Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Relmada Therapeutics Inc (RLMD, Financial) is advancing the development of new treatments for CNS disorders, including major depressive disorder (MDD), with a focus on derisking study design and execution.
- The company expects to report the outcome of the interim analysis for the Reliance II Phase III study by the end of 2024, which could be a significant derisking event for the REL-1017 program.
- Relmada Therapeutics Inc (RLMD) has designed its Phase III registrational program to build on key learnings from previous Phase II and Phase III programs.
- The company is on track to provide the outcome of the planned sample size reestimation interim analysis for the Reliance II study by the end of 2024.
- Relmada Therapeutics Inc (RLMD) has a cash position of approximately $54.1 million as of September 30, 2024, which is expected to support operations through key near-term milestones into 2025.
Negative Points
- Relmada Therapeutics Inc (RLMD) reported a net loss of $21.7 million for the third quarter of 2024, slightly lower than the $22 million loss in the same period of 2023.
- Cash used in operations increased to $16.7 million in the third quarter of 2024 from $11.6 million in the same period of 2023.
- The company's cash, cash equivalents, and short-term investments decreased from $96.3 million at the end of 2023 to $54.1 million as of September 30, 2024.
- The outcome of the interim analysis for the Reliance II study could potentially require the addition of more patients, indicating a need for increased resources and time.
- There is a risk that the Reliance II study could be deemed futile if the drug-placebo delta is below approximately 2.2 points, which would be a setback for the REL-1017 program.
Q & A Highlights
Q: What can we expect in the interim release regarding the Reliance II study? Will it be detailed or just a few sentences?
A: Sergio Traversa, CEO, stated that the level of detail in the interim release will depend on the outcome. They will provide as many details as possible, but the specifics will be determined by what the Data Management Committee (DMC) advises.
Q: Can you clarify the significance of the 2.2 points mentioned earlier?
A: Sergio Traversa clarified that the 2.2 points refer to the threshold for clinical significance. The futility threshold is set around a 2-point delta, which is the line between clinical and non-clinical significance.
Q: Will you have access to any additional information such as baseline characteristics or unblinded data during the interim analysis?
A: Sergio Traversa confirmed that they will only receive the outcomes from the DMC, which include whether the study is futile, can continue as planned, or needs more patients. No additional data will be shared to maintain data integrity.
Q: If the DMC recommends no change, will you continue to enroll up to 300 or 340 patients?
A: Sergio Traversa mentioned that they would likely enroll slightly more than the planned number to account for dropouts, aiming for a total between 300 and 340 patients.
Q: Are you taking a hit to alpha by conducting the interim analysis, and what are the screen failure rates in Reliance II compared to prior studies?
A: Sergio Traversa confirmed there is no alpha penalty as there is no plan for early stopping. The screen failure rate is in the mid-single digits, lower than previous trials, but this should not be interpreted as an efficacy indicator.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
