RELMADA THERAPEUTICS, INC.

Relmada Therapeutics, Inc. is a publicly traded, clinical-stage biotechnology company focused on developing new drug candidates. Following a strategic review in late 2024 and early 2025, the company shifted its development programs, terminating work on esmethadone (REL-1017) effective July 7, 2025, and REL-P11 effective May 12, 2025. Relmada now leverages its drug development expertise by acquiring new candidates. The company's lead product is NDV-01, a novel, controlled-release intravesical formulation of gemcitabine and docetaxel. NDV-01 is currently in a Phase 2 clinical trial in Israel, assessing its safety and efficacy in patients with aggressive forms of non muscle-invasive bladder cancer (NMIBC). Relmada plans to develop NDV-01 for two indications: the treatment of high-risk, 2nd line Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC, and the treatment of intermediate risk patients in the adjuvant setting. Phase 3 programs for each indication are expected to initiate mid-2026. Relmada's second product is sepranolone, a novel neurosteroid epimer of allopregnanolone. Sepranolone is being developed for potential applications in Prader-Willi syndrome (PWS), Tourette Syndrome (TS), essential tremor, and other diseases related to excessive GABAergic activity. The company expects to initiate a Phase 2b study in PWS mid-2026.