RELMADA THERAPEUTICS, INC.
For the period ended May 23, 2025. Filed Apr 11, 2025.
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May 23, 2025 · Filed Apr 11, 2025
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Schedule 14A
Proxy Statement Pursuant to Section 14(a) of the
Securities Exchange Act of 1934
(Amendment No. )
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April 11, 2025
Dear Fellow Shareholders,
As we reflect on the past year and look toward the future, we want to express our appreciation for your continued support and trust in Relmada Therapeutics, Inc. (“Relmada” or the “Company”). 2024 presented us with challenges and pivotal decisions that have reshaped our strategy and refocused our efforts on building long-term shareholder value.
Following a comprehensive strategic review, we have taken decisive actions to pivot our development programs in response to the interim analysis results of our Phase 3 study of esmethadone (REL-1017) for Major Depressive Disorder (MDD). The results indicated that the study was unlikely to meet its primary efficacy endpoint with statistical significance, leading us to pause any further work on REL-1017 while we conduct a thorough data analysis.
In response to this development, we have determined that the most strategic path forward is to leverage our extensive drug development expertise to acquire and advance new therapeutic candidates. These candidates are expected to offer strong potential while providing greater diversification and a more balanced risk profile. This refined strategic approach has led to rapid and significant pipeline advancements, including the recent in-licensing of NDV-01, a novel advanced delivery formulation of a widely used chemotherapy regimen for non-muscle-invasive bladder cancer (NMIBC), and the acquisition of Sepranolone, a Phase 2b-ready neurosteroid with potential applications in Prader-Willi Syndrome (PWS), essential tremor (ET), Tourette Syndrome (TS), and potentially other health disorders linked to excessive GABAergic activity.
Additionally, while our REL-P11 program — a modified-release formulation of psilocybin for metabolic diseases — successfully completed a Phase 1 safety study, we have decided to pause further development. This decision reflects our commitment to prioritizing assets with greater near-term potential amid evolving regulatory landscapes and new opportunities.
Strategic Priorities for Growth
Following an extensive evaluation of our business strategy and growth prospects, we have aligned our efforts around key priorities that will position Relmada for sustained success:
Innovation: Advancing novel and differentiated therapeutic solutions to address significant unmet medical needs.
Pipeline Diversification: Expanding our development portfolio to mitigate risk and enhance growth potential.
Prioritizing Mid- to Late-Stage Programs: Concentrating resources on assets with a clear path to commercialization.
Accelerating Market Entry: Streamlining development timelines to bring therapies to patients faster.
Pursuing Cost-Effective Development Paths: Optimizing resource allocation and strategic partnerships.
Targeted Commercialization Strategy: Focusing on opportunities that require minimal sales and marketing infrastructure.
Progress in Strategic Execution
As part of our commitment to executing this strategy, we have successfully closed two key transactions:
Sepranolone Acquisition: On February 6, 2025, Relmada acquired Sepranolone from Asarina Pharma AB, a Phase 2b-ready neurosteroid for PWS, essential tremor, TS and other diseases linked to excessive GABAergic activity.
NDV-01 In-Licensing: On March 25, 2025, Relmada in-licensed NDV-01 from Trigone Pharma Ltd., a novel delivery formulation of a widely used chemotherapeutic regimen for NMIBC.
Key Upcoming Milestones
Over the next 12 months, we anticipate achieving multiple key milestones, including:
NDV-01 Phase 2a data presentation at the 2025 American Urological Association Meeting — April 2025
NDV-01 Investigational New Drug (IND) clearance in the United States — 2nd Half 2025
Sepranolone clinical program initiation in PWS — Year-end 2025
Development Programs Overview
Sepranolone Program
Sepranolone is a synthetic version of Isoallopregnanolone, a naturally occurring neurosteroid that counteracts the effects of Allopregnanolone, which can exacerbate anxiety and compulsive behaviors in some individuals. Designed to selectively target GABAA receptor subtypes, Sepranolone offers a novel treatment approach for disorders such as PWS and TS.
Data from a Phase 2a study demonstrated that Sepranolone has the potential to improve TS symptoms, achieving a 28% reduction in tic severity based on the Yale Global Tic Severity Scale (YGTSS), along with significant improvements in quality-of-life measures. Notably, no off-target CNS effects or systemic side effects were observed, reinforcing Sepranolone’s potential as a differentiated treatment for diseases linked to excessive GABAergic activity.
NDV-01 Program
NDV-01 is an innovative intravesicular delivery system for gemcitabine and docetaxel, offering a controlled-release chemotherapy solution for NMIBC. Unlike conventional methods requiring lengthy instillation procedures, NDV-01 enables a single administration lasting approximately 10 minutes, delivering sustained localized chemotherapy for up to 10 days. This extended exposure potentially enhances efficacy while improving patient convenience.
With Phase 2 studies underway, we believe NDV-01 has the potential to improve treatment outcomes for NMIBC patients, addressing a critical need amid the ongoing BCG shortage.
Conclusion
We are confident that this refined strategic direction strengthens our ability to deliver shareholder value while maintaining our commitment to scientific innovation and positive patient impact. With a strengthened development pipeline, disciplined execution, and a forward-looking approach, we are poised for meaningful progress in 2025 and beyond.
We appreciate your ongoing confidence and look forward to continuing our journey together. Thank you for your trust and support.
Sincerely,
/s/ Sergio Traversa
Sergio Traversa
Chief Executive Officer
Relmada Therapeutics, Inc.
NOTICE OF ANNUAL MEETING OF STOCKHOLDERS
TO BE HELD ONMAY 23, 2025
To the stockholders of Relmada Therapeutics, Inc.,
You are cordially invited to attend the 2025 Annual Meeting of Stockholders of Relmada Therapeutics, Inc. to be held in a virtual-only meeting format via live webcast on the Internet on May 23, 2025 at 9:30 a.m. Eastern Time. At the annual meeting you will be asked to vote on the following matters:
Proposal 1: To elect Fabiana Fedeli, as a Class I director, to serve for a three-year term that expires at the Annual Meeting of Stockholders in 2028, or until her successor is elected and qualified or until her earlier resignation or removal;
Proposal 2: To ratify the appointment of CBIZ CPAs P.C. as our independent registered public accounting firm for the fiscal year ending December 31, 2025; and
Proposal 3: To approve an amendment to the Relmada Therapeutics, Inc. 2021 Equity Incentive Plan to increase the shares of our common stock available for issuance thereunder by 2.0 million shares;
We also will transact such other business as may properly come before the annual meeting or any adjournments thereof.
The Board of Directors recommends that you vote at the annual meeting “FOR” the election of each nominee as director and “FOR” each of the other proposals set forth in this Notice. These items of business are more fully described in the proxy statement that is attached to this Notice. The Board of Directors has fixed the close of business on March 27, 2025 as the “Record Date” for determining the stockholders that are entitled to notice of and to vote at the annual meeting and any adjournments thereof. A list of stockholders entitled to vote at the meeting will be available for examination by any stockholder, for any purpose related to the meeting to the Annual Meeting, by appointment, for a period of ten days before the meeting in person at our corporate offices in Coral Gables, Florida, and in electronic form at the meeting.
It is important that your shares are represented and voted at the meeting. You can vote your shares by completing, signing, and returning your completed proxy card or vote by mail, internet or by fax by following the instructions included in the proxy statement. You can revoke a proxy at any time prior to its exercise at the meeting by following the instructions in the proxy statement.
We are holding the 2025 Annual Meeting of Stockholders in a virtual-only meeting format via live webcast on the Internet. You will not be able to attend at a physical location. Stockholders will be able to join and attend online by logging in atwww.virtualshareholdermeeting.com/RLMD2025. Your proxy is revocable in accordance with the procedures set forth in the proxy statement.
| By Order of the Board of Directors | |
| /s/ Charles J. Casamento | |
| Coral Gables, FL | Chairman of the Board |
|---|
IMPORTANT NOTICE REGARDING THE AVAILABILITY OF PROXY MATERIALS
FOR THE ANNUAL MEETING OF SHAREHOLDERS
The Proxy Statement and the 2024 Annual Report on Form 10-K are available at
www.relmada.com or www.proxyvote.com
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.