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Core Viewpoint - Vir Biotechnology is focused on harnessing the human immune system to combat both infectious diseases and cancer, aiming to deliver transformational therapies for serious unmet medical needs [2][3]. Group 1: Company Overview - Vir Biotechnology is making swift progress across its pipeline in infectious disease and oncology [2]. - The company has a deep understanding of immunology since its inception, enabling the development of innovative solutions for serious diseases [3]. Group 2: Research and Development Focus - The company aims to utilize its powerful R&D engine to address devastating diseases in both infectious disease and oncology [3].

Summary of Vir Biotechnology FY Conference Call Company Overview - **Company**: Vir Biotechnology (NasdaqGS:VIR) - **Industry**: Biotechnology, focusing on infectious diseases and oncology - **Mission**: Harnessing the human immune system to combat diseases, including infectious diseases and cancer [2][3] Core Strategies and Pillars 1. **Hepatitis Delta Program**: - Aiming to deliver a transformational therapy for chronic hepatitis Delta, with a significant commercial opportunity in the U.S. and other regions [3][4] - Registration program for Hepatitis Delta is underway, with potential regulatory review expected in 2027 [4][16] - Estimated 174,000 viremic patients in key markets, with a global prevalence of about 7 million [6][9] 2. **T-cell Engagers for Oncology**: - Developing a clinical-stage lineup of dual-masked T-cell engagers targeting solid tumors, addressing high unmet needs [4][18] - Upcoming data on VIR-5500, a PSMA-targeting T-cell engager, expected in Q1 2026 [4][22] 3. **Discovery Engine**: - Focused on developing a pipeline of best-in-class preclinical T-cell engagers and cancer immunotherapies [5][30] - Utilizes a unique ProXTEN masking technology to enhance safety and efficacy of T-cell engagers [18][20] Key Data and Results - **Hepatitis Delta**: - Combination therapy of Tobevibart (monoclonal antibody) and elebsiran (siRNA) shows promising results, with 88% of patients achieving undetectable HDV RNA at 96 weeks [12][14] - Combination therapy demonstrated significant reductions in HBV surface antigen levels, critical for controlling the delta virus [13][15] - **Oncology**: - VIR-5500 has shown favorable efficacy and safety profiles in early trials, with low rates of cytokine release syndrome [22][25] - VIR-5818 (HER2-targeted) and VIR-5525 (EGFR-targeted) are also in development, with promising early efficacy signals [23][24] Financial and Strategic Partnerships - Entered a commercial license agreement with Norgine, including an upfront payment of EUR 550 million and milestone payments, which will help fund the Eclipse program [16][17] - Retained commercialization rights in the U.S. and other markets outside Greater China, indicating a strategic focus on growth in these regions [17] Future Milestones - Anticipated top-line data for the Eclipse studies in Q4 2026 and Q1 2027, with plans for rapid marketing authorization submission [31][32] - Continued focus on advancing the T-cell engager pipeline, with updates expected in early 2026 [32][33] Challenges and Considerations - Manufacturing scaling remains a focus, with expertise inherited from previous assets aiding in this process [39][40] - The company is not currently seeking additional opportunities in hepatitis B, focusing instead on existing programs [38] Conclusion Vir Biotechnology is positioned to make significant advancements in the treatment of hepatitis Delta and various cancers through its innovative therapies and strategic partnerships, with a strong pipeline and upcoming data expected to drive future growth and value creation [33]

Financial Highlights - Vir Biotechnology estimates approximately $781 million in cash and investments, providing a cash runway into Q4 2027[5, 6, 16, 52, 70] Chronic Hepatitis Delta (CHD) Program - The company's CHD combination therapy aims to drive near-term revenue sustainability[5, 15, 51] - In the Ph2 SOLSTICE trial, monthly combination therapy of tobevibart + elebsiran achieved undetectable HDV RNA in 88% of patients at Week 96, compared to 46% with monotherapy[29] - Approximately 90% of participants receiving tobevibart + elebsiran achieved very low HBsAg values by Week 24 and maintained suppression[35] - The ECLIPSE program is progressing ahead of schedule, with initial topline data anticipated in Q4 2026[46, 69] - Norgine holds an exclusive commercial license in Europe, Australia, and New Zealand, with an initial reimbursement of €55 million and potential milestones up to €495 million[49] Oncology Program - The company is accelerating its masked T-cell engager (TCE) immunotherapy portfolio[5, 15, 51] - VIR-5500 (PSMAxCD3) showed 100% PSA decline and 58% PSA50 responses at early doses in a Phase 1 study[61, 65] - VIR-5818 (HER2xCD3) showed a 33% response and 100% biomarker response in mCRC, with up to 50% tumor shrinkage across all HER2 tumors evaluated at early doses in a Phase 1 study[61]

Financial Position - Vir Biotechnology has approximately $781 million in cash and investments, providing a cash runway into Q4 2027[4]. - The company reported approximately $781 million in cash and investments, providing a cash runway into Q4 2027[15][21]. Chronic Hepatitis Delta (CHD) Therapy - The company aims to commercialize its chronic hepatitis delta (CHD) combination therapy to drive near-term revenue sustainability[4]. - The Phase 2 SOLSTICE trial for the CHD therapy shows that 88% of patients receiving the combination of tobevibart and elebsiran achieved undetectable HDV RNA by Week 96, compared to 46% with monotherapy[10]. - Nearly 90% of participants receiving the combination therapy achieved very low HBsAg values by Week 24, maintaining suppression[11]. - The CHD combination therapy is characterized by two complementary mechanisms of action, potentially making it best-in-class[8]. - The combination therapy of tobevibart and elebsiran achieved HDV RNA target not detected (TND) in 88% of participants by Week 96, with approximately 90% achieving HBsAg reductions to <10 IU/mL by Week 24[12]. - Vir Biotechnology has entered a collaboration with Norgine for the commercialization of its CHD regimen in Europe, Australia, and New Zealand, with an initial reimbursement of €55 million and potential milestones up to €495 million[14]. Oncology Pipeline - The oncology pipeline includes significant unmet needs, with projected drug-treated patients for various cancers reaching up to 431,000 for mNSCLC and 271,000 for mCRC by 2032[5]. - Vir Biotechnology's oncology solid tumor portfolio is expected to create sustainable long-term growth through its robust pipeline of cancer immunotherapies[4]. - The masked T-cell engager (TCE) portfolio is expected to drive near-term revenue sustainability and long-term growth through innovative cancer immunotherapies[15]. - The VIR-5500 PSMA-targeted TCE showed a 100% response rate in early dose cohorts, with 58% achieving PSA50 responses[19]. - The company aims to unlock multiple high-value indications with its TCE pipeline, targeting various solid tumors[18]. Research and Development - The company is leveraging AI and machine learning in its research and development efforts to engineer next-generation proteins[2]. - The PRO-XTEN® masking platform enhances the therapeutic index of TCEs, allowing for higher dosing and reduced toxicity[16]. Clinical Milestones - The ECLIPSE clinical program is progressing ahead of schedule, with initial topline data anticipated in Q4 2026 for ECLIPSE 1, and Q1 2027 for ECLIPSE 2 and 3[13]. - Upcoming clinical milestones include topline data for ECLIPSE 1 in Q4 2026 and updates on VIR-5500 and VIR-5818 in early 2026 and 2H 2026, respectively[24][25]. Strategic Collaborations - The company is focusing on strategic collaborations to unlock the value of its pipeline and maximize patient benefits[4]. - Vir Biotechnology retains all commercialization rights in the U.S. and other markets outside of Greater China, while Brii Biosciences holds rights in the Greater China Territory[14].

SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the Company has granted Norgine Pharma UK Limited, an affiliate of Norgine, a leading European specialty pharmaceutical company, an exclusive license for the commercial rights to the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta (CHD) in Europe, Australia and New Zealand. 1 Per the terms of the agreement, Vir Biotechnology will receive an initial reimbursement payment of EUR 55 m ...

Healthcare & Biotechnology Focus - Vir Biotechnology's CEO emphasizes a holistic approach to healthcare, encompassing prevention, treatment, and cure [1] - The CEO discussed the role of Artificial Intelligence (AI) in healthcare at the ForbesHealth Summit [1]

Summary of Vir Biotechnology FY Conference Call - December 03, 2025 Company Overview - **Company**: Vir Biotechnology (NasdaqGS:VIR) - **Focus**: Development of innovative therapies for infectious diseases and cancer, particularly through T cell engagers and hepatitis programs Key Accomplishments in 2025 - **Clinical Programs**: Significant advancements in three clinical-stage T cell engagers and a registration program for hepatitis delta [2][4] - **Data Reporting**: First-time reporting of data on Vir-5500 (PSMA CD3 T cell engager) and Vir-5818 (HER2 CD3 T cell engager) with promising early results [2][3] - **Hepatitis Delta Program**: Achieved transformative data with 66% of patients achieving undetectable virus levels after 48 weeks of treatment [4] Clinical Development Highlights - **Vir-5500**: - Unique dual masking technology enhances safety and efficacy by preventing toxicity associated with naked PSMA T cell engagers [8][10] - Extended half-life of 8-10 days allows for less frequent dosing [10] - Early clinical data showed 58% of patients achieving a PSA reduction of 50, with only 25% experiencing any CRS (cytokine release syndrome) [15][16] - **Hepatitis Delta**: - Phase two Solstice trial demonstrated significant efficacy, with 66% of patients achieving target not detected status [4][30] - Enrollment for phase three trials (Eclipse) completed ahead of schedule, indicating strong demand for therapy [32] Differentiation and Competitive Landscape - **Masking Technology**: - Vir-5500 utilizes a dual masking approach that is distinct from single mask competitors, providing a better therapeutic index [21][22] - The Xtend mask technology has been validated in other marketed drugs, enhancing confidence in safety and efficacy [11][22] - **Market Positioning**: - Potential to position Vir-5500 in both pre- and post-Pluvicto treatment settings, aiming for a balance of efficacy and safety [26][27] Future Expectations - **Upcoming Data**: - Next data cut expected in January will focus on early readouts such as PSA levels and safety data, with a meaningful dataset anticipated [24] - **Product Presentation**: - Anticipated to be two subcutaneous injections, allowing for at-home administration or by healthcare professionals [33] Industry Insights - **Feedback from Medical Community**: - Positive reception from KOLs regarding the unmet medical need in hepatitis delta, with enthusiasm for the efficacy demonstrated in clinical trials [29][30] - **Enrollment Trends**: - Rapid enrollment in Eclipse trials reflects strong demand and interest in the hepatitis delta treatment [32] Conclusion - Vir Biotechnology has made significant strides in its clinical programs, particularly with its innovative masking technology for T cell engagers and promising results in its hepatitis delta program. The company is well-positioned to address unmet medical needs in both oncology and infectious diseases, with strong support from the medical community and a clear path forward for upcoming data releases and product development.

Core Insights - Premarket trading is showing notable activity with early price movements indicating potential opportunities before the market opens [1] Premarket Gainers - Mawson Infrastructure Group Inc. (MIGI) is up 10% at $5.65 [3] - Mingteng International Corporation Inc. (MTEN) is up 9% at $1.88 [3] - Barnwell Industries, Inc. (BRN) is up 9% at $1.20 [3] - Amentum Holdings, Inc. (AMTM) is up 8% at $27.57 [3] - Antelope Enterprise Holdings Limited (AEHL) is up 8% at $2.75 [3] - Protagenic Therapeutics, Inc. (PTIX) is up 8% at $2.43 [3] - Envirotech Vehicles, Inc. (EVTV) is up 8% at $1.18 [3] - Vir Biotechnology, Inc. (VIR) is up 6% at $6.49 [3] - Zoom Communications Inc. (ZM) is up 5% at $82.73 [3] - Core AI Holdings (CHAI) is up 5% at $2.68 [3] Premarket Losers - Foxx Development Holdings Inc. (FOXX) is down 13% at $4.00 [4] - Jaguar Health, Inc. (JAGX) is down 11% at $1.13 [4] - AlphaTON Capital Corp. (ATON) is down 7% at $2.54 [4] - Semtech Corporation (SMTC) is down 6% at $65.81 [4] - Cypherpunk Technologies Inc. (CYPH) is down 5% at $1.73 [4] - SunPower Inc. (SPWR) is down 5% at $1.59 [4] - Visionary Holdings Inc. (GV) is down 4% at $1.23 [4] - Gelteq Limited (GELS) is down 4% at $1.01 [4] - Capricor Therapeutics, Inc. (CAPR) is down 3% at $4.47 [4] - Mobile-Network Solutions (MNDR) is down 3% at $2.82 [4]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Chijet Motor Company, Inc. (CJET) is up 40% at $2.67 - JX Luxventure Group Inc. (JXG) is up 19% at $4.12 - Inspire Medical Systems, Inc. (INSP) is up 15% at $103.50 - Epsium Enterprise Limited (EPSM) is up 15% at $4.14 - Oscar Health, Inc. (OSCR) is up 12% at $15.13 - Green Dot Corporation (GDOT) is up 11% at $13.21 - Butterfly Network, Inc. (BFLY) is up 6% at $2.82 - Cullinan Therapeutics, Inc. (CGEM) is up 5% at $10.00 - Vir Biotechnology, Inc. (VIR) is up 5% at $5.99 - Nvni Group Limited (NVNI) is up 5% at $3.17 [3] Premarket Losers - Clearside Biomedical, Inc. (CLSD) is down 69% at $0.82 - Twin Hospitality Group Inc. (TWNP) is down 20% at $2.84 - Shuttle Pharmaceuticals Holdings, Inc. (SHPH) is down 15% at $1.35 - Mobile-Network Solutions (MNDR) is down 12% at $4.16 - Waldencast plc (WALD) is down 10% at $2.75 - authID Inc. (AUID) is down 9% at $1.21 - EZGO Technologies Ltd. (EZGO) is down 6% at $1.98 - SciSparc Ltd. (SPRC) is down 5% at $2.34 - Twin Vee Powercats Co. (VEEE) is down 5% at $1.70 - Agape ATP Corporation (ATPC) is down 5% at $1.22 [4]