Relmada Therapeutics, Inc. Q2 FY2025 earnings call

• Added two product candidates: NDV-01 for non-muscle invasive bladder cancer and sepranolone for compulsivity disorders. • Positive 6-month follow-up data for NDV-01 showed 91% of patients achieving high-grade disease-free status. • Expanded team with Raj Pruthi as Chief Medical Officer, Oncology and Yair Lotan as Chair of Clinical Advisory Board. • Progress towards Phase III study for NDV-01 in first half of 2026 and Phase II study for sepranolone in Prader-Willi syndrome in 2026. • Raj Pruthi discussed NDV-01's Phase II data, including 91% complete response rate at any time point. • Maged Shenouda provided update on sepranolone and reviewed Q2 financial results, noting cash balance and R&D/GA expenses.

No specific segment performance data provided with absolute revenue and contribution % for product segments.

• Preparing to begin Phase III study for NDV-01 in the first half of 2026. • Intend to initiate Phase II study for sepranolone in Prader-Willi syndrome in 2026. • Prioritizing advancement of NDV-01 and having a line of sight to cash requirements and runway as clinical and regulatory strategies progress.

Q: Congrats on the 6 months data. How do the data and recent UroGen approval factor into NDV-01's go-forward? Also, what to accomplish with FDA?

A: Raj Pruthi stated UroGen's approval sets precedent for single-arm open-label studies. NDV-01 has opportunities in high-risk and low-grade intermediate risk. Conversation with FDA will focus on single-arm, open-label study path for chemoablation.

Q: How to think about R&D going forward as R&D expense dropped?

A: Sergio Traversa said R&D expense dropped because not enrolling patients now, but will increase when enrolling starts; have sufficient resources to handle needed activities now.