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]

Core Viewpoint - Vir Biotechnology, Inc. (VIR) shows significant upside potential with a mean price target of $31, indicating a 258.4% increase from the current trading price of $8.65 [1] Price Targets and Analyst Estimates - The mean estimate consists of eight short-term price targets with a standard deviation of $32.37, suggesting variability in analyst predictions [2] - The lowest price target of $13 indicates a 50.3% increase, while the highest target of $110 suggests a potential surge of 1171.7% [2] - A low standard deviation among price targets indicates strong agreement among analysts regarding the stock's price direction [7] Earnings Estimates and Analyst Sentiment - Analysts have shown increasing optimism about VIR's earnings prospects, with a positive trend in earnings estimate revisions [9] - Over the last 30 days, two estimates have been revised higher, leading to a 4% increase in the Zacks Consensus Estimate [10] - VIR holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors [11]

Core Insights - Vir Biotechnology, Inc. reported a quarterly loss of $1.02 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.93, marking an earnings surprise of -9.68% [1] - The company's revenues for the quarter ended June 2024 were $3.08 million, missing the Zacks Consensus Estimate by 71.79%, compared to $3.8 million in the same quarter last year [2] - The stock has underperformed the market, gaining about 1% since the beginning of the year, while the S&P 500 has gained 15.8% [3] Financial Performance - Over the last four quarters, Vir Biotechnology has surpassed consensus EPS estimates two times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.96 on revenues of $10.68 million, and for the current fiscal year, it is -$3.57 on revenues of $85.27 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Vir Biotechnology belongs, is currently in the top 35% of over 250 Zacks industries, indicating a favorable industry outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Core Viewpoint - Vir Biotechnology, Inc. (VIR) is a promising biotech company focused on developing innovative treatments for infectious diseases, including hepatitis, HIV, and COVID-19, with a strong valuation that suggests more upside potential than downside risk at this stage [1][4][35] Company Overview - Vir Biotechnology, founded in 2016 and headquartered in San Francisco, California, specializes in infectious and viral-associated diseases, utilizing proprietary platforms for monoclonal antibodies and T cell-based Viral Vector technology [5][4] - The company collaborates with notable entities such as the Bill & Melinda Gates Foundation, Alnylam Pharmaceuticals, and Gilead Sciences to enhance its research and development efforts [4][14] Product Pipeline - The pipeline includes drug candidates targeting HIV (VIR-1388), chronic hepatitis delta (tobevibart), chronic hepatitis B (tobevibart + elebsiran), and COVID-19 (VIR-7229), with various phases of clinical trials expected to yield significant data in the near future [6][23][25] - Positive results from the Phase 2 SOLSTICE trial for tobevibart indicated efficacy in reducing viral load and improving liver function, with 50% of participants showing normalization of alanine aminotransferase (ALT) levels [26] Financial Overview - As of Q1 2024, VIR has a market capitalization of $1.3 billion, with a balance sheet showing $160.7 million in cash, $985.1 million in short-term investments, and $359.7 million in long-term investments, totaling $1.5 billion in liquid resources [27][28] - The company reported total revenues of $56.376 million for Q1 2024, primarily from contract revenues related to its monoclonal antibody discovery platform [34] Market Potential - The total addressable markets (TAM) for the company's key therapeutic areas are substantial, with estimates of $0.7 billion for hepatitis delta, $35.6 billion for hepatitis B, and $34.1 billion for HIV, indicating significant revenue potential [35] - The COVID-19 market, while currently waning, still represents a potential value driver for the company [35] Valuation Analysis - VIR's book value stands at $1.5 billion, resulting in a price-to-book (P/B) ratio of 0.9, which is below the sector median of 2.5, suggesting that the company is undervalued [35] - The ongoing cash burn rate of approximately $443.2 million annually provides a cash runway of about 3.4 years, allowing the company to navigate its clinical development timeline [28]

[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 ...

Employee Growth and Operations - The company has experienced significant growth in employee numbers and operational scope, particularly in research, development, and regulatory affairs, and expects continued growth as clinical development progresses [475]. - The company has made lasting modifications to operations due to the COVID-19 pandemic, offering employees the choice of full-time in-office, hybrid, or full-time remote work [481]. Clinical Trials and COVID-19 Impact - The company has faced delays in clinical trials due to the COVID-19 pandemic, impacting site initiation and patient enrollment [480]. Acquisitions and Integration - The company has previously acquired TomegaVax, Humabs, Agenovir, and Statera, with the success of these acquisitions dependent on effective integration into existing product candidates [473]. Market and Financial Risks - The company is exposed to market risks related to investments, including changes in the fair value of equity securities held [472]. - The company acknowledges the potential for significant costs and operational disruptions due to business interruptions from natural disasters or geopolitical events [476]. - The company faces risks related to foreign currency exchange rate fluctuations, which can unpredictably affect its operating results [499]. Cybersecurity and Data Protection - The company has implemented security measures to protect data and information technology systems, but remains vulnerable to cyber threats and security breaches [483]. - The company may incur significant costs to mitigate network security problems and may not be successful in preventing disruptions [484]. - The company is subject to new cybersecurity disclosure requirements from the SEC, which could impact its reputation and financial condition [485]. - The company must devote significant resources to comply with evolving data protection laws, which may result in enforcement actions and significant penalties if non-compliance occurs [490]. - At least twelve states in the U.S. have passed comprehensive privacy laws that will impact the company's business activities, including the processing of personal information and sensitive data [488]. Financial Performance and Taxation - As of December 31, 2023, the company had net operating loss carryforwards of $487.0 million for federal tax purposes and $415.4 million for state tax purposes, with federal carryforwards beginning to expire in 2036 and state carryforwards in 2031 [494]. - The Tax Cuts and Jobs Act of 2017 requires the company to capitalize and amortize research and development expenditures over five or fifteen years, potentially reducing anticipated net operating losses [495]. Corporate Governance and Compliance - The concentration of ownership among executive officers and directors may prevent new investors from influencing significant corporate decisions [504]. - The company does not anticipate paying cash dividends in the foreseeable future, meaning capital appreciation will be the sole source of gain for investors [506]. - The company has incurred significant increased costs due to operating as a public company, including legal, accounting, and investor relations expenses [507]. - Compliance with the Sarbanes-Oxley Act and SEC regulations has imposed various requirements, leading to increased legal and financial compliance costs [508]. - The company is currently compliant with California Senate Bill 826 and Assembly Bill 979, which require a minimum number of female directors and directors from underrepresented communities, respectively [509]. Internal Control and Financial Reporting - Failure to maintain effective internal control over financial reporting could impair the accuracy of financial statements and investor confidence, potentially leading to a decline in stock price [510]. - A material weakness in internal control could lead to deficiencies in financial statement preparation, resulting in litigation claims and significant legal expenses [511]. - Compliance with Section 404 of the Sarbanes-Oxley Act requires management to assess internal control over financial reporting, which may necessitate upgrades to IT systems and hiring additional staff [512]. - Changes in generally accepted accounting principles could significantly affect reported financial results and require costly operational adjustments [513]. Corporate Structure and Litigation - Provisions in the corporate charter may make acquisitions more difficult and could limit stockholder attempts to replace current management [514]. - The exclusive forum provision in the amended certificate of incorporation may limit stockholders' ability to bring claims in favorable jurisdictions, potentially increasing litigation costs [515]. - The enforceability of exclusive-forum provisions has been challenged, and if found unenforceable, could lead to additional costs for the company [517].

Financial Performance - Total revenues for Q4 2023 were $16.8 million, a decrease of 66.0% compared to $49.4 million in Q4 2022; total revenues for the full year 2023 were $86.2 million, down 94.7% from $1.6 billion in 2022[16]. - The company reported a net loss of $(116.0) million, or $(0.86) per share, for Q4 2023, compared to a net loss of $(101.6) million, or $(0.76) per share, in Q4 2022; for the full year 2023, the net loss was $(615.1) million, or $(4.59) per share, compared to a net income of $515.8 million in 2022[24]. - Total revenues for the three months ended December 31, 2023, were $16,787 million, a decrease from $49,410 million in the same period of 2022, representing a decline of approximately 66%[46]. - Collaboration revenue for the year ended December 31, 2023, was $37,266 million, compared to $1,505,469 million in 2022, indicating a significant decrease[46]. - The net loss for the three months ended December 31, 2023, was $115,973 million, compared to a net loss of $101,603 million in the same period of 2022, showing a worsening of approximately 14%[46]. - The net loss attributable to Vir for the year ended December 31, 2023, was $615,061 million, compared to a net income of $515,837 million in 2022, indicating a significant turnaround[46]. - The basic net loss per share attributable to Vir for the three months ended December 31, 2023, was $0.86, compared to $0.76 in the same period of 2022, representing a decline of about 13%[46]. - Total operating expenses for the year ended December 31, 2023, were $770,485 million, slightly down from $782,729 million in 2022, indicating a decrease of approximately 2%[46]. - Interest income for the year ended December 31, 2023, was $86,990 million, an increase from $28,092 million in 2022, reflecting a growth of about 209%[46]. - The total other income for the year ended December 31, 2023, was $56,111 million, compared to a loss of $78,788 million in 2022, indicating a significant improvement[46]. Expenses - R&D expenses for Q4 2023 were $111.9 million, including $2.6 million in severance charges, compared to $155.2 million in Q4 2022; full year R&D expenses were $589.7 million, up from $474.6 million in 2022[19]. - SG&A expenses for Q4 2023 were $43.1 million, including $1.9 million in severance charges, compared to $38.7 million in Q4 2022; full year SG&A expenses were $178.0 million, an increase from $161.8 million in 2022[21]. - Vir provides full year 2024 guidance for GAAP combined R&D and SG&A expenses in the range of $650 million to $680 million[25]. - Stock-based compensation expense is projected to be between $105 million and $115 million, while restructuring charges are estimated to be between $25 million and $35 million[25]. - Approximately 3% to 4% of the GAAP combined R&D and SG&A expenses will be funded by grants, recognized as revenue[26]. Cash and Assets - As of December 31, 2023, the company had approximately $1.63 billion in cash, cash equivalents, and investments, a decline of approximately $108 million during Q4 2023[15]. - As of December 31, 2023, total current assets decreased to $1,588.2 million from $2,519.1 million in 2022, reflecting a decline of approximately 37%[44]. - Cash and cash equivalents dropped significantly from $848.6 million in 2022 to $241.6 million in 2023, a decrease of about 72%[44]. - Total liabilities decreased from $724.1 million in 2022 to $328.8 million in 2023, a reduction of approximately 55%[44]. - Total stockholders' equity fell from $2,078.0 million in 2022 to $1,590.2 million in 2023, a decline of about 23%[44]. Research and Development - The SOLSTICE trial for chronic hepatitis delta is on track to complete enrollment ahead of schedule, with over 90% of participants dosed and initial data expected in Q2 2024[2]. - The company expects to report 48-week end of treatment data from the MARCH Part B trial for chronic hepatitis B in Q4 2024[11]. - The company plans to file multiple new INDs in the next 12-24 months, including investigational antibodies against influenza A and B, and respiratory syncytial virus[16]. - The company and GSK terminated their collaboration for influenza monoclonal antibodies, allowing the company to pursue independent development of its investigational therapies[12]. - Vir's investigational product Tobevibart is designed to block hepatitis B and delta viruses and has been engineered to potentially function as a T cell vaccine[29]. - Elebsiran, an investigational siRNA targeting hepatitis B, is the first asset in collaboration with Alnylam Pharmaceuticals to enter clinical trials[30]. - The development of several investigational monoclonal antibodies, including VIR-7229 for COVID-19 and VIR-2981 for influenza, is ongoing, utilizing proprietary discovery platforms[36][33].

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Presents Vir Biotechnology's unaudited condensed consolidated financial statements and detailed notes for Q3 2023 and FY 2022 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Summarizes the company's financial position, assets, liabilities, and equity as of September 30, 2023, and December 31, 2022 | Metric (in thousands) | Sep 30, 2023 | Dec 31, 2022 | | :-------------------- | :----------- | :----------- | | **ASSETS** | | | | Cash and cash equivalents | $452,100 | $848,631 | | Short-term investments | $1,233,628 | $1,521,517 | | Total current assets | $1,769,176 | $2,519,077 | | TOTAL ASSETS | $2,044,895 | $2,802,088 | | **LIABILITIES & EQUITY** | | | | Total current liabilities | $165,050 | $511,029 | | TOTAL LIABILITIES | $369,810 | $724,125 | | TOTAL STOCKHOLDERS' EQUITY | $1,675,085 | $2,077,963 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $2,044,895 | $2,802,088 | - Total assets decreased from **$2.80 billion** at December 31, 2022, to **$2.04 billion** at September 30, 2023, primarily driven by a reduction in cash and cash equivalents and short-term investments[14](index=14&type=chunk) - Total liabilities significantly decreased from **$724.1 million** to **$369.8 million**, mainly due to a reduction in accrued and other liabilities[14](index=14&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Details the company's revenues, expenses, and net (loss) income for the three and nine months ended September 30, 2023 and 2022 | Metric (in thousands, except per share) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Total revenues | $2,639 | $374,557 | $69,393 | $1,566,387 | | Total operating expenses | $189,371 | $179,593 | $614,682 | $582,817 | | (Loss) income from operations | $(186,732) | $194,964 | $(545,289) | $983,570 | | Net (loss) income attributable to Vir | $(163,413) | $175,312 | $(499,088) | $617,440 | | Net (loss) income per share, basic | $(1.22) | $1.32 | $(3.73) | $4.66 | - Total revenues for the three months ended September 30, 2023, significantly decreased to **$2.6 million** from **$374.6 million** in the same period of 2022, primarily due to lower collaboration revenue[16](index=16&type=chunk) - The company reported a net loss of **$163.4 million** for the three months ended September 30, 2023, a substantial shift from a net income of **$175.3 million** in the prior year period[16](index=16&type=chunk) [Condensed Consolidated Statements of Comprehensive (Loss) Income](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20(Loss)%20Income) Presents net (loss) income and other comprehensive income (loss) for the three and nine months ended September 30, 2023 and 2022 | Metric (in thousands) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Net (loss) income | $(163,413) | $175,312 | $(499,144) | $617,440 | | Other comprehensive income (loss) | $1,003 | $(4,327) | $7,222 | $(10,781) | | Comprehensive (loss) income attributable to Vir | $(162,410) | $170,985 | $(491,866) | $606,659 | - Comprehensive loss attributable to Vir for the three months ended September 30, 2023, was **$(162.4) million**, compared to comprehensive income of **$171.0 million** in the prior year, reflecting the net loss and changes in unrealized gains/losses on investments[19](index=19&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Outlines changes in stockholders' equity, including common stock, additional paid-in capital, and retained earnings | Metric (in thousands, except shares) | Balance at Dec 31, 2022 | Balance at Sep 30, 2023 | | :----------------------------------- | :---------------------- | :---------------------- | | Common Stock (Shares) | 133,236,687 | 134,497,886 | | Common Stock (Amount) | $13 | $13 | | Additional Paid-in Capital | $1,709,835 | $1,798,823 | | Accumulated Other Comprehensive Loss | $(9,122) | $(1,900) | | Retained Earnings (Accumulated Deficit) | $377,237 | $(121,851) | | Total Stockholders' Equity | $2,077,963 | $1,675,085 | - Total stockholders' equity decreased from **$2.08 billion** at December 31, 2022, to **$1.68 billion** at September 30, 2023, primarily due to a net loss of **$499.1 million**[25](index=25&type=chunk) - Additional paid-in capital increased by **$89.0 million**, driven by stock-based compensation and proceeds from stock option exercises and ESPP[25](index=25&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Analyzes cash flows from operating, investing, and financing activities for the nine months ended September 30, 2023 and 2022 | Metric (in thousands) | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------- | :-------------------------- | :-------------------------- | | Operating activities | $(670,858) | $1,628,127 | | Investing activities | $269,440 | $(1,040,326) | | Financing activities | $5,800 | $32,750 | | Net (decrease) increase in cash, cash equivalents and restricted cash and cash equivalents | $(395,618) | $620,551 | | Cash, cash equivalents and restricted cash and cash equivalents at end of period | $472,350 | $983,966 | - Net cash used in operating activities was **$670.9 million** for the nine months ended September 30, 2023, a significant change from **$1.63 billion** provided by operating activities in the prior year, mainly due to a net loss and a decrease in accrued liabilities[28](index=28&type=chunk)[174](index=174&type=chunk) - Net cash provided by investing activities was **$269.4 million**, primarily from maturities of investments offsetting purchases of investments[28](index=28&type=chunk)[176](index=176&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations of accounting policies, fair value measurements, grant, and collaboration agreements [1. Organization](index=11&type=section&id=1.%20Organization) Describes Vir Biotechnology's focus on infectious diseases, its subsidiary Encentrio, and financial position - Vir Biotechnology, Inc. is an immunology company focused on treating and preventing serious infectious diseases, with a clinical pipeline targeting HBV, HDV, and HIV, and preclinical candidates for influenza, COVID-19, RSV, MPV, and HPV[30](index=30&type=chunk) - In January 2023, Vir incorporated Encentrio Therapeutics, Inc., a majority-owned subsidiary for oncology therapeutics research and development, increasing its ownership to **100%** during Q2 2023[31](index=31&type=chunk) - As of September 30, 2023, the Company had **$1.7 billion** in cash, cash equivalents, and investments, which is believed to be sufficient to fund operations for at least the next twelve months[33](index=33&type=chunk) [2. Summary of Significant Accounting Policies](index=11&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Outlines the accounting principles, consolidation practices, and revenue recognition methods used in financial reporting - The financial statements are prepared in conformity with GAAP and SEC rules, consolidating Vir and its majority-owned subsidiaries, with intercompany balances eliminated[34](index=34&type=chunk) - The company's financial instruments, including cash, cash equivalents, and investments, are subject to credit risk, but management believes this risk is not significant due to investment policies and the resolution of the SVB closure[39](index=39&type=chunk)[40](index=40&type=chunk) - Revenue recognition follows ASC 606 for collaboration, license, and contract revenue, identifying performance obligations, determining transaction price, and allocating it. Grant revenue is recognized when donor-imposed conditions are met[47](index=47&type=chunk)[55](index=55&type=chunk) [3. Fair Value Measurements](index=15&type=section&id=3.%20Fair%20Value%20Measurements) Details the valuation hierarchy and fair values of financial assets and liabilities, including equity investments and contingent consideration | Asset Type (in thousands) | Valuation Hierarchy | Amortized Cost | Aggregate Fair Value (Sep 30, 2023) | | :------------------------ | :------------------ | :------------- | :---------------------------------- | | Money market funds | Level 1 | $470,323 | $470,323 | | U.S. government treasuries | Level 2 | $1,073,982 | $1,072,988 | | U.S. government agency bonds and discount notes | Level 2 | $167,372 | $167,166 | | Equity securities | Level 1 | N/A | $10,825 | | Total financial assets | | $1,711,677 | $1,721,302 | - The company recognized an unrealized loss of **$2.7 million** for the three months and **$20.9 million** for the nine months ended September 30, 2023, on its equity investment in Brii Bio Parent[65](index=65&type=chunk) - Contingent consideration for the Humabs acquisition was valued at **$24.3 million** as of September 30, 2023, using Level 3 inputs including discount rates (**12.7%-13.3%**) and probability of achievement (**14.4%-60.0%**) for clinical/regulatory milestones, and a Monte Carlo simulation for commercial milestones[66](index=66&type=chunk)[67](index=67&type=chunk)[68](index=68&type=chunk) [4. Grant Agreements](index=17&type=section&id=4.%20Grant%20Agreements) Summarizes grant agreements with the Bill & Melinda Gates Foundation and BARDA for vaccine and antibody programs - Vir has grant agreements with the Bill & Melinda Gates Foundation totaling up to **$49.9 million** for HCMV vaccine programs (HIV, tuberculosis) and vaccinal antibody programs (HIV, malaria), expiring through June 2027[71](index=71&type=chunk) - Grant revenue from the Bill & Melinda Gates Foundation was **$3.8 million** and **$10.5 million** for the three and nine months ended September 30, 2023, respectively[73](index=73&type=chunk) - In September 2023, BARDA awarded Vir **$50.1 million** in new funding, including **$40.0 million** for VIR-7229 development through Phase 1 and **$10.1 million** for discovery of new mAbs against a second pandemic pathogen[77](index=77&type=chunk) - Grant revenue from BARDA was **$2.9 million** and **$29.0 million** for the three and nine months ended September 30, 2023, respectively, with **$60.9 million** of potential future reimbursement remaining[78](index=78&type=chunk) [5. Collaboration and License Agreements](index=18&type=section&id=5.%20Collaboration%20and%20License%20Agreements) Details key collaboration and license agreements, including amendments to the GSK SARS-CoV-2 agreement and the expanded GSK collaboration - The 2020 GSK Agreement for SARS-CoV-2 collaboration was amended in February 2023 to remove the Vaccine Program and narrow the Antibody Program to sotrovimab and VIR-7832, with Vir retaining independent development rights for terminated programs subject to royalties[79](index=79&type=chunk)[80](index=80&type=chunk) | Collaboration Revenue (in thousands) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :----------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Profit-sharing amount | $(6,038) | $291,226 | $(7,198) | $1,863,374 | | Profit-sharing amount previously constrained, released | $1,651 | $20,350 | $35,606 | $20,350 | | Total collaboration revenue, net | $(4,387) | $309,145 | $28,408 | $1,483,860 | - Collaboration revenue for the three and nine months ended September 30, 2023, was **negative $4.4 million** and **positive $28.4 million**, respectively, a significant decrease from 2022, primarily due to lower profit-sharing from sotrovimab sales and payments to GSK for manufacturing expenses[85](index=85&type=chunk)[86](index=86&type=chunk) - The 2021 Expanded GSK Collaboration focuses on influenza mAbs (excluding VIR-2482 unless GSK options in), expanded functional genomics, and additional programs for selected pathogens (RSV selected as first). Parties share **50%** of development costs and profits/losses[89](index=89&type=chunk)[91](index=91&type=chunk)[92](index=92&type=chunk) - GSK has an exclusive option for VIR-2482, with a **$300.0 million** exercise fee if criteria are met, and a potential **$200.0 million** milestone payment for the first influenza product[93](index=93&type=chunk) [6. Balance Sheet Components](index=21&type=section&id=6.%20Balance%20Sheet%20Components) Breaks down property and equipment, and accrued and other liabilities, highlighting changes over time | Property and Equipment, net (in thousands) | Sep 30, 2023 | Dec 31, 2022 | | :--------------------------------------- | :----------- | :----------- | | Laboratory equipment | $43,158 | $36,533 | | Leasehold improvements | $80,207 | $84,422 | | Total property and equipment, net | $99,309 | $105,609 | - Depreciation expenses were **$4.5 million** and **$14.6 million** for the three and nine months ended September 30, 2023, respectively, compared to **$1.6 million** and **$4.4 million** for the same periods in 2022[97](index=97&type=chunk) | Accrued and Other Liabilities (in thousands) | Sep 30, 2023 | Dec 31, 2022 | | :------------------------------------------- | :----------- | :----------- | | Research and development expenses | $65,693 | $48,880 | | Net profit-sharing amount | $6,964 | $357,762 | | Total accrued and other liabilities | $146,111 | $489,090 | - Accrued and other liabilities decreased significantly from **$489.1 million** at December 31, 2022, to **$146.1 million** at September 30, 2023, primarily due to a reduction in the net profit-sharing amount[98](index=98&type=chunk) [7. Commitments and Contingencies](index=21&type=section&id=7.%20Commitments%20and%20Contingencies) Addresses potential legal proceedings and indemnification provisions, noting no material impact on financial statements - The company may be party to legal proceedings in the normal course of business but is not currently involved in any material legal proceedings[99](index=99&type=chunk)[190](index=190&type=chunk) - Vir enters into agreements with indemnification provisions, but no demands have been made to date that would materially affect financial statements[100](index=100&type=chunk)[102](index=102&type=chunk) [8. Related Party Transaction](index=22&type=section&id=8.%20Related%20Party%20Transaction) Discloses Vir's minority equity interest in Brii Biosciences and shared board membership - Vir holds a minority equity interest in Brii Biosciences Offshore Limited through Brii Bio Parent, and one of Vir's board members also serves on Brii Bio Parent's board[103](index=103&type=chunk) [9. Stock-Based Awards](index=22&type=section&id=9.%20Stock-Based%20Awards) Details assumptions for stock option valuations and reports stock-based compensation expenses by functional area | Stock Option Assumption | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :---------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Expected term (years) | 6.1 | 6.1 | 5.5 - 6.1 | 5.3 - 6.1 | | Expected volatility | 99.9% - 100.9% | 110.6% - 110.8% | 99.6% - 101.5% | 103.8% - 111.2% | | Risk-free interest rate | 4.0% - 4.4% | 3.0% - 3.6% | 3.4% - 4.4% | 1.6% - 3.6% | | Expected dividend yield | — | — | — | — | | Stock-Based Compensation Expense (in thousands) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :---------------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Research and development | $15,819 | $12,607 | $46,284 | $39,791 | | Selling, general and administrative | $11,125 | $12,207 | $36,760 | $37,426 | | Total stock-based compensation | $26,944 | $24,814 | $83,044 | $77,217 | [10. Net (Loss) Income Per Share](index=23&type=section&id=10.%20Net%20(Loss)%20Income%20Per%20Share) Presents basic and diluted net (loss) income per share, including weighted-average shares outstanding | Metric | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :----- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Net (loss) income attributable to Vir | $(163,413) | $175,312 | $(499,088) | $617,440 | | Weighted-average shares outstanding, basic | 134,289,620 | 132,729,530 | 133,969,878 | 132,422,028 | | Net (loss) income per share, basic | $(1.22) | $1.32 | $(3.73) | $4.66 | | Net (loss) income per share, diluted | $(1.22) | $1.30 | $(3.73) | $4.58 | - For periods of net loss (e.g., Q3 2023 and 9M 2023), basic and diluted net loss per share are the same as potential common securities would be anti-dilutive[110](index=110&type=chunk) [11. Income Taxes](index=24&type=section&id=11.%20Income%20Taxes) Reports (loss) income before taxes, benefit from (provision for) income taxes, and effective tax rates | Metric (in thousands) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | (Loss) income before benefit from (provision for) income taxes | $(166,626) | $217,732 | $(507,437) | $905,918 | | Benefit from (provision for) income taxes | $3,213 | $(42,420) | $8,293 | $(288,478) | | Effective tax rate | **1.9%** | **19.5%** | **1.6%** | **31.8%** | - The benefit from income taxes for the three and nine months ended September 30, 2023, was primarily due to a pre-tax loss and the ability to carry back research and development credits to 2022[113](index=113&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operational results, clinical pipeline developments, collaboration impacts, and liquidity [Overview](index=25&type=section&id=Overview) Introduces Vir Biotechnology as an immunology company focused on infectious diseases with a diverse pipeline - Vir Biotechnology is an immunology company focused on treating and preventing serious infectious diseases, leveraging two technology platforms to stimulate and enhance the immune system[116](index=116&type=chunk)[117](index=117&type=chunk) - The company's clinical pipeline targets HBV, HDV, and HIV, with preclinical candidates for influenza, COVID-19, RSV, MPV, and HPV[117](index=117&type=chunk) - Vir has internal process development, manufacturing, and quality capabilities, supplemented by CDMOs for early- and late-stage product candidates[118](index=118&type=chunk) [Significant Developments](index=25&type=section&id=Significant%20Developments) Highlights recent clinical trial data, new funding, pipeline advancements, and key executive appointments - Phase 2 MARCH Part B data for VIR-3434 and VIR-2218 in chronic hepatitis B, and initial data from Phase 2 SOLSTICE trial for chronic HDV, were to be presented at AASLD on November 13, 2023[120](index=120&type=chunk) - Initial data from the Phase 2 PREVAIL platform trial, evaluating combinations of VIR-3434, VIR-2218, and/or peginterferon alpha in CHB, are expected in the first half of 2024[121](index=121&type=chunk) - Phase 1 trial of VIR-1388, an investigational HIV T cell vaccine, initiated in September 2023 with initial data expected in H2 2024, supported by NIH and Bill & Melinda Gates Foundation[126](index=126&type=chunk) - Awarded **$50 million** in new BARDA funding in October 2023: **$40 million** for VIR-7229 (COVID-19 mAb) Phase 1 development (expected to initiate in 2024, complete H2 2025) and **$10 million** for discovery of new mAbs against a second pandemic pathogen[126](index=126&type=chunk) - Full analysis of Phase 2 PENINSULA trial data for VIR-2482 (influenza A prevention) expected in Q1 2024; post-hoc analyses showed improved efficacy (**57% to 65%** reduction in symptomatic flu) with adjusted case definitions[126](index=126&type=chunk) - Preclinical pipeline advancing next-generation mAbs using AI/machine learning, with multiple new IND filings expected in the next 12-24 months, including VIR-2981 (influenza A/B), VIR-8190 (RSV/MPV), and VIR-1949 (HPV therapeutic vaccine)[124](index=124&type=chunk)[127](index=127&type=chunk) - Jennifer Towne, Ph.D., appointed Executive Vice President and Chief Scientific Officer, effective November 6, 2023[127](index=127&type=chunk) [Our Collaboration, License and Grant Agreements](index=27&type=section&id=Our%20Collaboration,%20License%20and%20Grant%20Agreements) Emphasizes the importance of collaboration, license, and grant agreements to the company's business - The company has various collaboration, license, and grant agreements, detailed in Notes 4 and 5 of the financial statements, which are crucial to its business[128](index=128&type=chunk) [Components of Operating Results](index=27&type=section&id=Components%20of%20Operating%20Results) Explains revenue recognition, research and development, and selling, general and administrative expense components - Sotrovimab's EUA in the U.S. has been excluded due to Omicron subvariants, and no BLA filing is planned, leading to uncertainty in future revenue from its sales[129](index=129&type=chunk) - Collaboration revenue includes profit-share from sotrovimab sales under the 2020 GSK Agreement, net of costs and allowable expenses, with variable consideration subject to constraint based on manufacturing expenses[130](index=130&type=chunk)[133](index=133&type=chunk) - Research and development expenses are recognized as incurred and are expected to increase substantially as product candidates advance through preclinical and clinical trials[137](index=137&type=chunk)[139](index=139&type=chunk) - Selling, general and administrative expenses are also expected to increase to support R&D, potential commercialization, and public company operations[143](index=143&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Compares total revenues, operating expenses, and net (loss) income for the current and prior periods | Metric (in thousands) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | Change (3 Months) | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | Change (9 Months) | | :-------------------- | :-------------------------- | :-------------------------- | :---------------- | :-------------------------- | :-------------------------- | :------------------ | | Total revenues | $2,639 | $374,557 | $(371,918) | $69,393 | $1,566,387 | $(1,496,994) | | Research and development | $148,253 | $114,166 | $34,087 | $477,756 | $319,475 | $158,281 | | Net (loss) income | $(163,413) | $175,312 | $(338,725) | $(499,144) | $617,440 | $(1,116,584) | - Collaboration revenue decreased significantly due to lower profit-sharing from sotrovimab sales, resulting in negative revenue of **$6.0 million** for Q3 2023, partially offset by a **$1.7 million** release of previously constrained profit-sharing[151](index=151&type=chunk) - Research and development expenses increased by **$34.1 million** (Q3 YoY) and **$158.3 million** (9M YoY), driven by higher personnel costs, contract manufacturing expenses (including **$21.9 million** for VIR-2482 cancellation costs), increased clinical trial costs, and impairment charges[156](index=156&type=chunk)[157](index=157&type=chunk) - Interest income increased due to higher interest rates and larger investment balances[161](index=161&type=chunk) - The company recorded a benefit from income taxes in 2023 due to pre-tax loss and R&D credit carry-back, contrasting with a provision for income taxes in 2022 due to significant taxable collaboration revenue[163](index=163&type=chunk) [Liquidity, Capital Resources and Capital Requirements](index=33&type=section&id=Liquidity,%20Capital%20Resources%20and%20Capital%20Requirements) Assesses the company's cash position, funding needs, and operating lease commitments for future operations - As of September 30, 2023, Vir had **$1.7 billion** in cash, cash equivalents, and investments, which is expected to fund operations for at least the next 12 months[164](index=164&type=chunk)[166](index=166&type=chunk) - The company may need additional capital to complete product development and commercialization, potentially through equity/debt financings, government funding, or collaborations, which could dilute stockholders or impose restrictions[167](index=167&type=chunk)[209](index=209&type=chunk) - Operating lease commitments total **$161.1 million** through 2033 for office and laboratory spaces[169](index=169&type=chunk) [Cash Flows](index=35&type=section&id=Cash%20Flows) Analyzes cash flows from operating, investing, and financing activities, detailing changes and primary drivers | Cash Flow Activity (in thousands) | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | | Operating activities | $(670,858) | $1,628,127 | | Investing activities | $269,440 | $(1,040,326) | | Financing activities | $5,800 | $32,750 | | Net (decrease) increase in cash, cash equivalents and restricted cash and cash equivalents | $(395,618) | $620,551 | - Net cash used in operating activities for 9M 2023 was **$670.9 million**, primarily due to a net loss of **$499.1 million** and a **$316.9 million** decrease in accrued liabilities related to profit-sharing settlement[173](index=173&type=chunk)[174](index=174&type=chunk) - Net cash provided by investing activities for 9M 2023 was **$269.4 million**, mainly from **$1.5 billion** in investment maturities, partially offset by **$1.2 billion** in new investment purchases[176](index=176&type=chunk) - Net cash provided by financing activities for 9M 2023 was **$5.8 million**, from stock option exercises and ESPP common stock issuance[178](index=178&type=chunk) [Critical Accounting Policies and Estimates](index=36&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Confirms no significant changes in critical accounting policies during the nine months ended September 30, 2023 - No significant changes in critical accounting policies occurred during the nine months ended September 30, 2023, compared to those disclosed in the 2022 Annual Report on Form 10-K[181](index=181&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Outlines exposure to market risks including interest rate, foreign currency, and equity investment risks - The company's exposure to interest rate risk is not significant, as investments are primarily short-term money market funds and U.S. government treasury bonds maturing prior to liquidity needs[183](index=183&type=chunk) - Foreign currency risk is primarily related to operations in Switzerland and Australia, and collaboration with GSK, affecting Swiss Franc, Australian dollar, and British pound, but transaction gains and losses were immaterial[184](index=184&type=chunk) - Equity investment risk stems from holding Brii Bio Parent ordinary shares, valued at **$10.8 million** as of September 30, 2023, with fair value changes impacting operating results[185](index=185&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective, with no material changes in internal control over financial reporting - Management concluded that disclosure controls and procedures were effective as of September 30, 2023, providing reasonable assurance that required information is recorded, processed, summarized, and reported timely[186](index=186&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended September 30, 2023, that materially affected or are reasonably likely to materially affect internal control over financial reporting[187](index=187&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not involved in any material legal proceedings or aware of significant threatened actions - Vir is not currently involved in any material legal proceedings and is unaware of any pending or threatened legal actions that could adversely affect its business, operating results, or financial condition[190](index=190&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) Details significant risks including financial losses, funding needs, regulatory uncertainties, competition, and operational challenges [Risk Factors Summary](index=38&type=section&id=Risk%20Factors%20Summary) Summarizes key risks such as net losses, funding requirements, regulatory uncertainties, and operational dependencies - The company has incurred net losses and expects to continue doing so, requiring substantial additional funding to finance operations[192](index=192&type=chunk) - Sotrovimab's EUA has been excluded in all U.S. regions, and its use is limited outside the U.S., with no meaningful sales expected without reauthorization[192](index=192&type=chunk) - Future success depends on timely clinical development, regulatory approval, and commercialization of product candidates, which is highly uncertain[192](index=192&type=chunk) - Significant risks include reliance on third parties for manufacturing, challenges in obtaining and maintaining patent protection, dependence on key personnel, and potential information system failures or security breaches[192](index=192&type=chunk) [Risks Related to Our Financial Position and Capital Needs](index=39&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) Addresses risks related to ongoing net losses, funding requirements, and potential impacts from financial industry instability - Vir incurred a net loss of **$499.1 million** for the nine months ended September 30, 2023, and expects to continue incurring significant expenses and net losses in the foreseeable future[194](index=194&type=chunk)[195](index=195&type=chunk) - Sotrovimab is not currently authorized for use in any U.S. region, and a BLA filing is not planned, creating uncertainty for future revenue and potential for continued net operating losses[196](index=196&type=chunk)[213](index=213&type=chunk) - The company may require substantial additional funding beyond its current **$1.7 billion** in cash and investments to complete development and commercialization, which could lead to stockholder dilution or relinquishing product rights[206](index=206&type=chunk)[209](index=209&type=chunk)[210](index=210&type=chunk) - Adverse developments in the financial services industry, such as bank failures (e.g., SVB), could impact liquidity and access to capital, despite current protection of deposits[226](index=226&type=chunk)[227](index=227&type=chunk)[228](index=228&type=chunk) [Risks Related to the Development and Commercialization](index=45&type=section&id=Risks%20Related%20to%20the%20Development%20and%20Commercialization) Covers uncertainties in clinical development, regulatory approval, market demand, and product liability for candidates - Future success is highly dependent on successful clinical development, regulatory approval, and commercialization of product candidates, which is uncertain and may face unforeseen challenges[229](index=229&type=chunk) - Sotrovimab's EUA exclusion in the U.S. and limitations abroad, coupled with no BLA filing plans, mean no meaningful sales are expected without FDA reauthorization[211](index=211&type=chunk)[213](index=213&type=chunk) - Market demand for COVID-19 product candidates is adversely impacted by new variants, competing therapies (mAbs, oral antivirals, vaccines), and administration challenges[219](index=219&type=chunk) - Success in preclinical studies or earlier clinical trials does not guarantee success in later trials; for example, VIR-2482's Phase 2 trial for influenza A did not meet primary or secondary efficacy endpoints[245](index=245&type=chunk)[246](index=246&type=chunk) - Clinical product development is lengthy, expensive, and uncertain, with potential for delays due to patient enrollment/retention issues, regulatory feedback, or unforeseen adverse events[250](index=250&type=chunk)[252](index=252&type=chunk)[258](index=258&type=chunk) - The use of novel technologies like HCMV as a vaccine vector (e.g., VIR-1388) may face increased regulatory scrutiny and public perception challenges, potentially delaying development and approval[254](index=254&type=chunk)[292](index=292&type=chunk)[293](index=293&type=chunk) - Product liability lawsuits could lead to substantial liabilities, decreased demand, and reputational harm, with insurance potentially inadequate to cover all risks[295](index=295&type=chunk)[297](index=297&type=chunk) [Risks Related to Regulatory Compliance](index=58&type=section&id=Risks%20Related%20to%20Regulatory%20Compliance) Addresses evolving regulatory pathways, biosimilar competition, healthcare fraud laws, reimbursement, and legislative reforms - Regulatory pathways for COVID-19 product candidates are evolving, with sotrovimab's EUA deauthorization in the U.S. and no BLA plans, creating uncertainty and potential for unexpected challenges[298](index=298&type=chunk) - Biologic product candidates may face competition from biosimilars after regulatory exclusivity periods, and from other products receiving EUA approval, impacting sales[299](index=299&type=chunk)[302](index=302&type=chunk) - Relationships with healthcare professionals and third-party payors are subject to federal and state healthcare fraud and abuse laws, with non-compliance potentially leading to substantial penalties[303](index=303&type=chunk)[304](index=304&type=chunk) - Coverage and adequate reimbursement for approved product candidates are uncertain, and inadequate reimbursement could hinder commercial success[306](index=306&type=chunk)[308](index=308&type=chunk) - Healthcare legislative reforms, such as the Inflation Reduction Act (IRA), could impose price negotiations, rebates, and other cost-containment measures, negatively impacting product pricing and demand[312](index=312&type=chunk)[314](index=314&type=chunk)[316](index=316&type=chunk) - The company is subject to anti-corruption, anti-bribery, and anti-money laundering laws, with non-compliance potentially leading to criminal/civil liability and reputational harm[319](index=319&type=chunk)[321](index=321&type=chunk) [Risks Related to Our Dependence on Third Parties](index=62&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) Highlights reliance on third-party CDMOs and CROs for manufacturing and clinical trials, and associated operational risks - Vir relies heavily on third-party CDMOs for process development, manufacturing, storage, and distribution of product candidates, lacking internal full-scale facilities[322](index=322&type=chunk) - Dependence on third-party manufacturers carries risks including delays, insufficient capacity, quality control issues, compliance failures (cGMP), and potential for increased costs or supply disruptions[323](index=323&type=chunk)[324](index=324&type=chunk)[327](index=327&type=chunk) - Reliance on foreign CDMOs exposes the company to trade restrictions, foreign regulatory requirements, and geopolitical risks (e.g., China's regulations, Ukraine-Russia war), which could impact supply and funding[325](index=325&type=chunk)[326](index=326&type=chunk) - The company relies on CROs and clinical trial sites for preclinical studies and clinical trials, with limited influence over their performance, posing risks of delays, data unreliability, and non-compliance with GLPs/GCPs[335](index=335&type=chunk)[336](index=336&type=chunk)[337](index=337&type=chunk) [Risks Related to Our Intellectual Property](index=66&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Covers risks of losing IP rights, inadequate patent protection, infringement claims, and inability to protect trade secrets - Breaching license agreements could lead to loss of intellectual property rights and termination of product development and commercialization efforts for related candidates[341](index=341&type=chunk)[342](index=342&type=chunk) - Failure to obtain and maintain broad or robust patent protection for product candidates and technology could allow competitors to commercialize similar products, adversely affecting Vir's competitive position[343](index=343&type=chunk)[344](index=344&type=chunk)[348](index=348&type=chunk) - Third parties may allege infringement, misappropriation, or violation of their intellectual property rights, leading to costly litigation, licensing requirements, or injunctions that could block development and commercialization[357](index=357&type=chunk)[358](index=358&type=chunk) - Inability to protect trade secrets, including unpatented know-how and proprietary information, could harm business and competitive position, especially if shared with third parties or independently developed by competitors[376](index=376&type=chunk)[377](index=377&type=chunk)[379](index=379&type=chunk) - The Bill & Melinda Gates Foundation's non-exclusive licenses to Vir's intellectual property, if exercised, could allow them to develop and commercialize competing products, negatively impacting Vir's market position[384](index=384&type=chunk)[385](index=385&type=chunk) [Risks Related to Our Business Operations, Employee Matters and Managing Growth](index=74&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations,%20Employee%20Matters%20and%20Managing%20Growth) Addresses dependence on key personnel, acquisition risks, growth management, business disruptions, and cybersecurity threats - The company is highly dependent on key personnel, and the loss of management, scientific, or clinical staff, or difficulties in recruiting and retaining talent, could harm business operations and growth strategy[386](index=386&type=chunk)[388](index=388&type=chunk)[389](index=389&type=chunk) - Acquisitions or investments in other companies/technologies could divert management attention, dilute stockholders, disrupt operations, and may not yield anticipated benefits, potentially leading to impairment charges[391](index=391&type=chunk)[392](index=392&type=chunk)[394](index=394&type=chunk) - Significant growth in employees and operations, including a hybrid/remote workforce model, presents management challenges, potential for increased costs, and risks to corporate culture and cybersecurity[395](index=395&type=chunk)[396](index=396&type=chunk)[402](index=402&type=chunk)[403](index=403&type=chunk) - Business disruptions from natural disasters, geopolitical events (e.g., Ukraine-Russia war), or public health pandemics (e.g., COVID-19) could seriously harm revenue, increase costs, and delay product development[397](index=397&type=chunk)[398](index=398&type=chunk)[399](index=399&type=chunk)[400](index=400&type=chunk) - Information system failures or security breaches (e.g., malware, cyber-attacks, user error) could disrupt product development, operations, lead to data loss, unauthorized disclosure of personal information, and incur significant remediation costs[405](index=405&type=chunk)[406](index=406&type=chunk)[407](index=407&type=chunk)[408](index=408&type=chunk) - The company is subject to stringent and evolving data privacy and security laws (HIPAA, GDPR, CCPA, CPRA), with non-compliance potentially leading to significant fines, penalties, litigation, and reputational damage[409](index=409&type=chunk)[411](index=411&type=chunk)[413](index=413&type=chunk)[415](index=415&type=chunk)[420](index=420&type=chunk) - Misconduct by employees, principal investigators, consultants, or partners (e.g., fraud, non-compliance with regulations, insider trading) could result in regulatory sanctions, penalties, and reputational harm[421](index=421&type=chunk)[423](index=423&type=chunk) - The ability to use net operating losses (NOLs) to offset future taxable income may be limited by ownership changes (Sections 382/383 of the Code) and changes in tax laws (e.g., Tax Cuts and Jobs Act of 2017)[424](index=424&type=chunk)[426](index=426&type=chunk)[427](index=427&type=chunk) [Risks Related to Ownership of Our Common Stock](index=82&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) Discusses stock price volatility, concentrated ownership, dividend policy, and public company compliance costs - Financial condition and operating results are expected to fluctuate significantly due to R&D costs, manufacturing expenses, clinical trial outcomes, competition, regulatory delays, market demand, and global economic/political factors[428](index=428&type=chunk)[429](index=429&type=chunk) - The market price of common stock has been and may remain volatile, influenced by industry trends, economic factors, public statements, and sales by stockholders, potentially leading to substantial losses for investors[430](index=430&type=chunk)[431](index=431&type=chunk)[432](index=432&type=chunk) - Concentrated ownership by executive officers, directors, and principal stockholders may limit new investors' influence on corporate decisions and could delay or prevent acquisitions[434](index=434&type=chunk) - The company does not anticipate paying cash dividends, making capital appreciation the sole source of gain for stockholders in the foreseeable future[436](index=436&type=chunk) - Operating as a public company incurs significant increased costs and requires substantial management time for compliance with SEC, Nasdaq, and other regulatory requirements (e.g., Sarbanes-Oxley Act, Dodd-Frank Act, state laws)[437](index=437&type=chunk)[438](index=438&type=chunk)[439](index=439&type=chunk) - Failure to develop or maintain effective internal control over financial reporting could impair accurate financial statements, erode investor confidence, and lead to stock price decline or regulatory sanctions[440](index=440&type=chunk)[441](index=441&type=chunk) - Provisions in corporate charter documents and Delaware law could make an acquisition more difficult and prevent stockholders from influencing management changes[445](index=445&type=chunk) - The exclusive forum provision in the amended and restated certificate of incorporation for Delaware-based disputes may limit stockholders' ability to choose a favorable judicial forum[446](index=446&type=chunk)[449](index=449&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=86&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds,%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This item is not applicable for the reporting period - This item is marked as 'Not applicable' for the reporting period[450](index=450&type=chunk) [Item 3. Defaults Upon Senior Securities](index=86&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable for the reporting period - This item is marked as 'Not applicable' for the reporting period[451](index=451&type=chunk) [Item 4. Mine Safety Disclosures](index=86&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable for the reporting period - This item is marked as 'Not applicable' for the reporting period[452](index=452&type=chunk) [Item 5. Other Information](index=86&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 trading arrangements were entered or terminated by directors or officers this quarter - No directors or officers entered into or terminated a Rule 10b5-1 trading arrangement or adopted/terminated a non-Rule 10b5-1 trading arrangement during the quarter ended September 30, 2023[455](index=455&type=chunk) - Transactions in company securities by directors and officers must comply with the company's insider trading policy and applicable U.S. federal securities laws[454](index=454&type=chunk) [Item 6. Exhibits](index=87&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed with Form 10-Q, including corporate governance, agreements, certifications, and XBRL files - Exhibits include Amended and Restated Certificate of Incorporation and Bylaws, Separation Agreement, Other Transaction for Advanced Research (OTAR) with BARDA and its amendment, and certifications from principal executive and financial officers[456](index=456&type=chunk) - XBRL Instance, Schema, Calculation, Definition, and Presentation Linkbase Documents are also filed as exhibits[456](index=456&type=chunk)

FORM 10-Q __________________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 __________________________________________________ For the quarterly period ended June 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: 001- ...