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Dec 30, 2024
Relmada Q4 2024 Earnings Report
Relmada Therapeutics reported its fourth quarter and full year 2024 financial results and provided a business update.
Key Takeaways
Relmada Therapeutics reported a net loss of $18.6 million for Q4 2024, an improvement from $25.1 million in Q4 2023. The company ended the year with a cash balance of $44.8 million and is focused on advancing its NDV-01 and sepranolone programs.
Net loss for Q4 2024 was $18.6 million, a decrease from $25.1 million in Q4 2023.
Research and development expense decreased by $3.7 million in Q4 2024 compared to Q4 2023.
General and administrative expense decreased by $4.0 million in Q4 2024 compared to Q4 2023.
Cash balance as of December 31, 2024, was $44.8 million, providing support for planned operations into H1 2026.
Relmada
Relmada
Forward Guidance
Relmada Therapeutics plans to advance its NDV-01 and sepranolone programs through key development milestones, including FDA interactions, material production, and study design finalization, with new studies expected to begin around year-end 2025 or Q1 2026.
Positive Outlook
- Topline Phase 2 data for NDV-01 expected at AUA 2025 in April.
- Advancing sepranolone towards Phase 2b study in Tourette syndrome with potential for other compulsion-related disorders.
- Planned FDA interactions to align on regulatory strategy for NDV-01 and sepranolone.
- Completion of next batch material production for NDV-01 and sepranolone.
- Finalizing design of next studies for NDV-01 and sepranolone, expected to begin late Q4 2025 or early Q1 2026.
Challenges Ahead
- Potential for Phase 2 NDV-01 data not to be presented at an upcoming medical conference.
- Potential for Phase 2 NDV-01 data not to deliver positive results supporting further development.
- Risk of clinical trials failing to deliver statistically and/or clinically significant evidence of efficacy and/or safety.
- Failure of top-line results to accurately reflect the complete results of the trial.
- Potential failure to secure FDA agreement on the regulatory path for sepranolone and NDV-01, or that future clinical results will not be acceptable to the FDA.