RELMADA THERAPEUTICS, INC. Q4 FY2024 earnings call

Strategic Product Acquisition Efforts

• Initiated a process to transform the company through strategic product acquisition efforts to maximize shareholder value, with progress ongoing. Evaluated several programs and recently acquired [indiscernible] with two product candidates: NDV-01 for non-muscle invasive bladder cancer and Sepranolone for compulsion-related disorders.

Product Pipeline Update

• NDV-01: Exclusive licensing agreement with Trigone Pharma for NDV-01, a Phase 2 program for high grade non-muscle invasive bladder cancer. Expected top line safety and efficacy data at the American Urological Association Meeting (AUA) in April 2025. Next study expected to be a registrational trial.
• Sepranolone: Acquired from Asarina Pharma for Tourette syndrome and potential Prader-Willi syndrome. Next studies include a signal finding study in Prader-Willi syndrome and a Phase 2b study in Tourette syndrome.
• REL-P11: Reevaluating further development due to competitive landscape and focus on patient populations, despite Phase 1 study showing good tolerability.

Financial Results

• Q4 2024 R&D expense: $11M (decrease of $3.7M from Q4 2023) due to completion of REL-1017 trials.
• Q4 2024 G&A expense: $8.1M (decrease of ~$4M from Q4 2023) due to decrease in stock-based compensation.
• Net loss for Q4 2024: $18.6M ($0.62 per share) compared to $25.1M ($0.84 per share) in Q4 2023.

No specific breakdown of product segments by absolute revenue and revenue contribution % was provided in the transcript.

Forward-Looking Statements

• Expect to interact with the FDA to align on regulatory strategy for NDV-01 and Sepranolone.
• NDV-01 expected initial proof of concept data at AUA 2025. Next study for NDV-01 is a registrational trial.
• Sepranolone next studies include a signal finding study in Prader-Willi syndrome and a Phase 2b study in Tourette syndrome.
• Plan to advance clinical programs and provide updates throughout the year.

No significant detailed discussion of risks and operational failures was prominently featured in the transcript.

Q: Approvable endpoint for Sepranolone and comparison to dopamine blockers for Tourette's.

A: Endpoints based on FDA process, will discuss with FDA; NDV-01 data expected to be competitive with existing treatments.\nQ: Expectation of in-licensing more compounds this year.

A: Relmada keeps eyes open for in-licensing but is selective, focusing on products that fit strategic criteria.