VIR 10-K & 10-Q changes, risk factors and insider trading

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 Annual Report on Form 10-K, including our audited 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 and/or prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this Annual Report on Form 10-K 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.

•We are developing, and in the future may develop, product candidates in combination with other therapies.therapies, which exposes us to additional risks.

•Success in preclinical studies or early-stage clinical studies may not be indicative of results in future clinical studies and we cannot assure you that any ongoing, planned or future clinical studies will lead to results sufficient for the necessary regulatory approvals and marketing authorizations. We have and may continue to commit substantial financial resources with respect to clinical studies that may not be successful, and we may not be able to recoup those investments.

•Although the combination of tobevibart and elebsiran has received Fast Track and 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 U.S.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.

•Enrollment and retention of patients in clinical studies is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control.

•The deployment of AI in our or our collaborators’ efforts to discover, develop and engineer next-generation antibodies or other investigational products,products or components, could adversely affect our business, reputation or financial results, and furthermore our competitors may be able to utilize such technologies more effectively than we can.

•EvenOur product candidates, if any of our product candidates receive marketing approval, theyapproved, may fail to achieve adoption by physicians, patients, third-party payorspayors, clinical guidelines or others in the medicalhealthcare community necessary for commercial success.

•We rely on third parties to produce clinical and future commercial supplies of our product candidates. There could be delays or supply shortages beyond our control limiting our access to clinical and future commercial supplies.

Although we recorded net income for the years ended December 31, 2022, and 2021, we have otherwise incurred net losses since inception in April 2016. We had net loss of $522.0$438.0 million and $615.1$522.0 million for the years ended December 31, 20242025, and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $759.8$1.2 million.billion.

We expect to continue to incur significant expenses and will continue to incur net losses in the foreseeable future as we develop our product candidates and technology platforms.

It could be several years, if ever, before we are able to commercialize any of our product candidates. Any net losses we incur may fluctuate significantly from quarter to quarter and year to year.year based on operating expenses and other factors. To become profitable, we must succeed in developing and eventually commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing preclinical and clinical studies of our current and future product candidates, obtaining regulatory approval, procuring commercial-scale manufacturing and marketing, and selling any products for which we obtain regulatory approval (including through third parties), as well as discovering or acquiring and developing additional product candidates. We are only in the preliminary stages of most of these activities, and we may never attain a level of commercial success that will generate sufficient revenue to offset our expenses and maintain profitability. Because of the numerous risks and uncertainties associated with biopharmaceutical product development, we are unable to accurately predict the timing or amount of expenses, or if we will be able to return to profitability. If we are required by regulatory authorities to perform studies in addition to those currently expected, or if there are any delays in the initiation and completion of our clinical studies or the development of any of our product candidates, our expenses could increase.

Our failure to return to beingprofitability profitable wouldcould decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations.

As an organization, beyond sotrovimab for COVID-19, we have not yet demonstrated an ability to successfully manufacture a BLA-approved,new drug application (NDA)- or biologics licensing application (BLA)-approved, commercial-scale product or conduct sales and marketing activities necessary for successful commercialization. Consequently, any predictions about our future success or viability may not be as accurate as they could be if we had a longer operatinghistory history.of commercialization. We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives, including with respect to our technology platforms and product candidates.

As of December 31, 2024,2025, we had cash, cash equivalents and investments of $1.1$781.6 billion.million. Based upon our current operating plan,plans, we believe that this amount will fund our current operating plansoperations 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. Moreover,In itaddition, is particularly difficult to estimate with certainty our future revenue and expenses given the dynamic and rapidly evolving nature of our business. We may also need to raise additional capital to complete the development and commercialization of our product candidates and fund certain of our existing manufacturing and other commitments. Other unanticipated costs may also arise. Becausebecause 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.

General economic conditions, both inside and outside the U.S.,United States, including capital market volatility, interest rate and currency rate fluctuations, and economic slowdown or recession, as well as geopolitical events, including civil or political unrest, terrorism, insurrection or war (such as the ongoing conflicts in the Middle East and Eastern Europe), and also investor concerns regarding the U.S. or international financial systems, have in the past resulted in, and may in the future cause, a significant disruption of financial markets. If the disruption persists and deepens, we could experience an inability to access additional capital or increased costs of financing through higher interest rates or costs or tighter financial and operating covenants, which could in the future negatively affect our capacity for certain corporate development transactions or our ability to make other important, opportunistic investments.

If we raise additional capital through future collaborations, strategic alliances or licensing arrangements, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidatescandidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional capital when needed, we may be required to delay, limit, reduce or terminate our research and productdevelopment developmentprograms or commercialization efforts or grant rights to develop and market product candidates that we would otherwise develop and market ourselves.

Our future success is substantially dependent on the successful clinical development, regulatory approval and commercialization of our product candidates in a timely manner. If we are not able to obtain required regulatory approvals, we will not be able to commercialize our product candidates,candidates and our ability to generate product revenue will be adversely affected.

We have invested a significant portion of our time and financial resources in the development, in-licensing and acquisition of our product candidates and have initiated clinical studies for multiple product candidates. Accordingly, our business is dependent on our ability to successfully complete clinical development of, obtain regulatory approval for, and successfully commercialize our product candidates, if approved, in a timely manner. We may face unforeseen challenges in our product development strategy, and we can provide no assurances that our product candidates will be successful in clinical studies or will ultimately receive regulatory approval. Prior to obtaining approval to commercialize any product candidate in the United States or abroad, we must demonstrate with substantial evidence from well-designed registrational clinical studies, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that such product candidate is safe and effective to treat its intended indications. Results from preclinical and clinical studies can be interpreted in different ways.ways, Evenand even if we believe that the preclinical or clinical data for our product candidates are promising, such data may not be sufficient for the FDA and comparable foreign regulatory authorities to support approval forapprove further development, manufacturing or commercialization of our product candidates by the FDA and other regulatory authorities.candidates. The FDA or these other comparable foreign regulatory authorities may also require us to conduct additional preclinical or clinical studies for our product candidates, either prior to or post-approval, or may object to elements of our clinical development program and require us to alter them. Additionally, the acceptance of data by the FDA from clinical trials conducted outside the United States, or by comparable foreign regulatory authorities for trials conducted outside of their respective jurisdictions, may be subject to conditions imposed by such regulatory authorities, including as relating to differences between medical practice, clinical endpoints, trial conduct and patient populations between the United States and foreign countries.

Any delay in obtaining, or inability to obtain, applicable regulatory approval or other marketing authorization would delay or prevent commercialization of that product candidate and would adversely impact our business and prospects. In addition, the FDA or comparable foreign regulatory authorities may change their policies, adopt additional regulations or revise existing regulationsregulations, experience disruptions or take other actions, which may prevent or delay approval of our future product candidates under development on a timely basis. Such policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain applicable regulatory approvals, increase the costs of compliance or restrict our ability to maintain any marketing authorizations we may have obtained.

Furthermore, even if we obtain regulatory approval for our product candidates, we may still need to developbuild a commercial organization, establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors, including government health administration authorities. As a company, we have no prior experience in these areas. If we are unable to successfully commercialize our product candidates or if there is an insufficient demand for our product candidates, we may not be able to generate sufficient revenue to continue our business.

A core element of our business strategy is to successfully develop our product candidate pipeline. Efforts to identify, acquire or in-license, and then develop product candidates require substantial technical, financial and human resources, whether or not any product candidates are ultimately identified. Even when we are successful in identifying and acquiring or in-licensing potential product candidates, such as our license to three clinical-stage TCEs (VIR-5818, VIR-5500 and VIR-5525) and the PRO-XTEN® universal masking platform from Sanofi, our efforts may fail to yield product candidates for clinical development, approved products or commercial revenue for many reasons.

Furthermore, we intend tomay seek marketing approval to marketfor our current and future product candidates outside of the U.S.,United andStates. mayWe alsohave dolimited soprior forexperience futurein product candidates. If we marketmarketing approved products outside of the U.S.,United weStates, expectand thatmarketing weproducts willin beforeign countries would subject us to additional risksrisks. in commercialization. As a company, we have no prior experience in these areas. In addition, thereThere are complex regulatory, tax, labor and other legal requirements imposed by many of the individual countries in which we may operate, with which we will need to comply.comply, Manyand biopharmaceuticalsuch companiesefforts have found the process of marketing their products in foreign countries tomay be expensive, time-consuming and challenging.

In our early-stage oncology programs, we are evaluating each of VIR-5818 and VIR-5525 in combination with pembrolizumab in a Phase 1 basket studystudies inacross multiple tumor types, including metastatic breast cancer and metastatic CRC.CRC for VIR-5818 and NSCLC, CRC, HNSCC and cSCC for VIR-5525. The inclusion of critically ill patients in our oncology clinical studies may result in serious adverse medical events, including death, due to other therapies or medications that such patients may be using or in combination with our product candidates. Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or comparable foreign regulatory authorities could revoke approval of the therapy used in combination with our product candidate. There is also a risk that safety, efficacy, manufacturing or supply issues could arise with these other existing therapies. For example, the other therapies may lead to toxicities that are improperly attributed to our product candidates or the combination of our product candidates with other therapies may result in toxicities that the product candidate or other therapy does not produce when used alone. This could result in our own products being removed from the market or being less successful commercially.

Success in preclinical studies or early-stage clinical studies may not be indicative of results in future clinical studies and we cannot assure you that any ongoing, planned or future clinical studies will lead to results sufficient for the necessary regulatory approvals and marketing authorizations. We have and may continue to commit substantial financial resources with respect to clinical studies that may not be successful, and we may not be able to recoup those investments.

Success in preclinical testing and early-stage clinical studies does not ensure that later clinical studies will generate similar results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate. Certain of our clinical programs have in the past, and may in the future, not yieldedyield positive results in late-stage studiesstudies. (such as our Phase 2 clinical study of VIR-2482 for the prevention of symptomatic influenza A illness, which did not meet primary or secondary efficacy endpoints, as announced in July 2023), and ourOur product candidates currently under development may similarly fail to meet efficacy endpoints or otherwise show the desired characteristics in clinical development sufficient to obtain regulatory approval, despite positive results in preclinical studies or having successfully advanced through early-stage clinical studies. We have and may continue to commit substantial financial resources with respect to clinical studies that may not be successful, and we may not be able to recoup those investments.

Although the combination of tobevibart and elebsiran has received Fast Track and 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 U.S.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 31, 2024, we announced that the FDA granted Fast Track designation and Breakthrough Therapy designation, respectively, for the combination of tobevibart and elebsiran for the treatment of CHD. In addition, the combination received PRIME designation from the EMA and European orphan drug designation in December 2024 infor the same indication. We can provide no assurances that the combination of tobevibart and elebsiran 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 in “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 “Part I, Item 1. Business” in this Annual Report on Form 10-K.

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must complete preclinical development and then conduct extensive clinical studies to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive, is difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. We do not know whether our planned clinical studies will begin or enroll on time, will be conducted as planned, will need to be redesigned or will be completed on schedule, if at all.

A failure or significant delay of one or morea clinical studiesstudy can occur at any stage of testing.stage. For example, during initial dose escalation studies,escalation, we, the FDA or comparable foreign regulatory authorities have in the past imposed and may in the future imposeimpose, restrictions relating to chemistry, manufacturing and control (CMC) standards, and such restrictions could then delay or limit our evaluation of a product candidate and its subsequent advancement to late-stage studies. 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 and/or require us to enroll a larger number of subjects to address competing treatments. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companiesanalyses that havecan believedresult theirin product candidates performed satisfactorily in preclinical and clinical studies have nonetheless failedfailing to obtain marketing approval of their products.approval. Any of these or other unforeseen events that we may experience prior to, during, or as a result of clinical studies could delay or prevent us from receiving marketing approval and ultimately commercializing our product candidates.

Any inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenue from future product sales or other sources. In addition, if we make manufacturing or formulation changes to our product candidates, we may need to conduct additional testing to bridge our modified product candidate to earlier versions.testing. Clinical trial delays could also shorten any periods during which we may have the exclusive right to commercialize our product candidates, if approved, or allow our competitors to bring competing products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our business, financial condition, results of operations and prospects.do.

Additionally, ifIf the results of our clinical studies are inconclusive or if there are safety concerns or SAEsserious adverse events associated with our product candidates, we may:

•obtain approval with labeling that includes significant use or distribution restrictionsrestrictions, contraindications or safety warningswarnings, or determine not to pursue any approval at all;

Furthermore, our product candidates are based on certain innovative technology platforms, which makes it even more difficult to predict the time and cost of product candidate development and obtaining necessary regulatory approvals.approval. In addition, the compounds we are developing may not demonstrate in patients the chemical and pharmacological properties ascribed to them in preclinical studies, and they may interact with human biological systems in unforeseen, ineffective or harmful ways.ways, which may result in our voluntary termination of related clinical development programs.

Enrollment and retention of patients in clinical studies is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control.

Identifying and qualifying patients to participate in our clinical studies is critical to our success. In particular, clinical studies for prophylaxis are impacted by many factors including competing therapies that tend to require enrollment of a larger number of subjects than clinical studies for treatments. We may encounter difficulties in enrolling patients in our clinical studies, thereby delaying or preventing development and approval of our product candidates. Even once enrolled, we may be unable to retain a sufficient number of patients to complete any of our studies. Patient enrollment and retention in clinical studies depend on many factors, including the size of the patient population, the nature of the trial protocol, the existing body of safety and efficacy data, changing standards of care, the number and nature of competing treatments and ongoing clinical studies of competing therapies for the same indication, the proximity of patients to clinical trial sites and the eligibility criteria for the trial. The enrollment and retention of patients in our clinical studies may be disrupted or delayed as a result of, for example, regulatory feedback, clinicians’ and patients’ perceptions as to the potential advantages of therapies in development in relation to other available therapies, including products that have been recently authorized under EUAs or approved and licensed through NDAs and BLAs. In addition, enrollment and retention of patients in clinical studies could be disrupted 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, public health pandemics or epidemics,epidemics or other business interruptions.

Delays or failures in planned patient enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability to develop our product candidates or could render further development impossible. In addition, we may rely on CROs and clinical trial sites to ensure proper and timely conduct of our future clinical studies and, while we intend to enter into agreements governing their services, we will be limited in our ability to ensure their actual performance, which may result in rejection of the data generated at particular clinical trial sites or delays in the completion of our current and future clinical studies.

We are a party to various strategic collaboration and license agreements that are important to our business and to our current and future product candidatescandidates, pursuant to which we license a number of technologies to form our technology platforms and in-license certain product candidates.candidates, Theseas 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 in the event certain milestone events are achieved.achieved with respect to an in-licensed product candidate, or alternatively relinquish certain rights relating to the development and commercialization of an out-licensed product candidate.

A core element of our business strategy includes continuing to acquireacquire, in-license or in-licenseout-license, or otherwise collaborate on additional technologies or product candidates for the treatment and prevention of serious infectious diseases, cancer and other serious conditions. As a result, we intend to periodically explore a variety of possible strategic collaborations or licenses in an effort to gain access to additional product candidates, technologiescandidates or technologies, as well as commercial, financial or other resources.

•while we have assumed regulatory sponsorship for all current TCE trial programs, we may, during any transition period with respect to future in-licensed clinical programs, be reliant on licensors to continue serving as regulatory sponsors (and executing all appropriate sponsorship responsibilities or delegations of such responsibilities) until a complete transition of sponsorship can be made;

•disputes may arise between us and our strategic collaborators that result in costly litigation or arbitration that diverts resources and management’s attention andfrom consumesour resourcescore business;

The deployment of AI in our or our collaborators’ efforts to discover, develop and engineer next-generation antibodies or other investigational products,products or components, could adversely affect our business, reputation or financial results, and furthermore our competitors may be able to utilize such technologies more effectively than we can.

We integrate AI in our efforts to develop and engineer next-generation antibodies, including through the use of our proprietary dAIsY™ AI engine, and we might utilize AI in the future in connection with drug discovery activities. AI maycan be difficult to deploy successfully due to operational and technical issues inherent in such methods. In particular, AI algorithmsalgorithms’ mightuse utilizeof machine learning and predictive analytics which maycould lead to flawed, biased or inaccurate results, whichwhich, if detected, could lead to ineffective product or target candidates and exposure to competitive and reputational harm. In addition, any latency, disruption, or failure in our AI operations or infrastructure could result in failures, delays or errors in our discovery and development of next-generation antibodies or other investigational products. Developing, testing and deploying resource-intensive AI systems may also require additional investment and increase our costs, and there is no guarantee that our investment in such systems will lead to more effective or efficient discovery or development of antibodies or other investigational products, or lead to eventual regulatory approval or commercialization of any new products.

We currently focus our product development on product candidates for the treatment and prevention of serious infectious diseases, cancer and other serious conditions. Our eligible patient population, pricing estimates and available coverage and reimbursement may differ significantly from the actual market addressable by our product candidates. Our estimates of the number of people who have these diseases, the subset of people with these diseases who have the potential to benefit from treatment with our product candidatescandidates, and the market demand for our product candidatescandidates, are each based on our beliefs and analyses. These estimates have been derived from a variety of sources, including the scientific literature, patient foundations or market research, and may prove to be incorrect. Further,Furthermore, new studies may change the estimated incidence or prevalence of the diseases we are targeting. The FDA or the comparable foreign regulatory authorities also may approve or authorize for marketing a product candidate for a more limited indication or patient population than we originally request. Additionally, the availability of superior or competitive therapies from our competitors could negatively impact or eliminate market demand for our product candidates. If the market opportunities for our product candidates are smaller than we estimate, it could have ana material adverse effect on our business, financial condition, results of operations and prospects.

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 infectious diseases 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.

As a result of these factors, our competitors may achieve patent protection or obtain regulatory approval or authorization of their products before we are able to, which could result in our competitors establishing a strong market position before we are able to enter the market. Our competitors may also develop therapies that aredemonstrate safer,stronger moresafety effective,and efficacy data, have fewer or less severe side effects, are more convenient, more widely accepted or less expensive than ours, and may also be more successful than we are in manufacturing, marketing or obtaining reimbursement for their products. These advantages could render our product candidates obsolete or non-competitive before we can recover the development and commercialization costs of such product candidates’ development and commercialization.candidates. For additional information regarding our competitors, see the section titled “Competition” in “Part I, Item 1. Business—Competition” ofin this Annual Report on Form 10-K.

EvenOur product candidates, if any of our product candidates receive marketing approval, theyapproved, may fail to achieve adoption by physicians, patients, third-party payorspayors, clinical guidelines or others in the medicalhealthcare community necessary for commercial success.

Even if any of our product candidates receive marketingregulatory approval, they may fail to achieve adoption by physicians, patients, third-party payors and others in the medical community. If such product candidates do not achieve an adequate level of acceptance, we may not generate significant product revenuerevenue, and may not become profitable. Thethe degree of market acceptance of any product candidate, if approved for commercial sale, will depend on a number of factors, including but not limited to:

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,Vir Bio,” “we,” “our” and “us” refer to Vir Biotechnology, Inc. and its consolidated subsidiaries.

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,Vir Bio, we have a bold vision – powering the immune system to transform lives. Our clinical-stage portfolio includes infectious disease programs for CHD and CHBmultiple infections and multiplePRO-XTEN® dual-masked TCEs across validated targets in solid tumor indications. We also hashave a preclinical portfolio of preclinical 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,HDV, our phase 3 ECLIPSE registrational program evaluating the combination of tobevibart and elebsiran is scheduledfully tounderway commencewith inall thethree firsttrials half of 2025.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-5500 in patients with PSMA-expressing mCRPC and VIR-5818 in patients with HER2-expressing tumors and VIR-5500 in patients with PSMA-expressing mCRPC.tumors. We are also advancing our third TCE program,VIR-5525,program, VIR-5525, in patients with EGFR-expressing tumors, with the first patient dosed in phase 1 clinical studies expected to begin in the first half ofJuly 2025. WeIn addition, we are also developing therapeutic candidates in hepatitis B, HIV cure,cure and other solid tumors, leveraging our expertise and platform strengths.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 andimmunology, infectious diseasesdiseases, 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.

•Tobevibart and elebsiran combination therapy hasis receivedsupported by multiple regulatory designations potentially supporting an expedited developmentU.S. and reviewEU processregulatory anddesignations, recognizing the significant unmet need in CHD: U.S.including FDA Breakthrough Therapy designation, U.S. FDA Fast Track designation, European PRIME designation and European Orphan Drug designation.designation, signifying the significant unmet need in CHD.

•We are advancingcurrently multipleprogressing undiscloseda dual-maskednumber of PRO-XTEN® masked TCEs targetingin preclinical studies directed at clinically validated targets with potential applications across a variety of solid tumors.tumors, including lung, colorectal and bladder. These preclinical candidates leverageintegrate the PRO-XTEN™® masking technology with novel TCEs discovered and engineered using our antibody discovery platform and our proprietary dAIsY™ AI engine.

•We willhave continueadvanced to advance our HIVa broadly neutralizing antibody programto fordevelopment candidate status in our HIV cure program in collaboration with the Gates Foundation.

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.

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, 2024,2025, we had $1.1$781.6 billionmillion in cash, cash equivalents, and investments. Based upon our current operating plan, we believe that the $1.1$781.6 billionmillion 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, 2024,2025, we had $95.7$8.9 million in restricted cash and cash equivalents, which includes the $75.0 million subject to VIR-5525 achieving “first in human dosing” by 2026.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$438.0 million for the year ended December 31, 2024,2025, compared to net loss of $522.0 million and $615.1 million for the yearyears ended December 31, 20232024 and net income of $515.8 million for the year ended December 31, 2022,2023, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $759.8$1.2 million.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.

We manufacture product candidates for three therapeutic modalities: mAbs, masked TCEs and siRNA. 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-GMPnon-cGMP manufacturing for preclinical studies and selected quality control testing. Our headquarters also conducts cell line development for our antibody and TCE product candidates.

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 mayexpect to continue to incur net operating losses for the foreseeable future. In December 2024, the FDA revoked EUA granted to sotrovimab in May 2021. Although certain countries outside the U.S. continue to maintain access to 500 mg IV while noting that the clinical efficacy is unknown or uncertain against existing and emerging variants, we cannot predict whether other countries will further limit the use of sotrovimab. We do not expect meaningful license and collaboration revenue in the future from the sale of sotrovimab for the treatment of COVID-19.

ContractLicense and collaboration revenue includes recognition of revenuerevenues generated from license rights issuedissues to Norgine and GSK, including our profit-share from researchthe andsales developmentof servicessotrovimab underpursuant third-partyto contracts,the and2020 fromGSK a third-party clinical supply agreement.Agreement.

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

In addition, under our license agreement with Sanofi,Sanofi and other licensors, we may incur additional clinical, and regulatory milestone payments based on the development progress of certain oncologyclinical 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 “Part I, Item 1A. Risk Factors” section of this Annual Report.

Restructuring, long-livedLong-Lived assetAsset impairmentImpairment and relatedRelated chargesCharges, Net

Restructuring, long-lived asset impairment and related chargescharges, 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.

Other (Expense) Income,Expense, Net

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 AnnualQuarterly Report on Form 10-K,10-Q, including our audited 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 AnnualQuarterly Report on Form 10-K10-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.

•Although the combination of tobevibartelebsiran and elebsirantobevibart has received Fast Track and 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.

•We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments to fund our share of development activities, upon achievement of milestone events and, in certain cases, 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 adverselyhave affecta material adverse effect on our business, reputationbusiness or financial results, and our competitors may be able to utilize such technologies more effectively than we can.

Although we recorded net income for the years ended December 31, 2022,2022 and 2021,2021 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 $125.7$45.6 million and $121.0$231.9 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $1.3$1.2 billion.

ItThere couldis besubstantial severaluncertainty years,around ifthe ever,future beforedevelopment and commercialization of our product candidates, and we aremay ablenot toultimately commercialize any of our product candidates.candidates on the timelines we expect, or at all. Any net losses we incur may fluctuate significantly from quarter to quarter and year to year based on operating expenses and other factors. To become profitable, we must succeed in developing and eventually commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing preclinical and clinical studies of our current and future product candidates, obtaining regulatory approval, procuring commercial-scale manufacturing and marketing, and selling any products for which we obtain regulatory approval (including through third parties), as well as discovering or acquiring and developing additional product candidates. We are only in the preliminary stages of most of these activities, and we may never attain a level of commercial success that will generate sufficient revenue to offset our expenses and maintain profitability. Because of the numerous risks and uncertainties associated with biopharmaceutical product development, we are unable to accurately predict the timing or amount of expenses, or if we will be able to return to profitability. If we are required by regulatory authorities to perform studies in addition to those currently expected, or if there are any delays in the initiation and completion of our clinical studies or the development of any of our product candidates, our expenses could increase.

As of MarchJune 31,30, 2026, we had cash, cash equivalents and investments of $809.3approximately million.$1.01 billion. 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.

We are pursuing development of the combination of tobevibartelebsiran and elebsirantobevibart as a treatment for CHD, which includes both our ECLIPSE registrational trial program evaluating the doublet combination and an ongoing Phase 2 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.

In our early-stage oncology programs, we are evaluating each of VIR-5500, VIR-5818 and VIR-5525 in combination with pembrolizumab in Phase 1 basket studies across multiple tumor types, including metastatic breastexisting cancer and metastatic colorectal cancer (CRC) for VIR-5818 and non-small cell lung cancer (NSCLC), CRC, head and neck squamous cell carcinoma (HNSCC) and cutaneous squamous cell carcinoma (cSCC) for VIR-5525. We are also evaluating VIR-5500 in combination with enzalutamide in mCRPC and with darolutamide in mHSPC in a Phase 1 study with plans to initiate the combination dose-expansion cohorts in both early-line mCRPC and mHSPC in the coming months.therapies. The inclusion of critically ill patients in our oncology clinical studies may result in serious adverse medical events, including death, due to these other therapies or additional medications that such patients may be usingusing, or intheir combination with our product candidates. Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or comparable foreign regulatory authorities could revoke approval of the therapy used in combination with our product candidate. There is also a risk that safety, efficacy, manufacturing or supply issues could arise with these other existing therapies. For example, the other therapies may lead to toxicities that are improperly attributed to our product candidates or the combination of our product candidates with other therapies may result in toxicities that the product candidate or other therapy does not produce when used alone. This could result in our own products being removed from the market or being less successful commercially.

From time to time, we have published, and may publishin the future publish, interim, “top-line” or preliminary data from our clinical studies. Interim data from clinical studies that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or “top-line” data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data is available. Differences between preliminary or interim data and final data could significantly harm our business prospects and may cause the price and/or trading pricevolume of our common stock to fluctuate significantly.

Although the combination of tobevibartelebsiran and elebsirantobevibart has received Fast Track and 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 tobevibartelebsiran and elebsirantobevibart 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. We can provide no assurances that the combination of tobevibartelebsiran and elebsirantobevibart 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,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.

•experience damagereputational to our reputation.harm.

We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments to fund our share of development activities, upon achievement of milestone events and, in certain cases, 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 relinquish certain rights relating to the development and commercialization of an out-licensed product candidate.

At this time, we cannot predict what form such strategic collaborations or licenses might take. We are likely to face significant competition in seeking appropriate strategic collaborators, and in addition such strategic collaborations, licenses and similar arrangements can be complex. We have in the past and may in the future need to renegotiate such arrangements from time to time, and we may not be able to negotiate these arrangements on acceptable terms, or at all. If we are unable to enter into new strategic collaborations or licenses related to our current or potential product candidates in certain geographies for certain indications, or if we are unable to maintain our current strategic collaborations or license on acceptable terms,terms or remain aligned with our collaborators on particular development or commercialization strategies, we may not be able to developrealize andthe commercializefull value of certain of our product candidates,candidates or successfully develop and commercialize them at all, which would harm our business prospects, financial condition and results of operations.

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 adverselyhave affecta material adverse effect on our business, reputationbusiness or financial results, and our competitors may be able to utilize such technologies more effectively than we can.

We integrate AI in our efforts to develop and engineer next-generation antibodies, including through the use of our proprietary dAIsY™ (data, AI structure and antibodY) platform, AI engine, and we might utilize AI in the future in connection with drug discovery activities. AI can be difficult to deploy successfully due to operational and technical issues inherent in such methods. In particular, AI algorithms’ use of machine learning and predictive analytics could lead to flawed, biased or inaccurate results, which, if detected,undetected, could lead to ineffective product or target candidates and exposure to competitive and reputational harm. In addition, any latency, disruption, or failure in our AI operations or infrastructure could result in failures, delays or errors in our discovery and development of next-generation antibodies or other investigational products. Developing, testing and deploying resource-intensive AI systems may also require additional investment and increase our costs, and there is no guarantee that our investment in such systems will lead to more effective or efficient discovery or development of antibodies or other investigational products, or lead to eventual regulatory approval or commercialization of any new products. In addition, our competitors may be able to use AI-powered technologies more effectively than we can.

We currently focus our product development on product candidates for the treatment and prevention of serious infectious diseases, cancer and other serious conditions. Our eligible patient population, pricing estimates and available coverage and reimbursement may differ significantly from the actual market addressable by our product candidates. Our estimates of the number of people who have these diseases, the subset of people with these diseases who have the potential to benefit from treatment with our product candidates, and the market demand for our product candidates, are each based on our beliefs and analyses. These estimates have been derived from a variety of sources, including the scientific literature, patient foundations or market research, and may prove to be incorrect. Furthermore, new studies may change the estimated incidence or prevalence of the diseases we are targeting. The FDA or the comparable foreign regulatory authorities also may approve or authorize for marketing a product candidate for a more limited indication or patient population than we originally request. Additionally, the availability of superiorequivalent or competitivesuperior therapies from our competitors could negatively impact or eliminate market demand for our product candidates. If the market opportunities for our product candidates are smaller than we estimate, it could have a material adverse effect on our business, financial condition, results of operations and prospects.

As a result of these factors, our competitors may achieve patent protection or obtain regulatory approval or authorization of their products before we are able to, which could result in our competitors establishing a strong market position before we are able to enter the market. For example, in May 2026, the FDA approved a therapy for the treatment of CHD in adults, the first such approved therapy in the United States. We are pursuing development of the combination of elebsiran and tobevibart as a treatment for CHD in registrational trials, and the availability of an approved therapy for CHD in the United States could affect the standard of care, physician adoption, patient expectations, the market size and the competitive landscape for our CHD program. Our competitors may also develop and obtain approval for therapies that demonstrate stronger safety and efficacy data, have fewer or less severe side effects, are more convenient,conveniently administered, or are more widely accepted or less expensive than ours, and such competitors may also be more successful than we are in manufacturing, marketing or obtaining reimbursement for their products. These advantages could render our product candidates obsolete or non-competitive before we can recover the development and commercialization costs of such product candidates. For additional information regarding our competitors, see the section titled “Part I, Item 1. Business—Competition” in our Annual Report on Form 10-K for the year ended December 31, 2025.

•injuryreputational to our reputationharm and/or significant negative media attention.

Even if resolved in our favor, litigation or other legal proceedings relating to healthcare laws and regulations can be expensive and time-consuming and could divert management’s attention from our core business. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if research analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price or trading volume of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development, manufacturing, sales, marketing or distribution activities. Uncertainties resulting from the initiation and continuation of litigation or other proceedings relating to applicable healthcare laws and regulations could have a material adverse effect on our ability to compete in the marketplace.

In addition, noncomplianceNoncompliance with anti-corruption, anti-bribery or anti-money laundering laws could subject us to whistleblower complaints, investigations, sanctions, settlements, prosecution, other enforcement actions, disgorgement of profits, significant fines, damages, other civil and criminal penalties or injunctions, suspension and/or debarment from contracting with certain persons, the loss of export privileges, reputational harm, adverse media coverage and other collateral consequences. If any subpoenas or investigations are launched, or governmental or other sanctions are imposed, or if we do not prevail in any possible civil or criminal litigation, our business, financial condition, results of operations and prospects could be materially harmed. In addition, responding to any action will likely divert resources and management’s attention from our core business, as well as cause us to incur significant defense costs and other professional fees. EnforcementIf actionsany andsubpoenas or investigations are launched, or governmental or other sanctions couldare furtherimposed, harmor if we do not prevail in any possible civil or criminal litigation, our business, reputation, financial condition, results of operations and prospects.prospects could be materially harmed.

We are currently conducting process development and manufacturing materials for product candidates of three different therapeutic modalities: monoclonal antibodies, siRNAs and TCEs. Except for process, analytical and formulation development, cell line development, non-cGMP manufacturing and quality control testing for preclinical studies, we do not own or operate facilities for large-scale process development or product manufacturing, storage and distribution, or testing. We are dependent on multiple third parties, including strategic collaborators and contract development and manufacturing organizations (CDMOs), to obtain product raw materials and components, develop large-scale manufacturing processes for and manufacture clinical and future commercial supplies of our product candidates. The actual cost to manufacture our product candidates, including the requisite scale-up activities for commercial supplies, is difficult to estimate and could affect the commercial viability and competitive position of our product candidates. Additionally, scaling up a biologic manufacturing process is a difficult and uncertain task and involves additional risks, including cost overruns, process reproducibility, stability issues, cGMP compliance, lot consistency and timely availability of manufacturing slots and sufficient quantityquantities of raw materials.

We also intend to rely on CDMOs to supply us with sufficient quantities of our product candidates to be used, if approved, for commercialization. Any shortfall in a CDMO’s manufacturing capacity or reduction in anticipated manufacturing titer, yield per batch or batch success rates may adversely impact our ability to meet market demand. Furthermore, if we are not able to produce supply at low enough costs, it could negatively impact our ability to generate revenue,revenue harmand/or ourlead reputation,to reputational harm, and could have a material adverse effect on our business, financial condition, results of operations and prospects.

•reliance on single sources for raw materialsmaterials, components or components,finished products, including the risk that such single source may not remain in business or will be purchased by a competitor or other company not interested in continuing production, or the lack of qualified backup suppliers for those raw materials or components;

The U.S. government has made statements and taken actions that have led to certain changes and may lead to additional changes to U.S. and international trade policies. For example, President Trump has imposed or signaled to impose a series of tariffs on certain products manufactured outside the United States, including pharmaceutical products and raw materials and components for pharmaceutical products, and it is unknown whether and to what extent additional tariffs (or other new laws or regulations) will be adopted, or the effect that any such actions would have on us or our industry. While the tariffs imposed under the International Emergency Economic Powers Act were overturned by the U.S. Supreme Court, the Trump Administration has used other statutory authorities to implement temporary import surcharges and has proposed additional tariffs on multiple trading partners, and related court challenges remain pending, contributing to ongoing uncertainty around the scope and duration of U.S. tariff measures. Any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, may affect the demand for our product candidates, the competitive position of our product candidates, and import or export of raw materials and product used in our drug development, clinical manufacturing and future commercial activities.activities, While the tariffs imposed under the International Emergency Economic Powers Act were overturned by the U.S. Supreme Court, if any new tariffs, export controls, legislation and/or regulations are implemented, or if existing trade agreements are renegotiated or if the U.S. government takes retaliatory trade actions due to the ongoing trade tensions, such changeswhich could have ana material adverse effect on our business, financial condition andcondition, results of operations.operations and prospects.

Our commercial success depends, in part, upon our ability and the ability of others with whom we may collaborate to develop, manufacture, market and sell our current and any future product candidates and use our proprietary technologies without infringing, misappropriating or otherwise violating the proprietary rights and intellectual property of third parties. The biotechnology and pharmaceutical industries are characterized by extensive and complex litigation regarding patents and other intellectual property rights. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing our product candidates. We have in the past and may in the future become party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to our current and any future product candidates and technology, including interference proceedings, derivation proceedings, post grant review, inter partes review before the USPTO, or as counterclaims in litigation initiated by us. If we are found to infringe a third party’s valid and enforceable intellectual property rights, we could be required to obtain a license from such third party to continue developing, manufacturing and marketing our product candidate(s) and technology. Under any such license, we would most likely be required to pay various types of fees, milestones, royalties or other amounts and any such license could be nonexclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us. Moreover, we may not be able to obtain any required license on commercially reasonable terms or at all, including because companies that perceive us to be a competitor may be unwilling to assign or licenses rights to use, and if such an instance arises, our ability to commercialize our product candidates may be impaired or delayed, or we may have to abandon development of the related program or product candidate, which could in turn significantly harm our business. Parties making claims against us may also seek and obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our product candidates. We could be forced, including by court order, to cease developing, manufacturing and commercializing the infringing technology or product candidate. We may also have to redesign our products, which may not be commercially or technically feasible or require substantial time and expense.

In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent or other intellectual property right, and we may also be required to indemnify collaborators or contractors against such claims. Even if we are successful in defending against such claims, litigation can be expensive and time-consuming and could divert resources and management’s attention from our core business. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments, and if research analysts or investors perceive these results to be negative, it could have an adverse effect on the price or trading volume of our common stock.

We have in the past experienced, and expect to continue to experience, growth in the scope of our operations, particularly in the areas of research, clinical development and regulatory affairs.affairs as we continue to advance the clinical programs for our product candidates. In addition, if any of our product candidates receives marketing approval, we will need to build out our sales and marketing capabilities, either on our own or with others. To manage any future growth, we must continue to implement and improve our managerial, operational and financial systems, improve our facilities, and continue to recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and could divert business development resources and management’s attention. We may not be able to effectively manage any further expansion of our operations, recruit and train additional qualified personnel, or succeed at effectively integrating employees into our operations. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

Business disruptions could seriously harmimpact our future revenue and financial condition and increase our costs and expenses.

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 seriouslyhave harma material adverse impact on our operations and financial condition and increase our costs and expenses.

In addition, such a breach or cybersecurity incident may require public disclosure or notification to governmental agencies, supervisory bodies, credit reporting agencies, the media, individuals, collaborators or others pursuant to various federal, state and foreign data protection, privacy and security laws, regulations and guidelines, industry standards, our policies and our contracts, if applicable. These notices may be costly and could cause reputational harm ourand reputation andimpede our ability to compete, and our ultimate disclosure or failure to comply with such requirements could lead to a material adverse effect on our reputation, business,business or financial condition. Moreover, federal, state and foreign laws and regulations can expose us to enforcement actions and investigations by regulatory authorities, and potentially result in regulatory penalties and significant legal liability, if our information technology security efforts fail.

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 (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 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) contractual obligations of Vir Bio or 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 seriousreputational harm to our reputation.harm.

Beginning in 2022, the Tax Cuts and Jobs Act of 2017 eliminated the option to deduct research and development expenditures and required taxpayers to capitalize and amortize them over five or fifteen years pursuant to Section 174 of the Internal Revenue Code of 1986, as amended (the Code), which reduced our net operating losses. The OBBBA suspends the requirement to capitalize and amortize domestic “research or experimental expenditures” (as defined in the OBBBA) over five years and instead allows taxpayers to immediately deduct such expenses for tax years beginning after December 31, 2024. In addition, with respect to domestic research or experimental expenditures incurred in a taxable year beginning after December 31, 2021 and before January 1, 2025, taxpayers may elect to accelerate the remaining unamortized amounts of such expenses over a one- or two-year period. Both aforementioned changes under the OBBBA to the treatment and deductibility of such expenses could potentially increase our anticipated net operating losses. The treatment of foreign research and development expenses remains unchanged, requiring amortization over 15 years. We are continuing to evaluate the future impacts of the OBBBA as additional information is provided.

Some companies that have experienced volatility in the trading price of their shares have been the subject of securities class action litigation. Any lawsuit to which we are a party, with or without merit, may result in an unfavorable judgment. We also may decide to settle lawsuits on unfavorable terms. Any such negative outcome could result in payments of substantial damages or fines, damagereputational to our reputationharm or adverse changes to our business practices. Defending against litigation can be expensive and time-consuming and could divert resources and management’s attention from our core business. Furthermore, during the course of litigation, there could be negative public announcements of the results of hearings, motions or other interim proceedings or developments, which could have a negative effect on the market price of our common stock.

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

Following is a summary of selected significant developments affecting our business that occurred since the filing of our AnnualQuarterly Report on Form 10-K10-Q for the period ended DecemberMarch 31, 2025.2026. 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.

•◦Topline data from the Phase 3 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.

•On April 15, 2026, weWe 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-targetedPSMA-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 expect to report updated dose-escalation data from our Phase 1 dose-escalationtrial ofevaluating VIR-5818, a HER2-targeted PRO-XTEN® dual-masked TCE, as a monotherapy and in combination with pembrolizumab continues, with response data expectedpembrolizumab, in the second half of 2026. The dose-escalation parts of the Phase 1 trial have a basket design, enrolling across multiple tumor types.

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

•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.tumors.

•On AprilJuly 7,20, 2026, MarkJason Eisner,O’Byrne, MD,MBA, MPH,our Executive Vice President and Chief MedicalFinancial Officer of Vir Biotechnology, Inc. (the Company),Officer, informed us that he willwould be stepping down from his role, effective AprilAugust 24,3, 2026. TheWe Company hashave 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.”

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

In addition, under our some of our license agreements , 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 Quarterly Report.

Other Expense,(Expense) Income, Net

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

Comparison of the Three and Six Months Ended MarchJune 31,30, 2026 and 2025

The decreaseincrease in grantlicense and collaboration revenue for the three and six months ended MarchJune 31,30, 2026 compared to the same periodperiods in 2025 was primarily due to lowerthe recognition of $239.3 million in license and collaboration revenue recognizedrelated into accordancethe withupfront payment received under our collaboration and license agreement with theAstellas Gates(Astellas Foundation.Collaboration Certain grant agreements with the Gates Foundation expired in 2025.Agreement).

The decrease in other revenue for the three and six months ended MarchJune 31,30, 2026 compared to the same periodperiods in 2025 was primarily due to lower revenue recognized in connection with option-expiration and the sale of clinical supply to Brii Biosciences Limited (Brii Bio Parent).

The decreaseincrease in research and development expenses for the three months ended MarchJune 31,30, 2026 compared to the same periods in 2025 was primarily due to:

•higher contract manufacturing associatedattributable withto process performance qualificationPPQ batches (PPQs)for relatedour toCHD program and increased manufacturing activities supporting the advancement of our CHDoncology program;

The decreaseincrease in selling, general and administrative expenses for the three and six months ended MarchJune 31,30, 2026 compared to the same periodperiods in 2025 was nominal.primarily due to higher one-time advisory and legal fees in connection with the Astellas Collaboration Agreement.

The change in restructuring, long-lived assets impairment and related charges for the three and six months ended MarchJune 31,30, 2026 compared to the same periodperiods in 2025 was nominal.

Our equity investment consisted solely of shares of Brii Bio Parent, which is a marketable equity investment and remeasured to fair value at each reporting date. For the three and six months ended MarchJune 31,30, 2026, we recognized an unrealized loss of $0.2$1.7 million and $1.9 million due to the change in fair value, respectively, compared to an unrealized loss of $3.4 million and unrealized gain of $6.4$3.0 million for the same periodperiods in 2025.2025, respectively.

The decrease in interest income for the three and six months ended MarchJune 31,30, 2026 compared to the same periodperiods in 2025 was primarily due to lower balances of cash, cash equivalents, and investments and lower interest rates.

Other Expense,(Expense) Income, Net

The change in other expense,(expense) income, net for the three and six months ended MarchJune 31,30, 2026 compared to the same periods in 2025 was nominal.

The provision for income taxes for the three and six months ended MarchJune 31,30, 2026 compared to the same periodperiods in 2025 was nominal.

Liquidity, Capital Resources and Capital Requirements Sources of Liquidity

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 MarchJune 31,30, 2026, we had $809.3approximately million$1.01 billion in cash, cash equivalents, and investments and approximately $8.9 million in restricted cash and cash equivalents. As of MarchJune 31,30, 2026, our accumulated deficit was $1.3$1.2 billion.

In November 2023, we entered into a sales agreement (Sales Agreement) with Cowen and Company, LLC, as sales agent (TD Cowen), pursuant to which we may from time to time offer and sell shares of our common stock for an aggregate offering price of up to $300.0 million, through or to TD Cowen, acting as sales agent or principal. The shares will be offered and sold under the 2023 Shelf Registration Statement. We will pay TD Cowen a commission of up to 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide TD Cowen with customary indemnification and contribution rights. As of MarchJune 31,30, 2026, no shares have been issued under the Sales Agreement. The Sales Agreement will expire in November 2026.

We do not expect to generate significant revenue from the sale of our product candidates until we complete clinical development, submit regulatory filings and receive approvals from the applicable regulatory bodies for such product candidates, if ever. We may continue to incur net losses for the foreseeable future. Based upon our current operating plan, we believe that our existing cash, cash equivalents and investments as of MarchJune 31,30, 2026 as noted above will enable us to fund our operations for at least the next 12 months from the filing date of this Quarterly Report on Form 10-Q.

Our primary operating lease arrangements are for office and laboratory spaces located in California and Switzerland with contractual lease periods expiring between 2033 and 2035. As of MarchJune 31,30, 2026, we expect to make total lease payments of approximately $117.8$114.2 million through 2035.