RELMADA THERAPEUTICS, INC.

Pursuant to a lease agreement, dated August 1, 2021, and renewed for each subsequent year after, the Company leases office space at 2222 Ponce de Leon Blvd., Floor 3, Coral Gables, FL 33134. Under the 2021 lease agreement the average monthly rent expense was approximately $11,000. For 2024, 2025 and 2026, the renewed lease agreement was for an average monthly rent expense of approximately $7,000, $4,500 and $4,600, respectively.

Beginning on December 1, 2023, the Company leased office space at 12 E 49th Street, New York, NY 10022 for approximately $12,000 per month, that lease was terminated on May 31, 2024.

Beginning on May 29, 2024, the Company leased office space at 12 E 49th Street, New York, NY 10022 with monthly rent of approximately $10,500; that lease expired on May 30, 2025 with the Company continuing to lease the space under a month-to-month option.

• We have generated no revenue from commercial sales to date and our future profitability is uncertain.
• International commercialization of our product candidates faces significant obstacles.
• We have a history of losses and we may never achieve or sustain profitability.
• We have a limited operating history upon which to base an investment decision.
• Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
• We may not be successful in hiring and retaining key employees.
• Managing our growth as we expand operations may strain our resources.
• We 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.
• Business interruptions could limit our ability to operate our business.
• Risks Related to Clinical and Regulatory Matters
• If 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.
• If we or our collaborators are unable to design, conduct and complete successful clinical trials, our drug candidates will not be able to receive regulatory approval.
• We cannot predict whether regulatory agencies will determine that the data from our clinical trials support marketing approval.
• Developments by competitors may establish standards of care that affect our ability to conduct our clinical trials as planned.
• Conducting 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.
• If our drug candidates receive regulatory approval, we and our collaborators will also be subject to ongoing FDA obligations and continued regulatory review, such as continued safety reporting requirements, and we and our collaborators may also be subject to additional FDA post-marketing obligations or new regulations, all of which may result in significant expense and limit our and our collaborators’ ability to commercialize our drugs.
• Fast Track Designation may not lead to a faster development or regulatory review or approval process.
• Even if we obtain orphan drug designation in the United States for any of our drug product candidates, we may not obtain or maintain orphan drug exclusivity for that drug candidate, and we may not obtain orphan drug designation or exclusivity for any of our product candidates or indications.
• We 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.
• We may need to focus our future efforts in new therapeutic areas where we have little or no experience.
• If 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.
• Modifications to our products, if approved, may require new NDA approvals.
• Delays 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.
• Conducting successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit.
• Adverse safety outcomes could affect our ability to conduct our clinical trials or obtain approval of our product candidates.
• Our products will face significant competition in the markets for such products, and if they are unable to compete successfully, our business will suffer.
• We may be exposed to liability claims associated with the use of hazardous materials and chemicals.
• We 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
• Our business depends upon securing and protecting critical intellectual property.
• Our patent position is highly uncertain and involves complex legal and factual questions.
• If 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.
• Our ability to protect and enforce our patents does not guarantee that we will secure the right to commercialize our patents.
• Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
• Risks Related to Government Regulation
• We may undertake international operations, which will subject us to risks inherent with operations outside of the United States.
• Failure to comply with existing or future laws and regulations related to privacy or data security could lead to government enforcement actions (which could include civil or criminal fines or penalties), private litigation, other liabilities, and/or adverse publicity. Compliance or the failure to comply with such laws could increase the costs of our products and services, could limit their use or adoption, and could otherwise negatively affect our operating results and business.
• International political and economic instability, including geopolitical tensions, armed conflicts, trade restrictions, and sanctions, could disrupt our operations and adversely affect our business and financial results.
• Our operations and relationships with future customers, providers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to penalties including criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
• Enacted and future legislation may affect the prices we may set and third-party payment for our product candidates. The full effect of recent United States healthcare reform and other changes in the healthcare industry, laws, and regulations and in healthcare spending is currently unknown, and the reform and other changes may adversely affect our business model.
• Risks Related to Our Reliance on Third Parties
• We 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.
• We intend to rely on third parties to conduct our non-clinical 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
• There is a limited market for our common stock that may make it more difficult to dispose of your stock.
• Failure to maintain compliance with the continued listing standards of The Nasdaq Stock Market could result in delisting and adversely affect the market price and liquidity of our common stock.
• A sale of a substantial number of shares of our common stock may cause the price of the common stock to decline.
• We 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.
• If we fail to establish and maintain an effective system of internal control, we may not be able to report our financial results accurately or to prevent fraud. Any inability to report and file our financial results accurately and timely could harm our reputation and adversely impact the trading price of our common stock.
• Our stock price may be volatile.
• Our Stock Price May Be Volatile Due to Recent Developments
• The 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.
• Our bylaws provides that a Nevada court and the federal district courts of the United States will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.