RELMADA THERAPEUTICS, INC.
For the period ended Nov 13, 2025. Filed Nov 13, 2025.
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Nov 13, 2025 · Filed Nov 13, 2025
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Contents
EX-99.1 · NDV-01 Program Update:
NDV-01 Program Update:
| · | As previously announced, FDA Type B pre-IND meeting secured FDA alignment on key elements of planned Phase 3 registrational program (specific study design details to be further discussed with the agency): |
o In high-risk, 2 nd line BCG-unresponsive setting, FDA stated that a single arm trial might be acceptable in a more refractory patient population.
o In the intermediate-risk NMIBC setting, FDA agreed that a proposal to randomize patients post-TURBT (transurethral resection of bladder tumor) to adjuvant NDV-01 vs observation, evaluating a time-to-event endpoint, is generally acceptable.
o Further non-clinical studies are not required. FDA indicated that no further non-clinical studies are required to support a 505(b)(2) New Drug Application (NDA).
| · | 9-month follow-up for NDV-01 showed a 92% complete response rate (CRR) at any time, with favorable overall safety |
| Clinical Results (Response Data) | |
|---|---|
| Complete Response | % (n/N) |
| Anytime | 92% (23/25) |
| 3 months | 84% (21/25) |
| 6 months | 87% (20/23)* |
| 9 months | 85% (17/20)* |
| * Includes patients with CR after re-induction. 60% CR rate after re-induction | |
o Two subjects have reached 12-month assessment, and both have a CR
o No patient had progression to muscle-invasive disease
o No patient underwent a radical cystectomy
o No new safety signals in terms of type, number, or degree of AEs -- with no patients having a ≥ Grade 3 TRAE and no patients discontinued treatment due to AEs
o Of 36 enrolled patients receiving ≥ 1 dose, 22 (61%) experienced a treatment-related adverse event (AE). Among treatment-related AEs, 62% were transient (< 24 hours) grade 1 uncomfortable urination (dysuria), 9% were asymptomatic positive urine culture and 7% were hematuria.
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