Strong 12-Month Phase 2 Efficacy for NDV-01
NDV-01 demonstrated a 95% complete response (CR) rate at any time and a durable 76% CR at 12 months in high-risk NMIBC patients; in the BCG-unresponsive subpopulation NDV-01 showed a 94% CR at any time and an 80% CR at 12 months. No patients progressed to muscle-invasive disease and no patients underwent radical cystectomy.
Favorable Safety Profile
In the 12-month dataset, there were no grade 3 or higher treatment-related adverse events, no dose interruptions or discontinuations due to adverse events, and most treatment-related adverse events were grade 1.
Regulatory Alignment and Clear Phase 3 Path
Relmada achieved FDA alignment for a Phase 3 'rescue' registrational program with two pathways (second-line BCG-unresponsive CIS single-arm study and an intermediate-risk post-TURBT randomized adjuvant trial). The company expects to file the U.S. IND and initiate the rescue program across ~80 North American sites in mid-2026 and to report initial 3-month response data around year-end.
Strong Balance Sheet and Financing
Completed a $160M private placement with net proceeds of approximately $150M; cash balance at 03/31/2026 was $234M versus $94M at 12/31/2025 — approximately a 149% increase — providing an expected runway through 2029 including completion of the Phase 3 rescue program.
Intellectual Property Advancement
Filed a U.S. provisional patent application for NDV-01 formulations and methods (April 2026); company indicated that issued patents claiming priority to this filing could extend coverage into 2047, potentially lengthening commercial exclusivity if granted.
Operational and Commercial Differentiation
NDV-01 is a ready-to-use sustained-release Gem + Docetaxel (Gemdosi) intravesical formulation designed to be delivered in-office by a nurse/LPN in under 5 minutes without specialized pharmacy/hood — positioning it as a time- and resource-sparing alternative to conventional Gemdosi.
Planned Expansion of Pipeline
Preparing to initiate a Cipranolone proof-of-concept study in Prader-Willi syndrome in mid-2026, with FDA engagement and supply chain preparations underway.
Improved Cash Flow Usage
Net cash used in operating activities decreased to $15.1M for Q1 2026 from $18.1M in Q1 2025 — an improvement of approximately 16.6%.