Relmada Therapeutics (RLMD) Company presentation summary

Investment highlights and pipeline

• NDV-01, a late-stage sustained-release Gem/Doce therapy, targets non-muscle invasive bladder cancer (NMIBC) with a well-defined regulatory path and strong commercial potential.

• NDV-01 offers improved administration, extended tumor exposure, and leverages physician familiarity, aiming to become a next-generation standard of care.

• The pipeline includes NDV-01 for various NMIBC risk groups and Sepranolone for Prader-Willi Syndrome, with multiple Phase 3 and Phase 2 studies planned for mid-2026.

• Leadership team has deep experience in urology and NMIBC clinical trials.

Market opportunity and disease landscape

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

• Recurrence rates for high-risk NMIBC are 30–61% within one year, and 50–80% over five years.

• TURBT procedures are frequent, costly ($7,000–$10,000 each), and carry significant complication rates (>15%).

• Current treatment landscape includes surgery, intravesical chemotherapy, immunotherapy, and gene therapy, with Gem/Doce being the most preferred post-BCG therapy.

NDV-01 product profile and clinical data

• NDV-01 is a ready-to-use, sustained-release intravesical Gem/Doce formulation, enabling office-based administration in under 5 minutes.

• Provides prolonged tumor exposure (up to 10 days) and is suitable for community urology practices.

• In vitro data show stable, continuous drug release, minimizing systemic side effects and supporting biweekly dosing.

• Biodegradable polymer ensures safe excretion, unlike some competitors requiring device extraction.