Relmada Therapeutics (RLMD) Study Result Presentation summary

Study design and patient population

• Evaluated NDV-01 in high-risk NMIBC patients, including BCG-naive, BCG-unresponsive, intolerant, and experienced individuals.

• Study included 48 patients, median age 75, with 88% male and a range of BCG exposure statuses.

• Induction involved 6 biweekly instillations, followed by monthly maintenance for up to 24 months.

Efficacy results

• Achieved 95% complete response (CR) at any time and 76% CR at 12 months in all patients.

• BCG-unresponsive subgroup showed 94% anytime CR and 80% CR at 12 months.

• No progression to muscle invasive disease or need for radical cystectomy observed.

• Durable response rates: 87% at 3 months, 86% at 6 months, 85% at 9 months, and 76% at 12 months.

Safety and tolerability

• No grade 3 or higher treatment-related adverse events (TRAEs) reported.

• 61% experienced a TRAE, most commonly transient dysuria (53%), asymptomatic positive urine culture (8%), and hematuria (8%).

• No discontinuations due to adverse events.