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Vir Biotechnology, Inc. (VIR)

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  • Vir Biotechnology and GSK Provide Update on NIH-Sponsored  ACTIV-3 Trial Evaluating VIR-7831 in Hospitalized Adults with COVID-19
    GlobeNewswire

    Vir Biotechnology and GSK Provide Update on NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalized Adults with COVID-19

    SAN FRANCISCO and LONDON, March 03, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today provided an update on the VIR-7831 (GSK4182136) arm of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. The companies were informed that while VIR-7831 met initial pre-specified criteria to continue to the next phase of the ACTIV-3 trial and there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of potential benefit. The independent Data and Safety Monitoring Board (DSMB) has recommended that the VIR-7831 arm of the trial be closed to enrollment while the data mature. The companies will continue discussions with the NIH about appropriate ways to further assess the potential of VIR-7831 in the hospitalized population as all parties gain a fuller understanding of the still-emerging data. The DSMB recommendation was based on a routine, pre-planned safety and efficacy data review of the first 300 patients hospitalized with COVID-19 enrolled in ACTIV-3. George Scangos, Ph.D., chief executive officer of Vir, said: “While we are disappointed with the recommendation of the DSMB, we are encouraged by the safety profile of VIR-7831 and by the possibility of a benefit on top of remdesivir and corticosteroids in this advanced cohort of patients. We want to thank NIH for their work to assess the benefits of VIR-7831 and other agents, and look forward to working with them to further understand the potential of VIR-7831 to provide a benefit in this population. In addition, we are eagerly anticipating the upcoming data from the Phase 3 COMET-ICE trial in newly-diagnosed COVID-19 patients at high risk of hospitalization.” Christopher Corsico, Senior Vice President Development, GSK, said: “We want to thank the patients who participated in this study and the NIH for investing in the ACTIV trial to evaluate the four monoclonal antibodies, as it recognizes the need for differentiated treatments, especially as new variants emerge globally. These and other anticipated data will provide valuable insights about how VIR-7831 can contribute to the fight against this pandemic.” VIR-7831 is an investigational, dual-action monoclonal antibody that has been shown in preclinical trials to both block viral entry into healthy cells and clear infected cells, which may protect patients from disease progression. The antibody has also shown the ability to neutralize the SARS-CoV-2 live virus by binding to a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. So far, the variants of concern, including the UK, South African and Brazilian variants, do not overlap with the VIR-7831 targeted epitope of the virus, and, therefore, VIR and GSK believe that it should maintain full activity against these strains. In addition to the ACTIV-3 trial, VIR-7831 is also being evaluated in the outpatient setting in the following clinical trials: COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early): A Phase 3 trial to evaluate VIR-7831 for the early treatment of COVID-19 in adults at high risk of hospitalization or death.BLAZE-4 (sponsored by Eli Lilly and Company): A Phase 2 trial designed to assess the safety and efficacy of Eli Lilly’s bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19. Additionally, VIR-7831, along with VIR-7832, will be evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment. VIR-7831 and VIR-7832 are investigational compounds, not approved by the U.S. Food and Drug Administration or any other regulatory authority. About VIR-7831 / GSK4182136VIR-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 / GSK4182137VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor’s Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection. About the Vir and GSK CollaborationIn April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines. GSK commitment to tackling COVID-19GSK’s response to COVID-19 has been one of the broadest in the industry, with two potential treatments in addition to our vaccine candidates in development. GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to work with Sanofi, our collaboration with Medicago on an adjuvanted, protein-based vaccine candidate is now in late-stage clinical trials. An earlier stage collaboration with SK Bioscience is also ongoing, with funding from CEPI and Bill and Melinda Gates Foundation, to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced, contributing to protecting more people. GSK is also working with mRNA specialist, CureVac, to jointly develop next generation, multi-valent mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK will also support manufacturing of up to 100m doses of CureVac’s first generation COVID-19 vaccine, if approved. GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. About Vir BiotechnologyVir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio. About GSKGSK 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 StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing of availability of clinical data, program updates and data disclosures related to VIR-7831, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19, the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus and the ability of VIR-7831 to maintain full activity against variant strains of the virus. 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 StatementsGSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described 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 Q2 Results and any impacts of the COVID-19 pandemic. Registered in England & Wales:No. 3888792 Registered Office:980 Great West RoadBrentford, MiddlesexTW8 9GS CONTACT: Vir Biotechnology Contacts: Cara Miller VP, Corporate Communications cmiller@vir.bio +1 415 941 6746 GSK Contacts: Media: Simon Steel +44 (0) 20 8047 5502 (London) Tim Foley +44 (0) 20 8047 5502 (London) Kristen Neese +1 804 217 8147 (Philadelphia) Kathleen Quinn +1 202 603 5003 (Washington DC) Analysts/Investors: Sarah Elton-Farr +44 (0) 20 8047 5194 (London) Sonya Ghobrial +44 (0) 7392 784784 (Consumer) Danielle Smith +44 (0) 20 8047 0932 (London) James Dodwell +44 (0) 20 8047 2406 (London) Jeff McLaughlin +1 215 751 7002 (Philadelphia) Frannie DeFranco +1 215 751 4855 (Philadelphia)

  • Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2020 Financial Results
    GlobeNewswire

    Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2020 Financial Results

    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 infectionIn 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. PublicationsDuring 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-7831VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor’s Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. About VIR-7832 VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor’s Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection. About VIR-2218VIR-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-3434VIR-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-2482VIR-2482 is an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. VIR-2482 is designed as a universal prophylactic for influenza A. It has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response. VIR-2482, which incorporates Xencor’s Xtend technology, also has been half-life engineered so that a single dose has the potential to last the entire flu season. About VIR-1111VIR-1111 is an investigational subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit abundant T cells that recognize HIV epitopes in a way that differs from prior HIV vaccines. About Vir BiotechnologyVir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing of availability of clinical data, program updates and data disclosures related to Vir’s clinical trials, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19 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 EndedDecember 31, Year EndedDecember 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: Contact: Cara Miller VP, Corporate Communications cmiller@vir.bio +1-415-941-6746

  • GSK and Vir Biotechnology Expand Coronavirus Collaboration to Advance New Therapeutics for Influenza and Other Respiratory Viruses
    GlobeNewswire

    GSK and Vir Biotechnology Expand Coronavirus Collaboration to Advance New Therapeutics for Influenza and Other Respiratory Viruses

    – 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 (LSE/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 PlatformVir 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-2482VIR-2482 is an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. VIR-2482 is designed as a universal prophylactic for influenza A. It has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response. VIR-2482 has been half-life engineered so that a single dose has the potential to last the entire flu season. About VIR-7831 / GSK4182137VIR-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 / GSK4182136VIR-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 BiotechnologyVir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio. 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 StatementsGSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described 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:No. 3888792 Registered Office:980 Great West RoadBrentford, MiddlesexTW8 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. CONTACT: Vir Biotechnology Contact: Cara Miller VP, Corporate Communications cmiller@vir.bio + 1 415 941 6746 GSK Contacts: Media: Simon Steel +44 (0) 20 8047 5502 (London) Tim Foley +44 (0) 20 8047 5502 (London) Kristen Neese +1 804 217 8147 (Philadelphia) Kathleen Quinn +1 202 603 5003 (Washington DC) Analysts/Investors: Sarah Elton-Farr +44 (0) 20 8047 5194 (London) Sonya Ghobrial +44 (0) 7392 784784 (Consumer) James Dodwell +44 (0) 20 8047 2406 (London) Jeff McLaughlin +1 215 751 7002 (Philadelphia) Frannie DeFranco +1 215 751 4855 (Philadelphia)