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]