RELMADA THERAPEUTICS, INC. Q1 FY2025 earnings call

• 2025 started well with addition of NDV-01 for bladder cancer and sepranolone for Prader-Willi syndrome and Tourette syndrome with promising Phase 2 data. • Positive Phase 2 data for NDV-01 presented at AUA, progress on developing both programs. • Cash balance of $27.1 million as of March 31, 2025, down from $44.9 million on Dec 31, 2024. • R&D expense decreased due to completion of trials for REL-1017, offset by payments for sepranolone acquisition and NDV-01 in-licensing. • G&A expense decreased primarily due to lower stock-based compensation expense.

No product segment financial performance with revenue contribution % provided. Research and development expense for Q1 2025 was $12 million, down from $13.3 million in Q1 2024. General and administrative expense for Q1 2025 was $6.3 million, down from $9.7 million in Q1 2024. Net loss for Q1 2025 was $17.6 million, or $0.58 per share, compared to a net loss of $21.8 million, or $0.72 per share in Q1 2024.

• Preparing to begin next studies for NDV-01 and sepranolone. • Approaching FDA to discuss moving NDV-01 into registrational studies. • Planning to scale up supply of NDV-01, with plans for multiple manufacturers for risk management. • Expecting to have better visibility into requirements and runway as clinical and regulatory strategies for programs are finalized.

Q: What gives confidence that current Phase 2 data for NDV-01 is sufficient for FDA to agree to registrational studies?

A: Combination of gemcitabine plus docetaxel is well-known and effective, formulation's safety with no Grade 1+ treatment-related adverse events, and practicality of administration in office setting.

Q: Elaborate on scaling up supply for NDV-01?

A: Need for large quantity for commercial use, planning for at least two manufacturers for risk management, scaling up for clinical study and potential commercial use.

Q: When to expect complete response rate for entire population of NDV-01 Phase 2 study?

A: Next data point at six months, with data around end of June/July, then 9 and 12 months for the 20 patients.

Q: Thoughts on NDV-01 fit in treatment paradigm vs competitors?

A: NDV-01 has potential in BCG unresponsive space, intermediate risk space, and chemoablative space, with advantages in ease of use and sustained drug release.

Q: Design of Phase 3 for NDV-01?

A: Possible single-arm chemoablation route similar to UroGen's Envision trial or randomized trial in intermediate risk against placebo.