Relmada Therapeutics (RLMD) investor relations material

Investment highlights and pipeline

• NDV-01, a sustained-release gemcitabine/docetaxel therapy, leads a pipeline targeting non-muscle invasive bladder cancer (NMIBC) with a well-defined regulatory path and strong clinical rationale.

• NDV-01 offers improved administration, extended tumor exposure, and is positioned as a next-generation standard of care for NMIBC.

• The pipeline includes late-stage programs for high-risk and intermediate-risk NMIBC, with multiple Phase 3 trials planned for mid-2026.

• Sepranolone, a novel candidate for compulsivity disorders, is advancing to Phase 2 for Prader-Willi syndrome in mid-2026.

• Leadership team has deep expertise in urology and clinical development.

Market opportunity and disease landscape

• NMIBC represents 80% of new bladder cancer cases, with high recurrence rates and a $6.5B annual US treatment cost.

• Recurrence and progression risks are significant, especially for intermediate- and high-risk patients.

• Current treatments involve invasive procedures, high complication rates, and substantial patient burden.

• Gemcitabine/docetaxel is the most preferred therapy among urologists for BCG-unresponsive NMIBC.

NDV-01 product profile and clinical data

• NDV-01 enables rapid, office-based administration and sustained drug release for up to 10 days, improving convenience and tumor exposure.

• In vitro studies show stable, optimized drug levels, supporting biweekly dosing and reduced systemic side effects.

• Phase 2a data in high-risk NMIBC show 95% anytime complete response (CR) rate, with 76% CR at 12 months and no progression to muscle-invasive disease.

• No grade 3 or higher treatment-related adverse events; most common side effects were mild and transient.