Vir Biotechnology, Inc.
For the period ended Sep 30, 2025. Filed Nov 5, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 5, 2025
VIR$12.21+10.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-06.
0001628280-25-038431
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-05.
0001628280-25-049694
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 136 previous paragraphs and 132 current paragraphs.
90 unchanged; 31 reworded; 11 added; 15 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (11)
Current report
•The ECLIPSE 1 Phase 3 trial has completed enrollment approximately two months ahead of our internal projections. Primary completion is expected in the fourth quarter of 2026, with topline data expected in the first quarter of 2027. ECLIPSE 1 evaluates the combination of tobevibart and elebsiran compared to deferred treatment in regions such as the U.S. where bulevirtide is not available or in other regions where its use is limited.
Current report
•The ECLIPSE 3 Phase 2b trial is progressing ahead of schedule with strong enrollment momentum, and topline data are expected in the first quarter of 2027. ECLIPSE 3 evaluates the combination of tobevibart and elebsiran compared to bulevirtide monotherapy in bulevirtide treatment-naïve participants.
Current report
•Following positive data presented at American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2024, we will present Week 48 endpoint results from its SOLSTICE Phase 2 clinical study in patients with CHD at AASLD The Liver Meeting® 2025. The oral presentation will take place on Sunday, November 9.
Current report
•VIR-5500, a PRO-XTEN® dual-masked TCE targeting prostate-specific membrane antigen (PSMA), continues to advance through Phase 1 dose escalation as a monotherapy in heavily pre-treated patients with mCRPC and has demonstrated promising early anti-tumor activity and a favorable safety profile.
Current report
◦We plan to share a comprehensive VIR-5500 data update in late-line patients in the first quarter of 2026
Current report
•VIR-5818, a PRO-XTEN® dual-masked TCE targeting HER2, continues in Phase 1 dose escalation study in combination with pembrolizumab.
Current report
Other Expense, Net
Current report
•lower license, collaborations and contingent consideration expenses due to the expensing of $102.8 million in-process research and development obtained as part of our license agreement with Sanofi in the third quarter of 2024, partially offset by a $75.0 million milestone payment due upon VIR-5525 achieving “first in human dosing” in the third quarter of 2025;
Current report
The decrease in research and development expenses for the nine months ended September 30, 2025 compared to the same period in 2024 was primarily due to:
Current report
Additionally, ourlicense, collaborations and contingent consideration expensesfor the nine months ended September 30, 2025 include a $75.0 million milestone payment due upon VIR-5525 achieving “first in human dosing” and a $30.0 million expense in connection with signing the Restated Alnylam Agreement and milestone payments due upon the enrollment of the first patient in ECLIPSE registrational program for CHD. Ourlicense, collaborations and contingent consideration expensesfor the nine months ended September 30, 2024 include the expensing of $102.8 million in-process research and development obtained as part of our license agreement with Sanofi.
Current report
Other Expense, Net
Removed paragraphs (15)
Previous report
•ECLIPSE registrational program is fully underway following enrollment of the first patients in ECLIPSE 2 and ECLIPSE 3.
Previous report
◦ECLIPSE 3 will compare the combination of tobevibart and elebsiran to bulevirtide monotherapy in participants with CHD who have not received bulevirtide before.
Previous report
•ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies, including agencies in the U.S. and Europe. ECLIPSE 3 is expected to provide important supportive data to help establish access and reimbursement in key markets.
Previous report
◦Our Phase 1 clinical trial of PRO-XTEN™ masked VIR-5818 evaluates the TCE in multiple tumor types, including metastatic breast cancer and metastatic CRC.
Previous report
◦We have completed monotherapy dose escalation and are analyzing the data while continuing to dose escalate VIR-5818 in combination with pembrolizumab.
Previous report
•VIR-5500, the only dual-masked PSMA-targeting TCE in clinical trials, continues to advance through dose escalation.
Previous report
•Early Phase 1 data for VIR-5818 and VIR-5500 reported in January 2025 showed promising safety profiles for both clinical candidates, with maximum tolerated dose not yet reached, no dose-limiting cytokine release syndrome (CRS) observed and no CRS greater than grade 2 reported.
Previous report
•Initial clinical data demonstrate the PRO-XTEN™ masking technology’s potential to minimize systemic toxicity while enabling selective killing of cancer cells in the tumor microenvironment, minimizing CRS and expanding the therapeutic index compared to traditional therapeutic approaches.
Previous report
Chronic Hepatitis B (CHB)
Previous report
•We presented functional cure data from the 24-week follow-up of the MARCH Part B Phase 2 clinical study evaluating combinations of tobevibart and elebsiran, alone, or in combination with pegylated interferon alfa (PEG-IFNα) at the European Association for the Study of the Liver (EASL) Congress 2025 on May 9, 2025. The study-defined primary endpoint, proportion of participants with undetectable hepatitis B surface antigen (HBsAg) at 24 weeks post-end of treatment, was achieved by 17% (3/18) and 21% (3/14) of participants with baseline HBsAg<1,000 IU/mL receiving tobevibart and elebsiran without or with PEG-IFNα, respectively.
Previous report
Other Income (Expense), Net
Previous report
•higher license, collaborations and contingent consideration expenses related to the increase in fair value of contingent consideration obligation for the potential future milestone payments in connection with our CHD program.
Previous report
The increase in research and development expenses for the six months ended June 30, 2025 compared to the same period in 2024 was primarily due to:
Previous report
•higher license, collaborations and contingent consideration expenses related to a $30.0 million expense in connection with signing the Restated Alnylam Agreement and milestone payments due upon the enrollment of the first patient in ECLIPSE registrational program for CHD and, to lesser extent, the increase in fair value of contingent consideration obligation for the potential future milestone payments in connection with our CHD program. As part of the Restated Alnylam Agreement, Alnylam had elected to not opt-in to the profit-sharing arrangement for elebsiran, resulting in a milestone and royalty-based structure rather than a profit-sharing model. We are solely responsible for the development, manufacturing, and commercialization activities associated with elebsiran;
Previous report
Other Income (Expense), Net
Reworded paragraphs (31)
Previous wording
◦ECLIPSE 2 will compare the combination of tobevibart and elebsiran to continued bulevirtide monotherapy in participants with CHD who have not achieved undetectable hepatitis delta virus RNA despite bulevirtide treatment.
Current wording
•The ECLIPSE 2 Phase 3 trial continues enrolling well, and topline data are expected in the first quarter of 2027. ECLIPSE 2 evaluates the switch to the combination of tobevibart and elebsiran in participants who have not achieved undetectable hepatitis delta virus RNA with bulevirtide treatment.
Previous wording
◦We received Investigational New Drug clearance from the U.S. Food and Drug Administration (FDA) to evaluate VIR-5500 in combination with androgen receptor pathway inhibitors for earlier lines of metastatic castration-resistant prostate cancer treatment, unlocking new opportunities to transform patient lives.
Current wording
◦First patient dosed in Phase 1 clinical study of VIR-5500 in combination with androgen receptor pathway inhibitors (ARPIs) in first-line mCRPC.
Previous wording
◦VIR-5818 is the only dual-masked HER2-targeting TCE in clinical development.
Current wording
◦VIR-5818 is the only dual-masked HER2-targeting TCE in clinical development and is being evaluated in multiple tumor types, including metastatic colorectal cancer (CRC).
Previous wording
•First patient dosed in the Phase 1 clinical study of VIR-5525, our investigational PRO-XTEN™ dual-masked T-cell engager (TCE) targeting EGFR.
Current wording
•VIR-5525, a PRO-XTEN® dual-masked TCE targeting EGFR, continues enrollment in the Phase 1 trial as expected.
Previous wording
◦VIR-5525 will be evaluated for the treatment of a variety of EGFR-expressing solid tumors in areas of high unmet need such as non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), and cutaneous squamous cell carcinoma (cSCC).
Current wording
◦VIR-5525 leverages learnings from VIR-5500 and VIR-5818 and is being evaluated in a variety of EGFR-expressing solid tumors in areas of high unmet need, such as non-small cell lung cancer (NSCLC), CRC, head and neck squamous cell carcinoma (HNSCC) and cutaneous squamous cell carcinoma (cSCC).
Previous wording
•Leveraging our immune system expertise and platform strengths, we continue to progress multiple undisclosed PRO-XTEN™ dual-masked TCEs against clinically validated targets with potential applications across a number of solid tumors. These preclinical candidates integrate the PRO-XTEN™ masking technology with novel TCEs discovered and engineered using our antibody discovery platform and our proprietary dAIsY™ (data AI structure and antibody) AI engine.
Current wording
•Harnessing our deep immune system expertise combined with our discovery and engineering platform, and proprietary dAIsY™ (data AI structure and antibody) AI engine, we continue to advance multiple undisclosed PRO-XTEN® masked TCEs directed toward validated targets with potential application across a number of solid tumors.
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 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
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.
Previous wording
•expenses incurred under agreements with third-party contract manufacturing organizations, contract research organizations (CROs), and consultants;
Current wording
•expenses incurred under agreements with third-party contract development and manufacturing organizations (CDMO), contract research organizations (CROs), and consultants;
Previous wording
Other income (expense), net consists of gains and losses from foreign currency transactions and investment management expenses.
Current wording
Other expense, net consists of gains and losses from foreign currency transactions and investment management expenses.
Previous wording
Comparison of the Three and Six Months Ended June 30, 2025 and 2024
Current wording
Comparison of the Three and Nine Months Ended September 30, 2025 and 2024
Previous wording
The change in collaboration revenue for the three and six months ended June 30, 2025 compared to the same periods in 2024 was nominal.
Current wording
The change in collaboration revenue for the three and nine months ended September 30, 2025 compared to the same periods in 2024 was nominal.
Previous wording
The increase in contract revenue for the three months ended June 30, 2025 compared to the same period in 2024 was nominal. The decrease in contract revenue for the six months ended June 30, 2025 compared to the same period in 2024 was primarily due to $51.7 million of deferred revenue recognized during the first quarter of 2024 when GSK’s rights to select up to two additional non-influenza target pathogens expired on March 25, 2024.
Current wording
The decrease in contract revenue for the three months ended September 30, 2025 compared to the same period in 2024 was nominal. The decrease in contract revenue for the nine months ended September 30, 2025 compared to the same period in 2024 was primarily due to $51.7 million of deferred revenue recognized during the first quarter of 2024 when GSK’s rights to select up to two additional non-influenza target pathogens expired on March 25, 2024.
Previous wording
The decrease in grant revenue for the three and six months ended June 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 during the first half of 2025. We terminated our agreement with BARDA on December 31, 2024.
Current 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.
Previous wording
The decrease in cost of revenue for the three and six months ended June 30, 2025 compared to the same periods in 2024 was nominal.
Current wording
The decrease in cost of revenue for the three and nine months ended September 30, 2025 compared to the same periods in 2024 was nominal.
Previous wording
•lower other R&D expenses related to de-prioritized R&D programs and other ongoing cost savings; and
Current wording
•lower other R&D expenses related to de-prioritized research and development programs and other ongoing cost savings;
Previous wording
•higher clinical cost due to the initiation of our ECLIPSE registrational program and progression of our oncology programs; and
Current wording
•higher clinical cost due to the initiation of our ECLIPSE registrational program and progression of our oncology programs.
Previous wording
•lower other R&D expenses related to de-prioritized R&D programs and other ongoing cost savings;
Current wording
•lower other R&D expenses related to de-prioritized research and development programs and other ongoing cost savings;
Previous wording
The decrease in selling, general and administrative expenses for the three and six months ended June 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 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.
Previous wording
The decrease in restructuring, long-lived assets impairment and related charges for the three and six months ended June 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 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.
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 six months ended June 30, 2025, we recognized an unrealized loss of $3.4 million and unrealized gain of $3.0 million due to the change in fair value, respectively, compared to an unrealized gain of $0.4 million and unrealized loss of $5.5 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 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.
Previous wording
The decrease in interest income for the three and six months ended June 30, 2025 compared to the same periods in 2024 was primarily due to lower balances of cash, cash equivalents, and investments.
Current 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.
Previous wording
The change in other income (expense), net for the three and six months ended June 30, 2025 compared to the same periods in 2024 was nominal.
Current 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.
Previous wording
The provision for income taxes for the three and six months ended June 30, 2025 was nominal. The benefit for income taxes for the three and six months ended June 30, 2024 was primarily due to favorable adjustments in estimated tax payable.
Current 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.
Previous wording
On July 4, 2025, the One Big Beautiful Bill Act (OBBBA) was signed into law by President Trump, which includes permanent extensions of most expiring Tax Cuts and Jobs Act provisions and changes to international tax provisions. We are evaluating the potential impacts of the OBBBA.
Current wording
On July 4, 2025, the One Big Beautiful Bill Act (OBBBA) was signed into law by President Trump, which includes permanent extensions of most expiring Tax Cuts and Jobs Act provisions and changes to international tax provisions. The application of the OBBBA did not have a material impact on our financial statements during the three months ended September 30, 2025.
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 June 30, 2025, we had $892.1 million in cash, cash equivalents, and investments and $95.2 million in restricted cash and cash equivalents, which included the $75.0 million 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. As of June 30, 2025, our accumulated deficit was $991.7 million. 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 June 30, 2025, no shares have been issued under the Sales Agreement.
Current 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.
Previous wording
In December 2024, the FDA revoked 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 June 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
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.
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 June 30, 2025, we expect to make total lease payments of approximately $128.4 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 September 30, 2025, we expect to make total lease payments of approximately $125.0 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 six months ended June 30, 2025 increased compared to the same period in 2024 primarily due to milestone payments related to the enrollment of the first patient in ECLIPSE registrational program for CHD and overall higher payments for clinical costs associated with CHD and oncology programs, partially offset by ongoing cost saving realized through headcount reductions, the closing of our St. Louis, Missouri and Portland, Oregon sites and de-prioritized R&D 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 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.
Previous wording
Cash provided by investing activities during the six months ended June 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 six months ended June 30, 2025 was primarily related to $553.2 million in proceeds received from investments that matured or sold, partially offset by purchases of investments of $366.1 million. Cash provided by investing activities during six months ended June 30, 2024 was primarily due to $1.1 billion in proceeds received from investments that matured or sold, partially offset by purchases of investments of $834.3 million.
Current 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.
Previous wording
The change in cash provided by financing activities during the six months ended June 30, 2025 compared to the same period in 2024 was nominal.
Current 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.
Previous wording
There have been no significant changes in our critical accounting policies during the six months ended June 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 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.