Relmada Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update (Form 8-K)

Relmada Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update

CORAL GABLES, FL - May 12, 2026 (Globe Newswire) - Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today reported financial results for the first quarter ended March 31, 2026 and provided a corporate update.

"We made significant progress in the first quarter, highlighted by the robust 12-month Phase 2 data for NDV-01 in NMIBC and the successful completion of a $160 million PIPE financing, which has well-capitalized our balance sheet to fund the NDV-01 RESCUE Phase 3 program through completion," said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics. "We remain on track to file the NDV-01 IND and initiate the Phase 3 RESCUE registrational program in mid-2026 - a milestone that would mark a major inflection point for Relmada and for the patients we aim to serve. We believe NDV-01 has the potential to be a best-in-class therapy for patients with NMIBC and remain focused on maximizing its potential for success. To this end, in April, we filed a provisional patent application in the U.S. directed to formulations and methods of treatment for NDV-01. This application, if issued, could form the basis for worldwide patent filings, and have a term into 2047."

"The AUA2026 Annual Meeting provides an important opportunity to introduce NDV-01 to the broader urologic community," said Raj S. Pruthi, MD, Chief Medical Officer - Urology of Relmada Therapeutics. "Our presentations will highlight the 12-month Phase 2 data generated to date for NDV-01, including observed complete responses and safety findings. We will also be sharing the design and rationale for the Phase 3 RESCUE program. NDV-01 is a sustained-release gemcitabine and docetaxel (Gem/Doce) designed to support streamlined, in-office administration in less than five minutes. We believe AUA2026 provides an important national forum to increase awareness and engagement within the investigator community as we approach the initiation of the RESCUE program in mid-2026."

Upcoming AUA2026 Presentations and NDV-01 Phase 2 Data Highlights:

Relmada will present two abstracts at AUA2026 including: (1) NDV-01 Phase 2 data (12-month follow-up), and (2) the Phase 3 RESCUE program design (Clinical Trials in Progress session). The presentations are intended to raise awareness of NDV-01 and build investigator interest in the RESCUE registrational program. Key data to be highlighted include:

NDV-01 Intellectual Property:

In April 2026, Relmada filed a provisional patent application with the United States Patent and Trademark Office (USPTO) directed to pharmaceutical formulations and methods of treatment related to NDV-01. The provisional filing has the potential to form the basis for a comprehensive world-wide patent filing program for NDV-01. If issued, patents claiming priority to the provisional filing will be expected to have a term until April 2047.

Expected Upcoming Relmada Milestones:

Financial Results

First Quarter 2026 Financial Results

Conference Call and Webcast Information:

Relmada will host a conference call and webcast today at 4:30 PM ET to discuss recent business progress and financial results.

Conference Call and Webcast Information:

A replay of the webcast will be available in the Investors section of the Relmada website at https://www.relmada.com/investors/ir-calendar.

About NDV-01

NDV-01 is a ready-to-use, sustained-release intravesical formulation of gemcitabine and docetaxel (Gem/Doce) being developed for the treatment of non-muscle invasive bladder cancer (NMIBC). The formulation is engineered to provide prolonged bladder retention and controlled drug release over approximately 10 days. By forming a soft intravesical matrix, NDV-01 is designed to increase local drug exposure while limiting systemic toxicity. The treatment can be administered conveniently in an office setting in under 5 minutes without the need for anesthesia or specialized equipment. It is encompassed by multiple patent applications that if issued, could provide protection until 2047.

About the NDV-01 Phase 2 Study

The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with high-grade non-muscle invasive bladder cancer (HG-NMIBC). Patients are treated with NDV-01 in a biweekly induction phase, followed by monthly maintenance for up to one year. Patients were evaluated at 3-month intervals using cystoscopy and cytology, with biopsies performed at the treating physician's discretion. Time-to-event endpoints, including complete response (CR) and event free survival (EFS) rates, were analyzed as landmark events and using Kaplan-Meier (KM) analysis. The primary efficacy endpoints are safety and CR rate at 12 months, and secondary efficacy endpoints are duration of response (DOR) and EFS. Treatment-related adverse events (TRAEs) were graded according to CTCAE v5.0 (Common Terminology Criteria for Adverse Events, version 5.0).

About the NDV-01 Phase 3 RESCUE Registrational Pathways:

Relmada has received written feedback from the U.S. Food and Drug Administration (FDA) confirming alignment on two registrational development pathways for NDV-01, including study design, patient populations and primary endpoints. IND filing and program initiation remain on track for mid-2026.

Registration Pathway 1 - An open-label single-arm trial in second line (2L) BCG-unresponsive NMIBC with carcinoma in situ (CIS) patients who are currently refractory to approved or developmental therapies. Patients with BCG-unresponsive NMIBC with CIS who fail first line (1L) therapies, which we estimate to affect ~5,000 patients/year in the US, have few, if any, effective treatment alternatives to radical cystectomy. The primary endpoint of the study is complete response (CR) rate at any time.

Registrational Pathway 2 - An open label randomized controlled trial in intermediate-risk NMIBC of adjuvant therapy following TURBT (Transurethral Resection of Bladder Tumor, NDV-01 vs. observation). There are no approved adjuvant treatments for intermediate risk NMIBC, which we estimate affect ~75,000 patients/year in the US. The primary endpoint of the study is disease free survival (DFS).

About NMIBC

NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50 - 80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. High-grade BCG-unresponsive disease represents one of the most difficult-to-treat NMIBC subtypes, with limited bladder-sparing options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.

About Sepranolone and GABA Modulation

Sepranolone, a synthetic isoallopregnanolone, selectively modulates GABA_A receptors by antagonizing allopregnanolone (ALLO), without disrupting GABA signaling. It targets disorders linked to excess GABAergic activity such as Prader-Willi syndrome, Tourette syndrome, and Obsessive-Compulsive Disorder (OCD). More than 335 patients have been treated with sepranolone in clinical trials to date, with an excellent safety profile.

About Prader-Willi Syndrome (PWS)

PWS is a rare genetic disorder caused by chromosomal deletions on chromosome 15, leading to neurodevelopmental and behavioral complications. Global prevalence is estimated to be 350,000-400,000 patients. Current treatments address symptoms but do not modify the underlying neurobehavioral pathology.

About Relmada Therapeutics, Inc.

Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology and central nervous system conditions. Its lead candidates, NDV-01 and sepranolone, are advancing through mid-stage clinical development with the potential to address significant unmet needs.

For more information, visit www.relmada.com