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Dec 31, 2022
Relmada Q4 2022 Earnings Report
Relmada reported fourth quarter and full-year 2022 financial results and provided a corporate update.
Key Takeaways
Relmada Therapeutics reported their Q4 and full-year 2022 financial results, focusing on the analysis of Reliance I (Study 301) data and plans for further development of REL-1017 as an adjunctive treatment for major depressive disorder (MDD). They intend to implement changes to Reliance II (Study 302) and initiate a new trial, Study 304, with sufficient funding to execute these plans.
Analysis of Reliance I (Study 301) data identified key issues.
Focus on further development of REL-1017 as an adjunctive treatment for MDD.
Critical changes to Reliance II (Study 302) will be implemented, and a new trial, Study 304, will be initiated.
Relmada is sufficiently funded to fully execute the plans for the further development of REL-1017 with Study 302 and Study 304.
Relmada
Relmada
Forward Guidance
Relmada Therapeutics is focusing on clinical trial execution to gain approval for REL-1017, having identified key issues from Study 301 and planning to implement changes in ongoing and new trials.
Positive Outlook
- Identified the most reliable sites for trials.
- Identified the most suitable patients for trials.
- Improved study protocols.
- All other pre- and clinical, and CMC pieces are in place for a successful NDA filing for REL-1017.
- Sufficiently funded to fully execute plans for further development of REL-1017
Challenges Ahead
- Potential failure of Reliance trial results to demonstrate clinically significant evidence of efficacy and/or safety
- Failure of top-line results to accurately reflect the complete results of the trial
- Failure to obtain regulatory approval of REL-1017 for the treatment of major depressive disorder
- Risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements
- Not possible to predict or identify all the risks, uncertainties and other factors that may affect future results