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]

Core Insights - Relmada Therapeutics has made significant advancements in its lead program NDV-01, which shows promise as a best-in-class therapy for non-muscle invasive bladder cancer (NMIBC) [2][5][12] - The company successfully completed a $160 million PIPE financing, enhancing its financial position to support the development of NDV-01 [2][5] - Relmada is on track to initiate the Phase 3 RESCUE program for NDV-01 in mid-2026, following regulatory alignment with the FDA on two registrational pathways [2][3][4] Pipeline Progress - NDV-01 demonstrated a 95% complete response (CR) rate at any time and a durable 76% CR rate at 12 months in high-risk NMIBC patients, with no patients experiencing progression to muscle-invasive disease [5][6] - The FDA has confirmed alignment on two registrational pathways for NDV-01, which includes an open-label randomized controlled trial and a single-arm trial for BCG-unresponsive patients [3][4][7] Financial Performance - For the fourth quarter of 2025, the company reported a net loss of $19.9 million, or $0.27 per share, compared to a net loss of $18.6 million, or $0.62 per share, in the same period of 2024 [10][24] - The total operating expenses for the year ended December 31, 2025, were $59.1 million, a decrease from $83.9 million in 2024, primarily due to reduced research and development costs [10][24] - The cash balance as of December 31, 2025, was $93.0 million, bolstered by the recent PIPE financing, which is expected to fund operations through 2029 [5][10][26] Upcoming Milestones - The company plans to initiate the Phase 3 RESCUE program for NDV-01 in mid-2026, with initial data expected by the end of 2026 [10][12] - Sepranolone Phase 2 initiation in Prader-Willi syndrome is also expected in mid-2026 [10][12]

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 has experienced a transformational year in 2025, with significant progress in its clinical development and strategic initiatives [1] Strategic Review and Portfolio Expansion - A comprehensive strategic review was completed, reaffirming the mission to develop life-changing treatments and diversify the portfolio [2] - Two new Phase 2 product candidates were added, enhancing the long-term value proposition of the company [2] NDV-01 Development - NDV-01 has shown a 91% complete response rate in a Phase 2 study for non-muscle invasive bladder cancer (NMIBC), affecting approximately 600,000 patients in the U.S. [2] - Preparations are underway to initiate a Phase 3 registrational trial in the first half of 2026, including regulatory filings and manufacturing scale-up [3][8] - The NDV-01 program is further supported by the addition of two experts in bladder cancer to the team [4] Sepranolone Advancement - Positive proof-of-concept data in Tourette's syndrome indicates potential for sepranolone in treating compulsive disorders [5] - A Phase 2 study for sepranolone in Prader-Willi Syndrome (PWS) is planned to begin in the first half of 2026, targeting a rare genetic disorder affecting 350,000–400,000 people worldwide [5][13] Key Upcoming Milestones - Upcoming milestones include Phase 2 results for NDV-01 in Q4 2025 and Q1 2026, product supply scale-up in the second half of 2025, and U.S. IND clearance in the first half of 2026 [8] - The initiation of the Phase 3 registrational trial for NDV-01 is also scheduled for the first half of 2026 [8] Company Outlook - The company remains optimistic about its future, with the progress of NDV-01 and sepranolone, alongside a strengthened team, positioning it well for value creation [9]

Financial Data and Key Metrics Changes - As of December 31, 2024, cash, cash equivalents, and short-term investments totaled approximately $44.9 million, down from $96.3 million as of December 31, 2023 [34] - Net cash used in operating activities for Q4 2024 was approximately $8.8 million, compared to $10.2 million for the same period in 2023 [34] - The net loss for Q4 2024 was $18.6 million or $0.62 per basic and diluted share, compared to a net loss of $25.1 million or $0.84 per basic and diluted share for Q4 2023 [37] Business Line Data and Key Metrics Changes - Research and development expenses for Q4 2024 totaled $11 million, down from $14.7 million in Q4 2023, a decrease of $3.7 million [35] - General and administrative expenses for Q4 2024 were $8.1 million, compared to $12.1 million in Q4 2023, a decrease of approximately $4 million [36] Company Strategy and Development Direction - The company is focused on three priorities: progressing its product pipeline, exploring product acquisition opportunities, and maintaining careful resource prioritization [7][39] - The acquisition of NDV-01 and Sepranolone aligns with the company's strategy to maximize shareholder value and address underserved markets [10][22] - The company aims to present top-line safety and efficacy data for NDV-01 at the American Urological Association Meeting in April 2025 [14][40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strategic product acquisition process and the potential of NDV-01 and Sepranolone to address significant medical needs [9][39] - The company is cautious about the competitive landscape in metabolic disease and is reevaluating the development of REL-P11 [31][32] - Management highlighted the importance of aligning with the FDA on regulatory paths for both NDV-01 and Sepranolone [40] Other Important Information - The company has identified additional attractive opportunities for strategic product acquisition following the discontinuation of Phase 3 studies for REL-1017 [10] - NDV-01 is currently in a Phase 2 study for high-grade non-muscle invasive bladder cancer, with expectations for positive results [12][15] Q&A Session Summary Question: Understanding the acquisition process for NDV-01 and data expectations at the AUA meeting - Management indicated that the acquisition of NDV-01 was competitive, with Relmada's strong development capability being a key factor in winning the bid [45][48] - Regarding data expectations, management noted that the data will be collected in real-time and will not be included in the abstract due to ongoing patient evaluations [51][52] Question: Safety profile of Sepranolone and its potential in Prader-Willi syndrome - Management confirmed that Sepranolone has a well-known safety profile with low incidence of side effects, making it a well-tolerated drug [60] - There is confidence that Sepranolone can complement existing treatments for Prader-Willi syndrome due to its unique mechanism of action [61] Question: Approvable endpoints for pivotal studies and potential for accelerated approval for NDV-01 - Management stated that endpoints for Tourette syndrome will likely include the Yale scale, focusing on both tic control and compulsive behavior [66] - Discussions regarding the regulatory process for NDV-01 will occur after data presentation, with hopes for an accelerated approval pathway [70] Question: Future in-licensing of compounds - Management remains open to in-licensing opportunities but emphasizes the need for selectivity in acquiring products that meet their strategic criteria [72][74]