Vir(US:VIR)2025-08-06 21:30Financial Data and Key Metrics Changes - R&D expenses for Q2 2025 were $97.5 million, down from $105.1 million in Q2 2024, primarily due to cost savings from restructuring initiatives [34] - SG&A expenses for Q2 2025 were $22.3 million, compared to $30.3 million in Q2 2024, reflecting ongoing cost savings [35] - The net loss for Q2 2025 was CAD 111 million, an improvement from a net loss of CAD 138.4 million in Q2 2024 [35] - Cash, cash equivalents, and investments at the end of Q2 2025 totaled approximately $892 million, providing a cash runway extending into mid-2027 [36][37] Business Line Data and Key Metrics Changes - The ECLIPSE registrational program for hepatitis delta is actively recruiting patients globally, with significant progress in all three studies [5][15] - The oncology portfolio includes advancements in T cell engager programs, with the initiation of the Phase I study for VER-5525 [5][20] Market Data and Key Metrics Changes - The global market for hepatitis delta includes approximately 7 million active HBV RNA positive patients, with 61,000 in the U.S. and 113,000 in the EU [6][7] - The patient population is concentrated in major urban centers in the U.S., allowing for a targeted commercial approach [7] Company Strategy and Development Direction - The company aims to pursue commercialization partnerships in Europe and other key international markets for its hepatitis delta program [9] - The oncology strategy focuses on advancing clinical stage T cell engager programs and exploring their potential in earlier lines of treatment [14][37] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in the hepatitis delta program and the potential for effective intervention due to the high mortality rate associated with untreated disease [7][8] - The company is focused on maximizing the value of its assets while maintaining strict financial discipline [37] Other Important Information - The company received IND clearance to evaluate SER-5525 in earlier lines of prostate cancer treatment, marking an important step in its oncology strategy [12][31] - The Pro X10 platform's clinical validation across multiple targets is expected to enhance the development of preclinical candidates [32] Q&A Session Summary Question: Enrollment update on the ECLIPSE programs - Management confirmed that enrollment in ECLIPSE one is progressing well, with expectations to complete enrollment by the end of the year [44][45] Question: ECLIPSE one and two data for registration - Both ECLIPSE one and two are expected to be needed for the U.S. regulatory filing, but there are scenarios where ECLIPSE one could be filed with Solstice if it completes ahead [63][91] Question: Competitive landscape in chronic hepatitis delta - Management views the competitive landscape positively, noting that Gilead's potential approval could help educate physicians and promote testing for HBV, benefiting the company's launch [73][74]