Relmada reported a net loss of $19.9 million, or $0.27 per share, for the fourth quarter ended December 31, 2025, compared with a net loss of $18.7 million, or $0.62 per share, in Q4 2024. Increased investment in late-stage clinical trials and R&D drove the wider loss.

To bolster its clinical pipeline, Relmada plans to initiate a Phase III rescue program for NDV-01 in BCG-unresponsive second-line bladder cancer and launch a Phase II proof-of-concept study of sepranolone for Prader-Willi syndrome. The bladder cancer program will present updated 12-month efficacy data at the AUA meeting with quarterly data releases thereafter.

The company appointed Dr. Raj Pruthi as Chief Medical Officer, Oncology, to oversee late-stage development and regulatory strategy, and established a scientific advisory board comprising experts in oncology and rare diseases. These moves aim to accelerate trial execution and strengthen clinical oversight.

Management confirmed that second-line trial enrollment is limited to patients with no more than two prior therapies, with a 15-patient compliance review at three months. Enrollment is expected to be rapid given no approved treatments in this setting, and the FDA will focus on overall response durability and a 2-year recurrence-free survival target of 75% for intermediate-risk patients.