VIR Vir Biotechnology Inc.

57.74
-8.99  -13%
Previous Close 66.73
Open 66.5
52 Week Low 25.31
52 Week High 141.01
Market Cap $7,355,418,919
Shares 127,388,620
Float 64,339,852
Enterprise Value $7,167,558,270
Volume 1,241,630
Av. Daily Volume 1,801,789
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Upcoming Catalysts

Drug Stage Catalyst Date
VIR-7831 / GSK418213 (COMET-ICE)
COVID-19 antibody
Phase 3
Phase 3
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VIR-3434
Hepatitis B
Phase 1
Phase 1
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Bamlanivimab (LY-CoV555) and VIR-7831 (GSK4182136) - BLAZE-4
COVID-19 antibody
Phase 2
Phase 2
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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-7832 (AGILE)
COVID-19 vaccine/therapeutic
Phase 2
Phase 2
Phase 2 trial to commence 1Q 2021.
VIR-1111
HIV T cell vaccine
Phase 1
Phase 1
Phase 1 trial initiated December 2021.
VIR-7831/GSK4182136 (ACTIV-3)
Mild to moderate COVID-19
Phase 3
Phase 3
Phase 3 trial commencement announced December 17, 2020.
VIR-2703 / ALN-COV
COVID-19
Phase 1
Phase 1
IND filing has been delayed - announced November 5, 2020.

Latest News

  1. SAN FRANCISCO, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2020.

    "Vir closed 2020 delivering strong progress across our entire development pipeline with six distinct molecules addressing four serious infectious diseases. Our momentum continues in 2021 with the signing of new collaborations designed to help speed the development of multiple promising candidates, as well as pending data from two Phase 3 studies evaluating our novel monoclonal antibody, VIR-7831, against COVID-19," said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. "Additionally, we are now evaluating an…

    SAN FRANCISCO, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2020.

    "Vir closed 2020 delivering strong progress across our entire development pipeline with six distinct molecules addressing four serious infectious diseases. Our momentum continues in 2021 with the signing of new collaborations designed to help speed the development of multiple promising candidates, as well as pending data from two Phase 3 studies evaluating our novel monoclonal antibody, VIR-7831, against COVID-19," said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. "Additionally, we are now evaluating an intramuscular formulation of VIR-7831, and expect the first trial evaluating VIR-7832, our second antibody aimed at COVID-19, to begin shortly. Vir's strong execution is evident across our full portfolio, with the recent compelling initial data from our Phase 1 trial of VIR-3434 demonstrating a significant and rapid reduction in hepatitis B surface antigen, and the continued forward momentum of our influenza and HIV programs. We anticipate a transformational year ahead."

    Corporate Update

    Expanded GSK Collaboration

    • In February, the Company signed a binding agreement with Glaxo Wellcome UK Limited, a subsidiary of GlaxoSmithKline plc, 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; 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. Under the terms of the agreement, GSK, through its subsidiaries, will make an upfront payment of $225 million and a further equity investment in Vir of $120 million. Vir will fund the development of VIR-2482 through completion of Phase 2 trials, after which time GSK may pay a fee of $300 million to exercise its option to co-develop VIR-2482. The companies will share the development costs and related profits associated with the development of all other programs in this expanded collaboration. GSK may also pay Vir up to $200 million based on the successful delivery of pre-defined regulatory milestones for the first product arising from the influenza program. 

    SARS-CoV-2 Updates

    • In October, based on a positive evaluation of safety and tolerability data of VIR-7831 from the Phase 2 lead-in, the Company began enrolling patients in the global Phase 3 portion of COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early). VIR-7831 is a dual-action SARS-CoV-2 monoclonal antibody that, among other attributes, 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 (the virus that causes COVID-19) 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. COMET-ICE is evaluating VIR-7831 for the early treatment of COVID-19 in adults at high risk of hospitalization or death. Primary endpoint results are expected in the first quarter of 2021. If positive, these data will be used to seek Emergency Use Authorization and, ultimately, approval through the submission of a Biologics License Application.
    • In December, the Company announced the initiation of the National Institutes of Health (NIH)-sponsored ACTIV-3 Phase 3 trial evaluating VIR-7831 for the treatment of hospitalized adults with COVID-19. An evaluation of the benefit/risk profile of VIR-7831 in this challenging patient population is expected in the first quarter of 2021 and will determine whether VIR-7831 continues in the next part of the ACTIV-3 trial.
    • In January, the Company announced an agreement with the National Health Service-supported AGILE initiative 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 but has also been engineered to potentially be a therapeutic T cell vaccine to further help treat and/or prevent COVID-19. The AGILE trial, which is the first to test VIR-7832 in humans, is expected to begin in the first quarter of 2021.
    • In January, the Company announced a collaboration with Eli Lilly and Company to evaluate whether the administration of VIR-7831 together with Eli Lilly's bamlanivimab (LY-CoV555) can provide potential benefits beyond monotherapy in low-risk adults with mild to moderate COVID-19. Initial results for this arm of Eli Lilly's Phase 2 BLAZE-4 trial are expected in the first half of 2021.
    • In February, the Company initiated COMET-Patient SafEty, TolerAbility, PharmacoKinetics, or COMET-PEAK , a Phase 2 study with two parts. The first part will evaluate the similarity in pharmacokinetics between VIR-7831 manufactured by different processes. The second part will compare 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.
    • 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-19

      • COMET-STAR (Stop Transmission of Acute SARS-CoV-2) – a Phase 3 trial in uninfected adults at high risk to determine wither IM-administered VIR-7831 can prevent symptomatic 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 the first year following potential Emergency Use Authorization, and several fold that in the second year, depending on titer and yield.

    Chronic Hepatitis B Virus (HBV) Updates

    • In January, Vir entered into a clinical collaboration with Gilead Sciences, Inc. to evaluate the Company's HBV-targeting small interfering ribonucleic acid (siRNA), 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 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, two of whom received placebo, and six of whom received a single dose of 6 mg VIR-3434. Six of eight patients responded and 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 clinical data are anticipated in the second quarter of 2021. 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 are anticipated in the first half of 2021.
    • 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 are anticipated in the second quarter of 2021.
    • The Company expects Brii Biosciences Offshore Limited (Brii Bio) to initiate a Phase 2 trial evaluating VIR-2218 in combination with BRII-179, an investigational T cell vaccine, in the first half of 2021.

    Additional Pipeline Updates

    • In October, the Company presented new clinical data on VIR-2482 and health economics research on the burden of influenza A on the elderly at the Infectious Disease Society of America IDWeek 2020. 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.
    • 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 vaccine is designed to test the hypothesis that this new approach can elicit potentially protective immune responses that differ from other HIV vaccines, which, if observed, 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.

    Publications

    During and following the fourth quarter, seven manuscripts were published related to the Company's efforts to address SARS-CoV-2 and other viruses.

    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 spike protein and virulence of a prevalent immune evasion variant, N439K.

    In December:

    • The Lancet Regional Health – Europe published "Risk assessment and seroprevalence of SARS-CoV-2 infection in healthcare workers of COVID-19 and non-COVID-19 hospitals in Southern Switzerland" (Piccoli, et al.), demonstrating that the use of protective measures was effective in reducing nosocomial viral transmission among hospital healthcare workers.

    In January:

    • bioRxiv published "N-terminal domain antigenic mapping reveals a site of vulnerability for SARS-CoV-2" (McCallum, et al.), characterizing the N-terminal domain (NTD) on the SARS-CoV-2 spike protein.
    • 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 published "SARS-CoV-2 B.1.1.7 escape from mRNA vaccine-elicited neutralizing antibodies" (Collier, et al.), which highlights the importance of designing next- generation vaccines with mutated S sequences and using alternative viral antigens.
    • Research Square published "SARS-CoV-2 variants show resistance to neutralization by many monoclonal and serum-derived polyclonal antibodies" (Diamond, et al.), which indicates 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.

    New Board Appointment

    • In December, the Company appointed Jeffrey Hatfield to the Board of Directors. Mr. Hatfield is an accomplished industry executive with more than three decades of commercial and business experience. He currently serves as chief executive officer of Vividion Therapeutics, Inc.

    Fourth Quarter and Full Year 2020 Financial Results

    • Revenues: Total revenues for the quarter ended December 31, 2020, were, $1.7 million, compared to $1.0 million for the same period in 2019. Total revenue for the year ended December 31, 2020, were $76.4 million, compared to $8.1 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. The increase for the year was primarily due to $43.3 million of revenue related to the license granted to GSK under our collaboration agreement, and $22.7 million of revenue related to Brii Biosciences' exercise of its option to obtain exclusive rights to develop and commercialize compounds arising from VIR-2218 in the China territory.
    • Research and Development Expenses: Research and development expenses were $87.1 million for the quarter ended December 31, 2020, which includes $5.3 million of non-cash stock-based compensation expense, compared to $52.9 million for the same period in 2019, which included $1.1 million of non-cash stock-based compensation expense. For the year ended December 31, 2020, research and development expenses were $302.4 million, which includes $13.7 million of non-cash stock-based compensation expense, compared to $148.5 million for the same period in 2019, which includes $3.0 million of non-cash stock-based compensation expense. The increase for the quarter and the full year was primarily due to contract manufacturing expenses for our SARS-CoV-2 program, higher fair value of our contingent consideration due to achievement of clinical development milestones, costs incurred under our collaboration with GSK, personnel-related expenses due to additional headcount, and clinical costs due to activities related to VIR-7831, VIR-3434 and VIR-2218. 
    • General and Administrative Expenses: General and administrative expenses were $23.0 million for the quarter ended December 31, 2020, which includes $5.0 million of non-cash stock-based compensation expense, compared to $11.8 million for the same period in 2019, which includes $1.6 million of non-cash stock-based compensation expense. For the year ended December 31, 2020, general and administrative expenses were $70.9 million, which includes $13.9 million of non-cash stock-based compensation expense, compared to $37.6 million for the same period in 2019, which includes $5.7 million of non-cash stock-based compensation expense. The increase for the quarter and the full year 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, including additional compliance-related expenses as a result of no longer being an emerging growth company. 
    • Net Loss: Net loss for the quarter ended December 31, 2020, was $105.6 million, or $0.83 per share, basic and diluted, compared to a net loss of $63.8 million, or $0.69 per share, basic, and $0.71 per share, diluted, for the same period in 2019. For the year ended December 31, 2020, net loss was $298.7 million, or $2.51 per share, basic and diluted, compared to a net loss of $174.7 million, or $5.76 per share, basic and diluted, for the same period in 2019.
    • Cash and Cash Equivalents: As of December 31, 2020, excluding restricted cash, the Company had approximately $736.9 million in cash, cash equivalents and investments. For the year ended December 31, 2020, net cash used in operating activities and property and equipment purchases was $197.5 million.

    About VIR-7831

    VIR-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-2482

    VIR-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.

    About VIR-1111

    VIR-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 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 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 and 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-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 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.

    Vir Biotechnology, Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share data)

     Three Months Ended

    December 31,
      Year Ended

    December 31,
     
     2020  2019  2020  2019 
    Revenue:               
    Grant revenue$1,433  $609  $9,123  $7,380 
    License revenue from a related party       22,747  $ 
    Contract revenue 301   371   44,498   711 
    Total revenue 1,734   980   76,368   8,091 
    Operating expenses:               
    Research and development 87,095   52,932   302,411   148,472 
    General and administrative 23,043   11,807   70,937   37,598 
    Total operating expenses 110,138   64,739   373,348   186,070 
    Loss from operations (108,404)  (63,759)  (296,980)  (177,979)
    Other income (expense):               
    Interest income 288   1,947   2,836   8,511 
    Other income (expense), net 2,437   (1,810)  (4,467)  (5,061)
    Total other income (expense) 2,725   137   (1,631)  3,450 
    Loss before benefit from (provision for) income taxes (105,679)  (63,622)  (298,611)  (174,529)
    Benefit from (provision for) income taxes 30   (149)  (54)  (154)
    Net loss$(105,649) $(63,771) $(298,665) $(174,683)
    Net loss per share, basic$(0.83) $(0.69) $(2.51) $(5.76)
    Net loss per share, diluted$(0.83) $(0.71) $(2.51) $(5.76)
    Weighted-average shares outstanding, basic 127,295,719   91,871,498   119,159,424   30,349,920 
    Weighted-average shares outstanding, diluted 127,295,719   91,901,590   119,159,424   30,349,920 
                    

    Vir Biotechnology, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands, except share and per share data)

      December 31, 
      2020  2019 
    ASSETS        
    CURRENT ASSETS:        
    Cash and cash equivalents $436,575  $109,335 
    Short-term investments  300,286   274,101 
    Restricted cash and cash equivalents, current  7,993   6,181 
    Prepaid expenses and other current assets  27,511   13,378 
    Total current assets  772,365   402,995 
    Intangible assets, net  33,820   35,694 
    Goodwill  16,937   16,937 
    Property and equipment, net  17,946   16,308 
    Operating right-of-use assets  61,947    
    Restricted cash and cash equivalents, noncurrent  6,919   7,300 
    Long-term investments     24,290 
    Other assets  8,827   8,547 
    TOTAL ASSETS $918,761  $512,071 
    LIABILITIES AND STOCKHOLDERS' EQUITY        
    CURRENT LIABILITIES:        
    Accounts payable $5,077  $5,881 
    Accrued and other liabilities  76,936   26,495 
    Deferred revenue, current portion  6,451   6,181 
    Contingent consideration, current portion  10,600   8,200 
    Derivative liability     12,449 
    Total current liabilities  99,064   59,206 
    Deferred revenue, noncurrent  3,815   12,670 
    Operating lease liabilities, noncurrent  66,556    
    Contingent consideration, noncurrent  25,374   9,380 
    Deferred tax liability  3,253   3,305 
    Other long-term liabilities  3,847   3,568 
    TOTAL LIABILITIES  201,909   88,129 
    Commitments and contingencies        
    STOCKHOLDERS' EQUITY:        
    Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of December 31, 2020 and 2019; no shares issued or outstanding as of December 31, 2020 and 2019      
    Common stock, $0.0001 par value; 300,000,000 shares authorized as of December 31, 2020 and 2019, respectively; 127,416,740 and 107,648,925 shares issued and outstanding as of December 31, 2020 and 2019, respectively  13   11 
    Additional paid-in capital  1,385,301   793,051 
    Accumulated other comprehensive loss  (1,278)  (601)
    Accumulated deficit  (667,184)  (368,519)
    TOTAL STOCKHOLDERS' EQUITY  716,852   423,942 
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $918,761  $512,071 
             


    Contact:
    Cara Miller
    VP, Corporate Communications
    
    +1-415-941-6746

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  2. – Companies applying their combined expertise in immunology and infectious diseases to accelerate the development of promising monoclonal antibody candidates for influenza –

    – Functional genomics collaboration expanded to include respiratory viruses, Vir's unique technology, and access to GSK's small molecule compounds –

    – Additional exploration of up to three other antibodies for pathogens
    beyond influenza and coronaviruses –

    – GSK is increasing its equity investment by $120 million and making an upfront
    payment of $225 million –

    LONDON and SAN FRANCISCO, Feb. 17, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced they have signed a binding agreement to expand their existing…

    – Companies applying their combined expertise in immunology and infectious diseases to accelerate the development of promising monoclonal antibody candidates for influenza –

    – Functional genomics collaboration expanded to include respiratory viruses, Vir's unique technology, and access to GSK's small molecule compounds –

    – Additional exploration of up to three other antibodies for pathogens

    beyond influenza and coronaviruses –

    – GSK is increasing its equity investment by $120 million and making an upfront

    payment of $225 million –

    LONDON and SAN FRANCISCO, Feb. 17, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced they have signed a binding agreement 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 (mAbs) for the prevention or treatment of influenza. These include VIR-2482, an intramuscularly administered investigational mAb designed as a universal prophylactic for influenza A that has completed a Phase 1 trial, as well as next-generation antibodies for the prevention or treatment of influenza during a three-year research period. GSK will have the exclusive option to co-develop VIR-2482 after Vir completes and reports Phase 2 trial outcomes, and will share development costs on the development of all other influenza mAbs.

    Influenza causes up to 500,000 hospitalizations and 34,000 deaths each year in the United States alone,1 approximately 75% of which are caused by influenza A.2 The protection provided by current vaccines varies from season to season, based on the virus strains circulating. People over 65 years of age with at least one comorbidity, such as cardiovascular disease, diabetes or who are immunocompromised, are at significantly increased risk of flu and flu-related hospitalization and mortality. This is also a population where the currently available vaccines have historically had lower efficacy.

    As part of the new collaboration agreement, the companies will also engage in two additional research programs. The first is an expansion of their current functional genomics collaboration to develop potential pan-coronavirus therapeutics to now include other respiratory virus targets. Under the second program, the companies will collaborate to develop up to three neutralizing monoclonal antibodies identified using Vir's antibody technology platform to target non-influenza pathogens during a three-year research period.

    Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "We believe, now more than ever, that it is very important to develop new therapies to treat and ideally prevent infectious diseases. I am delighted that we are expanding our collaboration with Vir whose focus on novel antibodies, expertise in functional genomics, unique technology and talented scientists will further strengthen GSK's position as a world leader in infectious diseases."

    George Scangos, Ph.D., CEO, Vir Biotechnology, said: "GSK has been a valuable strategic partner and scientific collaborator in the fight against COVID-19. As part of our functional genomics collaboration directed at COVID-19, we have turned up multiple targets that have the potential to treat influenza and other respiratory viruses, and it makes sense to extend the scope of our collaboration to include these new targets. This expanded collaboration supports the rapid advancement of multiple promising investigational compounds in our pipeline, increasing the likelihood that these potential life-saving treatments will reach patients sooner, and will advance our shared goal of developing single drugs that can address multiple ‘bugs.'"

    Under the terms of the agreement, GSK will make an upfront payment of $225 million and a further equity investment in Vir of $120 million. Initially, Vir will continue to fund the development of VIR-2482 through completion of Phase 2 trials, after which time, if GSK exercises its option to co-develop VIR-2482, it will pay an option fee of $300 million. Following option exercise for VIR-2482, and for each other program in the expanded collaboration, the companies will share the development costs and related profits associated with this agreement. GSK will also pay Vir up to $200 million based on the successful delivery of pre-defined regulatory milestones. The equity investment and collaboration agreement are conditional upon customary conditions including regulatory review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

    GSK and Vir entered into an initial strategic collaboration in April 2020 to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The focus of the collaboration to date has been the development of specific antibody candidates identified by Vir's monoclonal antibody platform, VIR-7831 and VIR-7832, that have demonstrated the potential to both block viral entry into healthy cells and clear infected cells, and to provide a high barrier to resistance. VIR-7831 is currently in two global Phase 3 studies as monotherapy and one Phase 2 study as combination therapy, with initial results from the first of the Phase 3 studies expected in the first quarter of 2021. VIR-7832 has been accepted into the NHS-supported AGILE Phase 1b/2a study with a planned start in February 2021.

    About Vir's Antibody Platform

    Vir has a robust method for capitalizing on unusually successful immune responses naturally occurring in people who are protected from, or have recovered from, infectious diseases. The platform is used to identify rare antibodies from survivors that have the potential to treat and prevent rapidly evolving and/or previously untreatable pathogens via direct pathogen neutralization and immune system stimulation. Vir engineers the fully human antibodies that it discovers to enhance their therapeutic potential. This platform has been used to identify and develop antibodies for pathogens including SARS-CoV-2, hepatitis B virus, influenza A, Ebola (mAb114, approved for use in the U.S. as EbangaTM and marketed by Ridgeback Therapeutics LP), malaria and others.

    About VIR-2482

    VIR-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 has been half-life engineered so that a single dose has the potential to last the entire flu season.

    About VIR-7831 / GSK4182137

    VIR-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 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 / GSK4182136

    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 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. Importantly, VIR-7832 has also 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 Collaboration

    In 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 are leveraging 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 are also applying their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

    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 COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

    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.

    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 "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 statements regarding the potential benefits of the collaboration with GSK, the completion of a definitive collaboration agreement, the total potential deal value of the collaboration, the ability to obtain clearance under the HSR Act and to satisfy the other closing conditions, the potential benefits of VIR-2482, and Vir's ability to address influenza, respiratory diseases, coronaviruses, including the current COVID-19 pandemic, and future outbreaks of any such diseases. 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 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.

    GSK Cautionary Statement Regarding Forward-Looking Statements

    GSK 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 under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q4 Results and any impacts of the COVID-19 pandemic.

    Registered in England & Wales:

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    TW8 9GS

    1 2018-2019 flu season data from the Centers for Disease Control and Prevention.

    2 Zhou et al. Clinical Infectious Diseases. 2012:54:1427-1436.



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  3. SAN FRANCISCO, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the Company will provide a corporate update and report financial results for the fourth quarter and full year ended December 31, 2020 on Thursday, February 25, 2021.

    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…

    SAN FRANCISCO, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the Company will provide a corporate update and report financial results for the fourth quarter and full year ended December 31, 2020 on Thursday, February 25, 2021.

    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 COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.



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  4. – Scientists continuing to advance critical research on mechanisms of immune evasion exemplified by emerging SARS-CoV-2 variants –

    – Study identifies the N-terminal domain of the SARS-CoV-2 spike protein as a target of potent neutralizing antibodies, but a target that can vary –

    – Separate research results published in Cell characterize the virulence and antibody response to N439K, a prevalent variant of the SARS-CoV-2 receptor binding motif –

    SAN FRANCISCO, Feb. 01, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the publication of new research characterizing a novel site of vulnerability on the SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) spike protein – specifically the N-terminal domain…

    – Scientists continuing to advance critical research on mechanisms of immune evasion exemplified by emerging SARS-CoV-2 variants –

    – Study identifies the N-terminal domain of the SARS-CoV-2 spike protein as a target of potent neutralizing antibodies, but a target that can vary –

    – Separate research results published in Cell characterize the virulence and antibody response to N439K, a prevalent variant of the SARS-CoV-2 receptor binding motif –

    SAN FRANCISCO, Feb. 01, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the publication of new research characterizing a novel site of vulnerability on the SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) spike protein – specifically the N-terminal domain (NTD). The study findings were made available online on bioRxiv on January 14, 2021 and have been submitted to a peer-reviewed journal for future print publication. This manuscript, together with data on immune evasion by mutations elsewhere in the spike protein published by scientists in Cell, begin to paint a comprehensive picture of the mechanisms that SARS-CoV-2 may utilize to evade immunity. Collectively, these data indicate the importance of carefully targeting conserved regions of the spike for vaccines and clinical monoclonal antibodies.

    The receptor binding motif (RBM) of SARS-CoV-2, the region of the receptor binding domain (RBD) that interacts with the SARS-CoV-2 receptor, is a common target of COVID-19 natural and vaccine-induced immune responses, as well as monoclonal antibodies. However, recently published research has characterized the frequent occurrence of mutations within the RBM, highlighting the need for targeting alternate sites within the spike protein.

    "This new research indicates the NTD is another site on the SARS-CoV-2 spike protein that, like the RBM, contains mutations as well as deletions in emerging variants," said Davide Corti, Ph.D., senior vice president of antibody research for Vir. "Mutations in these immunodominant domains can evade natural immune responses and are of concern for vaccines and for therapeutic monoclonal antibodies targeting these regions. This underscores the need to advance therapies that have a high barrier to resistance."

    Little is known about neutralizing antibodies that bind to the NTD and their contribution to protection from infection and disease. In this new study, researchers at Vir, the University of Washington and other universities in the United States and Europe isolated and extensively characterized 41 human monoclonal antibodies that recognize the SARS-CoV-2 NTD. A subset of these NTD-specific monoclonal antibodies neutralize SARS-CoV-2 with potency similar to potential best-in-class monoclonal antibodies that target the RBD. Notably, several new SARS-CoV-2 genetic variants, including the widely prevalent variants identified in South Africa and the UK, were found to possess frequent mutations in the NTD.

    These new findings build upon recent research published in Cell by Vir scientists in collaboration with colleagues at MRC-University of Glasgow Centre for Virus Research, which demonstrate the RBM of the SARS-CoV-2 spike protein – a major target of neutralizing monoclonal antibodies – is particularly variable.

    "Our ongoing effort to characterize the SARS-CoV-2 spike protein is proving ever more critical as new variants continue to emerge. These new findings reinforce the approach we have taken with our monoclonal antibody, VIR-7831, which is currently in Phase 3 trials," said George Scangos, Ph.D., chief executive officer of Vir. "By targeting a very conserved region of the RBD, VIR-7831 was designed to be effective against SARS-CoV-2 and variants that might emerge in this outbreak or future outbreaks of related viruses."

    The findings published in Cell characterize the virulence, fitness, clinical and epidemiologic impact, molecular features and immune response to N439K, a prevalent RBM variant of the SARS-CoV-2 spike protein first identified in Scotland in March 2020. Since then, a second lineage has independently emerged in other European countries, which, by January 2021, was detected in more than 30 countries across the globe. Although N439K variants are not believed to be more virulent or transmissible than the original SARS-CoV-2 strain, this research is the first to demonstrate mutations that maintain viral fitness can evade immunity.

    To understand whether and how the N439K mutation might evade immunity, researchers in the findings published in Cell noted the binding of polyclonal sera to the 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.

    About VIR-7831

    VIR-7831 is an investigational dual-action 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 (the virus which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 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 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.

    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 "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 statements regarding print publication of Vir's research in a peer-reviewed journal, the emergence of new SARS-CoV-2 variants, the identification of N-terminal domain as a target of potent neutralizing antibodies, the importance of advancing therapies that have a high barrier to resistance and the potential ability of VIR-7831 to evade such variants in the protection and treatment of COVID-19 and in the prevention of future pandemics of related coronaviruses. 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 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.



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  5. INDIANAPOLIS, SAN FRANCISCO and LONDON, Jan. 27, 2021 (GLOBE NEWSWIRE) -- Eli Lilly and Company (NYSE:LLY), Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced a collaboration to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate COVID-19. Lilly has expanded its ongoing BLAZE-4 trial to evaluate the administration of bamlanivimab (LY-CoV555) 700mg with VIR-7831 (also known as GSK4182136) 500mg, two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein. This unique collaboration marks the first time that monoclonal antibodies from separate companies will be brought together to explore potential outcomes.

    Bamlanivimab is a neutralizing…

    INDIANAPOLIS, SAN FRANCISCO and LONDON, Jan. 27, 2021 (GLOBE NEWSWIRE) -- Eli Lilly and Company (NYSE:LLY), Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced a collaboration to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate COVID-19. Lilly has expanded its ongoing BLAZE-4 trial to evaluate the administration of bamlanivimab (LY-CoV555) 700mg with VIR-7831 (also known as GSK4182136) 500mg, two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein. This unique collaboration marks the first time that monoclonal antibodies from separate companies will be brought together to explore potential outcomes.

    Bamlanivimab is a neutralizing antibody directed against the spike protein of SARS-CoV-2 designed to block viral attachment and entry into human cells, thus neutralizing the virus. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Bamlanivimab is authorized for emergency use for the treatment of mild to moderate COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.

    VIR-7831 is a dual-action monoclonal antibody that was selected for clinical development based on its potential to both block viral entry into healthy cells and clear infected cells, as well as its potential to provide a high barrier to resistance. In pre-clinical trials, the antibody has shown the ability to neutralize the SARS-CoV-2 live virus by binding to an epitope on SARS-CoV-2 shared with SARS-CoV-1, indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. Vir and GSK are advancing VIR-7831 as part of their collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2.

    "Bamlanivimab is a potent antibody – with data from multiple Phase 2 and 3 clinical trials, which have demonstrated robust evidence for both treating and preventing COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "With a virus like SARS-CoV-2, it's expected that variants could emerge that require new therapeutic options, which is why Lilly is studying bamlanivimab together with other neutralizing antibodies, including etesevimab. Adding VIR-7831 to our study is an important part of our commitment to develop therapies to treat current and future strains of COVID-19 until vaccines are widely available and utilized."

    "We believe that VIR-7831 has significant potential as a single agent, and we are optimistic about the pending interim data from two Phase 3 trials evaluating its potential for early treatment and in hospitalized patients," said George Scangos, Ph.D., chief executive officer of Vir. "As the virus continues to evolve, we, along with Lilly and GSK, share the view that we should pursue all possibilities to help end the pandemic and maximize the number of lives that can be saved. This trial is a first step to assess whether the administration of VIR-7831, with its high barrier to resistance and potent effector function, alongside bamlanivimab, which has strong outcomes data in early treatment, can provide potential benefits beyond monotherapy."

    "Despite the significant progress on vaccines, there remains an urgent patient need for multiple therapeutic approaches to prevent the more severe consequences of COVID-19," said Dr. Hal Barron, chief scientific officer and president R&D of GSK. "Partnering with Lilly to study VIR-7831 with bamlanivimab will provide the scientific community with further data on the important role these therapies could play in reducing the impact of this devastating pandemic."

    Bamlanivimab alone has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) based on interim data from the Phase 2 BLAZE-1 trial, which was published in the New England Journal of Medicine. These data show the therapy may help patients clear the virus and reduce COVID-19-related hospitalizations when given early in the disease course. The safety and efficacy of bamlanivimab is being evaluated with other neutralizing antibodies to provide a possible safeguard against potential viral resistance.

    VIR-7831 is an investigational compound, not approved by the U.S. FDA or any other regulatory authority. VIR-7831 is also being evaluated in the global Phase 2/3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial for the early treatment of COVID-19 in adults at high risk of hospitalization.

    Important Information about bamlanivimab

    Bamlanivimab has not been approved by the FDA for any use. It is not known if bamlanivimab is safe and effective for the treatment of COVID-19.

    Bamlanivimab is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

    Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers (English) (Spanish).

    Authorized Use and Important Safety Information

    Bamlanivimab 700 mg injection is authorized for use under EUA for treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

    Limitations of Authorized Use

    • Bamlanivimab is not authorized for use in patients:

      • who are hospitalized due to COVID-19, OR

      • who require oxygen therapy due to COVID-19, OR

      • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
    • Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19.

    Important Safety Information

    There are limited clinical data available for bamlanivimab. Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab use.

    Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

    There is a potential for serious hypersensitivity reaction, including anaphylaxis, with administration of bamlanivimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.

    Infusion-related reactions have been observed with administration of bamlanivimab. Signs and symptoms of infusion-related reactions may include:

    • fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness.

    If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.

    Limitations of Benefit and Potential Risk in Patients with Severe COVID-19

    Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. See Limitations of Authorized Use.

    Adverse Events

    Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg and placebo were Nausea (3% vs 4%), Diarrhea (1% vs 5%), Dizziness (3% vs 2%), Headache (3% vs 2%), Pruritus (2% vs 1%) and Vomiting (1% vs 3%).

    Use in Specific Populations

    Pregnancy

    There are insufficient data on the use of bamlanivimab during pregnancy. Bamlanivimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

    Breastfeeding

    There are no available data on the presence of bamlanivimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

    About BLAZE-4

    BLAZE-4 (NCT04634409) is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of bamlanivimab alone, and bamlanivimab with other neutralizing antibodies including VIR-7831 (GSK4182136) versus placebo for the treatment of symptomatic COVID-19 in the outpatient setting. Across all treatment arms, the trial will enroll an estimated 1,000 participants in the United States and Puerto Rico.

    The primary outcome measure is percentage of participants who have a viral load greater than 5.27 at day 7. Additional endpoints include change from baseline to day 7 in SARS-CoV-2 viral load, percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.

    About bamlanivimab

    Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

    Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

    Bamlanivimab is authorized in the U.S. for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

    About etesevimab

    Etesevimab (LY-CoV016, also known as JS016) is a recombinant, fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science (IMCAS). Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world.

    Lilly has successfully completed a Phase 1 study (NCT04441931) of etesevimab in healthy U.S. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. Junshi Biosciences has completed a similar Phase 1 study in healthy volunteers in China and has initiated Phase 1b/2 trials in COVID-19 patients globally.

    About VIR-7831 / GSK4182136

    VIR-7831 (GSK4182136) is an investigational dual-action 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 which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 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.

    The COMET clinical development program for VIR-7831 includes a planned Phase 3 trial for the prevention of symptomatic infection. VIR-7831 is also being evaluated in a sub-trial of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. 

    About Lilly's COVID-19 Efforts

    Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Visit Lilly's COVID-19 disease area page for resources related to Lilly's COVID-19 efforts.

    GSK commitment to tackling COVID-19

    GSK's response to COVID-19 has been one of the broadest in the industry with potential treatments and vaccine candidates in development.

    GSK is collaborating with several organisations working on promising COVID-19 vaccines by providing access to our adjuvant technology. In a collaboration with Sanofi that brings together two of the world's largest vaccine companies, GSK is developing an adjuvanted recombinant protein-based COVID-19 vaccine candidate with a phase 2b study expected to start in February 2021. GSK also is collaborating with Medicago and Clover Biopharmaceuticals on adjuvanted, protein-based vaccine candidates, which are progressing into late-stage clinical trials. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people.

    GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. Currently, collaborating on the phase 3 clinical development of VIR-7831 (GSK4182136), a dual-action monoclonal antibody that has shown the ability in preclinical trials to both neutralize SARS-CoV-2 live virus in vitro and in vivo and kill already infected cells.

    About Eli Lilly and Company 

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/news

    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 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

    Lilly Cautionary Statement Regarding Forward-Looking Statements

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about bamlanivimab (LY-CoV555) as a potential treatment for patients with or at risk of infection from COVID-19, alone and in combination with other neutralizing antibodies, including VIR-7831 and etesevimab (LY-CoV016), Lilly's development plans and collaboration efforts, and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development and commercialization and in drug collaborations. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that bamlanivimab alone or administered with VIR-7831or etesevimab will prove to be a safe and effective treatment or preventative for COVID-19, that bamlanivimab alone or administered with VIR-7831 or etesevimab will receive regulatory approvals or additional authorizations, that patients will volunteer to participate in a study of bamlanivimab alone or administered with VIR-7831 or etesevimab or achieve positive outcomes or that Lilly and its partners can provide an adequate supply of bamlanivimab alone or administered with VIR-7831 or etesevimab in all circumstances. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements. 

    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 "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 statements regarding the potential benefits of VIR-7831 as a single agent and in combination with bamlanivimab in the treatment of COVID-19, the potential benefits of participating in the BLAZE-4 trial, and the potential benefits of Vir, Lilly, and GSK's collaboration in addressing the current COVID-19 pandemic and future outbreaks of the disease. 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 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 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. 

    GSK's cautionary statement regarding forward-looking statements

    GSK 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 under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q3 Results and any impacts of the COVID-19 pandemic. 



    Contact:
    
    Investors, Vir
    Neera Ravindran, M.D.
    VP, Head of Investor Relations & Strategic Communications
    
    +1-415-506-5256
    
    Media, Vir
    Cara Miller
    VP, Corporate Communications
    
    +1-415-941-6746
    
    Investors, Lilly
    Kevin Hern
    
    +1-317-277-1838
    
    Media, Lilly
    Molly McCully
    
    +1-317-478-5423
    
    Media, Lilly
    Dani Barnhizer
    
    +1-317-607-6119
    
    Investors, GSK
    Jeff McLaughlin
    
    +1-215-751-7002
    
    Media, GSK
    Lyndsay Meyer
    
    +1-202-302-4595

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