Vir Biotechnology Provides Corporate Update and Reports Third Quarter 2020 Financial Results
“I am proud of the Vir team’s effort and success in accelerating our lead SARS-CoV-2 product candidate, VIR-7831, into a global Phase 3 trial, particularly in light of the more than 141,000 new COVID-19 infections recently reported in a single day in the U.S.,” said
- In August, the Company initiated COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early), a Phase 2/3 clinical trial evaluating VIR-7831, a potent SARS-CoV-2 neutralizing monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization.
- In September, an Independent Data Monitoring Committee recommended the global expansion into Phase 3 of the COMET-ICE trial based on a positive evaluation of safety and tolerability data from the Phase 2 lead-in. Global Phase 3 enrollment is ongoing and interim data may be available as early as
January 2021. Results for the primary endpoint are expected in the first quarter of 2021.
- In connection with the advancement of its SARS-CoV-2 programs, the Company has established a strategic manufacturing network, which will enable the supply of millions of doses to patients the first year following approval, depending on titer and yield.
- The Company plans to initiate two additional Phase 3 trials in the COMET clinical development program for VIR-7831:
• A trial for the treatment of hospitalized adults with COVID-19 is planned as a sub-study of the
National Institutes of Health-sponsored ACTIV-3trial and is expected to begin as soon as regulatory and ethical approvals are in place.
• A trial for prophylaxis or prevention of symptomatic infection is expected to begin in the first quarter of 2021.
- The Company is also preparing to advance its second investigational SARS-CoV-2 neutralizing antibody into a Phase 1b/2a trial in the first quarter of 2021. VIR-7832 shares the same characteristics as VIR-7831, plus enhanced effector function, which may confer additional efficacy in treatment or prophylaxis by stimulating a T cell response.
- Pre-clinical studies for VIR-2703, an inhaled SARS-CoV-2-targeting small interfering ribonucleic acid (siRNA), are being led by Alnylam Pharmaceuticals, Inc. Alnylam is working to obtain additional efficacy data prior to further program advancement.
Additional Pipeline Updates
- In July, the Company initiated a Phase 2 combination trial of VIR-2218, an HBV-targeting siRNA, with pegylated interferon-alpha (PEG-IFN-α), evaluating the potential for this cocktail to result in functional cure of HBV-infected patients. Initial clinical data are anticipated in 2021.
- The Company also plans to evaluate VIR-2218 in combination with VIR-3434, an HBV-neutralizing monoclonal antibody with the potential to be a therapeutic T cell vaccine. VIR-3434 is currently being evaluated in a Phase 1 trial, the results of which are expected to enable the Company to initiate a Phase 2 combination trial of VIR-3434 in combination with VIR-2218 in 2021.
- In October, the Company presented data from its influenza A research program virtually at the
Infectious Disease Society of America IDWeek2020. Company presentations included two poster presentations on VIR-2482, an influenza A-neutralizing monoclonal antibody, and one oral presentation highlighting the severe economic and clinical burden of influenza A on elderly patients with underlying conditions in the United States. Initiation of the Phase 2 trial for VIR-2482, which was delayed due to the impact of COVID-19, is now expected in the fourth quarter of 2021 with proof-of-concept results anticipated in the first half of 2022.
- The Company expects to initiate a Phase 1 clinical trial for VIR-1111, an HIV T cell vaccine based on human cytomegalovirus, in the fourth quarter of this year. This trial is designed to determine whether VIR-1111 elicits a specific type of T cell immune response to HIV, known as an HLA-E restricted immune response.
During and following the third quarter, five manuscripts were published related to the Company’s efforts to address SARS-CoV-2 and other conditions that may benefit from treatment with monoclonal antibodies.
- Science published "Ultrapotent human antibodies protect against SARS-CoV-2 challenge via multiple mechanisms” (Tortorici, et al.), discussing the neutralizing abilities of two ultrapotent SARS-CoV-2 antibodies (S2E12 and S2M11) in clinical models.
- Cell published “Mapping Neutralizing and immunodominant sites on the SARS-CoV-2 spike receptor-binding domain by structure-guided high-resolution serology” (Piccoli, et al.), characterizing differences in both the binding properties and kinetics of neutralizing antibody responses to SARS-CoV-2.
- EMBO Molecular Medicine published “A combination of two human monoclonal antibodies cures symptomatic rabies” (de Melo, et al.), outlining proof-of-concept data for an antibody-based therapeutic approach for the treatment of symptomatic rabies.
- 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.
- bioRxiv published “The circulating SARS-CoV-2 spike variant N439K maintains fitness while evading antibody-mediated immunity” (Thomson, et al.), characterizing variation in the SARS-CoV-2 spoke protein and virulence of a prevalent immune evasion variant, N439K.
New Board Appointment
- In September, the Company announced the appointment of
Janet Napolitanoto the Board of Directors. Ms. Napolitanoformerly served as the Governor of Arizona, the U.S.Secretary of Homeland Security under President Barack Obama, and most recently as the President of the University of Californiafor the past seven years. Her appointment follows the July addition of Elliott Sigal, M.D., Ph.D., to the Board.
Third Quarter 2020 Financial Results
- Revenues: Total revenues for the quarter ended
September 30, 2020were $1.9 million, compared to $1.4 millionfor the same period in 2019. The increase for the quarter was primarily due to the timing of research activities under the HIV and TB grants with the Bill & Melinda Gates Foundation.
- Research and Development Expenses: Research and development expenses were
$70.7 millionfor the quarter ended September 30, 2020, which includes $4.2 millionof non-cash stock-based compensation expense, compared to $39.9 millionfor the same period in 2019, which included $0.9 millionof non-cash stock-based compensation expense. The increase for the quarter was primarily due to contract manufacturing expenses for our SARS-CoV-2 programs, higher fair value of our contingent consideration due to achievement of clinical development milestones, personnel-related expenses due to additional headcount, and clinical costs due to activities related to VIR-7831, VIR-3434 and VIR-1111.
- General and Administrative Expenses: General and administrative expenses were
$18.9 millionfor the quarter ended September 30, 2020, which includes $4.4 millionof non-cash stock-based compensation expense, compared to $9.2 millionfor the same period in 2019, which includes $1.3 millionof non-cash stock-based compensation expense. The increase for the quarter was primarily due to personnel-related expenses attributable to additional headcount, legal fees, external consulting and other expenses due to costs associated with operating as a public company.
- Net Loss: Net loss for the quarter ended
September 30, 2020was $84.6 million, or $0.67per share, basic and diluted, compared to a net loss of $48.3 million, or $4.60per share, basic and diluted, for the same period in 2019.
- Cash and Cash Equivalents: As of
September 30, 2020, excluding restricted cash, the Company had approximately $826.6 millionin cash, cash equivalents and investments.
VIR-7831 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro and in vivo. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 has been engineered with the potential to enhance lung bioavailability and have an extended half-life.
VIR-7832 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7832 has been engineered with the potential to enhance lung bioavailability, have an extended half-life, and function as a therapeutic and/or prophylactic T cell vaccine.
VIR-2703 is an inhaled SARS-CoV-2-targeting siRNA that has demonstrated the ability to significantly reduce SARS-CoV-2 live virus replication in vitro. VIR-2703 is designed to degrade the viral genome, leading to inhibition of viral protein synthesis and blocking the production of infectious virus. It targets a nucleic acid sequence in the SARS-CoV-2 genome that is highly conserved amongst currently available viral sequences and is also conserved in SARS-CoV-1 (also known as SARS). VIR-2703 leverages Alnylam Pharmaceuticals, Inc.’s latest advances in lung delivery of siRNAs.
VIR-2218 is a subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. VIR-2218 is the first asset in the company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.
VIR-3434 is a subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. VIR-3434 has been engineered to have an extended half-life as well as to potentially function as a T cell vaccine against HBV in infected patients.
VIR-2482 is an intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. VIR-2482 is designed as a universal prophylactic for influenza A. It has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response. VIR-2482 has been half-life engineered so that a single dose has the potential to last the entire flu season, which is typically five to six months long.
VIR-1111 is a subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit T cells that recognize HIV epitopes that are different from those recognized by prior HIV vaccines and to stimulate a different and specific type of T cell immune response to HIV, known as an HLA-E restricted immune response.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “aim,” “anticipate,” “estimate,” “intend,” “potential,” “prepare” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the timing of commencement of clinical trials and completion of preclinical studies, the timing of availability of clinical data, the evaluation criteria, designs, program updates and data disclosures related to Vir’s clinical trials, the ability of VIR-7831, VIR-7832, and VIR-2703 to treat and/or prevent COVID-19 and other diseases caused by the SARS-CoV-2 virus, the clinical efficacy of VIR-7831 and VIR-7832, the capacity to manufacture, develop and commercialize a product candidate to treat COVID-19, the timing of availability and expected number of therapeutic doses, the ability to address the current global COVID-19 pandemic and future outbreaks of diseases caused by coronaviruses, the potential for the combination of VIR-2218 and PEG-IFN-α to result in the functional cure of HBV, the ability of VIR-3434 to neutralize and treat HBV, the ability of VIR-2482 to provide broad strain coverage for the flu, and the ability of VIR-1111 to elicit a T cell immune response to HIV. Many factors may cause differences between current expectations and actual results, including delays or failures in planned patient enrollment or retention, clinical site activation rates or clinical trial enrollment rates that are lower than expected, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in neutralizing SARS-CoV-2, other coronaviruses and HBV, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Condensed Consolidated Statements of Operations
(unaudited; in thousands, except share and per share data)
|Three Months Ended
|Nine Months Ended
|License revenue from a related party||—||—||22,747||—|
|Research and development||70,684||39,863||215,316||95,541|
|General and administrative||18,859||9,220||47,894||25,790|
|Total operating expenses||89,543||49,083||263,210||121,331|
|Loss from operations||(87,615||)||(47,680||)||(188,576||)||(114,220||)|
|Other income (expense):|
|Other income (expense), net||2,616||(2,659||)||(6,904||)||(3,251||)|
|Total other income (expense)||3,028||(647||)||(4,356||)||3,313|
|Loss before benefit from (provision for) income taxes||(84,587||)||(48,327||)||(192,932||)||(110,907||)|
|Benefit from (provision for) income taxes||(22||)||13||(84||)||(5||)|
|Net loss per share, basic and diluted||$||(0.67||)||$||(4.60||)||$||(1.66||)||$||(11.53||)|
|Weighted-average shares outstanding, basic and diluted||125,810,907||10,500,848||116,427,529||9,615,379|
Condensed Consolidated Balance Sheets
(unaudited; in thousands, except share and per share data)
|Cash and cash equivalents||$||462,521||$||109,335|
|Restricted cash and cash equivalents, current||9,363||6,181|
|Prepaid expenses and other current assets||13,614||13,378|
|Total current assets||849,572||402,995|
|Intangible assets, net||33,944||35,694|
|Property and equipment, net||16,948||16,308|
|Operating right-of-use assets||14,762||—|
|Restricted cash and cash equivalents, noncurrent||1,201||7,300|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued and other liabilities||44,339||26,495|
|Deferred revenue, current portion||5,563||6,181|
|Contingent consideration, current portion||20,300||8,200|
|Total current liabilities||76,998||59,206|
|Deferred revenue, noncurrent||3,815||12,670|
|Operating lease liabilities, noncurrent||12,092||—|
|Contingent consideration, noncurrent||31,712||9,380|
|Deferred tax liability||3,305||3,305|
|Other long-term liabilities||2,982||3,568|
|Additional paid-in capital||1,374,362||793,051|
|Accumulated other comprehensive loss||(485||)||(601||)|
|TOTAL STOCKHOLDERS’ EQUITY||812,355||423,942|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||943,259||$||512,071|
Neera Ravindran, M.D. VP, Head of Investor Relations & Strategic Communicationsnravindran@vir.bio +1-415-506-5256 Media Cara MillerVP, Corporate Communications firstname.lastname@example.org +1-415-941-6746
Source: Vir Biotechnology, Inc.