Financial Data and Key Metrics Changes - R&D expenses for 2025 were $456 million, a decrease of $51 million or 10% from $507 million in 2024 [42] - SG&A expenses decreased to $92 million in 2025 from $119 million in the prior year, representing a 23% reduction [42] - The net loss for 2025 was $438 million, compared to $522 million in 2024 [43] - The company started 2026 with approximately $782 million in cash, cash equivalents, and investments, not including the upfront cash and equity from the Astellas collaboration [43] Business Line Data and Key Metrics Changes - The collaboration with Astellas is focused on the development and commercialization of VIR-5500, a T-cell engager for prostate cancer [6][12] - The total potential in combined upfront and milestone payments from the collaboration is $1.7 billion, with a 50/50 profit-sharing arrangement in the U.S. [13][41] Market Data and Key Metrics Changes - Prostate cancer represents a significant global health burden, with 1 in 8 men diagnosed in their lifetime and a five-year survival rate of only 30% for patients with metastatic castration-resistant prostate cancer (mCRPC) [9] - There are approximately 100,000 mCRPC patients in the U.S. and Europe, indicating a substantial unmet need for novel treatment solutions [9] Company Strategy and Development Direction - The strategic collaboration with Astellas aims to accelerate the development of VIR-5500 across various lines of prostate cancer, unlocking significant market opportunities [7][12] - The company plans to initiate dose expansion cohorts in late-line mCRPC monotherapy and combinations in the second quarter of 2026 [38][61] - The PRO-XTEN platform is expected to enable the development of next-generation T-cell engagers for solid tumors, with plans for further preclinical programs [44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of VIR-5500, highlighting its favorable safety and efficacy profile based on emerging Phase I data [6][18] - The collaboration with Astellas is seen as a key factor in maximizing the potential of VIR-5500 and expanding the company's pipeline [44][45] Other Important Information - The Phase I clinical study of VIR-5500 showed a favorable safety profile with no observed dose-limiting toxicities and limited cytokine release syndrome [30][32] - The company is positioned to transition into expansion cohorts and plans to continue dose optimization to meet FDA requirements [38][39] Q&A Session Summary Question: Can you comment on the range of PSA responses seen by prior line of therapies, particularly with regard to prior radiotherapy? - Management noted strong PSA responses, particularly at higher doses, but specific effects of prior treatments on PSA responses were difficult to determine due to the heavily pretreated population [52][54] Question: What are the next steps before moving to Phase 3 with Astellas? - The company plans to initiate expansion cohorts in Q2 2026, focusing on late-line mCRPC as a monotherapy and combinations with other therapies [60][61] Question: How does the larger cohort of patients evaluated on VIR-5500 evolve the thinking about its positioning within the treatment paradigm? - Management indicated plans to address a broad range of patients, including late-line mCRPC and combinations, highlighting the high unmet need in these populations [66] Question: Can you provide more information on the go-forward dose? - The go-forward dose is expected to be in the range of 3,000 to 3,500 micrograms per kilogram, with compelling dose-response data observed [76][77]

Core Insights - Vir Biotechnology has announced significant partnerships and advancements in its pipeline, including a global collaboration with Astellas and promising Phase 1 data for its oncology program VIR-5500, which targets hard-to-treat cancers [2][4]. Pipeline Programs - The company is advancing several investigational therapies, including VIR-5500 for metastatic castration-resistant prostate cancer (mCRPC), with positive Phase 1 data indicating dose-dependent anti-tumor activity [4][7]. - The Phase 1 study of VIR-5818, targeting HER2, is ongoing, with response data expected in the second half of 2026 [4]. - The Phase 1 study of VIR-5525, targeting EGFR, continues to enroll participants as planned [5]. Chronic Hepatitis Delta (CHD) Program - Vir Biotechnology has licensed to Norgine the combination of tobevibart and elebsiran for treating CHD, aiming to reach patients globally [2][7]. - Phase 2 SOLSTICE data showed that the combination therapy achieved undetectable hepatitis delta virus RNA in 88% of participants at Week 96 [7]. - The ECLIPSE registrational program is designed to evaluate the safety and efficacy of tobevibart and elebsiran, with topline data from ECLIPSE 1 expected in Q4 2026 and from ECLIPSE 2 and 3 in Q1 2027 [21]. Financial Results - As of December 31, 2025, the company reported approximately $781.6 million in cash, cash equivalents, and investments, a decline of $29.1 million in Q4 2025 [9]. - Revenue for Q4 2025 was $64.1 million, a significant increase from $12.4 million in Q4 2024, primarily due to a $64.3 million license revenue from the Norgine agreement [10]. - The net loss for Q4 2025 was $(42.9) million, an improvement from a net loss of $(104.6) million in Q4 2024 [17]. Future Outlook - The company expects its cash reserves to fund operations into the second quarter of 2028, bolstered by the Astellas collaboration and equity investment [18]. - The company plans to initiate pivotal Phase 3 trials for its oncology programs in 2027, following the expansion of dose cohorts for VIR-5500 [7][8].