Relmada Therapeutics Reports 12-Month Phase 2 Interim Data for NDV-01 in Non-Muscle Invasive Bladder Cancer

About this update from Relmada Therapeutics, Inc.

Durable 76% complete response (CR) rate at 12 months with 95% CR rate at any time in high-risk NMIBC BCG-unresponsive patients achieved an 80% CR rate at 12 months and 94% CR rate at any time Tolerability profile remains favorable – no ≥ Grade 3 treatment-related adverse events and no treatment-related discontinuations Data reinforces advancement of NDV-01 into Phase 3 RESCUE registrational program in second line (2L) BCG-unresponsive and adjuvant intermediate-risk NMIBC in mid-2026 CORAL GABLES, Fla. , March 09, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today announced 12-month interim data from its ongoing Phase 2 trial evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC). The Phase 2 trial of NDV-01 demonstrated a 12-month complete response (CR) rate of 76% with a favorable safety profile . Notably, a 12-month CR rate of 80% was achieved in the BCG-unresponsive population , one of the most difficult-to-treat segments of NMIBC. Taken together, these findings support the potential best-in-class profile of NDV-01 and support advancement into the Phase 3 RESCUE registrational program evaluating NDV-01 in both 2L BCG-unresponsive and adjuvant intermediate-risk NMIBC. “These 12-month data show the potential durability of NDV-01’s clinical response profile while continuing to demonstrate a clean safety profile,” said Raj S. Pruthi , MD, Chief Medical Officer-Oncology of Relmada Therapeutics . “Importantly, we continue to observe strong responses in patients with BCG-unresponsive disease, with no progression to muscle-invasive disease and no patients requiring radical cystectomy. We believe these interim results provide meaningful clinical validation of the program and support advancing NDV-01 into the registrational Phase 3 RESCUE program with two separate registrational pathways: 2L BCG-unresponsive and adjuvant intermediate-risk, which we expect to initiate in mid-2026.” “I am highly encouraged by NDV-01’s high response rates, 12-month durability and favorable tolerability profile. Building on the clinical community’s familiarity with conventional Gem/Doce, these Phase 2 results provide robust validation of NDV-01’s novel sustained release formulation. In addition, NDV-01’s less than 5-minute administration simplifies dosing for clinical staff, supporting broad adoption in community urology practices where ~80% of NMIBC patients are treated – and potentially offering a significantly more streamlined user experience than currently approved therapies,” said Max Kates , MD, Director of Urologic Oncology at Johns Hopkins and Relmada Clinical Advisor. Highlights of the 12-month follow-up data from the Ongoing Phase 2 study of NDV-01: Clinical Results (Response Data) Complete Response Anytime 95% (36/38) 3 month 87% (33/38) 6 month 86% (25/29) 9 month 85% (22/26) 12 month 76% (19/25) 12-month KM analysis 83% N=48 patients dosed in overall population; KM: Kaplan-Meier analysis Efficacy in BCG-Unresponsive Subpopulation**: Clinical Results (Response Data) Complete Response Anytime 94% (16/17) 3 month 82% (14/17) 6 month 86% (12/14) 9 month 91% (10/11) 12 month 80% (8/10) 12-month KM analysis 84% N=20 patients dosed in BCG-UR subpopulation; ** BCG-UR defined by FDA definition; BCG-UR: Bacillus Calmette-Guérin (BCG) – Unresponsive; KM: Kaplan-Meier analysis No patient had progression to muscle-invasive disease No patient underwent a radical cystectomy No patients had a ≥ Grade 3 treatment related adverse event (TRAE) No patients discontinued treatment due to AEs Of the 48 patients who received ≥ 1 dose, 30 (63%) experienced a treatment-related adverse event (AE). Among treatment-related AEs, 54% were transient uncomfortable urination (dysuria,

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