Relmada Therapeutics (4E2) Q2 2026 Earnings Report

Overall the call conveyed a constructive and execution-focused tone: Relmada reported a materially strengthened balance sheet (cash +134% YoY) with a cash runway into 2029, compelling 12-month Phase II efficacy and favorable safety for NDV-01, clear FDA-aligned registration pathways, an experienced new CBO, and engaged clinical sites. Key near-term risks center on manufacturing/CMC execution (GMP batch production and stability data), which shifted IND timing toward year-end 2026 and has increased R&D spend and operating cash use. On balance the company appears well-capitalized and positioned to advance registrational programs, but outcomes hinge on resolving manufacturing scale-up and timing.

Relmada reiterated guidance to file INDs for NDV‑01 and sepranolone by year‑end 2026 and to initiate the Phase III RESCUE program for NDV‑01 and a Phase II proof‑of‑concept study for sepranolone upon IND clearance; NDV‑01’s 12‑month Phase II results showed 95% of patients achieved a complete response at any time and 76% had a durable complete response at 12 months, the formulation and process are locked, analytics are complete, and GMP batch production plus stability data (manufacturing partner Piramal) are the remaining CMC gating items; the program has FDA alignment on two registration pathways, ~80 sites engaged (≈60 primary, 20 backup) and can begin dosing after IND clearance (30 days post‑filing), with an office‑based procedure of ~5 minutes; financial guidance and metrics included $217.7M cash, cash equivalents and short‑term investments (vs $93.0M at 12/31/2025) expected to fund operations through 2029 including Phase III, Q2 R&D expense $8.4M (vs $2.8M), G&A $6.6M (vs $7.4M), net cash used in operating activities $9.6M (vs $6.4M), and a Q2 net loss of $12.9M or $0.11 per share (vs $9.9M or $0.30), while market size references included >744,000 U.S. NMIBC patients and 350,000–400,000 people worldwide with PWS; the primary endpoint is response at any time (one re‑induction allowed).