Relmada Therapeutics (RLMD) risk factors, 2025 10-K

Risks Related to Our Business

1. 01Pausing of Our Former Primary Drug Candidate May Adversely Affect Our Business and Financial Condition
2. 02Our Refocusing on New Drug Candidates Involves Significant Uncertainty and Risk
3. 03The primary focus of our product development is NDV-01 and Sepranolone
4. 04Our license agreement for NDV-01 or esmethadone could terminate under certain circumstances, including if we terminate our Chief Executive Officer except for cause, and we would be unable to conduct our business as planned
5. 05We May Require Substantial Additional Funding, Which May Not Be Available on Favorable Terms, or at All
6. 06We have generated no revenue from commercial sales to date and our future profitability is uncertain
7. 07International commercialization of our product candidates faces significant obstacles
8. 08We have a history of losses and we may never achieve or sustain profitability
9. 09We have a limited operating history upon which to base an investment decision
10. 10Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
11. 11We may not be successful in hiring and retaining key employees
12. 12Managing our growth as we expand operations may strain our resources
13. 13We may expand our business through the acquisition of rights to new drug candidates that could disrupt our business, harm our financial condition and may also dilute current stockholders’ ownership interests in our company
14. 14Business interruptions could limit our ability to operate our business
15. 15There is doubt about our ability to continue as a going concern

Risks Related to Clinical and Regulatory Matters

1. 16If we or our potential collaborators fail to obtain the necessary regulatory approvals, or if such approvals are limited, we and our potential collaborators will not be allowed to commercialize our drug candidates, and we will not generate product revenues
2. 17Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and expensive nonclinical testing and clinical trials that the product is both safe and effective for use in each target indication
3. 18We or our collaborators may have to commit substantial time and additional resources to conducting further nonclinical studies and clinical trials before obtaining FDA approval for any of our drug candidates
4. 19We have a limited history of developing drug candidates. We do not know whether any of our ongoing or planned clinical trials will result in marketable drugs
5. 20We cannot predict whether regulatory agencies will determine that the data from our clinical trials support marketing approval
6. 21Conducting clinical trials of our drug candidates or commercial sales of a drug candidate may expose us to expensive product liability claims and we may not be able to maintain product liability insurance on reasonable terms or at all
7. 22Fast Track Designation may not lead to a faster development or regulatory review or approval process
8. 23We may not be able to obtain marketing exclusivity under the Hatch-Waxman Amendments or equivalent regulatory data exclusivity protection in other jurisdictions for our products
9. 24We may need to focus our future efforts in new therapeutic areas where we have little or no experience
10. 25Some of our product candidates contain controlled substances, the supply of which may be limited by U.S. statutes and regulations, and the use of which may generate public controversy
11. 26Failure to comply with the CSA or DEA regulations, or the cost of compliance with these regulations, may adversely affect our business
12. 27If we determine to restart our psilocybin development program, the potential reclassification of psilocybin in the United States could create additional regulatory burdens on our operations and negatively affect our results of operations
13. 28If a supplier of an active pharmaceutical ingredient (API) or a pharmaceutical excipient fails to provide us sufficient quantities, we may not be able to obtain an alternative supply on a timely or acceptable basis
14. 29Modifications to our products, if approved, may require new NDA approvals
15. 30Delays in the commencement or completion of pharmaceutical development, manufacturing or clinical testing could result in increased costs to us and delay our ability to generate revenues
16. 31Conducting successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit
17. 32Adverse safety outcomes could affect our ability to conduct our clinical trials or obtain approval of our product candidates
18. 33If approved, our drug candidates and any psilocybin-containing drug product we successfully develop may require Risk Evaluation and Mitigation Strategies (REMS)
19. 34Our products will face significant competition in the markets for such products, and if they are unable to compete successfully, our business will suffer
20. 35We may be exposed to liability claims associated with the use of hazardous materials and chemicals
21. 36We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits

Risks Related to Our Intellectual Property

1. 37Our business depends upon securing and protecting critical intellectual property
2. 38Our patent position is highly uncertain and involves complex legal and factual questions
3. 39As a result, our owned and licensed patents may not be valid and we may not be able to obtain and enforce patents and to maintain trade secret protection for the full commercial extent of our technology. The extent to which we are unable to do so could materially harm our business
4. 40If we are found to be infringing on patents or trade secrets owned by others, we may be forced to cease or alter our product development efforts, obtain a license to continue the development or sale of our products, and/or pay damages
5. 41Our ability to protect and enforce our patents does not guarantee that we will secure the right to commercialize our patents
6. 42Intellectual property rights do not necessarily address all potential threats to our competitive advantage

Risks Related to Government Regulation

1. 43We may undertake international operations, which will subject us to risks inherent with operations outside of the United States
2. 44If we were to experience any of the difficulties listed above, or any other difficulties, any international development activities and our overall financial condition may suffer and cause us to reduce or discontinue our international development and registration efforts
3. 45In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could, among other things, affect our ability to profitably sell any products for which we obtain marketing approval

Risks Related to Our Reliance on Third Parties

1. 46We have no manufacturing capabilities and depend on other parties for our manufacturing operations. If these manufacturers fail to meet our requirements and strict regulatory requirements, our product development and commercialization efforts may be materially harmed
2. 47We intend to rely on third parties to conduct our nonclinical studies and clinical trials. If these third parties do not perform as contractually required or otherwise expected, we may not be able to obtain regulatory approval for our product candidates

Risks Related to Ownership of Our Common Stock

1. 48There is a limited market for our common stock that may make it more difficult to dispose of your stock
2. 49We are not in compliance with The Nasdaq Stock Market $1.00 minimum bid price requirement and failure to maintain compliance with this standard could result in delisting and adversely affect the market price and liquidity of our common stock
3. 50A sale of a substantial number of shares of our common stock may cause the price of the common stock to decline
4. 51We are subject to the reporting requirements of federal securities laws, which can be expensive and may divert resources from other projects, thus impairing our ability grow
5. 52Our stock price may be volatile
6. 53Our Stock Price May Be Volatile Due to Recent Developments
7. 54The Nevada Revised Statutes and our articles of incorporation and bylaws contain provisions that could discourage, delay or prevent a change in control of our Company, prevent attempts to replace or remove current management and reduce the market price of our stock