Relmada reports NDV-01 92% CR rate; FDA alignment for Phase 3; closes $100M financing

RELMADA THERAPEUTICS, INC.

NDV-01 9-month data: 92% complete response (CR) at any time in NMIBC; 91% in BCG-unresponsive subgroup; no Grade 3 TRAEs.
FDA aligned on two Phase 3 registrational paths for NDV-01 in high-risk BCG-unresponsive and intermediate-risk NMIBC; trials start H1 2026.
Closed $100M underwritten offering of stock and pre-funded warrants on Nov 5; net ~$94M; cash runway extended into 2028.
Q3 2025 net loss $10.1M ($0.30 per share) vs $21.7M ($0.72) in Q3 2024; R&D expense fell to $4.0M from $11.1M.
Appointed Dr. Max Kates to Clinical Advisory Board; Sepranolone Phase 2 in Prader-Willi syndrome expected H1 2026.

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