Vir Biotechnology reported a net loss of $96.25 million

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For the quarterly period ended June September 30, 2026

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As of July 29, October 28, 2026, the registrant had 169,215,958 171,270,773 shares of common stock, $0.0001 par value per share, outstanding.

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Financial Statements (unaudited) 5 changes

Condensed Consolidated Balance Sheets as of June 3 0 , Se ptember 30, 2026 and December 31, 2025 (unaudited)

Condensed Consolidated Statements of Operations for the Three and Six Nine Months Ended June 3 0 , September 30, 2026 and 2025 (unaudited)

Condensed Consolidated Statements of Comprehensive Income Loss for the Three and Six Nine Months Ended June September 30, 2026 and 2025 (unaudited)

Condensed Consolidated Statements of Stockholders' Equity for the Three and Six N ine Months Ended Ju ne 3 0 , September 30, 2026 and 2025 (unaudited)

Condensed Consolidated Statements of Cash Flows for the Six Nine Months Ended June 3 0 , September 30, 2026 and 2025 (unaudited)

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Financial statements 234 changes

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Equity investments 4,133 6,077

Cash and cash equivalents $ 278,729 218,866 $ 232,185

Short-term investments 249,864 235,769 228,753

Restricted cash and cash equivalents, current 1,929 1,933 1,922

Equity investments 3,722 6,077

Prepaid expenses and other current assets 39,084 47,983 45,143

Total current assets 573,739 508,273 514,080

Intangible assets, net 7,702 7,628 7,850

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Other assets 24,647 24,699

Property and equipment, net 50,430 47,769 55,620

Operating right-of-use assets 59,391 57,993 62,099

Restricted cash and cash equivalents, noncurrent 6,944 6,915 6,963

Long-term investments 475,016 442,932 314,575

Other assets 23,408 24,699

TOTAL ASSETS $ 1,214,806 1,111,855 $ 1,002,823

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Accounts payable $ 17,754 $ 9,803

TOTAL LIABILITIES 232,313 237,547

Accounts payable $ 11,324 $ 9,803

Accrued and other liabilities 77,207 69,335 83,012

Total current liabilities 94,961 80,659 92,815

Operating lease liabilities, noncurrent 84,137 81,459 89,054

Contingent consideration obligation, noncurrent 34,340 32,980 34,100

Other long-term liabilities 18,875 20,721 21,578

TOTAL LIABILITIES 215,819 237,547

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Preferred stock, $ 0.0001 par value; 10,000,000 shares authorized as of June September 30, 2026 and December 31, 2025; no shares issued and outstanding as of June September 30, 2026 and December 31, 2025

Common stock, $ 0.0001 par value; 300,000,000 shares authorized as of June September 30, 2026 and December 31, 2025; 169,185,671 169,414,129 and 139,474,954 shares issued and outstanding as of June September 30, 2026 and December 31, 2025, respectively

Additional paid-in capital 2,230,464 2,242,553 1,965,090

Accumulated other comprehensive loss ( 4,602 6,896 ) ( 2,057 )

Accumulated deficit ( 1,243,386 1,339,638 ) ( 1,197,771 )

TOTAL STOCKHOLDERS' EQUITY 982,493 896,036 765,276

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 1,214,806 1,111,855 $ 1,002,823

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June 30, Six Months Ended

License and collaboration revenue $ 238,935 $ ( 495 ) $ 238,894 $ ( 565 )

Grant revenue 11 183 23 1,421

Total revenues 238,946 1,214 238,917 4,246

Research and development 135,283 97,509 244,205 216,154

Selling, general and administrative 30,196 22,283 53,535 46,227

Total operating expenses 165,479 119,631 297,740 262,210

Income (loss) from operations 73,467 ( 118,417 ) ( 58,823 ) ( 257,964 )

Change in fair value of equity investments ( 1,723 ) ( 3,382 ) ( 1,893 ) 3,000

Interest income 8,966 10,785 16,155 23,073

Other (expense) income, net ( 451 ) 226 ( 705 ) 154

Total other income 6,792 7,629 13,557 26,227

Income (loss) before provision for income taxes 80,259 ( 110,788 ) ( 45,266 ) ( 231,737 )

Provision for income taxes ( 179 ) ( 170 ) ( 349 ) ( 186 )

Net income (loss) $ 80,080 $ ( 110,958 ) $ ( 45,615 ) $ ( 231,923 )

Net income (loss) per share, basic $ 0.48 $ ( 0.80 ) $ ( 0.29 ) $ ( 1.68 )

Net income (loss) per share, diluted $ 0.47 $ ( 0.80 ) $ ( 0.29 ) $ ( 1.68 )

Weighted-average shares outstanding, basic 167,719,015 138,447,469 157,613,578 137,960,888

Weighted-average shares outstanding, diluted 168,879,127 138,447,469 157,613,578 137,960,888

September 30, Nine Months Ended

License and collaboration revenue $ ( 200 ) $ ( 65 ) $ 238,694 $ ( 630 )

Grant revenue 12 305 35 1,726

Other revenue — 1,526 — — 3,390

Total revenues ( 188 ) 240 238,729 4,486

Cost of revenue — 11 ( 11 ) — —

Research and development 80,040 151,463 324,245 367,617

Selling, general and administrative 24,430 22,231 77,965 68,458

Restructuring, long-lived assets impairment and related charges, net — — 172 ) — ( 182 )

Total operating expenses 104,470 173,683 402,210 435,893

Loss from operations ( 104,658 ) ( 173,443 ) ( 163,481 ) ( 431,407 )

Change in fair value of equity investments ( 409 ) 1,335 ( 2,302 ) 4,335

Interest income 9,323 9,363 25,478 32,436

Other expense, net ( 651 ) ( 228 ) ( 1,356 ) ( 74 )

Total other income 8,263 10,470 21,820 36,697

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 )

Net loss $ ( 96,252 ) $ ( 163,141 ) $ ( 141,867 ) $ ( 395,064 )

Net loss per share, basic and diluted $ ( 0.57 ) $ ( 1.17 ) $ ( 0.88 ) $ ( 2.86 )

Weighted-average shares outstanding, basic and diluted 169,275,049 138,930,173 161,555,686 138,287,533

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June 30, Six Months Ended

Net income (loss) $ 80,080 $ ( 110,958 ) $ ( 45,615 ) $ ( 231,923 )

Unrealized loss on investments ( 1,155 ) ( 295 ) ( 2,617 ) ( 598 )

Pension actuarial gain 36 49 72 94

Total other comprehensive loss ( 1,119 ) ( 246 ) ( 2,545 ) ( 504 )

Comprehensive income (loss) $ 78,961 $ ( 111,204 ) $ ( 48,160 ) $ ( 232,427 )

Condensed Consolidated Statements of Comprehensive Income Loss

September 30, Nine Months Ended

Net loss $ ( 96,252 ) $ ( 163,141 ) $ ( 141,867 ) $ ( 395,064 )

Other comprehensive (loss) income:

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and 154 more changes in the filing

Legal proceedings 80 changes

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June 30, Six Months Ended

September 30, Nine Months Ended

Expected term of options (in years) 5.5 - 6.1

Expected stock price volatility 81.7 81.3 % - 85.3 81.4 %

Risk-free interest rate 4.0 %- 4.4 % - 4.9 %

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June 30, Six Months Ended

Research and development $ 5,493 $ 6,946 $ 11,515 $ 13,951

Selling, general and administrative 6,898 5,505 12,963 12,559

Total stock-based compensation $ 12,391 $ 12,451 $ 24,478 $ 26,510

June 30, Six Months Ended

Net income (loss) $ 80,080 $ ( 110,958 ) $ ( 45,615 ) $ ( 231,923 )

Weighted-average shares outstanding, basic 167,719,015 138,447,469 157,613,578 137,960,888

Weighted-average effect of dilutive securities:

Options to purchase common stock 180,888 — — —

Restricted shares subject to future vesting 912,543 — — —

Shares to purchase under Employee Stock Purchase Plan 66,681 — — —

Weighted-average shares outstanding, diluted 168,879,127 138,447,469 157,613,578 137,960,888

Net income (loss) per share, basic $ 0.48 $ ( 0.80 ) $ ( 0.29 ) $ ( 1.68 )

Net income (loss) per share, diluted $ 0.47 $ ( 0.80 ) $ ( 0.29 ) $ ( 1.68 )

June 30, Six Months Ended

Options issued and outstanding 9,941,060 10,017,308 10,336,678 10,017,308

Restricted shares subject to future vesting 432,275 6,281,058 7,058,395 6,281,058

Total 10,373,335 16,298,366 17,395,073 16,298,366

September 30, Nine Months Ended

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

9. Net Income Loss Per Share

Basic net income loss per common share is computed by dividing the net income loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net income loss per common share is computed by dividing the net income loss by the sum of the weighted-average number of common shares outstanding during the period plus any and potential dilutive effects of common stock equivalents outstanding during the period calculated 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 securities stock equivalents outstanding would have been anti-dilutive.

The following is a calculation of the basic and diluted net income loss per share (in thousands, except share and per share data):

September 30, Nine Months Ended

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 income loss per common share in the future that were not included in the computation of diluted net income 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

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

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June 30, Six Months Ended

Income (loss) before provision for income taxes $ 80,259 $ ( 110,788 ) $ ( 45,266 ) $ ( 231,737 )

Provision for income taxes $ ( 179 ) $ ( 170 ) $ ( 349 ) $ ( 186 )

The table below presents our income loss before benefit from (provision for) income taxes, benefit from (provision for) income taxes and effective tax rate for the three and six nine months ended June September 30, 2026 and 2025 (in thousands):

September 30, Nine Months Ended

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 0.2 0.1 % ( 0.2 0.1 %) ( 0.8 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/loss, 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 $ 18.4 19.0 million and $ 17.3 million as of June September 30, 2026 and December 31, 2025, respectively, and if recognized, would favorably affect the effective tax rate in future periods.

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June 30, Six Months Ended

Other 11 183 23 1,421

Foreign ( 341 ) 1,031 ( 382 ) 2,825

Total segment and consolidated revenue $ 238,946 $ 1,214 $ 238,917 $ 4,246

The Company manages the business activities on a consolidated basis and operates as one 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 income loss that also is reported on the condensed consolidated statements of operations as consolidated net income loss. The measure of segment assets is reported on the condensed consolidated balance sheet as total consolidated assets. The CODM uses segment net income 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). Our The Company's revenues primarily include license and collaboration revenues recognized under the Company's collaboration agreements with Astellas. Revenue is attributed to geographic areas based on the location of the Company's customers and collaboration counterparties.

September 30, Nine Months Ended

Segment revenues revenue attributed to: 2026 2025 2026 2025

Astellas $ 239,276 — $ — $ 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

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June 30, Six Months Ended

Segment revenue $ 238,946 $ 1,214 $ 238,917 $ 4,246

September 30, Nine Months Ended

Segment revenue $ ( 188 ) $ 240 $ 238,729 $ 4,486

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Cost of revenue — 11 ( 11 ) — —

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Contract manufacturing 23,967 14,063 59,974 23,399

Clinical costs 22,532 20,361 48,666 40,967

Licenses, collaborations and contingent consideration, net 41,211 11,301 38,402 47,892

Contract manufacturing 25,755 9,644 85,729 33,043

Clinical costs 22,785 21,017 71,451 61,984

Licenses, collaborations and contingent consideration, net ( 11,852 ) 76,414 26,550 124,306

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Restructuring, long-lived assets impairment and related charges, net — — 172 ) — ( 182 )

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Segment and consolidated net income (loss) $ 80,080 $ ( 110,958 ) $ ( 45,615 ) $ ( 231,923 )

Segment and consolidated net loss $ ( 96,252 ) $ ( 163,141 ) $ ( 141,867 ) $ ( 395,064 )

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(4) Other segment items include change in fair value of equity investments, interest income, other expense, income, net, and benefit from (provision for) income taxes, all of which were presented on the condensed consolidated statements of operations.

12 . 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.

MD&A 133 changes

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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 PRO-XTEN ® 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.

In HDV, CHD, 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 elebsiran and tobevibart 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 PRO-XTEN ® 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).

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• We completed enrollment in the Phase 3 ECLIPSE 2 trial, and the entire ECLIPSE registrational program is now fully enrolled. ECLIPSE 2 evaluates the efficacy and safety of switching from bulevirtide to elebsiran and tobevibart in people with CHD who have not achieved viral suppression with bulevirtide therapy and is intended support medication transitions as appropriate. These data, along with data from ECLIPSE 1 and 3, will be part of a comprehensive global filing package.

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 March 31, June 30, 2026. 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.

• We will present expanded Phase 2 SOLSTICE results in oral presentations at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting ® 2026 on November 8.

• Topline data from the Phase 3 pivotal ECLIPSE 1 trial are expected in the fourth quarter of 2026.

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• We presented complete Week 96 Phase 2 SOLSTICE data at the European Association for the Study of the Liver (EASL) Congress in May 2026.

◦ In the intent-to-treat (ITT) analysis, the data showed 88% (28/32) of participants treated with the combination of elebsiran and tobevibart achieved undetectable hepatitis delta virus RNA (HDV RNA Target Not Detected, TND) compared to 53% (17/32) of participants on antibody monotherapy.

◦ In the last-observation carried forward analysis, the data showed the combination regimen achieved HDV RNA TND in 97% (31/32) of participants.

◦ The combination regimen continues to be generally well tolerated. Treatment-emergent adverse events were generally mild to moderate and transient, and there were no treatment-related serious adverse events or discontinuations.

• We closed our global strategic collaboration with Astellas US LLC (together with its subsidiaries and affiliates (including its indirect parent, Astellas Pharma Inc.), Astellas) to advance PSMA-targeted, PRO-XTEN® dual-masked T-cell engager (TCE) VIR-5500 for the treatment of prostate cancer. We and Astellas have built a strong operational infrastructure for collaboration and rapidly worked together on Phase 1 trial design to advance the dose-expansion cohorts.

• We initiated additional Phase 1 dose-expansion cohorts evaluating VIR-5500 at Q3W 800/2000/3500 µg/kg step-up dosing. The first patients were dosed in three monotherapy cohorts evaluating VIR-5500 in taxane naïve mCRPC, radioligand therapy naïve mCRPC and radioligand therapy exposed mCRPC, and one combination cohort evaluating VIR-5500 in combination with enzalutamide in early-line mCRPC.

• We anticipate initiating two additional Phase 1 dose-expansion cohorts, including VIR-5500 in combination with docetaxel in early-line mCRPC and VIR-5500 in combination with darolutamide in metastatic hormone-sensitive prostate cancer.

• We anticipate initiating pivotal Phase 3 trials in 2027.

• We expect to report updated dose-escalation data from our Phase 1 trial evaluating VIR-5818, a HER2-targeted PRO-XTEN ® dual-masked TCE, as a monotherapy and in combination with pembrolizumab, in the second half of 2026. The dose-escalation parts of the Phase 1 trial have a basket design, enrolling across multiple tumor types.

• Data from ECLIPSE 1, ECLIPSE 2 and ECLIPSE 3 will be part of a comprehensive global filing package.

• U.S. FDA granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN ® dual-masked TCE, for the treatment of late-line mCRPC.

• VIR-5500 has achieved proof of concept, reinforcing the scientific rationale for advancing the program into late-stage development. We expect multiple pivotal trials to begin in 2027.

• VIR-5500 is currently being evaluated in a Phase 1 trial (NCT05997615) as a monotherapy and combination therapy across six dose-expansion cohorts. Indications include taxane naïve mCRPC, radioligand therapy naïve mCRPC, radioligand therapy exposed mCRPC and metastatic hormone sensitive prostate cancer.

• The Phase 1 trial (NCT05356741) evaluating VIR-5818, a HER2-targeted PRO-XTEN ® dual-masked TCE, safety and pharmacokinetics, with dose-escalation and signal-finding components, has enrolled patients with a variety of HER2-expressing cancers. Following recent feedback from the FDA, we intend to add backfill cohorts in a more homogeneous patient population in the monotherapy arm of the study to determine optimal dose and schedule. This is aligned with the FDA's Project Optimus, an initiative to reform the dose optimization and dose selection paradigm in oncology drug development.

• Dose escalation of VIR-5818 in combination with pembrolizumab, a PD1 inhibitor, is ongoing.

• We expect to present data at a future scientific conference.

• The Phase 1 trial (NCT06960395) of VIR-5525, an EGFR-targeted PRO-XTEN ® dual-masked TCE, continues enrollment as expected, both as a monotherapy and in combination with pembrolizumab. continues enrollment as expected.

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• We are currently progressing a number of PRO-XTEN ® masked TCEs in preclinical studies directed at clinically validated targets with potential applications across a variety of solid tumors.

• On July 20, 2026, Jason O'Byrne, MBA, our Executive Vice President and Chief Financial Officer, informed us that he would be stepping down from his role, effective August 3, 2026. We have initiated a search for his successor. Additionally, on July 23, 2026, our Board of Directors appointed Brent Sabatini, CPA, MBA, our Senior Vice President and Chief Accounting Officer, as our interim "principal financial officer."

• On June 9, 2026, we appointed Timothy Coughlin, CPA to our Board of Directors and as Chair of the Audit Committee.

• On May 25, 2026, we announced that Saira Ramasastry, M.S., M.Phil., a member of our Board of Directors and Chair of our Audit Committee, would be stepping down from her role as a member of our Board of Directors and the Audit Committee.

• On April 16, 2026, we announced that Vicki Sato, Ph.D., the Chair of our Board of Directors, would not stand for reelection at our 2026 Annual Meeting of Stockholders on May 26, 2026. On May 26, 2026, Jeffrey S. Hatfield, MBA assumed the role of Chair of our Board of Directors.

• On April 7, 2026, Mark Eisner, MD, M.P.H., our Executive Vice President and Chief Medical Officer, informed us that he would be stepping down from his role, effective April 24, 2026. We have initiated a search for his successor.

• We announced a collaboration and license agreement with Gilead Sciences, Inc. (Gilead) to discover and engineer three novel PRO-XTEN ® dual-masked TCE development candidates targeting selected solid tumor-associated antigens. Under the agreement, Gilead will have an exclusive license to develop and commercialize the novel TCEs.

◦ In October 2026, we received $90 million in cash consideration, including a $65 million upfront payment and a $25 million equity investment, and are eligible to receive up to $45 million in potential near-term preclinical milestones. We also have the potential to receive up to $1.74 billion in further development, regulatory and commercial milestones, along with tiered royalties on net sales.

• On October 5, 2026, we appointed Aziz Sawaf, MBEE, MBA, CFA, as our Executive Vice President and Chief Financial Officer.

• On October 7, 2026, we appointed David Liu, M.D., Ph.D., as our Executive Vice President and Chief Medical Officer.

• On October 27, 2026, we appointed Suzanne Topalian, M.D., to our Board of Directors and as a member of the Science and Technology Committee.

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We have entered into collaboration, license and grant arrangements with various third parties. For details regarding these and other agreements, see Note 4—Grant Agreements and Note 5—Collaboration and License Agreements to our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, and Note 5—Grant Agreements and Note 6—Collaboration and License Agreements to our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025.

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Grant revenue is comprised of revenue derived from grant agreements with government-sponsored and private organizations.

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Our selling, general and administrative expenses consist primarily of personnel-related expenses for personnel in executive, finance and other administrative functions, facilities and other allocated expenses, other expenses for outside professional services, including legal, audit and accounting services, insurance costs. and change in fair value of certain contingent consideration obligations arising from business acquisitions. Personnel-related expenses consist of salaries, benefits and stock-based compensation. In the long-term as we advance our research and development programs toward potential commercialization, we expect our selling, general, and administrative expenses to increase in absolute dollars to support commercialization activities and related expansion in research and development activities.

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Change in fair value of equity investments consists of the remeasurement of our investment in Brii Biosciences Limited's, or Brii Bio Parent, Parent's, ordinary shares based on the quoted market price at each reporting date.

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Other (Expense) Income, Net

Other expense, income, net consists of gains and losses from foreign currency transactions and investment management expenses.

Benefit from (Provision for) Income Taxes

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

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Comparison of the Three and Six Nine Months Ended June September 30, 2026 and 2025

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June 30, Six Months Ended

September 30, Nine Months Ended

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License and collaboration revenue $ 238,935 $ (495) $ 239,430 $ 238,894 $ (565) $ 239,459

Grant revenue 11 183 (172) 23 1,421 (1,398)

Total revenues 238,946 1,214 237,732 238,917 4,246 234,671

Research and development 135,283 97,509 37,774 244,205 216,154 28,051

Selling, general and administrative 30,196 22,283 7,913 53,535 46,227 7,308

Total operating expenses 165,479 119,631 45,848 297,740 262,210 35,530

Income (loss) from operations 73,467 (118,417) 191,884 (58,823) (257,964) 199,141

Change in fair value of equity investments (1,723) (3,382) 1,659 (1,893) 3,000 (4,893)

Interest income 8,966 10,785 (1,819) 16,155 23,073 (6,918)

Other (expense) income, net (451) 226 (677) (705) 154 (859)

Total other income 6,792 7,629 (837) 13,557 26,227 (12,670)

Income (loss) before provision for income taxes 80,259 (110,788) 191,047 (45,266) (231,737) 186,471

Provision for income taxes (179) (170) (9) (349) (186) (163)

Net income (loss) $ 80,080 $ (110,958) $ 191,038 $ (45,615) $ (231,923) $ 186,308

License and collaboration revenue $ (200) $ (65) $ (135) $ 238,694 $ (630) $ 239,324

Grant revenue 12 305 (293) 35 1,726 (1,691)

Other revenue — 1,526 (1,526) — — — 3,390 (3,390)

Total revenues (188) 240 (428) 238,729 4,486 234,243

Cost of revenue — (11) 11 — 11 (11) — —

Research and development 80,040 151,463 (71,423) 324,245 367,617 (43,372)

Selling, general and administrative 24,430 22,231 2,199 77,965 68,458 9,507

Restructuring, long-lived assets impairment and related charges, net — (172) 172 — — — (182) 182

Total operating expenses 104,470 173,683 (69,213) 402,210 435,893 (33,683)

Loss from operations (104,658) (173,443) 68,785 (163,481) (431,407) 267,926

Change in fair value of equity investments (409) 1,335 (1,744) (2,302) 4,335 (6,637)

Interest income 9,323 9,363 (40) 25,478 32,436 (6,958)

Other expense, net (651) (228) (423) (1,356) (74) (1,282)

Total other income 8,263 10,470 (2,207) 21,820 36,697 (14,877)

Loss before benefit from (provision for) income taxes (96,395) (162,973) 66,578 (141,661) (394,710) 253,049

Benefit from (provision for) income taxes 143 (168) 311 (206) (354) 148

Net loss $ (96,252) $ (163,141) $ 66,889 $ (141,867) $ (395,064) $ 253,197

The increase decrease in license and collaboration revenue for the three months ended September 30, 2026 compared to the same period in 2025 was nominal. The increase in license and six collaboration revenue for the nine months ended June September 30, 2026 compared to the same periods period in 2025 was primarily due to the recognition of $239.3 million in license and collaboration revenue related to the upfront payment received under our collaboration and license agreement with Astellas (Astellas Collaboration Agreement).

The change in grant revenue for three and nine months ended September 30, 2026 compared to the same periods in 2025 was nominal.

There was no other revenue for the three months ended September 30, 2026 and 2025. The decrease in other revenue for the three and six nine months ended June September 30, 2026 compared to the same periods in 2025 was primarily due to lower one-time nonrecurring revenue recognized in the second quarter of 2025 in connection with option-expiration and the sale of clinical supply to Brii Biosciences Limited Brii Bio Parent.

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Three Months Ended June 30, Six Months Ended

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and 53 more changes in the filing

Market risk 3 changes

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We had cash, cash equivalents and restricted cash and cash equivalents of $287.6 $227.7 million as of June September 30, 2026, which primarily consisted of deposits in checking and sweep accounts at financial institutions and money market funds. Excluding equity investment, we also had short-term and long-term investments of $724.9 $678.7 million as of June September 30, 2026. The primary objective of our investment activities is to preserve capital to fund our operations. We also seek to maximize income from our investments without assuming significant risk. Because Our investments are investment portfolio consists primarily short-term in duration and consist of U.S. government treasuries, U.S. government agency bonds and discount notes, and securities issued by institutions with investment-grade credit ratings. These investments generally mature within two years and prior to our expected need for liquidity. Accordingly, we believe that our exposure to interest rate risk is not significant, and one percent movement in market interest rates would not have a significant impact on the total value of our portfolio. We had no debt outstanding as of June September 30, 2026.

The majority of our transactions occur in U.S. dollars. However, we do have certain transactions that are denominated in currencies other than the U.S. dollar. The functional currency of our foreign subsidiaries is the U.S. dollar. Monetary assets and liabilities of our foreign subsidiaries are remeasured into U.S. dollars at period end exchange rates and non-monetary assets and liabilities are remeasured to U.S. dollars using historical exchange rates. Revenue and expenses are translated at average rates throughout the respective periods. As of the date of this Quarterly Report on Form 10-Q, we are exposed to foreign currency risk primarily related to Euro, and Swiss Franc. and Australian dollar. Transaction gains and losses are included in other expense, income, net on the unaudited condensed consolidated statements of operations. We estimated that a 10% increase or decrease in current exchange rates were not material for the three and six nine months ended June September 30, 2026 and 2025.

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We hold ordinary shares of Brii Bio Parent, which we acquired in connection with our collaboration, option and license agreement. These equity securities are measured at fair value with any changes in fair value recognized in our unaudited condensed consolidated statements of operations. The fair value of these equity securities was approximately $4.1 $3.7 million as of June September 30, 2026. Changes in the fair value of these equity securities are impacted by the volatility of the stock market and changes in general economic conditions, among other factors. A hypothetical 10% increase or decrease in the stock price of these equity securities would increase or decrease their fair value as of June September 30, 2026 by approximately $0.4 million.

Controls and procedures 2 changes

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Our management, with the participation and supervision of our Chief Executive Officer and our Chief Accounting Financial Officer has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act)) as of the end of the period covered by this Quarterly Report on Form 10-Q. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on that evaluation, our Chief Executive Officer and our Chief Accounting Financial Officer have concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information was accumulated and communicated to our management, including our Chief Executive Officer and our Chief Accounting Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

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There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during our fiscal quarter ended June September 30, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Risk factors 51 changes

An investment in shares of our common stock involves a high degree of risk. You should carefully consider the following risk factors as well as the other information in this Quarterly Report on Form 10-Q, including our audited unaudited condensed consolidated financial statements and the related notes and "Management's Discussion and Analysis of Financial Condition and Results of Operations," before deciding whether to invest in our common stock. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations or prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this Quarterly Report on Form 10-Q and those we may make from time to time. In such an event, the market price of our common stock could decline, and you may lose all or part of your investment. You should consider all of the risk factors described when evaluating our business.

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• Although the combination certain of elebsiran and tobevibart has our product candidates have received Fast Track and and/or Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), as well as PRIME designation from the EMA and European orphan drug designation, in each case for the treatment of CHD, there can be no assurance that any of our product candidates that receive such designations in the United States or similar designations in any other regulatory jurisdictions will maintain such designations or receive regulatory approval any sooner than other product candidates that do not have such designations, or at all.

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• We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments, including to fund our share of development activities and upon achievement of milestone events, and in certain cases, we have relinquished important rights over the development and commercialization of certain current and future product candidates. We may explore additional strategic collaborations, which may never materialize or may require that we spend significant additional capital or that we relinquish rights to and control over the development and commercialization of our product candidates.

• The deployment of AI in our or our collaborators' efforts to discover, develop and engineer next-generation antibodies or other investigational products or components, could have a material adverse effect on our business, or financial condition or results of operations, and our competitors may be able to utilize such technologies more effectively than we can.

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Although we recorded net income for the years ended December 31, 2022 and 2021 and for the three months ended June 30, 2026, we have otherwise incurred net losses since inception in April 2016. We had net loss of $45.6 $141.9 million and $231.9 $395.1 million for the six nine months ended June September 30, 2026 and 2025 , respectively. As of June September 30, 2026, we had an accumulated deficit of $1.2 $1.3 billion.

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As of June September 30, 2026, we had cash, cash equivalents and investments of approximately $1.01 billion. $901.3 million. Based upon our current operating plans, we believe that this amount will fund our operations for at least the next 12 months. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional financing to fund our long-term operations sooner than planned. In addition, because the design and outcome of our clinical studies are highly uncertain, we cannot reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the development and commercialization of our product candidates, if approved, or any future product candidates that we develop. The dynamic and rapidly evolving nature of our business also makes it difficult to estimate with certainty our future revenue and expenses after any such successful development and commercialization.

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• the timing, progress and results of our ongoing preclinical and clinical studies of our product candidates;

• the scope, timing, progress, results and costs of preclinical development, laboratory testing and clinical studies of other our product candidates and of potential product candidates that we may pursue in the future;

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We are pursuing development of the combination of elebsiran and tobevibart as a treatment for CHD, which includes both our ECLIPSE registrational trial program evaluating the doublet combination and an ongoing Phase 2 SOLSTICE clinical trial evaluating tobevibart as a monotherapy in addition to the doublet combination. Each of these product candidates has demonstrated direct antiviral activity and the potential to stimulate an effective immune response.

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If we are unable to design and execute a clinical trial to support regulatory approval, we will suffer setbacks that could negatively impact our business, financial condition, results of operations and prospects. Moreover, our inability to bring a product to market or a significant delay in the expected approval and related launch date of a new product could have a negative effect on our stock price and related market capitalization, which could result in a significant impairment of goodwill, other intangible assets and long-lived assets. or on our ability to raise capital.

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Although the combination certain of elebsiran and tobevibart has our product candidates have received Fast Track and and/or Breakthrough Therapy designation from the FDA, as well as PRIME designation from the EMA and European orphan drug designation, in each case for the treatment of CHD, there can be no assurance that any of our product candidates that receive such designations in the United States or similar designations in any other regulatory jurisdictions will maintain such designations or receive regulatory approval any sooner than other product candidates that do not have such designations, or at all.

In June 2024 and December 2024, we announced that the FDA granted Fast Track designation and Breakthrough Therapy designation, respectively, for the combination of elebsiran and tobevibart for the treatment of CHD . In addition, the combination received PRIME designation from the EMA and European orphan drug designation in December 2024 for the same indication . Moreover, in October 2026, we announced that the FDA granted Fast Track designation to VIR-5500 for the treatment of late-line mCRPC. We can provide no assurances that the combination of elebsiran and tobevibart, VIR-5500, or any of our other product candidates that receive Fast Track, Breakthrough Therapy, Priority Review or similar designations in the U.S., EU or in any other regulatory jurisdictions will receive regulatory approval any sooner than other product candidates that do not have such designations, or at all. The FDA, EMA or other foreign regulatory authorities may also withdraw or revoke any such designation or elect to treat designated candidates in a manner different from what was originally indicated, if determined that any such product candidates that receive such designations no longer meet the relevant criteria. Failure to realize the potential benefits of any of these designations could materially and adversely affect our business, financial condition, cash flows and results of operations. For additional information, see the sections titled "Part I, Item 1. Business—Government Regulation and Product Approval—Expedited Development and Review Programs" and "Part I, Item 1. Business—Government Regulation and Product Approval—Foreign Regulation" in our Annual Report on Form 10-K for the year ended December 31, 2025.

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A failure or significant delay of a clinical study can occur at any stage. For example, during initial dose escalation, we, the FDA or comparable foreign regulatory authorities have in the past imposed and may in the future impose, restrictions relating to chemistry, manufacturing and control (CMC) standards, and such restrictions could delay or limit our evaluation of a product candidate and its subsequent advancement to late-stage studies. Similarly, consistent with the FDA's Project Optimus initiative, FDA feedback has in the past required, and may in the future require, us to modify our oncology clinical trials to further evaluate dose and schedule. In addition, we, the FDA or comparable foreign regulatory authorities, or any institutional review boards for any planned or ongoing study, could impose a clinical hold on such study, which could halt enrollment and/or require discontinuation for any product candidates under evaluation. Also, the availability of superior or competitive therapies coupled with changing standards of care could limit our ability to perform placebo-controlled studies or require us to enroll a larger number of subjects to address competing treatments. Moreover, preclinical and clinical data are susceptible to varying interpretations and analyses that can result in product candidates failing to obtain marketing approval. Any of these or other unforeseen events could delay or prevent us from receiving marketing approval and ultimately commercializing our product candidates.

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We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments, including to fund our share of development activities and upon achievement of milestone events, and in certain cases, we have relinquished important rights over the development and commercialization of certain current and future product candidates. We may explore additional strategic collaborations, which may never materialize or may require that we spend significant additional capital or that we relinquish rights to and control over the development and commercialization of our product candidates.

We are a party to various strategic collaboration and license agreements that are important to our business and to our current and future product candidates, pursuant to which we license a number of technologies to form our technology platforms and in-license certain product candidates, as well as out-license select product candidates or technologies to other companies for further development and potential commercialization. Certain of these agreements contain obligations that require us to make substantial payments to fund our share of development activities or in the event certain milestone events are achieved with respect to an in-licensed product candidate, or alternatively to relinquish certain rights relating to the development and commercialization of an out-licensed product candidate. In addition, some of our strategic collaborations include target- or program-specific exclusivity provisions that may limit our ability to pursue overlapping preclinical or clinical development programs or enter into collaborations with other partners involving the same or related targets or product candidates.

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• while we have assumed regulatory sponsorship for all current certain in-licensed TCE trial programs, regulatory sponsorship for certain programs has subsequently been transferred from us to our co-development partners or other collaborators, and we may also have in the future, past and may in certain cases expect to, the future rely on licensors to continue serving as regulatory sponsors for clinical trial programs until a complete transition of sponsorship can could be made, or alternatively transfer regulatory sponsorship from us to licensees or other collaborators, and in each case these other companies will execute all appropriate sponsorship responsibilities or delegate such responsibilities and thereby limit our ability to direct those clinical trial programs;

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• our strategic collaborators may select dosages or indications, or design clinical studies, in a way that may be less successful than if we were doing so or in a way that may differ from our strategy, which could negatively impact our development, manufacturing and commercialization of the same or a similar product candidate;

• our strategic collaborators may not pursue further development and commercialization of products resulting from the strategic collaboration arrangement, due to development or may delay or deprioritize such programs based on data readouts, changes in their strategic focus as a result of an acquisition of competitive products or other internal pipeline advancements, availability of funding or other external factors, that diverts resources or creates competing priorities, which could reduce or eliminate our ability to realize the anticipated future value from such collaborations;

• several programs that are or may be the subject of our strategic collaborations are preclinical or in early-stage clinical development and our strategic collaborators may determine that such programs do not meet their internal technical, safety, efficacy or commercial thresholds to justify further development or commercialization, which could limit our ability to realize their anticipated future value;

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• our strategic collaborators may experience financial difficulties;

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• our strategic collaborators may not properly maintain, enforce or defend our intellectual property rights or may use our proprietary information in a manner that could jeopardize or invalidate our proprietary information or expose us to potential litigation, or may allege such claims against us; and

• our strategic collaborators could terminate the arrangement or not exercise their opt-in rights, which may delay the development or increase the cost of developing our product candidates and result in a need for additional capital to pursue further development or commercialization of the applicable product candidates.

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The deployment of AI in our or our collaborators' efforts to discover, develop and engineer next-generation antibodies or other investigational products or components, could have a material adverse effect on our business, or financial condition or results of operations, and our competitors may be able to utilize such technologies more effectively than we can.

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The biopharmaceutical industry is characterized by rapidly advancing technologies, intense competition and an emphasis on proprietary products. We face potential competition from many different sources, including pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private research institutions. Regulatory incentives to develop products for treatment of serious infectious diseases, cancer and other serious conditions may lead to increased competition for clinical investigators and clinical trial subjects, as well as for future prescriptions, if any of our product candidates are successfully developed and approved.

Compared to us, our competitors may have significantly greater financial resources, established presence in the market, and expertise in research and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals, and ultimately marketing and obtaining reimbursement for their approved products. The in-licensing or acquisition of third-party intellectual property rights is a competitive area as well, and more established companies may have greater success in pursuing strategies to in-license or acquire third-party intellectual property rights that we may consider attractive or necessary. These competitors also compete with us in acquiring third-party contract manufacturing capacity and raw materials, recruiting and retaining qualified scientific, sales, marketing and management personnel, establishing clinical trial sites and patient registration for clinical studies, as well as acquiring technologies that are complementary to or necessary for our programs. Smaller or earlier-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. Additional mergers and acquisitions may result in even more resources being concentrated amongst our competitors.

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Even if we obtain regulatory approval in any particular jurisdiction, the applicable regulatory authorities may still impose significant restrictions on the indicated uses, marketing, manufacturing or distribution of our product candidates, or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance. Additionally, the holder of an approved NDA or BLA is required to comply with FDA rules, including as relating to record-keeping, reporting of adverse events and product deviations, periodic reporting, product sampling and distribution, lot release, and advertising and promotion. and The holder of an approved NDA or BLA is also subject to FDA review and periodic inspections, in addition to other potentially applicable federal and state laws, to ensure compliance with current Good Manufacturing Practice (cGMP), current Good Pharmacovigilance Practice (cGPvP) and current Good Distribution Practice (cGDP), as well as adherence to commitments made in the NDA or BLA.

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Failure to comply with such requirements, when and if applicable, could subject us to a number of actions by applicable regulatory authorities ranging from warning or untitled letters to product seizures or significant fines or monetary penalties, among other actions. The FDA and other federal and state government agencies, including the U.S. Department of Justice (DOJ), closely regulate and monitor the marketing and promotion of products in the United States to ensure that they are marketed and distributed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers' communications regarding off-label use, and if we market our medicines for uses other than their respective approved indications, we may be subject to DOJ-led enforcement actions for off-label marketing. Violations of the Federal Food, Drug, and Cosmetic Act and other statutes, including the False Claims Act, relating to the promotion and advertising of prescription drugs may lead to investigations and enforcement actions alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws, which violations may result in the imposition of significant administrative, civil, and criminal and administrative penalties. Any government investigation of alleged violations of laws or regulations could require us to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenue. For additional information regarding regulatory approval and ongoing regulatory oversight, see the section titled "Part I, Item 1. Business—Government Regulation and Product Approval" in our Annual Report on Form 10-K for the year ended December 31, 2025.

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In particular, obtaining should we choose to submit marketing authorization authorizations for our product candidates in the European Union (EU), from the European Commission (EC) following the process could be expensive and time-consuming as it requires a positive opinion of from the EMA if we choose to submit a marketing authorization application there, would be a lengthy and expensive process. ultimately approval from the European Commission (EC). Even if a product candidate receives marketing authorization, the EC and other EU regulatory authorities may limit the indications for which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming additional clinical studies or reporting as conditions of approval. Approval of certain product candidates outside of the United States, particularly those that target diseases that are more prevalent outside of the United States, will be important to the commercial success of such product candidates. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and additional costs for us and could delay or prevent the introduction of our product candidates in certain countries.

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Increased negative public opinion, or more restrictive government regulations in response thereto, would have a negative effect on our business, financial condition, results of operations or prospects, and may delay or impair the development and commercialization of our product candidates or demand for such product candidates. For example, perceived or actual technical, legal, compliance, privacy, security, ethical or other issues relating to the use of AI may cause regulators' or the public's confidence in AI to be undermined, which could impede our ability to develop products using AI. Also, adverse events in and any resulting negative publicity related to our preclinical or clinical studies or those of our competitors or of academic researchers utilizing similar technologies, even if not ultimately attributable to those particular product candidates we may discover and develop, and the resulting publicity could result in:

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Any such outcomes could negatively impact have a material adverse effect on our business, financial condition, results of operations and prospects. Furthermore, although we maintain product liability insurance coverage, such insurance may not be adequate to cover all liabilities that we may incur. We anticipate that we will need to increase our insurance coverage each time we commence a clinical trial and if we successfully commercialize any product candidate in the future. Insurance availability, coverage terms and pricing continue to vary with market conditions. We endeavor to obtain appropriate insurance coverage for insurable operational risks that we identify; however, we may fail to correctly anticipate or quantify insurable operational risks, we may not be able to obtain appropriate insurance coverage and insurers may not respond as we intend to cover insurable events that may occur. Conditions in the insurance markets relating to nearly all areas of traditional corporate insurance change rapidly and may result in higher premium costs, higher policy deductibles and lower coverage limits. For some risks, we may not have insurance coverage at all because of high cost and/or limited availability, and our financial condition could be negatively impacted should such risks come to fruition.

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Even if we are successful in achieving regulatory approval to commercialize any product candidate faster than our competitors, such product candidates may face competition from biosimilar or generic products. For example, in the United States, biologic product candidates are subject to approval and licensure under the BLA pathway, and small molecules, such as our small interfering RNA (siRNA) product candidate, elebsiran, are subject to approval and licensure under the NDA pathway. The Biologics Price Competition and Innovation Act of 2009 creates an abbreviated pathway for the approval of biosimilar and interchangeable biologic products following the approval of an original BLA. The Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act) creates a similar pathway for seeking approval of a generic version of an approved, small molecule innovator drug product. For additional information regarding biosimilars and exclusivity, see the section titled "Part I, Item 1. Business—Government Regulation and Product Approval—Biosimilars and Regulatory Exclusivity" in our Annual Report on Form 10-K for the year ended December 31, 2025.

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Physicians, other healthcare professionals and third-party payors, both in the United States and elsewhere, play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval. Our current and future arrangements with healthcare professionals, principal investigators, patients, consultants, customers and third-party payors subject us to various federal and state fraud and abuse laws and other healthcare laws, such as the U.S. federal Anti-Kickback Statute, civil monetary penalty laws, the False Claims Act (FCA) and other federal and state civil and criminal false claims fraud and abuse laws, and the healthcare fraud provisions of Health Insurance Portability and Accountability Act of 1996, as amended (HIPAA) and the Physician Payments Sunshine Act. These false claims laws and civil monetary penalty laws, among other things, may be enforced through civil whistleblower or qui tam actions and prohibit knowingly presenting, or causing to be presented, false or fraudulent claims for payment of federal government funds, including in federal healthcare programs.

These laws may impact the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute any product candidates, if approved. For additional information regarding these laws, see the section titled " P art I, Item 1. Business—Government Regulation and Product Approval" in our Annual Report on Form 10-K for the year ended December 31, 2025. Ensuring that our internal operations and business arrangements with third parties comply with applicable healthcare laws and regulations will likely continue to be costly. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participating in government-funded healthcare programs (such as Medicare and Medicaid), additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of noncompliance with these laws, contractual damages, reputational harm and the curtailment or restructuring of our operations, any of which could have a material adverse effect on our business, financial condition, results of operations and prospects.

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Should we seek and obtain regulatory approval in the United States, we expect that these and other healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria, and in additional downward pressure on the price that we receive for any approved product, which could have an adverse effect on demand for our product candidates, as well as additional downward pressure on the price for any approved product. Any reduction in reimbursement from Medicare, Medicaid or other government programs may result in a similar reduction in payments from private payors. The implementation of cost-containment measures or other healthcare reforms may prevent us from being able to generate revenue or attain profitability from commercializing our products.

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While we have policies and procedures to address compliance with such applicable laws in the United States and other jurisdictions, we cannot assure you that all of our employees and agents will not take actions in violation of our policies and applicable law, for which we may be ultimately held responsible. Detecting, investigating and resolving actual or alleged violations can be expensive and time-consuming, and could divert resources and management ' s attention from our core business.

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• inability of our CDMOs to execute process development, technology transfers, cGMP manufacturing, manufacturing or testing procedures, manufacturing and other logistical support requirements appropriately or on a timely basis;

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• disruptions caused by geopolitical events, including civil or political unrest, terrorism, insurrection or war (such as the ongoing conflicts in the Middle East and Eastern Europe), as well as man-made or natural disasters, or public health pandemics or epidemics to which our third-party suppliers or CDMOs may be differently exposed than us; and

• carrier disruptions or increased costs that are beyond our control, including increases in materials, labor or other manufacturing-related costs or higher supply chain logistics costs; and

• our inability to meet our supply obligations under applicable agreements with our development or commercial collaboration partners as a result of any failures, limitations or delays that originate from our third-party suppliers and CDMOs.

Suppliers and CDMOs may extend lead times, limit supplies, change manufacturing schedules, increase prices, or require significant upfront fees due to capacity and material supply constraints or other factors beyond our control. For example, the lead time needed to establish a relationship with a new raw material or component supplier or CDMO can be lengthy, and we may experience delays in meeting demand in the event we must switch to a new supplier or CDMO. The time and effort to effect a technology transfer to a new CDMO or to qualify a new supplier or CDMO could result in manufacturing delays, additional costs, diversion of resources or reduced manufacturing capacity or yields, any of which would negatively impact our operating results. Also, due to more limited knowledge of the manufacturing process for a product candidate during development stages, potential product loss and contaminations could lead to batch failures.

Furthermore, Specifically for synthetic siRNAs, we currently rely on a limited number of third-party suppliers and CDMOs that are able to meet our supply requirements. for synthetic siRNAs. Our CDMOs could face risks in meeting our delivery time requirements or provide adequate amounts of synthetic siRNAs to meet our needs, which may include extended lead times, delays or shortages of raw materials and components, synthesis and purification failures and/or contamination during the manufacturing process, or difficulty complying with the applicable manufacturing requirements. To fulfill our siRNA supply requirements, we may need to secure alternative suppliers of synthetic siRNAs or key raw materials and components, and such alternative third-party suppliers are limited and may not be readily available, or we may be unable to enter into agreements with them on reasonable terms and in a timely manner. Further, Furthermore, engaging alternative suppliers would could require filing and additional regulatory filings and approvals.

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We license a number of technologies to form our antibody platform, and we license the PRO-XTEN ® platform from Sanofi and the siRNA technology from Alnylam. We have also developed certain product candidates using intellectual property licensed from third parties or in-licensed certain product candidates from third parties. A core element of our business strategy includes continuing to acquire or in-license additional technologies or product candidates for the treatment and prevention of serious infectious diseases, cancer and other serious conditions. If we fail to meet our obligations under these agreements, our licensors may have the right to terminate our licenses. If any of our license agreements are terminated, and we lose our intellectual property rights under such agreements, this may result in a complete termination of our product development and any commercialization efforts for the product candidates which we are developing under such agreements. While we would expect to exercise all rights and remedies available to us, including seeking to cure any breach by us, and otherwise seek to preserve our rights under such agreements, we may not be able to do so in a timely manner, at an acceptable cost or at all. We may also be subject to risks related to disputes between us and our licensors regarding the intellectual property subject to a license agreement. We could also be subject to expensive litigation which would detract us from our core business of researching and developing product candidates.

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We may not successfully integrate and realize the anticipated benefits from any acquired business. We face many risks in connection with acquisitions and investments, whether or not consummated. A significant portion of the purchase price of companies we acquire may be allocated to acquired goodwill and other intangible assets, which must be assessed for impairment at least annually. If our acquisitions do not yield expected returns, we may in the future be required to take charges to our operating results based on this impairment assessment process, which could adversely affect have a material adverse effect on our business, financial condition, results of operations and prospects.

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Our operations, and those of our CDMOs, clinical trial sites, CROs and other contractors and consultants, could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, public health pandemics or epidemics, geopolitical events, including civil or political unrest in any of our business locations, terrorism, insurrection or war (such as the ongoing conflicts in the Middle East and Eastern Europe), as well as other business interruptions, for which we are predominantly self-insured. Our existing business continuity preparations may not sufficiently mitigate the occurrence of any of these business disruptions, which could have a material adverse impact effect on our operations and financial condition and increase our costs and expenses.

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Our computer and information technology systems, cloud-based computing services and those of our current and any future collaborators, service providers and other parties upon whom we rely can be vulnerable to malware, computer viruses, denial-of-service attacks, ransomware attacks, user error or malfeasance, data corruption, cyber-based attacks, natural disasters, public health pandemics or epidemics, geopolitical events, including civil or political unrest, terrorism, war and telecommunication and electrical failures that can result in damage to or the interruption or impairment of key business processes, or the loss or corruption of our information, including intellectual property, proprietary business information and personal information. We have in the past and may in the future experience server malfunction, software or hardware failures, supply-chain cyber-attacks, loss of data or other computer assets and other similar issues. In addition, we have in the past and may in the future experience security events affecting our information technology systems, such as through business email compromises or other network intrusions, including threats to exfiltrate and disclose proprietary information; however, none of these attacks to date, either individually or in the aggregate, have had a material adverse effect on our business, financial condition, results of operations or prospects. The techniques used to sabotage or to obtain unauthorized access to information systems, and networks in which cyber threat actors store data or through which they transmit data change frequently and we may be unable to implement adequate preventative measures. For example, attackers have used AI threat actors may use artificial intelligence, including increasingly autonomous AI-enabled capabilities, to launch more automated, targeted automate, enhance and coordinated attacks scale cyber-attacks against various targets. us, our third-party service providers and other business partners. Any significant system failure, accident or security breach could have a material adverse effect on our business, financial condition, results of operations and prospects.

We may be required to expend significant resources, fundamentally change our business activities and practices, or modify our operations, including our clinical trial activities, or information technology in an effort to protect against security breaches and to detect, investigate (including performing required forensics), mitigate and remediate actual and potential vulnerabilities. Relevant laws, regulations, industry standards and contractual obligations may require us to implement specific security measures or use industry-standard or otherwise reasonable measures to protect against security breaches. The costs to us to mitigate network security problems, bugs, viruses, worms, malicious software programs, security breaches and security vulnerabilities could be significant, and while we have implemented security measures to protect our data security and information technology systems, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, data loss or corruption, delays, cessation of service and other harm to our business and our competitive position. If the information technology systems of our third-party vendors become subject to disruptions or security breaches, we may have insufficient recourse against such third parties, and we may have to expend significant resources to mitigate the impact of such an event, and to as well as develop and implement protections to prevent the future events occurrence of this nature from occurring. similar events. Although we maintain cybersecurity insurance coverage, such insurance may not be adequate to cover all liabilities that we may incur. Furthermore, if a significant security breach were to occur and cause significant interruptions in our operations, it could result in a disruption of our development programs and our business operations, whether due to a loss of our trade secrets or other proprietary information or other similar disruptions.

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We are exposed to the risk of fraud or other misconduct by our employees, principal investigators, consultants and commercial partners. Misconduct by these parties could include intentional failures, reckless and/or negligent conduct or unauthorized activities that violates violate (i) the laws and regulations of FDA and other regulatory authorities, including those laws requiring the reporting of true, complete and accurate information to such authorities, (ii) manufacturing standards, (iii) federal and state data privacy, security, fraud and abuse, and other healthcare laws and regulations impacting healthcare in the United States and abroad, (iv) laws that require the true, complete and accurate reporting of financial information or data, (v) insider trading laws that restrict the buying and selling of shares of securities while in possession of material non-public information, (vi) federal and state data privacy laws and regulations and (vii) our contractual obligations of Vir Bio or those of such parties. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. Such misconduct also could involve the improper use of individually identifiable information, including, without limitation, information obtained in the course of clinical studies, creating fraudulent data in our preclinical or clinical studies or illegal misappropriation of drug product, which could result in regulatory sanctions and/or cause reputational harm.

It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from government investigations or other actions or lawsuits stemming from a failure to comply with these contractual provisions, laws or regulations. Additionally, we are subject to the risk that a person or government could allege such fraud, violations or other misconduct, even if none occurred. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could result in significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participating in government-funded healthcare programs (such as Medicare and Medicaid), additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of noncompliance with these laws, contractual damages, reputational harm and the curtailment or restructuring of our operations, any of which could have a negative impact material adverse effect on our business, financial condition, results of operations and prospects.

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As of December 31, 2025, we had $1.2 billion and $446.4 million of US federal and state net operating loss (NOL) carryforwards of $1.2 billion for available to offset future federal tax purposes and $446.4 million for state tax purposes. taxable income. If not utilized, federal carryforwards net operating losses generated in tax years beginning after December 31, 2017 may be carried forward indefinitely but utilization is limited to 80% of taxable income generated in the carryforward year. Any net operating losses generated in taxable years prior to December 31, 2017 are not limited in their utilization but will begin expiring to expire in 2036. and Under current state law, the state net operating loss carryforwards will begin expiring to expire in 2037. Our ability to use our federal and state NOLs to offset potential future taxable income is dependent upon our generation of future taxable income before any expiration dates of the NOLs, and we cannot predict with certainty when, or whether, we will generate sufficient taxable income to use all of our NOLs.

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Effective internal control over financial reporting are is necessary for us to provide reliable financial reports and effectively prevent fraud and operate successfully as a public company. Any failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition, results of operations or cash flows. If our internal control over financial reporting is not effective, investors may lose confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities. Failure to remedy any material weakness in our internal control over financial reporting could also restrict our future access to the capital markets.

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Generally accepted accounting principles in the United States are subject to interpretation by the Financial Accounting Standards Board or the SEC, and as well as various bodies formed to promulgate and interpret appropriate accounting principles. A change in these principles or interpretations could have a significant effect on our reported financial results, may retroactively affect previously reported results, could cause unexpected financial reporting fluctuations and may require us to make costly changes to our operational processes and accounting systems.

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Other information 2 changes

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On April 27, 2026, Mark Eisner , M.D., M.P.H., our former Executive Vice President and Chief Medical Officer , terminated a trading arrangement intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (the Eisner Trading Plan). The Eisner Trading Plan was originally adopted on May 19, 2025 for the purpose of selling shares of the Company's common stock, with a duration lasting until December 31, 2026. As of April 27, 2026 , a total of 1,889 shares had been sold pursuant to the Eisner Trading Plan. No further trades will be executed under the Eisner Trading Plan.

On May 26, August 25, 2026 , for estate and financial planning purposes, Vanina de Verneuil, J.D. Brent Sabatini , CPA, MBA, our Executive Senior Vice President General Counsel and Corporate Secretary Chief Accounting Officer , adopted a Rule 10b5-1 trading plan for the sale of our common stock that is intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c) (the de Verneuil Sabatini Trading Plan). The de Verneuil Sabatini Trading Plan provides for sales a sale of RSU and employee stock purchase plan (ESPP) shares pursuant to a market and limit orders, which orders will be in effect from approximately September order on December 1, 2026. to August 31, 2027 . The RSU share sales are intended to generate funds to satisfy Ms. de Verneuil's tax obligations in connection with RSU shares that will vest in 2026 and 2027 pursuant to RSU awards granted to her. The total number of RSU and ESPP shares that will be sold under this arrangement will be less than 2,500 shares. The actual number of shares to be sold is not currently determinable as the number it will vary be based on the extent to which vesting conditions are satisfied, the number of ESPP shares purchased in the future, the Company's stock price, and the number of RSU shares that are sold upon vesting pursuant to the mandatory sell to cover tax withholding arrangements included in her applicable RSU agreements. by Mr. Sabatini on November 30, 2026. Under the Company's 10b5-1 plan guidelines, Ms. de Verneuil Mr. Sabatini is prohibited from selling more than 50,000 shares in a single trading day. The de Verneuil Sabatini Trading Plan will expire upon the earlier of (i) on December 1, 2026 , the date that all sales contemplated by the de Verneuil Sabatini Trading Plan have been will be executed. or (ii) August 31, 2027.

Exhibits 11 changes

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Second Amendment to the License Agreement between the Company and Amunix Pharmaceuticals, Inc., dated June 24, 2026

Offer Letter between the Company and Aziz Sawa f , dated September 1 , 202 6

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† Certain portions of this exhibit (indicated by [***]) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.

+ Indicates a management contract or compensatory plan or arrangement.

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Date: August 5, 2026

Date: November 4, 2026

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Date: August 5, 2026

Brent Sabatini, CPA, MBA

Date: November 4, 2026

Aziz Sawaf, MBEE, MBA, CFA

Senior Executive Vice President and Chief Accounting Financial Officer

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