Full Press Release Details
Vir Biotechnology Provides Corporate Update and Reports Third Quarter 2020 Financial Results
SAN FRANCISCO, November 10, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, today provided a corporate update and reported financial results for the third quarter ended September 30, 2020.
"I am proud of the Vir team's effort and success in accelerating our lead SARS-CoV-2 product candidate, VIR-7831, into a global Phase 3 trial, particularly in light of the more than 141,000 new COVID-19 infections recently reported in a single day in the U.S.," said George Scangos, Ph.D., chief executive officer of Vir. "We expect to share initial results from the trial as early as January and look forward to advancing VIR-7831 into new patient populations alongside the initiation of a Phase 1b/2a trial for our second investigational SARS-CoV-2 neutralizing antibody, VIR-7832. Simultaneously, we continue to advance our broader portfolio of product candidates for chronic hepatitis B, influenza A and HIV, as we seek to address some of the world's most challenging infectious diseases."
Additional Pipeline Updates
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.
New Board Appointment
Third Quarter 2020 Financial Results
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.
About Vir Biotechnology
Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "aim," "anticipate," "estimate," "intend," "potential," "prepare" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the timing of commencement of clinical trials and completion of preclinical studies, the timing of availability of clinical data, the evaluation criteria, designs, program updates and data disclosures related to Vir's clinical trials, the ability of VIR-7831, VIR-7832, and VIR-2703 to treat and/or prevent COVID-19 and other diseases caused by the SARS-CoV-2 virus, the clinical efficacy of VIR-7831 and VIR-7832, the capacity to manufacture, develop and commercialize a product candidate to treat COVID-19, the timing of availability and expected number of therapeutic doses, the ability to address the current global COVID-19 pandemic and future outbreaks of diseases caused by coronaviruses, the potential for the combination of VIR-2218 and PEG-IFN- 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.
Neera Ravindran, M.D.
VP, Head of Investor Relations & Strategic Communications
VP, Corporate Communications
Vir Biotechnology, Inc.
Condensed Consolidated Statements of Operations
(unaudited; in thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenues: | ||||||||||||||||
| Grant revenue | $ | 1,740 | $ | 1,166 | $ | 7,690 | $ | 6,771 | ||||||||
| License revenue from a related party | - | - | 22,747 | - | ||||||||||||
| Contract revenue | 188 | 237 | 44,197 | 340 | ||||||||||||
| Total revenue | 1,928 | 1,403 | 74,634 | 7,111 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 70,684 | 39,863 | 215,316 | 95,541 | ||||||||||||
| General and administrative | 18,859 | 9,220 | 47,894 | 25,790 | ||||||||||||
| Total operating expenses | 89,543 | 49,083 | 263,210 | 121,331 | ||||||||||||
| Loss from operations | (87,615 | ) | (47,680 | ) | (188,576 | ) | (114,220 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 412 | 2,012 | 2,548 | 6,564 | ||||||||||||
| Other income (expense), net | 2,616 | (2,659 | ) | (6,904 | ) | (3,251 | ) | |||||||||
| Total other income (expense) | 3,028 | (647 | ) | (4,356 | ) | 3,313 | ||||||||||
| Loss before benefit from (provision for) income taxes | (84,587 | ) | (48,327 | ) | (192,932 | ) | (110,907 | ) | ||||||||
| Benefit from (provision for) income taxes | (22 | ) | 13 | (84 | ) | (5 | ) | |||||||||
| Net loss | $ | (84,609 | ) | $ | (48,314 | ) | $ | (193,016 | ) | $ | (110,912 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.67 | ) | $ | (4.60 | ) | $ | (1.66 | ) | $ | (11.53 | ) | ||||
| Weighted-average shares outstanding, basic and diluted | 125,810,907 | 10,500,848 | 116,427,529 | 9,615,379 |
Vir Biotechnology, Inc.
Condensed Consolidated Balance Sheets
(unaudited; in thousands, except share and per share data)
| September 30, 2020 | December 31, 2019 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 462,521 | $ | 109,335 | ||||
| Short-term investments | 364,074 | 274,101 | ||||||
| Restricted cash and cash equivalents, current | 9,363 | 6,181 | ||||||
| Prepaid expenses and other current assets | 13,614 | 13,378 | ||||||
| Total current assets | 849,572 | 402,995 | ||||||
| Intangible assets, net | 33,944 | 35,694 | ||||||
| Goodwill | 16,937 | 16,937 | ||||||
| Property and equipment, net | 16,948 | 16,308 | ||||||
| Operating right-of-use assets | 14,762 | - | ||||||
| Restricted cash and cash equivalents, noncurrent | 1,201 | 7,300 | ||||||
| Long-term investments | - | 24,290 | ||||||
| Other assets | 9,895 | 8,547 | ||||||
| TOTAL ASSETS | $ | 943,259 | $ | 512,071 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 6,796 | $ | 5,881 | ||||
| Accrued and other liabilities | 44,339 | 26,495 | ||||||
| Deferred revenue, current portion | 5,563 | 6,181 | ||||||
| Contingent consideration, current portion | 20,300 | 8,200 | ||||||
| Derivative liability | - | 12,449 | ||||||
| Total current liabilities | 76,998 | 59,206 | ||||||
| Deferred revenue, noncurrent | 3,815 | 12,670 | ||||||
| Operating lease liabilities, noncurrent | 12,092 | - | ||||||
| Contingent consideration, noncurrent | 31,712 | 9,380 | ||||||
| Deferred tax liability | 3,305 | 3,305 | ||||||
| Other long-term liabilities | 2,982 | 3,568 | ||||||
| TOTAL LIABILITIES | 130,904 | 88,129 | ||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of September 30, 2020 and December 31, 2019; no shares issued and outstanding as of September 30, 2020 and December 31, 2019 | - | - | ||||||
| Common stock, $0.0001 par value; 300,000,000 shares authorized as of September 30, 2020 and December 31, 2019; 126,991,631 and 107,648,925 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively | 13 | 11 | ||||||
| Additional paid-in capital | 1,374,362 | 793,051 | ||||||
| Accumulated other comprehensive loss | (485 | ) | (601 | ) | ||||
| Accumulated deficit | (561,535 | ) | (368,519 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 812,355 | 423,942 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 943,259 | $ | 512,071 |