Positive 9-month follow-up data for NDV-01 showed a 92% overall response rate at any time in non-muscle invasive bladder cancer (NMIBC), with favorable overall safety Secured FDA alignment on key elements of Phase 3 program with two independent paths for approval in two separate NMIBC indications: High-risk 2nd line BCG-unresponsive, and Intermediate-risk patients in the adjuvant setting; Studies expected to begin H1 2026 Completed $100M underwritten offering of common stock and pre-funded warrants on Novem ...

Core Insights - Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies for oncology and central nervous system conditions [2] - The company plans to host a conference call and webcast on November 13, 2025, to discuss its financial results for Q3 2025 and recent business progress [1] Company Overview - Relmada's lead candidates, NDV-01 and sepranolone, are in mid-stage clinical development and aim to address significant unmet medical needs [2] - The company is advancing therapies that could transform treatment options in their targeted areas [2] Conference Call Details - The conference call is scheduled for November 13, 2025, at 4:30 PM ET [1][3] - Participants can access the call via US and international dial-in numbers, and a replay will be available on the company's website [3]

Core Points - Relmada Therapeutics, Inc. has announced the pricing of an underwritten offering of 40,142,000 shares of common stock at $2.20 per share, along with pre-funded warrants to purchase up to 5,315,000 shares at $2.199 each, aiming for gross proceeds of approximately $100 million before expenses [1][2][3] Group 1 - The offering is expected to close on November 5, 2025, subject to customary closing conditions [1] - Major investors in the offering include Janus Henderson Investors, Ferring Ventures SA, and OrbiMed among others [1] - Jefferies and Leerink Partners are acting as joint book-running managers, with Mizuho as a book-runner for the offering [2] Group 2 - The net proceeds will be used for working capital, clinical studies for regulatory approvals, and further development of product candidates [3] - The company may also invest in or acquire synergistic companies and engage in licensing activities related to current and future product candidates [3] Group 3 - The securities were offered under a shelf registration statement declared effective by the SEC on September 12, 2024, with a final prospectus supplement to be filed [4]

Core Points - Relmada Therapeutics, Inc. has regained compliance with Nasdaq's $1.00 minimum bid price requirement as of September 15, 2025 [1][2] - The company achieved the required minimum closing bid price of $1.00 for at least 10 consecutive business days, specifically on September 12, 2025 [2] - Relmada is now fully compliant with all Nasdaq continued listing requirements and will continue to be traded under the ticker "RLMD" [2] Company Overview - Relmada Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapies for oncology-related and central nervous system conditions [2] - The company's lead candidates, NDV-01 and sepranolone, are currently advancing through mid-stage clinical development [2]

Financial Data and Key Metrics Changes - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments of approximately $20.6 million, down from $44.9 million as of December 31, 2024 [22] - Cash used in operations in Q2 2025 was $6.4 million, compared to $13.3 million for the same period in 2024 [22] - The net loss for Q2 2025 was $9.9 million or $0.30 per share, compared to a net loss of $17.8 million or $0.59 per share for Q2 2024 [24] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2025 totaled $2.8 million, down from $10.7 million in Q2 2024, primarily due to lower study costs from the wind down of clinical trials for REL-ten seventeen [23] - General and administrative expenses for Q2 2025 were $7.4 million, compared to $8.1 million in Q2 2024, driven by a decrease in stock-based compensation [24] Market Data and Key Metrics Changes - The company is focusing on two product candidates: NDV-one for non-muscle invasive bladder cancer and sopranolone for compulsivity disorders, targeting significant and underserved markets [6][20] - NDV-one has shown a complete response rate of 91% at any time point following treatment in high-risk patients [14] Company Strategy and Development Direction - The company aims to initiate a Phase III study for NDV-one in 2026 and a proof of concept study for sopranolone in Prader Willi syndrome also in 2026 [18][27] - The management team has expanded with the addition of experts in bladder cancer and urologic oncology, which is expected to enhance the company's strategic objectives [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of NDV-one as a promising treatment for non-muscle invasive bladder cancer, with plans to engage with the FDA regarding trial design [18][36] - The company believes that the recent approval of a competitor's product sets a precedent for their own approach in the market [33] Other Important Information - The company reported a clean balance sheet and a strong cash position, which positions it well for future value-creating steps [27] - Management emphasized the importance of upcoming milestones and the disciplined development strategy to enhance the long-term value proposition [22] Q&A Session Summary Question: How do recent data and competitor approvals affect NDV-one's strategy? - Management acknowledged the opportunity in both high-grade and low-grade non-muscle invasive bladder cancer, noting the significant efficacy data for high-grade disease while also considering the larger market for low-grade patients [31][33] Question: What are the goals for the upcoming FDA meeting? - The main goal is to discuss the viability of a single-arm open-label study for chemoablation, similar to the path taken by a competitor [36] Question: How should R&D expenses be viewed going forward? - R&D expenses have decreased due to a lack of patient enrollment, but costs will rise again as the company prepares to start new trials [41]

Core Insights - Relmada Therapeutics reported a 91% overall response rate for NDV-01 in non-muscle invasive bladder cancer during a 6-month follow-up of a Phase 2 study, indicating strong efficacy and safety [1][3][4] - The company is preparing to initiate a Phase 3 registration trial for NDV-01 in the first half of 2026 and plans to start a Phase 2 study for sepranolone in Prader-Willi syndrome in the same timeframe [1][5] Clinical Results - The Phase 2 study of NDV-01 involved 29 patients, with a median age of 73 years. The study reported a complete response rate of 91% at any time point, 83% at 3 months, and 90% at 6 months [2][3] - No patients progressed to muscle invasive disease or underwent radical cystectomy, and no patients experienced Grade 3 treatment-related adverse events [3][4] Pipeline Developments - NDV-01 is a sustained-release formulation of gemcitabine and docetaxel, designed for intravesical administration, which enhances drug retention and minimizes systemic toxicity [10][12] - Sepranolone is a first-in-class GABAA Modulating Steroid Antagonist targeting disorders linked to excess GABAergic activity, with plans for further clinical development [5][13] Financial Performance - For the second quarter ended June 30, 2025, Relmada reported a net loss of $9.9 million, or $0.30 per share, compared to a net loss of $17.8 million, or $0.59 per share, in the same period of the previous year [5][24] - Research and development expenses were $2.8 million for the quarter, down from $10.7 million in Q2 2024, primarily due to reduced trial costs [5][24] Market Opportunity - The U.S. market for high-grade/intermediate-grade non-muscle invasive bladder cancer is significant, with approximately 600,000 prevalent cases, highlighting the potential for NDV-01 as a frontline or salvage therapy [7][12] - Prader-Willi syndrome, targeted by sepranolone, has an estimated U.S. prevalence of 20,000 patients, representing an orphan disease market [7][14]

Core Insights - Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies for oncology and central nervous system conditions [2] - The company plans to host a conference call and webcast on August 7, 2025, to discuss its financial results for Q2 2025 and recent business progress [1] Company Overview - Relmada's lead candidates, NDV-01 and sepranolone, are in mid-stage clinical development and aim to address significant unmet medical needs [2] - The company is advancing therapies that could transform treatment options in their targeted areas [2] Conference Call Details - The conference call is scheduled for August 7, 2025, at 4:30 PM ET [3] - Dial-in numbers for participants include 1-877-407-0792 for US and 1-201-689-8263 for international callers [3] - Webcast access will be available through the company's investor relations section [1][3]

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].

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]

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]