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VIR Jul 2021 70.000 call

OPR - OPR Delayed price. Currency in USD
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2.90000.0000 (0.00%)
As of 1:53PM EDT. Market open.
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Previous close2.9000
Open3.3000
Bid0.9500
Ask1.8500
Strike70.00
Expiry date2021-07-16
Day's range2.9000 - 3.3000
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Volume10
Open interest30
  • GSK and Vir Biotechnology Announce the Start of the EMA Rolling Review of  VIR-7831 (sotrovimab) for the Early Treatment of COVID-19
    GlobeNewswire

    GSK and Vir Biotechnology Announce the Start of the EMA Rolling Review of VIR-7831 (sotrovimab) for the Early Treatment of COVID-19

    – Rolling review will evaluate sotrovimab in adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19 – – Review will support a formal Marketing Authorization Application – – GSK and Vir continue discussions with global regulators to make sotrovimabavailable to patients with COVID-19 – LONDON and SAN FRANCISCO, May 07, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the European Medicines Agency (EMA) has started a rolling review of data on sotrovimab (previously VIR-7831), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The rolling review will continue until enough evidence is available to support a formal marketing authorization application. The EMA will assess the medicine’s compliance with the usual standards for efficacy, safety and quality. While the overall review timeline cannot be forecast yet, the process should be quicker than a regular evaluation due to the time gained during the rolling review. The review of the data is being carried out by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The decision to start the rolling review is based on the interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Results of the interim analysis, based on data from 583 randomized patients, demonstrated an 85% (p=0.002) reduction in hospitalizations over 24 hours or deaths in those receiving sotrovimab compared to placebo, the primary endpoint of the trial. Separately, the CHMP is also reviewing sotrovimab under Article 5(3) of Regulation 726/2004 and is expected to provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal Marketing Authorization. Sotrovimab is an investigational compound and has not been granted a marketing authorization anywhere in the world. An Emergency Use Authorization (EUA) application for sotrovimab has been submitted to the US Food and Drug Administration (FDA). Sotrovimab is also under review by other global regulators including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs. About the COMET-ICE Study DesignThe multi-center, double-blind, placebo-controlled, Phase 3 COMET-ICE trial investigated sotrovimab in adults with mild or moderate COVID-19 at high risk of progression to severe disease. This Phase 3 trial evaluated the safety and efficacy of a single IV infusion of sotrovimab (500 mg) or placebo in non-hospitalized participants globally. The efficacy interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American. The primary efficacy endpoint was the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for at least 24 hours or death within 29 days of randomization. In March 2021, an Independent Data Monitoring Committee recommended that the COMET-ICE trial be stopped for enrollment due to evidence of efficacy and is continuing to follow study participants for 24 weeks. Additional results, including epidemiology and virology data, will be forthcoming once the trial is completed and will be published in a peer reviewed medical journal. In COMET-ICE, infusion-related reactions were reported at a low frequency (1%) in sotrovimab-treated patients and was comparable to the incidence in the placebo arm (1%). These infusion-related reactions occurring within 24 hours of study treatment included pyrexia, chills, dizziness, dyspnea, pruritus and rash, which were Grade 1 (mild) or Grade 2 (moderate) and no events consistent with antibody dependent enhancement (ADE) were observed. About the Sotrovimab Clinical Development ProgramIn addition to the COMET-ICE trial, the full COMET clinical development program for sotrovimab includes: COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered sotrovimab to 500 mg intravenously administered sotrovimab among low-risk adults with mild to moderate COVID-19, and to evaluate the similarity in pharmacokinetics between sotrovimab manufactured by different processesCOMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 as an early treatment in high-risk adults to assess whether IM-administered sotrovimab can reduce hospitalization or death due to COVID-19COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered sotrovimab can prevent symptomatic infection. Sotrovimab was also evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including sotrovimab, versus placebo in low-risk adults with mild to moderate COVID-19. An interim analysis found that bamlanivimab (700 mg) co-administered with sotrovimab (500 mg) demonstrated a 70% relative reduction of patients with persistently high viral load at day 7 compared to placebo, meeting the primary endpoint. The three companies are engaging with the FDA regarding the possible co-administration of bamlanivimab and sotrovimab for the treatment of COVID-19. Additionally, sotrovimab, along with VIR-7832, is being evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment. About SotrovimabSotrovimab is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, and less likely to mutate over time. Sotrovimab, which incorporates Xencor’s Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. About VIR-7832 / GSK4182137VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor’s Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection. About the Vir and GSK CollaborationIn April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines. GSK Commitment to Tackling COVID-19GSK’s response to COVID-19 has been one of the broadest in the industry, with three potential treatments in addition to our vaccine candidates in development. GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, a collaboration with Sanofi on an adjuvanted, protein-based vaccine candidate is now in Phase 2. An earlier stage collaboration with SK Bioscience is also ongoing. SK Bioscience receives funding from CEPI and the Bill and Melinda Gates Foundation to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protecting more people. GSK is also working with mRNA specialist, CureVac, to jointly develop next generation, multi-valent mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK will also support manufacturing of up to 100m doses of CureVac’s first generation COVID-19 vaccine. GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. We recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of efficacy, based on an interim analysis of data from the trial. An Emergency Use Authorization (EUA) application for sotrovimab has been submitted to the US Food and Drug Administration (FDA). We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system. Vir’s Commitment to COVID-19Vir was founded with the mission of addressing the world’s most serious infectious diseases. In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. Sotrovimab is the first SARS-CoV-2-targeting antibody we advanced into the clinic. It was carefully selected for its unique characteristics demonstrated during preclinical research, including a high barrier to resistance and dual-action ability to both block the virus from entering healthy cells and clear infected cells. Sotrovimab has since demonstrated positive monotherapy results in a Phase 3 clinical trial for the early treatment of COVID-19 in high-risk adult patients, and proven in preclinical studies to retain activity against all known circulating COVID-19 variants of concern. Vir is continuing to pursue novel therapeutic and prophylactic solutions to combat SARS-CoV-2 and future coronavirus pandemics, both independently and in collaboration with our partners. About GSK GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us. About Vir BiotechnologyVir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio. GSK Cautionary Statement Regarding Forward-Looking StatementsGSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic. Vir Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing and availability of sotrovimab to providers and patients, including arrangements with commercial payers, the timing of availability of clinical data, program updates and data disclosures related to sotrovimab, the ability of sotrovimab and VIR-7832 to treat and/or prevent COVID-19, the potential of sotrovimab in the hospitalized population, the ability of sotrovimab to neutralize the SARS-CoV-2 live virus, statements related to the planned full analysis of the COMET-ICE trial, and statements related to marketing authorizations and regulatory authorizations and approvals, including plans and discussions with the EMA, FDA, Health Canada and other global regulators. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by Vir’s competitors, changes in expected or existing competition, delays in or disruptions to Vir’s business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the US Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Registered in England & Wales:No. 3888792 Registered Office:980 Great West RoadBrentford, MiddlesexTW8 9GS CONTACT: Vir Biotechnology Contacts: Cara Miller VP, Corporate Communications cmiller@vir.bio +1 415 941 6746 GSK Contacts: Media: Simon Steel +44 (0) 20 8047 5502 (London) Tim Foley +44 (0) 20 8047 5502 (London) Kristen Neese +1 804 217 8147 (Philadelphia) Kathleen Quinn +1 202 603 5003 (Washington DC) Lyndsay Meyer +1 202 302 4595 (Washington DC) Analysts/Investors: James Dodwell +44 (0) 20 8047 2406 (London) Sonya Ghobrial +44 (0) 7392 784784 (Consumer) Mick Readey +44 (0) 7990 339653 (London) Jeff McLaughlin +1 215 751 7002 (Philadelphia) Frannie DeFranco +1 215 751 4855 (Philadelphia)

  • Vir Biotechnology, Inc. (VIR) Reports Q1 Loss, Misses Revenue Estimates
    Zacks

    Vir Biotechnology, Inc. (VIR) Reports Q1 Loss, Misses Revenue Estimates

    Vir Biotechnology, Inc. (VIR) delivered earnings and revenue surprises of -473.91% and -98.84%, respectively, for the quarter ended March 2021. Do the numbers hold clues to what lies ahead for the stock?

  • Vir Biotechnology Provides Corporate Update and Reports First Quarter 2021 Financial Results
    GlobeNewswire

    Vir Biotechnology Provides Corporate Update and Reports First Quarter 2021 Financial Results

    SAN FRANCISCO, May 06, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the first quarter ended March 31, 2021. “We’ve had an active start to the year, achieving significant clinical and collaboration milestones across our portfolio of investigational compounds for serious infectious diseases,” said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. “Based on the profound efficacy results from our Phase 3 trial of VIR-7831 and our belief in its ongoing ability to address known variants of concern, we remain confident in the potential of this dual-action monoclonal antibody to play an important role in bringing the COVID-19 pandemic to an end. We look forward to the pending Emergency Use Authorization decisions in the U.S. and Europe. In the interim, we are rapidly progressing the initiation of new studies aimed at both the prevention and treatment of COVID-19, as well as new delivery methods that we hope will help ease administration and access in the future. Importantly, we are also excited to share several new data sets from our robust hepatitis B pipeline in the second quarter, and expect to maintain our executional momentum throughout the year.” Corporate Update COVID-19 Updates In February, the Company initiated COMET-PEAK (COVID-19 Monoclonal antibody Efficacy Trial - Patient SafEty, TolerAbility, PharmacoKinetics), a Phase 2 trial with two parts. The first part, initiated in February, is evaluating the similarity in pharmacokinetics between VIR-7831 manufactured by different processes. The second part, which began in April, is comparing the safety and viral kinetics of intramuscularly (IM) administered VIR-7831 to intravenously (IV) administered VIR-7831 among low-risk adults with mild to moderate COVID-19. The low 500 mg dose of VIR-7831 lends itself to administration via an IM route, and could facilitate broader access to monoclonal antibody therapy in settings where IV administration is not feasible. Data are expected in the second half of 2021.In March, the Company announced that the VIR-7831 arm of the National Institutes of Health’s (NIH) ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) Program Phase 3 clinical trial met initial pre-specified criteria, and no safety signals were reported. Based on sensitivity analyses of the available data, the independent Data and Safety Monitoring Board recommended the VIR-7831 arm be closed to enrollment. The Company anticipates an NIH-led manuscript to be published later this year.In March, the Company announced an Independent Data Monitoring Committee (IDMC) recommended the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of profound efficacy. The IDMC recommendation was based on an interim analysis of data from 583 patients enrolled in the COMET-ICE trial, which demonstrated an 85% (p=0.002) reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo, the primary endpoint of the trial. VIR-7831 was well tolerated. As the trial remains ongoing and blinded with patients continuing to be followed for 24 weeks, additional results, including epidemiology and virology data, will be forthcoming once the trial is completed.In March, the Company announced the submission of an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) for VIR-7831 for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death. The submission is based on the interim analysis of efficacy and safety data from the Phase 3 COMET-ICE trial. These data will also form the basis for a Biologics License Application (BLA) submission to the FDA, planned in the second half of 2021.In March, the Company announced topline data from Eli Lilly and Company’s (Eli Lilly) expanded Phase 2 BLAZE-4 trial evaluating the potential benefits of VIR-7831 together with Eli Lilly’s investigational bamlanivimab (LY-CoV555) in low-risk adult patients with mild to moderate COVID-19. Results from the trial, which began dosing in January, showed that bamlanivimab 700 mg co-administered with VIR-7831 500 mg demonstrated a 70% (p<0.001) relative reduction in persistently high viral load (>5.27; cycle threshold value <27.5) at day 7 compared to placebo, meeting the primary endpoint. In addition, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared to placebo in the key virologic secondary endpoints of mean change from baseline to days 3, 5, and 7 in SARS-CoV-2 viral load. No serious adverse events were reported in either trial arm. Together with Eli Lilly and GlaxoSmithKline plc (GSK), the Company is engaging with the FDA and anticipates working with other global regulators regarding the possible co-administration of bamlanivimab and VIR-7831 for the treatment of COVID-19.In April, the Company announced that the European Medicines Agency (EMA) initiated a review of VIR-7831 for the treatment of adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. The review is being carried out by the EMA’s Committee for Human Medicinal Products (CHMP) and will provide European Union-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal Marketing Authorization Application.In April, the first patient was dosed in the UK National Health Service-supported AGILE initiative. The trial initiative, which the Company announced in January, is the first to evaluate VIR-7832 in a Phase 1b/2a trial of adults with mild to moderate COVID-19. VIR-7832 shares the same characteristics as VIR-7831 and has been engineered to potentially be a therapeutic T cell vaccine to further help treat and/or prevent COVID-19. Initial safety data are expected in the second half of 2021.In the second quarter of 2021, the Company plans to initiate two additional trials evaluating IM administration of VIR-7831: COMET-TAIL (Treatment of Acute COVID-19 with Intramuscular monocLonal antibody) – a Phase 3 trial in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19COMET-STAR (Stop Transmission of Acute SARS-CoV-2) – a Phase 3 trial in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic COVID-19 infection In connection with the advancement of Vir’s SARS-CoV-2 monoclonal antibody programs, the Company has established a strategic manufacturing network that will enable the manufacture of approximately two million doses to patients in the first year following potential EUA, and several fold that in the second year, depending on titer and yield. Chronic Hepatitis B Virus (HBV) Updates In January, the Company entered into a clinical collaboration with Gilead Sciences, Inc. (Gilead) to evaluate VIR-2218 in a Phase 2 combination therapy trial with selgantolimod (GS-9688), Gilead’s investigational TLR-8 agonist, and nivolumab, an approved PD-1 inhibitor, in both treatment-experienced and treatment-naïve patients with HBV. The trial, which is aimed at developing a functional cure for chronic HBV, is expected to start in the second half of 2021.In late January, the Company announced initial topline data from an ongoing Phase 1 trial evaluating VIR-3434, an HBV-neutralizing monoclonal antibody with the potential to be a therapeutic T cell vaccine, for the treatment of patients with chronic HBV. The first blinded cohort consisted of eight patients with chronic HBV who were taking nucleoside reverse transcriptase inhibitors (NRTIs), two of whom received placebo, and six of whom received a single dose of 6 mg VIR-3434. Six of eight patients achieved a mean 1.3 log10 IU/mL reduction in serum HBV surface antigen (HBsAg) by day eight, the day when nadir was achieved in most patients. Additional safety and efficacy data will be presented at The European Association for the Study of the Liver’s (EASL) International Liver Conference in June. The Company also expects to initiate a Phase 2 trial of VIR-3434 in combination with VIR-2218 in the second half of 2021.In February, the Company presented encore data on VIR-2218 at the Asian Pacific Association for the Study of the Liver. Presentations included preliminary results from the Company’s ongoing Phase 2 trial of VIR-2218 (oral) and data characterizing the urine and plasma pharmacokinetics of VIR-2218 (poster). One-year response durability data for VIR-2218 as a monotherapy for HBV will be presented at the EASL International Liver Conference in June.In April, the Company announced that its collaborator Brii Biosciences initiated a Phase 2 trial evaluating VIR-2218 in combination with BRII-179, an investigational T cell vaccine, for the treatment of chronic HBV infection.During the quarter, the Company continued to progress a Phase 2 combination trial of VIR-2218 with pegylated interferon-alpha (PEG-IFN-α) to evaluate the potential for this combination to result in a functional cure for HBV. Initial clinical data will be presented at the EASL International Liver Conference in June.The Company received notification of acceptance of four abstracts for presentation at the EASL International Liver Conference, to be hosted virtually June 23-26. Oral Presentation: A Phase 1 study evaluating the neutralizing, vaccinal monoclonal antibody VIR-3434 in participants with chronic hepatitis B virus infection. (Presenter: Dr. Kosh Agarwal)Oral Presentation: Safety and antiviral activity of VIR-2218, an X-targeting RNAi therapeutic, in participants with chronic hepatitis B infection: week 48 follow-up results. (Presenter: Prof. Edward Gane)Poster Presentation: Preliminary on-treatment data from a Phase 2 study evaluating VIR-2218 in combination with pegylated interferon alfa-2a in participants with chronic hepatitis B infection. (Presenter: Prof. Man-Fung Yuen)Poster Presentation: Preliminary pharmacokinetics and safety in healthy volunteers of VIR-3434, a monoclonal antibody for the treatment of chronic hepatitis B infection (Presenter: Dr. Sneha Gupta) Additional Pipeline Updates In January, the Company initiated a Phase 1 clinical trial of VIR-1111, an investigational HIV T cell vaccine based on human cytomegalovirus (HCMV). This proof-of concept trial is designed to test the hypothesis that this new approach can elicit potentially protective immune responses that differ from other HIV vaccines. If observed, this T cell vaccine could potentially have utility in additional types of infections and other challenging areas, including cancer. Initial clinical data are anticipated in the second half of 2021.In February, the Company signed a binding collaboration agreement with GSK to expand their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses. The expanded collaboration, which builds on the agreement signed in 2020 to research and develop therapies for coronaviruses, provides GSK exclusive rights to collaborate with Vir on the development of potential best-in-class monoclonal antibodies for the prevention or treatment of influenza. As part of the agreement, the companies will also engage in two additional research programs: 1) an expansion of the current functional genomics collaboration to include other respiratory virus targets; and 2) the development of up to three neutralizing monoclonal antibodies identified using Vir’s antibody technology platform to target non-influenza pathogens during a three-year research period. Given the relatively low incidence of influenza during the COVID-19 pandemic, the companies are currently evaluating the potential timelines for advancing VIR-2482 and other influenza therapies covered under the expanded agreement. Under the terms of the agreement, GSK will pay $345 million in a combination of an upfront payment and a further equity investment in Vir. PublicationsDuring and following the first quarter, nine manuscripts were published related to the Company’s efforts to address SARS-CoV-2 and other viruses. In January: Cell published “Circulating SARS-CoV-2 spike N439K variants maintain fitness while evading antibody-mediated immunity” (Thompson, et al.), which was previously posted on bioRxiv. The paper characterized the virulence, fitness, clinical and epidemiologic impact, molecular features and immune response to N439K, a prevalent receptor binding motif (RBM) variant of the SARS-CoV-2 spike protein first identified in Scotland in March 2020, and how this mutation might evade immunity. In February: medRxiv posted a pre-print manuscript, “SARS-CoV-2 B.1.1.7 escape from mRNA vaccine-elicited neutralizing antibodies” (Collier, et al.), which highlighted the importance of designing next-generation vaccines with mutated S sequences and using alternative viral antigens.Research Square posted a pre-print manuscript, “SARS-CoV-2 variants show resistance to neutralization by many monoclonal and serum-derived polyclonal antibodies” (Diamond, et al.), which indicated that the cell line in which the virus is grown and the cell line in which the assays are performed significantly affected the in vitro potency of certain antibodies against SARS-CoV-2. In March: bioRxiv posted a pre-print manuscript, “The dual function monoclonal antibodies VIR-7831 and VIR-7832 demonstrate potent in vitro and in vivo activity against SARS-CoV-2” (Cathcart, et al.), which demonstrated that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants.Cell published “N-terminal domain antigenic mapping reveals a site of vulnerability for SARS-CoV-2” (McCallum, et al.), which was pre-published in January on bioRxiv. The paper characterized the N-terminal domain (NTD) on the SARS-CoV-2 spike protein. In April: bioRxiv posted a pre-print manuscript, “SARS-CoV-2 immune evasion by variant B.1.427/B.1.429” (McCallum, et al.), which further established the ability of VIR-7831 to maintain its neutralizing activity against a mutation in the receptor binding domain (RBD) of SARS-CoV-2, called L452R, which is found in the California variant (B.1.427/B.1.429). bioRxiv posted a pre-print manuscript, “Membrane lectins enhance SARS-CoV-2 infection and influence the neutralizing activity of different classes of antibodies” (Lempp, et al.), which adds to the growing body of evidence suggesting monoclonal antibodies that target a conserved epitope, such as VIR-7831, have the potential to be highly effective against SARS-CoV-2 and associated known mutations.bioRxiv posted a pre-print manuscript, “Structural basis for broad sarbecovirus neutralization by a human monoclonal antibody” (Tortorici, et al.), which further recognized the importance of monoclonal antibodies with a highly conserved epitope, broad neutralization capabilities and the potential for a high barrier to resistance to address pan sarbecoviruses. bioRxiv posted a pre-print manuscript, “Antibodies to the SARS-CoV-2 receptor-binding domain that maximize breadth and resistance to viral escape” (Starr, et al.), which highlighted the importance of mAbs that target the RBD, given their high neutralization activity and potency, and suggested the potential for RBD-based vaccines as a means of addressing future variants. First Quarter 2021 Financial Results Revenues: Total revenues for the quarter ended March 31, 2021, were $2.0 million, compared to $5.7 million for the same period in 2020. The decrease for the quarter was primarily due to timing of research activities under our grant agreements with the Bill & Melinda Gates Foundation.Research and Development Expenses: Research and development expenses were $134.9 million for the quarter ended March 31, 2021, which includes $8.4 million of non-cash stock-based compensation expense, compared to $65.0 million for the same period in 2020, which included $1.5 million of non-cash stock-based compensation expense. The increase for the quarter was primarily due to clinical activities related to VIR-7831 and VIR-2218, higher fair value of our contingent consideration, costs incurred under our collaboration with GSK and contract manufacturing expenses for our COVID-19 programs, and personnel-related expenses due to additional headcount.General and Administrative Expenses: General and administrative expenses were $25.7 million for the quarter ended March 31, 2021, which includes $7.0 million of non-cash stock-based compensation expense, compared to $12.6 million for the same period in 2020, which included $1.5 million of non-cash stock-based compensation expense. The increase for the quarter was primarily due to personnel-related expenses attributable to additional headcount, legal fees and external consulting expenses.Net Loss: Net loss for the quarter ended March 31, 2021, was $168.9 million, or $1.32 per share, basic and diluted, compared to a net loss of $77.2 million, or $0.71 per share, basic and diluted, for the same period in 2020.Cash and Cash Equivalents: As of March 31, 2021, excluding restricted cash, the Company had approximately $733.0 million in cash, cash equivalents and investments. This includes $120.0 million from equity sold to GSK under the expanded collaboration agreement signed in February 2021. About VIR-7831VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor’s Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. About VIR-7832 VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor’s Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection. About VIR-2218 VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. VIR-2218 is the first asset in the company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials. About VIR-3434 VIR-3434 is an investigational subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. VIR-3434, which incorporates Xencor’s Xtend and other Fc technologies, has been engineered to potentially function as a T cell vaccine against HBV in infected patients, as well as to have an extended half-life. About VIR-1111VIR-1111 is an investigational subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit abundant T cells that recognize HIV epitopes in a way that differs from prior HIV vaccines. About VIR-2482VIR-2482 is an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. VIR-2482 is designed as a universal prophylactic for influenza A. It has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response. VIR-2482, which incorporates Xencor’s Xtend technology, also has been half-life engineered so that a single dose has the potential to last the entire flu season. Vir’s Commitment to COVID-19Vir was founded with the mission of addressing the world’s most serious infectious diseases. In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. VIR-7831 is the first SARS-CoV-2-targeting antibody we advanced into the clinic. It was carefully selected for its unique characteristics demonstrated during preclinical research, including a high barrier to resistance and dual-action ability to both block the virus from entering healthy cells and clear infected cells. VIR-7831 has since demonstrated positive monotherapy results in a Phase 3 clinical trial for the early treatment of COVID-19 in high-risk adult patients, and proven in preclinical studies to retain activity against all known circulating COVID-19 variants of concern. Vir is continuing to pursue novel therapeutic and prophylactic solutions to combat SARS-CoV-2 and future coronavirus pandemics, both independently and in collaboration with our partners. About Vir BiotechnologyVir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing of availability of clinical data, program updates and data disclosures related to Vir’s clinical trials, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19, the ability of VIR-7831 to be administered via an IM route, the timing and expected number of therapeutic doses that Vir will be able to supply to patients, the potential of Vir’s combination therapy trials with VIR-2218 to result in a functional cure for HBV, initial topline data from the ongoing Phase 1 trial of VIR-3434 in the treatment of patients with HBV and VIR-3434’s potential to be a therapeutic T cell vaccine, the ability of VIR-1111 to elicit a T cell immune response to HIV, potential timelines for advancing influenza therapies, including VIR-2482 and other therapies covered under the expanded agreement with GSK. Many factors may cause differences between current expectations and actual results, including challenges in enrollment, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by Vir’s competitors, changes in expected or existing competition, delays in or disruptions to Vir’s business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Contact:Cara MillerVP, Corporate Communicationscmiller@vir.bio+1-415-941-6746 Vir Biotechnology, Inc.Condensed Consolidated Statements of Operations(unaudited; in thousands, except share and per share data) Three Months Ended March 31, 2021 2020 Revenues: Grant revenue$1,371 $5,231 Contract revenue 605 487 Total revenue 1,976 5,718 Operating expenses: Research and development 134,870 64,979 General and administrative 25,739 12,649 Total operating expenses 160,609 77,628 Loss from operations (158,633) (71,910)Other income (expense): Interest income 164 1,755 Other expense, net (10,246) (7,069)Total other income (expense) (10,082) (5,314)Loss before provision for income taxes (168,715) (77,224)Provision for income taxes (196) (16)Net loss$(168,911) $(77,240)Net loss per share, basic and diluted$(1.32) $(0.71)Weighted-average shares outstanding, basic and diluted 127,742,614 108,387,913 Vir Biotechnology, Inc.Condensed Consolidated Balance Sheets(unaudited; in thousands, except share and per share data) March 31,2021 December 31,2020 ASSETS CURRENT ASSETS: Cash and cash equivalents$521,396 $436,575 Short-term investments 211,636 300,286 Restricted cash and cash equivalents, current 8,601 7,993 Receivable from collaboration 112,500 — Contract asset 112,500 — Prepaid expenses and other current assets 26,481 27,511 Total current assets 993,114 772,365 Intangible assets, net 33,687 33,820 Goodwill 16,937 16,937 Property and equipment, net 17,291 17,946 Operating right-of-use assets 60,461 61,947 Restricted cash and cash equivalents, noncurrent 6,998 6,919 Other assets 7,096 8,827 TOTAL ASSETS$1,135,584 $918,761 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable$3,701 $5,077 Accrued and other liabilities 70,069 76,936 Deferred revenue, current portion 262,929 6,451 Contingent consideration, current portion 24,400 10,600 Total current liabilities 361,099 99,064 Deferred revenue, noncurrent 3,815 3,815 Operating lease liabilities, noncurrent 66,615 66,556 Contingent consideration, noncurrent 46,036 25,374 Deferred tax liability 3,253 3,253 Other long-term liabilities 3,815 3,847 TOTAL LIABILITIES 484,633 201,909 STOCKHOLDERS’ EQUITY: Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of March 31, 2021 and December 31, 2020; no shares issued and outstanding as of March 31, 2021 and December 31, 2020 — — Common stock, $0.0001 par value; 300,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 129,891,856 and 127,416,740 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively 13 13 Additional paid-in capital 1,488,337 1,385,301 Accumulated other comprehensive loss (1,304) (1,278)Accumulated deficit (836,095) (667,184)TOTAL STOCKHOLDERS’ EQUITY 650,951 716,852 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY$1,135,584 $918,761