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Item 1. Business

2026-02-23 compared with 2025-02-27 · 330 added, 357 removed, 564 unchanged (55% of the section changed)

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Vir Biotechnology, Inc.

(including its subsidiaries, referred to as “VirBio,” “the Company,” “we,” “our” or “us”) is 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.

(including its subsidiaries, referred to as “Vir Bio,” “the Company,” “we,” “our” or “us”) is 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.

These diseases represent formidable challenges to human health.

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Our mission is to develop innovative therapies that can transform patients' lives by addressing areas of high unmet medical need.

Our clinical development pipeline consists of investigational therapies targeting hepatitis delta virus (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.

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 T-cell engagers (TCEs):

VIR-5818 in patients with HER2-expressing tumors and VIR-5500 in patients with PSMA-expressing metastatic castration-resistant prostate cancer (mCRPC).

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

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

Advancement of our HBV program beyond the current MARCH study is contingent upon securing a worldwide (excluding People’s Republic of China, Taiwan, Hong Kong and Macau, collectively the “China Territory”) development and commercialization partner.

Our clinical development pipeline consists of investigational therapies targeting hepatitis delta virus (HDV) and multiple solid tumors.

In hepatitis delta, we have initiated our registrational ECLIPSE clinical program evaluating the tobevibart and elebsiran combination in people living with chronic hepatitis delta (CHD).

The three randomized, controlled trials (ECLIPSE 1, 2, and 3) are ongoing, with ECLIPSE 1 and 3 completing enrollment ahead of the Company’s expectations.

Topline results from ECLIPSE 1 are expected in the fourth quarter of 2026 with topline results from ECLIPSE 2 and 3 expected in the first quarter of 2027.

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 CHD patients, for whom approved treatment options are either limited or unavailable.

In oncology, we are advancing three Phase 1 clinical studies of dual-masked T-cell engagers (TCEs):

VIR-5500 in patients with Prostate-Specific Membrane Antigen (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.

We are developing therapeutic candidates in HIV cure and multiple solid tumors.

Our HIV broadly neutralizing antibodies (bnAbs) are being developed as a potential long-acting treatment or cure in combination with existing or investigational regimens.

These research and development efforts are driven by two core technology platforms—an advanced antibody discovery and protein engineering platform, and the exclusive PRO-XTEN ™ dual-masked TCE platform (a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company (PRO-XTEN ™ )), which we in-licensed from Sanofi for worldwide rights in oncology and infectious diseases.

These platforms, individually and in combination, enable us to modulate the immune system in innovative ways, harnessing its power to combat viruses and fight cancer.

Our antibody platform leverages artificial intelligence and machine learning (collectively referred to as AI) for optimization, while the PRO-XTEN ™ platform allows for the development of potentially best-in-class TCEs with improved safety and efficacy profiles across multiple therapeutic areas.

We have also made available for external partnerships our next-generation preclinical influenza A and B antibodies and antibody drug conjugates (ADCs), along with our next generation coronavirus (COVID) monoclonal antibodies.

We are advancing multiple undisclosed PRO-XTEN ® 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 TCE fragments discovered and engineered using our antibody discovery platform.

These research and development efforts are driven by Vir Bio’s discovery engine, comprised of our exceptional protein engineering and antibody discovery expertise and our two core technology platforms — our proprietary dAIsY™ (data, AI structure and antibodY) platform utilizing artificial intelligence and machine learning (collectively referred to as AI) for antibody optimization, and the exclusive PRO-XTEN ® (a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company) masking platform, which we in-licensed from Sanofi for worldwide rights in oncology and infectious diseases.

The PRO-XTEN ® platform allows for the development of potentially best-in-class TCEs with improved safety and efficacy profiles across multiple therapeutic areas.

The dAIsY™ and PRO-XTEN ® platforms, individually and in combination, enable us to modulate the immune system in innovative ways, harnessing its power to combat viruses and fight cancer.

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.

Given the global impact of infectious diseases and cancer, we are committed to developing transformative therapies that can make a meaningful difference in the lives of people living with these serious diseases.

Our Research and Development Pipeline

Millions of people suffer from infectious diseases and cancer, where a key factor is evasion of the innate immune system.

Our strategy leverages this commonality to power the immune system to fight back.

We use our world-class capabilities in antibody discovery and engineering, coupled with our proprietary AI engine (data AI structure and antibody system, or dAIsY ™ system), and the PRO-XTEN ™ masking technology, to quickly and effectively discover and optimize potential new medicines.

At Vir Bio, we are advancing our mission of powering the immune system with innovative medicines to transform lives, with the goal of driving better outcomes for patients in areas of high unmet medical need, such as infectious diseases and cancer.

We use our world-class capabilities in antibody discovery and engineering, coupled with our proprietary AI engine dAIsY ™ system, and the PRO-XTEN ® masking platform, to quickly and effectively discover and optimize potential new medicines.

We have built a strong foundation based on cutting-edge core scientific capabilities and a world-class team of experts who bring deep knowledge and experience to our R&D efforts.

This has enabled us to make significant strides in developing treatments for infectious diseases and strategically expand our approach to address critical oncology indications with limited treatment options.

Our pipeline includes multiple candidates in clinical development stages for diseases with significant unmet medical need, which is summarized by disease area in the chart below.

This has enabled us to make significant strides in developing treatments for infectious diseases and to strategically expand our approach to address critical oncology indications with limited treatment options.

Our pipeline includes multiple candidates in clinical development for diseases with significant unmet medical need, which is categorized by disease area in the chart below.

Masked TCEs licensed from Sanofi

Human Immunodeficiency Virus;

peg-interferon alfa-2a;

monoclonal antibody;

small interfering RNA;

2 In collaboration with the Gates Foundation

androgen receptor pathway inhibitors;

epidermal growth factor receptor;

human epidermal growth factor receptor 2;

human immunodeficiency virus;

prostate-specific membrane antigen;

epidermal growth factor receptor.

small interfering RNA;

T-cell engager

Tobevibart incorporates Xencor’s Xtend TM and other Fc technologies.

Norgine holds exclusive license for the commercial rights to the combination of tobevibart and elebsiran in Europe, Australia and New Zealand

Brii Bioscience retains rights to the combination of tobevibart and elebsiran in the Greater China Territory (People’s Republic of China, Hong Kong, Taiwan and Macau)

Infectious Diseases

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subviral particle

Chronic Hepatitis Delta (CHD)

CHD is a chronic, progressive liver disease caused by the HDV, which requires HBV for its replication.

This means that hepatitis delta infection cannot occur in the absence of HBV.

CHD is a progressive liver disease caused by HDV, which requires HBV for its replication.

This means that HDV infection cannot occur in the absence of HBV.

HDV-HBV coinfection is the most severe form of chronic viral hepatitis.

CHD increases the risk of liver cancer and accelerates progression to cirrhosis and liver failure, which often occurs within 5 years of infection.

HDV, recently classified as carcinogenic by the International Agency for Research on Cancer, increases the risk of liver cancer and accelerates progression to cirrhosis and liver failure, which often occurs within five years of infection.

There is no approved CHD treatment in the U.S., and options are limited in the European Union and globally.

VirBio is working to develop a chronic suppressive therapy to help address this significant unmet medical need, based on a combination of our investigational antibody, tobevibart, and a siRNA, elebsiran.

Vir Bio is working to develop a chronic suppressive therapy to help address this significant unmet medical need, based on a combination of our investigational antibody, tobevibart, and a siRNA, elebsiran.

Tobevibart + elebsiran for CHD

Phase 2 Trial of tobevibart, both alone and in combination with elebsiran in hepatitis delta .

SOLSTICE is a Phase 2 study to evaluate the safety, tolerability, and efficacy of tobevibart, alone or in combination with elebsiran, in people with CHD.

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Primary endpoints include proportion of participants with protocol defined virologic endpoint (defined as HDV RNA equal or greater than 2 log 10 decrease from baseline or below limit of detection) up to Week 24, alanine aminotransferase (ALT) normalization (defined as ALT below upper limit of normal) up to Week 24, and treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) up to 118 weeks.

Secondary endpoints include proportion of participants with undetectable HDV RNA and different timepoints up to 192 weeks.

Secondary endpoints include proportion of participants with undetectable HDV RNA at different timepoints up to 192 weeks.

Clinical trial participants have been randomized to receive tobevibart 300 mg monotherapy every two weeks (n=33) or a combination of tobevibart 300 mg and elebsiran 200 mg every four weeks (combination de novo arm, n=32).

In addition, the participants from previous tobevibart or elebsiran monotherapy cohorts could rollover to receive the combination of tobevibart 300 mg and elebsiran 200 mg every four weeks (combination rollover , n=13).

The latest data from the ongoing clinical trial was presented in an oral session at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting ® , in San Diego, CA, in November 2024.

The data included rates of virologic suppression and ALT normalization evaluated at Week 24, and Weeks 36, 48 and 60 in those participants that had reached each timepoint.

The trial assesses the combined endpoint of HDV RNA decrease ≥ 2 log 10 compared to baseline or HDV RNA below LOD and ALT normalization, which is the current combined endpoint used for regulatory approval.

At the same time, HDV RNA below the lower limit of quantification (< LLOQ), target not detected (HDV RNA TND) and the composite endpoint of HDV RNA TND and ALT normalization is also being monitored to assess efficacy.

100% of participants across combination arms achieved an HDV RNA ≥2 log 10 decrease or below LOD at Week 24, and this rate was sustained over time in all participants at Weeks 36 (22/22) and those in the combination rollover cohort that reached Week 60 (5/5).

HDV RNA TND was achieved in 41% (13/32) of participants across combination arms at Week 24 and this rose to 64% (14/22) at Week 36.

By week 60, this had risen further with 80% (4/5) of participants in the combination rollover cohort having achieved no detectable viral RNA.

ALT decreased in most participants between Day 1 and Week 24 and normalized in 47% (15/32) of participants in the combination de novo cohort and 56% (5/9) in the combination rollover cohort by Week 24.

These rates were sustained at Week 36.

The protocol defined combined endpoint of HDV RNA decrease ≥ 2 log 10 compared to baseline or HDV RNA below LOD and ALT normalization at Week 24 was observed in 47% (15/32) of participants in the combination de novo arm.

The more stringent composite endpoint of HDV RNA TND and ALT normalization was achieved in 19% (6/32) of participants in the combination de novo arm at Week 24, which increased to 27% (6/22) by Week 36.

This trend was reflected in the combination rollover cohort in which 33% (3/9) of participants achieved this endpoint at Week 24 and 40% (2/5) at Week 60.

Rates of HDV RNA suppression and ALT normalization were similar between non-cirrhotic and cirrhotic participants across combination arms.

The safety profile of tobevibart and elebsiran is consistent with previous studies.

TEAEs were generally mild or moderate and transient across all treatment groups, with influenza-like symptoms being the most common event.

No ALT flares were observed.

There were no study-related discontinuations in the combination arms, and no treatment-related SAEs were reported.

A Phase 3 registrational clinical program, ECLIPSE, which will evaluate the tobevibart and elebsiran combination in people living with CHD, is expected to commence in the first half of 2025.

The trial will include three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide.

All studies will enroll both cirrhotic and non-cirrhotic participants.

The combination of tobevibart and elebsiran have now been recognized by the U.S.

48-week data from the ongoing clinical trial was presented in an oral session at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting ® , in Washington, D.C., in November 2025 and simultaneously published in the New England Journal of Medicine .

Additional data was later presented at the 44ᵗʰ Annual J.P.

Morgan Healthcare Conference in January 2026.

These data demonstrate that undetectable hepatitis delta virus RNA (HDV RNA Target Not Detected, TND) was achieved and maintained by 77% (24/31) of participants receiving the combination of tobevibart and elebsiran at Week 72, and this rate increased to 88% (21/24) in the subset of participants evaluated through Week 96.

By contrast, HDV RNA TND was achieved by 53% (17/32) of participants receiving tobevibart antibody monotherapy at Week 72 and 46% (11/24) in the subset of participants evaluated through Week 96.

Additionally, approximately 90% of participants receiving the combination therapy achieved reduction in HBsAg to values <10 IU/mL by Week 24 and kept that response through Week 72 and (for the subset of patients evaluable) Week 96, compared to approximately 20% of participants receiving antibody monotherapy at every time point.

HBsAg reduction indicates suppression of the fundamental biologic mechanisms that HDV requires for viral replication.

ALT was normalized in approximately half of participants by Week 72 and (for the subset of patients evaluable) Week 96.

There were no grade 3 or higher treatment-related adverse events in the combination arm, and treatment emergent adverse events were generally mild to moderate and transient.

Vir Bio initiated its registrational clinical program, ECLIPSE, evaluating the tobevibart and elebsiran combination in people living with CHD, in March of 2025.

The program includes three randomized, controlled trials (ECLIPSE 1, 2, and 3) designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide.

All three trials are ongoing, with ECLIPSE 1 and 3 completing enrollment ahead of the Company’s expectations.

Topline results from ECLIPSE 1 are expected in the fourth quarter of 2026, and topline results from ECLIPSE 2 and ECLIPSE 3 are expected in the first quarter of 2027.

The combination of tobevibart and elebsiran has now been recognized by the U.S.

Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for their potential to address the critical unmet need in CHD.

In June 2024, the combination received Fast Track designation from the FDA, which was followed by Breakthrough Therapy designation in December 2024.

In addition, the combination received a Priority Medicines (PRIME) designation from the EMA, and orphan drug designation from the European Commission (EC), each in December 2024.

The investigational combination therapy has been granted Breakthrough Therapy and Fast Track designations by the U.S.

Food and Drug Administration (FDA), and Priority Medicines (PRIME) and orphan drug designations by the EMA.

On December 15, 2025, we and Norgine Pharma UK Limited (together with its affiliates in the Norgine group of companies, Norgine) entered into a License Agreement (the Norgine Agreement) with respect to certain commercial and certain development rights to the combination of tobevibart and elebsiran for the treatment of people living with CHD as described in further detail below under “—Our Collaboration, License and Grant Agreements,” Under the terms of the Norgine Agreement, Vir Bio granted Norgine an exclusive license for the commercial rights and certain development rights to the combination for the treatment of CHD in Europe, Australia, and New Zealand (collectively, the Norgine Territory), while Vir Bio will retain commercial rights for the combination in the United States and all other international markets outside of the People’s Republic of China and Taiwan.

Chronic Hepatitis B (CHB)

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The rate of functional cure (lifelong control of the virus after a finite duration of treatment) with current approved treatments is 3%-7%.

Alternatively, suppressive therapy with daily nucleotide/nucleoside transcriptase inhibitors (NRTIs) is commonly used, and CHB patients often require a lifetime of therapy, and NRTIs reduce but do not eliminate the risk of further progression and developing end-stage liver disease complications such as cirrhosis or cancer.

We are pursuing a functional cure for CHB based on a combination regimen of tobevibart and elebsiran with or without pegylated interferon alpha (PEG-IFNα).

Tobevibart + elebsiran ± PEG-IFNα for CHB

Phase 2 Trial of tobevibart in combination with elebsiran alone (doublet regimen) or in combination with PEG-IFNα (triplet regimen) .

Alternatively, suppressive therapy with daily nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) is commonly used, and CHB patients often require a lifetime of therapy, and NRTIs reduce but do not eliminate the risk of further progression and developing end-stage liver disease complications such as cirrhosis or cancer.

In July 2021 we initiated the MARCH two-part study to evaluate the combination of tobevibart and elebsiran in virally suppressed HBV patients.

MARCH Part A evaluated short treatment courses of tobevibart and elebsiran to rapidly evaluate safety, pharmacokinetics and HBsAg suppression when tobevibart is given weekly concomitantly with or after pre-treatment with elebsiran.

Results from MARCH Part A in 2022 showed that the combination of tobevibart and elebsiran resulted in an approximate 3 log 10 IU/mL decline in HBsAg with no safety signals.

In November 2022, we announced end of treatment data for all MARCH Part A that the combination of tobevibart and elebsiran achieved mean HBsAg reductions >2.7 log 10 IU/mL in all cohorts, absolute HBsAg levels <10 IU/mL were achieved in most participants, and no safety signals.

Follow-up data after end of treatment showed rebounds in HBsAg levels over time.

MARCH Part B includes cohorts treated for 24- and 48-weeks with monthly doses of tobevibart plus elebsiran with and without PEG-INF-α.

In November 2024, we presented 48-week end-of-treatment data from MARCH Part B that evaluated the combination of tobevibart and elebsiran alone or with IFN-α (doublet and triplet regimens, respectively) in an oral session at the AASLD The Liver Meeting ® , in San Diego, CA.

This analysis included data from 51 participants in the doublet regimen arm and 27 participants in the triplet regimen arm at the end of treatment.

The study demonstrated promising rates of HBsAg loss (seroclearance, defined as HBsAg below the lower limit of quantification) in participants with low baseline HBsAg (<1000 IU/mL) in both combination regimens.

The efficacy and safety profile support continued development to evaluate the potential to achieve a functional cure.

The doublet and triplet regimens resulted in HBsAg loss at the end of treatment in 39% (7/18) and 46% (5/11) of participants with baseline HBsAg<1,000 IU/mL, respectively.

The proportion of participants with varying baseline HBsAg levels who achieved HBsAg loss at end of treatment was 16% (8/51) for the doublet and 22% (6/27) for the triplet regimen.

The doublet regimen resulted in 50% (4/8) of participants who had achieved HBsAg loss also achieving anti–hepatitis B surface antibody (anti-HBs) seroconversion.

All participants with HBsAg loss at the end of treatment who received the triplet regimen achieved anti-HBs seroconversion (100%, 6/6).

Participants with HBsAg seroclearance at end of treatment who meet eligibility criteria will discontinue treatment.

Functional cure assessment will occur 24 weeks after treatment discontinuation.

Functional cure data is expected in the first half of 2025.

The Phase 2 PREVAIL platform trial evaluating the efficacy and safety of tobevibart and elebsiran in participants with CHB is ongoing.

This trial is designed to evaluate combinations of tobevibart, elebsiran and/or PEG-IFNα in two patient populations:

immune-active but treatment-naïve and inactive carriers.

The latest results from the MARCH Part B Phase 2 trial evaluating the combination of tobevibart and elebsiran without or with pegylated interferon alpha (PEG-IFNα) were presented in an oral session at the European Association for the Study of the Liver (EASL) congress in Amsterdam (The Netherlands) in May 2025.

The 24-week post-end of treatment data revealed that the study-defined primary endpoint, proportion of participants with undetectable HBsAg at 24 weeks post-end of treatment, was achieved by 17% (3/18) and 21% (3/14) of participants with baseline HBsAg<1,000 IU/mL receiving tobevibart and elebsiran without or with PEG-IFNα, respectively.

These proportions were 8% (4/51) and 16% (5/32) for tobevibart and elebsiran without or with PEG-IFNα, respectively, in all participants.

The safety and tolerability profile of tobevibart and elebsiran was consistent with prior studies, with no new safety concerns and generally only mild or moderate treatment emergent adverse events being reported throughout the study.

Vir Bio decided not to pursue Phase 3 development of combinations of tobevibart, and elebsiran in CHB.

We have streamlined the final stages of the MARCH Phase 2 program to ensure continued participant benefit and safety.

Elebsiran is also being evaluated in additional Phase 2 clinical trials with collaborators.

Brii Biosciences Offshore Limited (Brii Bio) is the sponsor for the Phase 2 trial of elebsiran in combination with BRII-179, an investigational therapeutic vaccine, for the treatment of chronic HBV infection.

As described in further detail below under the heading “Our Collaboration, License and Grant Agreements,” we granted Brii Bio an option to obtain exclusive rights to develop and commercialize elebsiran and tobevibart in the China Territory, for the treatment, palliation, diagnosis, prevention or cure of acute and chronic diseases of infectious pathogen origin or hosted by pathogen infection, or the Field of Use.

As described in further detail below under “—Our Collaboration, License and Grant Agreements,” we granted Brii Bio an option to obtain exclusive rights to develop and commercialize elebsiran and tobevibart in the Greater China Territory (People’s Republic of China, Hong Kong, Taiwan and Macau), for the treatment, palliation, diagnosis, prevention or cure of acute and chronic diseases of infectious pathogen origin or hosted by pathogen infection, or the Field of Use.

HIV treatment and functional cure

Despite major advances in HIV treatment, most people living with HIV must take daily antiretroviral medications for viral control.

HIV broadly neutralizing antibodies (bnAbs) are a novel modality that has shown promise for controlling the virus without daily antiretroviral medications.

Furthermore, HIV bnAb treatment can induce a state of viral control off therapy, effectively a functional cure.

While these outcomes are currently only found in rare individuals and for limited time periods, it suggests that HIV bnAbs could be an important part of a functional cure regimen.

With the support of the Gates Foundation, we are developing a unique and innovative HIV bnAb therapeutic.

We have in-licensed HIV bnAbs from Togontech GmbH, including the 04-A06 bnAb published in Nature Immunology, that shows what we believe to be favorable preclinical properties, including neutralization breadth and potency to combat the diversity of HIV strains worldwide and resistance to the ability of the virus to escape from therapeutic intervention.

We are further engineering HIV bnAbs with our Fc engineering technology to enhance their half-life, effector functions, and engagement with the patient’s immune system.

We believe the resulting therapeutic can make an important impact on the lives of people living with HIV.

One in five people worldwide develop cancer during their lifetime, and although tremendous strides have been made in cancer prevention and treatment, cancer still remains the second-leading cause of death globally and remains the leading or second-leading cause of premature death (before age 70 years) in 112 countries.

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TCEs are potent anti-tumor agents that direct the immune system, specifically T-cells, to attack cancer cells.

VirBio’s bi-specific TCE is comprised of two antibody fragments:

Vir Bio’s bi-specific TCE is comprised of two antibody fragments:

a tumor-associated antigen (TAA) binding domain and a CD3 binding domain.

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This technology specifically leverages overactivity of proteases in the tumor microenvironment (whereas proteases are tightly regulated by protease inhibitors elsewhere in the body).

By attaching masks joined by protease cleavable linkers to the TCE, VirBio’s TCEs are designed to remain inactive until they reach the tumor microenvironment.

By attaching masks joined by protease cleavable linkers to the TCE, Vir Bio’s TCEs are designed to remain inactive until they reach the tumor microenvironment.

Once in the tumor microenvironment, tumor-specific proteases can cleave off the mask and release the unmasked TCE, which can bind to both T-cell and tumor cells expressing the TAA, and lead to killing of cancer cells.

By limiting the unmasking of the TCEs to the tumor microenvironment, we aim to limit the toxicity of these agents in the periphery and potentially increase their safety and efficacy.

We are currently advancing three clinical-stage dual-masked TCEs, VIR-5818 (phase 1), VIR-5500 (phase 1), and VIR-5525 (IND cleared, initiating phase 1), that leverage the PRO-XTEN ™ masking technology with TCEs targeting CD3 on T-cells, and HER2, PSMA and EGFR, respectively, on tumor cells.

We are currently advancing three clinical-stage dual-masked TCEs:

VIR-5500 (Phase 1);

VIR-5818 (Phase 1);

and VIR-5525 (Phase 1).

These molecules leverage the PRO-XTEN ® masking technology with TCEs targeting CD3 on T-cells and HER2, PSMA and EGFR, respectively, on tumor cells.

VIR-5500 for the treatment of metastatic castration-resistant prostate cancer

Molecular Characteristics and Preclinical Data .

VIR-5500 is a protease-activated, bispecific dual-masked TCE, designed to exploit the dysregulated protease activity in tumors relative to healthy tissues, thus expanding the safety margin and therapeutic index.

The VIR-5500 core consists of a VHH (single-variable domain on a heavy chain) domain targeting PSMA and an scFv-targeting CD3.

The core is flanked by two unstructured polypeptide masks (XTEN ™ masks) that sterically reduce target engagement in healthy tissue and extend the half-life of the protein.

Protease cleavage sites at the base of the XTEN ™ masks enable proteolytic activation of unmasked protein in the tumor microenvironment, unleashing a small, highly potent unmasked TCE, designed to redirect cytotoxic T-cells to kill PSMA-expressing tumor cells.

In healthy tissues, in which protease activity is minimal due to tight regulation, VIR-5500 should remain predominantly inactive.

Phase 1 Trial of VIR-5500 .

VIR-5500 is being evaluated in a Phase 1 clinical trial designed to assess its safety, pharmacokinetics, and preliminary efficacy as a monotherapy in late-line mCRPC and standard-of-care combinations in earlier-line settings.

Positive updated monotherapy dose-escalation data from the ongoing Phase 1 trial will be presented at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in February 2026.

These data support VIR-5500’s favorable safety and tolerability profile and show that treatment with VIR-5500 provided dose-dependent anti-tumor activity as measured by both PSA declines and radiographic responses.

Data across all patients receiving VIR-5500 monotherapy in the Phase 1 trial (n=58) show that VIR‑5500 was generally well tolerated with no dose‑limiting toxicities observed to date.

Grade ≥3 treatment‑related adverse events occurred in 12% (7/58) of patients and were manageable.

Limited CRS was observed in 50% (29/58) of patients, with events generally limited to Grade 1 (fever only).

Prophylactic steroids were not required and were only explored in a small cohort of three patients.

Enrolled patients were heavily pretreated (median of four prior lines) and a substantial proportion presented with high tumor burden, including 45% (25/58) with visceral metastases.

Dose‑dependent activity was observed across the entire treatment group as measured by both prostate-specific antigen (PSA) declines and radiographic responses.

Efficacy data were reported in the highest dose cohorts (≥3,000 µg/kg Q3W;

n=22/58) as of the January 9, 2026 data cut-off.

In these cohorts, among those patients who were PSA-evaluable (i.e., received a full cycle of treatment and had completed both pre- and post-treatment PSA assessments in accordance with applicable prostate cancer clinical trial guidance) (n=17), PSA50 1 declines occurred in 82% (14/17) and PSA90 2 declines occurred in 53% (9/17) of patients.

Among RECIST (Response Evaluation Criteria in Solid Tumors)‑evaluable patients, objective responses were seen in 45% (5/11).

Of the five responders, four achieved confirmed responses with one patient pending confirmation.

Reductions on PSMA‑PET (positron emission tomography) affirm PSA declines and radiographic responses, with tumor shrinkage observed across multiple lesions, including visceral metastases.

These findings support proof‑of‑concept and further evaluation in expansion cohorts.

We have concluded QW and Q3W monotherapy dose-escalation in late-line mCRPC and has 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.

1 PSA decline of 50%-100% from baseline.

2 PSA decline of 90%-100% from baseline.

VIR-5818 ± pembrolizumab for the treatment of HER2-positive solid tumors

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In healthy tissues, in which protease activity is tightly regulated, VIR-5818 should remain predominantly masked and as an intact prodrug.

Additional information is available in “Our Technology Platforms” section.

In preclinical ( in vitro ) studies, binding affinities of VIR-5818 were found to be similar between human and cynomolgus monkey HER2 and CD3, thus cynomolgus monkeys are a relevant species for toxicology studies.

Additional information is available below under “— Our Technology Platforms.”

GLP NHP toxicology studies have demonstrated minimal toxicities with a NOAEL at the top dose evaluated of 6mg/kg.

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VIR-5818 is being evaluated in a Phase 1 clinical trial designed to study its safety and pharmacokinetics alone, and in combination with pembrolizumab, in participants with a variety of HER2-expressing cancers, including breast and colorectal cancer (CRC).

As of November 2024, the study had enrolled 79 heterogeneous and heavily pretreated participants in monotherapy cohorts, and we presented early safety and efficacy data from the monotherapy cohort at an investor event on January 8, 2025.

Early safety and efficacy data from the monotherapy cohort was presented at an investor event on January 8, 2025.

Early efficacy data showed that 50% (10/20) of participants receiving VIR-5818 doses ≥400 µg/kg experienced dose-dependent tumor shrinkage across multiple HER2-positive tumor types at either QW or Q3W dosing schedule after an initial step-up dosing in Cycle 1.

This includes participants who had received up to 9 prior lines of therapy.

This includes participants who had received up to nine prior lines of therapy.

Strong anti-tumor activity was observed in a subset of participants with HER2-positive CRC who have exhausted standard of care.

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Preliminary pharmacokinetics and safety data indicate low systemic unmasking of the TCE, suggesting tumor-specific activation.

Dual masking results in a half-life of approximately 6 days, which may enable a less frequent dosing regimen.

As a result, VirBio is currently evaluating a Q3W dosing regimen.

Dose escalation is ongoing, and the MTD has of VIR-5818 has not yet been reached.

VIR-5500 for the treatment of metastatic castration-resistant prostate cancer

Dual masking results in a half-life of approximately six days, which may enable a less frequent dosing regimen, such as Q3W.

VIR-5818 continues to advance through dose escalation as a monotherapy, and in combination with pembrolizumab, in multiple tumor types, including metastatic breast cancer and metastatic colorectal cancer.

Molecular Characteristics and Preclinical Data .

Similar to VIR-5818, VIR-5500 is a protease-activated, bispecific dual-masked TCE, designed to exploit the dysregulated protease activity in tumors relative to healthy tissues, thus expanding the safety margin and therapeutic index.

The VIR-5500 core consists of a VHH (single-variable domain on a heavy chain) domain targeting PSMA and an scFv-targeting CD3.

The core is flanked by 2 unstructured polypeptide masks (XTEN ™ masks) that sterically reduce target engagement in healthy tissue and extend the half-life of the protein.

In healthy tissues, in which protease activity is minimal due to tight regulation, VIR-5500 should remain predominantly inactive.

VIR-5525 is an investigational dual-masked TCE that combines a bispecific EGFR and CD3 binding TCE with the PRO-XTEN ® masking technology.

Similarly to VIR-5818 and VIR-5500, VIR-5525 is also conditionally activated and designed to exploit dysregulated protease activity in tumors while sparing healthy tissues in which there is minimal protease activity, thus broadening the safety margin and therapeutic index.

The core consists of two, tandem, single-chain variable fragments (scFvs) targeting CD3 and EGFR, that are flanked by two unstructured polypeptide masks (XTEN™) that sterically reduce target engagement in normal tissues and extend half-life.

Protease cleavage sites at the base of the XTEN™ masks enable proteolytic activation of fully masked TCE in the tumor microenvironment, unleashing a small, highly potent, unmasked TCE, which is able to redirect cytotoxic T-cells to kill target-expressing tumor cells.

The potent, unmasked form (uTCE) of VIR-5525, also has a much shorter half-life to potentially increase the therapeutic index if the activated form should leak back into circulation.

In healthy tissues, in which protease activity is tightly regulated, VIR-5525 should remain predominantly masked and as an intact prodrug.

Phase 1 Trial of VIR-5525.

VIR-5500 is being evaluated in a Phase 1 clinical trial designed to assess its safety, pharmacokinetics, and preliminary efficacy in participants with mCRPC.

As of November 2024, the study had enrolled 18 participants with significant disease burden who have received 3 to 6 prior lines of therapy, and we presented early safety and efficacy data from the ongoing dose escalation trial at an investor event on January 8, 2025.

PSA reductions were observed in 100% (12/12) of participants after an initial dose ≥120 µg/kg.

PSA50 response was confirmed in 58% (7/12) of participants receiving a first dose ≥120 µg/kg.

Preliminary data show no dose-limiting toxicities observed up to 1000 µg/kg without the use of prophylactic corticosteroids or anti-IL6 antibodies.

Safety findings showed minimal grade 1 or 2 CRS (17% and 11%, respectively) and no grade 3 or greater CRS at any dose.

Most TEAEs were low grade.

No hearing loss has been reported, suggesting safety benefits of dual masking in preventing on-target, off-tumor toxicities.

Dose escalation is ongoing, and the MTD for VIR-5500 has not yet been reached.

Preliminary pharmacokinetics and safety data indicate tumor-specific activation with minimal unmasking outside the tumor.

The dual-masked TCE shows a preliminary half-life of 8-10 days, potentially enabling a Q3W dosing regimen, which is currently being evaluated.

The safety and tolerability profile observed for VIR-5500 in ongoing dose escalation, together with the observed signs of early anti-tumor activity at low doses, may enable a wide therapeutic index.

The Epidermal Growth Factor Receptor (EGFR) is a clinically validated target, well-known to play a key role in cancer.

This molecule is over-expressed in a variety of solid tumors, such as colorectal, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma, making it an attractive target for targeted cancer therapy.

We are advancing VIR-5525, an investigational dual-masked TCE that combines a bispecific EGFR and CD3 binding TCE with the PRO-XTEN ™ masking technology.

This technology is designed to keep the TCEs inactive until they reach the tumor microenvironment, where tumor-specific proteases can cleave off the mask and activate the TCEs leading to killing of cancer cells.

By driving the activity exclusively tin the tumor microenvironment, we aim to increase efficacy and tolerability while limiting toxicity.

The FDA has cleared the IND for VIR-5525, and a Phase 1 clinical study is expected to begin enrollment in the first half of 2025.

VIR-5525 is being evaluated in a Phase 1 clinical trial designed to assess its safety, pharmacokinetics, and preliminary efficacy as a monotherapy and in combination with pembrolizumab in a variety of EGFR-expressing solid tumors, such as non-small cell lung cancer (NSCLC), CRC, head and neck squamous cell carcinoma (HNSCC), and cutaneous squamous cell carcinoma (cSCC).

We announced in July 2025 that the first patient in the trial had been dosed.

VIR-5525 continues to advance through Phase 1 dose escalation as a monotherapy.

Undisclosed PRO-XTEN ® TCE Targets

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

We are advancing multiple undisclosed PRO-XTEN ® 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 TCE fragments discovered and engineered using our antibody discovery platform.

Despite major advances in HIV treatment, most persons living with HIV must take daily antiretroviral medications for viral control.

HIV bnAbs are a novel modality that have shown promise for controlling virus without daily antiretroviral medications.

Furthermore, in rare individuals, HIV bnAb treatment has induced a state of sustained viral control off all therapy, effectively achieving a functional cure.

With the support of the Gates Foundation, we are developing a unique and innovative HIV bnAb therapeutic.

We are selecting and engineering HIV bnAbs (including using dAIsY ™ ) for exceptional breadth and potency to combat both the diversity of HIV strains worldwide and the ability of the virus to escape from therapeutic intervention.

In addition, we are modifying these bnAbs with our Fc engineering technology to enhance their half-life, effector functions, and engagement with the patient’s immune system.

We believe the resulting therapeutic can make an important impact on the lives of people living with HIV.

Our Technology Platforms

Vir Biotechnology, Inc.

has built a strong foundation based on cutting-edge core scientific capabilities and a team of experts who bring deep knowledge and experience to our R&D efforts.

Vir Bio has built a strong foundation based on cutting-edge core scientific capabilities and a team of experts who bring deep knowledge and experience to our R&D efforts.

This has enabled us to make significant strides in infectious disease, and strategically expand our focus to address critical unmet needs in oncology.

Platforms for the Creation of Transformative Medicines

Millions of people suffer from infectious diseases and cancer, both of which result in chronic disease by evading the immune system.We have purposefully assembled a portfolio of technology platforms that we believe will, individually or in combination, allow us to modulate the immune system in innovative ways, harnessing its power to combat viruses and fight cancer.

Our R&D engine is propelled by two core technology platforms:

Antibody Platform:

Millions of people suffer from infectious diseases and cancer, both of which result in disease by evading the immune system.

We have purposefully assembled a portfolio of technology platforms that we believe will, individually or in combination, allow us to modulate the immune system in innovative ways, harnessing its power to combat viruses and fight cancer.

Vir Bio’s Discovery Engine is propelled by our exceptional protein engineering and antibody discovery expertise and our two core technology platforms:

Antibody and TCE Discovery and Engineering Platform:

We continue to leverage our expertise in antibody discovery and development, enhanced by machine learning and artificial intelligence.

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This discovery platform is utilized to generate antibodies that can be further developed into therapeutic molecules, including the generation of dual-masked TCEs against novel tumor targets.

PRO-XTEN ™ Masking Platform:

Exclusively in-licensed from Sanofi in 2024, this platform enables the development of potentially best-in-class masked TCEs for solid tumors.

The dual-masking approach is designed to enhance tumor specificity while minimizing off-target effects, potentially improving both efficacy and safety.

This technology could make our future medicines more specific, effective, and tolerable by ensuring they act only where needed, reducing damage to healthy cells and tissue.

Initial Phase 1 data has provided clinical proof of concept for this approach across multiple tumor types.

These platforms are complemented by our internal capabilities in process development, analytical development, manufacturing, and quality control.

PRO-XTEN ® Masking Technology Platform:

This innovative technology aims to prevent potential toxicity of highly active drugs outside of their intended site of action.

In oncology, this means anti-cancer agents, such as TCEs, become active selectively when entering the tumor microenvironment.

This enhances tumor specificity while minimizing off-target effects, potentially improving both efficacy and safety.

Masking also increases half-life in circulation, potentially resulting in more convenient dosing regimens for patients and clinicians.

Importantly, the PRO-XTEN ® masking technology is a universal platform – meaning that it can be used with different molecules without the need to tailor it every single time.

This discovery engine is complemented by our internal capabilities in process development, analytical development, manufacturing, and quality control.

We also maintain strategic partnerships with contract development and manufacturing organizations (CDMOs) to support our clinical programs.

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artificial intelligence

Antibody Platform

We have developed cutting-edge platforms to identify and enhance rare, potent monoclonal antibodies (mAbs) using AI-enabled protein engineering for the treatment of infectious diseases and cancer.

Antibody and TCE Discovery and Engineering Platform

We have developed cutting-edge platforms to identify and enhance rare, potent mAbs using AI-enabled protein engineering for the treatment of infectious diseases and cancer.

Our platforms leverage the efficient interrogation of memory B cells from two primary sources:

convalescent human patients and transgenic mice expressing human- immunoglobulin G (IgG) following immunization.

This approach enables the selection of highly potent antibodies with unique characteristics that can be further developed into therapeutic molecules, including dual-masked TCEs targeting novel TAA.

This approach enables the selection of highly potent antibodies with unique characteristics that can be further developed into therapeutic molecules, including PRO-XTEN ® dual-masked TCEs targeting novel TAAs.

Our platform has been successfully applied to identify mAbs for multiple pathogens including SARS-CoV-2, HBV, HDV, Ebola virus, and HIV.

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Our approach combines rapid, high-throughput isolation of rare and highly potent fully human mAbs from cell culture-based libraries of clonal B lymphocytes.

Our deep expertise in antibody discovery and engineering provides a strong foundation for developing next-generation TCEs as well as antibody-based therapeutics for multiple therapeutic areas, including cancer.

Our proprietary antibody screening technology enables the screening of antibodies from hundreds of millions of B cells derived from either convalescent individuals or human-Ig immunized mice.

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In this context, we have developed a set of novel and proprietary Fc mutations that have the potential to enhance the anti-tumor efficacy of antibodies.

Hu-Ig = humanized immunoglobulin

PRO-XTEN ™ Masking Platform

The PRO-XTEN ™ masking technology exploits the high protease activity of the tumor microenvironment to specifically release the active form of a drug via release of the mask only in tumor tissues.

It can be applied to a variety of molecules such as TCEs, cytokines, or other molecules to broaden the therapeutic index for patients.

The preferential release of the drug in the tumor microenvironment is designed to minimize on-target, off-tissue toxicity.

The XTEN ™ masks are designed to extend the half-life resulting in more convenient dosing regimens for patients and clinicians.

PRO-XTEN ® Masking Technology Platform

The PRO-XTEN ® masking technology exploits the high protease activity of the tumor microenvironment to specifically release the active form of a drug via release of the mask selectively in tumor tissues.

It can be applied to a variety of molecules such as TCEs or cytokines to broaden the therapeutic index for patients.

The preferential release of the drug in the tumor microenvironment is designed to minimize on-target, off-tumor toxicity.

The PRO-XTEN ® mask is designed to extend the half-life resulting in more convenient dosing regimens for patients and clinicians.

This masking approach could be key to pursuing validated oncology targets typically associated with therapies of high toxicity, ultimately offering an opportunity to potentially increase the therapeutic index of drug candidates and deliver more efficacious and safer options for patients.

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The PRO-XTEN ® masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the masks and activate the TCEs leading to killing of cancer cells.

By driving the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability.

By driving the activity selectively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability.

T-Cell Engager

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Upon unmasking, they are designed to simultaneously recruit T-cells to cells expressing the target TAA, preferentially cancer cells, directing the cytotoxic activity of T-cells against the tumor.

Our discovery and antibody engineering capabilities are extendable to optimizing TAA and T-cell engagement component and identifying novel TCE fragments for additional targets, not only in oncology but also in infectious disease.

Our discovery and antibody engineering capabilities are extendable to optimizing TAA and T-cell engagement components and identifying novel TCE fragments for additional targets.

The protease-activated linkers that are part of PRO-XTEN ® were discovered by applying a combination of in vitro and in vivo experiments together with a genetic algorithm for sequence optimization.

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Our Collaboration, License and Grant Agreements

Collaboration and License Agreement with Astellas

On February 19, 2026, we and Astellas US LLC (together with its subsidiaries and affiliates (including its indirect parent, Astellas Pharma Inc.), Astellas) entered into a Collaboration and License Agreement (the Astellas Agreement).

Upon closing of the transaction contemplated by the Astellas Agreement, we and Astellas will enter into a global strategic collaboration to co-develop and co-commercialize VIR-5500, an investigational PRO-XTEN ® dual-masked CD3 TCE targeting PSMA for the treatment of prostate cancer that is currently in Phase 1 development, through a sharing of expenses and revenues.

We have agreed to grant to Astellas, subject to certain intellectual property rights of Sanofi, an exclusive license to develop, manufacture, commercialize and otherwise exploit VIR-5500 and certain related derivative compounds throughout the world for therapeutic, prophylactic, palliative and diagnostic uses.

Under the terms of the Astellas Agreement, in the U.S., we will share profits and losses from future sales of VIR-5500 equally with Astellas, should VIR-5500 receive regulatory approval, and we will have the option to co-promote VIR-5500.

Outside of the U.S., Astellas will obtain exclusive rights to commercialize VIR-5500 and be responsible for all commercialization costs.

We will jointly develop VIR-5500, with global clinical development costs shared 40% by us and 60% by Astellas, while costs of U.S.-specific studies will be shared equally, and Astellas will be solely responsible for costs of ex-U.S.-specific studies.

In addition, we have the option to opt out of development cost sharing responsibilities and U.S.

profit sharing, and in such case, Astellas will pay us royalties on net sales made in the U.S., as described below.

We will receive $335 million in upfront and near-term milestone payments, including $240 million in cash, a $75 million equity investment pursuant to a separate Stock Purchase Agreement (the Astellas SPA, described further below), and a near-term $20 million milestone payment upon completion of manufacturing technology transfer, anticipated in the second quarter or third quarter of 2027.

We will also be eligible to receive up to $1.37 billion in future development, regulatory and ex-U.S.

sales milestones, along with tiered, double-digit royalties on ex-U.S.

net sales, which royalties are subject to reduction under certain specified circumstances.

If we elect to opt out of development cost sharing responsibilities and U.S.

profit sharing, we would be eligible to receive up to $1.37 billion (or $1.60 billion if we have met a pre-defined limited funding threshold at the time of the opt-out) in future development, regulatory and global sales milestones, along with tiered, double-digit royalties on global net sales, which royalties are subject to reduction under certain specified circumstances.

Further, certain opt-out milestones, if met, will include reimbursement of a portion of our previously expensed development and commercialization spend.

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.

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

Either party may terminate the Astellas Agreement in cases of uncured, material breaches or insolvency.

Astellas may terminate the Astellas Agreement for convenience in its entirety (upon 90 days’ notice to us if there has not been any commercial sale for any licensed product in any covered territory or else upon 180 days’ written notice) or with respect to a licensed product and a given country (upon 90 days’ written notice if there has been no commercial sale in the relevant country or else upon 180 days’ written notice).

Astellas may also terminate the agreement in its entirety or with respect to one or more products upon 30 days’ written notice if Astellas determines in good faith that the risks to patients from continuing the development or commercialization of the relevant product or products are greater than the potential benefits of such development and commercialization.

Subject to certain conditions, we have the right to terminate the agreement upon certain patent challenges by Astellas or if Astellas does not conduct any material development or commercialization activities or otherwise ceases or abandons all such activities for 12 consecutive months.

Concurrently with the execution of the Astellas Agreement, we have also entered into the Astellas SPA, pursuant to which Astellas has agreed to purchase 7,239,382 shares of our common stock for an aggregate purchase price of approximately $75 million, subject to customary closing conditions and the closing of the Astellas Agreement.

The purchase price per share of our common stock of $ 10.36 is equal to a 50% premium of the 30-day volume weighted average price of a share of our common stock as of February 17, 2026.

The Astellas SPA includes standstill, voting and lockup provisions, with customary exceptions, that expire one year after the date of the anticipated closing of the Astellas SPA.

One year after the anticipated closing of the Astellas SPA, Astellas will have, under certain circumstances, a customary right to require us to register the resale of the shares purchased pursuant to the Astellas SPA.

License Agreement with Norgine

In exchange, we received an initial reimbursement of development costs from Norgine in the amount of €55 million in December 2025 and are eligible to receive up to an additional €495 million in clinical, regulatory and sales milestones, along with tiered, mid-teen to high-twenties percent royalties on net sales in the Norgine Territory.

In addition, clinical development costs for the ongoing trials in our ECLIPSE registrational program (ECLIPSE 1, 2 and 3) will be shared, with Norgine contributing approximately 25% of go-forward external costs.

The Norgine Agreement will remain in force, on a licensed product-by-licensed product and country-by-country basis, until the latest of (a) the 12 th anniversary of the first commercial sale;

(b) the date of expiration of the last-to-expire valid claim of any licensed patent;

and (c) the expiration of regulatory exclusivity.

Either party may terminate the Norgine Agreement in cases of material breaches or insolvency.

Norgine may terminate the Norgine Agreement with 180 days’ prior written notice prior to the first commercial sale of any licensed product and with 12 months’ prior written notice on or after the first commercial sale of any licensed product.

License Agreement with Sanofi

On September 9, 2024, we closed a license agreement with Amunix Pharmaceuticals, a Sanofi company, previously announced on August 1, 2024 (the Sanofi Agreement), pursuant to which we obtained an exclusive (as to Sanofi and its affiliates), worldwide, royalty-bearing, sublicensable (through multiple tiers), transferable license to research, develop, manufacture, commercialize and otherwise exploit:

(i) three clinical-stage masked TCEs of Sanofi, for all therapeutic, prophylactic, palliative, and diagnostic uses, excluding the ophthalmological field, and (ii) the PRO-XTEN ™ universal masking technology for oncology and infectious disease, excluding the ophthalmological field.

As part of the closing of the Sanofi Agreement, we made an upfront payment to Sanofi in the amount of $100.0 million and transferred $75.0 million to an escrow account that is due to former shareholders of Amunix Pharmaceuticals, Inc.

upon VIR-5525 achieving “first in human dosing” by 2026.

On September 9, 2024, we closed a license agreement with Amunix Pharmaceuticals Inc.

(Amunix), a Sanofi company, previously announced on August 1, 2024 (the Sanofi Agreement), pursuant to which we obtained an exclusive (as to Sanofi and its affiliates), worldwide, royalty-bearing, sublicensable (through multiple tiers), transferable license to research, develop, manufacture, commercialize and otherwise exploit:

(i) three clinical-stage masked TCEs of Sanofi, for all therapeutic, prophylactic, palliative, and diagnostic uses, and (ii) the PRO-XTEN ® universal masking technology for oncology and infectious disease, excluding the ophthalmological field.

As part of the closing of the Sanofi Agreement, we made an upfront payment to Sanofi in the amount of $ 100.0 million and transferred $ 75.0 million to an escrow account that was due to former shareholders of Amunix upon VIR-5525 achieving “first in human dosing” by 2026.

In July 2025, the first patient was dosed in a phase 1 study evaluating VIR-5525 and as a result, we paid the $ 75.0 million milestone during the third quarter of 2025.

Sanofi will also be eligible to receive up to an additional $ 323.0 million in future development and regulatory milestone payments, up to an additional $ 1.49 billion in commercial net sales-based milestone payments, and low single-digit to low double-digit tiered royalties on worldwide net sales.

In addition, if, within a two-year period from the execution of the Sanofi Agreement, we execute a transaction that gives rise to VirBio receiving certain sublicense income related to the licenses obtained from the Sanofi Agreement, Sanofi may be eligible to receive a portion of such income.

In addition, if, within a two-year period from the execution of the Sanofi Agreement, we execute a transaction that gives rise to Vir Bio receiving certain sublicense income related to the licenses obtained from the Sanofi Agreement, Sanofi may be eligible to receive a portion of such income.

The Sanofi Agreement will remain in force, on a product-by-product and country-by-country basis, until the expiration of all royalty payment obligations.

We may terminate the Sanofi Agreement in its entirety, or on a target-by-target basis, for convenience upon 120 days’ written notice if there have been no commercial sales of such target or upon 12 months written notice after the first commercial sale of such target as long as such termination is after December 31, 2026.

We may terminate the Sanofi Agreement in its entirety, or on a product-by-product basis, for convenience upon 120 days’ written notice if there have been no commercial sales of such target or upon 12 months written notice after the first commercial sale of such target as long as such termination is after December 31, 2026.

Collaboration Agreements with GSK

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In June 2020, we entered into a definitive collaboration agreement with GSK (the 2020 GSK Agreement), pursuant to which we agreed to collaborate to research, develop and commercialize products for the prevention, treatment and prophylaxis of diseases caused by SARS-CoV-2, the virus that causes COVID-19, and potentially other coronaviruses.

The collaboration initially focused on the development and commercialization of three types of collaboration products under three programs:

(1) antibodies targeting SARS-CoV-2, and potentially other coronaviruses (the Antibody Program);

(2) vaccines targeting SARS-CoV-2, and potentially other coronaviruses (the Vaccine Program);

and (3) products based on genome-wide CRISPR screening of host targets expressed in connection with exposure to SARS-CoV-2, and potentially other coronaviruses (the Functional Genomics Program).

The antibody under the Antibody Program is sotrovimab, developed and commercialized for the treatment and prophylaxis of COVID-19.

In connection with the 2020 GSK Agreement, we also entered into a stock purchase agreement in April 2020, pursuant to which we issued 6,626,027 shares of our common stock to Glaxo Group Limited, an affiliate of GSK (GGL), at a price per share of $37.73 and an aggregate purchase price of approximately $250.0 million.

In February 2023, we and GSK entered into two amendments to the 2020 GSK Agreement.

Pursuant to the amendments, we and GSK agreed to remove the Vaccine Program from the 2020 GSK Agreement and to wind down and terminate the cost-sharing arrangements and all ongoing activities in relation to the Vaccine Program.

As of the effective date of amendments, the Vaccine Program had not yet advanced to its predefined development candidate stage.

We retained the right to progress development of vaccine products directed to SARS-CoV-2 and other coronaviruses independently (including with or for third parties) outside the scope of the 2020 GSK Agreement, subject to the payment of tiered royalties to GSK on net sales of any vaccine products covered by certain GSK intellectual property rights in the low single digits.

In addition, we and GSK agreed to modify the Antibody Program to remove from the collaboration all coronavirus antibodies other than sotrovimab and VIR-7832, and certain variants thereof, which remained subject to the terms of the 2020 GSK Agreement.

The collaboration was originally structured around three categories of product candidates;

however, only sotrovimab, VIR-7832, and certain related antibody variants remain active programs under the 2020 GSK Agreement.

In connection with the 2020 GSK Agreement, we also entered into a stock purchase agreement in April 2020, pursuant to which we issued 6,626,027 shares of our common stock to Glaxo Group Limited, an affiliate of GSK, at a price per share of $37.73 and an aggregate purchase price of approximately $250.0 million.

We retained the sole right to progress the development and commercialization of the terminated antibody products independently (including with or for third parties), subject to the payment of tiered royalties to GSK on net sales of such terminated antibody products at percentages ranging from the very low single digits to the mid-single digits, depending on the nature of the antibody product being commercialized.

Subject to an opt-out mechanism, the parties share all development costs, manufacturing costs, and costs and expenses for the commercialization of the collaboration products, with us bearing 72.5% of such costs for sotrovimab, except that GSK has the sole right to develop (including to seek, obtain or maintain regulatory approvals), manufacture and commercialize sotrovimab in and for mainland China, Hong Kong, Macau and Taiwan at GSK’s sole cost and expense.

Regarding sotrovimab, the parties share all development costs, manufacturing costs, and costs and expenses for the commercialization of the collaboration products, with us bearing 72.5% of such costs for sotrovimab, except that GSK has the sole right to develop (including to seek, obtain or maintain regulatory approvals), manufacture and commercialize sotrovimab in and for the Greater China Territory at GSK’s sole cost and expense.

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.

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Either party has the right to terminate the 2020 GSK Agreement in the case of the insolvency of the other party, an uncured material breach of the other party with respect to a collaboration program or collaboration product, or as mutually agreed by the parties.

In May 2021, the FDA granted an EUA in the United States for sotrovimab, for the early treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and at high risk for progression to severe COVID-19, including hospitalization or death.

In May 2021, the FDA granted an EUA in the U.S.

for sotrovimab, for the early treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and at high risk for progression to severe COVID-19, including hospitalization or death.

In December 2021, the EC granted marketing authorization to Xevudy ® (sotrovimab) in the EU for the treatment of adults and adolescents at increased risk of progressing to severe COVID-19.

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regions due to the continued proportion of COVID-19 cases caused by certain variants, and in December 2024, the FDA revoked EUA granted to sotrovimab.

Going forward, 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.

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

2021 Expanded GSK Collaboration

In 2021, we entered into the 2021 GSK Agreement under which the parties agreed to expand the 2020 GSK Agreement, to include collaboration on three separate programs:

(1) a program to research, develop and commercialize mAbs for the prevention, treatment or prophylaxis of the influenza virus, excluding VIR-2482 unless GSK exercises its exclusive option (the VIR-2482 Option) to co-develop and commercialize after the Company completes a Phase 2 clinical trial (the Influenza Program);

(2) an expansion of the parties’ current Functional Genomics Program to focus on functional genomics screens directed to targets associated with respiratory viruses (the Expanded Functional Genomics Program);

and (3) additional programs to develop neutralizing mAbs directed to up to three non-influenza target pathogens selected by GSK (the Selected Pathogens, and such programs the Additional Programs).

In connection with the 2021 GSK Agreement, we entered into a stock purchase agreement with GGL pursuant to which we issued 1,924,927 shares of our common stock to GGL for an aggregate purchase price of approximately $120.0 million.

On February 21, 2024, the Company and GSK entered into a letter agreement (the Letter Agreement) pursuant to which the Company and GSK agreed to remove the Influenza Program from the 2021 GSK Agreement and to wind down and terminate the cost-sharing arrangements and all ongoing activities in relation to the Influenza Program.

As of the effective date of the Letter Agreement, GSK’s VIR-2482 Option was terminated.

The Company has no further obligations to GSK with respect to VIR-2482.

In addition, as of the effective date of the Letter Agreement, GSK exercised its opt-out option with respect to VIR-2372 and VIR-2981.

The Company had no further obligations to GSK with respect to VIR-2372 and VIR-2981.

As a result of GSK’s opt-out to VIR-2372 and VIR-2981, the Company may continue to pursue the development and commercialization of those programs unilaterally.

If either of those programs is commercialized, the Company will pay GSK a royalty on net sales in the low single digits.

As it relates to the Expanded Functional Genomics Program, all remaining targets selected were mutually rejected in the first quarter of 2024, with remaining exclusivity to such targets expiring in mid-2025.

No further research activity is expected by either party under the program.

Regarding the Additional Programs, GSK selected RSV as its first pathogen in 2022.

During the first quarter of 2024, we recognized contract revenue of $51.7 million as GSK’s rights to select the remaining up to two additional non-influenza target pathogens expired on March 25, 2024.

In 2021, we entered into the 2021 GSK Agreement under which the parties agreed to expand the 2020 GSK Agreement and to collaborate on three separate programs, all of which had been subsequently terminated except for an RSV program selected in 2022.

We opted-out of the RSV program during the fourth quarter of 2024.

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If the RSV program reaches commercialization, GSK will pay us a royalty on net sales in the low single digits.

Collaboration and License Agreement with Alnylam

In October 2017, we and Alnylam Pharmaceuticals (Alnylam) entered into a collaboration and license agreement (the Alnylam Agreement).

Pursuant to the Alnylam Agreement, we obtained a worldwide, exclusive license to develop, manufacture and commercialize the siRNA product candidates directed to HBV, including elebsiran, for all uses and purposes including the treatment of HBV and HDV.

In addition, Alnylam granted us an exclusive option, for each of the infectious disease siRNA programs directed to our four selected targets, to obtain a worldwide, exclusive license to develop, manufacture and commercialize siRNA products directed to the target of each such program for all uses and purposes other than certain excluded fields.

Our options are each exercisable during a specified period following selection of candidates for each program, or two years following the initiation of certain activities under an agreed-upon development plan, if earlier.

On a product-by-product basis for each siRNA product directed to HBV and, if we exercise our license option, the siRNA products directed to the up to four infectious disease targets, Alnylam has an exclusive option, exercisable during a specified period for each such product, to negotiate and enter into a profit-sharing agreement for such product.

We and Alnylam were jointly responsible for funding the initial research and development activities for elebsiran through completion of proof of concept trials.

Prior to the exercise of our option for each siRNA program directed to one of our selected infectious disease targets, Alnylam is responsible for conducting all development activities, at our expense, in accordance with an agreed-upon development plan.

Following our exercise of an option for a program and payment of the program option exercise fee and any outstanding program costs due to Alnylam, we are solely responsible, at our expense, for conducting all development, manufacture and commercialization activities for products arising from each such program unless Alnylam exercises its profit-sharing option.

We are required to use commercially reasonable efforts to develop and commercialize one siRNA product directed to HBV, whether for the treatment of HBV or HDV, as well as one siRNA product directed to the target of each other infectious disease program for which we exercise our option, in the United States and certain specified major markets.

If Alnylam exercises a profit-sharing option for a product, such as elebsiran, we will negotiate the terms of such profit-sharing agreement.

We retain final decision-making authority with respect to which infectious disease product candidates we advance and the development programs for the HBV and HDV, as well as infectious disease product candidates, subject to certain limitations.

During the term of the Alnylam Agreement, neither we nor Alnylam may develop or commercialize any gene-silencing, oligonucleotide-based product directed to the same target as any product candidate under the Alnylam Agreement, other than pursuant to the Alnylam Agreement, subject to certain exceptions.

Pursuant to the Alnylam Agreement, we paid Alnylam an upfront fee of $10.0 million and issued to Alnylam 1,111,111 shares of our common stock.

Upon the achievement of a certain development milestone, as further discussed below, we were obligated to issue shares of our common stock equal to the lesser of (i) 1,111,111 shares or (ii) a certain number of shares based on our stock price at the time such milestone was achieved.

We are required to pay Alnylam up to $190.0 million in the aggregate for the achievement of specified development and regulatory milestones for the first siRNA product directed to HBV, whether for the treatment of HBV or HDV, and up to $115.0 million for the achievement of specified development and regulatory milestones for the first product directed to the target of each infectious disease siRNA program for which we exercised our option.

In March 2020, we achieved one of the specified development milestones relating to elebsiran pursuant to the Alnylam Agreement.

As such, we paid Alnylam $15.0 million in April 2020, thereby reducing the $190.0 million referenced above to $175.0 million of potential development and regulatory milestones remaining to be paid related to elebsiran.

Following commercialization, we will be required to pay to Alnylam up to $250.0 million in the aggregate for the first achievement of specified levels of net sales by siRNA products directed to HBV, whether for the treatment of HBV or HDV related to elebsiran, and up to $100.0 million for the achievement of specified levels of net sales by products directed to the target of each infectious disease siRNA program for which we exercised our option.

We will also be required to pay Alnylam tiered royalties at percentages ranging from the low double-digits to mid-teens on annual net sales of siRNA products directed to HBV, such as elebsiran, whether for the treatment of HBV or HDV, and tiered royalties at percentages ranging from the high single-digits to the sub-teen double-digits on annual net sales of licensed infectious disease products, in each case subject to specified reductions and offsets.

In October 2017, we and Alnylam Pharmaceuticals, Inc.

(Alnylam) entered into a collaboration and license agreement (the Alnylam Agreement).

Under the Alnylam Agreement, we obtained a worldwide, exclusive license to develop, manufacture and commercialize siRNA product candidates directed to HBV, including elebsiran, for all uses and purposes including the treatment of HBV and HDV indications.

Under the Alnylam Agreement, we also held options to obtain similar licenses to siRNA product candidates for up to four other infectious disease targets selected by Vir Bio, but following an amendment and restatement of the Alnylam Agreement in March 2025 (the Restated Alnylam Agreement), those options (and all rights and obligations related to those infectious disease targets) were terminated.

At the same time Alnylam elected to not opt-in to the profit-sharing arrangement with respect to any licensed siRNA product candidates, including elebsiran, directed to HBV or HDV.

We remain solely responsible, at our expense, for conducting all development, manufacture and commercialization activities for elebsiran in HBV and HDV indications, and we are required to use commercially reasonable efforts to develop and commercialize elebsiran for the treatment of HBV or HDV indications in the United States and specified major markets.

In connection with the Restated Alnylam Agreement and Alnylam’s election to not opt-in to the profit-sharing arrangement, we paid Alnylam $30.0 million in April 2025, and we will be required to pay Alnylam up to $145.0 million for remaining development and regulatory milestones for elebsiran.

Such development and regulatory milestones for elebsiran will be payable to Alnylam only once, irrespective of dosage, formulation forms, route of administration or indication.

Following commercialization, we will be required to pay Alnylam up to $250.0 million in the aggregate for the first achievement of specified levels of net sales by elebsiran products directed to HBV, whether for the treatment of HBV or HDV indications.

The royalties are payable on a product-by-product and country-by-country basis until the later of the expiration of all valid claims of specified patents covering such product in such country and 10 years after the first commercial sale of such product in such country.

Alnylam is also entitled to receive a portion of any consideration we receive as a result of granting a sublicense under the licenses granted to us by Alnylam under the Alnylam Agreement or an option to acquire such a sublicense, determined based on the timing of the grant of such sublicense.

In November 2018, in connection with the inclusion of the HBV siRNA program as the subject of a potential grant of a sublicense to Brii Bio under the Brii Agreement, as defined below), which triggered certain payment obligations under the Alnylam Agreement, we entered into a letter agreement with Alnylam (the Alnylam Letter), making certain modifications to the payments due to Alnylam as a result of the grant of the option and potential payments that would result from Brii Bio’s exercise of rights under such sublicense.

As a result of the rights granted under the Brii Agreement and pursuant to the Alnylam Letter, in February 2020 we transferred to Alnylam a specified percentage of the equity consideration allocable to the HBV siRNA program that we received from Brii Bio and its affiliated companies in connection with the entry into the Brii Agreement.

The term of the Alnylam Agreement will continue, on a product-by-product and country-by-country basis, until expiration of all royalty payment obligations under the Alnylam Agreement.

If we do not exercise our option for an infectious disease program directed to one of our selected targets, the Alnylam Agreement will expire upon the expiration of the applicable option period with respect to such program.

However, if Alnylam exercises its profit sharing option for any product, the term of the Alnylam Agreement will continue until the expiration of the profit-sharing arrangement for such product.

Alnylam is entitled to receive a portion of consideration we receive as a result of granting a sublicense under the licenses granted to Vir Bio by Alnylam under the Alnylam Agreement.

The term of the Restated Alnylam Agreement will continue, on a product-by-product and country-by-country basis, until expiration of all royalty payment obligations under the Restated Alnylam Agreement.

We may terminate the Alnylam Agreement on a program-by-program basis or in its entirety for any reason on 90 days’ written notice.

Either party may terminate the agreement for cause for the other party’s uncured material breach on 60 days’ written notice (or 30 days’ notice for payment breach), or if the other party challenges the validity or enforceability of any patent licensed to it under the Alnylam Agreement on 30 days’ notice.

Exclusive License Agreement with the Institute for Research in Biomedicine

Prior to our acquisition of Humabs BioMed SA (referred to herein as Humabs) in August 2017, the former parent company of Humabs (later consolidated into Humabs) entered into an exclusive license agreement in December 2011 with the Institute for Research in Biomedicine (IRB, and the agreement, the IRB Agreement).

The IRB Agreement amended and restated an original 2004 exclusive license agreement between the parties in connection with IRB’s proprietary technologies relating to human monoclonal antibodies and the discovery of unique epitopes recognized by such antibodies.

Prior to our acquisition of Humabs BioMed SA (referred to herein as Humabs) in August 2017, it entered into an exclusive license agreement in December 2011 with the Institute for Research in Biomedicine (IRB, and the agreement, the IRB Agreement).

In May 2008, Humabs entered into an exclusive license agreement with IRB (the Humabs IRB Agreement, and together with the IRB Agreement, the Current IRB License Agreements).

Pursuant to the Humabs IRB Agreement, IRB granted to Humabs an exclusive license under certain intellectual property rights for the development of certain monoclonal antibodies.

In February 2012, Humabs and IRB entered into a research agreement, or the IRB Research Agreement, to provide for a continuing research collaboration between Humabs and IRB, and to coordinate the exploitation of intellectual property rights arising from the IRB Research Agreement with the rights granted under the Current IRB License Agreements.

Pursuant to the Humabs IRB Agreement, IRB granted to Humabs an exclusive license under certain intellectual property rights for the development of certain monoclonal antibodies with certain proprietary technologies of the IRB.

In February 2012, Humabs and IRB entered into a research agreement (the IRB Research Agreement) to provide for a continuing research collaboration between Humabs and IRB, and to coordinate the exploitation of intellectual property rights arising from the IRB Research Agreement with the rights granted under the Current IRB License Agreements.

Under the terms of the IRB Research Agreement, IRB performs certain research activities for Humabs, and all intellectual property rights arising under the IRB Research Agreement are either owned by Humabs, or included in and licensed to Humabs pursuant to the terms of the Current IRB License Agreements.

We use technology licensed under the Current IRB License Agreements in our antibody platform and in our product candidate tobevibart.

Pursuant to the Current IRB License Agreements, IRB granted to Humabs an exclusive, worldwide, royalty-bearing, sublicensable license under patent and know-how rights covering or associated with IRB’s proprietary technology platform relating to antibody discovery, as well as rights in certain antibodies, including as a result of activities under the IRB Research Agreement, in each case for all purposes, including to practice the licensed technology platform, and to develop, manufacture and commercialize any drug, vaccine or diagnostic product containing such licensed antibodies.

We use technology licensed under the Current IRB License Agreements in our product candidate tobevibart.

Pursuant to the Current IRB License Agreements, IRB granted to Humabs an exclusive, worldwide, royalty-bearing, sublicensable license under patent and know-how rights covering or associated with certain IRB’s proprietary technology platforms relating to antibody discovery, as well as rights in certain antibodies, including as a result of activities under the IRB Research Agreement, in each case for all purposes, including to practice the licensed technology platform, and to develop, manufacture and commercialize any drug, vaccine or diagnostic product containing such licensed antibodies.

Humabs is required to use commercially reasonable efforts to develop and commercialize licensed products, as well as maintain an active program to commercialize licensed products.

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Each of the Current IRB License Agreements remains in force until the expiration of all valid claims of the licensed patent rights and trade secrets included in the licensed IRB know-how.

In addition, no royalties shall be payable under IRB know-how for any licensed product in any country after ten years from the date of first commercialization of such licensed product in that country.

Humabs may terminate the IRB Agreement at will on 90 days’ written notice to IRB, and either party may terminate either of the Current IRB License Agreements on 60 days’ written notice for the uncured material breach of the other party.

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We use technology licensed under the Rockefeller Agreement in our antibody platform and in our product candidate tobevibart.

Under the agreement we are required to pay annual license maintenance fees of $1.0 million, which will be creditable against royalties following commercialization.

Under the agreement we are required to pay license maintenance fees of $1.0 million annually, which will be creditable against royalties following commercialization.

In addition, for the future achievement of specified development, regulatory and commercial success milestone events, we will be required to pay up to $80.3 million, in the aggregate, for up to six infectious disease products.

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Our obligation to pay royalties to Rockefeller will terminate, on a product-by-product and jurisdiction-by-jurisdiction basis, upon the latest of the expiration of the last valid claim of a licensed patent in such jurisdiction, the expiration of all regulatory exclusivity in such jurisdiction or 12 years following the first commercial sale of the applicable licensed product in such jurisdiction.

If we grant a sublicense to a non-affiliate third party under the Rockefeller technology, we will be required to pay to Rockefeller a specified percentage of the consideration received from such sublicensee for the grant of the sublicense, depending on the date of receipt of the applicable sublicense income from such sublicensee.

If we grant a sublicense to a non-affiliate third party under the Rockefeller technology, we will be required to pay Rockefeller a specified percentage of the consideration received from such sublicensee for the grant of the sublicense, depending on the date of receipt of the applicable sublicense income from such sublicensee.

The Rockefeller Agreement will remain in force, absent earlier termination, until the expiration of all of our obligations to pay royalties to Rockefeller in all jurisdictions.

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Collaboration, Option and License Agreement with Brii Bio

In May 2018, we entered into a collaboration, option and license agreement with Brii Biosciences Limited (Brii Bio Parent) (formerly known as BiiG Therapeutics Limited), and Brii Bio (and such agreement, the Brii Agreement), pursuant to which we granted to Brii Bio, with respect to up to four of our programs, an exclusive option to obtain exclusive rights to develop and commercialize compounds and products arising from such programs in the China Territory (People’s Republic of China, Taiwan, Hong Kong and Macau), for the treatment, palliation, diagnosis, prevention or cure of acute and chronic diseases of infectious pathogen origin or hosted by pathogen infection, or the Field of Use.

Our elebsiran program being developed under the Amended Alnylam Agreement (described above) is included within the Brii Agreement as a program for which Brii Bio has exercised one of its options that is further discussed below.

Brii Bio may exercise each of its options following the achievement by us of proof of concept for the first product in such program.

In partial consideration for the options granted by us to Brii Bio, Brii Bio Parent and Brii Bio granted us, with respect to up to four of Brii Bio Parent’s or Brii Bio’s programs, an exclusive option to be granted exclusive rights to develop and commercialize compounds and products arising from such Brii Bio programs in the United States for the Field of Use.

The number of options that we may exercise for a Brii Bio program is limited to the corresponding number of options that Brii Bio exercises for a VirBio program.

All options granted to Brii Bio under the Brii Agreement that are not exercised will expire no later than seven years following the effective date.

In May 2018, we entered into a collaboration, option and license agreement with Brii Biosciences Limited (Brii Bio Parent) (formerly known as BiiG Therapeutics Limited), and Brii Bio (and such agreement, the Brii Agreement), pursuant to which we granted to Brii Bio, with respect to up to four of our programs, an exclusive option to obtain exclusive rights to develop and commercialize compounds and products arising from such programs in the Greater China Territory, for the treatment, palliation, diagnosis, prevention or cure of acute and chronic diseases of infectious pathogen origin or hosted by pathogen infection, or the Field of Use.

In partial consideration for the options granted by us to Brii Bio, Brii Bio Parent and Brii Bio in turn granted us, with respect to up to four of Brii Bio Parent’s or Brii Bio’s programs, an exclusive option to be granted exclusive rights to develop and commercialize compounds and products arising from such Brii Bio programs in the United States for the Field of Use.

The number of options that we may exercise for a Brii Bio program is limited to the corresponding number of options that Brii Bio exercises for a Vir Bio program.

All options granted to Brii Bio under the Brii Agreement that are not exercised expired in May 2025.

All options granted to us under the Brii Agreement that are not exercised will expire no later than two years following the expiration of all options granted to Brii Bio.

We are responsible, at our expense and discretion, for the conduct of all development activities under our programs prior to the exercise of Brii Bio’s options, and Brii Bio is responsible, at its expense and discretion, for all activities under its programs prior to the exercise of our options.

Following the exercise of an option for a specified program by either us or Brii Bio, the exercising party is granted an exclusive, royalty-bearing license to develop, manufacture and commercialize products arising from the applicable program in the United States (where we are exercising the option) or the China Territory (where Brii Bio is exercising the option), and such party is thereafter responsible for all development and commercialization activities, at its expense, in the optioned territory.

Following the exercise of an option for a specified program by either us or Brii Bio, the exercising party is granted an exclusive, royalty-bearing license to develop, manufacture and commercialize products arising from the applicable program in the United States (where we are exercising the option) or the Greater China Territory (where Brii Bio is exercising the option), and such party is thereafter responsible for all development and commercialization activities, at its expense, in the optioned territory.

If Brii Bio exercises its option with respect to our development program being conducted under the Amended Alnylam Agreement, Brii Bio’s rights will be subject to the terms of such amended agreement.

Under the terms of the Brii Agreement, following our option exercise, we are obligated to use commercially reasonable efforts to develop at least one licensed product arising from each optioned Brii Bio program, and to commercialize each such product in the United States following regulatory approval, and following Brii Bio’s option exercise, Brii Bio is obligated to use commercially reasonable efforts to develop at least one licensed product arising from each optioned VirBio program and to commercialize each such product in the China Territory following regulatory approval.

With respect to programs for which Brii Bio exercises its options, Brii Bio will be required to pay us an option exercise fee for each such VirBio program ranging from the mid-single-digit millions up to $20.0 million, determined based on the commercial potential of the licensed program.

Brii Bio will also be required to pay regulatory milestone payments on a licensed product-by-licensed product basis ranging from the mid-single-digit millions up to $30.0 million, also determined based on the commercial potential of such program.

Following commercialization, Brii Bio will be required to make sales milestone payments based on certain specified levels of aggregate annual net sales of products arising from each licensed program in the China Territory, up to an aggregate of $175.0 million per licensed program.

Brii Bio also will pay us royalties that range from the mid-teens to the high-twenties.

On June 12, 2020, Brii Bio notified us of the exercise of its option to obtain exclusive rights to develop and commercialize compounds and products arising from elebsiran in the China Territory.

Under the terms of the Brii Agreement, following our option exercise, we are obligated to use commercially reasonable efforts to develop at least one licensed product arising from each optioned Brii Bio program, and to commercialize each such product in the United States following regulatory approval, and following Brii Bio’s option exercise, Brii Bio is obligated to use commercially reasonable efforts to develop at least one licensed product arising from each optioned Vir Bio program and to commercialize each such product in the Greater China Territory following regulatory approval.

On June 12, 2020, Brii Bio notified us of the exercise of its option to obtain exclusive rights to develop and commercialize compounds and products arising from elebsiran in the Greater China Territory.

Brii Bio paid us a $20.0 million option exercise fee in connection with the option exercise.

We separately paid $10.0 million, half of the option proceeds, to Alnylam in connection with the Amended Alnylam Agreement.

In July 2022, Brii Bio notified us of the exercise of its option to obtain exclusive rights to develop and commercialize compounds and products arising from tobevibart in the China Territory.

As mentioned above, our elebsiran program is being developed under the Amended Alnylam Agreement and as a result, we separately paid $10.0 million, half of the option proceeds, to Alnylam.

In July 2022, Brii Bio notified us of the exercise of its option to obtain exclusive rights to develop and commercialize compounds and products arising from tobevibart in the Greater China Territory.

Brii Bio paid us a $20.0 million option exercise fee in connection with the option exercise.

With respect to elebsiran and tobevibart for which Brii Bio exercised its options, Brii Bio will be required to pay regulatory milestone payments on a licensed product-by-licensed product basis ranging from the mid-single-digit millions up to $30.0 million, also determined based on the commercial potential of such program.

Following commercialization, Brii Bio will be required to make sales milestone payments based on certain specified levels of aggregate annual net sales of products arising from each licensed program in the Greater China Territory, up to an aggregate of $175.0 million per licensed program.

Brii Bio also will pay us royalties that range from the mid-teens to the high-twenties.

As partial consideration for our entry into the Brii Agreement, upon closing of Brii Bio Parent’s Series A preferred stock financing, we received Class A ordinary shares equal to 9.9% of the outstanding shares in Brii Bio Parent.

As a result of Brii Bio’s right to exercise one of its options for our HBV siRNA program, under the terms of the Amended Alnylam Agreement, in February 2020 we transferred to Alnylam a specified percentage of such equity consideration allocable to such program.

As a result of Brii Bio’s right to exercise one of its options for elebsiran, under the terms of the Amended Alnylam Agreement, in February 2020 we transferred to Alnylam a specified percentage of such equity consideration allocable to such program.

In July 2021, Brii Bio Parent completed its initial public offering, or the Brii Bio Parent IPO, on the Stock Exchange of Hong Kong Limited.

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We will also be required to make sales milestone payments based on certain specified levels of aggregate annual net sales of products in the United States arising from each licensed program, up to an aggregate of $175.0 million per licensed program.

In addition, we are obligated under the Brii Agreement to pay Brii Bio tiered royalties based on net sales of products arising from the programs licensed to VirBio in the United States, and Brii Bio is obligated to pay us tiered royalties based on net sales of products arising from the programs licensed to Brii Bioin the China Territory.

In addition, we are obligated under the Brii Agreement to pay Brii Bio tiered royalties based on net sales of products arising from the programs licensed to Vir Bio in the United States, and Brii Bio is obligated to pay us tiered royalties based on net sales of products arising from the programs licensed to Brii Bio in the Greater China Territory.

The rates of royalties payable by us to Brii Bio, and by Brii Bio to us on net sales range from mid-teens to high-twenties.

Each party’s obligations to pay royalties expires, on a product-by-product and territory-by-territory basis, on the latest of 10 years after the first commercial sale of such licensed product in the United States or China Territory, as applicable;

the expiration or abandonment of licensed patent rights that cover such product in the United States or China Territory, as applicable;

and the expiration of regulatory exclusivity in the United States or the China Territory, as applicable.

the expiration or abandonment of licensed patent rights that cover such product in the United States or Greater China Territory, as applicable;

and the expiration of regulatory exclusivity in the United States or the Greater China Territory, as applicable.

Royalty rates are subject to specified reductions and offsets.

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The royalties are payable, on a product-by-product and country-by-country basis, until the expiration of the last to expire valid claim in the licensed patents covering such product in such country.

In March 2020, we entered into a patent license agreement, which was amended in February 2021, or the 2020 Xencor Agreement, with Xencor pursuant to which we obtained a non-exclusive license to Xencor’s licensed technologies into, and to evaluate, antibodies that target any component of a coronavirus, including SARS-CoV-2, SARS-CoV and MERS-CoV, and a worldwide, non-exclusive, sublicensable license to develop and commercialize products containing such antibodies incorporating such technologies for all uses, including the treatment, palliation, diagnosis and prevention of human or animal diseases, disorders or conditions.

We are obligated to use commercially reasonable efforts to develop and commercialize an antibody product that incorporates Xencor’s licensed technologies, for each of the coronavirus research programs.

These technologies are used in sotrovimab, incorporating Xencor’s Xtend technology.

In consideration for the grant of the license, we are obligated to pay royalties based on net sales of licensed products at the mid-single-digits.

The royalties are payable, on a product-by-product and country-by-country basis, until the later of the expiration of the last to expire valid claim in the licensed patents covering such product in such country or 12 years.

The 2019 Xencor Agreement and 2020 Xencor Agreement will remain in force, on a product-by-product and country-by-country basis, until the expiration of all royalty payment obligations under each of the respective agreements.

We may terminate each agreement in its entirety, or on a target-by-target basis, for convenience upon 60 days’ written notice.

Either party may terminate each agreement for the other party’s uncured material breach upon 60 days’ written notice (or 30 days in the case of non-payment) or in the event of bankruptcy of the other party immediately upon written notice.

Xencor may terminate each agreement immediately upon written notice if we challenge, or upon 30 days’ written notice if any of our sublicensees challenge, the validity or enforceability of any patent licensed to us under each respective agreement.

The 2019 Xencor Agreement will remain in force, on a product-by-product and country-by-country basis, until the expiration of all royalty payment obligations.

We may terminate the agreement in its entirety, or on a target-by-target basis, for convenience upon 60 days’ written notice.

Either party may terminate the agreement for the other party’s uncured material breach upon 60 days’ written notice (or 30 days in the case of non-payment) or in the event of bankruptcy of the other party immediately upon written notice.

Xencor may terminate the agreement immediately upon written notice if we challenge, or upon 30 days’ written notice if any of our sublicensees challenge the validity or enforceability of any patent licensed to us under each respective agreement.

Amended and Restated Letter Agreement with the Gates Foundation

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In connection with the Gates Agreement, the Gates Foundation purchased $10.0 million of shares of our Series A-1 convertible preferred stock in December 2016, $10.0 million of shares of our Series B convertible preferred stock in January 2019 and $40.0 million of shares of our common stock in January 2022.

We were obligated to use the proceeds of the Gates Foundation’s December 2016 and January 2019 investments in furtherance of its charitable purposes to (i) conduct our programs to develop products to treat or prevent infectious disease caused by HIV and tuberculosis, or TB, respectively, with at least 50% of the funds to be used for such programs and (ii) develop our HCMV-based vaccine technology platform in a manner reasonably expected to result in the generation of products for the treatment or prevention of other specified infectious diseases, and we were obligated to use the proceeds of the Gates Foundation’s January 2022 investment in furtherance of its charitable purposes to develop our vaccinal antibody program, in each case for use in specified developing countries.

We agreed to use reasonable efforts to achieve specified research and development milestones with respect to our HIV program, TB program and vaccinal antibody program, and, if requested by the Gates Foundation.

Additionally, we are bound by specified global access commitments including a commitment to provide any products developed using the proceeds of the Gates Foundation’s investment at an affordable price to the people most in need within the specified developing countries, not to exceed a specified percentage over our fully burdened manufacturing and sales costs.

We are obligated to use the proceeds of the Gates Foundation’s January 2022 investment in furtherance of its charitable purposes to develop our vaccinal antibody program, in each case for use in specified developing countries.

We agreed to use reasonable efforts to achieve specified research and development milestones with respect to our vaccinal antibody program, and, if requested by the Gates Foundation and agreed by us, on further development of such programs beyond stated milestones.

Additionally, we are bound by specified global access commitments including a commitment to provide any products developed using the proceeds of the Gates Foundation’s investment at an affordable price to the people most in need within the specified low- and middle-income countries, not to exceed a specified percentage over our fully burdened manufacturing and sales costs.

As of December 31, 2025, the Company had stock purchase premium liability of $9.3 million, which will be recognized as we advance the development of our vaccinal antibody program with the Gates Foundation.

If we fail to comply with (i) our obligations to use the proceeds of the Gates Foundation’s investment for the purposes described in the paragraph above and to not use such proceeds for specified prohibited uses, (ii) specified reporting requirements or (iii) specified applicable laws, or if we materially breach our specified global access commitments (any such failure or material breach, a Specified Default), we will be obligated to redeem or arrange for a third party to purchase all of our stock purchased by the Gates Foundation under the Gates Agreement at the Gates Foundation’s request, at a price equal to the greater of (a) the original purchase price or (b) the fair market value, such redemption or sale, a Gates Foundation Redemption.

Following a Gates Foundation Redemption, if a sale of the company or all of our material assets relating to the Gates Agreement occurs prior to the six month anniversary of the first redemption or sale of any stock in such Gates Foundation Redemption, then the Gates Foundation will receive compensation equal to the excess of what it would have received in such transaction if it still held the stock redeemed or sold at the time of such sale transaction over what it actually received in the Gates Foundation Redemption.

Additionally, if a specified default occurs, if we are unable or unwilling to continue the HIV program, TB program, vaccinal antibody program or, if applicable, the mutually agreed additional program (except for scientific or technical reasons), or if we institute bankruptcy or insolvency proceedings, then the Gates Foundation will have the right to exercise a non-exclusive, fully-paid license (with the right to sublicense) under our intellectual property to the extent necessary to use, make and sell products arising from such programs, in each case solely to the extent necessary to benefit people in the developing countries in furtherance of the Gates Foundation’s charitable purpose.

Additionally, if a specified default occurs, if we are unable or unwilling to continue the vaccinal antibody program or, if applicable, any mutually agreed additional program (except for scientific or technical reasons), or if we institute bankruptcy or insolvency proceedings, then the Gates Foundation will have the right to exercise a non-exclusive, fully-paid license (with the right to sublicense) under our intellectual property to the extent necessary to use, make and sell products arising from such programs, in each case solely to the extent necessary to benefit people in specified low- and middle-income countries (as defined in the Gates Agreement) in furtherance of the Gates Foundation’s charitable purpose.

In the event that we sell, exclusively license, or transfer to a third party all or substantially all of our assets, the technology platform, or products arising from programs that are funded using the proceeds of the Gates Foundation’s investment, such third party is required to assume our specified global access commitments on terms that are reasonably acceptable to the Gates Foundation.

Additionally, we will not grant to any third party any rights or enter into any agreement with any third party that would restrict the Gates Foundation’s rights with respect to our specified global access commitments unless such third party expressly assumes such commitments to the reasonable satisfaction of the Gates Foundation..

Additionally, we will not grant any third party any rights or enter into any agreement with any third party that would restrict the Gates Foundation’s rights with respect to our specified global access commitments unless such third party expressly assumes such commitments to the reasonable satisfaction of the Gates Foundation.

The global access commitments will continue for as long as the Gates Foundation continues to be a charitable entity.

In connection with the purchase of $40.0 million of shares of our common stock in January 2022, we entered into a stock purchase agreement, or the Gates Stock Purchase Agreement, with the Gates Foundation.

The Gates Foundation purchased the shares of our common stock at $45.38 price per share.

In relation to the agreements discussed above, we have entered into various grant agreements with the Gates Foundation, to support our HIV vaccine program, TB vaccine program, HIV vaccinal antibody program and malaria vaccinal antibody program.

The term of the grant agreements will expire at various dates through June 2027.

The grant agreements may be terminated early by the Gates Foundation for our breach, failure to progress the applicable funded projects, in the event of our change of control, change in our tax status, or significant changes in our leadership that the Gates Foundation reasonably believes may threaten the success of the applicable project.

As of December 31, 2024, the Company had deferred revenue of $11.1 million, related to the grants with the Gates Foundation and $11.6 million within accrued and other liabilities, which may need to be refunded to the Gates Foundation.

In August 2024, we announced a strategic realignment that included phasing out certain research programs which include programs associated with the grant agreements for the HCMV-based vaccine technology platform, which includes the HIV vaccine program and the TB vaccine program, but excludes the HIV vaccinal antibody program.

Biomedical Advanced Research and Development Authority

On September 28, 2022, VirBio entered into a multi-year agreement under Other Transaction Authority (OTA) with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S.

Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response, with the potential for up to $1.0 billion to advance the development of a full portfolio of innovative solutions to address influenza and potentially other infectious disease threats.

BARDA initially invested $55.0 million for the development of VIR-2482, an investigational prophylactic mAb designed to protect against seasonal and pandemic influenza, with the balance of the award subject to BARDA exercising up to 12 options in further support of the development of pre-exposure prophylactic antibodies including and beyond VIR-2482 for the prevention of influenza illness or possibly supporting medical countermeasures for other pathogens of pandemic potential.

The BARDA agreement also outlines potential support for VirBio’s clinical development of additional future pandemic influenza mAbs, as well as the potential development of up to 10 emerging infectious disease or Chemical, Biological, Radiological, and Nuclear medical countermeasure candidates.

On September 28, 2023, BARDA awarded VirBio approximately $50.1 million in new funding to advance the development of novel mAb candidates and delivery solutions to widen the applicability of mAbs in COVID-19 and in pandemic preparedness and response.

The new funding will support research and development of novel alternative mAb delivery technologies that have the potential to revolutionize mAb delivery by increasing expression relative to existing technologies.

Such delivery could widen the breadth of administration options and shorten development and manufacturing timelines.

This new investment falls under VirBio’s existing OTA.

The balance of the potential remaining funding is subject to BARDA exercising up to 12 options in further support of the development of pre-exposure prophylactic antibodies for the prevention of influenza illness or supporting medical countermeasures for other pathogens of pandemic potential.

$40 million of the total funds is part of ‘Project NextGen,’ an initiative by the HHS to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19 and will support the development of VIR-7229 through Phase 1 in the context of developing alternative mAb delivery technologies.

VirBio was also awarded approximately $11.0 million in additional BARDA funding that was applied to wind down activities for the BARDA-supported Phase 2 pre-exposure prophylaxis trial of VIR-2482.

In September 2024, we and BARDA entered into Amendment No.

P00003 to the BARDA Agreement, pursuant to which the parties agree to partially de-obligate certain funds from two of the exercised options related to the development of VIR-7229.

Under this Amendment the current BARDA commitment was decreased by $42.1 million.

On October 25, 2024, we notified BARDA of intent to terminate the OTA on December 31, 2024.

All remaining funds were de-obligated upon the date of termination.

During the year, all of the grant agreements expired except for the HIV vaccine program, for which the term expires in June 2027.

The remaining grant agreement may be terminated early by the Gates Foundation for our breach, failure to progress the applicable funded projects, in the event of our change of control, change in our tax status, or significant changes in our leadership that the Gates Foundation reasonably believes may threaten the success of the applicable project.

Sales and Marketing

Given our stage of development, we have not yet established a meaningful commercial (sales or marketing) organization, nor distribution capabilities.

We intend to build a commercial infrastructure to support the sales and marketing of our product candidates.

We expect to manage sales, marketing and distribution through internal resources and third-party relationships.

While we may commit significant financial and management resources to commercial activities, we will also consider collaborating with one or more biopharmaceutical companies to enhance our commercial capabilities.

We intend to build a commercial infrastructure to support the sales and marketing of our product candidates, if approved, including tobevibart and elebsiran for the treatment of CHD.

We expect to manage sales, marketing and distribution through internal resources and third-party relationships, including with Norgine with respect to commercialization of the combination of tobevibart and elebsiran for the treatment of CHD patients in the Norgine Territory.

While we may commit significant financial and management resources to commercial activities for tobevibart and elebsiran and our broader portfolio, we will also consider collaborating with one or more biopharmaceutical companies to enhance our commercial capabilities going forward, as we have with the exclusive license granted to Norgine.

Manufacturing

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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-current Good Manufacturing Practice (cGMP) manufacturing for preclinical studies.

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

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These manufacturing platforms are based on mAb technology and industrial processes that have been optimized, standardized and well-established across the biopharmaceutical industry over the last 30 years to enable process portability between biomanufacturing facilities and manufacturing with high success rates at most biologic CDMOs, as well as the partnered use of excess capacity with other biopharmaceutical companies.

In 2023, we completed the build-out of additional in-house capabilities in our San Francisco headquarters for mAb cell line development, Phase 1/2 process development, and small-scale drug substance and drug product manufacturing to produce non-GMP material for preclinical studies.

Our new process development laboratory was successfully brought on line in 2024.

We established in-house capabilities in our San Francisco headquarters for mAb cell line development, Phase 1/2 process development, and small-scale drug substance and drug product manufacturing to produce non-cGMP material for preclinical studies.

Our new process development laboratory was successfully brought online in 2024.

T-Cell Engager - PRO-XTEN ®

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coli -derived TCEs in our San Francisco facility.

Similar to our antibody programs, we leverage on the E.coli process platforms and manufacturing facilities of our CDMOs and strategic collaborators for further development and optimization, manufacturing and supply of our preclinical, clinical and future E.coli TCE product candidates.

The manufacturing processes for TCE drug substances (DS) and drug products (DP) have been developed by our scientists based on established E.

coli manufacturing technology and pharmaceutical industrial processes that have been optimized, standardized and well-established across the biopharmaceutical industry for other biologics.

VirBio licensed and conducted a technology transfer of the siRNA DS and DP process for Elebsiran.

The manufacturing processes for TCE drug substances (DS) and drug products (DP) have been developed by our scientists based on standard E.

coli manufacturing and pharmaceutical processes that have been well-established across the biopharmaceutical industry for other biologics.

Similar to our antibody programs, we leverage the E.coli process platforms and manufacturing facilities of our CDMOs and strategic collaborators for further development and optimization, manufacturing and supply of our preclinical, clinical and future E.coli TCE product candidates.

Vir Bio licensed and conducted a technology transfer of the siRNA DS and DP process for elebsiran.

Similarly, we rely on the siRNA process platforms and manufacturing facilities of our CDMOs and strategic collaborators for further development, optimization, manufacturing and supply of our siRNA product candidate.

Manufacturing Agreements

In first quarter of 2024, we and a large CDMO entered into various scopes of work and continue to do so with the respect to process performance qualification (PPQ) for Tobevibart drug substance (the Tobevibart agreements).

Under the terms of these agreements, the CDMO is obligated to reserve these manufacturing slots and will manufacture the agreed upon number of batches in accordance with an agreed upon manufacturing schedule to successfully complete PPQ.

As of December 31, 2024, we had unaccrued unpaid commitments of approximately $23 million under the Tobevibart Agreements.

Future commercial supply will be subject to finalizing a commercial supply agreement and relevant terms at the appropriate time.

In the third and fourth quarter of 2024, we entered into binding commitments with a large CDMO for process characterization and manufacture through completion of PPQ of Elebsiran DS (the Elebsiran agreements).

As of December 31, 2024, we had unaccrued unpaid commitments of approximately $9 million under the Elebsiran Agreements.

Future commercial supply will be subject to finalizing a commercial supply agreement and relevant terms at the appropriate time.

For TCEs, we have agreements with CDMOs to manufacture our drug substance and drug products for clinical trials on a yearly basis with no long-term commitments.

In 2024, we and a large CDMO entered into various scopes of work and continue to do so with the respect to process performance qualification (PPQ) for tobevibart DS (the Tobevibart Agreements).

Under the terms of these agreements, the CDMO has reserved these manufacturing slots and will manufacture the agreed upon number of batches in accordance with an agreed upon manufacturing schedule to successfully complete PPQ.

Future commercial supply will be subject to finalizing a commercial supply agreement and relevant terms by the end of 2026.

In 2024, we entered into binding commitments with a large CDMO for process characterization and manufacture through completion of PPQ of elebsiran DS (the Elebsiran Agreements).

Under the terms of these agreements, the CDMO has reserved these manufacturing slots and will manufacture the agreed upon number of batches in accordance with the agreed upon manufacturing schedule to successfully complete PPQ.

Future commercial supply will be subject to finalizing a commercial supply agreement and relevant terms in 2026.

As of December 31, 2025, we had unaccrued unpaid commitments of approximately $24 million under the Tobevibart Agreements and Elebsiran Agreements.

For TCEs, we have agreements with CDMOs to manufacture our DS and DP for clinical trials on a yearly basis with commitments through 2028.

In 2025, we entered into binding commitments with a CDMO for manufacture of our TCE products.

As of December 31, 2025, we had unaccrued unpaid commitments of approximately $20 million for various TCE programs.

The pharmaceutical industry is characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products.

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The key competitive factors affecting the success of all of our programs are likely to be efficacy, safety, convenience, and cost/access.

There are currently no FDA-approved treatments for chronic HDV infection.

There are currently no FDA-approved treatments for CHD.

Gilead’s bulevirtide is approved for use by the EMA.

We understand that Gilead received a Complete Response Letter (CRL) for bulevirtide from the FDA in October 2022 and has indicated that it remains in active discussions with the FDA to work toward FDA approval.

Bulevirtide has not been shown to lead to HDV clearance, and requires daily injections to maintain viral suppression.

There are a few small pharmaceutical companies developing programs with various mechanisms of actions, including Bluejay Therapeutics, Huahui Health, and Assembly Biosciences (in partnership with Gilead).

Current FDA-approved treatments for chronic HBV infection are primarily oral antiviral agents such as NRTIs, marketed by Gilead and Bristol-Myers Squibb Company.

These treatments do not lead to either a functional or a complete cure in the vast majority of patients, and in the case of NRTIs, require life-long therapy.

Several large and small pharmaceutical companies are developing programs with various mechanisms of action, to be used alone or in combination, with the goal of achieving an HBV functional cure or complete cure.

GSK is currently developing their lead asset, bepirovirsen, in a Phase 3 program.

Companies with RNAi agents in clinical development include GSK, and Arbutus Biopharma.

In addition, several companies are developing antibodies against surface antigen including Bluejay Therapeutics & Huahui Health.

Several companies, including Gilead, Brii, and Virion have therapeutic vaccines in early clinical development.

HER2-associated Breast Cancer and Colorectal Cancer

There are several HER2 therapies currently approved and in development for HER2 associated cancers.

For HER2 positive breast cancer, there are a number of approved drugs including antibody drug conjugates (ADCs) (e.g.

ENHERTU from AstraZeneca and KADCYLA from Roche);

Gilead has refiled for bulevirtide with the FDA and has announced that they expect a U.S.

launch in the first half of 2026 should bulevirtide be approved by the FDA.

Bulevirtide has led to limited HDV clearance and requires daily injections to maintain viral suppression.

Mirum recently acquired Bluejay Therapeutics and their pipeline asset, brelovitug, which is currently in pivotal trials.

Additionally, there are two known small pharmaceutical companies developing programs with various mechanisms of action, including Huahui Health and Assembly Biosciences (in partnership with Gilead).

Prostate Cancer

Novartis’ lutetium Lu 177 vipivotide tetraxetan is the only currently approved PSMA-targeted therapy for prostate cancer.

There are a number of PSMA therapies in development for prostate cancer including TCEs (e.g., Janux’s JANX007), ADC’s (e.g., Johnson & Johnson’s JNJ-8177) and other mechanisms of action from various companies, including Regeneron, GSK, and Bayer, among others.

Beyond PSMA-targeted therapies, there are other clinical development programs focused on other prostate cancer targets (STEAP1, KLK2, B7-H3, etc.) utilizing various mechanisms of action that are sponsored by various companies, including J&J, Amgen, Novartis, Merck (MSD), Pfizer, and AstraZeneca, among others.

HER2-Expressing Solid Tumors

There are several HER2 therapies currently approved and in development for HER2-expressing solid tumors.

For HER2 positive breast cancer, there are a number of approved drugs including ADCs (e.g.

AstraZeneca’s and Daiichi Sankyo’s trastuzumab deruxtecan, Roche’s trastuzumab emtansine);

monoclonal antibodies (e.g.

HERCEPTIN & PERJETA from ROCHE);

Roche’s trastuzumab & pertuzumab);

and inhibitors (e.g.

Pfizer's TUKYSA).

Roche recently discontinued their non-masked HER2 TCE, and we are unaware of other compounds currently in clinical development.

While there are fewer HER2 therapies approved for HER2 positive CRC (ENHERTU from AstraZeneca and TUKYSA from Pfizer), the overall CRC space is highly competitive with standard of care agents (e.g.

Roche’s AVASTIN and Lilly’s ERBITUX) as well as pipeline agents across a number of modalities.

Prostate Cancer

While there are many currently approved options in mCRPC, there are limited options available to patients in later lines that have additional therapeutic benefits with manageable safety profiles as patients relapse.

There are several companies with ongoing efforts in development of later lines that are PSMA-targeting clinical-stage therapeutics.

These include, but are not limited to:

Amgen’s xaluritamig and Janux’s JANX007);

radioligand therapies (e.g.

Novartis’ PLUVICTO) and ADCs (e.g.

Johnson & Johnson’s ARX517).

Competition can also vary by line of therapy for metastatic disease, and many pipeline agents are also being evaluate with standard of care regimens such as anti-androgens (e.g.

Pfizer’s XTANDI).

Pfizer's tucatinib).

Outside of HER2 positive breast cancer, there are other companies evaluating HER2 therapies in HER2-expressing solid tumors with various mechanisms of action including AstraZeneca, Daiichi Sankyo, Pfizer, Remegen, Jazz, BioNTech, Duality Bio, Hengrui Pharma, Adagene among others.

Beyond HER2 therapies, companies are also developing programs targeting other tumor targets (non-HER2) that could also compete in HER2-expressing solid tumors.

EGFR-Expressing Solid Tumors

There are several EGFR therapies currently approved and in development for EGFR-expressing solid tumors.

For colorectal cancer, EGFR-targeting mAbs including Lilly’s cetuximab and Amgen’s cetuximab are currently approved globally.

Outside of colorectal cancer, there are also other companies evaluating EGFR therapies in EGFR-expressing solid tumors with various mechanisms of action including Janux, Regeneron, J&J, Genmab, Bicara, BMS, SystImmune, Affimed, AstraZeneca and others.

Beyond EGFR therapies, companies are also developing programs targeting other tumor targets (non-EGFR) that could also compete in EGFR-expressing solid tumors.

Intellectual Property

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We require our employees, consultants and advisors to enter into confidentiality agreements prohibiting the disclosure of confidential information and requiring disclosure and assignment to us of the ideas, developments, discoveries and inventions important to our business.

Our patent portfolio includes patents and patent applications that are licensed from a number of collaborators and other third parties, including Sanofi, Alnylam, the Institute for Research in Biomedicine, or IRB, Rockefeller and Xencor, and patents and patent applications that are owned by us.

Our patent portfolio includes patents and patent applications that cover our product candidates sotrovimab, elebsiran, tobevibart, VIR-5818, VIR-5500, and VIR-5525, and the use of these candidates for therapeutic purposes.

Our proprietary technology has been developed primarily through acquisitions, relationships with academic research centers and contract research organizations (CROs).

Our patent portfolio includes patents and patent applications that are licensed from several collaborators and other third parties, including Sanofi, Alnylam, IRB, Rockefeller and Xencor, and patents and patent applications that are owned by us.

Our patent portfolio includes patents and patent applications that cover our product candidates elebsiran, tobevibart, VIR-5500, VIR-5818, and VIR-5525, and the use of these candidates for therapeutic purposes.

Our proprietary technology has been developed primarily through in-licenses, acquisitions, relationships with academic research centers, and contract research organizations (CROs).

For our product candidates, we will, in general, initially pursue patent protection covering compositions of matter and methods of use.

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Dates in parentheses reflect the estimated expiration date of patents which may issue from currently pending applications.

The estimated expiration dates do not include any potential additional exclusivity (e.g., patent term extension, supplementary protection certificates or pediatric exclusivity) that has not yet been granted.

Key Product Candidates Patent Expiration

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(2044) (2044)

Patent Portfolio by Technology Platform

Platform Patent Portfolio by Technology Platform

Antibody Platform

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The 20-year term of the first of these families expired in 2024.

The US patent in this family is, however, still in force as its term was extend until 2027 due to patent office delay.

The US patent in this family is, however, still in force as its term was extended until 2027 due to patent office delay.

The 20-year term of the issued patents and any patent issuing from the pending patent applications in the second patent family is estimated to expire in 2038, absent any available patent term adjustments or extensions.

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However, we may be able to apply for patent term extensions or supplementary protection certificates in some countries.

For example, extensions for the patents or supplementary protection certificates on many of our products have been granted in the United States and in a number of European countries, compensating in part for delays in obtaining marketing approval.

For example, extensions for the patents or supplementary protection certificates on many of our products have been granted in the United States and in several European countries, compensating in part for delays in obtaining marketing approval.

Similar patent term extensions may be available for other products we are developing, but we cannot be certain we will obtain them in some countries.

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Future litigation or other proceedings regarding the enforcement or validity of our existing patents, or any future patents could result in the invalidation of our patents or substantially reduce their protection.

Our pending patent applications and the patent applications filed by our collaborative partners may not result in the issuance of any patents or may result in patents that do not provide adequate protection.

Our pending patent applications and patent applications filed by our collaborative partners may not result in the issuance of any patents or may result in patents that do not provide adequate protection.

As a result, we may not be able to prevent third parties from developing compounds or products that are closely related to those which we have developed or are developing.

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These agreements are designed to protect our proprietary information and, in the case of the invention assignment agreements, to grant us ownership of technologies that are developed by our employees and through relationships with third parties.

For more information, see the section titled “Risk Factors—Risks Related to Our Intellectual Property.”

For more information, see “Item 1A.

Risk Factors—Risks Related to Our Intellectual Property.”

Government Regulation and Product Approval

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A company, institution or organization which takes responsibility for the initiation and management of a clinical development program for such products is typically referred to as a sponsor.

We, along with third-party contractors, will be required to navigate the various preclinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or trials or seek approval or licensure of our product candidates.

We, as a sponsor, along with third-party contractors, will be required to navigate the various preclinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or trials, seek approval or licensure or commercialize our product candidates.

Biopharmaceuticals Regulation

The process required by the FDA before drug and biologic product candidates may be marketed in the United States generally involves the following:

• completion of extensive preclinical laboratory tests and animal trials performed in accordance with applicable regulations, including the FDA’s Good Laboratory Practice (GLP), regulations;

• design of a clinical protocol and submission to the FDA of an IND application which must become effective before clinical trials may begin;

• completion of extensive preclinical laboratory tests and animal trials performed in accordance with applicable regulations, including the FDA’s current Good Laboratory Practice (cGLP), regulations;

• design of a clinical protocol and submission to the FDA of an application(s) which must become effective before clinical trials may begin;

• approval by an independent institutional review board or ethics committee at each clinical site before the trial is commenced;

• performance of adequate and well-controlled human clinical trials in accordance with FDA’s Good Clinical Practice (GCP) regulations to establish the safety and efficacy of a drug candidate, and compliance with GMP to establish safety, purity and potency of a proposed biologic product candidate for its intended purpose;

• performance of adequate and well-controlled human clinical trials in accordance with FDA’s current Good Clinical Practice (cGCP) regulations to establish the safety and efficacy of a drug candidate, and compliance with cGMP to establish safety, purity and potency of a proposed product candidate for its intended purpose;

• preparation of and submission to the FDA of a new drug application (NDA) or biologics licensing application (BLA), as applicable, after completion of all pivotal clinical trials;

• satisfactory completion of an FDA Advisory Committee review, if applicable;

• a determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for review;

• satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with GMP and of selected clinical investigation sites to assess compliance with GCP;

• a determination by the FDA within 60 days of its receipt of an NDA or BLA whether the application is accepted for filing;

• satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with cGMP and of selected clinical investigation sites to assess compliance with cGCP;

• FDA review and approval of an NDA or BLA to permit commercial marketing of the product for particular indications for use in the United States;

• completion of any post-approval requirements, including the potential requirement to implement a risk evaluation and mitigation strategy, or REMS, and any post-approval studies required by the FDA.

Preclinical and Clinical Development

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The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day period, raises safety concerns or questions about the proposed clinical trial.

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCP, which include the requirement that all research subjects provide their informed consent for their participation in any clinical study.

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with cGCP, which include the requirement that all research subjects provide their informed consent for their participation in any clinical study.

Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.

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For purposes of biopharmaceutical development, human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

The investigational product is initially introduced into patients with the target disease or condition.

The investigational product is initially introduced into patients with the target disease or condition or healthy volunteers.

These trials are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

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The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites.

These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.

In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved to gain more information about the product.

These so-called Phase 4 trials may be made a condition to approval of the application.

These clinical trials are intended to establish the overall benefit-risk ratio of the investigational product and to provide an adequate basis for product approval.

In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved or as a condition to full approval to gain more information about the safety and efficacy of the product.

Concurrent with clinical trials, companies must finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.

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Once an NDA or BLA has been accepted for filing, the FDA’s goal is to review standard applications within 10 months after it accepts the application for filing, or, if the application qualifies for priority review, six months after the FDA accepts the application for filing.

In both standard and priority reviews, the review process is often significantly extended by FDA requests for additional information or clarification.

In both standard and priority reviews, the review process can be extended by FDA requests for additional information or clarification.

The FDA reviews an NDA to determine whether a drug is safe and effective for its intended use and a BLA to determine whether a biologic is safe, pure and potent.

The FDA also reviews whether the facility in which the product is manufactured, processed, packed or held meets standards designed to assure and preserve the product’s identity, safety, strength, quality, potency and purity.

The FDA also reviews and conducts inspections to determine whether the facility in which the product is manufactured, processed, packed or held meets standards designed to assure and preserve the product’s identity, safety, strength, quality, potency and purity.

The FDA may convene an advisory committee to provide clinical insight on application review questions.

Before approving an NDA or BLA, the FDA will typically inspect the facility or facilities where the product is manufactured.

The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.

After the FDA evaluates an application and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be manufactured, the FDA may issue an approval letter or a CRL.

An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications.

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Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

In 2025, the FDA announced a new pilot program called National Priority Voucher (CNPV).

This program is designed to further accelerate drug review time for companies supporting US national interests.

The review time may be reduced from 10-12 months to just 1-2 months under this pilot program.

Orphan Drug Designation

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Such off-label uses are common across medical specialties.

Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances.

Physicians may believe that such off-label uses are the best treatment for their patients in varied circumstances.

The FDA does not regulate the behavior of physicians in their choice of treatments.

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The FDA has since approved a number of biosimilars products.

Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency, can be shown through analytical trials, animal trials and a clinical trial or trials.

Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.

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A claim includes “any request or demand” for money or property presented to the U.S.

A number of biopharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly providing payments or other items of value to customers with the expectation that the customers would bill federal programs for their products or services.

Other companies have been prosecuted for causing false claims to be submitted because of the companies’ marketing of products for unapproved, and thus non-reimbursable, uses.

The federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

A number of biopharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly providing payments or other items of value to customers with the expectation that the providers, payers, and other third parties would bill federal programs for their products or services.

Other companies have been prosecuted for causing false claims to be submitted because of the companies’ marketing of products for unapproved uses.

The federal Health Insurance Portability and Accountability Act of 1996, as amended (HIPAA), created additional federal healthcare fraud criminal statutes that prohibit, among other things, knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

Also, many states have similar fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.

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Third-party payors may limit coverage to specific products on an approved list, or formulary, which might not include all of the FDA-approved products for a particular indication.

Similarly, because certain of our product candidates are physician-administered, separate reimbursement for the product itself may or may not be available.

Similarly, because certain of our product candidates are intended to be physician-administered, separate reimbursement for the product itself may or may not be available.

Instead, the administering physician may only be reimbursed for providing the treatment or procedure in which our product is used.

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imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023);

and replaces the Part D coverage gap discount program with a new discounting program (to go into effect in 2025).

and replaces the prior Part D coverage gap discount program with the new Manufacturer Discount Program (effective in January 2025).

The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

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Among other things, the IRA contains many provisions aimed at reducing this financial burden on individuals by reducing the co-insurance and co-payment costs, expanding eligibility for lower income subsidy plans, and price caps on annual out-of-pocket expenses, each of which could have potential pricing and reporting implications.

While it is currently unclear certain new measures, including the drug pricing provisions of the IRA, will ultimately be effectuated, we cannot predict with certainty what impact any federal or state health reforms will have on us, but such changes could impose new or more stringent regulatory requirements on our activities or result in reduced reimbursement for our products, any of which could adversely affect our business, results of operations and financial condition.

While it is currently unclear whether certain new measures, including the drug pricing provisions of the IRA, will ultimately be effectuated, we cannot predict with certainty what impact any federal or state health reforms will have on us, but such changes could impose new or more stringent regulatory requirements on our activities or result in reduced reimbursement for our products, any of which could adversely affect our business, results of operations and financial condition.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control biopharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

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The legislative and regulatory landscape for privacy and data protection continues to evolve in jurisdictions worldwide, subject to differing applications and interpretations, and in some cases inconsistencies or conflicts with other rules.

At the federal level, HIPAA, imposes specific requirements on certain types of individuals and entities relating to the privacy, security and transmission of individually identifiable health information and although we are not considered to be a covered entity or business associate under HIPAA, certain third parties with whom we collaborate in administering our clinical studies (or may collaborate with in the future for any clinical, regulatory or commercial activities) are within the scope of HIPAA.

Penalties for failure to comply with these requirements vary significantly, and include significant civil monetary penalties and, in certain circumstances, criminal penalties and/or imprisonment.

Various states, such as California, Colorado, Oregon, Texas, Utah and Virginia, among others, have adopted privacy laws, including laws and regulations similar to HIPAA, that impose restrictive requirements regulating the use and disclosure of health information and other types of personal information.

Congress has also considered passing a federal privacy law.

Numerous U.S.

states, such as California, Colorado, Oregon, Texas, Utah and Virginia, among others, have adopted comprehensive privacy laws, including laws and regulations similar to HIPAA, that impose restrictive requirements regulating the processing of “sensitive” data (which includes health data in some cases).

Where state laws are more protective, we have to comply with the stricter provisions.

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The failure of third parties to obtain consents that are valid under applicable law could result in our own non-compliance with privacy laws.

Such failure would expose us to risk of enforcement actions from data protection authorities in the United States, EU and elsewhere, with the potential for significant financial penalties and/or orders requiring us to change our practices if we are found to be non-compliant, as well as private lawsuits or adverse publicity, all of which could negatively affect our operating results and business.

Such failure would expose us to risk of enforcement actions from data protection authorities in the United States, EU and elsewhere, with the potential for significant civil or criminal penalties and/or orders requiring us to change our practices if we are found to be non-compliant, as well as private lawsuits or adverse publicity, all of which could negatively affect our operating results and business.

Human Capital Management

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In addition to highly competitive base compensation, cash bonuses granted pursuant to our annual incentive plan and stock-based awards granted pursuant to our equity incentive plan, we offer numerous benefits to employees on a country-by-country basis, including a 401(k) plan with matching, health (medical, dental and vision) insurance, life insurance, paid time off, paid parental leave and short-term and long-term disability.

To drive further engagement and individual ownership of the Company, we also maintain an employee stock purchase plan, which provides eligible employees an opportunity to purchase additional Company stock at a discounted price.

Equity, Inclusion and Development

We take a proactive approach to promoting equity and inclusion.

In addition to being an equal opportunity employer, we proactively use a specialized software tool to reduce bias in our job postings to ensure that we utilize inclusive language to reach the broadest range of applicants.

We support formalized employee resource groups and initiatives such as heritage and inclusivity focused events, open forum discussions, ongoing mentoring, and networking for our employees.

To ensure pay equity at all levels, we use a leading independent third party pay equity firm to perform an annual independent audit of our pay practices.

To ensure pay equity at all levels, we use a leading independent third party pay equity firm to perform an independent audit of our pay practices periodically.

We offer ongoing, targeted inclusive developmental training for employees and leaders.

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Within this, we focus on individual opportunities for growth, developing people managers’ skills and cultivating our leaders’ capabilities to align the organization in service of our mission.

Additionally , we value the diversity of our leaders, with women and minorities comprising 36% and 60% of our board of directors and executive management team, respectively, as of December 31, 2024.

Our Corporate Information

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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 1. Business