Vir Biotechnology, Inc.

Previous wording

We are 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. Our clinical-stage portfolio includes programs for Chronic Hepatitis Delta (CHD) and multiple dual-masked T-cell engagers (TCEs) across validated targets in solid tumor indications. We also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.

Current wording

We are 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. At Vir Bio, we have a bold vision – powering the immune system to transform lives. Our clinical-stage portfolio includes programs for chronic hepatitis delta (CHD) and multiple dual-masked T-cell engagers (TCEs) across validated targets in solid tumor indications. We also have a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.

Previous wording

Our clinical development pipeline consists of investigational therapies targeting hepatitis delta virus (HDV) and various solid tumors. In HDV, ECLIPSE registrational program is fully underway with all three trials initiated. Should the ECLIPSE program yield positive results that support regulatory approval and subsequent commercial launch, we believe the combination has the potential to be a new standard of care for hepatitis delta patients, for whom approved treatment options are either limited or unavailable. In oncology, we are advancing phase 1 clinical studies for our dual-masked TCEs: VIR-5818 in patients with HER2-expressing tumors and VIR-5500 in patients with PSMA-expressing metastatic castration-resistant prostate cancer (mCRPC). We are also advancing our third TCE program, VIR-5525, in patients with EGFR-expressing tumors, with the first patient dosed in phase 1 clinical studies in July 2025. We are also developing therapeutic candidates in HIV cure, and other solid tumors, leveraging our expertise and platform strengths.

Current wording

In HDV, our ECLIPSE registrational program is fully underway with all three trials initiated. Should the ECLIPSE program yield positive results that support regulatory approval and subsequent commercial launch, we believe the combination of tobevibart and elebsiran has the potential to be a new standard of care for hepatitis delta patients, for whom approved treatment options are either limited or unavailable. In oncology, we are advancing phase 1 clinical studies for our dual-masked TCEs: VIR-5500 in patients with PSMA-expressing metastatic castration-resistant prostate cancer (mCRPC), VIR-5818 in patients with HER2-expressing tumors, and VIR-5525 in patients with EGFR-expressing tumors. In addition, we are developing therapeutic candidates in HIV cure and other solid tumors, leveraging our expertise and platform strengths, and we have made available for external partnerships our next-generation preclinical influenza A and B antibodies and antibody-drug conjugates (ADCs) along with our next-generation COVID monoclonal antibodies (mAbs).

Previous wording

Following is a summary of selected significant developments affecting our business that occurred since the filing of our Quarterly Report on Form 10-Q for the period ended June 30, 2025. For additional developments or for a more comprehensive discussion of certain developments below, see our Annual Report on Form 10-K for the year ended December 31, 2024 and our Quarterly Report on Form 10-Q for the period June 30, 2025.

Current wording

Following is a summary of selected significant developments affecting our business that occurred since the filing of our Annual Report on Form 10-K for the period ended December 31, 2025. For additional developments or for a more comprehensive discussion of certain developments below, see our Annual Report on Form 10-K for the year ended December 31, 2025.

Previous wording

•VIR-5818, a PRO-XTEN® dual-masked TCE targeting HER2, continues in Phase 1 dose escalation study in combination with pembrolizumab.

Current wording

•Phase 1 dose-escalation of VIR-5818, a HER2-targeted PRO-XTEN® dual-masked TCE, in combination with pembrolizumab continues, with response data expected in the second half of 2026.

Previous wording

Other than sotrovimab, we have not obtained regulatory approval for our product candidates, and we do not expect to generate any significant revenue from the sale of our product candidates until we complete clinical development, submit regulatory filings and receive approvals from the applicable regulatory bodies for such product candidates, if ever. In December 2024, the FDA revoked the emergency use authorization (EUA) granted to sotrovimab in May 2021. Although certain countries outside the U.S. continue to maintain access to 500 mg IV while noting that the clinical efficacy is unknown or uncertain against existing and emerging variants, we cannot predict whether other countries will further limit the use of sotrovimab. We do not expect meaningful collaboration revenue in the future from the sale of sotrovimab for the treatment of COVID-19.

Current wording

We do not expect to generate any significant revenue from the sale of our product candidates until we complete clinical development, submit regulatory filings and receive approvals from the applicable regulatory bodies for such product candidates, if ever.

Previous wording

Contract revenue includes recognition of revenue generated from license rights issued to GSK, from research and development services under third-party contracts, and from a third-party clinical supply agreement.

Current wording

Other revenue includes recognition of revenue generated from research and development services under third-party contracts and from a third-party clinical supply agreement.

Previous wording

(Provision for) benefit from income taxes consists primarily of income taxes on our domestic and foreign operations.

Current wording

Provision for income taxes consists primarily of income taxes on our domestic and foreign operations.

Previous wording

Comparison of the Three and Nine Months Ended September 30, 2025 and 2024

Current wording

Comparison of the Three Months Ended March 31, 2026 and 2025

Previous wording

The decrease in grant revenue for the three and nine months ended September 30, 2025 compared to the same periods in 2024 was primarily due to lower revenue recognized in accordance with our agreement with BARDA and the Gates Foundation. Certain grant agreements with the Gates Foundation expired in 2025. We terminated our agreement with BARDA on December 31, 2024.

Current wording

The decrease in grant revenue for the three months ended March 31, 2026 compared to the same period in 2025 was primarily due to lower revenue recognized in accordance with our agreement with the Gates Foundation. Certain grant agreements with the Gates Foundation expired in 2025.

Previous wording

The decrease in selling, general and administrative expenses for the three and nine months ended September 30, 2025 compared to the same periods in 2024 was primarily due to efficiencies and cost savings from previously announced restructuring initiatives.

Current wording

The decrease in selling, general and administrative expenses for the three months ended March 31, 2026 compared to the same period in 2025 was nominal.

Previous wording

The decrease in restructuring, long-lived assets impairment and related charges for the three and nine months ended September 30, 2025 compared to the same periods in 2024 was due to the substantial completion of previously announced restructuring initiatives by the end of 2024.

Current wording

The change in restructuring, long-lived assets impairment and related charges for the three months ended March 31, 2026 compared to the same period in 2025 was nominal.

Previous wording

Our equity investment consisted solely of shares of Brii Bio Parent, which is a marketable equity investment and remeasured to fair value at each reporting date. For the three and nine months ended September 30, 2025, we recognized an unrealized gain of $1.3 million and $4.3 million due to the change in fair value, respectively, compared to an unrealized gain of $1.1 million and unrealized loss of $4.4 million for the same periods in 2024, respectively.

Current wording

Our equity investment consisted solely of shares of Brii Bio Parent, which is a marketable equity investment and remeasured to fair value at each reporting date. For the three months ended March 31, 2026, we recognized an unrealized loss of $0.2 million due to the change in fair value, compared to an unrealized gain of $6.4 million for the same period in 2025.

Previous wording

The decrease in interest income for the three and nine months ended September 30, 2025 compared to the same periods in 2024 was primarily due to lower balances of cash, cash equivalents, and investments and lower interest rates.

Current wording

The decrease in interest income for the three months ended March 31, 2026 compared to the same period in 2025 was primarily due to lower balances of cash, cash equivalents, and investments and lower interest rates.

Previous wording

The change in other expense, net for the three and nine months ended September 30, 2025 compared to the same periods in 2024 was nominal.

Current wording

The change in other expense, net for the three months ended March 31, 2026 compared to the same periods in 2025 was nominal.

Previous wording

The provision for income taxes for the three and nine months ended September 30, 2025 and for three months ended September 30, 2024 was nominal. The benefit for income taxes for the nine months ended September 30, 2024 was primarily due to favorable adjustments in estimated tax payable.

Current wording

The provision for income taxes for the three months ended March 31, 2026 compared to the same period in 2025 was nominal.

Previous wording

To date, we have financed our operations primarily through sales of our common stock from our initial public offering and subsequent follow-on offering, sales of our convertible preferred securities, and payments received under our grant and collaboration agreements. As of September 30, 2025, we had $810.7 million in cash, cash equivalents, and investments and $9.2 million in restricted cash and cash equivalents. As of September 30, 2025, our accumulated deficit was $1.2 billion. In November 2023, we 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 shelf registration statement on Form S-3 and a related prospectus that we filed with the U.S. Securities and Exchange Commission (SEC) on November 3, 2023. We 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, 2025, no shares have been issued under the Sales Agreement.

Current wording

In November 2023, we entered into a sales agreement (Sales Agreement) with Cowen and Company, LLC, as sales agent (TD Cowen), pursuant to which we may from time to time offer and sell shares of our 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. We 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 March 31, 2026, no shares have been issued under the Sales Agreement. The Sales Agreement will expire in November 2026.

Previous wording

In December 2024, the FDA revoked the EUA granted to sotrovimab in May 2021. We do not expect to generate significant revenue from the sale of our product candidates until we complete clinical development, submit regulatory filings and receive approvals from the applicable regulatory bodies for such product candidates, if ever. We may continue to incur net losses for the foreseeable future. Based upon our current operating plan, we believe that our existing cash, cash equivalents and investments as of September 30, 2025 as noted above will enable us to fund our operations for at least the next 12 months from the filing date of this Quarterly Report on Form 10-Q.

Current wording

We do not expect to generate significant revenue from the sale of our product candidates until we complete clinical development, submit regulatory filings and receive approvals from the applicable regulatory bodies for such product candidates, if ever. We may continue to incur net losses for the foreseeable future. Based upon our current operating plan, we believe that our existing cash, cash equivalents and investments as of March 31, 2026 as noted above will enable us to fund our operations for at least the next 12 months from the filing date of this Quarterly Report on Form 10-Q.

Previous wording

However, our operating plan may change as a result of many factors currently unknown to us, and we may need to raise additional capital to complete the development and commercialization of our product candidates and fund certain of our existing manufacturing and other commitments. We expect to finance our cash needs through public or private equity or debt financings, third-party (including government) funding, and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. See the sections titled “Risk Factors—Risks Related to Our Financial Position and Capital Needs—Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates” and “Risk Factors—Risks Related to Our Financial Position and Capital Needs—We may require substantial additional funding to finance our operations. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our research and development programs or other operations” for a description of the risks that may be associated with any future capital raises.

Current wording

Our operating plan may change as a result of many factors currently unknown to us, and we may need to raise additional capital to complete the development and commercialization of our product candidates and fund certain of our existing manufacturing and other commitments. We expect to finance our cash needs through public or private equity or debt financings, third-party (including government) funding, and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. See the sections titled “Risk Factors—Risks Related to Our Financial Position and Capital Needs—Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates” and “Risk Factors—Risks Related to Our Financial Position and Capital Needs—We may require substantial additional funding to finance our operations. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our research and development programs or other operations” for a description of the risks that may be associated with any future capital raises.

Previous wording

Our primary operating lease arrangements are for office and laboratory spaces located in California and Switzerland with contractual lease periods expiring between 2033 and 2035. As of September 30, 2025, we expect to make total lease payments of approximately $125.0 million through 2035.

Current wording

Our primary operating lease arrangements are for office and laboratory spaces located in California and Switzerland with contractual lease periods expiring between 2033 and 2035. As of March 31, 2026, we expect to make total lease payments of approximately $117.8 million through 2035.

Previous wording

Cash used in operating activities is derived by adjusting our net loss for non-cash items and changes in operating assets and liabilities. Cash used in operating activities during the nine months ended September 30, 2025 increased compared to the same period in 2024 primarily due to milestone payments related to the first patient dosed in Phase 1 study evaluating VIR-5525 and the enrollment of the first patient in ECLIPSE registrational program for CHD, the refund of $9.5 million unused grant funds to the Gates Foundation upon the vaccinal antibody program grant not being extended and overall higher payments for clinical costs associated with our CHD and oncology programs, partially offset by the payment made under our license agreement with Sanofi in the third quarter 2024 and ongoing cost saving realized through headcount reductions, the closing of our St. Louis, Missouri and Portland, Oregon sites and de-prioritized research and development programs.

Current wording

Cash used in operating activities is derived by adjusting our net loss for non-cash items and changes in operating assets and liabilities. Cash used in operating activities during the three months ended March 31, 2026 increased compared to the same period in 2025 primarily due to increase in contract manufacturing and clinical costs related to the advancement of our CHD and oncology programs and the payment timing of the $30.0 million expense in the first quarter of 2025 in connection with signing the Restated Alnylam Agreement and milestone payments due upon the enrollment of the first patient in phase 3 ECLIPSE registrational program for CHD, which was paid in April 2025.

Previous wording

Cash provided by investing activities during the nine months ended September 30, 2025 decreased compared to the same period in 2024 primarily due to lower cash provided by maturities and sales of investment, net of investment purchases. Cash provided by investing activities during nine months ended September 30, 2025 was primarily related to $858.4 million in proceeds received from investments that matured or sold, partially offset by purchases of investments of $630.5 million. Cash provided by investing activities during nine months ended September 30, 2024 was primarily due to $1.4 billion in proceeds received from investments that matured or sold, partially offset by purchases of investments of $1.1 billion.

Current wording

Cash provided by investing activities during the three months ended March 31, 2026 decreased compared to the same period in 2025 primarily due to lower cash provided by maturities and sales of investment, net of investment purchases. Cash provided by investing activities during three months ended March 31, 2026 was primarily related to $170.6 million in proceeds received from investments that matured or were sold, partially offset by purchases of investments of $158.4 million. Cash provided by investing activities during three months ended March 31, 2025 was primarily due to $301.9 million in proceeds received from investments that matured or were sold, partially offset by purchases of investments of $173.7 million.

Previous wording

The change in cash provided by financing activities during the nine months ended September 30, 2025 compared to the same period in 2024 was nominal.

Current wording

Cash provided by financing activities during the three months ended March 31, 2026 increased compared to the same period in 2025 primarily due to the issuance of our common stock in connection with our follow-on public offering of $162.3 million.

Previous wording

There have been no significant changes in our critical accounting policies during the nine months ended September 30, 2025, as compared with those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.

Current wording

There have been no significant changes in our critical accounting policies during the three months ended March 31, 2026, as compared with those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.