RLMD — Relmada Therapeutics, Inc.

Summary of Relmada Therapeutics, Inc. Q3 2025 Earnings Call

1. Key Financial Results and Metrics:

• Cash Position: As of September 30, 2025, Relmada had cash, cash equivalents, and short-term investments of approximately $13.9 million, down from $44.9 million at the end of 2024. This figure does not include the recent $94 million from a $100 million underwritten offering completed on November 5, 2025.
• Operational Cash Burn: Cash used in operations for Q3 2025 was $6.7 million, significantly lower than $16.7 million in Q3 2024.
• Expenses:
  • Research and Development (R&D) expenses were $4 million for Q3 2025, down from $11.1 million in the same quarter of 2024.
  • General and Administrative (G&A) expenses totaled $6.3 million, compared to $11.9 million in Q3 2024.
• Net Loss: The net loss for Q3 2025 was $10.1 million, or $0.30 per share, compared to a net loss of $21.7 million, or $0.72 per share, in Q3 2024.

2. Strategic Updates and Business Highlights:

• Product Development:
  • NDV-01: A sustained release formulation for non-muscle invasive bladder cancer (NMIBC) showed a 92% overall response rate in a Phase 2 study, with a favorable safety profile. The FDA has aligned on key elements for a Phase 3 program, which is set to begin in 2026.
  • Sepranolone: Targeting Prader-Willi syndrome, with plans to initiate a Phase 2 study in 2026.
• Leadership and Advisory Board: The appointment of Dr. Raj S. Pruthi as Chief Medical Officer and the establishment of a clinical advisory board to guide the NDV-01 program were highlighted as significant enhancements to the team.

3. Forward Guidance and Outlook:

• Clinical Trials: Both the Phase 3 trials for NDV-01 and the Phase 2 study for Sepranolone are expected to start in 2026. The company anticipates the first patient in for the NDV-01 study in Q2 2026, with top-line data expected in Q2 2028.
• Financial Outlook: The company believes its cash position, bolstered by the recent capital raise, will support operations through 2028.

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

• Cash Decrease: The significant reduction in cash reserves from the previous year raises concerns about operational sustainability without the recent capital raise.
• Market Competition: The potential for competitive pressures from existing treatments for NMIBC, particularly from established therapies like BCG and other novel therapies, could impact market penetration and pricing strategies.
• Regulatory Risks: While the FDA alignment is positive, any changes in regulatory requirements or delays in trial initiation could pose risks to the projected timelines.

5. Notable Q&A Insights:

• Market Opportunity: The potential market for NDV-01 in high-risk NMIBC is estimated at 8,000 patients annually, with a larger population of approximately 40,000 in the intermediate-risk category. Both trials are expected to start concurrently in 2026.
• Pricing Strategy: Discussions around pricing indicated that while it is early to set a price, the company will observe competitor pricing and base its strategy on the perceived value of its therapies.
• Differentiation from Existing Treatments: NDV-01's formulation aims to simplify administration compared to current Gemdosi treatments, which require specialized pharmacy handling, thus potentially expanding its market reach to community urologists.

This earnings call reflects Relmada's strategic positioning and optimistic outlook for its clinical programs, while also acknowledging the challenges and competitive landscape it faces.