VIR Vir Biotechnology Inc.

31.23
-0.65  -2%
Previous Close 31.88
Open 32.56
52 Week Low
52 Week High
Market Cap $3,978,346,603
Shares 127,388,620
Float 64,339,852
Enterprise Value $3,250,358,205
Volume 1,295,630
Av. Daily Volume 1,072,861
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Upcoming Catalysts

Drug Stage Catalyst Date
VIR-7831 / GSK418213
COVID-19 antibody
Phase 2/3
Phase 2/3
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VIR-3434
Hepatitis B
Phase 1
Phase 1
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VIR-2218
Chronic hepatitis B virus (HBV)
Phase 2
Phase 2
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IR-2218 with pegylated interferon-alpha (PEG-IFN-α)
Hepatitis B
Phase 2
Phase 2
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VIR-2482
Influenza
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
VIR-1111
HIV T cell vaccine
Phase 1
Phase 1
Phase 1 trial to be initiated 4Q 2020.
VIR-7832
COVID-19 vaccine/therapeutic
Phase 2
Phase 2
Phase 2 trial to commence 1Q 2021.
VIR-2703 / ALN-COV
COVID-19
Phase 1
Phase 1
IND filing has been delayed - announced November 5, 2020.

Latest News

  1. SAN FRANCISCO, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, today provided a corporate update and reported financial results for the third quarter ended September 30, 2020.

    "I am proud of the Vir team's effort and success in accelerating our lead SARS-CoV-2 product candidate, VIR-7831, into a global Phase 3 trial, particularly in light of the more than 141,000 new COVID-19 infections recently reported in a single day in the U.S.," said George Scangos, Ph.D., chief executive officer of Vir. "We expect to share initial results from the trial as early as January and look forward to advancing VIR-7831 into new patient…

    SAN FRANCISCO, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, today provided a corporate update and reported financial results for the third quarter ended September 30, 2020.

    "I am proud of the Vir team's effort and success in accelerating our lead SARS-CoV-2 product candidate, VIR-7831, into a global Phase 3 trial, particularly in light of the more than 141,000 new COVID-19 infections recently reported in a single day in the U.S.," said George Scangos, Ph.D., chief executive officer of Vir. "We expect to share initial results from the trial as early as January and look forward to advancing VIR-7831 into new patient populations alongside the initiation of a Phase 1b/2a trial for our second investigational SARS-CoV-2 neutralizing antibody, VIR-7832. Simultaneously, we continue to advance our broader portfolio of product candidates for chronic hepatitis B, influenza A and HIV, as we seek to address some of the world's most challenging infectious diseases."

    Corporate Update

    SARS-CoV-2 Updates

    • In August, the Company initiated COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early), a Phase 2/3 clinical trial evaluating VIR-7831, a potent SARS-CoV-2 neutralizing monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization.
    • In September, an Independent Data Monitoring Committee recommended the global expansion into Phase 3 of the COMET-ICE trial based on a positive evaluation of safety and tolerability data from the Phase 2 lead-in. Global Phase 3 enrollment is ongoing and interim data may be available as early as January 2021. Results for the primary endpoint are expected in the first quarter of 2021.
    • In connection with the advancement of its SARS-CoV-2 programs, the Company has established a strategic manufacturing network, which will enable the supply of millions of doses to patients the first year following approval, depending on titer and yield.
    • The Company plans to initiate two additional Phase 3 trials in the COMET clinical development program for VIR-7831:

      • A trial for the treatment of hospitalized adults with COVID-19 is planned as a sub-study of the National Institutes of Health-sponsored ACTIV-3 trial and is expected to begin as soon as regulatory and ethical approvals are in place.

      • A trial for prophylaxis or prevention of symptomatic infection is expected to begin in the first quarter of 2021.
    • The Company is also preparing to advance its second investigational SARS-CoV-2 neutralizing antibody into a Phase 1b/2a trial in the first quarter of 2021. VIR-7832 shares the same characteristics as VIR-7831, plus enhanced effector function, which may confer additional efficacy in treatment or prophylaxis by stimulating a T cell response.
    • Pre-clinical studies for VIR-2703, an inhaled SARS-CoV-2-targeting small interfering ribonucleic acid (siRNA), are being led by Alnylam Pharmaceuticals, Inc. Alnylam is working to obtain additional efficacy data prior to further program advancement.

    Additional Pipeline Updates

    • In July, the Company initiated a Phase 2 combination trial of VIR-2218, an HBV-targeting siRNA, with pegylated interferon-alpha (PEG-IFN-α), evaluating the potential for this cocktail to result in functional cure of HBV-infected patients. Initial clinical data are anticipated in 2021.
    • The Company also plans to evaluate VIR-2218 in combination with VIR-3434, an HBV-neutralizing monoclonal antibody with the potential to be a therapeutic T cell vaccine. VIR-3434 is currently being evaluated in a Phase 1 trial, the results of which are expected to enable the Company to initiate a Phase 2 combination trial of VIR-3434 in combination with VIR-2218 in 2021.
    • In October, the Company presented data from its influenza A research program virtually at the Infectious Disease Society of America IDWeek 2020. Company presentations included two poster presentations on VIR-2482, an influenza A-neutralizing monoclonal antibody, and one oral presentation highlighting the severe economic and clinical burden of influenza A on elderly patients with underlying conditions in the United States. Initiation of the Phase 2 trial for VIR-2482, which was delayed due to the impact of COVID-19, is now expected in the fourth quarter of 2021 with proof-of-concept results anticipated in the first half of 2022.
    • The Company expects to initiate a Phase 1 clinical trial for VIR-1111, an HIV T cell vaccine based on human cytomegalovirus, in the fourth quarter of this year. This trial is designed to determine whether VIR-1111 elicits a specific type of T cell immune response to HIV, known as an HLA-E restricted immune response.

    Publications

    During and following the third quarter, five manuscripts were published related to the Company's efforts to address SARS-CoV-2 and other conditions that may benefit from treatment with monoclonal antibodies.

    In September:

    • Science published "Ultrapotent human antibodies protect against SARS-CoV-2 challenge via multiple mechanisms" (Tortorici, et al.), discussing the neutralizing abilities of two ultrapotent SARS-CoV-2 antibodies (S2E12 and S2M11) in clinical models.

    • Cell published "Mapping Neutralizing and immunodominant sites on the SARS-CoV-2 spike receptor-binding domain by structure-guided high-resolution serology" (Piccoli, et al.), characterizing differences in both the binding properties and kinetics of neutralizing antibody responses to SARS-CoV-2.

    • EMBO Molecular Medicine published "A combination of two human monoclonal antibodies cures symptomatic rabies" (de Melo, et al.), outlining proof-of-concept data for an antibody-based therapeutic approach for the treatment of symptomatic rabies.

    In October:

    • Nature published "Fc-optimized antibodies elicit CD8 immunity to viral respiratory infection" (Bournazos, et al.), detailing results from research in an influenza clinical model highlighting a new mechanism for enhancing the efficacy of monoclonal antibodies to treat viral infection and induce a protective response.

    In November:

    • bioRxiv published "The circulating SARS-CoV-2 spike variant N439K maintains fitness while evading antibody-mediated immunity" (Thomson, et al.), characterizing variation in the SARS-CoV-2 spoke protein and virulence of a prevalent immune evasion variant, N439K.

    New Board Appointment

    • In September, the Company announced the appointment of Janet Napolitano to the Board of Directors. Ms. Napolitano formerly served as the Governor of Arizona, the U.S. Secretary of Homeland Security under President Barack Obama, and most recently as the President of the University of California for the past seven years. Her appointment follows the July addition of Elliott Sigal, M.D., Ph.D., to the Board.

    Third Quarter 2020 Financial Results

    • Revenues: Total revenues for the quarter ended September 30, 2020 were $1.9 million, compared to $1.4 million for the same period in 2019. The increase for the quarter was primarily due to the timing of research activities under the HIV and TB grants with the Bill & Melinda Gates Foundation.
    • Research and Development Expenses: Research and development expenses were $70.7 million for the quarter ended September 30, 2020, which includes $4.2 million of non-cash stock-based compensation expense, compared to $39.9 million for the same period in 2019, which included $0.9 million of non-cash stock-based compensation expense. The increase for the quarter was primarily due to contract manufacturing expenses for our SARS-CoV-2 programs, higher fair value of our contingent consideration due to achievement of clinical development milestones, personnel-related expenses due to additional headcount, and clinical costs due to activities related to VIR-7831, VIR-3434 and VIR-1111.
    • General and Administrative Expenses: General and administrative expenses were $18.9 million for the quarter ended September 30, 2020, which includes $4.4 million of non-cash stock-based compensation expense, compared to $9.2 million for the same period in 2019, which includes $1.3 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, external consulting and other expenses due to costs associated with operating as a public company.
    • Net Loss: Net loss for the quarter ended September 30, 2020 was $84.6 million, or $0.67 per share, basic and diluted, compared to a net loss of $48.3 million, or $4.60 per share, basic and diluted, for the same period in 2019.
    • Cash and Cash Equivalents: As of September 30, 2020, excluding restricted cash, the Company had approximately $826.6 million in cash, cash equivalents and investments.

    About VIR-7831

    VIR-7831 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro and in vivo. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 has been engineered with the potential to enhance lung bioavailability and have an extended half-life.

    About VIR-7832

    VIR-7832 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7832 has been engineered with the potential to enhance lung bioavailability, have an extended half-life, and function as a therapeutic and/or prophylactic T cell vaccine.

    About VIR-2703

    VIR-2703 is an inhaled SARS-CoV-2-targeting siRNA that has demonstrated the ability to significantly reduce SARS-CoV-2 live virus replication in vitro. VIR-2703 is designed to degrade the viral genome, leading to inhibition of viral protein synthesis and blocking the production of infectious virus. It targets a nucleic acid sequence in the SARS-CoV-2 genome that is highly conserved amongst currently available viral sequences and is also conserved in SARS-CoV-1 (also known as SARS). VIR-2703 leverages Alnylam Pharmaceuticals, Inc.'s latest advances in lung delivery of siRNAs.

    About VIR-2218

    VIR-2218 is a 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 a 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 has been engineered to have an extended half-life as well as to potentially function as a T cell vaccine against HBV in infected patients.

    About VIR-2482

    VIR-2482 is an 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 has been half-life engineered so that a single dose has the potential to last the entire flu season, which is typically five to six months long.

    About VIR-1111

    VIR-1111 is a subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit T cells that recognize HIV epitopes that are different from those recognized by prior HIV vaccines and to stimulate a different and specific type of T cell immune response to HIV, known as an HLA-E restricted immune response.

    About Vir Biotechnology

    Vir 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 SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. 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," "expect," "plan," "aim," "anticipate," "estimate," "intend," "potential," "prepare" 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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the timing of commencement of clinical trials and completion of preclinical studies, the timing of availability of clinical data, the evaluation criteria, designs, program updates and data disclosures related to Vir's clinical trials, the ability of VIR-7831, VIR-7832, and VIR-2703 to treat and/or prevent COVID-19 and other diseases caused by the SARS-CoV-2 virus, the clinical efficacy of VIR-7831 and VIR-7832, the capacity to manufacture, develop and commercialize a product candidate to treat COVID-19, the timing of availability and expected number of therapeutic doses, the ability to address the current global COVID-19 pandemic and future outbreaks of diseases caused by coronaviruses, the potential for the combination of VIR-2218 and PEG-IFN-α to result in the functional cure of HBV, the ability of VIR-3434 to neutralize and treat HBV, the ability of VIR-2482 to provide broad strain coverage for the flu, and the ability of VIR-1111 to elicit a T cell immune response to HIV. Many factors may cause differences between current expectations and actual results, including delays or failures in planned patient enrollment or retention, clinical site activation rates or clinical trial enrollment rates that are lower than expected, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in neutralizing SARS-CoV-2, other coronaviruses and HBV, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our 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.

    Vir Biotechnology, Inc.

    Condensed Consolidated Statements of Operations

    (unaudited; in thousands, except share and per share data)

      Three Months Ended

    September 30,
      Nine Months Ended

    September 30,
     
      2020  2019  2020  2019 
    Revenues:                
    Grant revenue $1,740  $1,166  $7,690  $6,771 
    License revenue from a related party        22,747    
    Contract revenue  188   237   44,197   340 
    Total revenue  1,928   1,403   74,634   7,111 
    Operating expenses:                
    Research and development  70,684   39,863   215,316   95,541 
    General and administrative  18,859   9,220   47,894   25,790 
    Total operating expenses  89,543   49,083   263,210   121,331 
    Loss from operations  (87,615)  (47,680)  (188,576)  (114,220)
    Other income (expense):                
    Interest income  412   2,012   2,548   6,564 
    Other income (expense), net  2,616   (2,659)  (6,904)  (3,251)
    Total other income (expense)  3,028   (647)  (4,356)  3,313 
    Loss before benefit from (provision for) income taxes  (84,587)  (48,327)  (192,932)  (110,907)
    Benefit from (provision for) income taxes  (22)  13   (84)  (5)
    Net loss $(84,609) $(48,314) $(193,016) $(110,912)
    Net loss per share, basic and diluted $(0.67) $(4.60) $(1.66) $(11.53)
    Weighted-average shares outstanding, basic and diluted  125,810,907   10,500,848   116,427,529   9,615,379 
                     

    Vir Biotechnology, Inc.

    Condensed Consolidated Balance Sheets

    (unaudited; in thousands, except share and per share data)

      September 30,

    2020
      December 31,

    2019
     
    ASSETS        
    CURRENT ASSETS:        
    Cash and cash equivalents $462,521  $109,335 
    Short-term investments  364,074   274,101 
    Restricted cash and cash equivalents, current  9,363   6,181 
    Prepaid expenses and other current assets  13,614   13,378 
    Total current assets  849,572   402,995 
    Intangible assets, net  33,944   35,694 
    Goodwill  16,937   16,937 
    Property and equipment, net  16,948   16,308 
    Operating right-of-use assets  14,762    
    Restricted cash and cash equivalents, noncurrent  1,201   7,300 
    Long-term investments     24,290 
    Other assets  9,895   8,547 
    TOTAL ASSETS $943,259  $512,071 
    LIABILITIES AND STOCKHOLDERS' EQUITY        
    CURRENT LIABILITIES:        
    Accounts payable $6,796  $5,881 
    Accrued and other liabilities  44,339   26,495 
    Deferred revenue, current portion  5,563   6,181 
    Contingent consideration, current portion  20,300   8,200 
    Derivative liability     12,449 
    Total current liabilities  76,998   59,206 
    Deferred revenue, noncurrent  3,815   12,670 
    Operating lease liabilities, noncurrent  12,092    
    Contingent consideration, noncurrent  31,712   9,380 
    Deferred tax liability  3,305   3,305 
    Other long-term liabilities  2,982   3,568 
    TOTAL LIABILITIES  130,904   88,129 
    STOCKHOLDERS' EQUITY:        
    Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of September 30, 2020 and December 31, 2019; no shares issued and outstanding as of September 30, 2020 and December 31, 2019      
    Common stock, $0.0001 par value; 300,000,000 shares authorized as of September 30, 2020 and December 31, 2019; 126,991,631 and 107,648,925 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively  13   11 
    Additional paid-in capital  1,374,362   793,051 
    Accumulated other comprehensive loss  (485)  (601)
    Accumulated deficit  (561,535)  (368,519)
    TOTAL STOCKHOLDERS' EQUITY  812,355   423,942 
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $943,259  $512,071 
             
    Contact:
    
    Investors
    Neera Ravindran, M.D.
    VP, Head of Investor Relations & Strategic Communications
    
    +1-415-506-5256
    
    Media
    Cara Miller
    VP, Corporate Communications
    
    +1-415-941-6746

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  2. SAN FRANCISCO, Nov. 06, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the publication of new research demonstrating that the immunodominant SARS-CoV-2 receptor binding motif (RBM) is the least conserved region in the SARS-CoV-2 spike protein, allowing for the occurrence of mutations without disrupting human ACE2 (hACE2) binding, which mediates viral entry. Researchers also characterize the virulence and fitness of N439K, a prevalent variant in the RBM that demonstrated resistance to human neutralizing monoclonal antibodies (mAbs), including one that is currently being evaluated in clinical trials. The manuscript, which was developed by Vir in collaboration with the MRC-University of Glasgow Centre for Virus…

    SAN FRANCISCO, Nov. 06, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the publication of new research demonstrating that the immunodominant SARS-CoV-2 receptor binding motif (RBM) is the least conserved region in the SARS-CoV-2 spike protein, allowing for the occurrence of mutations without disrupting human ACE2 (hACE2) binding, which mediates viral entry. Researchers also characterize the virulence and fitness of N439K, a prevalent variant in the RBM that demonstrated resistance to human neutralizing monoclonal antibodies (mAbs), including one that is currently being evaluated in clinical trials. The manuscript, which was developed by Vir in collaboration with the MRC-University of Glasgow Centre for Virus Research, was published online November 5, 2020 on bioRxiv, and has been submitted to a peer-reviewed journal for future print publication.  

    "This study shows that the receptor binding motif of SARS-CoV-2, a major target of neutralizing antibodies, is evolving at a higher rate than the rest of the receptor binding domain and spike, and is resilient to change," said Herbert "Skip" Virgin, M.D., Ph.D., chief scientific officer of Vir. "It is reminiscent of our experience with influenza A, where the mutability of the region targeted by the most potent neutralizing antibodies results in ineffective immunity year-over-year. Our demonstration of a virulent SARS-CoV-2 immune evasion mutant provides a cautionary tale for how we address this pandemic, and indicates the importance of ongoing surveillance for immune evasion mutations in the development of antibodies and vaccines."

    Data analyzed from approximately 130,000 SARS-CoV-2 genomic sequences, alongside evaluation of a published deep mutational scanning of the receptor binding domain (RBD), demonstrated that the RBM has a high degree of structural plasticity that permits significant changes in the amino acid sequence of the RBM, including N439K, while maintaining hACE2 binding.

    Researchers also sought to define the clinical and epidemiologic impact, molecular features and immune response to the RBM variant, N439K. The goal was to determine if variants emerging in the pandemic have immune evasion potential. This variant, which was first identified in Scotland in March 2020, has since re-emerged independently in a second lineage and has been observed in 14 countries, including the United States. At the time of manuscript submission, it was the second most common circulating RBD variant.

    Based on a review of sequenced viral isolates from 1,918 Scottish patients and clinical outcomes for 1,591 of these patients, N439K demonstrated similar clinical virulence to the wild-type 439N strain, full replication in the upper respiratory tract, the capacity to replicate in cultured cells, and the ability to effectively compete in in vitro growth assays with the wild-type virus. These data demonstrate that the virus exhibits fitness despite a mutation in the RBM.

    To understand whether and how the N439K mutation might evade immunity, researchers noted that the binding of polyclonal sera to SARS-CoV-2 spike was reduced by the mutation in a sizeable fraction of the 445 samples obtained from recovered individuals. Additionally, out of 144 human neutralizing mAbs isolated from individuals who recovered from SARS-CoV-2 infection early in the pandemic, a significant number failed to efficiently recognize N439K. When tested across four clinical-stage antibodies – S309 (the precursor of VIR-7831), LY-CoV555, REGN10933 and REGN10987 – S309, which targets a non-RBM epitope, LY-CoV555 and REGN10933 were capable of neutralizing the N439K variant.

    "These data provide critical evidence that more immune-evasive SARS-CoV-2 variants are likely to emerge, necessitating the updating of vaccines and the development of monoclonal antibodies that are highly resistant to viral escape," said George Scangos, Ph.D., chief executive officer of Vir. "This is what we had in mind when we designed VIR-7831. By targeting a highly conserved epitope with the potential for a high barrier to resistance, we hoped to evade ongoing mutations and increase the long-term immunity of people exposed to SARS-CoV-2. We look forward to continuing to evaluate the utility of VIR-7831 in the prevention and treatment of COVID-19."

    This study was conducted in collaboration with Professors Emma Thomson, M.D, Ph.D., and David Robertson, Ph.D., and their teams at the MRC-University of Glasgow Centre for Virus Research.

    As part of Vir's ongoing commitment to addressing the COVID-19 pandemic, Vir scientists continue to publish new research designed to enhance the scientific understanding of SARS-CoV-2 and COVID-19. The Company's most recent publications highlight:

    • The mechanisms and risk for antibody-mediated enhancement of disease (Nature, October 2020);
    • The identification and characterization of ultra-potent anti-COVID neutralizing mAbs (Science September 2020);
    • The nature and half-life of human anti-SARS-CoV-2 antibodies in recovered individuals (Cell, September 2020). This research also showed that the part of the SARS-CoV-2 spike that contains the N439K mutation is a dominant target of the antibody response in many individuals;
    • A mAb, S309 (the parent of VIR-7831 and VIR-7832), that covers both SARS-CoV-1 and SARS-CoV-2, which may be useful for the current and future pandemics (Nature, May 2020); and
    • How to engineer mAbs with significantly increased efficacy in the treatment and prophylaxis of respiratory viral infections (Nature, April 2020).

    About VIR-7831

    VIR-7831 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro and in vivo. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 has been engineered with the potential to enhance lung bioavailability and have an extended half-life.

    About Vir Biotechnology

    Vir 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 hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio

    Vir 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 "potential," "may," "will," "could," "expect," "plan," "anticipate," "believe," "estimate," "goal," "intend," "candidate," "continuing," "developing" 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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding print publication of Vir's research in a peer-reviewed journal, the emergence of SARS-CoV-2 variants, the ability of VIR-7831 to evade mutations and increase long-term immunity and the utility of VIR-7831 in the prevention and treatment of COVID-19. 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 neutralizing SARS-CoV-2, difficulty in collaborating with other companies or government agencies, and challenges in accessing manufacturing capacity. 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:
    
    Investors
    Neera Ravindran, M.D.
    VP, Head of Investor Relations & Strategic Communications
    
    +1-415-506-5256
    
    Media
    Cara Miller
    VP, Corporate Communications
    
    +1-415-941-6746

    Primary Logo

    View Full Article Hide Full Article
  3. SAN FRANCISCO, Oct. 27, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, today announced that it will provide a corporate update and report financial results for the third quarter ended September 30, 2020 on Tuesday, November 10, 2020.

    The update will be provided via a press release after market close, and will be accessible under Press Releases in the Investors section of the Vir website at www.vir.bio.

    About Vir Biotechnology

    Vir 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…

    SAN FRANCISCO, Oct. 27, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, today announced that it will provide a corporate update and report financial results for the third quarter ended September 30, 2020 on Tuesday, November 10, 2020.

    The update will be provided via a press release after market close, and will be accessible under Press Releases in the Investors section of the Vir website at www.vir.bio.

    About Vir Biotechnology

    Vir 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 hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis.  

    Contact:
    
    Investors
    Neera Ravindran, M.D.
    VP, Head of Investor Relations & Strategic Communications
    
    +1-415-506-5256
    
    Media 
    Cara Miller
    VP, Corporate Communications 
     
    +1-415-941-6746

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  4. Preclinical data show VIR-2482 has broad neutralizing potential against
    all major strains of influenza A from the last 100 years

    – Extended half-life observed in Phase 1 demonstrates potential for once-per-season dosing –

    – Claims-based analysis highlights the high hospitalization rates and elevated costs among high-risk elderly patients, reinforcing need for new approaches to prevention

    SAN FRANCISCO, Oct. 21, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, today announced the presentation of preclinical and Phase 1 data demonstrating the broad neutralizing ability, high-level effector function, extended half-life and…

    Preclinical data show VIR-2482 has broad neutralizing potential against

    all major strains of influenza A from the last 100 years

    – Extended half-life observed in Phase 1 demonstrates potential for once-per-season dosing –

    – Claims-based analysis highlights the high hospitalization rates and elevated costs among high-risk elderly patients, reinforcing need for new approaches to prevention

    SAN FRANCISCO, Oct. 21, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, today announced the presentation of preclinical and Phase 1 data demonstrating the broad neutralizing ability, high-level effector function, extended half-life and tolerability of VIR-2482 in the prevention of influenza A. The Company also released new health economics outcomes research, which shows that elderly adults with comorbidities suffer more severe consequences of influenza. The data will be presented at IDWeek 2020, which takes place virtually Oct. 21-25.

    "Despite widespread influenza vaccination, the elderly in the U.S. have a high risk of hospitalization and incur significantly higher healthcare costs," said Phil Pang, M.D., Ph.D., chief medical officer of Vir Biotechnology. "The data presented at IDWeek quantify the magnitude of the urgent need for a universal influenza A-neutralizing monoclonal antibody with high efficacy. The data also suggest that VIR-2482, because of its broad influenza A strain coverage, potency and prolonged half-life, has the potential to be the first neutralizing monoclonal antibody to address this large unmet need."

    The two abstracts accepted for poster presentation include:

    • Preliminary, blinded pharmacokinetic and safety data from the first-in-human, randomized, placebo-controlled Phase 1 study, which demonstrate that intramuscular dosing of VIR-2482 was well tolerated among healthy volunteers at doses up to 1,800mg (Abstract #631). The preliminary pharmacokinetic profile also shows a prolonged half-life, which could enable once-per-season dosing.



    • Preclinical data, which show that VIR-2482 has broad binding and neutralizing potential against all major strains of influenza A, including pandemic strains, from the last 100 years (Abstract #1231). Additionally, VIR-2482 administered prophylactically 24 hours prior to lethal doses of influenza significantly reduced morbidity and prevented mortality in mouse models.

    A separate claims-based analysis accepted for oral presentation demonstrates the significant health and economic impact of influenza A on elderly patients (>65 years old) with comorbidities (Abstract #86). According to an analysis of insurance claims data from the IQVIA PharMetrics® Plus database (October 1, 2013, to March 1, 2019), 19%-44% of elderly influenza patients were hospitalized within 30 days of diagnosis compared to 3%-13% of non-influenza patients. Associated healthcare costs ranged from $4,122-$8,181 per patient in the month after diagnosis, with the highest attributable costs observed among elderly patients with congestive heart failure, stroke or chronic pulmonary disease. The health and economic implications of this analysis demonstrate the ongoing need among high-risk elderly groups for additional protection against influenza.

    VIR-2482 Scientific Research Presented at IDWeek 2020

    Poster Presentations

    Oral Presentation

    About VIR-2482 

    VIR-2482 is an 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 influenza pandemic. VIR-2482 is designed as a universal prophylactic for influenza A. It has the potential to overcome the limitations of current influenza 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 has been half-life engineered so that a single dose has the potential to last the entire influenza season, which is typically five to six months long.

    About Vir Biotechnology

    Vir 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 hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio

    Vir 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 "potential," "may," "will," "could," "expect," "plan," "anticipate," "believe," "estimate," "goal," "intend," "candidate," "continuing," "developing" 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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential benefits of VIR-2482, including its ability to broadly neutralize against all major strains of influenza A, its high-level effector function and binding capability and its extended half-life, the potential of VIR-2482 in treating high-risk, elderly patients, the potential of VIR-2482 as a universal prophylaxis for influenza A and the health and economic implications of influenza A on elderly patients. Many factors may cause differences between current expectations and actual results including unexpected safety or pharmacokinetic data observed during preclinical or clinical studies, challenges in treating influenza A, difficulty in collaborating with other companies or government agencies, and challenges in accessing manufacturing capacity. 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:
    
    Investors
    Neera Ravindran, M.D.
    VP, Head of Investor Relations & Strategic Communications
    
    +1-415-506-5256
    
    Media
    Cara Miller
    VP, Corporate Communications
    
    +1-415-941-6746

    Primary Logo

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  5. SAN FRANCISCO and CAMBRIDGE, Mass., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) announced today that Phil Pang, M.D., Ph.D., Chief Medical Officer of Vir, and Vasant Jadhav, Ph.D., Vice President, Research at Alnylam, will jointly participate in a virtual fireside chat at the H.C. Wainwright Hepatitis B Virus Mini-Conference on Tuesday, October 20, 2020 at 9:30 am PT/ 12:30 pm ET via webcast.

    A live webcast of the presentation can be accessed under Events & Presentations in the Investors section of the Vir website at www.vir.bio and will be archived there following the presentation for 30 days. A live audio webcast of the presentation will also be available on the…

    SAN FRANCISCO and CAMBRIDGE, Mass., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) announced today that Phil Pang, M.D., Ph.D., Chief Medical Officer of Vir, and Vasant Jadhav, Ph.D., Vice President, Research at Alnylam, will jointly participate in a virtual fireside chat at the H.C. Wainwright Hepatitis B Virus Mini-Conference on Tuesday, October 20, 2020 at 9:30 am PT/ 12:30 pm ET via webcast.

    A live webcast of the presentation can be accessed under Events & Presentations in the Investors section of the Vir website at www.vir.bio and will be archived there following the presentation for 30 days. A live audio webcast of the presentation will also be available on the Investors section of Alnylam's website at www.alnylam.com/events. A replay will be available on the Alnylam website within 48 hours after the event.

    About Vir Biotechnology

    Vir 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 hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.

    About Alnylam Pharmaceuticals

    Alnylam (NASDAQ:ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, infectious, and central nervous system (CNS)/ocular diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of severe and debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust RNAi therapeutics platform. Alnylam's commercial RNAi therapeutic products are ONPATTRO® (patisiran), approved in the U.S., EU, Canada, Japan, Switzerland and Brazil, and GIVLAARI® (givosiran), approved in the U.S., EU, and Brazil. Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its "Alnylam 2020" strategy of building a multi-product, commercial-stage biopharmaceutical company with a sustainable pipeline of RNAi-based medicines to address the needs of patients who have limited or inadequate treatment options. Alnylam is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on Twitter at @Alnylam or on LinkedIn.

    Contact:
    Vir Biotechnology, Inc.
    
    Investors
    Neera Ravindran, MD
    VP, Head of Investor Relations & Strategic Communications
     
    +1-415-506-5256
    
    Media
    Cara Miller
    VP, Corporate Communications 
     
    +1-415-941-6746
    
    Alnylam Pharmaceuticals, Inc.
    
    Christine Regan Lindenboom
    (Investors and Media)
    +1-617-682-4340
    
    Josh Brodsky
    (Investors)
    +1-617-551-8276

    Primary Logo

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