Relmada Therapeutics Q3 2024 Financial Results and Business Update

Relmada Therapeutics, Inc., a biotechnology company focused on central nervous system (CNS) disorders, provided a corporate update and preliminary financial results for Q3 2024. The company will discuss these updates in a conference call today, November 7, at 4:30 PM ET.

Relmada’s CEO, Sergio Traversa, emphasized the potential value of the company’s clinical programs. Their lead product candidate, REL-1017, is undergoing Phase 3 trials as an adjunct treatment for major depressive disorder (MDD). Two trials, Reliance II and Relight, aim to build on successful Phase 2 results with improved site selection and stricter patient enrollment criteria. The Reliance II study includes a pre-planned interim analysis to evaluate futility and sample size, expected by year-end, which could significantly de-risk the program and the company.

Traversa also noted the upcoming Phase 1 safety study for REL-P11, targeting metabolic disease. This modified-release psilocybin formulation has shown promising results in preclinical models, improving multiple metabolic parameters. The Phase 1 study, expected to start in Canada by the end of 2024, will assess the pharmacokinetic, safety, and tolerability profile of REL-P11 in obese subjects. A Phase 2a proof-of-concept study is anticipated in the first half of 2025.

Key milestones expected include the interim analysis for Reliance II by the end of 2024 and the start of enrollment for the REL-P11 program by the same period.

Financially, Relmada reported an increase in research and development expenses for Q3 2024, totaling $11.1 million, up from $10.4 million in Q3 2023. The increase was mainly due to higher study costs for the ongoing Phase 3 trials. General and administrative expenses slightly decreased to $11.9 million from $12.2 million in the previous year, primarily due to reduced stock-based compensation expenses. The net loss for Q3 2024 was $21.7 million, or $0.72 per share, compared to $22.0 million, or $0.73 per share, in Q3 2023.

For the nine months ending September 30, 2024, research and development expenses decreased to $35.2 million from $40.1 million in the same period in 2023, reflecting lower study costs following the completion of two Phase 3 trials and a long-term safety trial in 2023. General and administrative expenses also fell to $29.6 million from $36.8 million, again due to lower stock-based compensation. Net cash used in operating activities was $43.0 million, compared to $41.4 million in the same period in 2023. The net loss for the first nine months of 2024 was $61.3 million, or $2.03 per share, down from $73.6 million, or $2.45 per share, in the prior year.

As of September 30, 2024, Relmada had cash, cash equivalents, and short-term investments totaling approximately $54.1 million, compared to $96.3 million at the end of 2023. The current cash position is expected to support operations through key milestones into 2025. The company had 30,174,202 common shares outstanding as of November 4, 2024.

Relmada is developing REL-1017, a novel NMDA receptor channel blocker, as a rapid-acting, oral adjunctive treatment for MDD in adults. The clinical program includes two Phase 3 studies, Reliance II and Relight, designed to evaluate the safety and efficacy of REL-1017, with the primary endpoint being the change in the Montgomery-Asberg Depression Rating Scale at Day 28.

Additionally, Relmada is working on REL-P11, a low-dose, modified-release psilocybin formulation aimed at treating metabolic diseases. This formulation has shown potential in preclinical models and is set for a Phase 1 study in Canada by the end of 2024.

Relmada Therapeutics remains committed to addressing CNS disorders, with a focus on MDD, and aims to make significant advancements in the field with its ongoing and upcoming clinical programs.