceedingsNew
27. 32Digital Assets held by us are not subject to FDIC or SIPC protectionsNew
28. 33Digital Assets are novel assets, and are subject to significant legal, commercial, regulatory, and technical uncertaintyNew
29. 34We could be subject to legal or regulatory action, including fines, in the event the SEC, a foreign regulatory authority, or a court were to determine that a digital asset held by us is a “security” under applicable lawsNew

Risks Relating to Our Intellectual Property Rights

1. 35We cannot ensure protection of our licensed intellectual property rights
2. 36If we fail to obtain or maintain patent or trade secret protection for our product candidates or our technologies, third parties could use our licensed or owned intellectual property, which could impair our ability to compete in the market and adversely affect our ability to generate revenues and attain profitability
3. 37Our product candidates may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development and commercialization efforts
4. 38Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements

General Company-Related Risks

1. 39Litigation or legal proceedings could expose us to significant liabilities and have a negative impact on our business
2. 40If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to identify and develop new or next generation product candidates will be impaired, could result in loss of markets or market share and could make us less competitive
3. 41Cyberattacks, malicious internet-based activity, online and offline fraud and other similar activities threaten the confidentiality, integrity, and availability of our sensitive information and information technology systems, and those of the third parties upon which we rely
4. 42We are exposed to cyber-attacks and data breaches, including the risks and costs associated with protecting our systems and maintaining integrity and security of our business information, as well as personal data of our guests, employees and business partners

Risks Related to Ownership of Our Common Stock

1. 43Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our Common Stock100% rewritten
2. 44Future equity offerings, license transactions or acquisitions may dilute our existing stockholders’ ownership and/or have other adverse effects on our operations
3. 45Our common stock price is volatile
4. 46We are a “smaller reporting company,” and the reduced disclosure requirements applicable to us as such may make our common stock less attractive to our stockholders and investors
5. 47We do not currently intend to pay dividends to our stockholders in the foreseeable future, and consequently, your ability to achieve a return on your investment will depend on appreciation in our value
6. 48Provisions in our corporate documents and Delaware law could have the effect of delaying, deferring, or preventing a change in control of us, even if that change may be considered beneficial by some of our stockholders
7. 49Provisions in our bylaws provide for indemnification of officers and directors, which could require us to direct funds away from our business and the development of our product candidates