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]
Relmada Therapeutics(RLMD) - 2025 Q2 - Earnings Call Transcript