RLMD — Relmada Therapeutics, Inc.

Summary of Relmada Therapeutics, Inc. Q4 2025 Earnings Call

1. Key Financial Results and Metrics:

• Cash Position: As of December 31, 2025, Relmada reported a cash balance of $93 million, up from $45 million at the end of 2024, bolstered by a $94 million stock offering in November 2025 and a subsequent $160 million private financing in March 2026.
• Expenses: Q4 2025 R&D expenses totaled $8.1 million, down from $11.0 million in Q4 2024, primarily due to the completion of two Phase III trials for REL-1017. General and administrative expenses rose to $12.3 million from $8.1 million in the prior year, mainly due to increased compensation costs.
• Net Loss: The net loss for Q4 2025 was $19.9 million, or $0.27 per share, compared to a net loss of $18.7 million, or $0.06 per share, in Q4 2024.

2. Strategic Updates and Business Highlights:

• NDV-01 Program: The company reported promising 12-month efficacy data from its Phase II study of NDV-01, a sustained-release formulation for treating non-muscle invasive bladder cancer (NMIBC). A complete response rate of 76% was noted, with 80% in BCG-unresponsive patients.
• Phase III RESCUE Program: FDA alignment has been achieved for a registrational Phase III program, set to initiate mid-2026, with two pathways targeting intermediate-risk and BCG-unresponsive patients.
• Cipranolone Development: The company plans to begin a proof-of-concept study for cipranolone in Prader-Willi syndrome in mid-2026.
• Team Expansion: Strengthened the development team with the appointment of Dr. Raj S. Pruthi as CMO, Oncology.

3. Forward Guidance and Outlook:

• Relmada expects 2026 to be a significant year, with the initiation of the Phase III RESCUE program and the cipranolone study. The company has sufficient capital to fund operations through 2029, including the completion of the NDV-01 program.

4. Bad News, Challenges, or Points of Concern:

• Competitive Landscape: The NMIBC treatment space is becoming increasingly crowded, raising concerns about enrollment rates and competitive pressures.
• Patient Population Concerns: There were questions regarding the classification of second-line patients, with some potentially being third-line, which could affect the study's outcomes and market positioning.
• Regulatory and Market Risks: The FDA has not set a minimum follow-up requirement for the Phase III trials, which could introduce variability in the data presented for approval.

5. Notable Q&A Insights:

• Data Presentation: Relmada plans to present updated 12-month data at the AUA conference and aims for quarterly updates as new data becomes available.
• Enrollment Cadence: The company believes the in-office administration profile of NDV-01 could provide a recruitment advantage despite the crowded market.
• Response Rate Expectations: The company targets a complete response rate exceeding historical benchmarks in both the intermediate-risk and BCG-unresponsive populations, with a focus on maintaining rigorous patient selection criteria.

Overall, Relmada Therapeutics has made significant strides in its clinical programs and financial positioning, although it faces challenges from competitive pressures and regulatory uncertainties as it moves forward with its development plans.