Core Insights - The company reported promising results from the Phase 2 trial of NDV-01, showing a high complete response rate and durable efficacy in treating high-risk non-muscle invasive bladder cancer (NMIBC) [2][3][7] - The company plans to initiate a Phase 3 registrational program for NDV-01 in mid-2026, with two independent pathways targeting different patient populations [4][8][9] - Financially, the company ended 2025 with approximately $93 million in cash, bolstered by recent financings, which are expected to fund operations through 2029 [5][16][17] Clinical Development - NDV-01 demonstrated a 12-month complete response rate of 76% overall and 80% in BCG-unresponsive patients, with no progression to muscle-invasive disease or grade 3 or higher treatment-related adverse events [7] - The Phase 3 RESCUE program will consist of two pathways: one for intermediate-risk patients post-TURBT and another for BCG-unresponsive carcinoma in situ [8][9] - The company expects to report initial 3-month response data from the second-line BCG-unresponsive study by the end of 2026 [9][12] Financial Performance - The company reported a net loss of $19.9 million for Q4 2025, compared to a net loss of $18.7 million in Q4 2024, with a decrease in R&D expenses attributed to the completion of two Phase 3 trials for REL-1017 [5][20] - G&A expenses increased to $12.3 million in Q4 2025 from $8.1 million in Q4 2024, primarily due to higher compensation costs [20] - The company raised approximately $160 million through a private placement and other financings, which, along with existing cash, is expected to support operations through 2029 [5][17] Future Outlook - The company is preparing for a proof-of-concept study for sepranolone in Prader-Willi syndrome, with plans to begin in mid-2026 [6][14] - Management emphasized the importance of execution as they prepare to initiate the RESCUE registrational program and continue to update investors in upcoming quarters [17]

Financial Data and Key Metrics Changes - Relmada closed 2025 with a cash balance of $93 million, an increase from approximately $45 million at the end of 2024, primarily due to a successful $160 million private financing [19][20] - Research and development expenses for Q4 2025 totaled $8.1 million, a decrease from $11 million in Q4 2024, driven by reduced study costs from completed trials [20] - General and administrative expenses increased to $12.3 million in Q4 2025 from $8.1 million in Q4 2024, primarily due to higher compensation costs [21] - The net loss for Q4 2025 was $19.9 million, or $0.27 per share, compared to a net loss of $18.7 million, or $0.62 per share, in Q4 2024 [23] Business Line Data and Key Metrics Changes - The NDV-01 program reported a 12-month complete response rate of 76% in high-risk NMIBC patients, with an 80% response rate in the BCG unresponsive population [11][12] - Sepranolone is preparing for a proof of concept study in Prader-Willi syndrome, with plans to initiate in mid-2026 [18] Market Data and Key Metrics Changes - The U.S. market for intermediate-risk bladder cancer patients is estimated at 70,000-75,000 annually, while the second-line treatment for BCG unresponsive patients is about 5,000 annually [13][15] - Only 35% of intermediate-risk patients currently receive adjuvant therapy, indicating significant market potential for new treatments [53] Company Strategy and Development Direction - The company plans to initiate the phase 3 RESCUE program for NDV-01 in mid-2026, with two registrational pathways focusing on intermediate-risk and BCG unresponsive patients [5][13] - The strategic focus includes enhancing clinical data presentation and establishing a robust supply chain for sepranolone [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical programs and long-term prospects, emphasizing the importance of execution in the upcoming RESCUE program [24][57] - The company aims to redefine the standard of care in bladder cancer with NDV-01, leveraging its unique sustained-release formulation [17] Other Important Information - The company has strengthened its development team with the appointment of Dr. Raj S. Pruthi as Chief Medical Officer-Urology [6] - A successful $160 million private financing was completed, providing capital through 2029 [8][20] Q&A Session Summary Question: Will additional data from the phase two study be presented? - Management confirmed that updated 12-month data will be presented at AUA and plans to share data every three months [26][29] Question: How will the company ensure that second-line patients are accurately categorized? - The company will limit prior therapy lines to two and will monitor patient characteristics closely to ensure accurate categorization [27][30] Question: What is the expectation for enrollment cadence across the studies? - Management indicated that the unique in-office profile of NDV-01 could serve as a recruitment advantage, despite a crowded market [34][35] Question: What is the FDA's requirement for follow-up duration before submitting the NDA? - The FDA has not stipulated a minimum follow-up duration but is interested in the totality of the data regarding response and durability [36] Question: How do the complete response rates compare between phase 2 and phase 3? - Management expects to exceed the benchmark of 75% two-year recurrence-free survival based on the statistics structured for the trial [42]

Group 1 - Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies for oncology and central nervous system disorders [2] - The company plans to host a conference call and webcast on March 19, 2026, at 4:30 PM ET to discuss its financial results for the fourth quarter ended December 31, 2025, and recent business progress [1] - The lead candidates of the company, NDV-01 and sepranolone, are advancing through mid-stage clinical development, addressing significant unmet needs in their respective fields [2] Group 2 - A replay of the webcast will be available in the Investors section of the Relmada website [1] - Contact information for investor inquiries is provided, with Brian Ritchie from LifeSci Advisors as the point of contact [2] - Media inquiries can be directed to the corporate communications team via the provided email [3]

Core Viewpoint - Relmada Therapeutics, Inc. is actively participating in the Leerink Partners Global Healthcare Conference, highlighting its commitment to advancing innovative therapies in oncology and central nervous system disorders [1]. Group 1: Conference Participation - The CEO Sergio Traversa and CFO Maged Shenouda will represent the company at the conference held in Miami, Florida from March 8-11, 2026 [1]. - A fireside chat is scheduled for March 10, 2026, at 8:40 AM ET, with a webcast available for interested parties [2]. - Management will also be available for one-on-one investor meetings during the conference, indicating an opportunity for direct engagement with investors [2]. Group 2: Company Overview - Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology and central nervous system conditions [4]. - The company's lead candidates, NDV-01 and sepranolone, are progressing through mid-stage clinical development, aiming to address significant unmet medical needs [4].

Core Insights - Relmada Therapeutics, Inc. is participating in the Leerink Partners Global Healthcare Conference from March 8-11, 2026, with CEO Sergio Traversa and CFO Maged Shenouda attending [1] - The conference will feature a fireside chat on March 10, 2026, at 8:40 AM ET, and management will be available for one-on-one investor meetings [2] Company Overview - Relmada Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapies for oncology and central nervous system disorders [4] - The company's lead candidates, NDV-01 and sepranolone, are in mid-stage clinical development and aim to address significant unmet medical needs [4]

Core Viewpoint - Relmada Therapeutics, Inc. has announced a PIPE financing expected to generate approximately $160 million in gross proceeds to support its research and development efforts in oncology and central nervous system therapies [1][3]. Group 1: PIPE Financing Details - The PIPE financing involves the sale of 29,474,569 shares of common stock at a price of $4.75 per share and pre-funded warrants for 4,210,527 shares at a price of $4.749 per warrant, with an exercise price of $0.001 per share [2]. - The financing is anticipated to close around March 11, 2026, pending customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the PIPE financing will be utilized for working capital and general corporate purposes, including advancing the research and development of the company's product candidates [3]. Group 3: Company Overview - Relmada is a clinical-stage biotechnology company focused on developing innovative therapies for oncology and central nervous system conditions, with lead candidates NDV-01 and sepranolone in mid-stage clinical development [6].

Core Insights - Relmada Therapeutics reported a 92% overall response rate for NDV-01 in non-muscle invasive bladder cancer (NMIBC) with favorable safety data [1][3][5] - The company secured FDA alignment on key elements of its Phase 3 program for NDV-01, which includes two independent paths for approval targeting high-risk and intermediate-risk NMIBC patients [1][3][8] - Relmada completed a $100 million underwritten offering to support its operations and planned studies into 2028 [1][3][12] Clinical Results - NDV-01 demonstrated a 92% complete response rate at any time point, with 84% at 3 months, 87% at 6 months, and 85% at 9 months [5][6] - In the BCG-unresponsive subpopulation, the complete response rate was 91% at any time point [7] - No patients progressed to muscle-invasive disease or underwent radical cystectomy [6] FDA Alignment and Study Design - FDA indicated that a single-arm trial may be acceptable for high-risk, 2nd line BCG-unresponsive patients [5][8] - For intermediate-risk NMIBC, a randomized study design post-TURBT was deemed generally acceptable [5][8] - No further non-clinical studies are required to support a 505(b)(2) New Drug Application [5] Financial Results - For Q3 2025, Relmada reported a net loss of $10.1 million, or $0.30 per share, compared to a net loss of $21.7 million, or $0.72 per share in Q3 2024 [13][28] - Research and development expenses were $4.0 million, down from $11.1 million in Q3 2024 [12][28] - General and administrative expenses decreased to $6.3 million from $11.9 million in Q3 2024 [12][28] Upcoming Milestones - NDV-01 twelve-month data from the ongoing Phase 2 NMIBC study is expected in Q1 2026 [12] - Initiation of Phase 3 trials for NDV-01 in high-risk and intermediate-risk settings is anticipated in the first half of 2026 [12][8] - A Phase 2 trial for sepranolone in Prader-Willi Syndrome is also set to begin in the first half of 2026 [12]

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]