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]

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]