Financial Data and Key Metrics Changes - R&D expense for Q3 2025 was $151.5 million, down from $195.2 million in Q3 2024, primarily due to lower license expenses and cost savings from restructuring initiatives [18][19] - SG&A expense for Q3 2025 was $22.2 million, compared to $25.7 million in Q3 2024, reflecting efficiencies from restructuring [19] - Net loss for Q3 2025 was $163.1 million, an improvement from a net loss of $213.7 million in the same period last year [19] - The company ended Q3 2025 with approximately $810.7 million in cash, cash equivalents, and investments, projecting a cash runway extending into mid-2027 [20][21] Business Line Data and Key Metrics Changes - The hepatitis delta program achieved significant milestones, including the completion of enrollment in the ECLIPSE-1 study, which is pivotal for regulatory submissions [4][5] - The oncology portfolio is advancing with multiple T-cell inhibitor programs, including Vireo 5500, Vireo 5818, and Vireo 5525, with ongoing dose escalation and patient enrollment [8][16] Market Data and Key Metrics Changes - The hepatitis delta market has approximately 61,000 RNA-positive patients in the U.S. and 113,000 in EU markets, indicating a substantial commercial opportunity [6] - The company is preparing to present the complete 48-week SOLSTICE data set at AASLD, which is expected to provide insights into the safety and efficacy of its combination regimen [6][12] Company Strategy and Development Direction - The company is focused on advancing its registrational hepatitis delta program and oncology pipeline, prioritizing investments in programs with the greatest potential for patient impact and value creation [20][21] - The ProX10 platform is being leveraged to develop T-cell inhibitors targeting various tumor-associated antigens, with a strategic approach combining internal development and potential partnerships [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data updates and the potential for significant value-creating opportunities ahead, particularly in the hepatitis delta and oncology programs [3][4] - The completion of ECLIPSE-1 enrollment ahead of projections reflects strong investigator confidence and the unmet medical need in hepatitis delta [5][10] Other Important Information - The company plans to share a comprehensive data update for Vireo 5500 in the first quarter of 2026, which will include insights from multiple dose levels [7][25] - The ECLIPSE-3 study is progressing ahead of schedule and will provide critical comparative data for access and reimbursement discussions [12][16] Q&A Session Summary Question: Differentiation of PSMA asset and clinical bar for HDV - Management highlighted excitement for the upcoming data update for Vireo 5500 and emphasized the unique dual masking approach of the ProX10 platform, which aims for exceptional therapeutic index [25][26] - For HDV, management expects strong virologic outcomes from the ECLIPSE program, with significant efficacy in suppressing HDV viral RNA [27] Question: Timing of Vireo 5500 data presentation and AASLD focus - The exact timing for the Vireo 5500 update in Q1 2026 is yet to be announced, while the AASLD presentation will focus on the complete 48-week data for the combination regimen [30] Question: Clarification on Vireo 5500 update and Gilead's bulevirtide - The first quarter update will not include data from the first-line mCRPC combination study, and management views Gilead's upcoming launch as a positive for driving disease awareness [34][35] Question: Addressable patient population for HDV treatment - The company estimates approximately 61,000 viremic patients in the U.S. and plans to treat a broad population, leveraging the high unmet medical need for effective therapies [53][54]