Relmada Therapeutics, Inc. Q4 FY2025 earnings call

1. NDVO1: Recently reported 12 - month follow - up data shows potential as best - in - class for non - muscle invasive bladder cancer (NMIBC). Planned to initiate Phase III rescue program in the middle of 2026. Phase III regulatory strategy has two pathways: one for adjuvant therapy in intermediate - risk bladder cancer (affecting about 75,000 patients in the US) and the other for second - line treatment of BCG unresponsive patients (about 5,000 patients in the US). 2. Cepranolone: Getting ready to begin a proof of concept study in Prader - Willi syndrome in the middle of 2026. 3. Team: Substantially strengthened the development team by appointing Dr. Raj Pruthi as chief medical officer oncology and established a scientific advisory board. 4. Financial strength: Completed a successful $160 million private financing, which, along with existing cash balance, provides capital through 2029 and for the planned NDVO1 program

1. Plan to initiate the Phase III rescue program for NDVO1 in bladder cancer and the Phase II proof of concept trial for Cepranolone in Prader - Willi syndrome in 2026. 2. Expect to report the initial three - month response data from the Phase III BCG unresponsive second - line study by the end of 2026

Q: Asked about whether additional data from the Phase II study will be presented, if there will be updates every three months, and if there will be data at AUA. Also asked about ensuring second - line patients are truly second - line and about three - month data in the Phase III.

A: Raj responded that they will present updated data at AUA, plan to share data every three months as the Phase III progresses, limit prior therapy lines to two for second - line patients, and plan to share three - month data from the Phase III BCG unresponsive second - line study by the end of 2026.

Q: Asked about enrollment cadence across the two studies and if the office profile can serve as a recruitment advantage.

A: Raj said NDVO1 has a competitive advantage in the second - line setting and expects rapid enrollment in the intermediate - risk study.

Q: Asked if the FDA has stipulated a minimum duration of follow - up required for submitting the NDA.

A: The FDA hasn't required a minimum of follow - up but wants the totality of the data.

Q: Asked about the CR rate at the three - month mark and benchmarking.

A: Raj discussed the target RFS in the intermediate - risk study and compared CR rates in the second - line setting to prior therapies.

Q: Asked about patient baseline characteristics and the CIS vs papillary split.

A: Sergio and Raj discussed data on CR rates in CIS and papillary patients and how it compares to competitors