Relmada Therapeutics Q1 2025: Unpacking Contradictions on Sepranolone's Safety, Pipeline Focus, and Interim Analysis

Sepranolone's safety profile and indication opportunities, pipeline and strategic focus, interim analysis outcomes and enrollment numbers, statistical significance and futility threshold, timeline for interim analysis are the key contradictions discussed in Relmada Therapeutics' latest 2025Q1 earnings call



Product Candidate Advancements:
- Relmada Therapeutics added two unique product candidates, NDV-01 for bladder cancer and sepranolone for Prader-Willi syndrome and Tourette syndrome, to its portfolio.
- The company reported promising initial proof-of-concept Phase 2 data for NDV-01 at the American Urology Association meeting, with an overall response rate of 85% at 3 months and 100% at 6 months for CIS patients.
- This growth was driven by the in-licensing of NDV-01 based on strong science and field data, and the potential for NDV-01 to become a class-leading bladder-sparing chemotherapy.

Financial Position and Cash Usage:
- Relmada ended Q1 2025 with a cash balance of approximately $27.1 million, down from $44.9 million at the end of Q4 2024.
- Cash used in operations was $18.1 million in Q1 2025, compared to $13 million in the same period in 2024.
- The decrease in cash balance was primarily due to expenses associated with the completion of clinical trials for REL-1017 and payments for the sepranolone acquisition and NDV-01 in-licensing.

Research and Development Expenses:
- Research and development expenses for Q1 2025 totaled $12 million, compared to $13.3 million in Q1 2024, a decrease of $1.3 million.
- The lower spend was primarily driven by lower study costs with the completion of clinical trials for REL-1017, offset by payments for the sepranolone acquisition and NDV-01 in-licensing.
- This trend reflects the company's focus on advancing NDV-01 and sepranolone through key development milestones while managing costs efficiently.