Core Insights - Vir Biotechnology (NASDAQ: VIR) is developing treatments for hepatitis B (HB) and hepatitis delta (HD) and is expected to report data in the oncology space that may positively impact its stock performance [1] Company Developments - The company has been focusing on trading around significant events such as trial results and NDA/BLA approvals, indicating a strategic approach to market movements [1]

Core Insights - Vir Biotechnology has significantly transformed its strategic focus and technological platforms since July, phasing out its vaccines and viral immunotherapy programs while maintaining the development of chronic hepatitis treatment [1] Group 1 - The company has shifted its focus away from vaccines and viral immunotherapy [1] - Development efforts are now concentrated on chronic hepatitis treatment [1]

Financial Performance - Total revenues for the three months ended September 30, 2024, were $2,380,000, a decrease from $2,639,000 in the same period of 2023[14] - The net loss for the three months ended September 30, 2024, was $213,717,000, compared to a net loss of $163,413,000 for the same period in 2023, representing an increase of approximately 30%[14] - The company reported a net loss per share attributable to Vir of $(1.56) for the three months ended September 30, 2024, compared to $(1.22) for the same period in 2023[14] - As of September 30, 2023, the company reported a net loss of $499.1 million, compared to a net loss of $417.4 million for the nine months ended September 30, 2024[21][23] - Total revenues for the nine months ended September 30, 2024, were $61,831 thousand, down from $69,393 thousand in the same period of 2023, a decrease of $7,562 thousand[125] - Net loss for Q3 2024 was $(213,717) thousand compared to $(163,413) thousand in Q3 2023, an increase in loss of $50,304 thousand[125] Expenses - Research and development expenses for the nine months ended September 30, 2024, were $400,416,000, compared to $470,754,000 for the same period in 2023, reflecting a decrease of approximately 15%[14] - The company reported a total operating expense of $233,684,000 for the three months ended September 30, 2024, an increase from $189,371,000 in the same period of 2023[14] - Research and development expenses for Q3 2024 increased to $195,178 thousand from $145,028 thousand in Q3 2023, an increase of $50,150 thousand[129] - Selling, general and administrative expenses for Q3 2024 decreased to $25,744 thousand from $40,933 thousand in Q3 2023, a decrease of $15,189 thousand[125] - Total operating expenses for the nine months ended September 30, 2024, were $531,846 thousand, down from $614,682 thousand in the same period of 2023, a decrease of $82,836 thousand[125] - The company incurred restructuring expenses of approximately $10.4 million in Q3 2024, with $8.2 million classified as research and development expenses[82] Equity and Liabilities - Total stockholders' equity as of September 30, 2024, was $1,240,727,000, down from $1,590,236,000 as of December 31, 2023[11] - The accumulated deficit as of September 30, 2024, was $(655,195,000), compared to $(237,824,000) as of December 31, 2023[11] - The total liabilities and stockholders' equity as of September 30, 2024, were $1,498,356,000, down from $1,919,060,000 as of December 31, 2023[11] - The company had no debt outstanding as of September 30, 2024, indicating a strong liquidity position[149] Cash Flow - The company had $1.19 billion in cash, cash equivalents, and investments as of September 30, 2024, which is expected to fund operations for at least the next twelve months[26] - The company reported net cash used in operating activities of $358.7 million for the nine months ended September 30, 2024, a decrease from $670.9 million for the same period in the previous year[23] - Cash, cash equivalents, and investments totaled $1.19 billion as of September 30, 2024, with an accumulated deficit of $655.2 million[137] - Cash provided by investing activities increased to $358.6 million for the nine months ended September 30, 2024, compared to $269.4 million in 2023[143] Research and Development - The company has a clinical development pipeline targeting hepatitis delta virus (HDV) and hepatitis B virus (HBV), along with multiple oncology programs[25] - Research and development expenses primarily relate to discovery efforts and clinical development, with costs recognized as incurred[43] - The company recognized additional net research and development expenses of $1 million and $6.1 million during the three months ended September 30, 2024 and 2023, respectively, under the 2020 GSK Agreement[76] Grants and Collaborations - The Company has been awarded grants totaling up to $49.9 million from the Bill & Melinda Gates Foundation to support various vaccine programs[64] - Under the BARDA Agreement, the Company may receive up to $1.0 billion, with $55.0 million allocated for the development of VIR-2482[65] - The Company recognized grant revenue related to BARDA of $0.5 million and $2.9 million for the three months ended September 30, 2024 and 2023, respectively[67] Strategic Initiatives - The company entered into a sales agreement to offer and sell shares of its common stock for an aggregate offering price of up to $300 million[26] - The company announced a workforce reduction of approximately 25%, equating to about 140 employees, as part of a strategic shift[108] - The company expects to recognize restructuring expenses of approximately $11 million to $13 million primarily related to employee severance cash payouts in the second half of 2024[82] Future Outlook - The company does not expect significant revenue from product candidates until regulatory approvals are obtained, with a nominal amount of collaboration revenue anticipated in 2024[111] - The FDA has excluded the use of sotrovimab in all U.S. regions, leading to uncertainty regarding future collaboration revenue from this product[112] - The company plans to present additional data from the Phase 2 chronic hepatitis delta SOLSTICE trial in November 2024, involving approximately 60 patients[105]

Financial Data and Key Metrics - R&D expenses for Q3 2024 were approximately $195 million, up from $145 million in Q3 2023, driven by $103 million related to the Sanofi transaction [34] - SG&A expenses for Q3 2024 were $25.7 million, down from $40.9 million in Q3 2023, due to cost-saving initiatives [34] - Restructuring and impairment charges for Q3 2024 were $12.7 million, up from $3.4 million in Q3 2023, primarily due to severance charges and facility closure [35] - Cash, cash equivalents, and investments at the end of Q3 2024 were approximately $1.19 billion, down from $1.43 billion at the end of Q2 2024 [36] - Full-year 2024 GAAP expense guidance adjusted to $660 million to $680 million, including Sanofi transaction expenses, stock-based compensation, and restructuring [37] Business Line Data and Key Metrics - The company closed an exclusive worldwide licensing agreement with Sanofi, including 3 clinical-stage masked T-cell engagers and the PRO-XTEN platform for oncology and infectious diseases [5][6] - The hepatitis delta program (SOLSTICE trial) showed promising results, with all 11 participants in the de novo combination cohort achieving virologic suppression below the lower limit of quantification [21][22] - The hepatitis B program (MARCH Part B trial) is expected to report end-of-treatment data at the AASLD meeting, with functional cure data anticipated in Q2 2025 [13][14] - The T-cell engager programs (VIR-5818, VIR-5500, VIR-5525) are progressing, with preliminary monotherapy data expected in Q1 2025 [27][29][30] Market Data and Key Metrics - The hepatitis delta market is estimated to have approximately 100,000 patients in the US and 200,000 in Europe, with significant unmet medical needs [9] - The hepatitis B market includes an estimated 1.6 million patients in the US and approximately 254 million globally [13] - The HER2-positive cancer market, particularly metastatic breast and colorectal cancer, represents a significant unmet need [27] Company Strategy and Industry Competition - The company is focusing on advancing its hepatitis programs and expanding into oncology with the addition of T-cell engager assets and the PRO-XTEN platform [5][6][32] - The company is engaging with health authorities to expedite the initiation of its registrational program for hepatitis delta [24] - The company is prioritizing its clinical-stage pipeline opportunities and streamlining operations to allocate resources more efficiently [18] Management Commentary on Operating Environment and Future Outlook - The company is optimistic about its future, with a strong balance sheet and a focus on maximizing shareholder value [19] - The company is committed to disciplined capital deployment and financial stewardship [33] - The company is working to improve early diagnosis and treatment outcomes for hepatitis delta patients [11] Other Important Information - The company will host an investor event focused on its hepatitis franchise following the AASLD conference in November [15][16] - The company welcomed Jason O'Byrne as the new CFO, who is focused on financial strategy and disciplined capital deployment [17][33] Q&A Session Summary Question: Status of the end of Phase II meeting with the FDA and T-cell engager program for VIR-5818 - The company is finalizing the clinical development program and will share details at the hepatitis-focused investor meeting on November 19 [41] - Preliminary monotherapy data for VIR-5818 and VIR-5500 will be shared in Q1 2025 [41] Question: Pivotal path forward in HDV and combination vs. monotherapy evaluation - The company is committed to the combination regimen of tobevibart and elebsiran, which achieved deep and sustained virologic responses [43] Question: Phase III trial design and FDA interactions - The company had a productive meeting with the FDA and will share more details at the investor event around AASLD [44] Question: HDV data and T-cell engager initial Phase I data - The company will present detailed HDV data at the AASLD meeting, including target not detected rates and ALT normalization [47] - Initial monotherapy data for T-cell engagers will be shared in Q1 2025 [48] Question: Data expectations for VIR-5818 and VIR-5500 in Q1 2025 - The company will share preliminary monotherapy data for both programs in Q1 2025, focusing on safety and dosimetry [51] Question: HDV Phase III trial design and patient population - The Phase III program will include both cirrhotic and non-cirrhotic patients, with more details to be provided at the investor event [55] Question: HBV functional cure rates and patient stratification - The company is targeting a 30% functional cure rate for the interferon-containing regimen and 20% for the regimen excluding interferon [56] Question: HDV pivotal program update and TCE differentiation - The company will disclose the final trial design for the HDV pivotal program at the investor event [60] - Differentiation for TCEs will be data-driven, with more color to be provided in the future [61] Question: HDV combination vs. bulevirtide and HBV functional cure rates - The combination of tobevibart and elebsiran is expected to achieve higher target not detected rates compared to bulevirtide [65] - The HBV functional cure rates are anticipated in all-comers, with more clarity expected at the AASLD meeting [67]

Vir Biotechnology, Inc. (VIR) closed the last trading session at $8.65, gaining 2.6% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $31 indicates a 258.4% upside potential. The mean estimate comprises eight short-term price targets with a standard deviation of $32.37. While the lowest estimate of $13 indicates a 50.3% increase from the current price level, the most optimistic anal ...

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis for the first quarter of 2024 [Item 1. Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements for Vir Biotechnology, Inc. as of March 31, 2024, and for the three months ended March 31, 2024 and 2023 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased from **$1.92 billion** at year-end 2023 to **$1.79 billion** as of March 31, 2024, primarily due to reduced cash and investments, while total liabilities also decreased Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $160,711 | $241,576 | | Short-term investments | $985,125 | $1,270,980 | | Total current assets | $1,213,097 | $1,588,226 | | **Total Assets** | **$1,793,969** | **$1,919,060** | | **Liabilities & Equity** | | | | Total current liabilities | $94,068 | $175,407 | | **Total Liabilities** | **$246,613** | **$328,824** | | **Total Stockholders' Equity** | **$1,547,356** | **$1,590,236** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net loss of **$65.3 million** for Q1 2024, a significant improvement from **$140.9 million** in Q1 2023, driven by lower operating expenses despite a slight revenue decrease Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended Mar 31, 2024 | Three Months Ended Mar 31, 2023 | | :--- | :--- | :--- | | Collaboration revenue | $(987) | $46,574 | | Contract revenue | $52,191 | $138 | | **Total revenues** | **$56,376** | **$62,957** | | Research and development | $100,125 | $157,643 | | Selling, general and administrative | $36,273 | $46,778 | | **Total operating expenses** | **$136,457** | **$206,328** | | **Loss from operations** | **$(80,081)** | **$(143,371)** | | **Net loss attributable to Vir** | **$(65,276)** | **$(140,900)** | | **Net loss per share, basic and diluted** | **$(0.48)** | **$(1.06)** | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities decreased to **$109.4 million** in Q1 2024, while net cash provided by investing activities also decreased, resulting in an **$80.8 million** total cash decrease Cash Flow Highlights (in thousands) | Activity | Three Months Ended Mar 31, 2024 | Three Months Ended Mar 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(109,390) | $(125,782) | | Net cash provided by investing activities | $28,420 | $98,079 | | Net cash provided by financing activities | $152 | $2,344 | | **Net decrease in cash, cash equivalents and restricted cash** | **$(80,818)** | **$(25,359)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, business overview, and financial arrangements, including the company's focus on infectious diseases, liquidity, collaboration agreements, and a recent restructuring plan - The company is an immunology firm focused on treating and preventing infectious diseases, with a clinical pipeline targeting **HDV, HBV, and HIV**[27](index=27&type=chunk) - As of March 31, 2024, the company had **$1.51 billion** in cash, cash equivalents, and investments, which is believed to be sufficient to fund operations for at least the next **twelve months**[30](index=30&type=chunk) - In Q1 2024, collaboration revenue with GSK was negative **$(0.987) million** due to profit-sharing adjustments for sotrovimab. However, the company recognized **$51.7 million** in contract revenue as GSK's rights to select two additional non-influenza pathogens expired[84](index=84&type=chunk)[89](index=89&type=chunk) - A restructuring plan initiated in December 2023 involves closing two R&D facilities and eliminating approximately **75 positions (12% of workforce)**. The company expects to incur an additional **$25 million to $35 million** in restructuring charges, primarily for facility closures[94](index=94&type=chunk)[97](index=97&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations for Q1 2024, detailing pipeline progress, revenue fluctuations, and liquidity [Significant Developments](index=24&type=section&id=Significant%20Developments) The company reported significant clinical pipeline progress, including completed enrollment for hepatitis delta and B trials, anticipated HIV vaccine data, and plans for multiple IND filings, alongside a CFO transition - The Phase 2 SOLSTICE trial for chronic hepatitis delta (CHD) completed enrollment, with **24-week treatment data expected in Q4 2024**[121](index=121&type=chunk) - Initial immunogenicity data from the Phase 1 trial of **VIR-1388**, an investigational HIV vaccine, is expected in the **second half of 2024**[123](index=123&type=chunk) - The company expects to file multiple Investigational New Drug (IND) applications within the next **18 months** for candidates targeting HPV, COVID-19, influenza, and RSV/MPV[125](index=125&type=chunk) - The Executive Vice President and Chief Financial Officer, **Sung Lee**, will be stepping down, and a search for a successor has been initiated[125](index=125&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Total revenues decreased to **$56.4 million** in Q1 2024, primarily due to a **$47.6 million** drop in collaboration revenue offset by a **$52.1 million** increase in contract revenue, while net loss narrowed to **$65.3 million** due to reduced R&D expenses Comparison of Results of Operations (in thousands) | Item | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | **Total revenues** | **$56,376** | **$62,957** | **$(6,581)** | | Collaboration revenue | $(987) | $46,574 | $(47,561) | | Contract revenue | $52,191 | $138 | $52,053 | | **Total operating expenses** | **$136,457** | **$206,328** | **$(69,871)** | | Research and development | $100,125 | $157,643 | $(57,518) | | **Net loss attributable to Vir** | **$(65,276)** | **$(140,900)** | **$75,624** | - The decrease in R&D expenses was primarily due to lower clinical and contract manufacturing costs associated with winding down the **Phase 2 PENINSULA trial for VIR-2482**[150](index=150&type=chunk) [Liquidity, Capital Resources and Capital Requirements](index=31&type=section&id=Liquidity%2C%20Capital%20Resources%20and%20Capital%20Requirements) As of March 31, 2024, the company held **$1.51 billion** in cash and investments, deemed sufficient for at least the next **12 months**, with potential for additional capital raises and existing manufacturing commitments - As of March 31, 2024, the company possessed **$1.51 billion** in cash, cash equivalents, and investments, which is expected to fund operations for at least the next **12 months**[156](index=156&type=chunk)[158](index=158&type=chunk) - The company has an agreement to sell up to **$300.0 million** in common stock, but no shares had been sold under this agreement as of March 31, 2024[156](index=156&type=chunk) - The company has unpaid commitments of approximately **$20 million** for the manufacturing of tobevibart as of March 31, 2024[163](index=163&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks from interest rates, foreign currency, and equity investments, with a primary focus on capital preservation - The company's exposure to interest rate risk is considered not significant, and a **1%** movement in market interest rates would not have a significant impact on its portfolio value[171](index=171&type=chunk) - The company holds an equity investment in Brii Bio Parent valued at **$3.9 million** as of March 31, 2024. A hypothetical **10%** change in the stock price would impact its fair value by approximately **$0.4 million**[173](index=173&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal controls - Management concluded that as of the end of the period, the company's disclosure controls and procedures were effective[174](index=174&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the fiscal quarter ended March 31, 2024[175](index=175&type=chunk) [PART II. OTHER INFORMATION](index=34&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, and other disclosures relevant to the company's operations and governance [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings, nor is it aware of any pending or threatened actions - The company is not currently party to any material legal proceedings[177](index=177&type=chunk) [Risk Factors](index=34&type=page&id=Item%201A.%20Risk%20Factors) This section details significant risks across financial position, development, third-party reliance, intellectual property, and operations that could adversely affect the company - The company has a history of net losses and anticipates they will continue for the foreseeable future[179](index=179&type=chunk)[181](index=181&type=chunk) - The company does not expect meaningful future revenue from its COVID-19 treatment, **sotrovimab**, and its future success is substantially dependent on the successful development and approval of other product candidates[179](index=179&type=chunk)[186](index=186&type=chunk) - The company may require substantial additional funding and raising capital could cause **dilution to stockholders** or restrict operations[179](index=179&type=chunk)[195](index=195&type=chunk) - The company relies on **third parties** for manufacturing and clinical trials, and any failure by these parties could harm the business[181](index=181&type=chunk)[269](index=269&type=chunk)[283](index=283&type=chunk) [Risks Related to Our Financial Position and Capital Needs](index=35&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) This subsection outlines financial risks, including a history of net losses, no expected future revenue from sotrovimab, and the potential need for substantial dilutive additional funding - The company has incurred net losses and anticipates continuing to do so in the foreseeable future, with an accumulated deficit of **$303.1 million** as of March 31, 2024[181](index=181&type=chunk) - The company does not expect meaningful future revenue from **sotrovimab** for COVID-19, as it is not currently authorized for use in any U.S. region and the company does not plan to file a BLA at this time[186](index=186&type=chunk)[189](index=189&type=chunk) - The company may need to raise additional capital, which could cause **dilution to stockholders**, restrict operations, or require relinquishing rights to product candidates[195](index=195&type=chunk)[201](index=201&type=chunk) [Risks Related to Development and Commercialization](index=39&type=section&id=Risks%20Related%20to%20Development%20and%20Commercialization) This subsection details risks in product development and commercialization, including dependency on clinical success, regulatory approval, market acceptance, and intense competition - Future success is substantially dependent on the successful clinical development, regulatory approval, and commercialization of its product candidates[206](index=206&type=chunk) - Success in preclinical or early clinical trials may not be indicative of results in future trials, as exemplified by the **Phase 2 trial of VIR-2482 for influenza A**, which did not meet its endpoints[217](index=217&type=chunk)[218](index=218&type=chunk) - The company faces substantial competition from other biopharmaceutical companies, which may have greater financial resources and develop products more successfully or rapidly[238](index=238&type=chunk)[241](index=241&type=chunk) - Even if products receive marketing approval, they may fail to achieve market adoption by physicians, patients, and payors, which is necessary for commercial success[244](index=244&type=chunk) [Risks Related to Our Dependence on Third Parties](index=51&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) This subsection highlights the company's reliance on third-party CDMOs and CROs for manufacturing and clinical trials, exposing it to supply, compliance, and geopolitical risks, particularly with Chinese suppliers - The company is dependent on third-party **CDMOs** for the manufacturing of its product candidates and does not own or operate its own full-scale manufacturing facilities[269](index=269&type=chunk) - The company relies on **CROs** to conduct, supervise, and monitor its preclinical studies and clinical trials, and is responsible for ensuring their compliance with regulations like GLP and GCP[283](index=283&type=chunk)[284](index=284&type=chunk) - The company faces risks related to its reliance on foreign suppliers and manufacturers, particularly in **China**. Proposed U.S. legislation like the **BIOSECURE Act** could restrict its ability to work with Chinese CDMOs such as **WuXi Biologics**[273](index=273&type=chunk)[281](index=281&type=chunk) [Risks Related to Our Intellectual Property](index=55&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This subsection discusses intellectual property risks, including challenges in obtaining and maintaining patent protection, potential infringement lawsuits, trade secret protection, and the Bill & Melinda Gates Foundation's license rights - The company's success depends on its ability to obtain and maintain patent protection for its products and technology, but the patent position of biotech companies is highly uncertain[288](index=288&type=chunk)[289](index=289&type=chunk) - The company may be subject to legal proceedings from third parties alleging infringement of their intellectual property rights, which could be costly and uncertain[300](index=300&type=chunk) - The company relies on trade secrets and confidentiality agreements to protect its competitive position, but these may be breached or may not be effective[318](index=318&type=chunk)[319](index=319&type=chunk) - The **Bill & Melinda Gates Foundation** has the right to a non-exclusive license to certain of the company's IP for use in developing countries if the company defaults on its agreement, which could adversely impact its market position[324](index=324&type=chunk)[326](index=326&type=chunk)[327](index=327&type=chunk) [Risks Related to Our Business Operations, Employee Matters and Managing Growth](index=63&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations%2C%20Employee%20Matters%20and%20Managing%20Growth) This subsection covers operational risks, including dependence on key personnel, business disruptions, cybersecurity threats, data privacy compliance, and potential limitations on utilizing net operating losses - The company is highly dependent on its key management and scientific personnel, and the loss of their services could impede objectives. Recent leadership changes, including a **CEO transition**, create uncertainty[328](index=328&type=chunk)[329](index=329&type=chunk) - Business operations could be seriously harmed by disruptions such as earthquakes, public health pandemics (like **COVID-19**), and geopolitical events[336](index=336&type=chunk)[338](index=338&type=chunk) - Information systems are vulnerable to security breaches and cyber-attacks, which could disrupt development programs and lead to unauthorized disclosure of sensitive information[343](index=343&type=chunk) - The company is subject to complex and evolving data privacy laws (e.g., **GDPR**, U.S. state laws), and failure to comply could result in significant fines and reputational harm[347](index=347&type=chunk)[348](index=348&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=73&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This section is not applicable for the reporting period - Not applicable[377](index=377&type=chunk) [Defaults Upon Senior Securities](index=73&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable for the reporting period - Not applicable[378](index=378&type=chunk) [Mine Safety Disclosures](index=73&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable for the reporting period - Not applicable[379](index=379&type=chunk) [Other Information](index=73&type=section&id=Item%205.%20Other%20Information) This section discloses the adoption of Rule 10b5-1 trading plans by certain directors and officers, including sell-to-cover tax withholding arrangements - On February 29, 2024, Board Chair **Vicki Sato, Ph.D.**, adopted a Rule 10b5-1 trading plan for the potential sale of up to **263,040 shares** of common stock for estate and financial planning reasons[382](index=382&type=chunk) - On January 31, 2024, EVP and CTO **Ann Hanly, Ph.D.**, adopted a Rule 10b5-1 trading plan for the sale of up to **22,518 shares** from vested stock options[383](index=383&type=chunk) - Several officers, including the **CEO, CFO, and CTO**, entered into Rule 10b5-1 trading arrangements for automatic sell-to-cover transactions to satisfy tax withholding obligations upon the vesting of RSUs[384](index=384&type=chunk) [Exhibits](index=75&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including corporate documents and certifications [Signatures](index=76&type=section&id=Signatures) The report is duly signed on May 3, 2024, by the Chief Executive Officer and Chief Financial Officer

– $1.51 billion in cash, cash equivalents and investments as of March 31, 2024 – – Conference call scheduled for May 2, 2024 at 1:30 p.m. PT / 4:30 p.m. ET – SAN FRANCISCO, May 2, 2024 – Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the first quarter ended March 31, 2024. "We are excited to share important data from our Phase 2 chronic hepatitis delta SOLSTICE trial at the upcoming EASL congress. This milestone brings us closer to addressing the s ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________________________________________ FORM 10-K ________________________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 1-39083 _____________ ...

Exhibit 99.1 Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results – Prior data from the Phase 2 SOLSTICE trial in chronic hepatitis delta participants demonstrated that after only 12 weeks of combination therapy, 100% (6/6) of participants had HDV RNA less than the lower limit of quantification – – Phase 2 SOLSTICE trial on track to complete enrollment ahead of schedule with initial data expected in the second quarter; greater than 90% of participants d ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 __________________________________________________ FORM 10-Q __________________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from___________to Commission File Number: ...