What Relmada Therapeutics (RLMD) Said on Its Q3 Earnings Call

Key Points

• Relmada expects to file an IND for bladder cancer candidate NDV-01 by year-end 2026 and, if cleared, begin its Phase III SPECTRUM program with the first patient potentially enrolling in Q1 2027.
• In Phase II, NDV-01 showed a 77% complete-response rate at 12 months among high-risk patients; 12 of 14 evaluable patients remained in complete response at 18 months. The company reported no treatment-related Grade 3-or-higher adverse events, serious adverse events, or discontinuations.
• Relmada reported $202.1 million in cash, cash equivalents, and short-term investments, which it expects to fund operations through 2029, including the Phase III studies. Q3 net loss widened to $13.9 million as R&D expenses increased.

Relmada Therapeutics NASDAQ: RLMD expects to submit applications for its bladder cancer treatment candidate NDV-01 and Prader-Willi syndrome program sepranolone by the end of 2026, executives said on the company’s third-quarter earnings call.

Chief Executive Officer Sergio Traversa said progress on manufacturing has kept the NDV-01 investigational new drug application, or IND, on track for a year-end filing. If regulators clear the application, Relmada plans to begin its Phase III program, now called SPECTRUM.

Traversa said the company could enroll the first patient in the first quarter of 2027 if the IND is cleared in a reasonable amount of time. He estimated that clearance could take 30 to 45 days, including the holidays.

Phase II Results and Study Plans

NDV-01 is a sustained-release intravesical formulation combining gemcitabine and docetaxel, designed for administration in a urology office. Relmada is studying it in non-muscle invasive bladder cancer, or NMIBC.

Chief Business Officer Bipin Dalmia said 23 high-risk patients who had a complete response at 12 months entered a long-term extension study. Of the 14 evaluable at 18 months, 12, or 86%, remained in complete response. In the subgroup whose disease was unresponsive to BCG treatment, seven of eight evaluable patients remained in complete response.

Two BCG-naive patients progressed to muscle-invasive disease at month 15, Dalmia said. Both had responded through 12 months, and he said there were no early warning signs. The patients did not fully comply with maintenance dosing between months 12 and 15, which he said could have been a factor, though the company does not know. No patients in the study had undergone a radical cystectomy to date, he said.

Updated 12-month results included 51 high-risk patients, with an anytime complete response rate of 94% and a 12-month rate of 77%. Among BCG-unresponsive patients, the respective rates were 96% and 73%.

Dalmia said there had been no treatment-related adverse events of Grade 3 or higher, treatment-related serious adverse events or treatment-related discontinuations in the Phase II study to date.

The SPECTRUM program has two independent registrational pathways that Dalmia described as aligned with the Food and Drug Administration. One is a single-arm study in second-line, high-risk BCG-unresponsive patients with carcinoma in situ, with or without papillary disease. It also includes an exploratory cohort for patients with papillary-only disease. The other is a randomized study comparing NDV-01 after transurethral resection of a bladder tumor with observation in low-grade, intermediate-risk NMIBC.

In response to an analyst’s question, Dalmia said Relmada had not yet analyzed efficacy for the subset of Phase II patients who had failed another treatment after BCG and matched the second-line SPECTRUM population.

Manufacturing and Financial Update

Traversa said Relmada was writing the NDV-01 application and awaiting stability data from manufacturing efforts with Piramal in the U.S. and Sinai in Israel. He said the available data from both efforts looked good, but the company had not decided how it would move forward.

The Phase II product was a prototype made in a hospital pharmacy, so Relmada had to develop a manufacturing process suitable for scaling up and an IND filing, Traversa said. He said the company had made batches under good manufacturing practice standards and that approximately nine weeks of stability data appeared to be within FDA requirements.

For sepranolone, Relmada is finalizing stability testing of a prefilled syringe and expects to begin a Phase II proof-of-concept study after IND clearance, Traversa said.

Chief Financial Officer Maged Shenouda said Relmada ended September with $202.1 million in cash equivalents and short-term investments, up from $93 million at the end of 2025. The company expects its cash to fund operations through 2029, including completion of the Phase III SPECTRUM studies.

Third-quarter research and development expenses rose to $9.2 million from $4 million a year earlier, primarily because of study preparation, manufacturing and storage costs. General and administrative expenses fell to $3.9 million from $6.3 million. Net loss widened to $13.9 million, or $0.12 per share, from $10.1 million, or $0.30 per share, a year earlier.

About Relmada Therapeutics (NASDAQ:RLMD)

Relmada Therapeutics, Inc. is a clinical-stage biotechnology company developing investigational treatments for central nervous system disorders, with a focus on depression. The company's work centers on advancing drug candidates through clinical research; it does not have an approved commercial product. Its best-known candidate, REL-1017 (esmethadone), is an oral compound that acts on NMDA receptors. Relmada has studied it as an add-on treatment for adults with major depressive disorder who have not responded adequately to existing antidepressants.

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