What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-02-23 compared with 2025-02-27 · 115 added, 124 removed, 189 unchanged (56% of the section changed)

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You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our audited consolidated financial statements and the related notes and other financial information included elsewhere in this Annual Report on Form 10-K.

Unless the context requires otherwise, references in this Annual Report on Form 10-K to the “Company”, “VirBio,” “we,” “our” and “us” refer to Vir Biotechnology, Inc.

Unless the context requires otherwise, references in this Annual Report on Form 10-K to the “Company”, “Vir Bio,” “we,” “our” and “us” refer to Vir Biotechnology, Inc.

and its consolidated subsidiaries.

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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, we have a bold vision – powering the immune system to transform lives.

Our clinical-stage portfolio includes infectious disease programs for CHD and CHB infections and multiple dual-masked TCEs across validated targets in solid tumor indications.

We also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.

Our clinical development pipeline consists of investigational therapies targeting HDV and various solid tumors.

In hepatitis delta, our phase 3 ECLIPSE registrational program evaluating the combination of tobevibart and elebsiran is scheduled to commence in the first half of 2025.

At Vir Bio, we have a bold vision – powering the immune system to transform lives.

Our clinical-stage portfolio includes programs for CHD and multiple PRO-XTEN ® dual-masked TCEs across validated targets in solid tumor indications.

We also have a portfolio of preclinical programs across a range of infectious diseases and oncologic malignancies.

In HDV, our ECLIPSE registrational program is fully underway with all three trials initiated.

Should the ECLIPSE program yield positive results that support regulatory approval and subsequent commercial launch, we believe the combination has the potential to be a new standard of care for hepatitis delta patients, for whom approved treatment options are either limited or unavailable.

In oncology, we are advancing phase 1 clinical studies for our dual-masked TCEs:

VIR-5818 in patients with HER2-expressing tumors and VIR-5500 in patients with PSMA-expressing mCRPC.

We are also advancing our third TCE program,VIR-5525, in patients with EGFR-expressing tumors, with phase 1 clinical studies expected to begin in the first half of 2025.

We are also developing therapeutic candidates in hepatitis B, HIV cure, and other solid tumors, leveraging our expertise and platform strengths.

We have an industry-leading management team and board of directors with significant immunology and infectious diseases and oncology experience, including a proven track record of progressing product candidates from early-stage research through clinical development, and worldwide regulatory approval and commercialization experience.

VIR-5500 in patients with PSMA-expressing mCRPC and VIR-5818 in patients with HER2-expressing tumors.

We are also advancing our third TCE program, VIR-5525, in patients with EGFR-expressing tumors, with the first patient dosed in phase 1 clinical studies in July 2025.

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 ADCs along with our next generation COVID mAbs.

We have an industry-leading management team and board of directors with significant immunology, infectious diseases, and oncology experience, including a proven track record of progressing product candidates from early-stage research through clinical development, and worldwide regulatory approval and commercialization experience.

Given the global impact of infectious diseases and cancer, we are committed to developing transformative therapies that can make a meaningful difference in patients’ lives.

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Pipeline Programs

Chronic Hepatitis Delta (CHD)

• ECLIPSE Phase 3 registrational clinical program in CHD is advancing with the first patient in expected during the first half of 2025.

• Positive data from the SOLSTICE Phase 2 clinical trial were presented in at the AASLD The Liver Meeting ® in November 2024.

This data demonstrated the potential of the first-of-its-kind investigational combination to address a critical unmet need in CHD, showing rapid and sustained virologic suppression, using the most stringent measure of zero detectable hepatitis delta RNA in the blood or target not detected (TND defined as HDV RNA < 0 IU/mL), and no treatment-related SAEs.

• Tobevibart and elebsiran combination therapy has received multiple regulatory designations potentially supporting an expedited development and review process and recognizing the significant unmet need in CHD:

FDA Breakthrough Therapy designation, U.S.

FDA Fast Track designation, European PRIME designation and European Orphan Drug designation.

• In January 2025, we presented encouraging early safety and efficacy data in ongoing Phase 1 dose escalation trials for its dual-masked TCE programs.

◦ VIR-5818, the only dual-masked HER2-targeting TCE in clinical trials, showed tumor shrinkage across various tumor types in 50% (10/20) of participants receiving doses ≥400 µg/kg, with cPRs in 33% (2/6) of participants with HER2-positive CRC.

◦ VIR-5500, the only dual-masked PSMA-targeting TCE in clinical trials, showed PSA declines in 100% (12/12) of mCRPC patients after an initial dose ≥120 µg/kg.

PSA 50 response was confirmed in 58% (7/12) of participants.

◦ Both clinical candidates have shown promising safety profiles, with MTD not yet reached, no dose-limiting CRS observed and no CRS greater than grade 2.

• Initial clinical data demonstrate 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.

• We are advancing VIR-5818 and VIR-5500 through ongoing Phase 1 dose escalation studies, aiming to further optimize dosing and efficacy.

Additionally, we plan to initiate a Phase 1 study of VIR-5525, a dual-masked EGFR-targeting TCE, in the first quarter of 2025, evaluating its potential across a number of solid tumor indications.

Chronic Hepatitis B (CHB)

• We anticipate functional cure data from the 24-week follow-up of the MARCH Part B Phase 2 study in the second quarter of 2025.

• Positive end-of-treatment results of the MARCH Part B Phase 2 trial evaluating tobevibart and elebsiran in combination with PEG-IFNα or tobevibart and elebsiran alone were presented at AASLD The Liver Meeting ® in November 2024.

The data demonstrated compelling HBsAg loss and anti-HBs development at the end of treatment.

• Future advancement in CHB by us will be contingent on securing a worldwide development and commercialization partner outside of the China Territory to best enable further development in this area of high unmet need.

• To support global commercialization of the combination of tobevibart and elebsiran for the treatment of CHD, the Company granted Norgine an exclusive commercial license in Europe, Australia and New Zealand.

• Phase 2 SOLSTICE data presented at the 44ᵗʰ Annual J.P.

Morgan Healthcare Conference in January 2026 showed the combination of tobevibart and elebsiran is well tolerated and achieved undetectable hepatitis delta virus RNA (HDV RNA TND) in 88% (21/24) of CHD participants evaluable at 96 Weeks of treatment.

Previous positive Phase 2 SOLSTICE data at Week 48 were presented at the AASLD The Liver Meeting ® 2025 and simultaneously published in the New England Journal of Medicine.

3 Asselah T, Chattergoon MA, Jucov A, et al.

“A Phase 2 Trial of Tobevibart plus Elebsiran in Hepatitis D” N Engl J Med .

4 (2026), 343-353, doi:10.1056/NEJMoa2508827.

• The ECLIPSE 1 and ECLIPSE 3 Phase 3 trials have completed enrollment.

The ECLIPSE 2 Phase 3 trial continues enrolling well.

Topline data from the ECLIPSE 1 trial are expected in the fourth quarter of 2026.

Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027.

• Tobevibart and elebsiran combination therapy is supported by multiple U.S.

and EU regulatory designations, including FDA Breakthrough Therapy designation, U.S.

FDA Fast Track designation, European PRIME designation and European Orphan Drug designation, signifying the significant unmet need in CHD.

• 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.

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.

ECLIPSE 3 evaluates the combination of tobevibart and elebsiran compared to bulevirtide monotherapy in bulevirtide treatment-naïve participants.

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.

ECLIPSE 3 is expected to provide important supportive data to help establish access and reimbursement in key markets.

• On February 19, 2026, we executed a global strategic collaboration with Astellas to advance PSMA-targeted PRO-XTEN ® dual-masked TCE VIR-5500, currently in development for metastatic castration-resistant prostate cancer.

Upon closing of the transaction, the parties will co-develop and co-commercialize VIR-5500.

We will have the option to co-promote with Astellas in the U.S., and Astellas will obtain exclusive rights to commercialize outside the U.S.

Under the terms of the agreement, we will receive $335 million in upfront and near-term milestone payments, including $240 million in cash, $75 million in equity investment at a 50% premium, and a $20 million near-term milestone upon completion of manufacturing process technology transfer, anticipated in mid-2027.

Global development costs for VIR-5500 will be shared between Astellas and Vir Biotechnology with a 60:40 split.

Profits and losses will be shared equally in the U.S, and outside the U.S.

we are entitled to receive tiered, double-digit royalties on net sales.

In addition, we are eligible to receive up to $1.37 billion in additional development, regulatory and ex-U.S.

sales milestones.

Under the terms of our licensing agreement with Sanofi, we will share with Sanofi 20% of certain future collaboration proceeds from the Astellas collaboration agreement, including the upfront payment, equity premium and the portion of milestones, profit-share and royalties that exceed amounts already owed to Sanofi.

The closing of the transaction is subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

• Positive updated Phase 1 data for VIR-5500 monotherapy shows dose-dependent anti-tumor activity and a well-tolerated safety profile to date in patients with mCRPC.

The data will be shared in an oral presentation at the 2026 ASCO Genitourinary Cancers Symposium on February 26 (Oral Abstract #17).

The oral presentation will be delivered by Dr.

Johann de Bono, Principal Investigator and Director of the Drug Development Unit and Head of Prostate Cancer Targeted Therapy Group at the Institute of Cancer Research.

• Phase 1 monotherapy dose-escalation of weekly and once every three weeks dosing of VIR-5500 is complete, and we have defined a preliminary go-forward dose and regimen recommendation for expansion.

In parallel, dose-escalation of VIR-5500 in combination with enzalutamide continues in early line mCRPC patients.

• We anticipate initiating monotherapy dose-expansion cohorts in late-line mCRPC and combination dose-expansion cohorts in both early-line mCRPC and metastatic hormone-sensitive prostate cancer (mHSPC) in the second quarter of 2026, followed by pivotal, Phase 3 trials in 2027.

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

VIR-5818 is the only dual-masked HER2-targeting TCE in clinical development and is being evaluated in multiple tumor types, including CRC.

• The Phase 1 study of VIR-5525, an EGFR-targeted PRO-XTEN ® dual-masked TCE, continues enrollment as expected.

VIR-5525 is being evaluated in a variety of EGFR-expressing solid tumors in areas of high unmet need, such as NSCLC, CRC, HNSCC and cSCC.

Preclinical Pipeline Candidates

• We are advancing multiple undisclosed dual-masked TCEs targeting clinically validated targets with potential applications across a variety of solid tumors.

These preclinical candidates leverage the PRO-XTEN ™ masking technology with novel TCEs discovered and engineered using our antibody discovery platform and our proprietary dAIsY™ AI engine.

• We will continue to advance our HIV broadly neutralizing antibody program for HIV cure in collaboration with the Gates Foundation.

• 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, including lung, colorectal and bladder.

These preclinical candidates integrate the PRO-XTEN ® masking technology with novel TCEs discovered and engineered using our antibody discovery platform and our proprietary dAIsY™ AI engine.

• We have advanced a broadly neutralizing antibody to development candidate status in our HIV cure program in collaboration with the Gates Foundation.

Corporate Update

• In January 2025, we announced Maninder Hora, Ph.D.

will assume the role of Executive Vice President, Chief Technical Operations in February 2025, on departure of our current Chief Technology Officer, Aine Hanley, Ph.D.

• In September 2024, we announced the appointment of Jason O’Byrne as Executive Vice President and Chief Financial Officer, effective October 2, 2024.

• In August 2024 we announced an exclusive worldwide license to use of the proprietary PRO-XTEN ™ universal masking technology for oncology and infectious disease and to three clinical-stage masked TCEs with potential applications in a range of cancers.

The agreement became effective on September 9, 2024.

◦ Certain former employees of Sanofi joined us following the closing of the agreement.

• In August 2024 we announced the phase-out of clinical programs in influenza, COVID-19, and its T-cell based viral vector platform.

The Company is seeking partners to advance these clinical programs through further development.

Additionally, the Company announced a workforce reduction of approximately 25%, or approximately 140 employees.

• In May 2024, we announced the appointment of Mark D.

Eisner, M.D., M.P.H.

as Executive Vice President and Chief Medical Officer, effective June 3, 2024.

• Effective May 3, 2024, Sung Lee, Executive Vice President and Chief Financial Officer stepped down from his role to pursue another career opportunity.

• In April 2024, we announced that founding board members Phillip Sharp, Ph.D.

and Robert Perez would not stand for reelection.

Effective May 29, 2024, two new independent directors were elected in their place, including Norbert Bischofberger, Ph.D., who brings close to 40 years of biotech leadership experience and Ramy Farid, Ph.D., whose pioneering work applying advanced computational methods to drug discovery has enabled high-quality, novel molecules for drug development and materials applications.

• In March 2025, we and Alnylam amended and restated their collaboration agreement (Restated Alnylam Agreement), with Alnylam electing not to opt-in to its profit-sharing option for elebsiran in CHB and CHD indications.

Financial Overview

We were incorporated in April 2016 and commenced principal operations later that year.

To date, we have focused primarily on organizing and staffing our company, business planning, raising capital, identifying, acquiring, developing and in-licensing our technology platforms and product candidates, and conducting preclinical studies and clinical trials.

To date, we have focused primarily on organizing and staffing our company, business planning, identifying, acquiring, developing and in-licensing our technology platforms and product candidates, and conducting preclinical studies and clinical trials.

We have financed our operations primarily through sales of our common stock from our initial public offering, subsequent follow-on offering, and payments received under our grant and collaboration agreements.

As of December 31, 2024, we had $1.1 billion in cash, cash equivalents, and investments.

Based upon our current operating plan, we believe that the $1.1 billion will enable us to fund our operations for at least the next 12 months.

As of December 31, 2025, we had $781.6 million in cash, cash equivalents, and investments.

Based upon our current operating plan, we believe that the $781.6 million will enable us to 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, as of December 31, 2024, we had $95.7 million in restricted cash and cash equivalents, which includes the $75.0 million subject to VIR-5525 achieving “first in human dosing” by 2026.

In addition, as of December 31, 2025, we had $8.9 million in restricted cash and cash equivalents.

See the section titled “ Liquidity, Capital Resources and Capital Requirements—Funding Requirements and Conditions ” below for additional information.

Our net loss was $522.0 million for the year ended December 31, 2024, compared to net loss of $615.1 million for the year ended December 31, 2023 and net income of $515.8 million for the year ended December 31, 2022, respectively.

As of December 31, 2024, we had accumulated deficit of $759.8 million.

Our net loss was $438.0 million for the year ended December 31, 2025, compared to net loss of $522.0 million and $615.1 million for the years ended December 31, 2024 and 2023, respectively.

As of December 31, 2025, we had an accumulated deficit of $1.2 billion.

Although we recorded net income for the years ended December 31, 2022 and 2021, we have otherwise incurred net losses since inception and may continue to incur net losses in the foreseeable future.

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We have established our own internal process, analytical and pharmaceutical development, manufacturing, supply chain and quality organizations that work with our selected CDMOs, to develop, manufacture, test and supply our early- and late-stage product candidates developed with our proprietary and external technology platforms.

Contract development and

manufacturing of our antibody, TCE and siRNA product candidates is supported at our San Francisco, California, corporate headquarters for process, analytical and formulation development, small-scale non-GMP manufacturing for preclinical studies and selected quality control testing.

Contract development and manufacturing of our antibody, TCE and siRNA product candidates is supported at our San Francisco, California, corporate headquarters for process, analytical and formulation development, small-scale non-cGMP manufacturing for preclinical studies and selected quality control testing.

Our headquarters also conducts cell line development for our antibody and TCE product candidates.

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Components of Operating Results

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 other product candidates until we complete clinical development, submit regulatory filings and receive approvals from the applicable regulatory bodies for such product candidates, if ever.

Although we have previously recognized revenue from our profit-share related to sotrovimab under our definitive collaboration agreement with GSK executed in June 2020, or the 2020 GSK Agreement, we may continue to incur net operating losses for the foreseeable future.

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.

Although we have previously recognized revenue from our profit-share related to sotrovimab under our definitive collaboration agreement with GSK executed in June 2020, or the 2020 GSK Agreement, we expect to continue to incur net operating losses for the foreseeable future.

In December 2024, the FDA revoked EUA granted to sotrovimab in May 2021.

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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.

We do not expect meaningful license and collaboration revenue in the future from the sale of sotrovimab for the treatment of COVID-19.

Our revenues consist of the following:

Collaboration revenue includes recognition of our profit-share from the sales of sotrovimab pursuant to the 2020 GSK Agreement.

As the lead party for all manufacturing and commercialization activities, GSK incurs all of the manufacturing, sales and marketing expenses and is the principal on sales transactions with third parties.

As the agent, we recognize our contractual share (72.5%) of the profit-sharing amounts as revenue, based on sales net of various estimated deductions such as rebates, discounts, chargebacks, credits and returns, less cost of sales and allowable expenses (including manufacturing, distribution, medical affairs, selling, and marketing expenses) in the period the sale occurs.

To record collaboration revenue, we utilize certain information from our collaboration partner, including actual net product sales and costs incurred for sales activities, and make key judgments based on business updates related to commercial and clinical activities, such as expected commercial demand, commercial supply plan, manufacturing commitments, risks related to expired or obsolete inventories, and risks related to potential product returns or contract terminations.

Manufacturing costs include inventory revaluation adjustments, lower of cost or market inventory adjustments, inventory write-downs and write-offs, and binding purchase commitments with a third-party manufacturer, among other manufacturing costs.

Our contractual share of the profit-sharing amounts is subject to potential future adjustments to allowable expenses, which we account for as a form of variable consideration.

In 2023, GSK reported to us certain allowable manufacturing expenses related to excess sotrovimab supply and binding reserved manufacturing capacity not utilized, which we had previously reserved as a constraint on our cumulative profit-sharing amounts.

GSK may continue to adjust allowable manufacturing expenses for our share of the excess supply write-offs and unused binding manufacturing capacity and report to us as cost-sharing amounts in future periods.

We evaluate the latest available facts and circumstances to update our evaluation of whether any portion of profit-sharing amounts should continue to be constrained.

We re-assess these estimates at each reporting period.

Actual results could materially differ from estimates.

In 2025, we expect a nominal amount of collaboration revenue, if any, from our 2020 GSK Agreement, and we may incur negative collaboration revenue related to costs for ongoing required support efforts that our partner GSK leads.

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

License and collaboration revenue includes revenues generated from license rights issues to Norgine and GSK, including our profit-share from the sales of sotrovimab pursuant to the 2020 GSK Agreement.

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

License revenue from a related party is comprised of revenue related to Brii Bio’s exercise of its option to obtain exclusive rights to develop and commercialize compounds arising from tobevibart in China Territory recognized in the year ended December 31, 2022.

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

Operating Expenses

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• personnel-related expenses, including salaries, benefits and stock-based compensation for personnel contributing to research and development activities;

• expenses incurred under agreements with third-party contract manufacturing organizations, CROs, and consultants;

• expenses incurred under agreements with third-party CDMO, CROs, and consultants;

• clinical costs, including laboratory supplies and costs related to compliance with regulatory requirements;

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the safety and efficacy of our product candidates, early clinical data, investment in our clinical programs, the ability of collaborators to successfully develop our licensed product candidates, competition, manufacturing capability and commercial viability.

In addition, under our license agreement with Sanofi, we may incur additional clinical, and regulatory milestone payments based on the development progress of certain oncology programs.

In addition, under our license agreement with Sanofi and other licensors, we may incur additional clinical, and regulatory milestone payments based on the development progress of certain clinical programs.

We may also be required to pay commercial milestone payments and royalties in the event of a successful product launch and our receipt of commercial revenues.

Therefore, we are unable to predict the timing or the final cost to complete our clinical programs or validation of our manufacturing and supply processes and delays may occur due to numerous factors.

Factors that could cause or contribute to delays or additional costs include, but are not limited to, those discussed in the “Risk Factors” section of this Annual Report.

Factors that could cause or contribute to delays or additional costs include, but are not limited to, those discussed in the “ Part I, Item 1A.

Risk Factors ” section of this Annual Report.

As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate significant revenue from the commercialization and sale of any of our product candidates.

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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.

Restructuring, long-lived asset impairment and related charges

Restructuring, long-lived asset impairment and related charges consist primarily of charges incurred in connection with our cost saving initiatives implemented during the second half of 2024 and 2023, respectively, including severance and other employee-related expenses and long-lived assets impairment charges and disposal losses.

Restructuring, Long-Lived Asset Impairment and Related Charges, Net

Restructuring, long-lived asset impairment and related charges, net consist primarily of charges incurred in connection with our cost saving initiatives implemented during the second half of 2024 and 2023, respectively, including severance and other employee-related expenses and long-lived assets impairment charges and disposal losses.

Change in Fair Value of Equity Investments

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Interest income consists of interest earned on our cash, cash equivalents and investments.

Other (Expense) Income, Net

Other (expense) income, net consists of gains and losses from foreign currency transactions and the remeasurement of our contingent consideration obligation.

Benefit from (Provision for) Income Taxes

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

Net Loss Attributable to Noncontrolling Interest

Net loss attributable to noncontrolling interest consists of net loss attributable to our noncontrolling interest in Encentrio Therapeutics, Inc., our subsidiary, during the three months ended March 31, 2023.

Other Expense, Net

Other expense, net consists of gains and losses from foreign currency transactions, investment management expenses, and the remeasurement of our contingent consideration obligation.

(Provision for) Benefit from Income Taxes

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

Results of Operations

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2025 2024 Change

Collaboration revenue $ 8,379 $ 37,266 $ (28,887)

Contract revenue 55,333 2,228 53,105

License and collaboration revenue $ 63,130 $ 61,370 $ 1,760

Grant revenue 2,036 10,493 (8,457)

Other revenue 3,390 2,342 1,048

Total revenues 68,556 74,205 (5,649)

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Selling, general and administrative 92,074 119,031 (26,957)

Restructuring, long-lived assets impairment and related charges 34,995 13,559 21,436

Restructuring, long-lived assets impairment and related charges, net (182) 34,995 (35,177)

Total operating expenses 547,884 661,370 (113,486)

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Total other income 41,558 64,060 (22,502)

Loss before benefit from income taxes (523,105) (628,194) 105,089

Benefit from income taxes 1,145 13,077 (11,932)

Loss before (provision for) benefit from income taxes (437,770) (523,105) 85,335

(Provision for) benefit from income taxes (217) 1,145 (1,362)

Net loss $ (437,987) $ (521,960) $ 83,973

Net loss attributable to noncontrolling interest — (56) 56

Net loss attributable to VirBio $ (521,960) $ (615,061) $ 93,101

The decrease in collaboration revenue for the year ended December 31, 2024 compared to the same period in 2023 was due to lower revenues from the release of sotrovimab profit-sharing amount previously constrained under our 2020 GSK Agreement.

The increase in contract revenue for the year ended December 31, 2024 compared to the same period in 2023 was primarily due to the recognition of $51.7 million revenue from the deferred revenue during the first quarter of 2024 when GSK’s rights to select up to two additional non-influenza target pathogens under the 2021 GSK Agreement expired on March 25, 2024.

The increase in license and collaboration revenue for the year ended December 31, 2025 compared to the same period in 2024 was primarily due to the recognition of $64.3 million license revenue related to the initial payment received under the Norgine Agreement.

We granted Norgine an exclusive license with respect to commercial rights to the combination of tobevibart and elebsiran for the treatment of CHD in Europe, Australia, and New Zealand.

Such increase was partially offset by $51.7 million revenue during the first quarter of 2024 when GSK’s rights to select up to two additional non-influenza target pathogens under the 2021 GSK Agreement expired on March 25, 2024, and lower GSK profit-sharing revenue in 2025 from GSK under our 2020 GSK Agreement.

The decrease in grant revenue for the year ended December 31, 2025 compared to the same period in 2024 was primarily due to lower revenue recognized in accordance with our agreement with BARDA and to a lesser extent, lower revenue recognized from the Gates Foundation.

In August 2024, we announced a strategic realignment that included phasing out certain research programs, which impacted certain programs funded by Gates Foundation grants.

We continue to advance our HIV broadly neutralizing antibody program for HIV cure in collaboration with the Gates Foundation.

We terminated our agreement with BARDA on December 31, 2024.

All but one of our grant agreements with the Gates Foundation expired in 2025, and we terminated our agreement with BARDA at the end of 2024.

The change in other revenue for the year ended December 31, 2025 compared to the same period in 2024 was nominal.

Cost of Revenue

The decrease in cost of revenue for the year ended December 31, 2024 compared to the same period in 2023 was due to lower third-party royalties owed based on the lower collaboration revenue under the 2020 GSK Agreement.

The decrease in cost of revenue for the year ended December 31, 2025 compared to the same period in 2024 was nominal.

Research and Development Expenses

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2025 2024 Change

Contract manufacturing $ 40,081 $ 114,262 $ (74,181)

Clinical costs 57,624 121,422 (63,798)

Personnel $ 125,274 $ 162,960 $ (37,686)

Licenses, collaborations and contingent consideration 125,058 129,846 (4,788)

Clinical costs 87,173 57,624 29,549

Contract manufacturing 47,622 40,081 7,541

Other 70,839 115,988 (45,149)

Total research and development expenses $ 455,966 $ 506,499 $ (50,533)

The decrease in research and development expenses for the year ended December 31, 2024 compared to the same period in 2023 was primarily due to lower contract manufacturing costs and clinical costs associated with the wind down of our Phase 2 PENINSULA trial evaluating VIR-2482, lower contract manufacturing costs associated with elebsiran used in the our CHD and CHB clinical trials, and lower personnel costs associated with the reduction in the headcount resulting from the cost saving initiatives implemented in 2023 and 2024, partially offset by the increase in licenses, collaboration and contingent consideration expenses primarily due to a portion of the upfront payment made to Sanofi allocated to in-process research and development and expensed.

The decrease in research and development expenses for the year ended December 31, 2025 compared to the same period in 2024 was primarily due to:

• lower other R&D expenses related to de-prioritized research and development programs and other ongoing cost savings;

• lower personnel expenses associated with headcount reductions;

• 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 the $75.0 million milestone payment due upon VIR-5525 achieving first-in-human dosing in the third quarter of 2025, the $30.0 million expense in connection with signing the Restated Alnylam Agreement, and milestone payments due upon the enrollment of the first patient in phase 3 ECLIPSE registrational program for CHD in the first quarter of 2025.

partially offset by:

• higher clinical cost due to the initiation of our phase 3 ECLIPSE registrational program and progression of our oncology programs.

Selling, General and Administrative Expenses

The decrease in selling, general and administrative expenses for the year ended December 31, 2024 compared to the same period in 2023 was primarily due to savings realized through headcount reductions and the closing of our St.

Louis, Missouri and Portland, Oregon sites, as part of our cost saving initiatives implemented in 2023 and 2024.

Restructuring, long-lived assets impairment and related charges

The increase in restructuring, long-lived assets impairment and related charges for the year ended December 31, 2024 compared to the same period in 2023 was primarily due to the right-of-use asset and leasehold improvement impairment charges related to closing our facilities in St.

Louis, Missouri and Portland Oregon in 2024, which was previously announced on December 13, 2023, and severance charges incurred related to our strategic restructuring announcement in August 2024.

The decrease in selling, general and administrative expenses for the year ended December 31, 2025 compared to the same period in 2024 was primarily due to efficiencies and cost savings from previously announced restructuring initiatives.

Restructuring, Long-Lived Assets Impairment and Related Charges, Net

The decrease in restructuring, long-lived assets impairment and related charges for the year ended December 31, 2025 compared to the same period in 2024 was primarily due to the substantial completion of previously announced restructuring initiatives by the end of 2024.

Change in Fair Value of Equity Investments

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 period.

For the year ended December 31, 2024, we recognized an unrealized loss of $5.5 million due to the change in fair value, compared to an unrealized loss of $21.9 million for the same period in 2023.

For the year ended December 31, 2025, we recognized an unrealized gain of $1.7 million, compared to an unrealized loss of $5.5 million for the same period in 2024.

Interest Income

The decrease in interest income was primarily due to lower balances of cash, cash equivalents, and investments for the year ended December 31, 2024 compared to the same period in 2023.

The decrease in interest income was primarily due to lower balances of cash, cash equivalents, and investments and lower interest rates for the year ended December 31, 2025 compared to the same period in 2024.

Other Expense, Net

The decrease in other expense, net for the year ended December 31, 2024 compared to the same period in 2023 was primarily due to a decrease in foreign exchange measurement loss related to the accrued liability recognized in connection with the profit-sharing amount constrained under the 2020 GSK Agreement.

Benefit from Income Taxes

The benefit from income taxes for the year ended December 31, 2024 was nomimal.

The benefit from income taxes for the year ended December 31, 2023 was primarily due to a pre-tax loss and our ability to carry back the research and development credit to 2022.

The change in other expense, net, for the year ended December 31, 2025 compared to the same period in 2024 was nominal.

(Provision for) Benefit from Income Taxes

The change in (provision for) benefit from income taxes for the year ended December 31, 2025 compared to the same period in 2024 was nominal.

Liquidity, Capital Resources and Capital Requirements

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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 December 31, 2024, we had $1.1 billion in cash, cash equivalents, and investments.

In addition, as of December 31, 2024, we had $95.7 million in restricted cash and cash equivalents, which included the $75.0 million subject to VIR-5525 achieving “first in human dosing” by 2026.

As of December 31, 2025, we had $781.6 million in cash, cash equivalents, and investments.

In November 2023, we entered into a sales agreement (the 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.

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As of December 31, 2025, no shares have been issued under the Sales Agreement.

The Sales Agreement will expire in November 2026.

Funding Requirements and Conditions

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To date, we have entered into collaboration, license and acquisition agreements where the payment obligations are contingent upon future events such as our achievement of specified development, regulatory and commercial milestones, and we are required to make royalty payments in connection with the sale of products developed under those agreements.

For additional information regarding these agreements, including our payment obligations thereunder, see the sections titled “Business—Our Collaboration, License and Grant Agreements,” as well as Note 6 Collaboration and License Agreements to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.

For information related to our future commitments under our facilities and manufacturing agreements, see Note 9 Leases and

Note 10 Commitments and Contingencies to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.

For additional information regarding these agreements, including our payment obligations thereunder, see the sections titled “ Part I, Item 1.

Business—Our Collaboration, License and Grant Agreements, ” as well as Note 6 Collaboration and License Agreements to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.

For information related to our future commitments under our facilities and manufacturing agreements, see Note 9 Leases and Note 10 Commitments and Contingencies to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements.

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Financing activities 3,785 4,388

Net increase (decrease) in cash, cash equivalents and restricted cash and cash equivalents $ 57,403 $ (606,676)

Net (decrease) increase in cash, cash equivalents and restricted cash and cash equivalents $ (77,625) $ 57,403

Operating Activities

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 decreased in 2024 compared to 2023 primarily due to lower payments to GSK related to profit-sharing amount constrained under the 2020 GSK Agreement, and lower clinical development and contract manufacturing activities related to the wind down of the Phase 2 PENINSULA trial evaluating VIR-2482, partially offset by the $103.7 million upfront payment made under our license agreement with Sanofi.

Cash used in operating activities decreased in 2023 compared to 2022 primarily due to lower cash received for the sales of sotrovimab and higher cash payments made to GSK related to profit-sharing amount constrained as part of the 2020 GSK Agreement.

Cash used in operating activities decreased in 2025 compared to 2024 primarily due to $64.3 million initial payment received under the Norgine Agreement 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 in 2025, along with $103.7 million upfront payment made under our license agreement with Sanofi in 2024.

The decrease was partially offset by $75 million milestone payment related to the first patient dosed in Phase 1 study evaluating VIR-5525 and $50.5 million milestone payments related to the enrollment of the first patient in ECLIPSE registrational program for CHD in 2025.

Investing Activities

Cash provided by investing activities during 2024 was primarily due to $1.7 billion in proceeds received from investments that matured or sold during the year, partially offset by purchases of investments of $1.2 billion.

Cash provided by investing activities during 2023 was primarily due to $2.2 billion in proceeds received from investments that matured or sold during the period, partially offset by purchases of investments of $2.0 billion and property and equipment of $21.6 million.

Cash provided by investing activities during 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.

Financing Activities

Cash provided by financing activities during 2024 was primarily due to of proceeds from the issuance of common stock under our employee stock purchase plan of $3.8 million.

Cash provided by financing activities during 2023 was primarily due to of proceeds from the issuance of common stock under our employee stock purchase plan of $4.3 million and exercises of stock options of $3.5 million.

Cash provided by financing activities during 2025 compared to the same period in 2024 was nominal.

Critical Accounting Policies and Estimates

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis