Relmada Therapeutics Secures $160M Financing to Advance Bladder Cancer Drug into Phase 3 — Relmada Therapeutics, Inc.

Event summary

Relmada Therapeutics reported 12-month Phase 2 data for NDV-01 in non-muscle invasive bladder cancer (NMIBC), showing a 95% complete response rate at any time and a 76% durable response rate at 12 months.
The company completed a $160 million PIPE financing in March 2026, strengthening its balance sheet to support NDV-01 Phase 3 development.
Relmada is on track to initiate the Phase 3 RESCUE registrational program for NDV-01 in mid-2026, with two FDA-aligned pathways.
As of December 31, 2025, Relmada had a cash balance of $93.0 million, expected to fund operations through 2029, including the completion of the NDV-01 RESCUE program.

The big picture

Relmada Therapeutics' successful $160 million PIPE financing and positive Phase 2 data for NDV-01 position the company to advance its lead oncology candidate into pivotal trials. The FDA's alignment on two registrational pathways reduces regulatory risk and accelerates the potential approval timeline for NDV-01, a differentiated therapy for non-muscle invasive bladder cancer. The company's strengthened balance sheet provides a solid foundation for executing its clinical development strategy.

What we're watching

Clinical Efficacy: Whether the durable 76% complete response rate at 12 months for NDV-01 can be replicated in the Phase 3 RESCUE program.
Regulatory Pathways: How the FDA's alignment on two registrational pathways for NDV-01 will impact the speed and success of the Phase 3 trials.
Financial Runway: The pace at which Relmada Therapeutics will deploy its $93.0 million cash balance and $160 million PIPE financing to support operations through 2029.