Full Press Release Details
Vir Biotechnology Provides Corporate Update and Reports
First Quarter 2021 Financial Results
SAN FRANCISCO, May 6, 2021 - Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the first quarter ended March 31, 2021.
"We've had an active start to the year, achieving significant clinical and collaboration milestones across our portfolio of investigational compounds for serious infectious diseases," said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. "Based on the profound efficacy results from our Phase 3 trial of VIR-7831 and our belief in its ongoing ability to address known variants of concern, we remain confident in the potential of this dual-action monoclonal antibody to play an important role in bringing the COVID-19 pandemic to an end. We look forward to the pending Emergency Use Authorization decisions in the U.S. and Europe. In the interim, we are rapidly progressing the initiation of new studies aimed at both the prevention and treatment of COVID-19, as well as new delivery methods that we hope will help ease administration and access in the future. Importantly, we are also excited to share several new data sets from our robust hepatitis B pipeline in the second quarter, and expect to maintain our executional momentum throughout the year."
Chronic Hepatitis B Virus (HBV) Updates
Additional Pipeline Updates
During and following the first quarter, nine manuscripts were published related to the Company's efforts to address SARS-CoV-2 and other viruses.
First Quarter 2021 Financial Results
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.
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.
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.
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.
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.
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.
Vir's Commitment to COVID-19
Vir was founded with the mission of addressing the world's most serious infectious diseases. In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. VIR-7831 is the first SARS-CoV-2-targeting antibody we advanced into the clinic. It was carefully selected for its unique characteristics demonstrated during preclinical research, including a high barrier to resistance and dual-action ability to both block the virus from entering healthy cells and clear infected cells. VIR-7831 has since demonstrated positive monotherapy results in a Phase 3 clinical trial for the early treatment of COVID-19 in high-risk adult patients, and proven in preclinical studies to retain activity against all known circulating COVID-19 variants of concern. Vir is continuing to pursue novel therapeutic and prophylactic solutions to combat SARS-CoV-2 and future coronavirus pandemics, both independently and in collaboration with our partners.
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, the ability of VIR-7831 to be administered via an IM route, 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-1111 to elicit a T cell immune response to HIV, potential timelines for advancing influenza therapies, including VIR-2482 and other therapies covered under the expanded agreement with GSK. Many factors may cause differences between current expectations and actual results, including challenges in enrollment, 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. 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.
VP, Corporate Communications
Vir Biotechnology, Inc.
Condensed Consolidated Statements of Operations
(unaudited; in thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Revenues: | ||||||||
| Grant revenue | $ | 1,371 | $ | 5,231 | ||||
| Contract revenue | 605 | 487 | ||||||
| Total revenue | 1,976 | 5,718 | ||||||
| Operating expenses: | ||||||||
| Research and development | 134,870 | 64,979 | ||||||
| General and administrative | 25,739 | 12,649 | ||||||
| Total operating expenses | 160,609 | 77,628 | ||||||
| Loss from operations | (158,633 | ) | (71,910 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 164 | 1,755 | ||||||
| Other expense, net | (10,246 | ) | (7,069 | ) | ||||
| Total other income (expense) | (10,082 | ) | (5,314 | ) | ||||
| Loss before provision for income taxes | (168,715 | ) | (77,224 | ) | ||||
| Provision for income taxes | (196 | ) | (16 | ) | ||||
| Net loss | $ | (168,911 | ) | $ | (77,240 | ) | ||
| Net loss per share, basic and diluted | $ | (1.32 | ) | $ | (0.71 | ) | ||
| Weighted-average shares outstanding, basic and diluted | 127,742,614 | 108,387,913 |
Vir Biotechnology, Inc.
Condensed Consolidated Balance Sheets
(unaudited; in thousands, except share and per share data)
| March 31, 2021 | December 31, 2020 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 521,396 | $ | 436,575 | ||||
| Short-term investments | 211,636 | 300,286 | ||||||
| Restricted cash and cash equivalents, current | 8,601 | 7,993 | ||||||
| Receivable from collaboration | 112,500 | - | ||||||
| Contract asset | 112,500 | - | ||||||
| Prepaid expenses and other current assets | 26,481 | 27,511 | ||||||
| Total current assets | 993,114 | 772,365 | ||||||
| Intangible assets, net | 33,687 | 33,820 | ||||||
| Goodwill | 16,937 | 16,937 | ||||||
| Property and equipment, net | 17,291 | 17,946 | ||||||
| Operating right-of-use assets | 60,461 | 61,947 | ||||||
| Restricted cash and cash equivalents, noncurrent | 6,998 | 6,919 | ||||||
| Other assets | 7,096 | 8,827 | ||||||
| TOTAL ASSETS | $ | 1,135,584 | $ | 918,761 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 3,701 | $ | 5,077 | ||||
| Accrued and other liabilities | 70,069 | 76,936 | ||||||
| Deferred revenue, current portion | 262,929 | 6,451 | ||||||
| Contingent consideration, current portion | 24,400 | 10,600 | ||||||
| Total current liabilities | 361,099 | 99,064 | ||||||
| Deferred revenue, noncurrent | 3,815 | 3,815 | ||||||
| Operating lease liabilities, noncurrent | 66,615 | 66,556 | ||||||
| Contingent consideration, noncurrent | 46,036 | 25,374 | ||||||
| Deferred tax liability | 3,253 | 3,253 | ||||||
| Other long-term liabilities | 3,815 | 3,847 | ||||||
| TOTAL LIABILITIES | 484,633 | 201,909 | ||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of March 31, 2021 and December 31, 2020; no shares issued and outstanding as of March 31, 2021 and December 31, 2020 | - | - | ||||||
| Common stock, $0.0001 par value; 300,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 129,891,856 and 127,416,740 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 13 | 13 | ||||||
| Additional paid-in capital | 1,488,337 | 1,385,301 | ||||||
| Accumulated other comprehensive loss | (1,304 | ) | (1,278 | ) | ||||
| Accumulated deficit | (836,095 | ) | (667,184 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 650,951 | 716,852 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 1,135,584 | $ | 918,761 |