RELMADA THERAPEUTICS INC

DEF 14A 1 ea0200088-01.htm PROXY STATEMENT

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. )

Check the appropriate box:

(Name of Registrant as Specified In Its Charter)

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April 9, 2024

Dear Stockholders,

The recently completed year was a period of intense analysis, followed by the revision and relaunch of our pivotal Phase 3 program for REL-1017 for the adjunctive treatment of Major Depressive Disorder (MDD). Based on the data generated to date and the market potential of adjunctive MDD treatment, we decided to focus on the development of REL-1017 for adjunctive use. We implemented critical changes to the ongoing Study 302, a Phase 3 two-arm, placebo-controlled, pivotal study evaluating REL-1017 25mg, and initiated a new trial, Study 304, also for adjunctive MDD. The amended Study 302 protocol has been implemented across all our clinical sites. The two most important drivers for study success, as with all trials in depression, are recruiting the appropriate patients with true MDD, and controlling for placebo response.

REL-1017, unlike the conventional monoaminergic antidepressants, acts by blocking the NMDA receptor and correcting the consequences of dysregulated glutamatergic pathways believed to underlie the pathophysiology of MDD. It does not affect mood by altering neurotransmitter levels, or independently of pathophysiology. It is believed that REL-1017 has no effect in the situationally depressed, so its efficacy signal is dependent on enrolling appropriate subjects with a true MDD pathophysiology and diagnosis into the trial.

Therefore, in 2023, we focused intently on recruiting appropriately diagnosed subjects, controlling placebo response, and enhancing signal detection. Additionally, we strengthened our relationships and collaborations with preferred and selected clinical sites.

Regarding patient selection, in a post-hoc analysis of subjects in previously completed Study 301, a striking difference was seen in the results of verifiable vs. unverifiable sources. Verifiably sourced patients, including current patients, patients obtained from site databases and health care professional referrals, had a change from baseline of 17.2 points on MADRS10 score at day 28 vs. 11.8 points for placebo. This amounts to a 5.5-point difference versus placebo with a p-value of 0.02. Non-verifiably sourced patients, including those obtained through radio and TV ads, social media, internet searches and recruitment companies, performed much more poorly.

In our current ongoing studies, among several adjudication initiatives, we are requiring that patients have verified sources of their MDD diagnosis through medical records to verify depression diagnosis and antidepressant therapy history.

With respect to clinical site selection, our highest enrolling sites in Study 301 were particularly impacted by paradoxical data and placebo response. When we excluded data from our two highest enrolling sites, the population was reduced by only approximately 40 patients, and we saw a 4.1-point placebo-adjusted difference at day 28 on the MADRS total score favoring REL-1017. These important post-hoc learnings allowed us to make site selection improvements and prioritize those sites that were better able to control for placebo response. Moreover, we are limiting the number of patients enrolled per site, so no single site can have a disproportionate effect on study outcomes, as was observed in the prior controlled trials.

We strongly believe that these collective changes will significantly enhance the probability of success for our current studies.

Enrollment in Study 302 is steadily progressing as we leverage our close relationships with the study sites and execute several ongoing initiatives to drive trial awareness with prospective patients. We plan to enroll approximately 300 patients in Study 302 and expect top-line data in the second half of 2024.

We began dosing patients in Study 304 during the third quarter of 2023. This study also has a planned enrollment of approximately 300 patients. Completion of enrollment in this trial is anticipated in the second half of this year. Like Study 302, Study 304 is a randomized, double-blind, placebo-controlled 4-week trial evaluating the efficacy and safety of REL-1017 as an adjunctive treatment of MDD in patients experiencing inadequate response to ongoing background antidepressant treatment. The primary endpoint of both studies is the same — the change in the MADRS total score from baseline to Day 28 for REL-1017 as compared to placebo.

Of note, we have completed all necessary pre-clinical, manufacturing and Phase 1 studies required for a potential REL-1017 NDA filing and are now focused on executing various pre-commercial readiness activities.

Beyond REL-1017, in 2023, we initiated a new program in metabolic diseases based on the novel and pleiotropic metabolic effects of low-dose psilocybin discovered by Relmada scientists. We in-licensed our novel low-dose psilocybin program in 2021 with the objective of developing agents complementary to REL-1017 for use in various neurodegenerative indications. Relmada scientists investigating low-dose psilocybin for its neuroplastogenic effects in a rodent model of reduced neurogenesis, obese rodents fed a high-fat, high-fructose (HF/HF) diet to induce diabetes, observed that chronic, low dosing of psilocybin had profound and manifold metabolic effects.

Specifically, preclinical data presented at the November 2023 AASLD meeting demonstrated that low-dose psilocybin administered chronically in animals with diet-induced diabetes and maintained on an HF/HF diet significantly reduced hepatic steatosis, exerted significant glycemic control, restored plasma and liver triglyceride levels to those of the standard-diet fed controls, modulated the expression of multiple metabolism-related genes, and resulted in a 12% reduction in body weight gain without affecting food intake. Based on these results, low dose psilocybin could improve lipids and glucose with potential for fewer side effects over other investigative treatment approaches, such as GLP-1, glucagon, and GIP.

Low-dose psilocybin’s scope of metabolic effects, coupled with its unique mechanism of action and therapeutic profile, distinct from and potentially complementary to that of the incretins, is highly promising in the treatment of a host of metabolic conditions. Relmada intends to initiate a Phase 1 single-ascending dose trial of its proprietary modified-release formulation of psilocybin, REL-P11, in obese and normal subjects in the first half of 2024, to establish its pharmacokinetic, safety and tolerability profile. This is to be followed by a Phase 2 proof-of-concept trial in obese subjects suffering from a range of metabolic anomalies, with data expected in the first half of next year.

As we execute on the revised clinical development plan for REL-1017 and further advance our modified-release psilocybin formulation, it is important to highlight that we do so from a position of financial strength. We implemented key cost controls in 2023 and we expect our current cash on hand takes us into 2025. We are sufficiently funded to fully execute our plans to reach data readouts from both REL-1017 Phase 3 trials, as well as conduct the planned Phase 1 for our modified-release psilocybin formulation. Importantly, we avoided dilution in 2023 and did not raise money at unattractive valuations.

We firmly believe we have the right strategy and team in place to ensure long-term success and are deeply grateful for the dedication and commitment of patients, clinical partners, our employees, strategic partners, and Board of Directors, as well as the support of our shareholders. We look forward to a productive 2024 as we move further ahead with our compelling REL-1017 development program for MDD and continue to progress our modified-release psilocybin formulation. Thank you, again, for your interest in and support of Relmada.

Sincerely,

/s/ Sergio Traversa

Sergio Traversa

Chief Executive Officer

NOTICE OF ANNUAL MEETING OF STOCKHOLDERS

TO BE HELD ONMAY 24, 2024

To the stockholders of Relmada Therapeutics, Inc.,

You are cordially invited to attend the 2024 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 24, 2024 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 John Glasspool and Paul Kelly, as Class III directors, each to serve for a three-year term that expires at the Annual Meeting of Stockholders in 2027, or until his successor is elected and qualified or until his earlier resignation or removal;

• Proposal 2: To ratify the appointment of Marcum LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2024;

• 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 4.5 million shares; and

• Proposal 4: To provide an advisory vote to approve executive compensation.

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, 2024 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 2024 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/RLMD2024. Your proxy is revocable in accordance with the procedures set forth in the proxy statement.

IMPORTANT NOTICE REGARDING THE AVAILABILITY OF PROXY MATERIALS

FOR THE ANNUAL MEETING OF SHAREHOLDERS

The Proxy Statement and the 2023 Annual Report on Form 10-K are available at

www.relmada.com or www.proxyvote.com