At 6:45 a.m. ET on Tuesday, premarket trading is seeing notable activity in several stocks, with early price movements signaling potential opportunities before the opening bell.For active traders, premarket trading offers a head start in spotting potential breakouts, reversals, or sharp price swings. These early moves often indicate where momentum may carry into the regular session, making premarket analysis a key part of the trading day.In the Green - Premarket GainersThe following stocks are trading high ...

At 7:35 a.m. ET on Monday, premarket trading is seeing notable activity in several stocks, with early price movements signaling potential opportunities before the opening bell.For active traders, premarket trading offers a head start in spotting potential breakouts, reversals, or sharp price swings. These early moves often indicate where momentum may carry into the regular session, making premarket analysis a key part of the trading day.In the Green - Premarket GainersThe following stocks are trading highe ...

Vir Biotechnology (NasdaqGS:VIR) 2025 Conference November 18, 2025 09:00 AM ET Company ParticipantsMarianne Backer - CEOModeratorGood afternoon, everyone. Thank you for joining Jefferies Healthcare Conference 2025 edition. I'm very happy to have Marianne Backer with us, CEO of Vir Biotechnology. Thank you.Marianne BackerThank you, Juliette. Hello and good afternoon, everyone. Thank you, Jefferies, for the opportunity to provide the latest update on Vir Biotechnology and the rapid progress we are making acro ...

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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]

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]

Financial Performance - Total revenues for the three months ended September 30, 2025, were $240,000, a decrease of 89.9% compared to $2,380,000 for the same period in 2024[14] - Net loss for the three months ended September 30, 2025, was $163,141,000, compared to a net loss of $213,717,000 for the same period in 2024, representing a 23.6% improvement[14] - For the nine months ended September 30, 2025, the net loss was $395.064 million, an improvement from a net loss of $417.371 million in the same period of 2024, representing a decrease of approximately 5.5%[25] - The basic and diluted net loss per share for the three months ended September 30, 2025, was $(1.17), compared to $(1.56) for the same period in 2024, indicating a 25% reduction in loss per share[91] - Total revenues for the nine months ended September 30, 2025, were $4,486 thousand, down $57,345 thousand from $61,831 thousand in 2024[132] Expenses and Liabilities - Research and development expenses for the nine months ended September 30, 2025, were $367,617,000, a decrease of 8.2% from $400,416,000 for the same period in 2024[14] - The company had total current liabilities of $75,222,000 as of September 30, 2025, down from $119,662,000 as of December 31, 2024, a decrease of 37.1%[12] - Stock-based compensation expenses decreased to $37.866 million in 2025 from $62.616 million in 2024, a reduction of about 39.5%[25] - Total operating expenses for the nine months ended September 30, 2025, were $435,893 thousand, down $95,953 thousand from $531,846 thousand in 2024[132] Cash and Investments - Cash and cash equivalents as of September 30, 2025, were $170,084,000, down from $222,947,000 as of December 31, 2024, reflecting a decrease of 23.6%[12] - The company had $810.7 million in cash, cash equivalents, and investments as of September 30, 2025, which is expected to fund operations for at least the next twelve months[29] - The total cash, cash equivalents, and investments as of September 30, 2025, were $810.7 million[50] - The company expects to fund operations for at least the next 12 months with existing cash and investments[148] Assets and Equity - Total assets decreased to $1,019,453,000 as of September 30, 2025, from $1,398,813,000 as of December 31, 2024, a decline of 27.2%[12] - Total stockholders' equity as of September 30, 2025, was $796,098,000, down from $1,150,385,000 as of December 31, 2024, indicating a decrease of 30.8%[12] - As of September 30, 2025, total financial assets amounted to $801.2 million, a decrease from $1,095.4 million as of December 31, 2024[50] Research and Development - The company is focused on developing medicines for serious infectious diseases and cancer, with a clinical-stage portfolio that includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers[27] - The ECLIPSE 1 Phase 3 trial for Chronic Hepatitis Delta (CHD) completed enrollment approximately two months ahead of projections, with topline data expected in Q1 2027[109] - The ECLIPSE 2 Phase 3 trial continues to enroll well, with topline data also expected in Q1 2027[109] - The company expects research and development expenses to increase substantially as product candidates advance through clinical studies[121] Collaborations and Agreements - The upfront payment made to Sanofi under the license agreement was $100 million, with an additional $75 million milestone payment made during the three months ended September 30, 2025[66] - The Company has potential future milestone payments to Sanofi totaling up to $1.49 billion based on commercial net sales[67] - The company paid Alnylam $30 million in connection with the Restated Alnylam Agreement, with remaining development and regulatory milestones totaling $145 million[73] - The company is obligated to make substantial payments upon achieving milestone events in strategic collaboration and license agreements[208] Risks and Challenges - The company may require substantial additional funding to finance its operations, and if unable to raise capital when needed, it could be forced to delay or terminate certain research and development programs[177] - The company faces risks related to the lengthy and expensive clinical product development process, which may incur additional costs and delays[170] - The company may encounter difficulties in patient enrollment and retention for clinical studies, which could delay product development and approval[203] - The company has limited prior experience in marketing approved products outside the United States, which subjects it to additional regulatory and operational risks[191] Future Outlook - The company does not expect to generate significant revenue from product candidates until clinical development is completed and regulatory approvals are obtained[113] - The company expects to continue incurring significant expenses and net losses in the foreseeable future as it develops its product candidates and technology platforms[172] - The company anticipates nominal collaboration revenue in 2025 from the GSK Agreement, with potential negative revenue due to ongoing support costs[117]

Financial Overview - Vir Biotechnology had $810.7 million in cash and investments as of September 30, 2025, providing a cash runway into mid-2027[11] - Q3 2025 total revenues were $0.2 million, a 92% decrease from $2.4 million in Q3 2024[134] - Research and development expenses for Q3 2025 were $151.5 million, a 22% decrease from $195.2 million in Q3 2024[134] - Net loss for Q3 2025 was $(163.1) million, compared to $(213.7) million in Q3 2024, a 24% improvement[134] Hepatitis Delta Program (Tobevibart + Elebsiran) - In an ongoing Phase 2 trial, 41% of participants achieved HDV RNA <Target Not Detected (0 IU/mL) at 24 weeks, and 64% at 36 weeks with tobevibart + elebsiran Q4W de novo[31] - 90% of participants receiving tobevibart + elebsiran achieved HBsAg <10 IU/mL, compared to only 22% with tobevibart monotherapy Q2W at Week 24[36] - ECLIPSE 1, a Phase 3 trial for Hepatitis Delta, is fully enrolled, with topline data for all three ECLIPSE studies expected in Q1 2027[40] Oncology - PRO-XTEN® Masked TCE Platform - VIR-5500 (PSMA): In Phase 1 testing, 58% of patients with 1st dose ≥ 120 µg/kg showed PSA50 responses[66] - VIR-5818 (HER2): In heavily pre-treated CRC patients (≥400 µg/kg), a 33% response rate was observed[118] - VIR-5818 (HER2): ctDNA Molecular response in 54% of subjects[118] - VIR-5525 (EGFR): Phase 1 study initiated in Q3 2025, targeting NSCLC, CRC, HNSCC, and cSCC[51]