Dr. Pruthi brings vast clinical development experience advancing novel therapies for NMIBC to Relmada and the NDV-01 program Phase 3 trial for NDV-01 expected to begin in H1 2026 CORAL GABLES, Fla., June 17, 2025 (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 indications, today announced the appointment of Raj S. Pruthi, MD as Chief Medical Officer-Urology ...

Relmada Therapeutics (RLMD) Q1 2025 Earnings Call May 12, 2025 04:30 PM ET Company Participants Brian Ritchie - Managing DirectorSergio Traversa - CEO & Member of Board of DirectorsMaged Shenouda - Chief Financial OfficerUy Ear - Vice PresidentYair Lotan - Professor of Urology & Chief of Urologic OncologyMatthew Barcus - Senior Research Associate Operator Good afternoon. Welcome to Ramada Therapeutics First Quarter twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. A ...

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments of approximately $27.1 million, down from $44.9 million as of December 31, 2024 [21] - Cash used in operations for Q1 2025 was $18.1 million, compared to $13 million for the same period in 2024 [22] - The net loss for Q1 2025 was $17.6 million, or $0.58 per share, compared to a net loss of $21.8 million, or $0.72 per share, for Q1 2024 [23] Business Line Data and Key Metrics Changes - Research and development expenses for Q1 2025 totaled $12 million, down from $13.3 million in Q1 2024, primarily due to lower study costs [22] - General and administrative expenses for Q1 2025 were $6.3 million, down from $9.7 million in Q1 2024, mainly due to a decrease in stock-based compensation [23] Market Data and Key Metrics Changes - The market opportunity for NDV-one includes approximately 75,000 new bladder cancer cases diagnosed each year in the U.S., with about 50% classified as high-grade disease [8] - Prader Willi syndrome, the first candidate indication for sopranolone, is estimated to affect approximately 350,000 people worldwide, including about 20,000 in the U.S. [16] Company Strategy and Development Direction - The company aims to advance its pipeline with two innovative product candidates, NDV-one for bladder cancer and sopranolone for Prader Willi syndrome and Tourette syndrome, both showing promising Phase two data [5][24] - The strategic plan includes securing U.S. IND clearance for NDV-one and progressing sopranolone into clinical development in early 2026 [15][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of NDV-one to improve care for bladder cancer patients, citing strong Phase two data and a favorable safety profile [14][32] - The company is optimistic about the upcoming discussions with the FDA regarding the registration study for NDV-one, highlighting the well-known efficacy and safety of the drug combination [30][32] Other Important Information - NDV-one is designed to be administered in less than ten minutes in a doctor's office, contrasting with conventional chemotherapy that requires lengthy preparation and administration [10] - The company has a clean balance sheet and a disciplined approach to its development plan, positioning it well for advancing its clinical milestones [6][25] Q&A Session Summary Question: What gives confidence that the current data from the Phase two study would be sufficient for the FDA to agree for NDV-one to move into registrational study? - Management highlighted the established use of gemcitabine and docetaxel, the safety profile of NDV-one, and the ease of administration as key factors for confidence in FDA discussions [30][32] Question: Could you elaborate on scaling up supply? - Management indicated that scaling up supply involves preparing for commercial quantities and ensuring multiple manufacturers for risk management [44] Question: When should we look forward to sharing the complete response rate for the entire population? - The next data point will be the six-month assessment, expected around June or July, with further updates planned for nine and twelve months [48][49] Question: What would you want the phase three trial to look like in terms of time points, endpoints, and types of patients? - Management discussed potential routes for the phase three trial, including a single-arm chemoablation route or a randomized trial against placebo, depending on FDA feedback [56][58]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________________ to ___________________________ Commission File Number: 000-55347 RELMADA THERAPEUTICS, INC. (Exact name of registrant as specified in its charte ...

Positive initial Phase 2 proof-of-concept data for NDV-01 at AUA 2025 showing a 90% overall response rate at any time in non-muscle invasive bladder cancer (US prevalence 600K patients) The Phase 2 study for NDV-01 continues with updates at 6, 9 and 12 month data follow-up over the course of 2025. Plans to start Phase III registration trial in H1 2026 Expecting to initiate a Phase 2 study for sepranolone in Prader-Willi syndrome in H1 2026 (US prevalence 20,000 patients) Conference Call and Webcast Today at ...

CORAL GABLES, Fla., May 08, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, or “the Company”), a clinical-stage biotechnology company committed to advancing innovative breakthrough therapies, today announced plans to host a conference call and webcast on Monday, May 12, 2025 at 4:30 PM ET to discuss financial results for the first quarter ended March 31, 2025 and recent business progress. Conference Call and Webcast Information: Date: Monday, May 12, 2025 at 4:30 PM ETParticipa ...

Relmada Therapeutics (RLMD) Update / Briefing April 28, 2025 09:27 PM ET Speaker0 Good afternoon, and welcome to the Realmada Pharmaceuticals Virtual KOL event. At this time, all attendees are in a listen only mode. A question and answer session will follow the formal presentations. If you'd like to submit a question, you may do so by using the q and a text box at the bottom of the webcast player. As a reminder, this call is being recorded and a replay will be made available on the Realmada website followin ...

90% of patients achieved high grade disease-free status at any time point with NDV-01, demonstrating strong proof-of-concept for sustained-release “GEM/DOCE” formulation* NDV-01 showed promising clinical activity in BCG-naïve and BCG-unresponsive patients, with favorable overall tolerability Data to be reviewed at Investor Event on April 28, 2025 at 4:30 PM ET CORAL GABLES, Fla., April 28, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a clinical-stage biotechn ...

Company Overview - Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on advancing innovative therapies for targeted patient populations [11] - The lead investigational program, NDV-01, is being evaluated for high-grade non-muscle invasive bladder cancer (HG-NMIBC) in a Phase 2 study [12] Product Details - NDV-01 is a novel, investigational sustained-release formulation of gemcitabine and docetaxel, designed for intravesical therapy [3][6] - The formulation aims to maximize local drug concentration while minimizing systemic toxicity, providing a gradual and sustained release over a 10-day period [7] - NDV-01 has the potential to be a first-line therapy for HG-NMIBC and may also be used in patients who have failed other treatments, including BCG immunotherapy [10] Market Opportunity - The U.S. prevalence of non-muscle invasive bladder cancer (NMIBC) is approximately 600,000 patients, with an estimated 62,000 new diagnoses annually [3][9] - The NMIBC market is considered a multi-billion dollar opportunity, driven by the increasing incidence of bladder cancer and the demand for effective therapies [10] - High recurrence rates in NMIBC lead to frequent re-treatment, highlighting the need for effective and minimally invasive therapies like NDV-01 [10] Upcoming Event - A virtual key opinion leader (KOL) event will be held on April 28, 2025, featuring discussions on topline efficacy and safety data from the Phase 2 study of NDV-01 [1][2]

CORAL GABLES, Fla., April 14, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (NASDAQ:RLMD, "Relmada", "the Company")), a clinical-stage biotechnology company, today announced the presentation of an abstract at the American Urology Association (AUA2025), taking place from April 26-29th in Las Vegas. Abstract OverviewAbstract Title:   Prospective Open Label Study to Evaluate the Safety and Efficacy of intravesical sustained release Gemcitabine Docetaxel combination (NDV-01) in High Risk NMIBCSession: P2 ...