Relmada Therapeutics Announces Q2 2024 Financial Results and Business Update

Relmada Therapeutics, Inc., a late-stage biotechnology firm focusing on central nervous system disorders, shared a corporate update and unveiled preliminary financial results for the second quarter of 2024. 

CEO Sergio Traversa expressed optimism about the progress of their clinical programs, particularly the Phase 3 trials for REL-1017, aimed at treating major depressive disorder (MDD). The company plans to complete enrollment for the Reliance II study by the end of 2024, followed by the Relight study approximately six months later. Both these studies aim to optimize patient outcomes by using stringent patient adjudication criteria.

The Reliance II study features a pre-planned interim analysis to check for futility and potentially adjust the sample size, aiming to mitigate risks. The results of this analysis are expected by the end of 2024. Additionally, Relmada plans to kickstart a Phase 1 study in Canada for REL-P11, a low-dose, modified-release psilocybin formulation for metabolic disorders, by the same deadline. The financial resources available are deemed sufficient to support operations through these key milestones and into 2025.

Key milestones anticipated for the near future include the outcome of the interim analysis for the Reliance II study and the completion of its enrollment by the end of 2024. The Relight study is set to follow six months after. Relmada also plans to begin the Phase 1 REL-P11 program in Canada within the year, aiming to investigate its pharmacokinetic, safety, and tolerability profiles. Topline results and the initiation of a Phase 2a proof-of-concept study are anticipated in the first half of 2025.

In terms of financial performance for the second quarter ending June 30, 2024, research and development expenses were reported at $10.7 million, a $3.0 million decrease from the same period in 2023. This reduction was mainly attributed to the conclusion of two Phase 3 trials and a long-term safety trial. General and administrative expenses also saw a decrease, totaling $8.1 million compared to $12.3 million in the previous year, largely due to reduced stock-based compensation expenses.

Net cash used in operating activities remained steady at $13.3 million for the quarter. The net loss for the quarter was $17.8 million, translating to $0.59 per basic and diluted share. This is a significant improvement from the net loss of $25.3 million, or $0.84 per share, reported for the same period in 2023.

For the first half of 2024, research and development expenses amounted to $24.0 million, down from $29.6 million in the first half of 2023. General and administrative expenses were $17.8 million, a decrease from $24.6 million during the same period last year, again primarily due to lower stock-based compensation costs. Net cash used in operating activities for the first half of 2024 was $26.3 million, compared to $29.8 million in the prior year. The net loss for the six months ended June 30, 2024, was $39.6 million, or $1.31 per share, down from $51.6 million, or $1.72 per share, in the same period of 2023.

As of June 30, 2024, Relmada reported having $70.4 million in cash, cash equivalents, and short-term investments, down from $96.3 million at the end of 2023. The company feels confident that this cash balance will support their planned operations into 2025.

Relmada Therapeutics specializes in developing treatments for central nervous system disorders, with its leading program, REL-1017, focusing on major depressive disorder. The company strives to make a significant impact on the lives of patients and their families by advancing innovative treatments.

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