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What changed in Vir Biotechnology, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Vir Biotechnology, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+635 added−667 removedSource: 10-K (2026-02-23) vs 10-K (2025-02-27)

Top changes in Vir Biotechnology, Inc.'s 2025 10-K

635 paragraphs added · 667 removed · 481 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

197 edited+87 added−98 removed186 unchanged
Biggest changeGoing 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. 13 Table of Contents 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).
Biggest changeGoing 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 and to collaborate on three separate programs, all of which had been subsequently terminated except for an RSV program selected in 2022.
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.
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.
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.
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.
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 benefit-risk ratio of the investigational product and to provide an adequate basis for product approval.
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.
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.
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.
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.
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.
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.
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 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.
Secondary endpoints include proportion of participants with undetectable HDV RNA and 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).
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).
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.
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.
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.
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 intended to be physician-administered, separate reimbursement for the product itself may or may not be available.
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.
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 Greater 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.
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.
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.
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. Brii Bio paid us a $20.0 million option exercise fee in connection with the option exercise.
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.
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.
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.
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.
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.
We believe our unified approach of leveraging our deep understanding of immunology to address seemingly disparate threats distinguishes us in the field. 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.
We believe our unified approach of leveraging our deep understanding of immunology to address seemingly disparate threats distinguishes us in the field. 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 multiple solid tumors.
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.
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 independent audit of our pay practices periodically.
The US patent in this family is, however, still in force as its term was extend 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.
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.
This combination of cutting-edge technologies, artificial intelligence-driven optimization, and deep immunological expertise positions us to create potentially transformative medicines for some of the more challenging diseases facing humanity today. 9 Table of Contents mAb: monoclonal antibody platform; prot. eng: protein engineering capabilities; AI: artificial intelligence Antibody Platform Overview 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.
This combination of cutting-edge technologies, artificial intelligence-driven optimization, and deep immunological expertise positions us to create potentially transformative medicines for some of the more challenging diseases facing humanity today. 9 Table of Contents mAb: monoclonal antibody platform; prot. eng: protein engineering capabilities; AI: artificial intelligence Antibody and TCE Discovery and Engineering Platform Overview 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.
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.
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.
Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. 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 prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for their patients in varied circumstances.
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.
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 (Complete Response Letter). An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications.
For purposes of biopharmaceutical development, human clinical trials are typically conducted in three sequential phases that may overlap or be combined: • Phase 1. The investigational product is initially introduced into patients with the target disease or condition.
For purposes of biopharmaceutical development, human clinical trials are typically conducted in three sequential phases that may overlap or be combined: • Phase 1. The investigational product is initially introduced into patients with the target disease or condition or healthy volunteers.
It is unclear whether the new Trump Administration will reverse or modify any existing regulatory requirements, pursue new reform initiatives or otherwise influence the overall healthcare regulatory environment, and even if proposed, whether such changes or modifications would be implemented or withstand potential litigation. Pharmaceutical Prices In August 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law.
It is unclear whether the new Trump Administration will reverse or modify any existing regulatory requirements, pursue new reform initiatives or otherwise influence the overall healthcare regulatory environment, and even if proposed, whether such changes or modifications would be implemented or withstand potential litigation. 33 Table of Contents Pharmaceutical Prices In August 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law.
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. Our Approach We are currently investigating the PRO-XTEN ™ technology in conjunction with TCEs.
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. 11 Table of Contents Our Approach We are currently investigating the PRO-XTEN ® technology in conjunction with TCEs.
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.
However, if the antigen is also expressed on healthy cells, bi-specific TCEs can similarly bind to TAAs present in non-cancerous cells or healthy tissue, driving on-target, off-tumor toxicity, including cytokine release syndrome (CRS), thus limiting the potential therapeutic index of TCEs. Masking of TCEs is a strategy designed to circumvent these limitations.
However, if the antigen is also expressed on healthy cells, bi-specific TCEs can similarly bind to TAAs present in non-cancerous cells or healthy tissue, driving on-target, off-tumor toxicity, including cytokine release syndrome (CRS), thus limiting the potential therapeutic index of TCEs. 6 Table of Contents Masking of TCEs is a strategy designed to circumvent these limitations.
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.
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 performed at the IRB.
TCE: T-Cell Engager 11 Table of Contents Our dual-masked TCEs are single protein polypeptides with three key functions, a bi-specific TCE at their core, two universal PRO-XTEN ™ masks, which are connected to the TCE component by protease-cleavable linkers. The bi-specific TCE is comprised of two antibody fragments: a TAA binding domain and a CD3 binding domain.
TCE: T-Cell Engager Our dual-masked TCEs are single protein polypeptides with three key functions, a bi-specific TCE at their core, two universal PRO-XTEN ® masks, which are connected to the TCE component by protease-cleavable linkers. The bi-specific TCE is comprised of two antibody fragments: a TAA binding domain and a CD3 binding domain.
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 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 with certain proprietary technologies of the IRB.
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 U.S. E.U.
The estimated expiration dates do not include any potential additional exclusivity (e.g., patent term extension, supplementary protection certificates or pediatric exclusivity) that have not yet been granted. Key Product Candidates Patent Expiration U.S. E.U.
Item 1. Business. Overview and Strategy Powering the Immune System to Transform Lives. 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.
Item 1. Business. Overview and Strategy Powering the Immune System to Transform Lives. Vir Biotechnology, Inc. (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.
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 influenza A and HBV research programs. These technologies are used in tobevibart, incorporating Xencor’s Xtend. 18 Table of Contents In consideration for the grant of the license, we paid Xencor an upfront fee.
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 influenza A and HBV research programs. These technologies are used in tobevibart, incorporating Xencor’s Xtend. In consideration for the grant of the license, we paid Xencor an upfront fee.
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 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).
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.
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 several European countries, compensating in part for delays in obtaining marketing approval.
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.
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.
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.
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 PRO-XTEN ® dual-masked TCEs targeting novel TAAs.
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.
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 testing, animal trials and clinical trials.
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.
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, Vir Bio’s TCEs are designed to remain inactive until they reach the tumor microenvironment.
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 key competitive factors affecting the success of all of our programs are likely to be efficacy, safety, convenience, and cost/access. HDV There are currently no FDA-approved treatments for chronic HDV infection. Gilead’s bulevirtide is approved for use by the EMA.
The key competitive factors affecting the success of all of our programs are likely to be efficacy, safety, convenience, and cost/access. HDV There are currently no FDA-approved treatments for CHD. Gilead’s bulevirtide is approved for use by the EMA.
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. 27 Table of Contents • Phase 2.
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. • Phase 2.
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.
After approval, most changes to the approved product, such as adding new indications, manufacturing methods or amended labeling claims, are subject to prior FDA review and approval. 29 Table of Contents The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
After approval, most changes to the approved product, such as adding new indications, manufacturing methods or amended labeling claims, are subject to prior FDA review and approval. The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
Among other things, the IRA: requires manufacturers of certain drugs to engage in price negotiations with Medicare (to go into effect in 2026), with prices that can be negotiated subject to a cap; 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).
Among other things, the IRA: requires manufacturers of certain drugs to engage in price negotiations with Medicare (to go into effect in 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the prior Part D coverage gap discount program with the new Manufacturer Discount Program (effective in January 2025).
For more information, see the section titled “Risk Factors—Risks Related to Our Intellectual Property.” Trademarks and Know-How In connection with the ongoing development and advancement of our products and services in the United States and various international jurisdictions, we seek to create protection for our marks and enhance their value by pursuing trademarks and service marks where available and when appropriate.
For more information, see the section titled “ Risk Factors—Risks Related to Our Intellectual Property .” 26 Table of Contents Trademarks and Know-How In connection with the ongoing development and advancement of our products and services in the United States and various international jurisdictions, we seek to create protection for our marks and enhance their value by pursuing trademarks and service marks where available and when appropriate.
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.
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.
Patents Owned by Us We also own, with our subsidiary Humabs, one patent family that includes, as of December 31, 2024, 34 pending applications in both the US and abroad. These applications include composition of matter claims, pharmaceutical composition claims, method of treatment claims and composition for use in treatment claims.
Patents Owned by Us We also own, with our subsidiary Humabs, one patent family that includes, as of December 31, 2025, 33 pending applications in both the US and abroad. These applications include composition of matter claims, pharmaceutical composition claims, method of treatment claims, and composition for use in treatment claims.
In both standard and priority reviews, the review process is often significantly 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.
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.
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. 35 Table of Contents Equity, Inclusion and Development We take a proactive approach to promoting equity and inclusion.
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 Company stock at a discounted price. Equity, Inclusion and Development We take a proactive approach to promoting equity and inclusion.
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.
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.
Simplified mechanism of action representation of tobevibart and elebsiran. cccDNA: covalently closed circular DNA, HBsAg: hepatitis B virus surface antigen, HBV: hepatitis B virus, HDV: hepatitis D virus, Int: integrated, NRTI: nucleoside/nucleotide reverse transcriptase inhibitor, RNP: ribonucleoprotein, SVP: subviral particle Chronic Hepatitis Delta (CHD) CHD is a chronic, progressive liver disease caused by the HDV, which requires HBV for its replication.
Simplified mechanism of action representation of tobevibart and elebsiran. cccDNA: covalently closed circular DNA, HBsAg: hepatitis B virus surface antigen, HBV: hepatitis B virus, HDV: hepatitis D virus, Int: integrated, NRTI: nucleoside/nucleotide reverse transcriptase inhibitor, RNP: ribonucleoprotein, SVP: subviral particle 4 Table of Contents CHD CHD is a progressive liver disease caused by HDV, which requires HBV for its replication.
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 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.
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. This Phase 2 study is a multi-center, open-label, randomized study.
Tobevibart + elebsiran for CHD 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. This Phase 2 study is a multi-center, open-label, randomized study.
For more information, see the section titled “Risk Factors—Risks Related to Our Intellectual Property.” Government Regulation and Product Approval The FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs and biologics such as those we are developing.
Risk Factors—Risks Related to Our Intellectual Property.” Government Regulation and Product Approval The FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs and biologics such as those we are developing.
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.
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.
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 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.
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.
We use technology licensed under the Rockefeller Agreement in our antibody platform and in our product candidate tobevibart. 16 Table of Contents Under the agreement we are required to pay annual license maintenance fees of $1.0 million, which will be creditable against royalties following commercialization.
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 license maintenance fees of $1.0 million annually, which will be creditable against royalties following commercialization.
There is no approved CHD treatment in the U.S., and options are limited in the European Union and globally. 4 Table of Contents 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.
There is no approved CHD treatment in the U.S., and options are limited in the European Union and globally. 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.
The potent, unmasked form (uTCE) of VIR-5818, 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-5818 should remain predominantly masked and as an intact prodrug. Additional information is available in “Our Technology Platforms” section.
The potent, unmasked form (uTCE) of VIR-5818, 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-5818 should remain predominantly masked and as an intact prodrug.
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.
Pfizer’s XTANDI). 23 Table of Contents Intellectual Property Our intellectual property is critical to our business and we strive to protect it, including by obtaining and maintaining patent protection in the United States and internationally for our product candidates, new therapeutic approaches and potential indications, and other inventions that are important to our business.
Intellectual Property Our intellectual property is critical to our business and we strive to protect it, including by obtaining and maintaining patent protection in the United States and internationally for our product candidates, new therapeutic approaches and potential indications, and other inventions that are important to our business.
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.
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 “Item 1A.
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. 26 Table of Contents U.S.
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. U.S.
As a result of our opt-out, GSK may continue to pursue the development and commercialization of the RSV program unilaterally. If the RSV program reaches commercialization, GSK will pay us a royalty on net sales in the low single digits.
We opted-out of the RSV program during the fourth quarter of 2024. As a result of our opt-out, GSK may continue to pursue the development and commercialization of the RSV program unilaterally. If the RSV program reaches commercialization, GSK will pay us a royalty on net sales in the low single digits.
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; • 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; • 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; • 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; and • 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.
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 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 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 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; and • 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 to maintain the marketed status in the US of an approved drug. 27 Table of Contents Preclinical and Clinical Development Prior to beginning the first clinical trial with a product candidate, we must submit an IND to the FDA.
We use technology licensed under the Current IRB License Agreements in our antibody platform and in our product candidate tobevibart.
We use technology licensed under the Current IRB License Agreements in our product candidate tobevibart.
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.
Other companies have been prosecuted for causing false claims to be submitted because of the companies’ marketing of products for unapproved uses.
As of January 2022, applicable manufacturers are also required to report such information regarding its payments and other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives during the previous year. We may also be subject to similar state laws.
As of January 2022, applicable manufacturers are also required to report such information regarding its payments and other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives during the previous year.
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.
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.
(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.
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.
Manufacturing We manufacture product candidates for three therapeutic modalities: mAbs, masked TCEs and siRNA. We have established our own internal process, analytical and pharmaceutical development, manufacturing, supply chain and quality organizations that work with our selected CDMOs, to develop, manufacture, test and supply our early- and late-stage product candidates developed with our proprietary and external technology platforms.
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.
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. Collaboration and License Agreement with Alnylam In October 2017, we and Alnylam Pharmaceuticals, Inc.
We acquired exclusive rights to these patents in the agreements we have with these parties. We may obtain patents for certain products many years before marketing approval is obtained. Because patents have a limited life that may begin to run prior to the commercial sale of the related product, the commercial value of the patent may be limited.
We may obtain patents for certain products many years before marketing approval is obtained. Because patents have a limited life that may begin to run prior to the commercial sale of the related product, the commercial value of the patent may be limited.
Because of the breadth of these laws and the narrowness of available statutory exceptions and regulatory safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of such laws.
We may also be subject to similar state laws. 32 Table of Contents Because of the breadth of these laws and the narrowness of available statutory exceptions and regulatory safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of such laws.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeClinical trial delays could also shorten any periods during which we may have the exclusive right to commercialize our product candidates, if approved, or allow our competitors to bring competing products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our business, financial condition, results of operations and prospects. 43 Table of Contents Additionally, if the results of our clinical studies are inconclusive or if there are safety concerns or SAEs associated with our product candidates, we may: • be delayed in obtaining marketing approval, or not obtain marketing approval at all; • obtain approval for indications or patient populations that are not as broad as intended or desired; • obtain approval with labeling that includes significant use or distribution restrictions or safety warnings; • be required to perform additional clinical studies to support approval or be subject to additional post-marketing testing requirements; • have regulatory authorities withdraw, or suspend, their approval of the product or impose restrictions on its distribution in the form of a risk evaluation and mitigation strategy (REMS); • be subject to the addition of labeling statements, such as warnings or contraindications; • be subject to lawsuits, investigations or other legal or regulatory proceedings; or • experience damage to our reputation.
Biggest changeIf the results of our clinical studies are inconclusive or if there are safety concerns or serious adverse events associated with our product candidates, we may: • have regulatory authorities withdraw, or suspend, their approval of the product or impose restrictions on its distribution in the form of a risk evaluation and mitigation strategy (REMS); • obtain approval for indications or patient populations that are not as broad as intended or desired; • obtain approval with labeling that includes significant use or distribution restrictions, contraindications or safety warnings, or determine not to pursue any approval at all; • be subject to lawsuits, investigations or other legal or regulatory proceedings; or • experience damage to our reputation.
The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and/or prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this Annual Report on Form 10-K and those we may make from time to time.
The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations or prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this Annual Report on Form 10-K and those we may make from time to time.
Success in preclinical studies or early-stage clinical studies may not be indicative of results in future clinical studies and we cannot assure you that any ongoing, planned or future clinical studies will lead to results sufficient for the necessary regulatory approvals and marketing authorizations.
Success in preclinical or early-stage clinical studies may not be indicative of results in future clinical studies and we cannot assure you that any ongoing, planned or future clinical studies will lead to results sufficient for the necessary regulatory approvals and marketing authorizations.
Approval of certain product candidates outside of the United States, particularly those that target diseases that are more prevalent outside of the United States will be particularly important to the commercial success of such product candidates.
Approval of certain product candidates outside of the United States, particularly those that target diseases that are more prevalent outside of the United States, will be important to the commercial success of such product candidates.
To fulfill our siRNA supply requirements, we may need to secure alternative suppliers of synthetic siRNAs and/or key raw materials and components, and such alternative third-party suppliers are limited and may not be readily available, or we may be unable to enter into agreements with them on reasonable terms and in a timely manner.
To fulfill our siRNA supply requirements, we may need to secure alternative suppliers of synthetic siRNAs or key raw materials and components, and such alternative third-party suppliers are limited and may not be readily available, or we may be unable to enter into agreements with them on reasonable terms and in a timely manner.
Competition is intense for these skilled employee candidates, and we may be unable to retain or recruit such personnel with the expertise or experience necessary to achieve our business objectives, and such efforts may be further undermined by restructurings, changing office policies and other initiatives we may undertake improve operational efficiencies and operating costs, as well as shifting dynamics in the biotechnology labor market.
Competition is intense for these skilled employee candidates, and we may be unable to retain or recruit such personnel with the expertise or experience necessary to achieve our business objectives, and such efforts may be further undermined by restructurings, changing office policies and other initiatives we may undertake to improve operational efficiencies and operating costs, as well as shifting dynamics in the biotechnology labor market.
If any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, our intellectual property or our stock performance (including changes in analyst recommendations or price targets for our stock), or if the clinical studies and operating results fail to meet the expectations of analysts, our stock could decline.
If any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, our intellectual property or our stock performance (including changes in analyst recommendations or price targets for our stock), or if the clinical studies and operating results fail to meet the expectations of analysts, our stock price could decline.
Even if we obtain regulatory approval in the United States, market acceptance and sales of any product candidates that we commercialize may depend in part on the extent to which reimbursement for these product and related treatments will be available from third-party payors, including government health administration authorities, managed care organizations and other private health insurers.
Even if we obtain regulatory approval in the United States, market acceptance and sales of any product candidates that we commercialize may depend in part on the extent to which reimbursement for these product and related treatments will be available from third-party payors, including government health administration authorities, managed care organizations and private health insurers.
In the United States and some foreign jurisdictions, there have been, and we expect there will continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product candidates for which we obtain marketing approval.
In the United States and some foreign jurisdictions, there have been, and we expect there will continue to be, legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product candidates for which we obtain marketing approval.
The techniques used to sabotage or to obtain unauthorized access to information systems, and networks in which cyber threat actors store data or through which they transmit data change frequently and we may be unable to implement adequate preventative measures. For example, attackers have used AI to launch more automated, targeted and coordinated attacks against targets.
The techniques used to sabotage or to obtain unauthorized access to information systems, and networks in which cyber threat actors store data or through which they transmit data change frequently and we may be unable to implement adequate preventative measures. For example, attackers have used AI to launch more automated, targeted and coordinated attacks against various targets.
In addition, we may rely on CROs and clinical trial sites to ensure proper and timely conduct of our future clinical studies and, while we intend to enter into agreements governing their services, we will be limited in our ability to ensure their actual performance, which may result in rejection of the data generated at particular clinical trial sites or delays in the completion of our future clinical studies.
In addition, we may rely on CROs and clinical trial sites to ensure proper and timely conduct of our future clinical studies and, while we intend to enter into agreements governing their services, we will be limited in our ability to ensure their actual performance, which may result in rejection of the data generated at particular clinical trial sites or delays in the completion of our current and future clinical studies.
Patent terms may be inadequate to protect our competitive position on our product candidates or any products approved in the future for an adequate amount of time and additional competitors could enter the market with generic or biosimilar versions of such products. Patents have a limited lifespan.
Patent terms may be inadequate to protect the competitive position of our product candidates or any products approved in the future for an adequate amount of time and additional competitors could enter the market with generic or biosimilar versions of such products. Patents have a limited lifespan.
Factors that may cause fluctuations in our financial condition and results of operations include, without limitation, those listed elsewhere in this “Risk Factors” section. In addition, our collaboration revenue and certain assets and liabilities are subject to foreign currency exchange rate fluctuations due to the global nature of our operations.
Factors that may cause fluctuations in our financial condition and results of operations include, without limitation, those listed elsewhere in this “Risk Factors” section. In addition, our license and collaboration revenue and certain assets and liabilities are subject to foreign currency exchange rate fluctuations due to the global nature of our operations.
There could be delays or supply shortages beyond our control limiting our access to clinical supplies. • We rely on third parties to conduct, supervise and monitor our preclinical and clinical studies, and if those third parties perform in an unsatisfactory manner, it may harm our business. • If we breach our license agreements or any of the other agreements under which we acquired, or will acquire, the intellectual property rights to our product candidates, we could lose the ability to continue the development and commercialization of the related product candidates. • If we are unable to obtain and maintain patent protection for our product candidates and technology, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our product candidates and technology may be adversely affected. 37 Table of Contents • We are highly dependent on our key personnel, and if we are not able to retain these members of our management team or recruit and retain additional management, clinical and scientific personnel, our business could be harmed. • Our success depends on our ability to manage our growth. • If our information systems, or those maintained on our behalf, fail or suffer security breaches, such events could result in, without limitation, the following: a significant disruption of our product development programs; an inability to operate our business effectively; unauthorized access to or disclosure of the personal information we process; and other adverse effects on our business, financial condition, results of operations and prospects. • The market price of our common stock has been, and in the future, may be, volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
There could be delays or supply shortages beyond our control limiting our access to clinical and future commercial supplies. • We rely on third parties to conduct, supervise and monitor our preclinical and clinical studies, and if those third parties perform in an unsatisfactory manner, it may harm our business. • If we breach our license agreements or any of the other agreements under which we acquired, or will acquire, the intellectual property rights to our product candidates, we could lose the ability to continue the development and commercialization of the related product candidates. • If we are unable to obtain and maintain patent protection for our product candidates and technology, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our product candidates and technology may be adversely affected. • We are highly dependent on our key personnel, and if we are not able to retain these members of our management team or recruit and retain additional management, clinical and scientific personnel, our business could be harmed. • Our success depends on our ability to manage our growth. • If our information systems, or those maintained on our behalf, fail or suffer security breaches, such events could result in, without limitation, the following: a significant disruption of our product development programs; an inability to operate our business effectively; unauthorized access to or disclosure of the personal information we process; and other adverse effects on our business, financial condition, results of operations and prospects. • The market price of our common stock has been, and in the future, may be, volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
Our future capital requirements will depend on many factors, including: • the timing, progress and results of our ongoing preclinical and clinical studies of our product candidates; • the scope, progress, results and costs of preclinical development, laboratory testing and clinical studies of other potential product candidates that we may pursue; • our ability to establish and maintain collaboration, license, grant and other similar arrangements, and the opt-in mechanisms contained in, and the financial terms of, any such arrangements, including timing and amount of any future milestones, royalty or other payments due thereunder; • the costs, timing and outcome of regulatory reviews of our product candidates; • the costs and timing of commercialization activities, including product manufacturing, marketing, sales and distribution, for our product candidates for which we receive marketing approval; • the amount of revenue received from commercial sales of any product candidates for which we receive marketing approval; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; • any expenses needed to attract, hire and retain skilled personnel; • the costs of operating as a public company; and • the extent to which we acquire or in-license other companies’ product candidates and technologies.
Our future capital requirements will depend on many factors, including: • the timing, progress and results of our ongoing preclinical and clinical studies of our product candidates; • the scope, progress, results and costs of preclinical development, laboratory testing and clinical studies of other potential product candidates that we may pursue; • our ability to establish and maintain collaboration, license, grant and other similar arrangements, and the opt-in mechanisms contained in, and the financial terms of, any such arrangements, including timing and amount of any future milestones, royalty or other payments due thereunder; • the costs, timing and outcome of regulatory reviews of our product candidates; • the costs and timing of commercialization activities, including product manufacturing, marketing, sales and distribution, for our product candidates for which we receive marketing approval; 39 Table of Contents • the amount of revenue received from commercial sales of any product candidates for which we receive marketing approval; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; • any expenses needed to attract, hire and retain skilled personnel; • the costs of operating as a public company; and • the extent to which we acquire or in-license other companies’ product candidates and technologies.
In June 2024 and December 31, 2024, we announced that the FDA granted Fast Track designation and Breakthrough Therapy designation, respectively, for the combination of tobevibart and elebsiran for the treatment of CHD . In addition, the combination received PRIME designation from the EMA and European orphan drug designation in December 2024 in the same indication .
In June 2024 and December 2024, we announced that the FDA granted Fast Track designation and Breakthrough Therapy designation, respectively, for the combination of tobevibart and elebsiran for the treatment of CHD . In addition, the combination received PRIME designation from the EMA and European orphan drug designation in December 2024 for the same indication .
Enrollment and retention of patients in clinical studies is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control. Identifying and qualifying patients to participate in our clinical studies is critical to our success.
Enrollment and retention of patients in clinical studies is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by factors outside our control. Identifying and qualifying patients to participate in our clinical studies is critical to our success.
Furthermore, if a security breach were to occur and cause interruptions in our operations, it could result in a disruption of our development programs and our business operations, whether due to a loss of our trade secrets or other proprietary information or other similar disruptions.
Furthermore, if a significant security breach were to occur and cause significant interruptions in our operations, it could result in a disruption of our development programs and our business operations, whether due to a loss of our trade secrets or other proprietary information or other similar disruptions.
Any increase in negative perceptions of the technologies that we rely on may result in fewer physicians prescribing our products or may reduce the willingness of patients to utilize our products or participate in clinical studies for our product candidates.
Any negative perceptions of the technologies that we rely on may result in fewer physicians prescribing our products or may reduce the willingness of patients to utilize our products or participate in clinical studies for our product candidates.
Adverse events in our preclinical or clinical studies or those of our competitors or of academic researchers utilizing similar technologies, even if not ultimately attributable to product candidates we may discover and develop, and the resulting publicity could result in increased governmental regulation, unfavorable public perception, potential regulatory delays in the testing or approval of potential product candidates we may identify and develop, stricter labeling requirements for those product candidates that are approved, a decrease in demand for any such product candidates and a suspension or withdrawal of approval by regulatory authorities of our product candidates.
Adverse events in our preclinical or clinical studies or those of our competitors or of academic researchers utilizing similar technologies, even if not ultimately attributable to those product candidates we may discover and develop, and the resulting publicity could result in: • increased governmental regulation; • unfavorable public perception; • potential regulatory delays in the testing or approval of potential product candidates we may identify and develop; • stricter labeling requirements for those product candidates that are approved; • a decrease in demand for those product candidates that are approved; or • a suspension or withdrawal of approval by regulatory authorities of our product candidates that are approved.
General economic conditions, both inside and outside the U.S., including capital market volatility, interest rate and currency rate fluctuations, and economic slowdown or recession, as well as geopolitical events, including civil or political unrest, terrorism, insurrection or war (such as the ongoing conflicts in the Middle East and Eastern Europe), and also investor concerns regarding the U.S. or international financial systems, have in the past resulted in, and may in the future cause, a significant disruption of financial markets.
General economic conditions, both inside and outside the United States, including capital market volatility, interest rate and currency rate fluctuations, and economic slowdown or recession, as well as geopolitical events, including civil or political unrest, terrorism, insurrection or war (such as the ongoing conflicts in the Middle East and Eastern Europe), and also investor concerns regarding the U.S. or international financial systems, have in the past resulted in, and may in the future cause, a significant disruption of financial markets.
Our estimates of the number of people who have these diseases, the subset of people with these diseases who have the potential to benefit from treatment with our product candidates and the market demand for our product candidates are based on our beliefs and analyses.
Our estimates of the number of people who have these diseases, the subset of people with these diseases who have the potential to benefit from treatment with our product candidates, and the market demand for our product candidates, are each based on our beliefs and analyses.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware (or, if and only if the Court of Chancery of the State of Delaware lacks subject matter jurisdiction, any state court located within the State of Delaware or, if and only if all such state courts lack subject matter jurisdiction, the federal district court for the District of Delaware) will be the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law: • any derivative action or proceeding brought on our behalf; • any action or proceeding asserting a claim of breach of a fiduciary duty owed by any of our current or former directors, officers or other employees to us or our stockholders; • any action or proceeding asserting a claim against us or any of our current or former directors, officers or other employees, arising out of or pursuant to any provision of the Delaware General Corporation Law, our certificate of incorporation or our bylaws; • any action or proceeding to interpret, apply, enforce or determine the validity of our certificate of incorporation or our bylaws; and • any action asserting a claim against us or any of our directors, officers or other employees governed by the internal affairs doctrine.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware (or, if and only if the Court of Chancery of the State of Delaware lacks subject matter jurisdiction, any state court located within the State of Delaware or, if and only if all such state courts lack subject matter jurisdiction, the federal district court for the District of Delaware) will be the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law: • any derivative action or proceeding brought on our behalf; • any action or proceeding asserting a claim of breach of a fiduciary duty owed by any of our current or former directors, officers or other employees to us or our stockholders; • any action or proceeding asserting a claim against us or any of our current or former directors, officers or other employees, arising out of or pursuant to any provision of the Delaware General Corporation Law, our certificate of incorporation or our bylaws; • any action or proceeding to interpret, apply, enforce or determine the validity of our certificate of incorporation or our bylaws; and 68 Table of Contents • any action asserting a claim against us or any of our directors, officers or other employees governed by the internal affairs doctrine.
We have and may continue to commit substantial financial resources with respect to clinical studies that may not be successful, and we may not be able to recoup those investments. • Interim, “top line” and preliminary data from our clinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data. • Although the combination of tobevibart and elebsiran has received Fast Track and Breakthrough Therapy designation from the FDA, as well as PRIME designation from the EMA and European orphan drug designation, in each case for the treatment of CHD, there can be no assurance that any of our product candidates that receive such designations in the U.S. or similar designations in any other regulatory jurisdictions will maintain such designations or receive regulatory approval any sooner than other product candidates that do not have such designations, or at all. • Clinical product development involves a lengthy and expensive process.
We have and may continue to commit substantial financial resources with respect to clinical studies that may not be successful, and we may not be able to recoup those investments. • Interim, “top line” and preliminary data from our clinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data. • Although the combination of tobevibart and elebsiran has received Fast Track and Breakthrough Therapy designation from the FDA, as well as PRIME designation from the EMA and European orphan drug designation, in each case for the treatment of CHD, there can be no assurance that any of our product candidates that receive such designations in the United States or similar designations in any other regulatory jurisdictions will maintain such designations or receive regulatory approval any sooner than other product candidates that do not have such designations, or at all. • Clinical product development involves a lengthy and expensive process.
If we are unable to successfully commercialize our product candidates or if there is an insufficient demand for our product candidates, we may not be able to generate sufficient revenue to continue our business.
If we are unable to successfully commercialize our product candidates or if there is insufficient demand for our product candidates, we may not be able to generate sufficient revenue to continue our business.
Misconduct by these parties could include intentional failures, reckless and/or negligent conduct or unauthorized activities that violates (i) the laws and regulations of FDA and other regulatory authorities, including those laws requiring the reporting of true, complete and accurate information to such authorities, (ii) manufacturing standards, (iii) federal and state data privacy, security, fraud and abuse and other healthcare laws and regulations in the United States and abroad, (iv) laws that require the true, complete and accurate reporting of financial information or data, (v) insider trading laws that restrict the buying and selling of shares of securities while in possession of material non-public information, (vi) federal and state data privacy laws and regulations and (vii) contractual obligations of VirBio or such parties.
Misconduct by these parties could include intentional failures, reckless and/or negligent conduct or unauthorized activities that violates (i) the laws and regulations of FDA and other regulatory authorities, including those laws requiring the reporting of true, complete and accurate information to such authorities, (ii) manufacturing standards, (iii) federal and state data privacy, security, fraud and abuse and other healthcare laws and regulations in the United States and abroad, (iv) laws that require the true, complete and accurate reporting of financial information or data, (v) insider trading laws that restrict the buying and selling of shares of securities while in possession of material non-public information, (vi) federal and state data privacy laws and regulations and (vii) contractual obligations of Vir Bio or such parties.
We may incur additional costs and encounter substantial delays or difficulties in our clinical studies. • Enrollment and retention of patients in clinical studies is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control. • Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval. • We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments upon achievement of milestone events and, in certain cases, have relinquished important rights over the development and commercialization of certain current and future product candidates.
We may incur additional costs and encounter substantial delays or difficulties in our clinical studies. • Enrollment and retention of patients in clinical studies is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by factors outside our control. 37 Table of Contents • Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval. • We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments upon achievement of milestone events and, in certain cases, have relinquished important rights over the development and commercialization of certain current and future product candidates.
Furthermore, even if we obtain regulatory approval for our product candidates, we may still need to develop a commercial organization, establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors, including government health administration authorities. As a company, we have no prior experience in these areas.
Furthermore, even if we obtain regulatory approval for our product candidates, we may still need to build a commercial organization, establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors, including government health administration authorities. As a company, we have no prior experience in these areas.
Although the FDA and comparable foreign regulatory agencies do not regulate a physician’s choice of drug treatment made in the physician’s independent medical judgment, they do restrict promotional communications from companies or their sales force with respect to off-label uses of products for which marketing clearance has not been issued.
Although the FDA and comparable foreign regulatory authorities do not regulate a physician’s choice of drug treatment made in the physician’s independent medical judgment, they do restrict promotional communications from companies or their sales force with respect to off-label uses of products for which marketing clearance has not been issued.
Our current and future strategic collaborations and licenses could subject us to a number of risks, including the following: • we may be required to assume substantial actual or contingent liabilities or pay regulatory or commercial milestone payments, which may make it difficult to predict the final cost to complete the related clinical programs or commercialize a product candidate; • we may, during any transition period with respect to in-licensed clinical programs, be reliant on licensors to continue serving as regulatory sponsors (and executing all appropriate sponsorship responsibilities or delegations of such responsibilities) until a complete transition of sponsorship can be made • we may not be able to control the amount and timing of resources that our strategic collaborators devote to the development or commercialization of our product candidates; • strategic collaborators may select dosages or indications, or design clinical studies, in a way that may be less successful than if we were doing so or in a way that may differ from our strategy, which could negatively impact our development, manufacturing and commercialization of the same or a similar product candidate; • strategic collaborators may not pursue further development and commercialization of products resulting from the strategic collaboration arrangement due to development programs based on data readouts, changes in their strategic focus as a result of an acquisition of competitive products or other internal pipeline advancements, availability of funding or other external factors, that diverts resources or creates competing priorities; • disputes may arise between us and our strategic collaborators that result in costly litigation or arbitration that diverts management’s attention and consumes resources; • strategic collaborators may experience financial difficulties; • strategic collaborators may not properly maintain, enforce or defend our intellectual property rights or may use our proprietary information in a manner that could jeopardize or invalidate our proprietary information or expose us to potential litigation, or may allege such claims against us; and 45 Table of Contents • strategic collaborators could terminate the arrangement or not exercise their opt-in rights, which may delay the development or increase the cost of developing our product candidates and result in a need for additional capital to pursue further development or commercialization of the applicable product candidates.
Our current and future strategic collaborations and licenses could subject us to a number of risks, including the following: • we may be required to assume substantial actual or contingent liabilities or pay regulatory or commercial milestone payments, which may make it difficult to predict the final cost to complete the related clinical programs or commercialize a product candidate; • while we have assumed regulatory sponsorship for all current TCE trial programs, we may, during any transition period with respect to future in-licensed clinical programs, be reliant on licensors to continue serving as regulatory sponsors (and executing all appropriate sponsorship responsibilities or delegations of such responsibilities) until a complete transition of sponsorship can be made; • we may not be able to control the amount and timing of resources that our strategic collaborators devote to the development or commercialization of our product candidates; • strategic collaborators may select dosages or indications, or design clinical studies, in a way that may be less successful than if we were doing so or in a way that may differ from our strategy, which could negatively impact our development, manufacturing and commercialization of the same or a similar product candidate; • strategic collaborators may not pursue further development and commercialization of products resulting from the strategic collaboration arrangement due to development programs based on data readouts, changes in their strategic focus as a result of an acquisition of competitive products or other internal pipeline advancements, availability of funding or other external factors, that diverts resources or creates competing priorities; 45 Table of Contents • disputes may arise between us and our strategic collaborators that result in costly litigation or arbitration that diverts resources and management’s attention from our core business; • strategic collaborators may experience financial difficulties; • strategic collaborators may not properly maintain, enforce or defend our intellectual property rights or may use our proprietary information in a manner that could jeopardize or invalidate our proprietary information or expose us to potential litigation, or may allege such claims against us; and • strategic collaborators could terminate the arrangement or not exercise their opt-in rights, which may delay the development or increase the cost of developing our product candidates and result in a need for additional capital to pursue further development or commercialization of the applicable product candidates.
Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize our product candidates. 62 Table of Contents We have in the past and may in the future acquire or invest in other companies or technologies, which could divert our management’s attention, result in dilution to our stockholders and otherwise disrupt our operations and adversely affect our operating results.
Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize our product candidates. 62 Table of Contents We have in the past and may in the future acquire or invest in other companies or technologies, which could divert management’s attention from our core business, result in dilution to our stockholders and otherwise disrupt our operations and adversely affect our operating results.
If we are unable to properly protect the privacy and security of protected health information, we could be found to have breached our contracts.
Further, if we are unable to properly protect the privacy and security of protected health information, we could be found to have breached our contracts.
In addition, such a breach may require notification to governmental agencies, supervisory bodies, credit reporting agencies, the media, individuals, collaborators or others pursuant to various federal, state and foreign data protection, privacy and security laws, regulations and guidelines, industry standards, our policies and our contracts, if applicable. In addition, the U.S.
In addition, such a breach may require notification to governmental agencies, supervisory bodies, credit reporting agencies, the media, individuals, collaborators or others pursuant to various federal, state and foreign data protection, privacy and security laws, regulations and guidelines, industry standards, our policies and our contracts, if applicable.
The deployment of AI in our or our collaborators’ efforts to discover, develop and engineer next-generation antibodies or other investigational products, could adversely affect our business, reputation or financial results, and furthermore our competitors may be able to utilize such technologies more effectively than we can.
The deployment of AI in our or our collaborators’ efforts to discover, develop and engineer next-generation antibodies or other investigational products or components, could adversely affect our business, reputation or financial results, and our competitors may be able to utilize such technologies more effectively than we can.
Because the design and outcome of our clinical studies are highly uncertain, we cannot reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the development and commercialization of our product candidates, if approved, or any future product candidates that we develop.
In addition, because the design and outcome of our clinical studies are highly uncertain, we cannot reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the development and commercialization of our product candidates, if approved, or any future product candidates that we develop.
Additionally, the process of obtaining trademark protection is expensive and time-consuming, and we may not be able to prosecute all necessary or desirable trademark applications at a reasonable cost or in a timely manner or obtain trademark protection in all jurisdictions that we consider to be important to our business.
Additionally, the process of obtaining trademark protection can be expensive and time-consuming, and we may not be able to prosecute all necessary or desirable trademark applications at a reasonable cost or in a timely manner or obtain trademark protection in all jurisdictions that we consider to be important to our business.
In addition, the FDA or comparable foreign regulatory authorities may change their policies, adopt additional regulations or revise existing regulations or take other actions, which may prevent or delay approval of our future product candidates under development on a timely basis.
In addition, the FDA or comparable foreign regulatory authorities may change their policies, adopt additional regulations or revise existing regulations, experience disruptions or take other actions, which may prevent or delay approval of our future product candidates under development on a timely basis.
Any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, may affect the demand for our product candidates, the competitive position of our product candidates, and import or export of raw materials and product used in our drug development and clinical manufacturing activities.
Any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, may affect the demand for our product candidates, the competitive position of our product candidates, and import or export of raw materials and product used in our drug development, clinical manufacturing and future commercial activities.
These estimates have been derived from a variety of sources, including the scientific literature, patient foundations or market research, and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of the diseases we are targeting.
These estimates have been derived from a variety of sources, including the scientific literature, patient foundations or market research, and may prove to be incorrect. Furthermore, new studies may change the estimated incidence or prevalence of the diseases we are targeting.
The clinical and commercial success of our product candidates will depend in part on public acceptance of the use of new technologies for the prevention or treatment of human diseases. Adverse public attitudes may adversely impact our ability to enroll clinical studies.
The clinical and commercial success of our product candidates will depend in part on public acceptance of the use of new technologies for the prevention or treatment of human diseases. Negative public attitudes may adversely impact our ability to enroll clinical studies.
If we or our CROs fail to comply with GCP, the clinical data generated in our clinical studies may be deemed unreliable, and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical studies before approving our marketing applications.
If we or our CROs fail to comply with cGCP, the clinical data generated in our clinical studies may be deemed unreliable, and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical studies before approving our marketing applications.
Regardless of merit or eventual outcome, liability claims may result in: • decreased demand for any product candidate that we may develop; • loss of revenue; • substantial monetary awards to trial participants or patients; • significant time and costs to defend the related litigation; • withdrawal of clinical trial participants; • increased insurance costs; • the inability to commercialize any product candidate that we may develop; and • injury to our reputation and significant negative media attention.
Regardless of merit or eventual outcome, liability claims may result in: • decreased demand for any product candidate that we may develop; • loss of revenue; • substantial monetary awards to trial participants or patients; • significant time and costs to defend the related litigation; • withdrawal of clinical trial participants; • increased insurance costs; • the inability to commercialize any product candidate that we may develop; and 49 Table of Contents • injury to our reputation and significant negative media attention.
Based upon our current operating plan, we believe that this amount will fund our current operating plans for at least the next 12 months. However, 38 Table of Contents our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional financing to fund our long-term operations sooner than planned.
Based upon our current operating plans, we believe that this amount will fund our operations for at least the next 12 months. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional financing to fund our long-term operations sooner than planned.
For example, during initial dose escalation studies, we, the FDA or comparable foreign regulatory authorities have in the past and may in the future impose restrictions relating to chemistry, manufacturing and control (CMC) standards, and such restrictions could then delay or limit our evaluation of a product candidate and its subsequent advancement to late-stage studies.
For example, during initial dose escalation, we, the FDA or comparable foreign regulatory authorities have in the past imposed and may in the future impose, restrictions relating to chemistry, manufacturing and control standards, and such restrictions could delay or limit our evaluation of a product candidate and its subsequent advancement to late-stage studies.
It is possible that these laws may be interpreted and applied in a manner that is inconsistent with our practices. We must devote significant resources to understanding and complying with this changing landscape.
We must devote significant resources to understanding and complying with this changing landscape, and our efforts may be unsuccessful. It is possible that these laws may be interpreted and applied in a manner that is inconsistent with our practices.
If the market opportunities for our product candidates are smaller than we estimate, it could have an adverse effect on our business, financial condition, results of operations and prospects. We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do.
If the market opportunities for our product candidates are smaller than we estimate, it could have a material adverse effect on our business, financial condition, results of operations and prospects. We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do.
Although the combination of tobevibart and elebsiran has received Fast Track and Breakthrough Therapy designation from the FDA, as well as PRIME designation from the EMA and European orphan drug designation, in each case for the treatment of CHD, there can be no assurance that any of our product candidates that receive such designations in the U.S. or similar designations in any other regulatory jurisdictions will maintain such designations or receive regulatory approval any sooner than other product candidates that do not have such designations, or at all.
Although the combination of tobevibart and elebsiran has received Fast Track and Breakthrough Therapy designation from the FDA, as well as PRIME designation from the EMA and European orphan drug designation, in each case for the treatment of CHD, there can be no assurance that any of our product candidates that receive such designations in the United States or similar designations in any other regulatory jurisdictions will maintain such designations or receive regulatory approval any sooner than other product candidates that do not have such designations, or at all.
Even if we eventually complete clinical testing and receive approval of an NDA, BLA or foreign marketing application for our product candidates, the FDA or comparable foreign regulatory authorities may grant an approval or other marketing authorization that is contingent on the performance of costly additional clinical studies, including post- 40 Table of Contents marketing clinical trials.
Even if we eventually complete clinical testing and receive approval of an NDA, BLA or foreign marketing application for our product candidates, the FDA or comparable foreign regulatory authorities may grant an approval or other marketing authorization that is contingent on the performance of costly additional clinical studies, including post-marketing clinical trials.
Department of Justice (DOJ), closely regulate and monitor the marketing and promotion of products to ensure that they are marketed and distributed only for the approved indications and in accordance with the provisions of the approved labeling.
Department of Justice (DOJ), closely regulate and monitor the marketing and promotion of products in the United States to ensure that they are marketed and distributed only for the approved indications and in accordance with the provisions of the approved labeling.
Our computer and information technology systems, cloud-based computing services and those of our current and any future collaborators, service providers and other parties upon whom we rely are potentially vulnerable to malware, computer viruses, denial-of-service attacks, ransomware attacks, user error or malfeasance, data corruption, cyber-based attacks, natural disasters, public health pandemics or epidemics, geopolitical events, including civil or political unrest, terrorism, war and telecommunication and electrical failures that may result in damage to or the interruption or impairment of key business processes, or the loss or corruption of our information, including intellectual property, proprietary business information and personal information.
Our computer and information technology systems, cloud-based computing services and those of our current and any future collaborators, service providers and other parties upon whom we rely can be vulnerable to malware, computer viruses, denial-of-service attacks, ransomware attacks, user error or malfeasance, data corruption, cyber-based attacks, natural disasters, public health pandemics or epidemics, geopolitical events, including civil or political unrest, terrorism, war and telecommunication and electrical failures that can result in damage to or the interruption or impairment of key business processes, or the loss or corruption of our information, including intellectual property, proprietary business information and personal information.
We cannot assure you that we will be successful in integrating the businesses or technologies we may acquire. The failure to successfully integrate these businesses could have a material adverse effect on our business, financial condition, results of operations and prospects. Our success depends on our ability to manage our growth.
We cannot assure you that we will be successful in integrating the businesses or technologies we may acquire. The failure to successfully integrate these businesses could have an adverse effect on our business, financial condition, results of operations and prospects. Our success depends on our ability to manage our growth.
Any failure to comply with U.S. federal and state and international laws and regulations regarding data privacy would expose us to risk of enforcement actions taken by data protection authorities, and with them the potential for significant penalties if we are found to be non-compliant.
Any failure to comply with U.S. federal and state and international laws and regulations regarding data privacy would expose us to risk of enforcement actions taken by data protection authorities, and with them the potential for significant civil or criminal penalties if we are found to be non-compliant.
If the FDA or a comparable foreign regulatory authority does not approve our CDMOs’ facilities for our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.
If the FDA or a comparable foreign regulatory authority does not approve our CDMOs' facilities for our product candidates or if it withdraws any such approval, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for, or market our product candidates.
Investor concerns regarding financial systems and general economic conditions, both inside and outside the U.S., including capital markets volatility, interest rate and currency rate fluctuations, and economic slowdown or recession, as well as geopolitical events, man-made or natural disasters, or public health pandemics or epidemics, may impact the market price of our common stock and result in volatility.
Investor concerns regarding financial systems and general economic conditions, both inside and outside the United States, including capital markets volatility, interest rate and currency rate fluctuations, and economic slowdown or recession, as well as geopolitical events, man-made or natural disasters, or public health pandemics or epidemics, may impact the market price of our common stock and result in volatility.
Our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party payors subject us to various federal and state fraud and abuse laws and other healthcare laws, such as the U.S. federal Anti-Kickback Statute, federal civil and criminal false claims laws, the healthcare fraud provisions of HIPAA and the Physician Payments Sunshine Act.
Our current and future arrangements with healthcare professionals, principal investigators, patients, consultants, customers and third-party payors subject us to various federal and state fraud and abuse laws and other healthcare laws, such as the U.S. federal Anti-Kickback Statute, civil monetary penalty laws, the False Claims Act (FCA) and other federal civil and criminal false claims laws, the healthcare fraud provisions of HIPAA and the Physician Payments Sunshine Act.
The regulatory authorities enforce GCP through periodic inspections of trial sponsors, principal investigators and clinical trial sites. Although we rely on CROs to conduct GLP-compliant and GCP-compliant preclinical and clinical studies, we remain responsible for ensuring that each of our GLP preclinical and clinical studies is conducted in accordance with its investigational plan and protocol and applicable laws and regulations.
The regulatory authorities enforce cGCP through periodic inspections of trial sponsors, principal investigators and clinical trial sites. Although we rely on CROs to conduct cGLP-compliant and cGCP-compliant preclinical and clinical studies, we remain responsible for ensuring that each of our cGLP preclinical and clinical studies is conducted in accordance with its investigational plan and protocol and applicable laws and regulations.
Violations of the FDCA and other statutes, including the False Claims Act, relating to the promotion and advertising of prescription drugs may lead to investigations and enforcement actions alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws, which violations may result in the imposition of significant administrative, civil and criminal penalties.
Violations of the Federal Food, Drug, and Cosmetic Act and other statutes, including the False Claims Act, relating to the promotion and advertising of prescription drugs may lead to investigations and enforcement actions alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws, which violations may result in the imposition of significant administrative, civil and criminal penalties.
Failure to realize the potential benefits of any of these designations could materially and adversely affect our business, financial condition, cash flows and results of operations. For additional information, see the sections titled “Government Regulation and Product Approval—Expedited Development and Review Programs” and “Government Regulation and Product Approval—Foreign Regulation” in “Part I, Item 1.
Failure to realize the potential benefits of any of these designations could materially and adversely affect our business, financial condition, cash flows and results of operations. For additional information, see the sections titled in “Part I, Item 1. Business—Government Regulation and Product Approval—Expedited Development and Review Programs” and “Part I, Item 1.
Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must complete preclinical development and then conduct extensive clinical studies to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive, is difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome.
Before obtaining marketing approval for the sale of our product candidates, we must complete preclinical development and conduct extensive clinical studies to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive, is difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome.
In addition, the lead time needed to establish a relationship with a new raw material or component supplier or CDMO can be lengthy and we may experience delays in meeting demand in the event we must switch to a new supplier or CDMO.
For example, the lead time needed to establish a relationship with a new raw material or component supplier or CDMO can be lengthy, and we may experience delays in meeting demand in the event we must switch to a new supplier or CDMO.
In addition, if analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
Moreover, if analysts fail to publish reports on us regularly or cease coverage of us entirely, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
If we are not able to obtain required 36 Table of Contents regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate product revenue will be adversely affected. • The development of additional product candidates is risky and uncertain, and we can provide no assurances that we will be able to successfully develop the additional product candidates we identify or replicate our approach for other diseases. • We are developing, and in the future may develop, product candidates in combination with other therapies. • Success in preclinical studies or early-stage clinical studies may not be indicative of results in future clinical studies and we cannot assure you that any ongoing, planned or future clinical studies will lead to results sufficient for the necessary regulatory approvals and marketing authorizations.
If we are not able to obtain required regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate product revenue will be adversely affected. • The development of additional product candidates is risky and uncertain, and we can provide no assurances that we will be able to successfully develop the additional product candidates we identify or replicate our approach for other diseases. • We are developing, and in the future may develop, product candidates in combination with other therapies, which exposes us to additional risks. • Success in preclinical or early-stage clinical studies may not be indicative of results in future clinical studies and we cannot assure you that any ongoing, planned or future clinical studies will lead to results sufficient for the necessary regulatory approvals and marketing authorizations.
Our failure to return to being profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. Our limited commercialization history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
Our failure to return to profitability could decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. Our limited commercialization history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
Additionally, if a specified default occurs or if we are unable or unwilling to continue the HIV program, tuberculosis 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 or if we are unable or unwilling to continue the HIV program, tuberculosis program, 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.
We do not know whether our planned clinical studies will begin or enroll on time, will be conducted as planned, will need to be redesigned or will be completed on schedule, if at all. A failure or significant delay of one or more clinical studies can occur at any stage of testing.
We do not know whether our planned clinical studies will begin or enroll on time, be conducted as planned, need to be redesigned or be completed on schedule, if at all. A failure or significant delay of a clinical study can occur at any stage.
As a result, we intend to periodically explore a variety of possible strategic collaborations or licenses in an effort to gain access to additional product candidates, technologies or resources. At this time, we cannot predict what form such strategic collaborations or licenses might take.
As a result, we intend to periodically explore a variety of possible strategic collaborations or licenses in an effort to gain access to additional product candidates or technologies, as well as commercial, financial or other resources. At this time, we cannot predict what form such strategic collaborations or licenses might take.
Moreover, our success will depend upon physicians specializing in our targeted diseases prescribing, and their patients being willing to receive, our product candidates as treatments in lieu of, or in addition to, existing, more familiar, treatments for which greater clinical data may be available.
Moreover, our success will depend upon physicians specializing in our targeted diseases prescribing, and their patients accepting, our product candidates as treatments in lieu of, or in addition to, existing and more familiar treatments for which greater clinical data may be available.
Furthermore, if we are not able to produce supply at low enough costs, it would negatively impact our ability to generate revenue, harm our reputation, and could have an adverse effect on our business, financial condition, results of operations and prospects.
Furthermore, if we are not able to produce supply at low enough costs, it could negatively impact our ability to generate revenue, harm our reputation, and could have a material adverse effect on our business, financial condition, results of operations and prospects.
We and our CROs are required to comply with GLP and GCP, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities in the form of International Conference on Harmonization guidelines for any of our product candidates that are in preclinical and clinical development.
We and our CROs are required to comply with cGLP and cGCP, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities in the form of International Conference on Harmonization guidelines for any of our product candidates that are in preclinical and clinical development.
To manage any future growth, we must continue to implement and improve our managerial, operational and financial systems, improve our facilities, and continue to recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources.
To manage any future growth, we must continue to implement and improve our managerial, operational and financial systems, improve our facilities, and continue to recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and could divert business development resources and management ’ s attention.
Provisions in our corporate charter and our amended and restated bylaws may discourage, delay or prevent a merger, acquisition or other change in control of us that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares.
Provisions in our amended and restated certificate of incorporation and our amended and restated bylaws may discourage, delay or prevent a merger, acquisition or other change in control of us that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares.
We expect to continue to incur significant expenses and will continue to incur net losses in the foreseeable future as we develop our product candidates and technology platforms. It could be several years, if ever, before we are able to commercialize any of our product candidates.
We expect to continue to incur significant expenses and net losses in the foreseeable future as we develop our product candidates and technology platforms. 38 Table of Contents It could be several years, if ever, before we are able to commercialize any of our product candidates.
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 (1) the original purchase price or (2) the fair market value, which amount may increase in the event of a sale of our company or all of our material assets relating to the Gates Agreement.
If we fail to comply with (i) our obligations to use the proceeds of the Gates Foundation’s investment for the purposes set forth in the Gates Agreement (and described in our filings with the SEC) 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, which amount may increase in the event of a sale of our company or all of our material assets relating to the Gates Agreement.
The position on a payor’s list of covered drugs and biological products, or formulary, generally determines the co-payment that a patient will need to make to obtain the therapy and can strongly influence the adoption of such therapy by patients and physicians.
The position on a payor’s list of covered drugs and biological products, or formulary, generally determines the cost-sharing that a patient will need to make to obtain the therapy and can strongly influence the adoption of such therapy by patients and physicians.
Any significant system failure, accident or security breach could have a material adverse effect on our business, financial condition and operations.
Any significant system failure, accident or security breach could have a material adverse effect on our business, financial condition, results of operations and prospects.
Furthermore, our product candidates are based on certain innovative technology platforms, which makes it even more difficult to predict the time and cost of product candidate development and obtaining necessary regulatory approvals.
Furthermore, our product candidates are based on certain innovative technology platforms, which makes it even more difficult to predict the time and cost of product candidate development and regulatory approval.
Healthcare providers, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval.
Physicians, other healthcare professionals and third-party payors, both in the United States and elsewhere, play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval.
For example, President Trump has imposed a series of tariffs on certain products manufactured outside the United States, and it is unknown whether and to what extent additional tariffs (or other new laws or regulations) will be adopted, or the effect that any such actions would have on us or our industry.
For example, President Trump has imposed or signaled to impose a series of tariffs on certain products manufactured outside the United States, including pharmaceutical products and raw materials and components for pharmaceutical products, and it is unknown whether and to what extent additional tariffs (or other new laws or regulations) will be adopted, or the effect that any such actions would have on us or our industry.
We may explore additional strategic collaborations, which may never materialize or may require that we spend significant additional capital or that we relinquish rights to and control over the development and commercialization of our product candidates. • The deployment of AI in our or our collaborators’ efforts to discover, develop and engineer next-generation antibodies or other investigational products, could adversely affect our business, reputation or financial results, and furthermore our competitors may be able to utilize such technologies more effectively than we can. • Even if any of our product candidates receive marketing approval, they may fail to achieve adoption by physicians, patients, third-party payors or others in the medical community necessary for commercial success. • We rely on third parties to produce clinical supplies of our product candidates.
We may explore additional strategic collaborations, which may never materialize or may require that we spend significant additional capital or that we relinquish rights to and control over the development and commercialization of our product candidates. • The deployment of AI in our or our collaborators’ efforts to discover, develop and engineer next-generation antibodies or other investigational products or components, could adversely affect our business, reputation or financial results, and our competitors may be able to utilize such technologies more effectively than we can. • Our product candidates, if approved, may fail to achieve adoption by physicians, patients, third-party payors, clinical guidelines or others in the healthcare community necessary for commercial success. • We rely on third parties to produce clinical and future commercial supplies of our product candidates.
Failure to comply with such requirements, when and if applicable, could subject us to a number of actions ranging from warning or untitled letters to product seizures or significant fines or monetary penalties, among other actions. The FDA and other agencies, including the U.S.
Failure to comply with such requirements, when and if applicable, could subject us to a number of actions by applicable regulatory authorities ranging from warning or untitled letters to product seizures or significant fines or monetary penalties, among other actions. The FDA and other state and federal government agencies, including the U.S.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeOur Senior Director, IT Application & Compliance and Interim Head of Information Technology (“HIT”), together with our Head of Information Security (“HIS”), and other members of our management team meet regularly to review current cybersecurity risks.
Biggest changeOur Head of Information Technology (HIT), together with our Head of Information Security (HIS), and other members of our management team meet regularly to review current cybersecurity risks. The HIT and management team representatives meet with the Audit Committee routinely to discuss and review our cybersecurity program and risk landscape.
The results of such assessments and reviews are reported to our management team, the Audit Committee and the Board, and we adjust our cybersecurity program as necessary based on the information provided by these assessments and reviews. 70 Table of Contents Governance Our Board, in coordination with the Audit Committee, oversees our risk management approach, including the management of risks arising from cybersecurity threats.
The results of such assessments and reviews are reported to our management team, the Audit Committee and the Board, and we adjust our cybersecurity program as necessary based on the information provided by these assessments and reviews. Governance Our Board, in coordination with the Audit Committee, oversees our risk management approach, including the management of risks arising from cybersecurity threats.
Our CEO, CFO and General Counsel each hold undergraduate and graduate degrees in their respective fields, and each have over 20 years of experience managing risks at VirBio and at similarly situated companies, including risks arising from cybersecurity threats.
Our CEO, CFO and General Counsel each hold undergraduate and graduate degrees in their respective fields, and each have over 20 years of experience managing risks at Vir Bio and at similarly situated companies, including risks arising from cybersecurity threats.
The HIT and HIS, in coordination with our management team, which includes our Chief Executive Officer (“CEO”), Chief Financial Officer (“CFO”) and General Counsel, work collaboratively to implement a program designed to protect our information systems from cybersecurity threats and to promptly respond to any cybersecurity incidents in accordance with our incident response plan.
The HIT and HIS, in coordination with our management team, which includes our Chief Executive Officer (CEO), Chief Financial Officer (CFO) and General Counsel, work collaboratively to implement a program designed to protect our information systems from cybersecurity threats and to promptly respond to any cybersecurity incidents in accordance with our incident response plan.
These measures are evaluated and improved through vulnerability assessments and penetration testing completed by third party experts, as well as cybersecurity threat intelligence. Incident Response and Recovery : We have established and maintain an incident response plan that addresses our response to a cybersecurity incident. This plan is evaluated regularly.
These measures are evaluated and improved through vulnerability assessments and penetration testing completed by third party experts, as well as cybersecurity threat intelligence. 69 Table of Contents Incident Response and Recovery : We have established and maintain an incident response plan that addresses our response to a cybersecurity incident. This plan is evaluated regularly.
Item 1C. Cybersecurity Our Board of Directors (the “Board”) and management recognize the importance of maintaining the trust and confidence of our patients, investors, business partners and employees. The Board and our Audit Committee are actively involved in oversight of our cybersecurity program as part of our approach to risk management.
Item 1C. Cybersecurity Our Board of Directors (the Board) and management recognize the importance of maintaining the trust and confidence of our patients, investors, business partners and employees. The Board and our Audit Committee are actively involved in oversight of our cybersecurity program as part of our approac h to risk management.
Risk Management and Strategy As one of the important elements that comprise and has been integrated into our overall enterprise risk management approach, our cybersecurity program includes the following: Governance : As discussed in more detail below under the heading “Governance,” our Board’s oversight of cybersecurity risk management is supported by the Audit Committee of the Board, which regularly reviews operational risks.
Risk Management and Strategy As one of the important elements integrated into our overall enterprise risk management approach, our cybersecurity program includes the following: Governance : As discussed in more detail below under the heading Governance, our Board’s oversight of cybersecurity risk management is supported by the Audit Committee of the Board, which regularly reviews operational risks.
Risk and Issues Disclosure We describe the risks we face, including cybersecurity risks, in Section 1A above, titled “Risk Factors”. For the period covered by this Annual Report on Form 10-K, we are unaware of any specific cybersecurity threats that have materially affected the Company, its business strategy, results of operations or financial condition.
Risk and Issues Disclosure We describe the risks we face, including cybersecurity risks, above under “Item 1A. — Risk Factors.” For the period covered by this Annual Report on Form 10-K, we are unaware of any specific cybersecurity threats that have materially affected the Company, its business strategy, results of operations or financial condition. 70 Table of Contents
The HIT and management team representatives also meet with the Audit Committee at least on a quarterly basis to discuss and review our cybersecurity program and risk landscape. Collaborative Approach : We have implemented a cross-functional approach involving all employees to help in identifying, preventing, and mitigating cybersecurity threats and incidents.
Collaborative Approach : We have implemented a cross-functional approach involving all employees to help in identifying, preventing, and mitigating cybersecurity threats and incidents.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties. Our corporate headquarters is located in San Francisco, California, where we lease approximately 133,896 square feet of office, research and development, engineering, and laboratory space pursuant to one lease agreement that expire in 2033 . We also have leased approximately 21,496 square feet of office and laboratory space in Bellinzona, Switzerland.
Biggest changeItem 2. Properties. Our corporate headquarters is located in San Francisco, California, where we lease approximately 133,896 square feet of office, research and development, engineering, and laboratory space pursuant to one lease agreement that expires in 2033 . We also have leased approximately 58,265 square feet of office and laboratory space in Bellinzona, Switzerland.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information for Common Stock Our common stock has been listed on The Nasdaq Global Select Market under the symbol “VIR” since October 11, 2019. Holders of Record As of February 20, 2025, there were approximately 156 stockholders of record of our common stock.
Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information for Common Stock Our common stock has been listed on The Nasdaq Global Select Market under the symbol “VIR” since October 11, 2019. Holders of Record As of February 17, 2026, there were approximately 119 stockholders of record of our common stock.
Stock Performance Graph The following graph shows the total stockholder’s return on an investment of $100 in cash at market close on December 31, 2019 through December 31, 2024 for (i) our common stock, (ii) the Nasdaq Composite Index and (iii) the Nasdaq Biotechnology Index.
Stock Performance Graph The following graph shows the total stockholder’s return on an investment of $100 in cash at market close on December 31, 2020 through December 31, 2025 for (i) our common stock, (ii) the Nasdaq Composite Index and (iii) the Nasdaq Biotechnology Index.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeCost of Revenue The decrease in cost of revenue for the year ended December 31, 2024 compared to the same period in 2023 was due to lower third-party royalties owed based on the lower collaboration revenue under the 2020 GSK Agreement. 80 Table of Contents Research and Development Expenses The following table shows the primary components of our research and development expenses for the years presented (in thousands): Years Ended December 31, 2024 2023 Change Contract manufacturing $ 40,081 $ 114,262 $ (74,181) Clinical costs 57,624 121,422 (63,798) Personnel 162,960 189,418 (26,458) Licenses, collaborations and contingent consideration 129,846 30,215 99,631 Other 115,988 124,403 (8,415) Total research and development expenses $ 506,499 $ 579,720 $ (73,221) The decrease in research and development expenses for the year ended December 31, 2024 compared to the same period in 2023 was primarily due to lower contract manufacturing costs and clinical costs associated with the wind down of our Phase 2 PENINSULA trial evaluating VIR-2482, lower contract manufacturing costs associated with elebsiran used in the our CHD and CHB clinical trials, and lower personnel costs associated with the reduction in the headcount resulting from the cost saving initiatives implemented in 2023 and 2024, partially offset by the increase in licenses, collaboration and contingent consideration expenses primarily due to a portion of the upfront payment made to Sanofi allocated to in-process research and development and expensed.
Biggest changeResearch and Development Expenses The following table shows the primary components of our research and development expenses for the years presented (in thousands): Years Ended December 31, 2025 2024 Change Personnel $ 125,274 $ 162,960 $ (37,686) Licenses, collaborations and contingent consideration 125,058 129,846 (4,788) Clinical costs 87,173 57,624 29,549 Contract manufacturing 47,622 40,081 7,541 Other 70,839 115,988 (45,149) Total research and development expenses $ 455,966 $ 506,499 $ (50,533) The decrease in research and development expenses for the year ended December 31, 2025 compared to the same period in 2024 was primarily due to: • lower other R&D expenses related to de-prioritized research and development programs and other ongoing cost savings; • lower personnel expenses associated with headcount reductions; • lower license, collaborations and contingent consideration expenses due to the expensing of $102.8 million in-process research and development obtained as part of our license agreement with Sanofi in the third quarter of 2024, partially offset by the $75.0 million milestone payment due upon VIR-5525 achieving first-in-human dosing in the third quarter of 2025, the $30.0 million expense in connection with signing the Restated Alnylam Agreement, and milestone payments due upon the enrollment of the first patient in phase 3 ECLIPSE registrational program for CHD in the first quarter of 2025. partially offset by: • higher clinical cost due to the initiation of our phase 3 ECLIPSE registrational program and progression of our oncology programs.
We have an industry-leading management team and board of directors with significant immunology and infectious diseases and oncology experience, including a proven track record of progressing product candidates from early-stage research through clinical development, and worldwide regulatory approval and commercialization experience.
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.
Components of Operating Results Revenues Other than sotrovimab, we have not obtained regulatory approval for our product candidates, and we do not expect to generate any significant revenue from the sale of our other product candidates until we complete clinical development, submit regulatory filings and receive approvals from the applicable regulatory bodies for such product candidates, if ever.
Components of Operating Results Revenues Other than sotrovimab, we have not obtained regulatory approval for our product candidates, and we do not expect to generate any significant revenue from the sale of our product candidates until we complete clinical development, submit regulatory filings and receive approvals from the applicable regulatory bodies for such product candidates, if ever.
Although we have previously recognized revenue from our profit-share related to sotrovimab under our definitive collaboration agreement with GSK executed in June 2020, or the 2020 GSK Agreement, we may continue to incur net operating losses for the foreseeable future. In December 2024, the FDA revoked EUA granted to sotrovimab in May 2021.
Although we have previously recognized revenue from our profit-share related to sotrovimab under our definitive collaboration agreement with GSK executed in June 2020, or the 2020 GSK Agreement, we expect to continue to incur net operating losses for the foreseeable future. In December 2024, the FDA revoked EUA granted to sotrovimab in May 2021.
Overview We are a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. At Vir, we have a bold vision – powering the immune system to transform lives.
Overview We are a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. At Vir Bio, we have a bold vision – powering the immune system to transform lives.
Our clinical development costs may vary significantly based on factors such as: • whether a collaborator is paying for some or all of the costs; 78 Table of Contents • per patient trial costs; • the number of studies required for approval; • the number of sites included in the studies; • enrollment and retention of patients in studies in countries disrupted by geopolitical events, including civil or political unrest; • the length of time required to enroll eligible patients; • the number of patients that participate in the studies; • the number of doses that patients receive; • the drop-out or discontinuation rates of patients; • potential additional safety monitoring requested by regulatory agencies; • the duration of patient participation in the studies and follow-up; • the cost and timing of manufacturing our product candidates; • the phase of development of our product candidates; and • the efficacy and safety profile of our product candidates.
Our clinical development costs may vary significantly based on factors such as: • whether a collaborator is paying for some or all of the costs; • per patient trial costs; • the number of studies required for approval; • the number of sites included in the studies; • enrollment and retention of patients in studies in countries disrupted by geopolitical events, including civil or political unrest; • the length of time required to enroll eligible patients; • the number of patients that participate in the studies; • the number of doses that patients receive; • the drop-out or discontinuation rates of patients; • potential additional safety monitoring requested by regulatory agencies; • the duration of patient participation in the studies and follow-up; • the cost and timing of manufacturing our product candidates; • the phase of development of our product candidates; and • the efficacy and safety profile of our product candidates.
Discussion and analysis of the year ended December 31, 2022 specifically, as well as the year-over-year comparison of our financial results and liquidity and capital resources for the years ended December 31, 2023 and 2022, are located in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on February 26, 2024.
Discussion and analysis of the year ended December 31, 2023 specifically, as well as the year-over-year comparison of our financial results and liquidity and capital resources for the years ended December 31, 2024 and 2023, are located in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on February 26, 2025.
See the sections titled “Risk Factors—Risks Related to Our Financial Position and Capital Needs—Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates.” and “Risk Factors—Risks Related to Our Financial Position and Capital Needs—We may require substantial additional funding to finance our operations.
See the sections titled “ Risk Factors—Risks Related to Our Financial Position and Capital Needs—Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates .” and “ Risk Factors—Risks Related to Our Financial Position and Capital Needs—We may require substantial additional funding to finance our operations.
The decrease in grant revenue for the year ended December 31, 2024 compared to the same period in 2023 was primarily due to lower revenue recognized in accordance with our agreement with BARDA and to a lesser extent, lower revenue recognized from the Gates Foundation.
The decrease in grant revenue for the year ended December 31, 2025 compared to the same period in 2024 was primarily due to lower revenue recognized in accordance with our agreement with BARDA and to a lesser extent, lower revenue recognized from the Gates Foundation.
Recent Accounting Pronouncements Not Yet Adopted See Note 2 Summary of Significant Accounting Policies to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for information about recent accounting pronouncements, the timing of their adoption, and our assessment, to the extent we have made one yet, of their potential impact on our financial condition or results of operations. 84 Table of Contents
Recent Accounting Pronouncements Not Yet Adopted See Note 2 Summary of Significant Accounting Policies to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for information about recent accounting pronouncements, the timing of their adoption, and our assessment, to the extent we have made one yet, of their potential impact on our financial condition or results of operations.
Significant Developments Following is a summary of significant developments affecting our business that have occurred and that we have reported since the filing of our Annual Report on Form 10-K for the year ended December 31, 2023.
Significant Developments Following is a summary of significant developments affecting our business that have occurred and that we have reported since the filing of our Annual Report on Form 10-K for the year ended December 31, 2024.
Our discussion and analysis below are focused on our financial results and liquidity and capital resources for the years ended December 31, 2024 and 2023, including year-over-year comparisons of our financial performance and condition for these years.
Our discussion and analysis below are focused on our financial results and liquidity and capital resources for the years ended December 31, 2025 and 2024, including year-over-year comparisons of our financial performance and condition for these years.
In addition, under our license agreement with Sanofi, we may incur additional clinical, and regulatory milestone payments based on the development progress of certain oncology programs. We may also be required to pay commercial milestone payments and royalties in the event of a successful product launch and our receipt of commercial revenues.
In addition, under our license agreement with Sanofi and other licensors, we may incur additional clinical, and regulatory milestone payments based on the development progress of certain clinical programs. We may also be required to pay commercial milestone payments and royalties in the event of a successful product launch and our receipt of commercial revenues.
If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our research and development programs or other operations” for a description of the risks that may be associated with any future capital raises.
If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our research and development programs or other operations ” for a description of the risks that may be associated with any future capital raises.
For information related to our future commitments under our facilities and manufacturing agreements, see Note 9 Leases and 82 Table of Contents Note 10 Commitments and Contingencies to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K. We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements.
For information related to our future commitments under our facilities and manufacturing agreements, see Note 9 Leases and Note 10 Commitments and Contingencies to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K. We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements.
In November 2023, we entered into a sales agreement (the “Sales Agreement”) with Cowen and Company, LLC, as sales agent (“TD Cowen”), pursuant to which the Company may from time to time offer and sell shares of its common stock for an aggregate offering price of up to $300.0 million, through or to TD Cowen, acting as sales agent or principal.
In November 2023, we entered into a sales agreement (the Sales Agreement) with Cowen and Company, LLC, as sales agent (TD Cowen), pursuant to which the Company may from time to time offer and sell shares of its common stock for an aggregate offering price of up to $300.0 million, through or to TD Cowen, acting as sales agent or principal.
Unless the context requires otherwise, references in this Annual Report on Form 10-K to the “Company”, “VirBio,” “we,” “our” and “us” refer to Vir Biotechnology, Inc. and its consolidated subsidiaries.
Unless the context requires otherwise, references in this Annual Report on Form 10-K to the “Company”, “Vir Bio,” “we,” “our” and “us” refer to Vir Biotechnology, Inc. and its consolidated subsidiaries.
Other (Expense) Income, Net Other (expense) income, net consists of gains and losses from foreign currency transactions and the remeasurement of our contingent consideration obligation. Benefit from (Provision for) Income Taxes Benefit from (provision for) income taxes consists primarily of income taxes on our domestic and foreign operations.
Other Expense, Net Other expense, net consists of gains and losses from foreign currency transactions, investment management expenses, and the remeasurement of our contingent consideration obligation. (Provision for) Benefit from Income Taxes (Provision for) benefit from income taxes consists primarily of income taxes on our domestic and foreign operations.
Based upon our current operating plan, we believe that the $1.1 billion will enable us to fund our operations for at least the next 12 months. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional financing to fund our long-term operations sooner than planned.
Based upon our current operating plan, we believe that the $781.6 million will enable us to fund our operations for at least the next 12 months. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional financing to fund our long-term operations sooner than planned.
See the section titled “Risk Factors—Risks Related to Our Financial Position and Capital Needs” for a description of certain risks that will affect our future capital requirements. We have various operating lease arrangements for office and laboratory spaces located in California and Switzerland with contractual lease periods expiring between 2033 and 2035.
See the section titled “ Risk Factors—Risks Related to Our Financial Position and Capital Needs ” for a description of certain risks that will affect our future capital requirements. We have various operating lease arrangements for office and laboratory spaces located in California and Switzerland with contractual lease periods expiring between 2033 and 2035.
Interest Income The decrease in interest income was primarily due to lower balances of cash, cash equivalents, and investments for the year ended December 31, 2024 compared to the same period in 2023.
Interest Income The decrease in interest income was primarily due to lower balances of cash, cash equivalents, and investments and lower interest rates for the year ended December 31, 2025 compared to the same period in 2024.
For details regarding these and other agreements, see the section titled “Business—Our Collaboration, License and Grant Agreements” and Note 5 Grant Agreements and Note 6 Collaboration and License Agreements to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
For details regarding these and other agreements, see the section titled “ Business—Our Collaboration, License and Grant Agreements ” and Note 5 Grant Agreements and Note 6 Collaboration and License Agreements to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
We will pay TD Cowen a commission of up to 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide TD Cowen with customary indemnification and contribution rights. As of December 31, 2024, no shares have been issued under the Sales Agreement.
We will pay TD Cowen a commission of up to 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide TD Cowen with customary indemnification and contribution rights. As of December 31, 2025, no shares have been issued under the Sales Agreement. The Sales Agreement will expire in November 2026.
For additional information regarding these agreements, including our payment obligations thereunder, see the sections titled “Business—Our Collaboration, License and Grant Agreements,” as well as Note 6 Collaboration and License Agreements to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
For additional information regarding these agreements, including our payment obligations thereunder, see the sections titled “ Part I, Item 1. Business—Our Collaboration, License and Grant Agreements, ” as well as Note 6 Collaboration and License Agreements to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate significant revenue from the commercialization and sale of any of our product candidates.
Risk Factors ” section of this Annual Report. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate significant revenue from the commercialization and sale of any of our product candidates.
We have financed our operations primarily through sales of our common stock from our initial public offering, subsequent follow-on offering, and payments received under our grant and collaboration agreements. As of December 31, 2024, we had $1.1 billion in cash, cash equivalents, and investments.
We have financed our operations primarily through sales of our common stock from our initial public offering, subsequent follow-on offering, and payments received under our grant and collaboration agreements. As of December 31, 2025, we had $781.6 million in cash, cash equivalents, and investments.
In oncology, we are advancing phase 1 clinical studies for our dual-masked TCEs: VIR-5818 in patients with HER2-expressing tumors and VIR-5500 in patients with PSMA-expressing mCRPC. We are also advancing our third TCE program,VIR-5525, in patients with EGFR-expressing tumors, with phase 1 clinical studies expected to begin in the first half of 2025.
In oncology, we are advancing phase 1 clinical studies for our dual-masked TCEs: VIR-5500 in patients with PSMA-expressing mCRPC and VIR-5818 in patients with HER2-expressing tumors. We are also advancing our third TCE program, VIR-5525, in patients with EGFR-expressing tumors, with the first patient dosed in phase 1 clinical studies in July 2025.
We do not expect meaningful collaboration revenue in the future from the sale of sotrovimab for the treatment of COVID-19. Our revenues consist of the following: Collaboration revenue includes recognition of our profit-share from the sales of sotrovimab pursuant to the 2020 GSK Agreement.
We do not expect meaningful license and collaboration revenue in the future from the sale of sotrovimab for the treatment of COVID-19. Our revenues consist of the following: License and collaboration revenue includes revenues generated from license rights issues to Norgine and GSK, including our profit-share from the sales of sotrovimab pursuant to the 2020 GSK Agreement.
Contract development and 76 Table of Contents 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. Our headquarters also conducts cell line development for our antibody and TCE product candidates.
Contract development and manufacturing of our antibody, TCE and siRNA product candidates is supported at our San Francisco, California, corporate headquarters for process, analytical and formulation development, small-scale non-cGMP manufacturing for preclinical studies and selected quality control testing.
Contingent Consideration associated with a Business Combination Contingent consideration related to a business combination are initially measured at their estimated fair values on the transaction date and subsequently remeasured each subsequent reporting period with changes recorded in the consolidated statement of operations.
Changes in these estimates could materially affect our results of operations. 83 Table of Contents Contingent Consideration associated with a Business Combination Contingent consideration related to a business combination are initially measured at their estimated fair values on the transaction date and subsequently remeasured each subsequent reporting period with changes recorded in the consolidated statement of operations.
Cash Flows The following table summarizes our cash flows for the years presented (in thousands): Years Ended December 31, 2024 2023 Net cash (used in) provided by: Operating activities $ (446,352) $ (778,785) Investing activities 499,367 164,629 Financing activities 4,388 7,480 Net increase (decrease) in cash, cash equivalents and restricted cash and cash equivalents $ 57,403 $ (606,676) Operating Activities Cash used in operating activities is derived by adjusting our net loss for non-cash items and changes in operating assets and liabilities.
Cash Flows The following table summarizes our cash flows for the years presented (in thousands): Years Ended December 31, 2025 2024 Net cash (used in) provided by: Operating activities $ (391,781) $ (446,352) Investing activities 310,371 499,367 Financing activities 3,785 4,388 Net (decrease) increase in cash, cash equivalents and restricted cash and cash equivalents $ (77,625) $ 57,403 Operating Activities Cash used in operating activities is derived by adjusting our net loss for non-cash items and changes in operating assets and liabilities.
The status and timing of actual services performed may vary from our estimates, resulting in adjustments to expense in future periods. Changes in these estimates could materially affect our results of operations.
The status and timing of actual services performed may vary from our estimates, resulting in adjustments to expense in future periods.
These preclinical candidates leverage the PRO-XTEN ™ masking technology with novel TCEs discovered and engineered using our antibody discovery platform and our proprietary dAIsY™ AI engine. • We will continue to advance our HIV broadly neutralizing antibody program for HIV cure in collaboration with the Gates Foundation.
These preclinical candidates integrate the PRO-XTEN ® masking technology with novel TCEs discovered and engineered using our antibody discovery platform and our proprietary dAIsY™ AI engine. • We have advanced a broadly neutralizing antibody to development candidate status in our HIV cure program in collaboration with the Gates Foundation.
Research and development expenses consist primarily of costs incurred for our product candidates in development and prior to regulatory approval, which include: • expenses related to license and collaboration agreements, and change in fair value of certain contingent consideration obligations arising from business acquisitions; • personnel-related expenses, including salaries, benefits and stock-based compensation for personnel contributing to research and development activities; • expenses incurred under agreements with third-party contract manufacturing organizations, CROs, and consultants; • clinical costs, including laboratory supplies and costs related to compliance with regulatory requirements; and • other allocated expenses, including expenses for rent and facilities maintenance, and depreciation and amortization.
Research and development expenses consist primarily of costs incurred for our product candidates in development and prior to regulatory approval, which include: • expenses related to license and collaboration agreements, and change in fair value of certain contingent consideration obligations arising from business acquisitions; • personnel-related expenses, including salaries, benefits and stock-based compensation for personnel contributing to research and development activities; • expenses incurred under agreements with third-party CDMO, CROs, and consultants; • clinical costs, including laboratory supplies and costs related to compliance with regulatory requirements; and • other allocated expenses, including expenses for rent and facilities maintenance, and depreciation and amortization. 77 Table of Contents We expect our research and development expenses to increase substantially in absolute dollars over time as we advance our product candidates into and through preclinical and clinical studies and pursue regulatory approval of our product candidates.
Our net loss was $522.0 million for the year ended December 31, 2024, compared to net loss of $615.1 million for the year ended December 31, 2023 and net income of $515.8 million for the year ended December 31, 2022, respectively. As of December 31, 2024, we had accumulated deficit of $759.8 million.
Our net loss was $438.0 million for the year ended December 31, 2025, compared to net loss of $522.0 million and $615.1 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2025, we had an accumulated deficit of $1.2 billion.
As of December 31, 2024, we expect to make total lease payments of $123.5 million through 2035.
As of December 31, 2025, we expect to make total lease payments of $121.4 million through 2035.
For more details on our critical accounting policies, refer to Note 2 Summary of Significant Accounting Policies to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K. 83 Table of Contents Asset Acquisitions We make certain judgments to determine whether acquisitions and other similar transactions should be accounted for as acquisitions of assets or business combinations using the guidance in Accounting Standard Codification, or ASC, Topic 805, Business Combinations, by first applying a screen test to assess if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets.
Asset Acquisitions We make certain judgments to determine whether acquisitions and other similar transactions should be accounted for as acquisitions of assets or business combinations using the guidance in Accounting Standard Codification, or ASC, Topic 805, Business Combinations, by first applying a screen test to assess if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets.
Financial Overview We were incorporated in April 2016 and commenced principal operations later that year. To date, we have focused primarily on organizing and staffing our company, business planning, raising capital, identifying, acquiring, developing and in-licensing our technology platforms and product candidates, and conducting preclinical studies and clinical trials.
To date, we have focused primarily on organizing and staffing our company, business planning, identifying, acquiring, developing and in-licensing our technology platforms and product candidates, and conducting preclinical studies and clinical trials.
For the year ended December 31, 2024, we recognized an unrealized loss of $5.5 million due to the change in fair value, compared to an unrealized loss of $21.9 million for the same period in 2023.
For the year ended December 31, 2025, we recognized an unrealized gain of $1.7 million, compared to an unrealized loss of $5.5 million for the same period in 2024.
Therefore, we are unable to predict the timing or the final cost to complete our clinical programs or validation of our manufacturing and supply processes and delays may occur due to numerous factors.
Therefore, we are unable to predict the timing or the final cost to complete our clinical programs or validation of our manufacturing and supply processes and delays may occur due to numerous factors. Factors that could cause or contribute to delays or additional costs include, but are not limited to, those discussed in the “ Part I, Item 1A.
Research and Development To date, our research and development expenses have related primarily to discovery efforts and preclinical and clinical development of our product candidates. Research and development expenses are recognized as incurred and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received.
Research and development expenses are recognized as incurred and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received. We do not track all research and development expenses by product candidate.
Restructuring, long-lived asset impairment and related charges Restructuring, long-lived asset impairment and related charges consist primarily of charges incurred in connection with our cost saving initiatives implemented during the second half of 2024 and 2023, respectively, including severance and other employee-related expenses and long-lived assets impairment charges and disposal losses.
In the long-term as we advance our research and development programs toward potential commercialization, we expect our selling, general, and administrative expenses to increase in absolute dollars to support commercialization activities and related expansion in research and development activities. 78 Table of Contents Restructuring, Long-Lived Asset Impairment and Related Charges, Net Restructuring, long-lived asset impairment and related charges, net consist primarily of charges incurred in connection with our cost saving initiatives implemented during the second half of 2024 and 2023, respectively, including severance and other employee-related expenses and long-lived assets impairment charges and disposal losses.
We may continue to incur net losses for the foreseeable future. Based upon our current operating plan, we believe that our existing cash, cash equivalents and investments as of December 31, 2024 as noted above will enable us to fund our operations for at least the next 12 months from the filing date of this Annual Report on Form 10-K.
Based upon our current operating plan, we believe that our existing cash, cash equivalents and investments as of December 31, 2025 as noted above will enable us to fund our operations for at least the next 12 months from the filing date of this Annual Report on Form 10-K. 81 Table of Contents However, our operating plan may change as a result of many factors currently unknown to us, and we may need to raise additional capital to complete the development and commercialization of our product candidates and fund certain of our existing manufacturing and other commitments.
The increase in contract revenue for the year ended December 31, 2024 compared to the same period in 2023 was primarily due to the recognition of $51.7 million revenue from the deferred revenue during the first quarter of 2024 when GSK’s rights to select up to two additional non-influenza target pathogens under the 2021 GSK Agreement expired on March 25, 2024.
Such increase was partially offset by $51.7 million revenue during the first quarter of 2024 when GSK’s rights to select up to two additional non-influenza target pathogens under the 2021 GSK Agreement expired on March 25, 2024, and lower GSK profit-sharing revenue in 2025 from GSK under our 2020 GSK Agreement.
The benefit from income taxes for the year ended December 31, 2023 was primarily due to a pre-tax loss and our ability to carry back the research and development credit to 2022. 81 Table of Contents Liquidity, Capital Resources and Capital Requirements Sources of Liquidity To date, we have financed our operations primarily through sales of our common stock from our initial public offering and subsequent follow-on offering, sales of our convertible preferred securities, and payments received under our grant and collaboration agreements.
Liquidity, Capital Resources and Capital Requirements Sources of Liquidity To date, we have financed our operations primarily through sales of our common stock from our initial public offering and subsequent follow-on offering, sales of our convertible preferred securities, and payments received under our grant and collaboration agreements.
Our clinical-stage portfolio includes infectious disease programs for CHD and CHB infections and multiple dual-masked TCEs across validated targets in solid tumor indications. We also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Our clinical development pipeline consists of investigational therapies targeting HDV and various solid tumors.
Our clinical-stage portfolio includes programs for CHD and multiple PRO-XTEN ® dual-masked TCEs across validated targets in solid tumor indications. We also have a portfolio of preclinical programs across a range of infectious diseases and oncologic malignancies. In HDV, our ECLIPSE registrational program is fully underway with all three trials initiated.
Cash provided by financing activities during 2023 was primarily due to of proceeds from the issuance of common stock under our employee stock purchase plan of $4.3 million and exercises of stock options of $3.5 million. Critical Accounting Policies and Estimates Our consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States.
Financing Activities Cash provided by financing activities during 2025 compared to the same period in 2024 was nominal. Critical Accounting Policies and Estimates Our consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States.
Preclinical Pipeline Candidates • We are advancing multiple undisclosed dual-masked TCEs targeting clinically validated targets with potential applications across a variety of solid tumors.
Preclinical Pipeline Candidates • We are currently progressing a number of PRO-XTEN ® masked TCEs in preclinical studies directed at clinically validated targets with potential applications across a variety of solid tumors, including lung, colorectal and bladder.
In addition, as of December 31, 2024, we had $95.7 million in restricted cash and cash equivalents, which includes the $75.0 million subject to VIR-5525 achieving “first in human dosing” by 2026. See the section titled “Liquidity, Capital Resources and Capital Requirements—Funding Requirements and Conditions” below for additional information.
In addition, as of December 31, 2025, we had $8.9 million in restricted cash and cash equivalents. See the section titled “ Liquidity, Capital Resources and Capital Requirements—Funding Requirements and Conditions ” below for additional information.
Our Collaboration, License and Grant Agreements We have entered into collaboration, license and grant arrangements with various third parties.
Our headquarters also conducts cell line development for our antibody and TCE product candidates. 76 Table of Contents Our Collaboration, License and Grant Agreements We have entered into collaboration, license and grant arrangements with various third parties.
Benefit from Income Taxes The benefit from income taxes for the year ended December 31, 2024 was nomimal.
Other Expense, Net The change in other expense, net, for the year ended December 31, 2025 compared to the same period in 2024 was nominal. (Provision for) Benefit from Income Taxes The change in (provision for) benefit from income taxes for the year ended December 31, 2025 compared to the same period in 2024 was nominal.
We are also developing therapeutic candidates in hepatitis B, HIV cure, and other solid tumors, leveraging our expertise and platform strengths.
In addition, we are developing therapeutic candidates in HIV cure and other solid tumors, leveraging our expertise and platform strengths, and we have made available for external partnerships our next-generation preclinical influenza A and B antibodies and ADCs along with our next generation COVID mAbs.
Operating Expenses Cost of Revenue Cost of revenue currently represents royalties earned by third-party licensors on net sales of sotrovimab. We recognize these royalties as cost of revenue when we recognize the corresponding revenue that gives rise to payments due to our licensors.
We recognize these royalties as cost of revenue when we recognize the corresponding revenue that gives rise to payments due to our licensors. Research and Development To date, our research and development expenses have related primarily to discovery efforts and preclinical and clinical development of our product candidates.
We expect our research and development expenses to increase substantially in absolute dollars over time as we advance our product candidates into and through preclinical and clinical studies and pursue regulatory approval of our product candidates. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming.
The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming.
Restructuring, long-lived assets impairment and related charges The increase in restructuring, long-lived assets impairment and related charges for the year ended December 31, 2024 compared to the same period in 2023 was primarily due to the right-of-use asset and leasehold improvement impairment charges related to closing our facilities in St.
Selling, General and Administrative Expenses The decrease in selling, general and administrative expenses for the year ended December 31, 2025 compared to the same period in 2024 was primarily due to efficiencies and cost savings from previously announced restructuring initiatives. 80 Table of Contents Restructuring, Long-Lived Assets Impairment and Related Charges, Net The decrease in restructuring, long-lived assets impairment and related charges for the year ended December 31, 2025 compared to the same period in 2024 was primarily due to the substantial completion of previously announced restructuring initiatives by the end of 2024.
Net Loss Attributable to Noncontrolling Interest Net loss attributable to noncontrolling interest consists of net loss attributable to our noncontrolling interest in Encentrio Therapeutics, Inc., our subsidiary, during the three months ended March 31, 2023. 79 Table of Contents Results of Operations Comparison of Years Ended December 31, 2024 and 2023 The following table summarizes our results of operations for the years presented (in thousands): Years Ended December 31, 2024 2023 Change Revenues: Collaboration revenue $ 8,379 $ 37,266 $ (28,887) Contract revenue 55,333 2,228 53,105 Grant revenue 10,493 46,686 (36,193) Total revenues 74,205 86,180 (11,975) Operating expenses: Cost of revenue 845 2,765 (1,920) Research and development 506,499 579,720 (73,221) Selling, general and administrative 119,031 174,441 (55,410) Restructuring, long-lived assets impairment and related charges 34,995 13,559 21,436 Total operating expenses 661,370 770,485 (109,115) Loss from operations (587,165) (684,305) 97,140 Other income: Change in fair value of equity investments (5,528) (21,888) 16,360 Interest income 71,809 86,990 (15,181) Other expense, net (2,221) (8,991) 6,770 Total other income 64,060 56,111 7,949 Loss before benefit from income taxes (523,105) (628,194) 105,089 Benefit from income taxes 1,145 13,077 (11,932) Net loss (521,960) (615,117) 93,157 Net loss attributable to noncontrolling interest — (56) 56 Net loss attributable to VirBio $ (521,960) $ (615,061) $ 93,101 Revenues The decrease in collaboration revenue for the year ended December 31, 2024 compared to the same period in 2023 was due to lower revenues from the release of sotrovimab profit-sharing amount previously constrained under our 2020 GSK Agreement.
Results of Operations Comparison of Years Ended December 31, 2025 and 2024 The following table summarizes our results of operations for the years presented (in thousands): Years Ended December 31, 2025 2024 Change Revenues: License and collaboration revenue $ 63,130 $ 61,370 $ 1,760 Grant revenue 2,036 10,493 (8,457) Other revenue 3,390 2,342 1,048 Total revenues 68,556 74,205 (5,649) Operating expenses: Cost of revenue 26 845 (819) Research and development 455,966 506,499 (50,533) Selling, general and administrative 92,074 119,031 (26,957) Restructuring, long-lived assets impairment and related charges, net (182) 34,995 (35,177) Total operating expenses 547,884 661,370 (113,486) Loss from operations (479,328) (587,165) 107,837 Other income: Change in fair value of equity investments 1,729 (5,528) 7,257 Interest income 40,238 71,809 (31,571) Other expense, net (409) (2,221) 1,812 Total other income 41,558 64,060 (22,502) Loss before (provision for) benefit from income taxes (437,770) (523,105) 85,335 (Provision for) benefit from income taxes (217) 1,145 (1,362) Net loss $ (437,987) $ (521,960) $ 83,973 79 Table of Contents Revenues The increase in license and collaboration revenue for the year ended December 31, 2025 compared to the same period in 2024 was primarily due to the recognition of $64.3 million license revenue related to the initial payment received under the Norgine Agreement.
Contract revenue includes recognition of revenue generated from license rights issued to GSK, from research and development services under third-party contracts, and from a third-party clinical supply agreement.
Grant revenue is comprised of revenue derived from grant agreements with government-sponsored and private organizations. Other revenue includes recognition of revenue generated from research and development services under third-party contracts and from a third-party clinical supply agreement. Operating Expenses Cost of Revenue Cost of revenue currently represents royalties earned by third-party licensors on net sales of sotrovimab.
Selling, General and Administrative Expenses The decrease in selling, general and administrative expenses for the year ended December 31, 2024 compared to the same period in 2023 was primarily due to savings realized through headcount reductions and the closing of our St. Louis, Missouri and Portland, Oregon sites, as part of our cost saving initiatives implemented in 2023 and 2024.
Cost of Revenue The decrease in cost of revenue for the year ended December 31, 2025 compared to the same period in 2024 was nominal.
Removed
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.
Added
Pipeline Programs CHD • To support global commercialization of the combination of tobevibart and elebsiran for the treatment of CHD, the Company granted Norgine an exclusive commercial license in Europe, Australia and New Zealand. • Phase 2 SOLSTICE data presented at the 44ᵗʰ Annual J.P.
Removed
Pipeline Programs Chronic Hepatitis Delta (CHD) • ECLIPSE Phase 3 registrational clinical program in CHD is advancing with the first patient in expected during the first half of 2025. • Positive data from the SOLSTICE Phase 2 clinical trial were presented in at the AASLD The Liver Meeting ® in November 2024.
Added
Morgan Healthcare Conference in January 2026 showed the combination of tobevibart and elebsiran is well tolerated and achieved undetectable hepatitis delta virus RNA (HDV RNA TND) in 88% (21/24) of CHD participants evaluable at 96 Weeks of treatment.
Removed
This data demonstrated the potential of the first-of-its-kind investigational combination to address a critical unmet need in CHD, showing rapid and sustained virologic suppression, using the most stringent measure of zero detectable hepatitis delta RNA in the blood or target not detected (TND defined as HDV RNA 74 Table of Contents • Tobevibart and elebsiran combination therapy has received multiple regulatory designations potentially supporting an expedited development and review process and recognizing the significant unmet need in CHD: U.S.
Added
Previous positive Phase 2 SOLSTICE data at Week 48 were presented at the AASLD The Liver Meeting ® 2025 and simultaneously published in the New England Journal of Medicine. 3 3 Asselah T, Chattergoon MA, Jucov A, et al.
Removed
FDA Breakthrough Therapy designation, U.S. FDA Fast Track designation, European PRIME designation and European Orphan Drug designation.
Added
“A Phase 2 Trial of Tobevibart plus Elebsiran in Hepatitis D” N Engl J Med . vol. 394, no. 4 (2026), 343-353, doi:10.1056/NEJMoa2508827. 74 Table of Contents • The ECLIPSE 1 and ECLIPSE 3 Phase 3 trials have completed enrollment. The ECLIPSE 2 Phase 3 trial continues enrolling well.
Removed
Solid Tumors • In January 2025, we presented encouraging early safety and efficacy data in ongoing Phase 1 dose escalation trials for its dual-masked TCE programs. ◦ VIR-5818, the only dual-masked HER2-targeting TCE in clinical trials, showed tumor shrinkage across various tumor types in 50% (10/20) of participants receiving doses ≥400 µg/kg, with cPRs in 33% (2/6) of participants with HER2-positive CRC. ◦ VIR-5500, the only dual-masked PSMA-targeting TCE in clinical trials, showed PSA declines in 100% (12/12) of mCRPC patients after an initial dose ≥120 µg/kg.
Added
Topline data from the ECLIPSE 1 trial are expected in the fourth quarter of 2026. Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027. • Tobevibart and elebsiran combination therapy is supported by multiple U.S. and EU regulatory designations, including FDA Breakthrough Therapy designation, U.S.
Removed
PSA 50 response was confirmed in 58% (7/12) of participants. ◦ Both clinical candidates have shown promising safety profiles, with MTD not yet reached, no dose-limiting CRS observed and no CRS greater than grade 2. • Initial clinical data demonstrate PRO-XTEN ™ masking technology’s potential to minimize systemic toxicity while enabling selective killing of cancer cells in the tumor microenvironment, minimizing CRS and expanding the therapeutic index compared to traditional therapeutic approaches. • We are advancing VIR-5818 and VIR-5500 through ongoing Phase 1 dose escalation studies, aiming to further optimize dosing and efficacy.
Added
FDA Fast Track designation, European PRIME designation and European Orphan Drug designation, signifying the significant unmet need in CHD. • ECLIPSE 1 evaluates the combination of tobevibart and elebsiran compared to deferred treatment in regions such as the U.S. where bulevirtide is not available or in other regions where its use is limited.
Removed
Additionally, we plan to initiate a Phase 1 study of VIR-5525, a dual-masked EGFR-targeting TCE, in the first quarter of 2025, evaluating its potential across a number of solid tumor indications.
Added
ECLIPSE 2 evaluates the switch to the combination of tobevibart and elebsiran in participants who have not achieved undetectable hepatitis delta virus RNA with bulevirtide treatment. ECLIPSE 3 evaluates the combination of tobevibart and elebsiran compared to bulevirtide monotherapy in bulevirtide treatment-naïve participants.
Removed
Chronic Hepatitis B (CHB) • We anticipate functional cure data from the 24-week follow-up of the MARCH Part B Phase 2 study in the second quarter of 2025. • Positive end-of-treatment results of the MARCH Part B Phase 2 trial evaluating tobevibart and elebsiran in combination with PEG-IFNα or tobevibart and elebsiran alone were presented at AASLD The Liver Meeting ® in November 2024.
Added
ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies, including agencies in the U.S. and Europe. ECLIPSE 3 is expected to provide important supportive data to help establish access and reimbursement in key markets.
Removed
The data demonstrated compelling HBsAg loss and anti-HBs development at the end of treatment. • Future advancement in CHB by us will be contingent on securing a worldwide development and commercialization partner outside of the China Territory to best enable further development in this area of high unmet need.
Added
Solid Tumors VIR-5500 • On February 19, 2026, we executed a global strategic collaboration with Astellas to advance PSMA-targeted PRO-XTEN ® dual-masked TCE VIR-5500, currently in development for metastatic castration-resistant prostate cancer. Upon closing of the transaction, the parties will co-develop and co-commercialize VIR-5500.
Removed
Corporate Update • In January 2025, we announced Maninder Hora, Ph.D. will assume the role of Executive Vice President, Chief Technical Operations in February 2025, on departure of our current Chief Technology Officer, Aine Hanley, Ph.D. • In September 2024, we announced the appointment of Jason O’Byrne as Executive Vice President and Chief Financial Officer, effective October 2, 2024. 75 Table of Contents • In August 2024 we announced an exclusive worldwide license to use of the proprietary PRO-XTEN ™ universal masking technology for oncology and infectious disease and to three clinical-stage masked TCEs with potential applications in a range of cancers.
Added
We will have the option to co-promote with Astellas in the U.S., and Astellas will obtain exclusive rights to commercialize outside the U.S.
Removed
The agreement became effective on September 9, 2024. ◦ Certain former employees of Sanofi joined us following the closing of the agreement. • In August 2024 we announced the phase-out of clinical programs in influenza, COVID-19, and its T-cell based viral vector platform. The Company is seeking partners to advance these clinical programs through further development.
Added
Under the terms of the agreement, we will receive $335 million in upfront and near-term milestone payments, including $240 million in cash, $75 million in equity investment at a 50% premium, and a $20 million near-term milestone upon completion of manufacturing process technology transfer, anticipated in mid-2027.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

6 edited+1 added−0 removed4 unchanged
Biggest changeWe had no debt outstanding as of December 31, 2024. Foreign Currency The functional currency of our foreign subsidiaries is the U.S. dollar. Monetary assets and liabilities of our foreign subsidiaries are translated into U.S. dollars at period-end exchange rates and non-monetary assets and liabilities are translated to U.S. dollars using historical exchange rates.
Biggest changeMonetary assets and liabilities of our foreign subsidiaries are translated into U.S. dollars at period-end exchange rates and non-monetary assets and liabilities are translated to U.S. dollars using historical exchange rates. Revenue and expenses are translated at average rates throughout the respective periods.
Transaction gains and losses are included in other (expense) income, net on the consolidated statements of operations and are not material for the years ended December 31, 2024, 2023 and 2022. Equity Investment Risk We hold ordinary shares of Brii Bio Parent, which we acquired in connection with our collaboration, option and license agreement.
Transaction gains and losses are included in other expense, net on the consolidated statements of operations and are not material for the years ended December 31, 2025, 2024 and 2023. Equity Investment Risk We hold ordinary shares of Brii Bio Parent, which we acquired in connection with our collaboration, option and license agreement.
These equity securities are measured at fair value with any changes in fair value recognized in our consolidated statements of operations. The fair value of these equity securities was approximately $4.4 million as of December 31, 2024.
These equity securities are measured at fair value with any changes in fair value recognized in our consolidated statements of operations. The fair value of these equity securities was approximately $6.1 million as of December 31, 2025.
A hypothetical 10% increase or decrease in the stock prices of these equity securities would increase or decrease their fair value as of December 31, 2024 by approximately $0.4 million. 85 Table of Contents
A hypothetical 10% increase or decrease in the stock prices of these equity securities would increase or decrease their fair value as of December 31, 2025 by approximately $0.6 million. 84 Table of Contents
Interest Rate Risk We had cash, cash equivalents and restricted cash and cash equivalents of $318.7 million as of December 31, 2024, which primarily consisted of deposits in checking and sweep accounts at financial institutions and money market funds. We also had short-term and long-term investments of $868.1 million as of December 31, 2024.
Interest Rate Risk We had cash, cash equivalents and restricted cash and cash equivalents of $241.1 million as of December 31, 2025, which primarily consisted of deposits in checking and sweep accounts at financial institutions and money market funds. We also had short-term and long-term investments of $543.3 million as of December 31, 2025.
Revenue and expenses are translated at average rates throughout the respective periods. As of the date of this Annual Report on Form 10-K, we are exposed to foreign currency risk primarily related to the operations of our Swiss and Australian subsidiaries and our collaboration with GSK and consequently the Swiss Franc, Australian dollar and British pound.
As of the date of this Annual Report on Form 10-K, we are exposed to foreign currency risk primarily related to the operations of our Swiss subsidiaries and our license agreement with Norgine and consequently the Swiss Franc and Euros.
Added
We had no debt outstanding as of December 31, 2025. Foreign Currency The majority of our transactions occur in U.S. dollars. However, we do have certain transactions that are denominated in currencies other than the U.S. dollar. The functional currency of our foreign subsidiaries is the U.S. dollar.

Other VIR 10-K year-over-year comparisons