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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 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 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 Reports First Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-05-12 20:01
Core Insights - Relmada Therapeutics has reported positive initial Phase 2 proof-of-concept data for NDV-01, showing a 90% overall response rate in non-muscle invasive bladder cancer (NMIBC) [1][4] - The company plans to initiate a Phase III registration trial for NDV-01 in the first half of 2026 and a Phase 2 study for sepranolone in Prader-Willi syndrome in the same timeframe [1][4] Pipeline Highlights - **NDV-01**: A sustained-release intravesical formulation of gemcitabine and docetaxel targeting high-grade NMIBC with a U.S. market opportunity of approximately 600,000 prevalent cases. The recent data shows a 90% overall response rate and 100% complete response in carcinoma in situ [5][10] - **Sepranolone**: A first-in-class GABAA Modulating Steroid Antagonist targeting disorders linked to excess GABAergic activity, with an estimated U.S. prevalence of 20,000 patients for Prader-Willi syndrome. A Phase 2 study is being prepared for initiation [5][11] Financial Results - For Q1 2025, the company reported a net loss of $17.5 million or $0.58 per share, compared to a net loss of $21.8 million or $0.72 per share in Q1 2024 [14][21] - Research and development expenses were $11.9 million, down from $13.3 million in Q1 2024, reflecting reduced trial costs [14][20] - Cash, equivalents, and short-term investments totaled $27.1 million as of March 31, 2025, down from $44.9 million at year-end 2024 [14][18]
Relmada Therapeutics to Report First Quarter 2025 Financial Results on Monday, May 12, 2025
Globenewswire· 2025-05-08 11:30
Group 1 - Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on advancing innovative therapies with potential clinical benefits for targeted patient populations [2][3] - The company plans to host a conference call and webcast on May 12, 2025, at 4:30 PM ET to discuss its financial results for Q1 2025 and recent business progress [1][4] - The lead investigational program, NDV-01, is currently being evaluated in a Phase 2 study for High-Grade Non-Muscle Invasive Bladder Cancer [3] Group 2 - Preparations are underway to advance sepranolone, an investigational product for compulsion-related disorders, into further studies [3] - The conference call will provide insights into the company's financial performance and strategic developments [1][4] - Contact information for investor relations and media inquiries is provided for further engagement [3]
Relmada Therapeutics Presents Positive Initial Phase 2 NDV-01 Data at AUA2025
Globenewswire· 2025-04-28 17:38
Core Insights - Relmada Therapeutics announced positive initial data from the Phase 2 study of NDV-01, showing that 90% of patients achieved high-grade disease-free status, indicating strong clinical activity for treating non-muscle invasive bladder cancer (NMIBC) [1][2][5] - The data was presented at the American Urology Association 2025 Annual Meeting, with a data cutoff date of April 20, 2025 [1][2] Efficacy Data - At the 3-month assessment, the overall response rate (ORR) was 85% (17 out of 20 patients), with high-grade recurrence-free survival (HGRFS) in papillary disease at 83.3% (15 out of 18 patients) [5] - Complete response (CR) in carcinoma in situ (CIS) patients was 100% (2 out of 2 patients) [5] - The treatment effect of NDV-01 was consistent across all patient groups, regardless of prior BCG exposure or disease pathology [3] Safety Profile - NDV-01 was well tolerated, with no treatment-related adverse events greater than Grade 1 [4] - The most common treatment emergent adverse events (TEAEs) were mild and transient, including urinary urgency, flank pain, and dysuria, resolving within 24-28 hours [4] Study Overview - The Phase 2 study is an open-label, single-arm, single-center study evaluating NDV-01 in patients with high-grade NMIBC, with a biweekly induction phase followed by monthly maintenance for up to one year [10] - The primary efficacy endpoints are safety and complete response rate at 12 months, while secondary endpoints include duration of response and event-free survival [7][10] Market Opportunity - The U.S. NMIBC market is estimated to be a multi-billion-dollar opportunity, driven by the increasing incidence of bladder cancer and the demand for effective, minimally invasive therapies like NDV-01 [12] - NDV-01 stands out due to its ease of administration and potential for durability of action, with expansion opportunities beyond first-line treatment [12]
UPDATE -- Relmada Therapeutics To Present NDV-01 Data at AUA2025
Newsfilter· 2025-04-14 12:41
Company Overview - Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on advancing innovative therapies for targeted patient populations [7] - The lead investigational program, NDV-01, is aimed at treating High-Grade Non-Muscle Invasive Bladder Cancer (HG-NMIBC) and is currently in a Phase 2 study [8] Product Details - NDV-01 is an investigational sustained-release formulation combining gemcitabine and docetaxel, designed for intravesical dosing without the need for anesthesia or specialized equipment [2][3] - The formulation aims to maximize local drug concentration and prolong exposure while minimizing systemic toxicity, with a gradual release over a 10-day period [3] - NDV-01 has the potential to be a first-line therapy for HG-NMIBC and may also be used for patients who have failed other treatments, including BCG immunotherapy [3][6] Market Opportunity - The U.S. market for Non-Muscle Invasive Bladder Cancer (NMIBC) is estimated to be a multi-billion dollar opportunity, driven by the increasing incidence of bladder cancer and the demand for effective therapies [6] - NMIBC has a high recurrence rate of 50-75% over seven years, leading to frequent re-treatment and progression, highlighting the need for effective solutions like NDV-01 [5][6] - The global market is expected to grow significantly, with limited approved treatment options currently available [6] Clinical Presentation - An abstract regarding NDV-01 will be presented at the American Urology Association (AUA2025) conference on April 28, 2025, at 10:04 AM PT [2]