RELMADA THERAPEUTICS, INC. 8-K

What Happened
Relmada Therapeutics, Inc. (RLMD) announced on March 9, 2026 that it signed a Securities Purchase Agreement for a private placement expected to close March 11, 2026 to raise approximately $160.0 million. The deal will sell 29,474,569 shares of common stock at $4.75 per share and pre‑funded warrants to purchase up to 4,210,527 shares at $4.749 each (exercise price $0.001). The company also disclosed 12‑month interim Phase 2 results for NDV‑01 in high‑risk non‑muscle invasive bladder cancer (NMIBC), showing a 12‑month complete response (CR) rate of 76% in the overall cohort and 80% in the BCG‑unresponsive subgroup, with a favorable safety profile. Relmada intends to use proceeds for working capital and to advance R&D, and plans to move NDV‑01 into a Phase 3 RESCUE registrational program.

Key Details

• Private placement: ~ $160.0 million aggregate; 29,474,569 shares at $4.75 and pre‑funded warrants for 4,210,527 shares at $4.749. Closing expected March 11, 2026.
• Pre‑Funded Warrants: immediately exercisable, $0.001 exercise price, beneficial‑ownership cap of 9.99% (or 4.99% if elected); ownership cap adjustable with 61 days’ notice.
• Registration rights: Company must file resale registration by the later of 45 days after closing or one business day after filing its 2025 Form 10‑K; liquidated damages of 1.0% of each purchaser’s purchase amount per 30 days for certain registration delays.
• NDV‑01 Phase 2 12‑month efficacy/safety highlights: overall 12‑month CR 76% (19/25; KM 83%); BCG‑unresponsive 12‑month CR 80% (8/10; KM 84%); no progression to muscle‑invasive disease, no radical cystectomies, no ≥Grade 3 treatment‑related adverse events; 63% had treatment‑related AEs, mainly transient Grade 1 dysuria (54%).
• Planned milestones: U.S. IND clearance and Phase 3 RESCUE initiation targeted mid‑2026; initial 3‑month Phase 3 2L results expected by year‑end 2026. Placement agents: Jefferies, Leerink Partners, Piper Sandler, Mizuho.

Why It Matters
The private placement, if completed, would materially strengthen Relmada’s cash position and fund near‑term operations and NDV‑01 development, including planned Phase 3 registrational trials. The 12‑month Phase 2 data indicate durable responses and a favorable safety profile in a difficult‑to‑treat NMIBC population, supporting the company’s planned RESCUE registrational pathways. Investors should note the filing includes forward‑looking statements and that completion of the financing and regulatory/timelines remain subject to customary conditions and risks disclosed in the company’s SEC filings.