Relmada Therapeutics (RLMD) Investor presentation summary

Pipeline and clinical development

• Advancing two main assets: NDV-01 for non-muscle invasive bladder cancer (NMIBC) and sepranolone for compulsivity-related disorders, including Prader-Willi Syndrome (PWS).

• NDV-01 demonstrated positive Phase 2a data in NMIBC, with plans for Phase 3 registration studies in H1 2026.

• Sepranolone targets normalization of GABAA receptor activity, with Phase 2 studies in PWS expected to begin in H1 2026.

• Both programs are supported by positive proof-of-concept data and ongoing FDA engagement.

NDV-01 clinical results and competitive positioning

• NDV-01 offers sustained intravesical delivery of gemcitabine/docetaxel, ready-to-use in prefilled syringes, and is biodegradable.

• In the ongoing TRCG-011 study, NDV-01 achieved a 92% anytime complete response rate and 84% at 3 months in high-risk NMIBC patients.

• No progression to muscle-invasive disease or need for radical cystectomy observed in treated patients.

• NDV-01 compares favorably to other approved therapies, offering office-based administration and no need for device removal.

Market opportunity and disease burden

• NMIBC represents 80% of new bladder cancer cases, with high recurrence rates and significant treatment costs ($6.5B annually in the US).

• Recurrence and progression risks are substantial, with frequent invasive procedures and high patient burden.

• Gemcitabine/docetaxel is widely used and preferred by urologists for BCG-unresponsive NMIBC.