Relmada Therapeutics Advances Clinical Programs and Reports Q1 2024 Financial Results

Relmada Therapeutics reports Q1 2024 financial results and provides business update, advancing Phase 3 program for REL-1017 in major depressive disorder. The company prepares to initiate Phase 1 trial for novel psilocybin derivative targeting obesity.

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Relmada Therapeutics Advances Clinical Programs and Reports Q1 2024 Financial Results

Relmada Therapeutics Advances Clinical Programs and Reports Q1 2024 Financial Results

Relmada Therapeutics Inc. (NASDAQ: RLMD), a biotech company focused on developing novel treatments for central nervous system (CNS) diseases, reported its financial results for the first quarter of 2024 and provided a business update on May 8, 2024. The company is making significant progress in advancing its Phase 3 program for REL-1017 as an adjunctive treatment for major depressive disorder (MDD) and preparing to initiate a Phase 1 trial for a psilocybin derivative targeting obesity.

Why this matters: The development of novel treatments for CNS diseases, such as major depressive disorder, has the potential to improve the lives of millions of people worldwide. The advancement of clinical programs like Relmada's could lead to breakthroughs in the treatment of mental health disorders, ultimately reducing the economic and social burdens associated with these conditions.

Relmada has implemented important modifications to the ongoing Phase 3 study, Reliance II (Study 302), to control placebo response and improve patient enrollment. The amended study protocol has been implemented across all clinical sites, and enrollment continues to advance, with approximately 300 patients expected to be enrolled. Top-line data from Reliance II is anticipated in the second half of 2024. Relmada is also enrolling and dosing patients in its second Phase 3 trial, Relight (Study 304), with a planned enrollment of approximately 300 patients.

In addition to its MDD program, Relmada is preparing to initiate a single ascending dose Phase 1 trial in obese patients in the first half of 2024 to define the pharmacokinetic, safety, and tolerability profile of its modified release psilocybin formulation. The Phase 1 trial will be followed by a Phase 2A trial to establish clinical proof of concept. Data from the Phase 1 trial is anticipated in the first half of 2025. This program is based on compelling preclinical data presented at the 2023 AASLD meeting, which showed the beneficial effect of low chronic dose psilocybin on multiple metabolic parameters in a rodent model.

"We continue to achieve meaningful progress in the advancement of our ongoing Phase 3 program for REL-1017 in major depressive disorder (MDD) as well as in the promising preclinical novel psilocybin program," said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics. "We are highly confident that these changes will substantially enhance the probability of success of the current studies."

Maged Shenouda, Chief Financial Officer of Relmada, reviewed the company's first quarter 2024 financial results during the conference call held on May 8, 2024. As of the end of Q1 2024, Relmada had a robust financial position with $83.6 million in cash and investments. The company's market capitalization stood at approximately $113.15 million, with an adjusted P/E ratio of 1.21, reflecting its current lack of profitability. Relmada does not pay dividends, suggesting potential returns for investors would come from stock appreciation rather than income.

With significant advancements in its Phase 3 program for REL-1017 in MDD and the upcoming initiation of a Phase 1 trial for its novel psilocybin derivative targeting obesity, Relmada Therapeutics continues to make strides in developing innovative treatments for CNS disorders. The company's strong financial position and the anticipated clinical milestones in the coming months underscore its commitment to bringing novel therapies to patients in need.