Relmada Therapeutics Q1 Earnings Call Highlights

Key Points

• Relmada said it is still on track to start its Phase 3 RESCUE registrational program for NDV-01 in mid-2026, after sharing 12-month Phase 2 data in non-muscle invasive bladder cancer and aligning with the FDA on the trial plan.
• The Phase 2 results for NDV-01 were strong, with a 95% complete response rate at any time in high-risk NMIBC, no progression to muscle-invasive disease, no radical cystectomies, and no grade 3 or higher treatment-related adverse events.
• Relmada strengthened its financial position with a $160 million private placement, ending the quarter with $234 million in cash and saying its resources should fund operations through 2029, including completion of the RESCUE program.

Relmada Therapeutics NASDAQ: RLMD said it remains on track to begin its Phase 3 RESCUE registrational program for NDV-01 in mid-2026 after reporting 12-month Phase 2 data in non-muscle invasive bladder cancer and strengthening its balance sheet through a private financing.

On the company’s first-quarter earnings call, Chief Executive Officer Dr. Sergio Traversa said the company has made “excellent progress” this year, citing 12-month efficacy data for NDV-01, alignment with the U.S. Food and Drug Administration on the planned registrational program, a new provisional patent filing and completion of a $160 million private placement financing.

NDV-01 is a ready-to-use, sustained-release intravesical formulation of gemcitabine and docetaxel, commonly referred to as Gem/Doce. Traversa said the product is designed to build on the established safety and efficacy profile of conventional Gem/Doce while offering a treatment that can fit into real-world urology practice.

NDV-01 Phase 2 Data Support Phase 3 Plans

Dr. Raj Pruthi, Relmada’s chief medical officer for urology, said NDV-01 demonstrated high response rates and durable efficacy in an ongoing open-label, single-arm Phase 2 study of patients with high-risk non-muscle invasive bladder cancer, or NMIBC.

The study was designed to enroll up to 70 patients. Participants receive six biweekly doses, followed by monthly maintenance for up to one year. The primary endpoints are safety and complete response rate at 12 months.

Pruthi said the 12-month data showed:

• A 95% complete response rate at any time and a 76% complete response rate at 12 months in high-risk NMIBC patients.
• A 94% complete response rate at any time and an 80% complete response rate at 12 months in the BCG-unresponsive subpopulation.
• No progression to muscle-invasive disease.
• No radical cystectomies.
• No grade 3 or higher treatment-related adverse events.
• No dose interruptions or discontinuations due to adverse events.

Pruthi said most treatment-related adverse events were grade 1. He added that the data “compare favorably to other programs in this space” and support NDV-01’s potential as a best-in-class therapy if approved.

Relmada plans to present the 12-month data and details of the Phase 3 RESCUE program at the American Urological Association annual meeting.

RESCUE Program Includes Two Registration Pathways

Pruthi said Relmada expects to file the U.S. investigational new drug application and initiate the RESCUE program across an estimated 80 sites in North America in mid-2026. The program includes two separate approval pathways.

The first pathway focuses on second-line BCG-unresponsive patients with carcinoma in situ who are refractory to first-line therapies that are approved or in development. Pruthi estimated that approximately 5,000 patients per year in the U.S. fall into this setting. The single-arm study will use complete response rate at any time as the primary endpoint, with secondary endpoints including duration of response, progression-free survival and recurrence-free survival.

Pruthi said Relmada expects to report the first three-month response data around year-end. During the question-and-answer session, he said the company hopes to have “a handful of patients” with three-month response and safety data by the end of the calendar year or early next year, with updates anticipated every three months into 2027.

The second pathway will evaluate NDV-01 as an adjuvant therapy after transurethral resection of bladder tumor, or TURBT, in intermediate-risk NMIBC. Pruthi estimated that about 75,000 U.S. patients per year fall into this group. The trial is designed as an open-label, randomized controlled study comparing NDV-01 with observation. The primary endpoint is disease-free survival, with secondary endpoints including high-grade recurrence-free survival, progression-free survival and quality-of-life measures.

Company Highlights Ease of Use and Patent Filing

Relmada executives emphasized NDV-01’s practical advantages for urology practices. Pruthi said NDV-01 forms a soft matrix in the bladder to enhance local urothelial exposure while minimizing systemic toxicity. He said it can be administered in a physician’s office by a nurse or licensed practical nurse in under five minutes and does not require a specialized pharmacy or hub.

Traversa also highlighted an April provisional patent application in the U.S. covering formulations and methods of treatment for NDV-01. He said that, if granted, the patent could serve as the basis for worldwide filings and extend coverage for NDV-01 into 2047, which he said would provide a nine-year extension of commercial exclusivity. In response to an analyst question, Traversa said he would not expect a response from the patent office for at least 12 months.

Sepranolone Study Planned for Mid-2026

Chief Financial Officer Maged Shenouda provided an update on sepranolone, which he described as a novel neurosteroid intended to modulate the GABA neurotransmitter pathway and normalize GABA-A receptor activity. Relmada is developing sepranolone for compulsivity disorders, including obsessive-compulsive disorder, Tourette syndrome and Prader-Willi syndrome.

Shenouda said the company plans to initiate a proof-of-concept study in Prader-Willi syndrome in mid-2026. Preparations include engaging with the FDA on the proposed trial design and establishing a supply chain.

First-Quarter Financial Results

Relmada ended the first quarter with $234 million in cash, compared with $94 million at Dec. 31, 2025. Shenouda said the balance included approximately $150 million in net proceeds from the private financing announced March 9. The company expects its current cash resources to fund operations through 2029, including completion of the Phase 3 RESCUE program for NDV-01.

Research and development expense was $8.1 million for the quarter ended March 31, 2026, down from $12 million in the same period of 2025. Shenouda said the decrease was primarily due to nonrecurring costs in 2025 tied to the acquisition of sepranolone and the NDV-01 license agreement, partially offset by increased costs related to startup of the NDV-01 Phase 3 trials, the sepranolone study and additional R&D personnel.

General and administrative expense rose to $11.4 million from $6.3 million a year earlier, driven primarily by increased compensation costs, partly offset by lower stock-based compensation. Net cash used in operating activities was $15.1 million, compared with $18.1 million in the prior-year period.

Relmada reported a first-quarter net loss of $19.1 million, or $0.22 per basic and diluted share, compared with a net loss of $17.6 million, or $0.58 per basic and diluted share, in the year-earlier quarter.

In closing remarks, Traversa said the company is focused on execution as it prepares to initiate the RESCUE program and expects to provide additional updates in coming quarters.

About Relmada Therapeutics NASDAQ: RLMD

Relmada Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on the development of novel therapies for pain and other central nervous system (CNS) disorders. The company applies a proprietary stereochemical approach to optimized drug candidates, aiming to improve safety, tolerability and efficacy profiles compared with existing treatments. Relmada's research efforts center on modulation of NMDA receptors to address unmet needs in depression, neuropathic pain and related indications.

Relmada's lead product candidate, REL-1017 (d-methadone), is being evaluated as a potential rapid-acting and maintenance treatment for major depressive disorder, with clinical studies underway to assess its utility in both acute and long-term settings.

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