Release Date: August 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) reported meaningful progress in its clinical programs, particularly with the Phase 3 program for REL-1017 as a potential adjunctive treatment for major depressive disorder (MDD).
- The company has designed its ongoing Phase 3 studies to incorporate several elements intended to de-risk each study, including careful patient selection and stringent enrollment criteria.
- Relmada Therapeutics Inc (RLMD) has a solid cash position, with cash, cash equivalents, and short-term investments of approximately $70.4 million as of June 30, 2024, which is expected to support operations into 2025.
- The company plans to initiate a Phase 1 study for its metabolic disease program, RELP-11, shortly, with expectations to complete the Phase 1 study and initiate a Phase 2a study in the first half of 2025.
- Relmada Therapeutics Inc (RLMD) has reduced its net loss for the three months ended June 30, 2024, to $17.8 million, compared to $25.3 million for the same period in 2023, indicating improved financial management.
Negative Points
- The company is experiencing a high screen failure rate of approximately 80% in its ongoing Phase 3 studies, which could impact the timeline and success of the trials.
- Relmada Therapeutics Inc (RLMD) reported a decrease in cash, cash equivalents, and short-term investments from $96.3 million as of December 31, 2023, to $70.4 million as of June 30, 2024.
- The net loss for the three months ended June 30, 2024, was still significant at $17.8 million, indicating ongoing financial challenges.
- The company faces potential delays in its clinical trials due to the need for sample size re-estimation and the high screen failure rate.
- There is uncertainty regarding the outcomes of the interim analysis for the RELIANCE-2 study, which could impact the overall success and timeline of the Phase 3 program for REL-1017.
Q & A Highlights
Q: Can you remind us of the baseline Madras score in the ongoing Reliance 2 study and how it compares with the Phase 2 MDD trial and the Phase 2 Reliance 1 study?
A: The baseline Madras average for the patient population is very similar across all studies, right in the mid-30s range, around 33-34. This is typical for depression studies.
Q: What gives you the confidence that Reliance will finish enrollment six months after Reliance 2? Would a potential sample size re-estimation impact the timeline for data?
A: We are confident because if Reliance 2 is successful, all resources will be dedicated to Reliance. We have close to 100 sites available, and based on current enrollment rates, we can finish in about six months. Sample size re-estimation may impact the timeline, but not materially.
Q: Why did the estimated patient number change from 300 to 340 in the clinical trials?
A: Clinicaltrials.gov provides a general indication for the SPA, stating up to 340 patients. This does not mean we will reach 340. The final number will be determined by the statistical plan, which is not yet finalized.
Q: Did you have to change the protocol or statistical plan for the futility analysis in the interim? Are you taking any statistical penalty with this option?
A: We spent the last few months working on the statistical plan to avoid issues faced in previous studies. The futility analysis will help de-risk the program. There is no alpha penalty for the futility analysis as it does not involve efficacy analysis or early stopping.
Q: What proportion of the Reliance 2 study will be completed ahead of the interim analysis? How soon after that can we expect top-line data?
A: The interim analysis will be conducted as late as possible, likely around 70-80% completion. We plan to finish enrollment by year-end, so top-line data could be available shortly after, possibly early 2025.
Q: Why is the Phase 1 study for psilocybin being conducted in Canada? Does this reflect any regulatory hurdles in the U.S.?
A: Canada has very good facilities for Phase 1 studies and the regulatory agency is more accustomed to psychedelics compared to the FDA. This makes the regulatory process easier in Canada.
Q: How many more patients might be added in the sample size re-estimation analysis?
A: The number will be recommended by the DMC. It will be a reasonable amount that is feasible in a reasonable timeframe, not doubling the patient number.
Q: Is the runway guidance still expected to cover the readout for Reliance 2 and Reliance?
A: The current cash position is expected to support operations into 2025, including the readout from the Reliance 2 study. The exact timeline for Reliance will depend on enrollment patterns.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
