Relmada Therapeutics Reports Promising Phase 2 Study Results, Announces Pipeline Expansion

Relmada Therapeutics reported promising 6-month follow-up data from its Phase 2 study of NDV-01 in non-muscle invasive bladder cancer, showing a 91% overall response rate. The company is preparing for a Phase 3 trial of NDV-01 and a Phase 2 study for sepranolone in Prader-Willi syndrome. Relmada Therapeutics' overall score reflects its high-risk, high-reward profile, weakened by zero revenue and significant cash burn, but tempered by strong cash reserves and strategic pipeline developments.

Relmada Therapeutics, Inc. (Nasdaq: RLMD) recently reported encouraging 6-month follow-up data from its Phase 2 study of NDV-01 in non-muscle invasive bladder cancer (NMIBC). The study demonstrated a 91% overall response rate, including a complete response (CR) in one patient. No patient progressed to muscle invasive disease, underwent a radical cystectomy, or experienced a Grade 3 treatment-related adverse event (TRAE). Additionally, no patient discontinued treatment due to adverse events (AEs) [1].

The Phase 2 study of NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel (Gem/Doce), is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with high-grade/intermediate-grade NMIBC. The study's primary efficacy endpoints are safety and complete response rate (CRR) at 12 months, with secondary endpoints including duration of response (DOR) and event-free survival (EFS).

Relmada is preparing to initiate a Phase 3 registration trial for NDV-01 in the first half of 2026. The company is also planning to start a Phase 2 study for sepranolone, a first-in-class GABAA Modulating Steroid Antagonist (GAMSA), in patients with Prader-Willi syndrome in the first half of 2026. Sepranolone targets disorders linked to excess GABAergic activity, including Prader-Willi syndrome, Tourette syndrome, and Obsessive-Compulsive Disorder (OCD) [1].

Relmada's financial results for the second quarter ended June 30, 2025, showed a net loss of $27.4 million or $0.86 per share. Research and development (R&D) expenses totaled $14.7 million, while general and administrative (G&A) expenses were $13.7 million. The company had $20.6 million in cash, equivalents, and short-term investments as of June 30, 2025 [1].

Relmada's high-risk, high-reward profile is evident in its pipeline, which includes NDV-01 and sepranolone. However, the company's significant cash burn and zero revenue pose challenges. Relmada's strong cash reserves and strategic pipeline developments, including the promising results for NDV-01, provide a glimmer of hope for investors.

Relmada will host a conference call today, August 7, 2025, at 4:30 PM ET to discuss its Q2 2025 results and pipeline progress. Dial-in numbers and webcast access information are available on the company's investor relations website [1].

References:
[1] https://finance.yahoo.com/news/relmada-therapeutics-reports-second-quarter-200500567.html