Tobevibart

SAN FRANCISCO--( BUSINESS WIRE )--Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the third quarter ended September 30, 2024. “ This quarter was transformational for Vir. We have bolstered our clinical pipeline with three potential best-in-class dual-masked T-cell engagers in oncology, and have sharpened our focus within infectious diseases to the areas where we believe we can make the most significant impact for patients. We are also thrilled to welcome Jason O’Byrne as our new CFO. Jason brings a wealth of financial leadership experience, further strengthening our ability to bring these potentially transformative therapies to patients as quickly as possible,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “ Looking ahead, this is an exciting time for the Company. We eagerly anticipate critical data in our hepatitis programs in the fourth quarter and look forward to sharing initial clinical data from our dual-masked T-cell engagers in the first quarter of 2025.” Pipeline Programs Chronic Hepatitis Delta (CHD) Preliminary data from the Phase 2 chronic hepatitis delta SOLSTICE study was presented at the European Study of the Liver (EASL) Meeting in June 2024. This data demonstrated the potential for transformative treatment for people living with chronic hepatitis delta, with both tobevibart as a monotherapy, and in combination with elebsiran, achieving high rates of virologic response and ALT normalization after 12 and 24 weeks of treatment. No treatment-related serious adverse events were observed. The combination of tobevibart and elebsiran has been granted Fast Track Designation by the U.S. FDA. Given the robust rates of virologic suppression observed with the combination, the Company is diligently working to advance this regimen into a pivotal development program as quickly as possible to address the urgent needs of these patients. At the upcoming American Association for the Study of Liver Diseases (AASLD) “The Liver Meeting” in November 2024, the Company will present additional data from the Phase 2 chronic hepatitis delta SOLSTICE trial, including: 24-week clinical data for both study cohorts in approximately 60 patients and further data for those patients who were on study beyond 24 weeks at the time of data cut-off. One cohort assesses the combination of tobevibart and elebsiran administered every four weeks, while a second cohort evaluates tobevibart monotherapy administered every two weeks. The SOLSTICE trial is evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of chronic hepatitis delta. Chronic Hepatitis B (CHB) The Company plans to share end-of-treatment data from the Phase 2 MARCH Part B trial as a Late Breaking presentation at the AASLD meeting in November 2024. The MARCH-B trial is evaluating the safety, tolerability and antiviral activity of the triplet combination of tobevibart and elebsiran plus peginterferon alfa-2a in approximately 30 participants, and approximately 50 participants treated with the doublet combination of tobevibart and elebsiran. The Company plans to share further data assessing a potential functional cure in the second quarter of 2025. Solid Tumors VIR-5818 is a dual-masked HER2-targeted T-cell engager in clinical development designed to minimize off-tumor toxicity, potentially allowing for higher doses and increased efficacy to address the significant unmet needs of patients with HER2 expressing cancers. A Phase 1 basket study of VIR-5818 as a monotherapy, and in combination with pembrolizumab, is on-going in multiple tumor types, including metastatic breast cancer and metastatic colorectal cancer. The Company plans to share initial clinical data for VIR-5818 in the first quarter of 2025. VIR-5500 is a dual-masked PSMA directed T-cell engager in clinical development designed to minimize off-tumor toxicity and potentially improve efficacy relative to the existing approved PSMA-targeted therapies. A Phase 1 dose escalation study of VIR-5500 is ongoing to assess its safety profile and optimal dose levels for future development in metastatic-castration resistant prostate cancer. The Company plans to share initial clinical data for VIR-5500 in the first quarter of 2025. VIR-5525 is a dual-masked EGFR targeted T-cell engager with a cleared Investigational New Drug Application (IND) from the U.S. FDA. The Company plans to initiate a Phase 1 basket study of VIR-5525 in the first quarter of 2025 in patients across a number of solid tumor indications of high unmet need, which may include metastatic head and neck squamous cell carcinoma, metastatic adenocarcinoma, squamous non-small cell lung cancer, and metastatic colorectal cancer. Preclinical Pipeline Candidates The Company continues to advance pre-clinical assets in respiratory syncytial virus in partnership with GSK and pursue HIV cure in collaboration with the Bill & Melinda Gates Foundation. Corporate Update On August 1, 2024 the Company announced an exclusive worldwide license to three clinical-stage masked T-cell engagers (TCEs) with potential applications in a range of cancers, as well as the exclusive use of the proprietary PRO-XTEN™ masking platform for oncology and infectious disease. The Company announced closing of the agreement with Sanofi on September 9, 2024. Key employees from Sanofi, possessing extensive scientific and development expertise in TCEs, and in-depth experience with the PRO-XTEN™ platform, joined the Company following the closing of the agreement. On August 1, 2024 the Company announced the phase-out of clinical programs in influenza, COVID-19, and its T-cell based viral vector platform. The Company is seeking partners to advance these clinical programs through further development. Additionally, the Company announced a workforce reduction of approximately 25%, or approximately 140 employees, and expects to end 2024 with approximately 435 employees – a decrease of approximately 200 from its peak headcount in the second quarter of 2023. On September 10, 2024, the Company announced the appointment of Jason O’Byrne as Executive Vice President and Chief Financial Officer, effective October 2, 2024. Mr. O’Byrne is an accomplished executive with more than 20 years of finance and operations experience, and brings leadership in capital allocation and formation, corporate strategy and operational excellence. The Company will host two virtual investor events instead of the previously scheduled R&D Day in the fourth quarter of 2024. The first event, focusing on our hepatitis programs, will be held in November 2024, following the AASLD conference, and will provide detailed updates on our hepatitis delta and hepatitis B programs. In the first quarter of 2025, the Company will share initial clinical data for our masked T-cell engager programs during a second dedicated investor event. Third Quarter 2024 Financial Results Cash, Cash Equivalents and Investments: As of September 30, 2024, the Company had approximately $1.19 billion in cash, cash equivalents and investments, representing a decrease of approximately $245.1 million during the third quarter of 2024. The decrease includes a $103.7 million upfront payment made to Sanofi upon the closing of the agreement and a $75.0 million escrowed milestone payment reclassified to restricted cash. The escrowed milestone is subject to VIR-5525 achieving "first in human dosing" by 2026. Excluding the impact of the Sanofi agreement, the decrease in cash, cash equivalents and investments in the third quarter was approximately $66.4 million. Revenues: Total revenues for the quarter ended September 30, 2024, were $2.4 million compared to $2.6 million for the same period in 2023. Cost of Revenue: Cost of revenue was nominal for the third quarter of 2024 and 2023. Research and Development Expenses (R&D): R&D expenses for the third quarter of 2024 were $195.2 million, which included $8.9 million of non-cash stock-based compensation expense, compared to $145.0 million for the same period in 2023, which included $15.8 million of non-cash stock-based compensation expense. The increase was primarily driven by $102.8 million of the Sanofi upfront payment being recognized as in-process research and development expense, partially offset by lower clinical development costs and manufacturing costs associated with the discontinued flu asset, VIR-2482. Selling, General and Administrative Expenses (SG&A): SG&A expenses for the third quarter of 2024 were $25.7 million, which included $7.8 million of non-cash stock-based compensation expense, compared to $40.9 million for the same period in 2023, which included $11.1 million of non-cash stock-based compensation expense. The decrease was largely related to cost savings initiatives implemented during the second half of 2023. Restructuring, long-lived assets impairment and related charges: Restructuring, long-lived assets impairment and related charges for the third quarter of 2024 were $12.7 million compared to $3.4 million for the same period in 2023. The increase was primarily driven by severance charges incurred related to our strategic restructuring announcement in August 2024 and to a lesser extent right-of-use asset impairment charges related to the closing of our Portland, Oregon facility, which was previously announced on December 13, 2023. Other Income: Other income for the third quarter of 2024 was $17.8 million compared to $20.1 million for the same period in 2023. The decrease was primarily due to lower interest income. (Provision for) Benefit from Income Taxes: Provision for income taxes for the third quarter of 2024 was $0.2 million compared to a benefit from income taxes of $3.2 million for the same period in 2023. Net Loss: Net loss attributable to Vir for the third quarter of 2024 was $(213.7) million, or $(1.56) per share, basic and diluted, compared to a net loss of $(163.4) million, or $(1.22) per share, basic and diluted for the same period in 2023. 20 24 Financial Guidance The Company has updated its operating expense guidance for the full-year 2024, which includes the upfront in-process research and development expense associated with the clinical-stage T-cell engagers licensed through its agreement with Sanofi: (in $ millions) GAAP operating expense range: $ 660 to $ 680 The following expenses are included in the GAAP operating expense range: Upfront payment to Sanofi recognized as R&D expense in the third quarter of 2024 $103 Stock-based compensation expense $ 90 to $ 80 Restructuring charges* $ 40 to $ 30 * Restructuring charges include employee severance cash payouts, as well as non-cash expense related to the closing of two R&D sites previously announced on December 13, 2023. The GAAP operating expense guidance does not include the effect of GAAP adjustments caused by events that may occur subsequent to the publication of this guidance, including, but not limited to, business development activities, litigation, in-process R&D impairments, and changes in the fair value of contingent considerations. Conference Call Vir will host a conference call to discuss the third quarter results at 1:30 p.m. PT / 4:30 p.m. ET today. A live webcast will be available on https://investors.vir.bio/ and will be archived on www.vir.bio for 30 days. About Tobevibart (VIR-3434) Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes, and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to have an extended half-life and was identified using Vir’s proprietary monoclonal antibody discovery platform. Tobevibart is administered subcutaneously, and it is currently in clinical development for treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. About Elebsiran (VIR-2218) Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. It is the first asset in Vir’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical studies. About VIR-5818, VIR-5500, VIR-5525 VIR-5818, VIR-5500, VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the PRO-XTEN™ masking technology with three different T-cell engagers (TCEs) targeting HER2, PSMA, and EGFR, respectively. TCEs are powerful anti-tumor agents that direct the immune system, specifically T-cells, to destroy cancer cells. The PRO-XTEN™ masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs leading to killing of cancer cells. By driving the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask also helps drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing more convenient dosing regimens for patients and clinicians. About Vir Biotechnology, Inc. Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Vir’s clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections, in addition to programs across several clinically validated targets in solid tumor indications. Vir also has a preclinical portfolio of programs across a range of other infectious diseases and oncologic malignancies. Vir routinely posts information that may be important to investors on its website. 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 “should,” “could,” “may,” “might,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “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; Vir’s cash balance; Vir’s future financial and operating results and its expectations related thereto including Vir’s financial guidance; Vir’s ability to realize the anticipated benefits from the exclusive worldwide license agreement with Sanofi; potential of, and expectations for, Vir’s pipeline; Vir’s clinical and preclinical development programs; clinical studies, including the enrollment of clinical studies, and the expected timing of data readouts and presentations; the potential benefits, safety, and efficacy of Vir’s investigational therapies; Vir’s strategy and plans; and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including whether or when anticipated cost reductions will be achieved; unexpected safety or efficacy data or results observed during clinical studies or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; 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 studies due to geopolitical changes or other external factors; failure to achieve any necessary regulatory approvals; the timing and amount of actual expenses, including, without limitation, Vir’s anticipated combined GAAP R&D and SG&A expenses; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. 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. PRO-XTEN™ is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company. VIR BIOTECHNOLOGY, INC. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) (unaudited) September 30, 2024 December 31, 2023 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 168,350 $ 241,576 Short-term investments 740,607 1,270,980 Restricted cash and cash equivalents, current 89,598 13,268 Equity investments 5,517 9,853 Prepaid expenses and other current assets 43,085 52,549 Total current assets 1,047,157 1,588,226 Intangible assets, net 19,258 22,565 Goodwill 16,938 16,937 Property and equipment, net 64,791 96,018 Operating lease right-of-use assets 60,779 71,182 Restricted cash and cash equivalents, noncurrent 6,382 6,448 Long-term investments 271,495 105,275 Other assets 11,556 12,409 TOTAL ASSETS $ 1,498,356 $ 1,919,060 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $ 7,305 $ 6,334 Accrued and other liabilities 94,658 104,220 Deferred revenue, current 15,198 64,853 Total current liabilities 117,161 175,407 Operating lease liabilities, noncurrent 93,405 111,673 Contingent consideration, noncurrent 33,170 25,960 Other long-term liabilities 13,893 15,784 TOTAL LIABILITIES 257,629 328,824 Commitments and contingencies (Note 8) STOCKHOLDERS’ EQUITY: Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of September 30, 2024 and December 31, 2023; no shares issued and outstanding as of September 30, 2024 and December 31, 2023 — — Common stock, $0.0001 par value; 300,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 136,706,350 and 134,781,286 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 14 13 Additional paid-in capital 1,894,781 1,828,862 Accumulated other comprehensive gain (loss) 1,127 (815 ) Accumulated deficit (655,195 ) (237,824 ) TOTAL STOCKHOLDERS’ EQUITY 1,240,727 1,590,236 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 1,498,356 $ 1,919,060 VIR BIOTECHNOLOGY, INC. Condensed Consolidated Statements of Operations ( in thousands, except share and per share data ) (unaudited) Three Months Ended September 30, 2024 2023 Revenues: Collaboration revenue $ (1,102 ) $ (4,387 ) Contract revenue 1,391 289 Grant revenue 2,091 6,737 Total revenues 2,380 2,639 Operating expenses: Cost of revenue 50 38 Research and development 195,178 145,028 Selling, general and administrative 25,744 40,933 Restructuring, long-lived assets impairment and related charges 12,712 3,372 Total operating expenses 233,684 189,371 Loss from operations (231,304 ) (186,732 ) Other income: Change in fair value of equity investments 1,130 (2,707 ) Interest income 17,527 21,931 Other (expense) income, net (893 ) 882 Total other income 17,764 20,106 Loss before (provision for) benefit from income taxes (213,540 ) (166,626 ) (Provision for) benefit from income taxes (177 ) 3,213 Net loss (213,717 ) (163,413 ) Net loss attributable to noncontrolling interest — — Net loss attributable to Vir $ (213,717 ) $ (163,413 ) Net loss per share attributable to Vir, basic and diluted $ (1.56 ) $ (1.22 ) Weighted-average shares outstanding, basic and diluted 136,653,753 134,289,620

– Phase 2 SOLSTICE Safety and Efficacy Data in Hepatitis Delta Trial at Week 24 to Be Presented – – Oral and Five Poster Presentations Highlight Important Progress in Hepatitis Delta and Hepatitis B Clinical Programs, and Deliver Key Insights on the Burden of Disease Among Patient Segments in Hepatitis Delta – SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (NASDAQ:VIR) today announced it will present new data from the Phase 2 SOLSTICE clinical trial evaluating the efficacy and safety pro tobevibart, an investigational monoclonal antibody (mAb), and elebsiran, an investigational small interfering ribonucleic acid (siRNA) for the potential treatment of chronic hepatitis delta. These data will be presented in an oral presentation at the upcoming American Association for the Study of Liver Diseases (AASLD) The Liver Meeting ® , in San Diego, CA, November 15-19, 2024. Vir will also present five poster presentations that further characterize these investigational therapies as well as recent efforts to improve the assessment and evaluation of hepatitis delta infection, and insights into the economic burden of hepatitis delta for patients and society. Vir will also share advances from across the chronic hepatitis B development program. “There is an urgent need for effective therapies for people living with hepatitis delta who can face rapid progression to liver cirrhosis and liver cancer. We are excited by the latest data from our hepatitis delta development program, and we look forward to sharing our latest findings at AASLD as we work to help patients living with this debilitating condition,” said Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, Vir Biotechnology. “Further, patients living with chronic hepatitis B face lifelong treatment and an increased risk of cirrhosis and liver cancer, so developing a functional cure could transform their lives. We are pleased to share data further characterizing our investigational therapies as we continue on our mission to advance a functional cure.” Vir will be presenting the following abstracts: Efficacy and safety of tobevibart (VIR-3434) alone or in combination with elebsiran (VIR-2218) in participants with chronic hepatitis delta virus infection: Week 24 primary endpoint analysis from the Phase 2 SOLSTICE trial Session: Hepatitis D: Natural History and Treatment Date: Monday, November 18 Time: 6:15 – 6.30 p.m. PT Presenter: Tarik Asselah, M.D., Ph.D., Professor of Hepatology at the Hôpital Beaujon, APHP, Clichy, France, and at the University of Paris, and Head of Viral Hepatitis at INSERM UMR1149, France Pharmacokinetics and safety of a single dose of elebsiran (VIR-2218, siRNA) subcutaneously administered in adult participants with moderate renal impairment (Poster #1340) Session: Hepatitis B Date: November 15 Time: 1:00 – 2:00 p.m. PT Presenter: Li Wang, Associate Director, Clinical Pharmacology, Vir Biotechnology, Inc. Dose-Dependent Effects of Neutralizing Anti-HBs Monoclonal Antibody VIR-3434 on Hepatitis B Surface Antigen Composition (Poster #1409) Session: Hepatitis B Date: November 15 Time: 1:00 – 2:00 p.m. PT Presenter: Florian van Bömmel, M.D., Professor of Medicine, Division of Hepatology, Department of Medicine II, Leipzig University Medical Center. Safety Pro tobevibart (VIR-3434) and elebsiran (VIR-2218) for the treatment of chronic hepatitis B and delta (CHB and CHD) (Poster #1375) Session: Hepatitis B Date: November 15 Time: 1:00 – 2:00 p.m. PT Presenter: Alina Jucov, M.D., Ph.D., Arensia Exploratory Medicine GmbH, Düsseldorf, Germany, and Nicolae Testemitanu, State University of Medicine and Pharmacy, Chişinău, Moldova. Review of evidence to support the use of surrogate endpoints and fibroscan in hepatitis D infection (Poster #1174) Session: Hepatitis – Other Infections Date: November 15 Time: 1:00 – 2:00 p.m. PT Presenter: Prajakta Bhounsule, Director, Health Economy and Marketing, Vir Biotechnology, Inc. Assessing economic burden among unique patient segments in an HDV-infected population (Poster #3294) Session: Health Services and Public Health Research Date: November 17 Time: 1:00 – 2:00 p.m. PT Presenter: Prajakta Bhounsule, Director, Health Economy and Marketing, Vir Biotechnology, Inc. About Tobevibart (VIR-3434) Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes, and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir’s proprietary antibody discovery platform and has been engineered to have an extended half-life and optimized binding to immune cells. Tobevibart is administered subcutaneously, and it is currently in clinical development for treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. About Elebsiran (VIR-2218) Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. It is the first asset in Vir’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical studies. About Chronic Hepatitis Delta Chronic hepatitis delta (CHD) is a long-lasting, inflammatory liver disease caused by the hepatitis D virus (HDV), which requires the presence of hepatitis B virus (HBV) for its replication 1 . CHD affects nearly 5% of people who have a chronic infection with HBV, and it is considered by the World Health Organization to be the most severe form of chronic viral hepatitis 2 . Co-infection with HDV accelerates progression towards liver cancer and liver-related death by almost a decade in comparison to HBV mono-infected persons, independently of their age 3 . There is no cure, and treatment options are limited. References: 1 NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis D - NIDDK (nih.gov) , accessed September 2024. 2 WHO Hepatitis Delta Factsheet - Hepatitis D (who.int) , accessed September 2024 3 CDC About Chronic Hepatitis B Chronic hepatitis B (CHB) a is a long-lasting, inflammatory liver disease caused by the hepatitis B virus (HBV) 1 . The World Health Organization estimates that 254 million people were living with CHB infection in 2022, with 1.2 million new infections each year, and an estimated 1.1 million yearly deaths associated to the disease 2 . Complications from CHB may include liver cirrhosis, liver failure and liver cancer 3 . Although CHB can be treated, there’s no cure available today 1 . References: 1 CDC Hepatitis B Basics | Hepatitis B | CDC 2 WHO Hepatitis B Factsheet - Hepatitis B (who.int) , accessed September 2024 3 NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis B - NIDDK (nih.gov) , accessed September 2024. About Vir Biotechnology, Inc. Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Vir’s clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections, in addition to multiple oncology programs. Vir also has a preclinical portfolio of programs across a range of other infectious diseases and oncologic malignancies. Vir routinely posts information that may be important to investors on its website. 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,” “expect,” “anticipate,” “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 Vir’s strategy and plans, the potential clinical effects of tobevibart and elebsiran, the potential benefits, safety and efficacy of tobevibart and elebsiran, the timing, nature and significance of data from Vir’s multiple ongoing trials evaluating tobevibart and elebsiran, Vir’s plans and expectations for its CHD and CHB programs, and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; 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 geopolitical changes or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. 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. Contacts Media Arran Attridge Senior Vice President, Corporate Communications aattridge@vir.bio Investors Richard Lepke Senior Director, Investor Relations rlepke@vir.bio