Relmada Therapeutics Reports Second Quarter 2025 Financial Results and Announces NDV-01 6-Month Follow-up Safety and Efficacy Data in NMIBC

About this update from Relmada Therapeutics, Inc.

6-month follow-up for NDV-01 showed a 91% overall response rate at any time in non-muscle invasive bladder cancer, with good overall safety Enrollment in the Phase 2 study for NDV-01 continues, with updates expected at 9 and 12 month data follow-up. Preparations underway to start Phase III registration trial in 1H 2026 Expecting to initiate a Phase 2 study for sepranolone in Prader-Willi syndrome in 1H 2026 Conference Call and Webcast Today at 4:30 PM ET CORAL GABLES, Fla., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology-related and central nervous system indications, today reported financial results for the second quarter ended June 30, 2025, announced 6-month follow-up data from the Phase 2 study of NDV-01 in bladder cancer and provided a corporate and pipeline update. Highlights of the 6-month follow-up data from the Phase 2 study of NDV-01: “We are pleased to report that the six-month follow-up from the Phase 2 study of NDV-01, a gemcitabine/docetaxel (Gem/Doce) sustained release formulation, produced impressive results, with a 91% CR rate at any time point following NDV-01 treatment. The data reported today, in combination with the previously reported 3-month results , raise our confidence in NDV-01 as a potential durable treatment for bladder cancer,” said Raj S. Pruthi, MD, CMO of Relmada. “Gem/Doce have long shown clinical utility in non-muscle invasive bladder cancer (NMIBC), but the complexity of administration has limited their broader use. The sustained release formulation of NDV-01, which is designed to increase exposure to drug and simplify delivery and accessibility, has the potential to significantly change how we manage patients with NMIBC in routine practice.” “As clinicians, we have embraced the combination of Gem/Doce as a highly effective therapy for many years,” said Yair Lotan, MD, Chair of Relmada’s Clinical Advisory Board . “However, it is difficult to formulate outside of the hospital setting, often creating a significant burden for patient and provider. NDV-01’s simple, ready-to-use sustained release formulation overcomes those burdens and could enable wider patient adoption transforming the care of NMIBC.” Pipeline Highlights NDV-01 A sustained-release intravesical formulation of gemcitabine and docetaxel (Gem/Doce) Sepranolone A first-in-class GABA A Modulating Steroid Antagonist (GAMSA) Financial Results Three Months Ended June 30, 2025 Results Six Month Ended June 30, 2025 Results Conference Call and Webcast Relmada will host a conference call today, August 7, 2025, at 4:30 PM ET to discuss its Q2 2025 results and pipeline progress. A replay of the webcast will be available on the Investors section of the Relmada website at  https://www.relmada.com/investors/ir-calendar . About NDV-01 NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. NDV-01 is convenient to administer in-office, in less than 10 minutes, and does not require anesthesia or specialized equipment. It is protected by patents through 2038. About the 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 HG-NMIBC. Patients are treated with NDV-01 in a biweekly induction phase, follow by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (CRR) at 12 months, and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS). About NMIBC NMIBC represents ~75% of all bladder cancer cases and is associated with high recurrence (50–75% over 7 years). With over 600,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. 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. US prevalence is estimated to be 20,000 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-related and central nervous system conditions. 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 . Forward-Looking Statements: The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “if”, “may”, “expects”, “anticipates”, “believes”, “will”, “will likely result”, “will continue”, “plans to”, “potential”, “promising”, and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential for Relmada’s product candidates to progress, including the potential for Phase 2 NDV-01 data to continue to deliver positive results supporting further development, potential for clinical trials to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to secure FDA agreement on the regulatory path for NDV-01, and sepranolone, or that future NDV-01, or sepranolone, clinical results will be acceptable to the FDA, failure to secure adequate NDV-10, or sepranolone, drug supply, and the other risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list. Investor Contact: Brian Ritchie LifeSci Advisors [email protected] Media Inquiries: Corporate Communications [email protected]

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