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Relmada Therapeutics(RLMD) - 2025 Q2 - Earnings Call Transcript
2025-08-07 21:30
Relmada Therapeutics (RLMD) Q2 2025 Earnings Call August 07, 2025 04:30 PM ET Speaker0Afternoon, and welcome to the Ramada Therapeutics Second Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the prepared remarks, we will conduct a question and answer session. As a reminder, this conference call is being recorded and will be available for replay on the Romada website. I would now like to turn the call over to Brian Ritchie from LifeSci Advi ...
Relmada Therapeutics(RLMD) - 2025 Q2 - Quarterly Results
2025-08-07 21:01
CORAL GABLES, FL – Aug 7, 2025 (GlobeNewswire) – 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 Phas ...
Relmada Therapeutics(RLMD) - 2025 Q2 - Quarterly Report
2025-08-07 20:06
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 June 30, 2025 or RELMADA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | | | (State or Other Jurisdiction of Incorporation or Organization) 2222 Ponce de Leon, Floor 3 Coral Gables, FL 33134 (Address of Principal Executive Offices) (Zip Code) (786) 629-1376 ☐ TRANSITION REPORT PUR ...
Relmada Therapeutics Reports Second Quarter 2025 Financial Results and Announces NDV-01 6-Month Follow-up Safety and Efficacy Data in NMIBC
Globenewswire· 2025-08-07 20:05
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 Appoints Renowned Urologic Oncologist, Yair Lotan, MD, to Chair the Clinical Advisory Board and Support Development of NDV-01
Globenewswire· 2025-07-15 12:00
Dr. Lotan's distinguished expertise in bladder cancer care and clinical development brings further scientific acumen to Relmada's NDV-01 program Yair Lotan, MD, is a urologic oncologist with over 20 years of experience caring for bladder cancer patients. Dr. Lotan graduated with high honors from the University of Texas at Austin and with honors from Baylor College of Medicine in Houston. He trained in general surgery and urology at UT Southwestern Medical Center in Dallas. Dr. Lotan heads a clinical researc ...
DIMERx Appoints Biotech Leader Sergio Traversa, PharmD, to Board of Directors
GlobeNewswire News Room· 2025-07-09 12:00
SAN FRANCISCO, July 09, 2025 (GLOBE NEWSWIRE) -- DIMERx, Inc., a late-stage clinical biopharmaceutical company developing covalently bonded dimer therapeutics, today announced the appointment of Sergio Traversa, PharmD, as an Independent Director to its Board of Directors, effective June 25, 2025. Dr. Traversa currently serves as CEO of Relmada Therapeutics (Nasdaq: RLMD), a clinical-stage biotechnology company focused on developing transformative therapies for oncology-related and central nervous system co ...
Relmada Therapeutics Appoints Urology Expert Raj S. Pruthi, MD as CMO-Urology
Globenewswire· 2025-06-17 11:00
Core Viewpoint - Relmada Therapeutics has appointed Dr. Raj S. Pruthi as Chief Medical Officer-Urology to advance the development of NDV-01, a novel therapy for non-muscle invasive bladder cancer (NMIBC), with a Phase 3 trial expected to begin in the first half of 2026 [2][4]. Company Overview - Relmada Therapeutics is a clinical-stage biotechnology company focused on innovative therapies for oncology and central nervous system conditions [11]. - The lead program, NDV-01, is designed for the treatment of NMIBC and aims to address significant unmet medical needs in this area [11]. Appointment of Dr. Raj S. Pruthi - Dr. Pruthi brings over 25 years of experience in urologic oncology, clinical trials, and robotic surgery, having previously served as Chief Medical Officer at enGene Holdings Inc. and Global Medical Affairs leader at Johnson and Johnson [3][5]. - His expertise includes developing practice guidelines for NMIBC and executing global clinical studies for bladder cancer treatments [3][6]. NDV-01 Program - NDV-01 is a sustained-release formulation of gemcitabine and docetaxel, designed for intravesical administration, allowing for gradual drug release over 10 days [9]. - The formulation aims to enhance local exposure while minimizing systemic toxicity and is designed for in-office administration in under 10 minutes without the need for anesthesia [9]. - Positive initial Phase 2 data presented at the AUA 2025 indicated impressive response rates and favorable tolerability for NDV-01 [4][10]. Market Opportunity - NMIBC accounts for approximately 75% of all bladder cancer cases, with a high recurrence rate of 50-75% over seven years, indicating a significant market opportunity for effective treatments [10]. - With over 600,000 prevalent cases in the U.S. and limited treatment options, NDV-01 has the potential to serve as a frontline or salvage therapy across multiple NMIBC subtypes [10].
Relmada Therapeutics(RLMD) - 2025 Q1 - Earnings Call Transcript
2025-05-12 21:32
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 ...
Relmada Therapeutics(RLMD) - 2025 Q1 - Earnings Call Transcript
2025-05-12 21:30
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]
Relmada Therapeutics(RLMD) - 2025 Q1 - Quarterly Report
2025-05-12 20:06
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 ...