Relmada Therapeutics Updates Corporate Status and Q1 2024 Financials

Relmada Therapeutics, Inc., a late-stage biotechnology company listed on Nasdaq under the symbol RLMD, has provided a corporate update and announced its preliminary and unaudited financial results for the first quarter of 2024, ending on March 31. The announcement was made from Coral Gables, Florida, on May 8, 2024. Relmada focuses on addressing diseases of the central nervous system (CNS) and is currently advancing its clinical programs and financial standing.

The company’s Chief Executive Officer, Sergio Traversa, reported significant progress in their Phase 3 program for REL-1017, aimed at treating major depressive disorder (MDD) as an adjunctive therapy. The Reliance II study (study 302) is expected to complete enrollment by the second half of 2024, with top-line data to follow. Additionally, enrollment continues for Relight (study 304), their second Phase 3 trial for REL-1017.

Relmada is also planning a Phase 1 trial for a modified-release psilocybin formulation (REL-P11) in obese patients. This trial, set to begin in the first half of 2024, will explore the pharmacokinetic, safety, and tolerability profile of the formulation. If successful, it will proceed to a Phase 2a trial by the first half of 2025 to establish clinical proof-of-concept.

Key milestones anticipated by the company include completing the patient enrollment for the Reliance II study and initiating the Phase 1 trial for the modified-release psilocybin in 2024.

Financially, the company reported a reduction in research and development expenses, down to $13.3 million for the first quarter of 2024 from $15.9 million in the same period in 2023. This decrease is attributed to the completion of two Phase 3 trials and a long-term safety study. General and administrative expenses also dropped to $9.7 million from $12.3 million, primarily due to lower stock-based compensation expenses. Net cash used in operating activities was $13.0 million, a decrease from $16.5 million in the previous year. The net loss for the first quarter was $21.8 million, down from $26.4 million the previous year. As of March 31, 2024, the company had cash, cash equivalents, and short-term investments totaling $83.6 million, compared to $96.3 million at the end of 2023.

REL-1017, Relmada’s lead program, is a novel NMDA receptor channel blocker currently in late-stage development for MDD. It is designed to target hyperactive channels while maintaining normal neurotransmission. The program includes two Phase 3 trials: Reliance II and Relight, both employing similar study designs to assess the drug’s efficacy and safety.

Relmada also acquired a novel psilocybin program in July 2021, which has shown potential neuroplastogen effects in preclinical models. The focus has been on its application in treating neurodegenerative conditions, particularly through low-dose psilocybin’s pleiotropic metabolic effects.

Relmada Therapeutics remains committed to developing treatments for CNS diseases, particularly major depressive disorder, and continues to advance its clinical programs and financial health. The company’s future activities include a conference call to discuss these updates further.