Vir Biotechnology, Inc.
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
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Sep 30, 2026 · Filed Nov 4, 2026
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Notes to Unaudited Condensed Consolidated Financial Statements
- Organization
Business Overview
Vir Biotechnology, Inc. (Vir Bio or the Company) is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN®dual-masked T-cell engagers (TCEs) across validated targets in solid tumor indications. Vir Bio also has a portfolio of preclinical programs across a range of oncologic malignancies. Vir Bio has exclusive rights to the PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
Liquidity and Capital Resources
In November 2023, the Company filed an automatic shelf registration statement on Form S-3 and a related prospectus (the 2023 Shelf Registration Statement) with the U.S. Securities and Exchange Commission (SEC) for the issuance of debt securities, common stock, preferred stock and warrants from time to time in one or more offerings.
In November 2023, the Company entered into a sales agreement (Sales Agreement) with Cowen and Company, LLC, as sales agent (TD Cowen), pursuant to which the Company may from time to time offer and sell shares of its common stock for an aggregate offering price of up to $300.0 million, through or to TD Cowen, acting as sales agent or principal. The shares will be offered and sold under the 2023 Shelf Registration Statement. The Company will pay TD Cowen a commission of up to 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide TD Cowen with customary indemnification and contribution rights. As of September 30, 2026, no shares have been sold under the Sales Agreement. The Sales Agreement expired in November 2026.
In February 2026, the Company completed a follow-on public offering (2026 Public Offering) pursuant to the 2023 Shelf Registration Statement and issued 20,294,117 shares of its common stock (including the exercise by the underwriters of their option to purchase an additional 2,647,058 shares of common stock) at a price to the public of $8.50 per share. Net proceeds from the 2026 Public Offering were approximately $162.2 million, after deducting underwriting discounts and commissions, and other offering expenses of approximately $10.3 million.
As of September 30, 2026, the Company had approximately $901.3 million in cash, cash equivalents, and investments, which the Company believes would be sufficient to fund its operations for a period through at least twelve months from the issuance date of these unaudited condensed consolidated financial statements. The Company also had approximately $8.8 million in restricted cash and cash equivalents as of September 30, 2026.
- Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The Company’s unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (GAAP) and applicable rules and regulations of the SEC regarding interim financial reporting. All intercompany balances and transactions have been eliminated upon consolidation. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s financial information. The unaudited condensed consolidated results of operations for the three and nine months ended September 30, 2026 are not necessarily indicative of the results to be expected for the year ending December 31, 2026, or for any other future annual or interim period.
Certain information and footnote disclosures typically included in the Company’s annual consolidated financial statements have been condensed or omitted. As such, these unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes included in the Annual Report on Form 10-K for the year ended December 31, 2025.
Use of Estimates
The preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates.
Segments
Operating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker (CODM) in deciding how to allocate resources and in assessing performance. The Company manages the business activities on a consolidated basis and operates asone reportable segment that constitutes all of the consolidated entity, which is the business of powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Factors used in determining the reportable segment include the nature of the Company’s operating activities, the organizational and reporting structure, and the type of information regularly provided to the CODM to allocate resources and evaluate financial performance. The Company’s CODM is its Chief Executive Officer.
Cash Equivalents
The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents, which consist of amounts invested primarily in money market funds and are stated at fair value.
Investments
Investments include available-for-sale debt securities and equity investments, which are carried at fair value.
Available-for-Sale Debt Securities
The Company’s valuations of marketable securities are generally derived from independent pricing services based on quoted prices in active markets for similar securities at period end. Generally, investments with original maturities beyond three months at the date of purchase and that mature at, or less than 12 months from, the unaudited condensed consolidated balance sheet date are considered short-term investments, with all others considered to be long-term investments. Unrealized gains and losses deemed temporary in nature are reported as a component of accumulated other comprehensive loss. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income on the unaudited condensed consolidated statements of operations. The cost of securities sold is based on the specific identification method.
Restricted Cash and Cash Equivalents
Restricted cash and cash equivalents primarily includes funds to secure standby letters of credit and security deposits with financial institutions under lease agreements and funds restricted as to withdrawal or usage under grant agreements.
Research and Development Expenses
To date, research and development expenses have related primarily to discovery efforts and preclinical and clinical development of product candidates. Research and development expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received. Research and development expenses include expenses related to license and collaboration agreements; contingent consideration from business acquisitions; personnel-related expenses, including salaries, benefits, and stock-based compensation for personnel contributing to research and development activities; expenses incurred under agreements with third-party contract development and manufacturing organizations (CDMOs), contract research organizations, and consultants; clinical costs, including laboratory supplies and costs related to compliance with regulatory requirements; and other allocated expenses, including expenses for rent, facilities maintenance, and depreciation and amortization.
The Company has acquired and may continue to acquire the rights to develop and commercialize new product candidates from third parties. Upfront payments and research and development milestone payments made in connection with acquired licenses or product rights are expensed as incurred, provided that they do not relate to a regulatory approval milestone or assets acquired in a business combination.
The Company’s expense accruals for clinical trials and manufacturing are based on estimates of contracted services provided by third-party vendors not yet billed. When billing terms under these contracts do not coincide with the timing of when the work is performed, the Company is required to make estimates of its outstanding obligations to those third parties as of the period end. The accrual estimates are based on a number of factors, including the Company’s knowledge of the research and development programs and clinical manufacturing activities, the status of the programs and activities, invoicing to date, and the provisions in the contracts. The Company obtains information regarding unbilled services directly from these service providers and performs procedures to support its estimates based on its internal understanding of the services provided to date. However, the Company may also be required to estimate these services based on information available to its internal clinical and manufacturing administrative staff if such information is not able to be obtained timely from its service providers.
Revenue Recognition
License and Collaboration Revenue
The Company analyzes its license and collaboration arrangements to determine whether they are within the scope of ASC 808, Collaborative Arrangements (ASC 808), and whether any units of account are within the scope of ASC 606, Revenue from Contracts with Customers(ASC 606). Units of account within the scope of ASC 606 are accounted for pursuant to ASC 606. For units of account outside the scope of ASC 606, the Company applies an appropriate recognition method by analogy to other authoritative accounting guidance or through a reasonable and consistently applied accounting policy election, which may include analogizing to ASC 606 or ASC 730, Research and Development(ASC 730), depending on the nature of the collaborative activities and the related contractual terms.
Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements within the scope of ASC 606, the Company applies the following five-step model: (i) identify the contract with a customer; (ii) identify the performance obligations; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations; and (v) recognize revenue when or as the Company satisfies a performance obligation.
The Company determines the transaction price based on the amount of consideration it expects to receive in exchange for transferring promised goods or services to a customer. The transaction price may include fixed consideration, upfront payments, milestone payments, royalties, profit- and loss-sharing arrangements, development cost-share settlements and other forms of variable consideration. Variable consideration is included in the transaction price only to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company reassesses the transaction price, including estimates of variable consideration and related constraints, at each reporting date.
When an arrangement includes multiple units of account, the Company allocates consideration to the respective units of account based on the underlying economics of the arrangement and in a manner consistent with the overall allocation objective of reflecting the amount of consideration to which the Company expects to be entitled in exchange for satisfying each unit of account. In making this determination, the Company considers the nature of the consideration, the underlying contractual payment terms, and whether the consideration is specifically attributable to a license, collaboration services, or other distinct units of account within the arrangement, as well as the standalone selling prices (“SSP”) of the respective units of account. The Company also assesses whether the resulting allocation is consistent with the overall allocation objective. In certain circumstances, consideration may be allocated entirely to one or more, but not all, units of account when the terms of the consideration relate specifically to the Company’s efforts to satisfy the applicable unit of account or to a specific outcome resulting from the satisfaction of that unit of account, and such allocation is consistent with the overall allocation objective.
The Company estimates SSP using methods appropriate for the nature of each unit of account. SSP for licenses of intellectual property may be estimated using a multi-period excess earnings income approach, while SSP for research and development or other service-related activities may be estimated using a cost-plus-margin approach. These estimates may require significant judgment, including assumptions regarding expected future cash flows, development and commercialization timelines, probability of technical and regulatory success, market opportunity, expected costs, margins and discount rates.
For licenses of intellectual property that are distinct from other promised goods or services, revenue is recognized at a point in time when control of the license transfers to the customer and the customer is able to use and benefit from the license. For licenses that are not distinct from other promised goods or services, revenue is recognized based on the pattern in which the combined performance obligation is satisfied. Sales-based or usage-based royalties, including certain sales-based milestone payments that relate predominantly to a license of intellectual property, are recognized when the related sales or usage occur. Development, regulatory, commercial and other milestone payments are included in the transaction price only when the related uncertainty is resolved or when it is probable that a significant reversal of cumulative revenue recognized will not occur.
Payments to or reimbursements from collaboration partners related to cost-sharing arrangements or other collaborative activities that are not transactions with a customer are accounted for under ASC 808. Amounts payable to collaboration partners for the Company’s share of research and development activities are generally recorded as research and development expense, while amounts reimbursable from collaboration partners are generally recorded as reductions of research and development expense.
New Accounting Pronouncement Not Yet Adopted
In November 2024, the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (ASU 2024-03), which requires entities to disclose specific information on the types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. The guidance is effective for annual periods beginning after December 15, 2026 and interim periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. ASU 2024-03 should be applied on a prospective basis, but retrospective application is permitted. The Company is currently evaluating the impact the adoption of ASU 2024-03 may have on its consolidated financial statements and related disclosures.
In September 2025, the FASB issued ASU No. 2025-06, Targeted Improvements to the Accounting for Internal-Use Software (ASU 2025-06), which clarifies and modernizes the accounting for costs related to internal-use software in Accounting Standards Codification Topic 350-40, Intangibles —Goodwill and Other — Internal-Use Software (ASC 350-40). ASU 2025-06 removed all references to project stages throughout ASC 350-40, and requires entities to begin capitalizing software costs when both of the following occur: (1) management, with the relevant authority, implicitly or explicitly authorizes and commits to funding a computer software project; and (2) it is probable that the project will be completed and the software will be used to perform the function intended (referred to as the probable-to-complete recognition threshold). The guidance is effective for annual periods beginning after December 15, 2027 and interim periods within those annual reporting periods. Early adoption is permitted. ASU 2025-06 should be either applied on a prospective basis, retrospective or modified prospective basis based on the status of the project and whether software costs were capitalized before the date of adoption. The Company is currently evaluating the impact the adoption of ASU 2025-06 may have on its consolidated financial statements and related disclosures.
In December 2025, the FASB issued ASU 2025-11 Interim Reporting (Topic 270): Narrow-Scope Improvements. The update provides clarifications intended to improve the consistency and usability of interim disclosure requirements, including a comprehensive listing of required interim disclosures and a new disclosure principle for reporting material events occurring after the most recent annual period. The amendments do not change the underlying objectives of interim reporting but are designed to enhance clarity in application. The guidance is effective for fiscal years beginning after December 15, 2027, including interim periods within those fiscal years. The Company is currently evaluating the impact of this guidance on its consolidated financial statements and related disclosures.
In December 2025, the FASB issued ASU 2025-12 Codification Improvements, which addresses suggestions received from stakeholders on the Accounting Standards Codification (“the Codification”) and to make other incremental improvements to U.S. GAAP. The update represents changes to the Codification that (i) clarify, (ii) correct errors, or (iii) make minor improvements. The amendments make the Codification easier to understand and apply. The guidance is effective for fiscal years beginning after December 15, 2026, including interim periods within those fiscal years. The Company is currently evaluating the impact of this guidance on its consolidated financial statements and related disclosures.
Reclassification
Certain reclassifications have been made to prior period amounts on the Company’s consolidated statement of operations to conform to the current period presentation and enhance comparability. As a result, the Company changed its presentation ofcollaboration revenue tolicense and collaboration revenue and its presentation ofcontract revenue toother revenue.
Certain reclassifications have been made to prior period amounts on the Company’s condensed consolidated statements of cash flows to conform to the current period presentation and enhance comparability. As a result, certain amounts related to deferred revenue, previously reflected inchanges in operating assets and liabilities –deferred revenue, were reclassified tochanges in operating assets and liabilities –accrued liabilities and other long-term liabilities.
- Fair Value Measurements
The Company determines the fair value of financial assets and liabilities using the fair value hierarchy, which establishes three levels of inputs that may be used to measure fair value, as follows:
Level 1: Inputs that include quoted prices in active markets for identical assets and liabilities.
Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The carrying amounts of certain financial instruments, including accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities.
Cash Equivalents and Available-for-Sale Securities
The following tables summarize the Company’s Level 1 and Level 2 financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of September 30, 2026 and December 31, 2025 (in thousands):
| ValuationHierarchy · AmortizedCost · GrossUnrealizedHoldingGains · GrossUnrealizedHoldingLosses · AggregateFair Value | |||||||
|---|---|---|---|---|---|---|---|
| Assets: | |||||||
| Money market funds | Level 1 | $80,101 | $— | $— | $80,101 | ||
| U.S. government treasuries | Level 2 | 421,395 | 41 | (2,337) | 419,099 | ||
| U.S. government agency bonds and discount notes | Level 2 | 60,277 | — | (569) | 59,708 | ||
| Asset-backed securities | Level 2 | 68,829 | 17 | (143) | 68,703 | ||
| Corporate bonds | Level 2 | 228,146 | 43 | (894) | 227,295 | ||
| Equity securities | Level 1 | N/A | N/A | N/A | 3,722 | ||
| Total financial assets | $858,748 | $101 | $(3,943) | $858,628 | |||
| Reconciliation to cash, cash equivalents and investments on condensed consolidated balance sheet | |||||||
| Minus: Restricted cash equivalents invested in money market funds | (7,927) | ||||||
| Plus: Cash deposits | 50,588 | ||||||
| Total cash, cash equivalents and investments | $901,289 | ||||||
| ValuationHierarchy · AmortizedCost · GrossUnrealizedHoldingGains · GrossUnrealizedHoldingLosses · AggregateFair Value | |||||||
|---|---|---|---|---|---|---|---|
| Assets: | |||||||
| Money market funds | Level 1 | $86,607 | $— | $— | $86,607 | ||
| U.S. government treasuries | Level 2 | 310,148 | 341 | (3) | 310,486 | ||
| U.S. government agency bonds and discount notes | Level 2 | 45,773 | 6 | (16) | 45,763 | ||
| Asset-backed securities | Level 2 | 84,676 | 277 | — | 84,953 | ||
| Corporate bonds | Level 2 | 156,160 | 499 | (1) | 156,658 | ||
| Equity securities | Level 1 | N/A | N/A | N/A | 6,077 | ||
| Total financial assets | $683,364 | $1,123 | $(20) | $690,544 | |||
| Reconciliation to cash, cash equivalents and investments on condensed consolidated balance sheet | |||||||
| Minus: Restricted cash equivalents invested in money market funds | (7,916) | ||||||
| Plus: Cash deposits | 98,962 | ||||||
| Total cash, cash equivalents and investments | $781,590 | ||||||
Accrued interest receivables excluded from both the fair value and amortized cost basis of the available-for-sale debt securities are presented within prepaid expenses and other current assets in the unaudited condensed consolidated balance sheets. Accrued interest receivables amounted to $5.4 million and $3.6 million as of September 30, 2026 and December 31, 2025, respectively. The Company didnot write off any accrued interest receivables during the nine months ended September 30, 2026 and 2025.
The Company recognized total net unrealized losses of $3.8 million and total net unrealized gains of $1.1 million in accumulated other comprehensive loss as of September 30, 2026 and December 31, 2025, respectively. The gross unrealized losses as of September 30, 2026 were due to changes in interest rates and temporary in nature. The Company currently does not intend, and it is highly unlikely that it will be required, to sell these securities before recovery of their amortized cost basis. As of September 30, 2026, no securities have contractual maturities (or weighted average life for asset-backed securities) longer thantwo years.
As of September 30, 2026, the Company’s equity investment consisted solely of ordinary shares of Brii Biosciences Limited (Brii Bio Parent). The equity securities of Brii Bio Parent are listed on the Stock Exchange of Hong Kong Limited and are considered to be marketable equity securities measured at fair value at each reporting date. Changes in fair value are recognized as other income in the unaudited condensed consolidated statement of operations.
Contingent Consideration
Contingent consideration primarily includes potential milestone payments in connection with the acquisition of Humabs BioMed SA (Humabs) in 2017. The Company classifies the contingent consideration as Level 3 financial liabilities within the fair value hierarchy as of September 30, 2026 and December 31, 2025. The estimated fair value of the contingent consideration related to the Humabs acquisition was determined by calculating the probability-weighted regulatory and commercial milestone payments based on the assessment of the likelihood and estimated timing that certain milestones would be achieved.
As of September 30, 2026, the Company calculated the estimated fair value of the remaining regulatory milestone related to tobevibart using the following significant unobservable inputs:
| Unobservable input | Value |
|---|---|
| Discount rate | 17.5% |
| Probability of achievement | 85.5% |
For the commercial milestones, the Company used a Monte Carlo simulation because of the availability of discrete revenue forecasts. As of September 30, 2026, the Monte Carlo simulation assumed a commercial product launch and associated discrete revenue forecasts, as well as the following significant unobservable inputs for the remaining commercial milestones related to tobevibart:
| Unobservable input | Value |
|---|---|
| Volatility | 65.0% |
| Discount rate | 12.0% |
| Probability of achievement | 85.5% |
The discount rate captures the credit risk associated with the payment of the contingent consideration when earned and due. As of September 30, 2026 and December 31, 2025, the estimated fair value of the contingent consideration related to the Humabs acquisition was $33.0 million and $34.1 million, respectively, with changes in the estimated fair value recorded in research and development expenses in the unaudited condensed consolidated statements of operations. The estimated fair value of the contingent consideration related to the Humabs acquisition involves significant estimates and assumptions, which give rise to measurement uncertainty.
The following table sets forth the changes in the estimated fair value of the Company’s contingent consideration obligations (in thousands):
| ContingentConsiderationObligation | |
|---|---|
| Balance at December 31, 2025 | $34,100 |
| Changes in fair value | (1,120) |
| Balance at September 30, 2026 | $32,980 |
- Grant Agreements
Gates Foundation Grants
The Company previously entered into various grant agreements with the Gates Foundation (formerly known as the Bill & Melinda Gates Foundation), under which it was awarded grants to support its HIV vaccine program, tuberculosis vaccine program, HIV vaccinal antibody program and malaria vaccinal antibody program.
In 2022, the Company entered into a stock purchase agreement with the Gates Foundation, under which the Gates Foundation purchased 881,365 shares of the Company’s common stock on January 13, 2022, at a price per share of $45.38, for an aggregate purchase price of approximately $40.0 million, which is used in furtherance of Gates Foundation’s charitable purposes to develop the Company’s vaccinal antibody program, in each case for use in specified developing countries.
The fair market value of the common stock issued to the Gates Foundation was $28.5 million, based on the closing stock price of $37.65 per share on the closing date and taking into account a discount for the lack of marketability due to the restrictions in place on the underlying shares, resulting in a $11.3 million premium received by the Company. The Company accounted for the common stock issued to the Gates Foundation based on its fair market value on the closing date. The stock purchase premium is recognized over time as required research and development activities are performed to advance the Company’s vaccinal antibody program. As of September 30, 2026, the Company had unrecognized premium balance of $8.1 million on its unaudited condensed consolidated balance sheet, including $3.6 million as part of accrued and other liabilities and $4.5 million as part of other long-term liabilities.
During 2025, all of the grant agreements expired except for the HIV vaccine program. Upon the expiration of the vaccinal antibody program grant the Company returned $9.5 million of unused grant funds to the Gates Foundation. The term of the HIV vaccine program grant agreement will expire mid-2027, unless earlier terminated by the Gates Foundation for the Company’s breach, failure to progress the funded project, in the event of the Company’s change of control, change in the Company’s tax status, or significant changes in the Company’s leadership that the Gates Foundation reasonably believes may threaten the success of the project.
Grant payments received in advance that are related to future research activities are deferred and recognized as revenue as the required research and development activities are performed. The grant revenue for the three and nine months ended September 30, 2026 and 2025 wasnot material. As of September 30, 2026 and December 31, 2025, the Company had $1.8 million within accrued and other liabilities on its condensed consolidated balance sheet, related to funds to be refunded to the Gates Foundation. The funds related to the $1.8 million liability as of September 30, 2026 is classified within restricted cash and cash equivalents, current on the Company’s condensed consolidated balance sheet.
- Collaboration and License Agreements
Collaboration and License Agreement with Astellas US LLC
On April 15, 2026, the Company closed the previously announced Collaboration and License Agreement (the Astellas Collaboration Agreement) with Astellas US LLC (together with its subsidiaries and affiliates (including its indirect parent, Astellas Pharma Inc.), Astellas). Upon closing, the Company received $240.0 million upfront payment from Astellas.
Concurrently with the closing of the Astellas Collaboration Agreement, the Company also closed the Stock Purchase Agreement with Astellas (the Astellas SPA, together with the Astellas Collaboration Agreement, the Astellas Agreements), under which Astellas purchased 7,239,382 shares of the Company’s common stock for an aggregate purchase price of approximately $75.0 million. The fair value of the common stock was $75.7 million, based on the market price of $10.46 per share on the closing day. As a result, $0.7 million of the $240.0 million upfront payment under the Astellas Collaboration Agreement was attributed to the common stock issuance for accounting purposes, resulting in a residual upfront payment of $239.3 million. The Astellas SPA includes standstill, voting and lockup provisions, with customary exceptions, that expire one year after the date of the closing of the Astellas SPA. One year after the closing of the Astellas SPA, Astellas will have, under certain circumstances, a customary right to require the Company to register the resale of the shares purchased pursuant to the Astellas SPA.
Under the Astellas Collaboration Agreement the parties entered into a global strategic collaboration to co-develop and co-commercialize VIR-5500, an investigational PRO-XTEN® dual-masked CD3 TCE targeting PSMA (Prostate-Specific Membrane Antigen) for the treatment of prostate cancer that is currently in Phase 1 development, through a sharing of expenses and revenues. The Company granted Astellas, subject to certain intellectual property rights of Sanofi, an exclusive, worldwide license (the VIR-5500 Program License) to develop, manufacture, commercialize and otherwise exploit VIR-5500 and certain related derivative compounds for therapeutic, prophylactic, palliative and diagnostic uses.
The Company and Astellas will jointly develop VIR-5500, with global clinical development costs shared 40% by the Company and 60% by Astellas, while costs of U.S.-specific studies will be shared equally, and Astellas will be solely responsible for costs of ex-U.S.-specific studies. The Company will be eligible to receive up to $1.39 billion in future development, regulatory and ex-U.S. sales milestones, along with tiered, double-digit royalties on ex-U.S. net sales. In the U.S., the Company will share profits and losses from sales of VIR-5500 equally with Astellas, should VIR-5500 receive regulatory approval, and the Company will have the option to co-promote VIR-5500. Outside of the U.S., Astellas will obtain exclusive rights to commercialize VIR-5500 and be responsible for all commercialization costs. In addition, the Company has the option to opt out of development cost sharing responsibilities and U.S. profit sharing. In such case, the Company will be eligible to receive up to $1.39 billion (or $1.62 billion if the Company has met a pre-defined limited funding threshold at the time of the opt-out) in future development, regulatory and global sales milestones, along with tiered, double-digit royalties on global net sales. Further, certain opt-out milestones, if met, will include reimbursement of a portion of the Company’s previously expensed development and commercialization spend.
The Astellas Agreements represent a collaborative arrangement within the scope of ASC 808. Apart from the aforementioned issuance of common stock unit of account under the Astellas SPA, the Company identified two additional units of account under the Astellas Collaboration Agreement: (i) the VIR‑5500 Program License, and (ii) participation in collaboration to advance VIR-5500, predominantly including certain clinical development activities in the ongoing Phase 1 trial. The Company concluded that the VIR‑5500 Program License is distinct from the collaboration activities because those activities are not expected to significantly modify or customize the licensed intellectual property.
The Company further evaluated whether any elements of the arrangement were within the scope of ASC 606 and determined that Astellas is a customer only with respect to the VIR‑5500 Program License. Accordingly, the VIR‑5500 Program License was accounted for under ASC 606, and the collaboration activities were accounted for under ASC 808 using an accounting policy election that analogizes to certain recognition and measurement principles of ASC 730.
The Company allocated the upfront payment and other forms of consideration under the Astellas Collaboration Agreement, including clinical development and regulatory milestones, development cost-share settlement, sales milestones and royalties, and U.S. profit- and loss-share settlements, to the appropriate units of account based on the underlying economics of the arrangement. In making this determination, the Company considered the allocation principles in ASC 606. The Company evaluated the nature of the consideration, the underlying contractual payment terms, and whether the consideration was predominantly driven by the clinical, regulatory, or commercial outcomes associated with products incorporating the licensed intellectual property, or by the level of effort or costs incurred in performing collaboration activities, as well as the standalone selling prices of the respective units of account. The Company also considered whether the resulting allocation was consistent with the overall allocation objective, including whether the attribution reflected the amount to which the Company expected to be entitled in exchange for transferring the VIR‑5500 Program License to Astellas and performing the collaboration activities. Variable consideration is included in these assessments only to the extent that it is probable that a significant reversal of cumulative amounts recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved and is not subject to the sales- or usage-based royalty exception.
The Company estimated the SSP of the VIR‑5500 Program License using a multi-period excess earnings income approach based on the estimated present value of future cash flows expected to be generated from the licensed intellectual property. The SSP of the clinical development activities was estimated using a cost-plus-margin approach.
The Company determined that the VIR‑5500 Program License was transferred to Astellas upon closing of the Astellas Collaboration Agreement. Amounts allocated to the collaboration activities are recognized over time as the related development activities are performed and costs are incurred. Because these activities are conducted as part of a collaborative arrangement and are not transactions with a customer, amounts recognized for the collaborative activities are recorded within operating expenses depending on the nature of the activities, either within research and development expense or within selling, general and administrative expenses. Cost-share reimbursements from Astellas are recognized as reductions of expenses, while amounts payable to Astellas are recognized as additional expense.
The Company recognized the residual upfront payment of $239.3 million in the second quarter of 2026 as license and collaboration revenue, related to the transfer of the VIR‑5500 Program License in its unaudited condensed consolidated statement of operations. During the three and nine months ended September 30, 2026, the Company recorded approximately $8.6 million and $13.6 million reduction of research and development expense, respectively, related to expected development cost-share reimbursements from Astellas. As of September 30, 2026, the Company had $8.6 million of collaboration receivables, which are classified within prepaid expenses and other current assets on its unaudited condensed consolidated balance sheet.
Additionally, in accordance with the Company’s license agreement with Sanofi, the Company will share with Sanofi 20% of certain collaboration proceeds from the Astellas Agreements, including the upfront payment and the portion of milestones, profit-share and royalties that exceed amounts already owed to Sanofi. In June 2026, after the closing of the Astellas Agreements, the Company made a $48.0 million payment to Sanofi, which was recorded as a research and development expense in the second quarter of 2026.
License Agreement with Norgine Pharma UK Limited
On December 15, 2025, the Company and Norgine Pharma UK Limited (together with its affiliates in the Norgine group of companies, Norgine) entered into a License Agreement (the Norgine Agreement) under which the Company granted Norgine an exclusive license with respect to commercial rights and certain development rights to the combination of elebsiran, an investigational small interfering ribonucleic acid (Licensed Product) and tobevibart, an investigational monoclonal antibody, for the treatment of people living with chronic hepatitis delta (CHD) in Europe, Australia, and New Zealand (collectively, the Norgine Territory), while Vir Bio will retain commercial rights for the Licensed Product in the United States and all other international markets outside of the People’s Republic of China and Taiwan.
The Company and Norgine collaborate on the development and commercialization of Licensed Product in Norgine Territory under the oversight of various joint committees, with the Company primarily responsible for development activities for the ongoing trials in Vir Bio’s ECLIPSE registrational program (ECLIPSE 1, 2 and 3) and Norgine primarily responsible for regulatory, medical affairs and commercialization activities. Vir Bio will also provide future commercial supply to Norgine.
Vir Bio received an initial reimbursement of historical development costs from Norgine in the amount of €55 million or $64.3 million in December 2025 and is eligible to receive up to an additional €495 million in clinical, regulatory and sales milestones, along with tiered, mid-teen to high-twenties percent royalties on net sales in the Norgine Territory. In addition, clinical development costs for the ongoing ECLIPSE registrational program are shared, with Norgine contributing approximately 25% of external costs starting from January 1, 2026.
During the three and nine months ended September 30, 2026, the Company recorded approximately $3.4 million and $10.9 million of cost reimbursement as reductions of research and development expenses, respectively, in its unaudited condensed consolidated statement of operations. As of September 30, 2026, the Company recorded $3.3 million of collaboration receivables, which are classified within prepaid expenses and other current assets on its unaudited condensed consolidated balance sheet.
License Agreement with Sanofi
On September 9, 2024 , the Company closed the license agreement with Amunix Pharmaceuticals, Inc., a Sanofi company, previously announced on August 1, 2024 (Sanofi Agreement). The Sanofi Agreement provides the Company with an exclusive worldwide license to use of the proprietary PRO-XTEN® universal masking technology for oncology and infectious disease, excluding the ophthalmological field, and tothree early-stage clinical dual-masked TCEs that all leverage the PRO-XTEN® universal masking platform within a range of oncology indications.
Under the Sanofi Agreement the Company made an upfront payment to Sanofi in the amount of $100.0 million and placed into escrow a $75.0 million milestone payment due to former shareholders of Amunix Pharmaceuticals, Inc., which is subject to VIR-5525 achieving “first in human dosing” by 2026. In July 2025, the first patient was dosed in phase 1 study evaluating VIR-5525, and the Company paid the $75.0 million during the third quarter of 2025.
Sanofi will also be eligible to receive up to an additional $323.0 million in future development and regulatory milestone payments, up to an additional $1.49 billion in commercial net sales-based milestone payments, and low single-digit to low double-digit tiered royalties on worldwide net sales. In addition, if, within atwo-year period from the execution of the Sanofi Agreement, the Company executes a transaction that gives rise to Vir Bio receiving certain sublicense income related to the licenses obtained from the Sanofi Agreement, Sanofi may be eligible to receive 20% of such income that exceeds amounts already owed to them. Accordingly, after the closing of the Astellas Agreements and the receipt of a $240 million upfront payment from Astellas, the Company made a $48 million payment to Sanofi in June 2026, which was recorded as research and development expense in the unaudited condensed consolidated statement of operations.
Alnylam Pharmaceuticals, Inc.
In October 2017, the Company and Alnylam Pharmaceuticals, Inc. (Alnylam) entered into a collaboration and license agreement (the Alnylam Agreement). Under the Alnylam Agreement, the Company obtained a worldwide, exclusive license to develop, manufacture and commercialize small interfering RNA (siRNA) product candidates directed to HBV, including elebsiran, for all uses and purposes including the treatment of hepatitis B virus (HBV) and hepatitis delta virus (HDV). Under the Alnylam Agreement, the Company also held options to obtain similar licenses to siRNA product candidates for up tofour other infectious disease targets selected by Vir Bio, but following an amendment and restatement of the Alnylam Agreement in March 2025 (the Restated Alnylam Agreement), those options (and all rights and obligations related to those infectious disease targets) were terminated. At the same time Alnylam elected to not opt-in to the profit-sharing arrangement with respect to any licensed siRNA product candidates, including elebsiran, directed to HBV or HDV. The Company remains solely responsible, at its expense, for conducting all development, manufacture and commercialization activities for elebsiran in HBV and HDV indications, and the Company is required to use commercially reasonable efforts to develop and commercialize elebsiran for the treatment of HBV or HDV in the United States and specified major markets.
In connection with the Restated Alnylam Agreement and Alnylam’s election to not opt-in to the profit-sharing arrangement, the Company paid Alnylam $30.0 million, which was recorded in the first quarter of 2025 as part of research and development expenses. After this payment, the remaining amount of the development and regulatory milestones is up to $145.0 million for elebsiran. Any development and regulatory milestones for elebsiran will be payable to Alnylam only once, irrespective of dosage, formulation forms, route of administration or indication. Following commercialization, the Company will be required to pay to Alnylam up to $250.0 million in the aggregate for the first achievement of specified levels of net sales by elebsiran products directed to HBV, whether for the treatment of HBV or HDV. The Company will also be required to pay Alnylam tiered royalties at percentages ranging from the low double-digits to mid-teens on annual net sales of siRNA products directed to HBV, such as elebsiran, whether for the treatment of HBV or HDV, subject to specified reductions and offsets. The royalties are payable on a product-by-product and country-by-country basis until the later of the expiration of all valid claims of specified patents covering such product in such country and 10 years after the first commercial sale of such product in such country. Alnylam is entitled to receive a portion of any consideration the Company receives as a result of granting a sublicense under the licenses granted to Vir Bio by Alnylam under the Alnylam Agreement.
- Balance Sheet Components
Property and Equipment, net
Property and equipment, net consists of the following (in thousands).
| Useful life(in years) | September 30,2026 | December 31,2025 | |
|---|---|---|---|
| Leasehold improvements | 8 - 12 | $56,293 | $56,180 |
| Laboratory equipment | 5 | 41,216 | 40,961 |
| Furniture and fixtures | 5 | 2,890 | 2,836 |
| Computer equipment | 3 | 2,692 | 2,689 |
| Construction in progress | N/A | — | 114 |
| Property and equipment, gross | 103,091 | 102,780 | |
| Less: accumulated depreciation | (55,322) | (47,160) | |
| Total property and equipment, net | $47,769 | $55,620 |
Depreciation expenses were $2.7 million and $2.9 million for the three months ended September 30, 2026 and 2025, respectively, and $8.1 million and $8.6 million for the nine months ended September 30, 2026 and 2025, respectively.
Accrued and Other Liabilities
Accrued and other liabilities consist of the following (in thousands):
| September 30,2026 | December 31,2025 | |
|---|---|---|
| Research and development expenses | $28,660 | $35,299 |
| Payroll and related expenses | 17,850 | 28,724 |
| Operating lease liabilities, current | 9,316 | 8,798 |
| Other professional and consulting expenses | 5,216 | 3,327 |
| Excess funds payable under grant agreements | 1,836 | 1,825 |
| Other accrued expenses | 6,457 | 5,039 |
| Total accrued and other liabilities | $69,335 | $83,012 |
- Commitments and Contingencies
Manufacturing and Supply Agreements
The Company has entered into various scopes of work with third-party CDMOs to support the advancement of its pipeline programs. As of September 30, 2026 , the Company had unaccrued unpaid commitments of approximately $5.3 million under manufacturing agreements related to elebsiran and tobevibart and unaccrued unpaid commitments of approximately $17.8 million under manufacturing agreements related to its oncology programs.
Legal Proceedings
The Company may from time to time be party to claims and legal proceedings that arise in the normal course of its business and that may or may not have, individually or in the aggregate, a material adverse effect on its results of operations, financial condition or liquidity.
Indemnification
In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Under such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. In addition, the Company has entered into indemnification agreements with its directors and certain officers that may require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. To date, no demands have been made upon the Company to provide indemnification under these agreements, and thus, there are no indemnification claims that the Company is aware of that could have a material effect on the unaudited condensed consolidated balance sheets, unaudited condensed consolidated statements of operations, or unaudited condensed consolidated statements of cash flows.
- Stock-Based Awards
The Company has maintained a stock incentive plan for the issuance of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock, other stock awards and performance cash awards, to employees, non-employee directors, and consultants. The Company also has an employee stock purchase plan (ESPP) for its employees.
Stock Options Granted to Employees
The fair value of stock options granted to employees was estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions:
| Three Months EndedSeptember 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Expected term of options (in years) | 6.1 | N/A | 5.5 - 6.1 | 5.5 - 6.1 |
| Expected stock price volatility | 81.3% - 81.4% | N/A | 81.3% - 93.3% | 87.6% - 89.9% |
| Risk-free interest rate | 4.4% - 4.9% | N/A | 3.8% - 4.9% | 4.0% - 4.5% |
| Expected dividend yield | — | — | — | — |
The valuation assumptions for stock options were determined as follows:
Expected Term —The expected term represents the period that the stock options granted are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term) as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock option grants.
Expected Volatility —Prior to 2026, the expected volatility was determined by using a blended approach of the Company and its industry peers’ historical volatilities. Starting from 2026, the expected volatility is determined by using historical volatilities based on the Company’s stock prices over a look-back period corresponding to the expected term.
Risk-Free Interest Rate —The Company determines the risk-free interest rate over the expected term of the stock options based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of the grant.
Expected Dividend Rate —The expected dividend is zero as the Company has not paid nor does it anticipate paying any dividends in the foreseeable future.
Stock-Based Compensation Expense
Stock-based compensation is recognized on a straight-line basis over the requisite service period, which is generally the vesting period. The following table sets forth the total stock-based compensation expense for all awards granted to employees and non-employees and the ESPP in the unaudited condensed consolidated statements of operations (in thousands):
| Three Months EndedSeptember 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Research and development | $4,436 | $5,546 | $15,951 | $19,497 |
| Selling, general and administrative | 6,019 | 5,810 | 18,982 | 18,369 |
| Total stock-based compensation | $10,455 | $11,356 | $34,933 | $37,866 |
- Net Loss Per Share
Basic net loss per common share is computed by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per common share is computed by dividing the net loss by the sum of the weighted-average number of common shares outstanding and potential dilutive common stock equivalents outstanding during the period as determined in accordance with the treasury stock method. For periods that the Company was in a net loss position, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential common stock equivalents outstanding would have been anti-dilutive.
The following is a calculation of the basic and diluted net loss per share (in thousands, except share and per share data):
| Three Months EndedSeptember 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Net loss | $(96,252) | $(163,141) | $(141,867) | $(395,064) |
| Weighted-average shares outstanding, basic and diluted | 169,275,049 | 138,930,173 | 161,555,686 | 138,287,533 |
| Net loss per share, basic and diluted | $(0.57) | $(1.17) | $(0.88) | $(2.86) |
Securities that could potentially dilute basic net loss per common share in the future that were not included in the computation of diluted net loss per common share because to do so would have been antidilutive for the periods presented were primarily as follows:
| Three and Nine Months Ended September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Options issued and outstanding | 9,487,422 | 8,808,357 |
| Unvested restricted shares | 6,417,276 | 5,984,554 |
| Total | 15,904,698 | 14,792,911 |
- Income Taxes
The table below presents our loss before benefit from (provision for) income taxes, benefit from (provision for) income taxes and effective tax rate for the three and nine months ended September 30, 2026 and 2025 (in thousands):
| Three Months EndedSeptember 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Loss before benefit from (provision for) income taxes | $(96,395) | $(162,973) | $(141,661) | $(394,710) |
| Benefit from (provision for) income taxes | $143 | $(168) | $(206) | $(354) |
| Effective tax rate | 0.1% | (0.1%) | (0.1%) | (0.1%) |
The Company is subject to income taxes in the United States and foreign jurisdictions. These foreign jurisdictions have statutory tax rates different from those in the United States. Accordingly, the Company’s effective tax rates will vary depending on the relative proportion of foreign to United States income or loss, the utilization of net operating loss and tax credit carry forwards and carrybacks, changes in jurisdictional mix of income and expense, changes in management’s assessment of matters such as the ability to realize deferred tax assets, and changes in tax laws.
Unrecognized tax benefits were $19.0 million and $17.3 million as of September 30, 2026 and December 31, 2025, respectively, and if recognized, would favorably affect the effective tax rate in future periods.
- Segment Reporting
The Company manages the business activities on a consolidated basis and operates asone reportable segment that constitutes all of the consolidated entity, which is the business of powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. The Company’s CODM is its Chief Executive Officer. The accounting policies of the segment are the same as those described in the summary of significant accounting policies. The measure of segment profit or loss is segment net loss that also is reported on the condensed consolidated statements of operations as consolidated net loss. The measure of segment assets is reported on the condensed consolidated balance sheet as total consolidated assets. The CODM uses segment net loss to monitor spending, assess performance for the Company and management, evaluate the progress of completing corporate goals, decide how to allocate resources among the Company’s clinical and pre-clinical portfolios, and make strategic decisions about business development opportunities.
The following table summarizes segment revenues by geographic area (in thousands). The Company’s revenues primarily include license and collaboration revenues recognized under the Company’s collaboration with Astellas. Revenue is attributed to geographic areas based on the location of the Company’s customers and collaboration counterparties.
| Three Months EndedSeptember 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| Segment revenue attributed to: | 2026 | 2025 | 2026 | 2025 |
| U.S. | ||||
| Astellas | $— | $— | $239,276 | $— |
| Other | 26 | 305 | 49 | 1,726 |
| Foreign | (214) | (65) | (596) | 2,760 |
| Total segment and consolidated revenue | $(188) | $240 | $238,729 | $4,486 |
The Company’s long-lived assets are primarily located in the U.S.
The segment revenue, segment profit or loss, and significant segment expenses regularly provided to CODM are summarized as follows (in thousands).
| Three Months EndedSeptember 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Segment revenue | $(188) | $240 | $238,729 | $4,486 |
| Less: Segment expenses (1) | ||||
| Cost of revenue | — | (11) | — | — |
| Research and development | ||||
| Contract manufacturing | 25,755 | 9,644 | 85,729 | 33,043 |
| Personnel (2) | 25,797 | 27,677 | 85,837 | 94,560 |
| Clinical costs | 22,785 | 21,017 | 71,451 | 61,984 |
| Licenses, collaborations and contingent consideration, net | (11,852) | 76,414 | 26,550 | 124,306 |
| Other R&D (3) | 17,555 | 16,711 | 54,678 | 53,724 |
| Selling, general and administrative (2) | 24,430 | 22,231 | 77,965 | 68,458 |
| Restructuring, long-lived assets impairment and related charges, net | — | — | — | (182) |
| Plus: Other segment items (4) | 8,406 | 10,302 | 21,614 | 36,343 |
| Segment and consolidated net loss | $(96,252) | $(163,141) | $(141,867) | $(395,064) |
(1) Refer to Note 6 Balance Sheet Components for depreciation and amortization expenses included in segment expenses.
(2) Refer to Note 8 Stock-Based Awards for stock-based compensation expenses included in segment expenses.
(3) Other research and development expenses primarily includes non-personnel research expenses, allocated facility and IT expenses, and depreciation expenses.
(4) Other segment items include change in fair value of equity investments, interest income, other expense, net, and benefit from (provision for) income taxes, all of which were presented on the condensed consolidated statements of operations.
- Subsequent Event
On October 9, 2026, the Company and Gilead Sciences, Inc. (Gilead) entered into a Collaboration and License Agreement (the Gilead Collaboration Agreement). Under the terms of the Gilead Collaboration Agreement, the Company will be responsible for discovery, design and optimization of three novel PRO-XTEN® dual-masked TCE preclinical development candidates targeting selected solid tumor-associated antigens. Gilead will have an exclusive license to nominate and advance candidates generated under the collaboration and will be responsible for subsequent development, manufacturing and commercialization activities.
Concurrently with the execution of the Gilead Collaboration Agreement, the Company and Gilead also entered into a Stock Purchase Agreement (the Gilead SPA), pursuant to which Gilead purchased 1,765,486 shares of Vir Bio’s common stock at $14.16 per share for an aggregate purchase price of approximately $25.0 million. The Gilead SPA includes standstill, voting and lockup provisions, with customary exceptions, that expire one year after the date of the closing of the Gilead SPA.
The Company received $90.0 million cash consideration in October 2026, which included $65.0 million in upfront payment and the $25.0 million equity investment. The Company will be eligible to receive up to $45.0 million in potential near-term preclinical milestones and up to $1.74 billion in further development, regulatory and commercial milestones, along with tiered high single-digit to low double-digit royalties on net sales.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.