Relmada Therapeutics, Inc. (RLMD) reported fourth-quarter and full-year 2025 results and highlighted a year of major clinical and corporate progress, led by strong 12-month data for its bladder-cancer candidate NDV-01 and a $160 million PIPE financing that extends its cash runway through 2029.
The clinical-stage biotech, which is developing therapies for oncology and central nervous system disorders, said the past year marked a "transformational" period as NDV-01 advanced toward late-stage development.
NDV-01 Delivers Durable 12-Months Responses in Bladder Cancer
Relmada's lead program, NDV-01 is a sustained-release intravesical formulation of Gemcitabine and Docetaxel designed for non-muscle invasive bladder cancer (NMIBC). Updated 12-month Phase 2 data showed 95% complete response (CR) rate at any time and a durable 76% CR rate at 12 months, 80% CR rate at 12 months in BCG-unresponsive patients, no progression to muscle-invasive disease, and no = Grade 3 treatment-related adverse events and discontinuations.
The company emphasized that NDV-01's ease of administration - a <5-minute in-office procedure using two prefilled syringes-could support broad adoption in community urology practices, where most NMIBC patients are treated.
Two Registrational Pathways Cleared With FDARelmada confirmed written alignment with the FDA on two Phase 3 registrational pathways for NDV-01:
1.Intermedaite-risk NMIBC- randomized trial of TURBT + NDV-01 vs TURBT alone, with disease-free survival as the primary endpoint.
2.Second-line BCG-unresponsive NMIBC with CIS-single-arm study measuring complete response rate.
Both Phase 3 RESCUE studies are expected to begin in mid-2026, with initial 3-month data from the 2L cohort anticipated by year-end 2026.
Pipeline Update
Beyond NDV-01, Relmada is advancing Sepranolone, a GABA-modulating therapy targeting compulsivity-related disorders. According to the IR deck:
-A Phase 2b trial in Prader-Willi syndrome is planned for mid-2026,
-Additional indications such as Tourette syndrome, OCD, and essential tremor are under evaluation, supported by prior proof-of-concept data.
Financial Results
For the fourth quarter of 2025 Relmada reported a net loss of $19.9 million, or $0.27 per share, compared to $18.6 million, or $0.62 per share during the prior-year quarter.
Net cash used in operating activities for the fourth quarter totaled $14.6 million compared to $8.8 million a year earlier.
For the full-year2025 the company reported a net loss of $57.4 million, or $1.45 per share, compared to $80.0 million, or $2.65 per share in 2024.
Net cash used in operating activities for the full year totaled $45.8 million compared to $51.8 million in the prior year.
Relmada ended 2025 with $93.0 million in cash, cash equivalents, and short-term investments. Combined with $160 million PIPE financing completed in March 2026, the company expects to be funded through 2029, including completion of the NDV-01 Phase 3 program.
RLMD has traded between $0.24 and $7.51 over the past year. The stock closed Thursday's trading at $6.25, up 0.64%.
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