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Exhibit 99.1 Relmada Therapeutics Reports Fourth Quarter and Full Year 2025 Results and Provides Business Update CORAL GABLES, FL – March 19, 2026 (Globe Newswire) – Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today reported audited financial results for the fourth quarter and full year ended December 31, 2025 and provided a corporate update highlighting signifi ...

Safety: No progression to muscle-invasive disease, no radical cystectomies, no grade 3 or higher treatment-related adverse events, and no interruptions or discontinuations due to adverse events; most treatment-related adverse events were grade 1.CR at any time: 95% overall (based on 38 patients) and 94% among BCG-unresponsive patients.Chief Medical Officer (Oncology/Urology) Dr. Raj Pruthi provided details on the 12-month dataset, describing NDV-01’s performance as a high response rate with durable efficacy ...

Financial Data and Key Metrics Changes - Relmada closed 2025 with a cash balance of $93 million, an increase from approximately $45 million at December 31, 2024, due to net proceeds from a $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, primarily due to reduced study costs [21] - General and administrative expenses increased to $12.3 million in Q4 2025 from $8.1 million in Q4 2024, driven by higher compensation costs [22] - 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] - The planned phase III RESCUE program will evaluate NDV-01 in both second-line BCG unresponsive disease and as adjuvant therapy for intermediate-risk bladder cancer [14][15] Market Data and Key Metrics Changes - The U.S. market for intermediate-risk bladder cancer is estimated to have about 75,000-80,000 patients, with only 35% currently receiving adjuvant therapy [53] - The second-line treatment population for BCG unresponsive patients is estimated at about 5,000 patients per year in the U.S. [15] Company Strategy and Development Direction - The company aims to initiate the phase III RESCUE program for NDV-01 in mid-2026, focusing on two independent registrational pathways [6][14] - The strategy includes addressing unmet needs in bladder cancer treatment with a unique sustained-release formulation [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical programs and long-term prospects for Relmada, highlighting the importance of execution in the upcoming RESCUE program [24] - The company anticipates 2026 to be another significant year for value creation, with the initiation of key clinical trials [8] Other Important Information - The company has strengthened its development team with the appointment of Dr. Raj S. Pruthi as Chief Medical Officer-Oncology [7] - A successful $160 million private financing was completed, providing capital through 2029 [8] Q&A Session Summary Question: Will additional data from the phase II study be presented? - Management confirmed that updated 12-month data will be presented at the AUA and plans to share data every three months as the RESCUE trial progresses [29][30] 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 [31] Question: What is the expected enrollment cadence across the studies? - Management indicated that the unique in-office profile of NDV-01 could serve as a recruitment advantage, and they expect rapid enrollment [34] Question: What is the FDA's requirement for follow-up duration prior to submitting the NDA? - The FDA has not stipulated a minimum follow-up duration but is interested in the totality of the data, including response and durability [36] Question: How does the company expect to compare against competitors in terms of CR rates? - Management indicated that they are targeting a two-year RFS of 75% and believe they can exceed this based on their data [42] Question: How does the company plan to build the market for intermediate-risk patients? - Management noted that the market is currently underserved, with only 35% receiving adjuvant therapy, and expects this number to grow as data from their studies becomes available [54]

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For fiscal year ended December 31, 2025 ☐ 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 charter) Nevada 45-5401931 (State or other jurisdiction o ...

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Positive 12-month Phase 2 data for NDV-01 in non-muscle invasive bladder cancer (NMIBC) demonstrated a 95% complete response (CR) rate at any time and a durable 76% CR rate at 12 months, with favorable safety profileCompleted an oversubscribed $160 million PIPE financing led by leading healthcare investors in March 2026, strengthens balance sheet to support NDV-01 Phase 3 developmentOn track to initiate Phase 3 RESCUE registrational program in second line (2L) BCG-unresponsive and adjuvant intermediate-risk ...

C O R P O R A T E O V E R V I E W Unlocking Life Changing Therapies March 2026 Disclosures The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement an ...

Core Insights - Relmada Therapeutics Inc is focused on developing therapies for central nervous system disorders, with a significant emphasis on its drug candidate NDV-01 for high-risk non-muscle invasive bladder cancer (NMIBC) [1][6] Stock Performance and Analyst Ratings - Mizuho Securities set a price target of $10 for RLMD, indicating a potential upside of approximately 69.2% from its trading price of $5.91 [2] - The stock has recently experienced a surge of 42% due to positive mid-stage study results for NDV-01, which reported a 12-month complete response rate of 76% [3][6] - Despite the surge, RLMD's current price is $5.91, reflecting a 3.90% decrease from the previous trading session [4] Market Capitalization and Trading Volume - Relmada's market capitalization is approximately $433.4 million, with a trading volume of 1,255,235 shares [4] Future Growth Potential - The promising data from NDV-01 and the planned phase III RESCUE studies, expected to start in mid-2026, could drive future growth for Relmada [5]