Relmada Therapeutics, Inc. Q3 FY2025 earnings call

• Sergio Traversa highlighted 2025 as a standout year with progress in product development, successful capital raise, and key messages including NDV-01 phase two data, FDA alignment for NDV-01 phase three, and being well capitalized. • Raj S. Pruthi provided an update on NDV-01, including nine-month follow-up data from the phase two study showing positive results and FDA meeting highlights. • Maged S. Shenouda discussed financial results, noting cash, cash equivalents, and short-term investments, R&D and G&A expense changes, and net loss figures.

Relmada has two key product segments. The NDV-01 program is in development for non-muscle invasive bladder cancer (NMIBC). The phase two study of NDV-01 in NMIBC showed a 92% overall response rate at any time with favorable safety. The Sepranolone program is intended for Prader-Willi syndrome, with plans to initiate a phase two study in 2026.

• Plan to initiate phase three studies for NDV-01 in NMIBC and phase two study for Sepranolone in PWS in 2026. • Anticipate top-line data for NDV-01 phase three in Q2 2028 for the unresponsive patient population and intermediate risk study with timelines depending on FDA interaction. • Current cash balance sufficient to support planned expenses into 2028.

Q: Help understand market opportunity, sequence of studies, and timelines for NDV-01 indications.

A: Raj S. Pruthi explained the sizes of the populations (BGC unresponsive ~8,000 patients/year, intermediate risk ~80,000 patients/year), plans to initiate both trials in 2026, with NDV-01 unresponsive patient trial top-line data expected in Q2 2028 and intermediate risk study with timelines depending on FDA.

Q: View on potential pricing of NDV-01 compared to existing products.

A: Sergio Traversa stated it's early to talk about pricing but mentioned considering value added for patients and existing products' pricing.

Q: Differentiation from conventional Gemdosi and impact on market.

A: Raj S. Pruthi explained that conventional Gemdosi requires specialized pharmacy and long procedural time, while NDV-01's formulation allows easier administration, opening up the market to community urologists.

Q: Impact of BRIDGE study success on NDV-01's potential off-label use.

A: Raj S. Pruthi noted the BRIDGE study's relevance to Gemdosi's noninferiority to BCG, suggesting it could significantly open the market for off-label use of NDV-01.