Relmada Therapeutics (RLMD) risk factors, 2026 10-K

Relmada Therapeutics's 2026 10-K, filed Mar 19, 2026, lists 53 risk factors in 12 groups. Against the prior year's 54: 6 new, 7 dropped, 13 substantially reworded.

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Risk factors listed
5312 groups
New this year
6vs 54 last year
Dropped
7since the prior 10-K
Substantially reworded
13of those kept
Section length
17k wordsItem 1A

What the changes say

  • Relmada terminated the development of its primary drug candidate, esmethadone, after the Phase 3 Reliance II study failed to meet its primary efficacy endpoint.
  • The company also dropped psilocybin development for metabolic disease and faced a Nasdaq minimum bid price deficiency.
  • Net operating loss carryforwards increased to approximately $246,410,000 for Federal and $2,719,000 for State.

What changed since the prior 10-K

New

  • NewRisks Related to Our Business

    Ending Development of Our Former Drug Candidates May Adversely Affect Our Business and Financial Condition

    We terminated development of our primary drug candidate, esmethadone, for major depressive disorder due to a failed Phase 3 study, as well as our psilocybin program REL-P11.

  • NewRisks Related to Our Business

    Preliminary or top-line results may not accurately reflect the complete results of the clinical study

    Preliminary or top-line clinical data are subject to audit and verification, which may cause final results to differ materially.

  • NewRisks Related to Clinical and Regulatory Matters

    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 fail to obtain or maintain orphan drug designation and marketing exclusivity for drug candidates targeting rare disease patient populations under 200,000 individuals.

  • NewRisks Related to Government Regulation

    In addition, HIPAA mandates that the Secretary of HHS conduct periodic compliance audits of HIPAA covered entities and business associates for compliance with the HIPAA privacy and security rules

    HIPAA compliance audits by HHS and strict breach notification rules requiring reporting within 60 days or for incidents affecting 500 or more patients increase our regulatory burdens.

  • NewRisks Related to Government Regulation

    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

    International political and economic instability, armed conflicts, trade restrictions, and sanctions could disrupt our global supply chain and operations.

  • NewRisks Related to Government Regulation

    If we are unable to anticipate or effectively respond to international political and economic developments, or if such events materially disrupt our operations or supply chain, our business, financial condition, and results of operations could be materially adversely affected

    Healthcare anti-kickback, fraud, and abuse laws will govern our future arrangements with providers and payors, exposing us to potential penalties and criminal sanctions.

Dropped

  • DroppedRisks Related to Our Business

    Pausing of Our Former Primary Drug Candidate May Adversely Affect Our Business and Financial Condition

    Pausing of Our Former Primary Drug Candidate May Adversely Affect Our Business and Financial Condition

  • DroppedRisks Related to Our Business

    Our 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

  • DroppedRisks Related to Our Business

    There is doubt about our ability to continue as a going concern

  • DroppedRisks Related to Clinical and Regulatory Matters

    Some 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

    Our license agreement for NDV-01 or esmethadone could terminate under certain circumstances.

  • DroppedRisks Related to Clinical and Regulatory Matters

    Failure to comply with the CSA or DEA regulations, or the cost of compliance with these regulations, may adversely affect our business

  • DroppedRisks Related to Clinical and Regulatory Matters

    If 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

  • DroppedRisks Related to Clinical and Regulatory Matters

    If approved, our drug candidates and any psilocybin-containing drug product we successfully develop may require Risk Evaluation and Mitigation Strategies (REMS)

Reworded

  • 87% rewrittenRisks Related to Clinical and Regulatory Matters

    Fast Track Designation may not lead to a faster development or regulatory review or approval process

    Removed specific references to paused esmethadone development while retaining general Fast Track Designation risks for product candidates.

  • 55% rewrittenRisks Related to Ownership of Our Common 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

    Updated our trading market from The Nasdaq Global Select Market to The Nasdaq Capital Market following a minimum bid price deficiency.

    Was: We 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

  • 53% rewrittenRisks Related to Our Business

    Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited

    Updated federal and state net operating loss carryforwards to approximately $246,410,000 and $2,719,000 respectively as of December 31, 2025.

  • 52% rewrittenRisks Related to Government Regulation

    If 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

    Retained general IT security and confidential data protection risks without substantive textual changes.

  • 50% rewrittenRisks Related to Ownership 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

    Removed specific reference to the registration statement covering up to 21,041,717 shares for selling stockholders.

  • 48% rewrittenRisks Related to Clinical and Regulatory Matters

    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

    Removed specific esmethadone references from Hatch-Waxman exclusivity and European data exclusivity disclosures, generalizing them to product candidates.

  • 48% rewrittenRisks Related to Clinical and Regulatory Matters

    We may need to focus our future efforts in new therapeutic areas where we have little or no experience

    Broadened strategic focus risks from depression-specific development to any therapeutic area where we have limited experience.

  • 38% rewrittenRisks Related to Clinical and Regulatory Matters

    Adverse safety outcomes could affect our ability to conduct our clinical trials or obtain approval of our product candidates

    Retained clinical trial adverse safety outcome and FDA delay risks without substantive changes.

  • 29% rewrittenRisks Related to Ownership of Our Common Stock

    Our Stock Price May Be Volatile Due to Recent Developments

  • 28% rewrittenRisks Related to Government Regulation

    In 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

  • 25% rewrittenRisks Related to Our Business

    We have a history of losses and we may never achieve or sustain profitability

  • 23% rewrittenRisks Related to Our Reliance on Third Parties

    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

    Was: We 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

  • 22% rewrittenRisks Related to Clinical and Regulatory Matters

    Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and expensive non-clinical testing and clinical trials that the product is both safe and effective for use in each target indication

    Was: Before 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

All 53 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business

  1. 01Ending Development of Our Former Drug Candidates May Adversely Affect Our Business and Financial ConditionNew
  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. 04Preliminary or top-line results may not accurately reflect the complete results of the clinical studyNew
  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 profitability25% rewritten
  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 limited53% rewritten
  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

Risks Related to Clinical and Regulatory Matters

  1. 15If 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. 16Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and expensive non-clinical testing and clinical trials that the product is both safe and effective for use in each target indication22% rewritten
  3. 17We or our collaborators may have to commit substantial time and additional resources to conducting further non-clinical studies and clinical trials before obtaining FDA approval for any of our drug candidates
  4. 18We 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. 19We cannot predict whether regulatory agencies will determine that the data from our clinical trials support marketing approval
  6. 20Conducting 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. 21Fast Track Designation may not lead to a faster development or regulatory review or approval process87% rewritten
  8. 22Even 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 indicationsNew
  9. 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 products48% rewritten
  10. 24We may need to focus our future efforts in new therapeutic areas where we have little or no experience48% rewritten
  11. 25If 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
  12. 26Modifications to our products, if approved, may require new NDA approvals
  13. 27Delays 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
  14. 28Conducting successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit
  15. 29Adverse safety outcomes could affect our ability to conduct our clinical trials or obtain approval of our product candidates38% rewritten
  16. 30Our products will face significant competition in the markets for such products, and if they are unable to compete successfully, our business will suffer
  17. 31We may be exposed to liability claims associated with the use of hazardous materials and chemicals
  18. 32We 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. 33Our business depends upon securing and protecting critical intellectual property
  2. 34Our patent position is highly uncertain and involves complex legal and factual questions
  3. 35As 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. 36If 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. 37Our ability to protect and enforce our patents does not guarantee that we will secure the right to commercialize our patents
  6. 38Intellectual property rights do not necessarily address all potential threats to our competitive advantage

Risks Related to Government Regulation

  1. 39We may undertake international operations, which will subject us to risks inherent with operations outside of the United States
  2. 40If 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 efforts52% rewritten
  3. 41In addition, HIPAA mandates that the Secretary of HHS conduct periodic compliance audits of HIPAA covered entities and business associates for compliance with the HIPAA privacy and security rulesNew
  4. 42International political and economic instability, including geopolitical tensions, armed conflicts, trade restrictions, and sanctions, could disrupt our operations and adversely affect our business and financial resultsNew
  5. 43If we are unable to anticipate or effectively respond to international political and economic developments, or if such events materially disrupt our operations or supply chain, our business, financial condition, and results of operations could be materially adversely affectedNew
  6. 44In 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 approval28% rewritten

Risks Related to Our Reliance on Third Parties

  1. 45We 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. 46We 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 candidates23% rewritten

Risks Related to Ownership of Our Common Stock

  1. 47There is a limited market for our common stock that may make it more difficult to dispose of your stock
  2. 48Failure 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 stock55% rewritten
  3. 49A sale of a substantial number of shares of our common stock may cause the price of the common stock to decline50% rewritten
  4. 50We 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. 51Our stock price may be volatile
  6. 52Our Stock Price May Be Volatile Due to Recent Developments29% rewritten
  7. 53The 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

Other Relmada Therapeutics 10-Ks

  • 2025 10-K risk factors
    54 risks

    Relmada Therapeutics paused its primary drug candidate esmethadone and pivoted to early-stage candidates NDV-01 and Sepranolone.

    Filed Mar 27, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.