Relmada Q4 2023 Earnings Report
Key Takeaways
Relmada Therapeutics announced progress in its Phase 3 program for REL-1017 and plans for a Phase 1 trial for REL-P11, while also reporting financial results for the fourth quarter and full year ended December 31, 2023.
Advancing Phase 3 program for REL-1017 as an adjunctive treatment for major depressive disorder (MDD).
Enrollment in Reliance II (study 302) is steadily proceeding, with top line data expected in the second half of 2024.
Dosing patients in the Relight (study 304) began during the third quarter of last year, with plans to complete enrollment by year-end 2024.
Intends to initiate a single-ascending dose Phase 1 trial in obese patients in the first half of this year for REL-P11.
Relmada
Relmada
Forward Guidance
Relmada Therapeutics is focused on advancing its clinical programs for REL-1017 and REL-P11, with key milestones expected in the near term.
Positive Outlook
- Steady progress in Reliance II (study 302) enrollment.
- Top line data from Reliance II expected in the second half of 2024.
- Patient dosing has begun in Relight (study 304).
- Enrollment completion for Relight planned by year-end 2024.
- Planned initiation of Phase 1 trial for REL-P11 in H1 2024.
Challenges Ahead
- Potential failure of clinical trial results to demonstrate statistically and/or clinically significant evidence of efficacy and/or safety.
- Possibility of top-line results not accurately reflecting the complete results of the trial.
- Risk of failure of the 310 open-label study to accurately reflect the results of the ongoing 302 and 304 blinded, randomized and controlled studies.
- Uncertainty in obtaining regulatory approval of REL-1017 for the treatment of major depressive disorder.
- Risk of failure of the planned psilocybin Phase 1 and Phase 2a trials to be successfully initiated and carried out.