Relmada Therapeutics (RLMD) Q3 2024 earnings summary

Executive summary

• Focus remains on advancing treatments for CNS disorders, especially major depressive disorder (MDD), with lead candidate Relmada 1017 (esmethadone) in phase III development, and a modified-release psilocybin (REL-P11) for metabolic indications entering clinical trials.

• Two ongoing phase III trials (RELIANCE II and RELIGHT) for REL-1017 as adjunctive MDD treatment, with interim analysis for RELIANCE II expected by year-end 2024.

• No products are approved or generating revenue; the company relies on external funding and faces substantial doubt about its ability to continue as a going concern.

• A psilocybin-based candidate (P11) for metabolic disease is entering phase I, with phase II-A planned for 2025.

Financial highlights

• Cash, cash equivalents, and short-term investments totaled $54.1 million as of September 30, 2024, down from $96.3 million at year-end 2023.

• Net loss for Q3 2024 was $21.7 million ($0.72 per share), compared to $22 million ($0.73 per share) in Q3 2023; net loss for the nine months ended September 30, 2024 was $61.3 million, down from $73.6 million year-over-year.

• Operating expenses for Q3 2024 totaled $23.0 million, up marginally from $22.7 million in Q3 2023; for the nine months, operating expenses were $64.8 million, down from $76.9 million year-over-year.

• Research and development expenses were $11.1 million in Q3 2024, up year-over-year, mainly due to increased activity in clinical studies.

• General and administrative expenses were $11.9 million in Q3 2024, down year-over-year, primarily due to lower stock-based compensation.

Outlook and guidance

• Current cash position is expected to support operations through key milestones into 2025, but management is evaluating the size and scope of future operations and clinical trials, with financing strategies under consideration.

• Reliance II interim analysis outcome will determine next steps: continue as planned, increase sample size, or stop for futility.

• Phase II-A study for P11 in metabolic disease anticipated to begin in 2025.