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]

Summary of Vir Biotechnology Conference Call Company Overview - **Company**: Vir Biotechnology (NasdaqGS:VIR) - **Industry**: Biotechnology focusing on immunology and infectious diseases Core Points and Arguments 1. **Commitment to Immunology**: Vir Biotechnology aims to leverage the human immune system to transform patient lives, with past successes in COVID-19 and Ebola treatments [2][3] 2. **Innovative Therapeutics**: The company is developing therapies that empower the immune system to combat cancer and viral infections, utilizing a patented platform for T-cell engagers [3][4] 3. **Pipeline Overview**: The pipeline includes multiple programs in oncology and infectious diseases, with a focus on solid tumors and hepatitis delta [4][5] 4. **Financial Position**: As of Q3, Vir has approximately $811 million in cash, providing a runway into mid-2027 to advance critical programs [6][30] 5. **Oncology Programs**: - **VIR-5500**: A PSMA-CD3 T-cell engager in phase 1 for prostate cancer, showing promising early results with significant PSA declines [12][14] - **VIR-5818**: A HER2 CD3 T-cell engager in phase 1, demonstrating transformative potential in heavily pretreated patients [19][20] - **VIR-5525**: An EGFR CD3 T-cell engager program, recently initiated in phase 1 [21] 6. **Hepatitis Delta Program**: - Currently in phase 3 trials, aiming to provide a chronic suppressive therapy with a dual regimen of an antibody and siRNA [5][25] - Recent data shows 66% of patients achieving "target not detected" status for Delta RNA after 48 weeks of treatment [25][26] - Monthly dosing regimen enhances patient compliance compared to daily injections required by existing treatments [27] 7. **Regulatory Designations**: The hepatitis delta program has received multiple designations from the FDA and EMA, facilitating accelerated development [28][29] 8. **Strategic Partnerships**: The company is actively pursuing partnerships for its hepatitis delta program and T-cell engager programs to enhance development and market reach [30] Additional Important Information - **T-cell Engager Technology**: The ProX10 platform allows for a universal masking approach to T-cell engagers, minimizing toxicity and enhancing therapeutic index [10][11] - **Patient Case Studies**: Specific patient cases highlighted the efficacy and safety of VIR-5500 and VIR-5818, showcasing significant tumor response and minimal toxicity [14][20] - **Market Need**: Hepatitis delta represents a significant unmet medical need, with no current treatment options available in the U.S. [24][25] This summary encapsulates the key points discussed during the conference call, emphasizing the company's innovative approaches, pipeline developments, and strategic positioning within the biotechnology industry.

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Core Insights - Vir Biotechnology, Inc. announced positive results from the Week 48 endpoint analysis of its Phase 2 SOLSTICE trial for chronic hepatitis delta (CHD) [1] Group 1: Trial Results - Participants receiving a monthly dose of the combination of tobevibart and elebsiran achieved robust and sustained rates of hepatitis delta virus (HDV) RNA target not detected (TND) [1] - The combination treatment was effective even among participants with cirrhosis and high baseline HDV RNA levels [1]

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Company Performance - Vir Biotechnology reported a quarterly loss of $1.17 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.7, representing an earnings surprise of -67.14% [1] - The company posted revenues of $0.24 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 96.59%, compared to revenues of $2.38 million in the same quarter last year [2] - Over the last four quarters, Vir Biotechnology has surpassed consensus EPS estimates only once and has not beaten consensus revenue estimates during this period [2] Stock Performance - Shares of Vir Biotechnology have declined approximately 28.5% since the beginning of the year, contrasting with the S&P 500's gain of 15.1% [3] - The current Zacks Rank for the stock is 3 (Hold), indicating that shares are expected to perform in line with the market in the near future [6] Future Outlook - The consensus EPS estimate for the upcoming quarter is -$0.64 on revenues of $5.59 million, while for the current fiscal year, the estimate is -$3.11 on revenues of $15.09 million [7] - The outlook for the industry, specifically the Medical - Biomedical and Genetics sector, is currently in the top 40% of over 250 Zacks industries, suggesting a favorable environment for stock performance [8]