Relmada Therapeutics(RLMD)

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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
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 Transcript
2025-04-29 01:27
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 ...
Relmada Therapeutics Presents Positive Initial Phase 2 NDV-01 Data at AUA2025
Globenewswire· 2025-04-28 17:38
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 ...
Relmada Therapeutics to Host KOL Event on Phase 2 NDV-01 Data
Newsfilter· 2025-04-24 12:00
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]
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]
Relmada Therapeutics To Present NDV-01 Data at AUA2025
Newsfilter· 2025-04-14 11:30
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 Safety and Efficacy of intravesical sustained release Gemcitabine Docetaxel combination (NDV-01) in High Ri ...
Relmada Therapeutics(RLMD) - 2024 Q4 - Earnings Call Transcript
2025-03-28 00:07
Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q4 2024 Earnings Conference Call March 27, 2025 4:30 PM ET Company Participants Brian Ritchie - LifeSci Advisors, IR Sergio Traversa - CEO Maged Shenouda - CFO Conference Call Participants Uy Ear - Mizuho Securities Andrew Tsai - Jefferies Operator Greetings, and welcome to the Relmada Therapeutics, Incorporated Quarter 4 2024 Financial Results Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal present ...
Relmada Therapeutics(RLMD) - 2024 Q4 - Earnings Call Transcript
2025-03-28 04:39
Relmada Therapeutics (RLMD) Q4 2024 Earnings Call March 28, 2025 12:39 AM ET Company Participants Brian Ritchie - Managing DirectorSergio Traversa - CEO & Member of Board of DirectorsMaged Shenouda - Chief Financial OfficerUy Ear - Vice PresidentBasma Radwan - Equity Research AssociateAndrew Tsai - SVP Operator Greetings, and welcome to La Ramada Therapeutics Incorporated Quarter four twenty twenty four Financial Results Call. At this time, all participants are in a listen only mode. A question and answer s ...
Relmada Therapeutics(RLMD) - 2024 Q4 - Annual Results
2025-03-27 20:42
Financial Performance - The net loss for Q4 2024 was $18.6 million, or $0.62 per share, compared to a net loss of $25.1 million, or $0.84 per share, in Q4 2023[7] - The net loss for the full year 2024 was $80 million, or $2.65 per share, compared to a net loss of $98.8 million, or $3.28 per share, in 2023[13] - Net loss for 2024 was $79,979,354, compared to a net loss of $98,791,746 in 2023, indicating an improvement of about 19%[33] Cash and Assets - The company reported a cash balance of $44.8 million as of December 31, 2024[1] - Cash and cash equivalents decreased to $3,857,026 as of December 31, 2024, down from $4,091,568 as of December 31, 2023[30] - Total current assets fell to $45,795,843 in 2024 from $97,508,917 in 2023, a decline of approximately 53%[30] Expenses - Research and development expenses for Q4 2024 totaled $11.0 million, a decrease of 25.2% from $14.7 million in Q4 2023[7] - General and administrative expenses for Q4 2024 were $8.1 million, down approximately 33.1% from $12.1 million in Q4 2023[7] - For the full year 2024, research and development expenses totaled $46.2 million, down from $54.8 million in 2023, a decrease of 15.7%[13] - Total operating expenses decreased to $83,891,036 in 2024 from $103,702,293 in 2023, representing a reduction of approximately 19%[33] - Research and development expenses decreased to $46,175,512 in 2024 from $54,807,348 in 2023, a reduction of approximately 16%[33] - General and administrative expenses decreased to $37,715,524 in 2024 from $48,894,945 in 2023, a decline of about 23%[33] Equity and Liabilities - Additional paid-in capital increased to $676,373,822 in 2024 from $646,229,824 in 2023, reflecting an increase of about 5%[30] - Total liabilities decreased to $10,295,857 in 2024 from $12,194,800 in 2023, a reduction of approximately 16%[30] - Stockholders' equity decreased to $35,521,961 in 2024 from $85,357,242 in 2023, a decline of about 58%[30] Development Programs - The company is advancing NDV-01, a Phase 2 program for high-grade non-muscle invasive bladder cancer, with topline data expected at AUA 2025[4] - Sepranolone, a Phase 2b-ready neurosteroid for Tourette syndrome, is also being developed with plans for evaluation in other compulsion-related disorders[4] - The company aims to initiate a registration-track study for NDV-01 in late Q4 2025 to early 2026[7] - The U.S. NMIBC market is estimated to be a multi-billion opportunity, driven by the increasing incidence of bladder cancer and demand for effective therapies[15] Share Information - The weighted average number of common shares outstanding increased to 30,163,751 in 2024 from 30,099,203 in 2023[33]