Peginterferon alfa-2b(Merck & Co)

Imdusiran data from IM-PROVE I and IM-PROVE II Phase 2a clinical trials to be presented at upcoming AASLD - The Liver Meeting 2024 Multiple-ascending doses of AB-101 in healthy subjects in the Phase 1a/1b clinical trial were generally safe and well-tolerated with evidence of receptor occupancy Now dosing cHBV patients with AB-101 in Part 3 of the Phase 1a/1b clinical trial Cash runway into the fourth quarter of 2026Conference Call and Webcast Today at 8:45 AM ET WARMINSTER, Pa., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, today reports third quarter 2024 financial results and provides a corporate update. “We are making significant progress in advancing the development of imdusiran to bring hope to millions of cHBV patients globally,” said Michael J. McElhaugh, Interim President and Chief Executive Officer of Arbutus Biopharma. “In June, we shared promising data from our IM-PROVE I Phase 2a clinical trial, showing that some patients treated with imdusiran and interferon were trending towards a functional cure. We look forward to presenting follow-up data from this trial, as well as end-of-treatment data from patients that received nivolumab in addition to imdusiran and VTP-300 in our IM-PROVE II Phase 2a trial, at the upcoming AASLD meeting. Assuming continued positive data, and with a projected cash runway extending into the fourth quarter of 2026, we are well-positioned to advance imdusiran into a Phase 2b clinical trial as a cornerstone in a treatment regimen aimed at functionally curing cHBV.” Mr. McElhaugh continued, “Our proprietary oral PD-L1 checkpoint inhibitor, AB-101, is progressing well, as we continue to see dose-dependent receptor occupancy and have now advanced into dosing cHBV patients in our Phase 1a/1b clinical trial. We look forward to providing updates as this trial progresses.” Clinical Development Update Imdusiran (AB-729, RNAi Therapeutic) End-of-treatment data from the IM-PROVE I Phase 2a clinical trial evaluating the safety, tolerability and antiviral activity of the combination of imdusiran (4 or 6 doses over 24 or 48 weeks, respectively), nucleos(t)ide analogue (NA) therapy and a short course of pegylated interferon alfa-2a (IFN, 12 or 24 weeks) in patients with cHBV was presented at the EASL Congress in June. The data showed that 33.3% (n=4/12) of patients in Cohort A1 receiving 48 weeks (6 doses) of imdusiran combined with 24 weeks of IFN and NA therapy achieved HBsAg loss at the end-of-treatment that was maintained in 100% of these patients 24 weeks after completing imdusiran and IFN treatment. HBsAg loss was achieved and maintained in 67% of those patients with HBsAg less than 1000 IU/mL at baseline. A total of six patients from Cohort A1 (n=4) and Cohort A2 (n=2) seroconverted with HBsAg loss. At the time the data was reported, all six of those patients had stopped all therapy, with two of those patients reaching 12 weeks off all therapy with sustained HBsAg and HBV DNA loss. The combination of imdusiran and IFN in this clinical trial was generally safe and well-tolerated. The Company will present a late-breaker poster with additional follow-up data at the upcoming AASLD-The Liver Meeting 2024 later this month. End-of treatment data from the IM-PROVE II Phase 2a clinical trial evaluating the safety and immunogenicity of imdusiran, NA therapy and Barinthus Bio’s VTP-300, an HBV antigen-specific immunotherapy was presented at the EASL Congress in June. The data showed that the combination of imdusiran and VTP-300 was generally safe and well-tolerated. At 24-weeks post-end of treatment, statistical significance (p<0.05) was achieved in HBsAg levels between the VTP-300 arm (n=5) and placebo (n=6). IM-PROVE II includes an additional cohort of patients who received 4 doses of imdusiran plus NA therapy for 24 weeks followed by VTP-300 plus up to two low doses of nivolumab, an approved anti-PD-1 monoclonal antibody. The Company will present a late-breaker poster with preliminary end-of-treatment data from this additional cohort at the upcoming AASLD - The Liver Meeting 2024 in November. AB-101 (Oral PD-L1 Inhibitor) AB-101-001 is a Phase 1a/1b double-blind, randomized, placebo-controlled clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single- and multiple-ascending oral doses of AB-101 in healthy subjects and patients with cHBV.Part 2 of this clinical trial has enrolled to date two sequential cohorts of ten healthy subjects each receiving 10 mg or 25 mg of AB-101 (n=8) or placebo (n=2) daily for 7 days. AB-101 was generally well-tolerated with evidence of dose-dependent receptor occupancy. In the 25 mg cohort, all subjects showed evidence of receptor occupancy, with seven of the eight subjects demonstrating receptor occupancy greater than 70% during the 7-day dosing period.Arbutus has moved into Part 3 of this clinical trial which evaluates repeat dosing of AB-101 for 28 days in patients with cHBV and expects to report preliminary data in the first half of next year. LNP Litigation Update Expert reports and expert depositions continue in the Moderna lawsuit. A trial date has been set for September 24, 2025, and is subject to the Court’s availability.The lawsuit against Pfizer/BioNTech is ongoing and a date for the claim construction hearing has been set for December 18, 2024.  Arbutus continues to protect and defend its intellectual property, which is the subject of the on-going lawsuits against Moderna and Pfizer/BioNTech. The Company is seeking fair compensation for Moderna’s and Pfizer/BioNTech’s use of its patented LNP technology that was developed with great effort and at a great expense, without which Moderna’s and Pfizer/BioNTech’s COVID-19 vaccines would not have been successful. Financial Results Cash, Cash Equivalents and Investments As of September 30, 2024, the Company had cash, cash equivalents and investments in marketable securities of $130.8 million compared to $132.3 million as of December 31, 2023. During the nine months ended September 30, 2024, the Company used $54.5 million in operating activities, which was partially offset by $44.1 million of net proceeds from the issuance of common shares under its “at-the-market” offering program (ATM Program) and $6.1 million of proceeds from the exercise of stock options. The Company did not issue any common shares under its ATM program in the third quarter of 2024. The Company expects its 2024 cash burn to range from $63 million to $67 million. With the organizational changes in the third quarter, the Company believes its cash, cash equivalents and investments in marketable securities will be sufficient to fund its operations into the fourth quarter of 2026. Revenue Total revenue was $1.3 million for the three months ended September 30, 2024 compared to $4.7 million for the same period in 2023. The decrease of $3.4 million was due primarily to: i) a decrease in license revenue recognized under the Company’s licensing agreement with Qilu Pharmaceutical; and ii) a decrease in license royalty revenue from Alnylam due to lower sales of ONPATTRO in 2024 compared to 2023. Operating Expenses Research and development expenses were $14.3 million for the three months ended September 30, 2024 compared to $20.2 million for the same period in 2023. The decrease of $5.9 million was due primarily to the discontinuation of the Company’s coronavirus and AB-161 programs in September 2023, along with related headcount reductions. General and administrative expenses were $4.5 million for the three months ended September 30, 2024 compared to $5.8 million for the same period in 2023. The decrease of $1.3 million was due primarily to decreased employee compensation and non-cash stock-based compensation expenses due to headcount reductions. The Company also incurred a $3.6 million one-time restructuring charge in the third quarter of 2024 related to its decision to cease all discovery efforts, discontinue its IM-PROVE III clinical trial, and reduce headcount to streamline the organization with a focus on advancing the clinical development of imdusiran and AB-101. Net Loss The Company’s net loss was $19.7 million for the three months ended September 30, 2024 and $20.1 million for the same period in 2023, with a loss per basic and diluted common share of $0.10 and $0.12, respectively. Outstanding Shares As of September 30, 2024, the Company had approximately 189.4 million common shares issued and outstanding. In addition, the Company had approximately 18.7 million stock options and unvested restricted stock units outstanding as of September 30, 2024. Roivant Sciences Ltd. owned approximately 21% of the Company’s outstanding common shares as of September 30, 2024. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS(in thousands, except share and per share data) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023 Revenue Collaborations and licenses$767 $3,935 $2,861 $13,329 Non-cash royalty revenue572 723 1,736 2,667 Total revenue1,339 4,658 4,597 15,996 Operating expenses Research and development14,273 20,169 45,227 56,136 General and administrative4,537 5,842 17,396 17,374 Change in fair value of contingent consideration344 205 735 (158)Restructuring3,625 - 3,625 - Total operating expenses22,779 26,216 66,983 73,352 Loss from operations(21,440) (21,558) (62,386) (57,356)Other income Interest income1,747 1,494 5,121 4,223 Interest expense(29) (46) (107) (415)Foreign exchange gain / (loss)5 6 (16) 11 Total other income1,723 1,454 4,998 3,819 Net loss$(19,717) $(20,104) $(57,388) $(53,537)Loss per share Basic and diluted$(0.10) $(0.12) $(0.31) $(0.32)Weighted average number of common shares Basic and diluted188,997,194 167,512,708 184,244,819 165,085,243 Comprehensive loss Unrealized gain on available-for-sale securities218 584 331 1,604 Comprehensive loss$(19,499) $(19,520) $(57,057) $(51,933) UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands) September 30, 2024 December 31, 2023Cash, cash equivalents and marketable securities, current$127,794 $126,003Accounts receivable and other current assets4,983 6,024Total current assets132,777 132,027Property and equipment, net of accumulated depreciation3,556 4,674Investments in marketable securities, non-current2,964 6,284Right of use asset1,144 1,416Total assets$140,441 $144,401Accounts payable and accrued liabilities$7,544 $10,271Deferred license revenue, current 10,911 11,791Lease liability, current468 425Total current liabilities18,923 22,487Liability related to sale of future royalties5,315 6,953Contingent consideration8,335 7,600Lease liability, non-current978 1,343Total stockholders’ equity106,890 106,018Total liabilities and stockholders’ equity$140,441 $144,401 UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(in thousands) Nine Months Ended September 30, 2024 2023Net loss$(57,388) $(53,537)Non-cash items5,453 4,613 Change in deferred license revenue(880) (10,349)Other changes in working capital(1,720) (9,371)Net cash used in operating activities(54,535) (68,644)Net cash provided by investing activities9,537 28,548 Issuance of common shares pursuant to the Open Market Sale Agreement44,124 26,000 Cash provided by other financing activities6,451 840 Net cash provided by financing activities50,575 26,840 Effect of foreign exchange rate changes on cash and cash equivalents(16) 11 Increase/(decrease) in cash and cash equivalents5,561 (13,245)Cash and cash equivalents, beginning of period26,285 30,776 Cash and cash equivalents, end of period31,846 17,531 Investments in marketable securities98,912 127,145 Cash, cash equivalents and marketable securities, end of period$130,758 $144,676 Conference Call and Webcast Today Arbutus will hold a conference call and webcast today, Wednesday, November 6, 2024, at 8:45 AM Eastern Time to provide a corporate update. To dial-in for the conference call by phone, please register using the following link: Registration Link. A live webcast of the conference call can be accessed through the Investors section of Arbutus' website at www.arbutusbio.com. An archived webcast will be available on the Arbutus website after the event. About Imdusiran (AB-729) Imdusiran is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. Clinical data generated thus far has shown single and multiple doses of imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. Imdusiran is currently in multiple Phase 2a clinical trials.   About AB-101 AB-101 is our oral PD-L1 inhibitor candidate that we believe will allow for controlled checkpoint blockade while minimizing the systemic safety issues typically seen with checkpoint antibody therapies. Immune checkpoints such as PD-1/PD-L1 play an important role in the induction and maintenance of immune tolerance and in T-cell activation. Preclinical data generated thus far indicates that AB-101 mediates re-activation of exhausted HBV-specific T-cells from cHBV patients. We believe AB-101, when used in combination with other approved and investigational agents, could potentially lead to a functional cure in patients chronically infected with HBV. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial. About HBV Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2.4 million people in the United States suffer from chronic HBV infection. Approximately 820,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options. About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics with distinct mechanisms of action, which can potentially be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). We believe the key to success in developing a functional cure involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses. Our pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729), and an oral PD-L1 inhibitor, AB-101. Imdusiran has generated meaningful clinical data demonstrating an impact on both surface antigen reduction and reawakening of the HBV-specific immune response. Imdusiran is currently in two Phase 2a combination clinical trials. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial. For more information, visit www.arbutusbio.com. Forward-Looking Statements and Information This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include statements about our future development plans for our product candidates; the expected cost, timing and results of our clinical development plans and clinical trials with respect to our product candidates; our expectations with respect to the release of data from our clinical trials and the expected timing thereof; our expectations and goals for our collaborations with third parties and any potential benefits related thereto; our expectations regarding our organizational changes; the potential for our product candidates to achieve success in clinical trials; our expectations regarding our pending litigation matters; and our expected financial condition, including our anticipated net cash burn, the anticipated duration of cash runways and timing regarding needs for additional capital. With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to patent litigation matters. Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested product candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; Arbutus may not realize the anticipated benefits from the organizational changes; Arbutus may incur additional unexpected expenses in connection with the organizational changes; Arbutus may experience additional employee turnover as a result of the organizational changes; uncertainties associated with litigation generally and patent litigation specifically; and Arbutus and its collaborators may never realize the expected benefits of the collaborations; market shifts may require a change in strategic focus. A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law. Contact Information Investors and Media Lisa M. CaperelliVice President, Investor RelationsPhone: 215-206-1822Email: lcaperelli@arbutusbio.com

SAN FRANCISCO--( BUSINESS WIRE )--Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the second quarter ended June 30, 2024. “ The positive preliminary SOLSTICE Phase 2 study together with the recent FDA IND clearance and Fast Track designation for tobevibart and elebsiran for the treatment of chronic hepatitis delta infection highlight the encouraging momentum we’re building towards addressing the substantial unmet medical need for patients affected by this life-threatening disease,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer. “ In addition, we are taking decisive steps to strategically restructure our organization and prioritize our resources to focus on the highest value near-term opportunities. These key strategic decisions will enable us to drive sustainable growth and accelerate patient impact as we advance in our mission of powering the immune system to transform lives.” Pipeline Programs Chronic Hepatitis Delta (CHD) The Company presented positive preliminary Phase 2 chronic hepatitis delta SOLSTICE study data at the European Association for the Study of the Liver, EASL™ Congress 2024. Tobevibart monotherapy and combination therapy with elebsiran achieved high virologic response and ALT normalization in people living with the hepatitis delta virus after 12 and 24 weeks of treatment. Complete 24-week treatment data on the approximately 60 participants is on track to be reported in the fourth quarter of 2024. On June 26, the U.S. Food and Drug Administration (FDA) cleared the Company's investigational new drug (IND) application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection. Chronic Hepatitis B (CHB) The Phase 2 MARCH Part B study is fully enrolled with 48-week end of treatment data expected in the fourth quarter of 2024. The study is evaluating the safety, tolerability and antiviral activity of the combination of tobevibart and elebsiran with and without peginterferon alpha. Initial data from the Phase 2 PREVAIL platform study and its THRIVE/STRIVE sub-protocols is expected in the first half of 2025. These studies are evaluating combinations of tobevibart, elebsiran and/or peginterferon alpha in two patient populations: immune-active but treatment-naïve and inactive carriers. Corporate Update As announced today, the Company signed an exclusive worldwide license agreement with Sanofi for multiple potential best-in-class clinical-stage T-cell engagers and exclusive use of the protease-cleavable masking platform, acquired by Sanofi from Amunix Pharmaceuticals. This license agreement is subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Act Antitrust Improvements Act of 1976, as amended (HSR). The Company initiated a strategic restructuring to advance the development of its hepatitis programs and focus on the highest near-term value opportunities. The organizational realignment and optimization include phasing out programs in influenza, COVID-19, and the Company’s T cell-based viral vector platform, as well as a workforce reduction of approximately 25% or approximately 140 employees. The Company expects to end 2024 with approximately 435 employees, a decrease of approximately 200 from its peak headcount in the second quarter of 2023. This includes the Sanofi employees who are expected to join Vir following receipt of HSR clearance. “ This decision was not taken lightly yet is essential to ensure that our resources are aligned with our evolving strategy and that Vir is positioned for sustainable growth and long-term success,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer. “ I am grateful for every Vir employee who has helped to progress our journey to bring life-saving therapies to patients and their families.” As a result of this strategic restructuring and prioritization the Company anticipates: Approximately $50 million of annual workforce cost savings starting in 2025. Combined with the strategic actions taken in December 2023, the Company lowered its cost structure by approximately $90 million since its peak in 2023, part of which will be redeployed to the newly anticipated key personnel from Sanofi. Cost savings of $50 million through the end of 2025 due to the phasing out of certain programs. These savings will substantially be reinvested in the newly licensed programs from Sanofi following closing of the transaction. Restructuring expenses estimated at $11 million to $13 million, primarily related to employee severance cash payouts. The Company expects to recognize most of these expenses in the second half of 2024. The Company will host a virtual R&D Day in late November 2024. On May 29, 2024, the Company announced the appointment of Mark D. Eisner, M.D., M.P.H. as Executive Vice President and Chief Medical Officer, effective June 3, 2024. Dr. Eisner brings extensive late-stage clinical development expertise and deep knowledge in the fields of immunology and infectious disease. On April 18, 2024, the Company announced that founding board members Phillip Sharp, Ph.D. and Robert Perez would not stand for reelection. Effective May 29, 2024, two new independent directors were elected in their place, including Norbert Bischofberger, Ph.D., who brings close to 40 years of biotech leadership experience and Ramy Farid, Ph.D., whose pioneering work applying advanced computational methods to drug discovery has enabled high-quality, novel molecules for drug development and materials applications. Second Quarter 2024 Financial Results Cash, Cash Equivalents and Investments: As of June 30, 2024, the Company had approximately $1.43 billion in cash, cash equivalents and investments. Cash, cash equivalents and investments declined by approximately $78 million during the second quarter of 2024. Revenues: Total revenues for the quarter ended June 30, 2024, were $3.1 million compared to $3.8 million for the same period in 2023. Cost of Revenue: Cost of revenue was nominal for the second quarter of 2024 and 2023. Research and Development Expenses (R&D): R&D expenses for the second quarter of 2024 were $105.1 million, which included $13.1 million of non-cash stock-based compensation expense, compared to $168.1 million for the same period in 2023, which included $17.1 million of non-cash stock-based compensation expense. The decrease was primarily driven by lower clinical development costs and manufacturing costs associated with VIR-2482, lower contract manufacturing costs associated with the Company's hepatitis programs, and lower personnel costs related to cost savings initiatives implemented during the second half of 2023. Selling, General and Administrative Expenses (SG&A): SG&A expenses for the second quarter of 2024 were $30.3 million, which included $9.1 million of non-cash stock-based compensation expense, compared to $45.5 million for the same period in 2023, which included $13.5 million of non-cash stock-based compensation expense. The decrease was primarily 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 second quarter of 2024 was $26.3 million compared to $5.4 million for the same period in 2023. The increase was primarily related to impairment charges related to closing our St. Louis, Missouri facility previously announced on December 13, 2023. Other Income: Other income for the second quarter of 2024 was $18.7 million compared to $17.6 million for the same period in 2023. Benefit from Income Taxes: Benefit from income taxes for the second quarter of 2024 was $1.5 million compared to $2.8 million for the same period in 2023. Net Loss: Net loss attributable to Vir for the second quarter of 2024 was $(138.4) million, or $(1.02) per share, basic and diluted, compared to a net loss of $(194.8) million, or $(1.45) per share, basic and diluted for the same period in 2023. 20 24 Financial Guidance The Company is lowering its operating expense guidance for the full-year 2024, inclusive of its recently announced transaction with Sanofi and strategic restructuring. This reduction is primarily due to savings from workforce restructuring and phasing out of influenza, COVID-19, and the Company’s T cell-based viral vector platform programs, as well as other ongoing cost saving efforts: GAAP operating expense range: $ 580 to $ 610 The following expenses are included in the GAAP operating expense range: 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 revised guidance excludes the accounting impact of the upfront payment and an escrowed milestone payment in connection with the Sanofi agreement. The Company will incorporate any associated impact to its guidance in its third quarter 2024 earnings press release. Approximately three percent of the GAAP operating expense will be funded by grants. These grants are recognized as revenue. Except for the pending transaction with Sanofi, 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 second 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 subcutaneously administered antibody designed to inhibit entry of hepatitis B and hepatitis delta viruses into hepatocytes, neutralize both hepatitis B virus and hepatitis delta virus virions and to reduce the level of virions 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. About Elebsiran (VIR-2218) Elebsiran is an investigational subcutaneously administered 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. Vir believes it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. 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 could result in an increased therapeutic index. Elebsiran is the first asset in the Company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical studies. 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. Vir also has a preclinical portfolio of programs across a range of other infectious diseases. 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 anticipated expenditures and annual savings in connection with the restructuring; the anticipated timing of such cost impacts; Vir’s cash balance; Vir’s financial guidance; Vir’s future financial and operating results and its expectations related thereto; Vir’s ability to realize the anticipated benefits from the exclusive worldwide license agreement with Sanofi (the “Agreement”); difficulties or unanticipated expenses in connection with the Agreement, and the potential effects on Vir’s earnings; the risk that Vir’s investment in connection with the Agreement will lose value for any number of reasons; the ability of the parties to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from studies, including those involving SAR446309 (AMX-818), SAR446329 (AMX-500) and SAR446368, and any additional programs that may become subject to the Agreement; the potential clinical effects, potential benefits, safety and efficacy of the investigational products that are the subject of these programs; data from ongoing studies evaluating such investigational products and programs; Vir’s ability to file applications for regulatory approval or receive regulatory approvals in a timely manner or at all for such investigational products and programs, and the risk that any such approvals may be subject to significant limitations on use; the possibility that closing of the transaction might not occur, that the Agreement may be terminated for any number of reasons, or that development of the investigational products and programs subject to the Agreement may be discontinued, and therefore may never be successfully commercialized; Vir’s ability to successfully commercialize any approved drug products resulting from the Agreement; 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 the 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. VIR BIOTECHNOLOGY, INC. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) (unaudited) June 30, 2024 December 31, 2023 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 296,864 $ 241,576 Short-term investments 849,833 1,270,980 Restricted cash and cash equivalents, current 13,946 13,268 Equity investments 4,368 9,853 Prepaid expenses and other current assets 40,729 52,549 Total current assets 1,205,740 1,588,226 Intangible assets, net 18,899 22,565 Goodwill 16,937 16,937 Property and equipment, net 66,063 96,018 Operating lease right-of-use assets 62,266 71,182 Restricted cash and cash equivalents, noncurrent 6,366 6,448 Long-term investments 279,992 105,275 Other assets 13,292 12,409 TOTAL ASSETS $ 1,669,555 $ 1,919,060 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $ 4,389 $ 6,334 Accrued and other liabilities 75,321 104,220 Deferred revenue, current 16,702 64,853 Total current liabilities 96,412 175,407 Operating lease liabilities, noncurrent 95,018 111,673 Contingent consideration, noncurrent 30,600 25,960 Other long-term liabilities 13,855 15,784 TOTAL LIABILITIES 235,885 328,824 Commitments and contingencies (Note 8) STOCKHOLDERS’ EQUITY: Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of June 30, 2024 and December 31, 2023; no shares issued and outstanding as of June 30, 2024 and December 31, 2023 — — Common stock, $0.0001 par value; 300,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 136,590,097 and 134,781,286 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 14 13 Additional paid-in capital 1,878,013 1,828,862 Accumulated other comprehensive loss (2,879 ) (815 ) Accumulated deficit (441,478 ) (237,824 ) TOTAL STOCKHOLDERS’ EQUITY 1,433,670 1,590,236 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 1,669,555 $ 1,919,060 VIR BIOTECHNOLOGY, INC. Condensed Consolidated Statements of Operations ( in thousands, except share and per share data ) (unaudited) Three Months Ended June 30, 2024 2023 Revenues: Collaboration revenue $ 55 $ (13,779 ) Contract revenue 886 1,057 Grant revenue 2,134 16,519 Total revenues 3,075 3,797 Operating expenses: Cost of revenue 52 22 Research and development 105,113 168,083 Selling, general and administrative 30,265 45,512 Restructuring, long-lived assets impairment and related charges 26,275 5,366 Total operating expenses 161,705 218,983 Loss from operations (158,630 ) (215,186 ) Other income: Change in fair value of equity investments 429 (5,086 ) Interest income 18,846 23,016 Other expense, net (535 ) (367 ) Total other income 18,740 17,563 Loss before benefit from income taxes (139,890 ) (197,623 ) Benefit from income taxes 1,512 2,848 Net loss (138,378 ) (194,775 ) Net loss attributable to noncontrolling interest — — Net loss attributable to Vir $ (138,378 ) $ (194,775 ) Net loss per share attributable to Vir, basic and diluted $ (1.02 ) $ (1.45 ) Weighted-average shares outstanding, basic and diluted 136,233,725 134,059,079