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Item 1A. Risk Factors

2026-02-23 compared with 2025-02-27 · 267 added, 315 removed, 540 unchanged (52% of the section changed)

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You should carefully consider the following risk factors as well as the other information in this Annual Report on Form 10-K, including our audited condensed consolidated financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding whether to invest in our common stock.

The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and/or prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this Annual Report on Form 10-K and those we may make from time to time.

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.

In such an event, the market price of our common stock could decline, and you may lose all or part of your investment.

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• Our future success is substantially dependent on the successful clinical development, regulatory approval and commercialization of our product candidates in a timely manner.

If we are not able to obtain required

regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate product revenue will be adversely affected.

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.

• Success in preclinical studies or early-stage clinical studies may not be indicative of results in future clinical studies and we cannot assure you that any ongoing, planned or future clinical studies will lead to results sufficient for the necessary regulatory approvals and marketing authorizations.

• We 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.

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.

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.

• Clinical product development involves a lengthy and expensive process.

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.

• 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.

• 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.

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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.

There could be delays or supply shortages beyond our control limiting our access to clinical supplies.

• 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.

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.

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We had net loss of $438.0 million and $522.0 million for the years ended December 31, 2025, and 2024 , respectively.

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

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.

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

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

It could be several years, if ever, before we are able to commercialize any of our product candidates.

Any net losses we incur may fluctuate significantly from quarter to quarter and year to year.

Any net losses we incur may fluctuate significantly from quarter to quarter and year to year based on operating expenses and other factors.

To become profitable, we must succeed in developing and eventually commercializing products that generate significant revenue.

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If we are required by regulatory authorities to perform studies in addition to those currently expected, or if there are any delays in the initiation and completion of our clinical studies or the development of any of our product candidates, our expenses could increase.

Our failure to return to 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 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.

Since our founding in April 2016, our operations have been largely focused on identifying, researching and conducting preclinical and clinical activities of our product candidates, acquiring and developing our technology platforms and product candidates, organizing and staffing our company, business planning, raising capital and establishing our intellectual property portfolio.

As an organization, beyond sotrovimab for COVID-19, we have not yet demonstrated an ability to successfully manufacture a BLA-approved, commercial-scale product or conduct sales and marketing activities necessary for successful commercialization.

Consequently, any predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history.

As an organization, beyond sotrovimab for COVID-19, we have not yet demonstrated an ability to successfully manufacture a new drug application (NDA)- or biologics licensing application (BLA)-approved, commercial-scale product or conduct sales and marketing activities necessary for successful commercialization.

Consequently, any predictions about our future success or viability may not be as accurate as they could be if we had a longer history of commercialization.

We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives, including with respect to our technology platforms and product candidates.

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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.

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

Based upon our current operating plan, we believe that this amount will fund our current operating plans for at least the next 12 months.

our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional financing to fund our long-term operations sooner than planned.

Moreover, it is particularly difficult to estimate with certainty our future revenue and expenses given the dynamic and rapidly evolving nature of our business.

We may also need to raise additional capital to complete the development and commercialization of our product candidates and fund certain of our existing manufacturing and other commitments.

Other unanticipated costs may also arise.

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.

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

Based upon our current operating plans, we believe that this amount will fund our operations for at least the next 12 months.

However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional financing to fund our long-term operations sooner than planned.

In addition, because the design and outcome of our clinical studies are highly uncertain, we cannot reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the development and commercialization of our product candidates, if approved, or any future product candidates that we develop.

The dynamic and rapidly evolving nature of our business also makes it difficult to estimate with certainty our future revenue and expenses after any such successful development and commercialization.

We expect to finance our cash needs through public or private equity or debt financings, third-party (including government) funding and marketing and distribution arrangements, as well as clinical trial financing and other collaborations, strategic alliances and licensing arrangements with other companies, or any combination of these approaches.

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• the extent to which we acquire or in-license other companies’ product candidates and technologies.

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.

For example, on February 19, 2026, we and Astellas entered into the Astellas Agreement.

Upon closing of the transaction contemplated by the Astellas Agreement, we and Astellas will enter into a global strategic collaboration to co-develop and co-commercialize VIR-5500 for the treatment of prostate cancer, and we will receive a $240 million upfront cash payment.

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

Certain of the closing conditions for each of the Astellas Agreement and the Astellas SPA are beyond our control, and no assurance can be given that the closing will take place on the timeline currently anticipated, or at all, or that we will receive the entire amount of expected proceeds on the timeline currently anticipated, or at all.

Any failure to close one or both of these transactions could materially and adversely impact our business, financial condition, results of operations and liquidity.

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.

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If we raise additional capital through future collaborations, strategic alliances or licensing arrangements, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us.

If we are unable to raise additional capital when needed, we may be required to delay, limit, reduce or terminate our research and product development or commercialization efforts or grant rights to develop and market product candidates that we would otherwise develop and market ourselves.

We do not expect meaningful future revenue from the sale of sotrovimab for the treatment of COVID-19, even if it were reauthorized by the FDA.

In December 2024, the FDA revoked the EUA that we and GSK had received in May 2021 for the sale of sotrovimab to treat COVID-19.

Even prior to the FDA’s revocation of our EUA, sotrovimab had not been authorized for use in any U.S.

region for the treatment of COVID-19 since the FDA’s exclusionary revisions to our EUA in March and April 2022.

Due to the evolving COVID-19 landscape and based on discussions with the FDA, we and GSK do not plan to file a BLA.

While sotrovimab still maintains emergency authorization, temporary authorization or marketing approval (under the brand name Xevudy ® ) for early treatment of COVID-19 in certain territories outside of the United States, we did not earn meaningful revenue from sales of sotrovimab during the most recent fiscal year ended December 31, 2024.

Moreover, foreign regulatory authorities may impose similar limitations to the FDA on the use of sotrovimab in jurisdictions where sotrovimab has been granted EUA, temporary authorization or other marketing approval, which could further reduce revenue.

For example, although certain countries outside the United States.

continue to maintain access to 500 mg IV while noting that the clinical efficacy is unknown or uncertain against existing and emerging Omicron variants, we cannot predict whether other countries will further limit the use of sotrovimab.

There are no assurances that we will secure future supply commitments from governments for sotrovimab, or that sotrovimab will be effective against any new COVID-19 variants or subvariants.

Even if we and GSK were to file a BLA or marketing applications in other jurisdictions, it is possible that the FDA and other regulatory authorities may not grant sotrovimab full marketing approval for the treatment of COVID-19, or that any such marketing approvals, if granted, may have similar or other significant limitations on its use.

If the FDA does not reauthorize the use of sotrovimab in the U.S., and/or if countries outside of the U.S.

continue to limit its use, we may be unable to sell sotrovimab in or outside of the U.S.

For these reasons, we do not currently expect meaningful future revenue from sotrovimab for the treatment of COVID-19.

If we are unable to raise additional capital when needed, we may be required to delay, limit, reduce or terminate our research and development programs or commercialization efforts or grant rights to develop and market product candidates that we would otherwise develop and market ourselves.

Risks Related to Development and Commercialization

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Prior to obtaining approval to commercialize any product candidate in the United States or abroad, we must demonstrate with substantial evidence from well-designed registrational clinical studies, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that such product candidate is safe and effective to treat its intended indications.

Results from preclinical studies can be interpreted in different ways.

Even if we believe that the preclinical or clinical data for our product candidates are promising, such data may not be sufficient to support approval for further development, manufacturing or commercialization of our product candidates by the FDA and other regulatory authorities.

The FDA or other comparable foreign regulatory authorities may also require us to conduct additional preclinical or clinical studies for our product candidates, either prior to or post-approval, or may object to elements of our clinical development program and require us to alter them.

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.

Results from preclinical and clinical studies can be interpreted in different ways, and even if we believe that the preclinical or clinical data for our product candidates are promising, such data may not be sufficient for the FDA and comparable foreign regulatory authorities to approve further development, manufacturing or commercialization of our product candidates.

The FDA or these other regulatory authorities may also require us to conduct additional preclinical or clinical studies for our product candidates, or may object to elements of our clinical development program and require us to alter them.

Additionally, the acceptance of data by the FDA from clinical trials conducted outside the United States, or by comparable foreign regulatory authorities for trials conducted outside of their respective jurisdictions, may be subject to conditions imposed by such regulatory authorities, including as relating to differences between medical practice, clinical endpoints, trial conduct and patient populations between the United States and foreign countries.

Furthermore, these authorities may not approve or authorize the labeling that we believe is necessary or desirable for the successful commercialization of our product candidates.

Any delay in obtaining, or inability to obtain, applicable regulatory approval or other marketing authorization would delay or prevent commercialization of that product candidate and would adversely impact our business and prospects.

In addition, the FDA or comparable foreign regulatory authorities may change their policies, adopt additional regulations or revise existing 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.

Such policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain applicable regulatory approvals, increase the costs of compliance or restrict our ability to maintain any marketing authorizations we may have obtained.

For example, in December 2022, with the passage of Food and Drug Omnibus Reform Act, Congress required sponsors to develop and submit a diversity action plan for each Phase 3 clinical trial or any other “pivotal study” of a new drug or biological product.

These plans are meant to encourage the enrollment of more diverse patient populations in late-stage clinical studies of FDA-regulated products.

Specifically, as further detailed in FDA’s Draft Guidance entitled, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” issued in June 2024, actions plans must include the sponsor’s goals for enrollment, the underlying rationale for those goals, and an explanation of how the sponsor intends to meet them.

The Trump Administration’s January 2025 Executive Order pausing certain diversity, equity and inclusion efforts has left uncertain how, whether or when the statute’s requirements will become operative.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies governing clinical studies, our development plans may be impacted.

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.

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.

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.

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.

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Efforts to identify, acquire or in-license, and then develop product candidates require substantial technical, financial and human resources, whether or not any product candidates are ultimately identified.

Even when we are successful in identifying and acquiring or in-licensing potential product candidates, such as our license to three clinical-stage TCEs from Sanofi, our efforts may fail to yield product candidates for clinical development, approved products or commercial revenue for many reasons.

Even when we are successful in identifying and acquiring or in-licensing potential product candidates, such as our license to three clinical-stage TCEs (VIR-5818, VIR-5500 and VIR-5525) and the PRO-XTEN ® universal masking platform from Sanofi, our efforts may fail to yield product candidates for clinical development, approved products or commercial revenue for many reasons.

We have limited financial and management resources and, as a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater market potential.

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If we are unsuccessful in developing additional product candidates or are unable to do so, or if the product candidates that we identify and acquire or in-license do not meet our expectations or fail to result in viable products, our business may be harmed.

Furthermore, we intend to seek approval to market our product candidates outside of the U.S., and may also do so for future product candidates.

If we market approved products outside of the U.S., we expect that we will be subject to additional risks in commercialization.

As a company, we have no prior experience in these areas.

In addition, there are complex regulatory, tax, labor and other legal requirements imposed by many of the individual countries in which we may operate, with which we will need to comply.

Many biopharmaceutical companies have found the process of marketing their products in foreign countries to be challenging.

Furthermore, we may seek marketing approval for our current and future product candidates outside of the United States.

We have limited prior experience in marketing approved products outside of the United States, and marketing products in foreign countries would subject us to additional risks.

There are complex regulatory, tax, labor and other legal requirements imposed by many of the individual countries in which we may operate, with which we will need to comply, and such efforts may be expensive, time-consuming and challenging.

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

We are pursuing a functional cure of CHB based on a combination regimen of tobevibart and elebsiran, with or without PEG-IFNα, as well as developing the combination of tobevibart and elebsiran as a treatment for CHD.

We are pursuing development of the combination of tobevibart and elebsiran as a treatment for CHD, which includes both our ECLIPSE registrational trial program evaluating the doublet combination and an ongoing Phase 2 clinical trial evaluating tobevibart as a monotherapy in addition to the doublet combination.

Each of these product candidates has demonstrated direct antiviral activity and the potential to stimulate an effective immune response.

We believe that a functional cure for CHB will require an effective immune response, in addition to antiviral activity, based on the latest functional cure data and on the observation that severe immunosuppression can reactivate CHB.

Accordingly, a combination therapy that includes both of these components may be needed to achieve a functional cure.

For CHB, we have ongoing Phase 2 clinical trials evaluating the combination of tobevibart and elebsiran, with or without PEG-IFNα, and we are also evaluating additional combinations with other immunotherapy agents and direct-acting antiviral agents.

For CHD, we have an ongoing Phase 2 clinical trial evaluating tobevibart as a monotherapy or in combination with elebsiran, and we have a planned registrational trial program that will further evaluate the doublet combination.

In our early-stage oncology programs, we are evaluating VIR-5818 in combination with pembrolizumab in a Phase 1 basket study in multiple tumor types, including metastatic breast cancer and metastatic CRC.

In our early-stage oncology programs, we are evaluating each of VIR-5818 and VIR-5525 in combination with pembrolizumab in Phase 1 basket studies across multiple tumor types, including metastatic breast cancer and metastatic CRC for VIR-5818 and NSCLC, CRC, HNSCC and cSCC for VIR-5525.

The inclusion of critically ill patients in our oncology clinical studies may result in serious adverse medical events, including death, due to other therapies or medications that such patients may be using or in combination with our product candidates.

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If the FDA or comparable foreign regulatory authorities do not approve these other drugs or revoke their approval of, or if safety, efficacy, manufacturing or supply issues arise with, the drugs we choose to evaluate in combination with any product candidate we develop, we may be unable to obtain approvals that will facilitate the successful commercialization of our product candidates.

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.

We have and may continue to commit substantial financial resources with respect to clinical studies that may not be successful, and we may not be able to recoup those investments.

Success in preclinical testing and early-stage clinical studies does not ensure that later clinical studies will generate similar results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate.

Certain of our clinical programs have not yielded positive results in late-stage studies (such as our Phase 2 clinical study of VIR-2482 for the prevention of symptomatic influenza A illness, which did not meet primary or secondary efficacy endpoints, as announced in July 2023), and our product candidates currently under development may similarly fail to meet efficacy endpoints or otherwise show the desired characteristics in clinical development sufficient to obtain regulatory approval, despite positive results in preclinical studies or having successfully advanced through early-stage clinical studies.

Certain of our clinical programs have in the past, and may in the future, not yield positive results in late-stage studies.

Our product candidates currently under development may similarly fail to meet efficacy endpoints or otherwise show the desired characteristics in clinical development sufficient to obtain regulatory approval, despite positive results in preclinical studies or having successfully advanced through early-stage clinical studies.

We have and may continue to commit substantial financial resources with respect to clinical studies that may not be successful, and we may not be able to recoup those investments.

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Differences between preliminary or interim data and final data could significantly harm our business prospects and may cause the trading price of our common stock to fluctuate significantly.

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.

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 in the same indication .

In addition, the combination received PRIME designation from the EMA and European orphan drug designation in December 2024 for the same indication .

We can provide no assurances that the combination of tobevibart and elebsiran or any of our other product candidates that receive Fast Track, Breakthrough Therapy, Priority Review or similar designations in the U.S., EU or in any other regulatory jurisdictions will receive regulatory approval any sooner than other product candidates that do not have such designations, or at all.

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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.

Business” in this Annual Report on Form 10-K.

For additional information, see the sections titled in “Part I, Item 1.

Business—Government Regulation and Product Approval—Expedited Development and Review Programs” and “Part I, Item 1.

Business—Government Regulation and Product Approval—Foreign Regulation” in this Annual Report on Form 10-K.

Clinical product development involves a lengthy and expensive process.

We may incur additional costs and encounter substantial delays or difficulties in our clinical studies.

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.

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.

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.

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.

Also, the availability of superior or competitive therapies coupled with changing standards of care could limit our ability to perform placebo-controlled studies and/or require us to enroll a larger number of subjects to address competing treatments.

Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical and clinical studies have nonetheless failed to obtain marketing approval of their products.

Any of these or other unforeseen events that we may experience prior to, during, or as a result of clinical studies could delay or prevent us from receiving marketing approval and ultimately commercializing our product candidates.

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.

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.

In addition, we, the FDA or comparable foreign regulatory authorities, or any institutional review boards for any planned or ongoing study, could impose a clinical hold on such study, which could halt enrollment and/or require discontinuation for any product candidates under evaluation.

Also, the availability of superior or competitive therapies coupled with changing standards of care could limit our ability to perform placebo-controlled studies or require us to enroll a larger number of subjects to address competing treatments.

Moreover, preclinical and clinical data are susceptible to varying interpretations and analyses that can result in product candidates failing to obtain marketing approval.

Any of these or other unforeseen events could delay or prevent us from receiving marketing approval and ultimately commercializing our product candidates.

Any inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenue from future product sales or other sources.

In addition, if we make manufacturing or formulation changes to our product candidates, we may need to conduct additional testing to bridge our modified product candidate to earlier versions.

Clinical trial delays could also shorten any periods during which we may have the exclusive right to commercialize our product candidates, if approved, or allow our competitors to bring competing products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our business, financial condition, results of operations and prospects.

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;

In addition, if we make manufacturing or formulation changes to our product candidates, we may need to conduct additional testing.

If 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);

• be subject to the addition of labeling statements, such as warnings or contraindications;

• 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;

• experience damage to our reputation.

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.

In addition, the compounds we are developing may not demonstrate in patients the chemical and pharmacological properties ascribed to them in preclinical studies, and they may interact with human biological systems in unforeseen, ineffective or harmful ways.

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.

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.

In particular, clinical studies for prophylaxis are impacted by many factors including competing therapies that tend to require enrollment of a larger number of subjects than clinical studies for treatments.

We may encounter difficulties in enrolling patients in our clinical studies, thereby delaying or preventing development and approval of our product candidates.

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Delays or failures in planned patient enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability to develop our product candidates or could render further development impossible.

In addition, we may rely on CROs and clinical trial sites to ensure proper and timely conduct of our future clinical studies and, while we intend to enter into agreements governing their services, we will be limited in our ability to ensure their actual performance, which may result in rejection of the data generated at particular clinical trial sites or delays in the completion of our future clinical studies.

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.

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Regulatory authorities may draw different conclusions and may require us to pause our clinical studies or require additional testing to confirm these determinations, if they occur.

In addition, it is possible that as we test our product candidates in larger, longer and more extensive clinical studies, or as use of these product candidates becomes more widespread if they receive regulatory approval, illnesses, injuries, discomforts and other adverse events that were not observed in earlier studies, as well as conditions that did not

occur or went undetected in previous studies, will be reported by subjects or patients.

Many times, side effects are only detectable after investigational products are tested in large-scale pivotal studies or, in some cases, after they are made available to patients on a commercial scale after approval.

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We are a party to various strategic collaboration and license agreements that are important to our business and to our current and future product candidates pursuant to which we license a number of technologies to form our technology platforms and in-license certain product candidates.

These agreements contain obligations that require us to make substantial payments in the event certain milestone events are achieved.

A core element of our business strategy includes continuing to acquire or in-license additional technologies or product candidates for the treatment and prevention of serious infectious diseases, cancer and other serious conditions.

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.

We are a party to various strategic collaboration and license agreements that are important to our business and to our current and future product candidates, pursuant to which we license a number of technologies to form our technology platforms and in-license certain product candidates, as well as out-license select product candidates or technologies to other companies for further development and potential commercialization.

Certain of these agreements contain obligations that require us to make substantial payments in the event certain milestone events are achieved with respect to an in-licensed product candidate, or alternatively relinquish certain rights relating to the development and commercialization of an out-licensed product candidate.

A core element of our business strategy includes continuing to acquire, in-license or out-license, or otherwise collaborate on additional technologies or product candidates for the treatment and prevention of serious infectious diseases, cancer and other serious conditions.

As a result, we intend to periodically explore a variety of possible strategic collaborations or licenses in an effort to gain access to additional product candidates 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.

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• 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

• 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;

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• 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;

• 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;

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If these or other risks from our current or potential future strategic collaborations and licenses occur, our business, financial condition, results of operations or prospects could be harmed.

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.

We integrate AI in our efforts to develop and engineer next-generation antibodies, and we might utilize AI in the future in connection with drug discovery activities.

AI may be difficult to deploy successfully due to operational and technical issues inherent in such methods.

In particular, AI algorithms might utilize machine learning and predictive analytics which may lead to flawed, biased or inaccurate results, which could lead to ineffective product or target candidates and exposure to competitive and reputational harm.

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.

We integrate AI in our efforts to develop and engineer next-generation antibodies, including through the use of our proprietary dAIsY™ AI engine, and we might utilize AI in the future in connection with drug discovery activities.

AI can be difficult to deploy successfully due to operational and technical issues inherent in such methods.

In particular, AI algorithms’ use of machine learning and predictive analytics could lead to flawed, biased or inaccurate results, which, if detected, could lead to ineffective product or target candidates and exposure to competitive and reputational harm.

In addition, any latency, disruption, or failure in our AI operations or infrastructure could result in failures, delays or errors in our discovery and development of next-generation antibodies or other investigational products.

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Our eligible patient population, pricing estimates and available coverage and reimbursement may differ significantly from the actual market addressable by our product candidates.

Our estimates of the number of people who have these diseases, the subset of people with these diseases who have the potential to benefit from treatment with our product candidates and the market demand for our product candidates are 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.

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.

Furthermore, new studies may change the estimated incidence or prevalence of the diseases we are targeting.

The FDA or the comparable foreign regulatory authorities also may approve or authorize for marketing a product candidate for a more limited indication or patient population than we originally request.

Additionally, the availability of superior or competitive therapies from our competitors could negatively impact or eliminate market demand for our product candidates.

If the market opportunities for our product candidates are smaller than we estimate, it could have an adverse effect on our business, financial condition, results of operations and prospects.

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.

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As a result of these factors, our competitors may achieve patent protection or obtain regulatory approval or authorization of their products before we are able to, which could result in our competitors establishing a strong market position before we are able to enter the market.

Our competitors may also develop therapies that are safer, more effective, have fewer or less severe side effects, are more convenient, more widely accepted or less expensive than ours, and may also be more successful than we are in manufacturing, marketing or obtaining reimbursement their products.

These advantages could render our product candidates obsolete or non-competitive before we can recover the costs of such product candidates’ development and commercialization.

For additional information regarding our competitors, see the section titled “Competition” in “Part I, Item 1.

Business” of this Annual Report on Form 10-K.

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.

Even if any of our product candidates receive marketing approval, they may fail to achieve adoption by physicians, patients, third-party payors and others in the medical community.

If such product candidates do not achieve an adequate level of acceptance, we may not generate significant product revenue and may not become profitable.

The degree of market acceptance of any product candidate, if approved for commercial sale, will depend on a number of factors, including but not limited to:

Our competitors may also develop therapies that demonstrate stronger safety and efficacy data, have fewer or less severe side effects, are more convenient, more widely accepted or less expensive than ours, and may also be more successful than we are in manufacturing, marketing or obtaining reimbursement for their products.

These advantages could render our product candidates obsolete or non-competitive before we can recover the development and commercialization costs of such product candidates.

For additional information regarding our competitors, see the section titled “ Part I, Item 1.

Business—Competition ” in this Annual Report on Form 10-K.

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.

Even if our product candidates receive regulatory approval, they may fail to achieve adoption by physicians, patients, third-party payors and others in the medical community.

If such product candidates do not achieve an adequate level of acceptance, we may not generate significant product revenue, and the degree of market acceptance will depend on a number of factors, including but not limited to:

• the convenience and ease of administration compared to alternative treatments and therapies;

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• the efficacy and potential advantages compared to alternative treatments and therapies;

• the effectiveness of sales and marketing efforts;

• acceptance in the medical and patient communities of our product candidates as a safe and effective treatments;

• the effectiveness of our sales and marketing efforts;

• acceptance in the medical and patient communities of our products as safe and effective treatments;

• the cost of treatment in relation to alternative treatments and therapies, including any similar generic treatments;

• our ability to offer such products for sale at competitive prices;

• the strength of marketing and distribution support;

• the strength of our marketing and distribution support;

• the availability of third-party coverage and adequate reimbursement, as well as patients’ willingness to pay out-of-pocket in the absence of third-party coverage or adequate reimbursement;

• the products’ safety profile including as compared to alternative treatments and therapies;

• any restrictions on the use of the product together with other medications.

If any of our product candidates are approved but fail to achieve market acceptance among physicians, patients, third-party payors and others in the medical community, we will not be able to generate significant revenue, which would compromise our ability to become profitable.

Even if we obtain regulatory approvals for our product candidates, they will remain subject to ongoing regulatory oversight and potential enforcement actions.

Even if we obtain regulatory approval in a jurisdiction, the regulatory authority may still impose significant restrictions on the indicated uses or marketing of our product candidates, or impose ongoing requirements for potentially costly post-approval studies, post-market surveillance or patient or drug restrictions.

Additionally, the holder of an approved BLA is required to comply with FDA rules and is subject to FDA review and periodic inspections, in addition to other potentially applicable federal and state laws, to ensure compliance with GMP and adherence to commitments made in the BLA.

If we or a regulatory agency discovers previously unknown problems with a product such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions relative to that product or the manufacturing facility, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

• the safety profiles of our products including as compared to alternative treatments and therapies;

• any restrictions on the use of our products together with other medications.

The resulting inability of any approved products to generate significant revenue would compromise our ability to return to profitability.

Our product candidates, if approved, will remain subject to ongoing regulatory oversight and potential enforcement actions.

Even if we obtain regulatory approval in any particular jurisdiction, the applicable regulatory authorities may still impose significant restrictions on the indicated uses, marketing, manufacturing or distribution of our product candidates, or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance.

Additionally, the holder of an approved NDA or BLA is required to comply with FDA rules, including relating to record-keeping, reporting of adverse events and product deviations, periodic reporting, product sampling and distribution, lot release, and advertising and promotion, and is subject to FDA review and periodic inspections, in addition to other potentially applicable federal and state laws, to ensure compliance with cGMP and current Good Distribution Practice, as well as adherence to commitments made in the NDA or BLA.

If we or any regulatory agency discovers previously unknown problems with an approved product such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, such regulatory agency may impose restrictions relative to that product or the manufacturing facility, including requiring recall or withdrawal of the product from the market or suspension of manufacturing for that jurisdiction.

Moreover, product labeling, advertising and promotion for any approved product will be subject to regulatory requirements, continuing regulatory review and review by other government agencies and third parties.

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Physicians, on the other hand, may prescribe products for off-label uses.

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.

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.

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.

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.

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.

Department of Justice (DOJ), closely regulate and monitor the marketing and promotion of products in the United States to ensure that they are marketed and distributed only for the approved indications and in accordance with the provisions of the approved labeling.

The FDA imposes stringent restrictions on manufacturers’ communications regarding off-label use and if we market our medicines for uses other than their respective approved indications, we may be subject to DOJ-led enforcement actions for off-label marketing.

Violations of the 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.

Any government investigation of alleged violations of laws or regulations could require us to expend significant time and resources in response and could generate negative publicity.

The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenue.

For additional information regarding regulatory approval and ongoing regulatory oversight, see the section titled “Government Regulation and Product Approval.” in “Part I, Item 1.

Business” of this Annual Report on Form 10-K.

Even if we obtain and maintain approval for our product candidates from the FDA, we may never obtain approval outside of the United States, which would limit our market opportunities.

For additional information regarding regulatory approval and ongoing regulatory oversight, see the section titled “ Part I, Item 1.

Business—Government Regulation and Product Approval ” in this Annual Report on Form 10-K.

We may never obtain approval for our product candidates outside of the United States, which would limit our market opportunities.

Approval of a product candidate in the United States by the FDA does not ensure approval of such product candidate by regulatory authorities in other countries or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA.

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In some cases, the price that we intend to charge for any product candidates, if approved, is also subject to approval.

In particular, obtaining approval for our product candidates in the EU from the EC following the opinion of the EMA if we choose to submit a marketing authorization application there, would be a lengthy and expensive process.

In particular, obtaining approval for our product candidates in the EU from the European Commission following the opinion of the EMA if we choose to submit a marketing authorization application there, would be a lengthy and expensive process.

Even if a product candidate is approved, the EMA may limit the indications for which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming additional clinical studies or reporting as conditions of approval.

Approval of certain product candidates outside of the United States, particularly those that target diseases that are more prevalent outside of the United States will be 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.

Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and additional costs for us and could delay or prevent the introduction of our product candidates in certain countries.

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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.

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.

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.

Negative public attitudes may adversely impact our ability to enroll clinical studies.

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.

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.

Increased negative public opinion, or more restrictive government regulations in response thereto, would have a negative effect on our business, financial condition, results of operations or prospects and may delay or impair the development and commercialization of our product candidates or demand for such product candidates.

For example, perceived or actual technical, legal, compliance, privacy, security, ethical or other issues relating to the use of AI may cause regulators’ or the public’s confidence in AI to be undermined, which could impede our ability to develop products using AI.

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.

• 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;

• a suspension or withdrawal of approval by regulatory authorities of our product candidates that are approved.

Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop.

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Insurance availability, coverage terms and pricing continue to vary with market conditions.

We endeavor to obtain appropriate insurance coverage for insurable risks that we identify such as cybersecurity-related issues;

however, we may fail to correctly anticipate or quantify insurable risks, we may not be able to obtain appropriate insurance coverage and insurers may not respond as we intend to cover insurable events that may occur.

We endeavor to obtain appropriate insurance coverage for insurable operational risks that we identify;

however, we may fail to correctly anticipate or quantify insurable operational risks, we may not be able to obtain appropriate insurance coverage and insurers may not respond as we intend to cover insurable events that may occur.

Conditions in the insurance markets relating to nearly all areas of traditional corporate insurance change rapidly and may result in higher premium costs, higher policy deductibles and lower coverage limits.

For some risks, we may not have or maintain insurance coverage because of high cost and/or limited availability.

For some risks, we may not have insurance coverage at all because of high cost and/or limited availability, and our financial condition could be negatively impacted should such risks come to fruition.

Risks Related to Regulatory Compliance

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For example, in the United States, biologic product candidates are subject to approval and licensure under the BLA pathway, and small molecules, such as our siRNA product elebsiran, are subject to approval and licensure under the NDA pathway.

The BPCIA creates an abbreviated pathway for the approval of biosimilar and interchangeable biologic products following the approval of an original BLA.

The Hatch-Waxman Act creates a similar pathway for seeking approval of a generic version of an approved, small molecule innovator drug product.

For additional information regarding biosimilars and exclusivity, see the section titled “Government Regulation and Product Approval—Biosimilars and Regulatory Exclusivity” in “Part I, Item 1.

Business” of this Annual Report on Form 10-K.

The Biologics Price Competition and Innovation Act of 2009 creates an abbreviated pathway for the approval of biosimilar and interchangeable biologic products following the approval of an original BLA.

The Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act) creates a similar pathway for seeking approval of a generic version of an approved, small molecule innovator drug product.

For additional information regarding biosimilars and exclusivity, see the section titled “ Part I, Item 1.

Business—Government Regulation and Product Approval—Biosimilars and Regulatory Exclusivity ” in this Annual Report on Form 10-K.

If competitors are able to obtain marketing approval for generics or biosimilars referencing our licensed small molecule or biologic products after the expiration of applicable periods of regulatory exclusivity, our products may become subject to competition from such generics or biosimilars, with the attendant competitive pressure and potential adverse consequences.

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If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

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.

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.

Physicians, other healthcare professionals and third-party payors, both in the United States and elsewhere, play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval.

Our current and future arrangements with healthcare professionals, principal investigators, patients, consultants, customers and third-party payors subject us to various federal and state fraud and abuse laws and other healthcare laws, such as the U.S.

federal Anti-Kickback Statute, civil monetary penalty laws, the False Claims Act (FCA) and other federal civil and criminal false claims laws, the healthcare fraud provisions of HIPAA and the Physician Payments Sunshine Act.

Civil and criminal false claims laws and civil monetary penalty laws can be enforced through civil whistleblower or qui tam actions and prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment of federal government funds, including in federal healthcare programs, that are false or fraudulent.

These laws may impact the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute any product candidates, if approved.

For additional information regarding these laws, see the section titled “Government Regulation and Product Approval” in “Part I, Item 1.

Business” in this Annual Report on Form 10-K.

For additional information regarding these laws, see the section titled “ Part I, Item 1.

Business—Government Regulation and Product Approval ” in this Annual Report on Form 10-K.

Ensuring that our internal operations and business arrangements with third parties comply with applicable healthcare laws and regulations will likely continue to be costly.

If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participating in government-funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of noncompliance with these laws, contractual damages, reputational harm and the curtailment or restructuring of our operations.

If the physicians or other providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to significant civil, criminal or administrative sanctions, including exclusions from government-funded healthcare programs.

Even if resolved in our favor, litigation or other legal proceedings relating to healthcare laws and regulations may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities.

In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments.

If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.

Even if resolved in our favor, litigation or other legal proceedings relating to healthcare laws and regulations can be expensive and time-consuming and could divert management ’ s attention from our core business.

In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if research analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.

Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development, manufacturing, sales, marketing or distribution activities.

Uncertainties resulting from the initiation and continuation of litigation or other proceedings relating to applicable healthcare laws and regulations could have an adverse effect on our ability to compete in the marketplace.

If we obtain regulatory approval in the United States, coverage and adequate reimbursement may not be available for any product candidates that we commercialize, which could make it difficult for us to sell profitably.

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.

Third-party payors decide which therapies they will pay for and establish reimbursement levels.

While no uniform policy for coverage and reimbursement exists in the United States, third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies.

However, decisions regarding the extent of coverage and amount of reimbursement to be provided for any product candidates that we develop will be made on a payor-by-payor basis.

Uncertainties resulting from the initiation and continuation of litigation or other proceedings relating to applicable healthcare laws and regulations could have a material adverse effect on our ability to compete in the marketplace.

Coverage and adequate reimbursement may not be available for any product candidates that we commercialize, which could make it difficult for us to sell profitably.

Third-party payors decide which therapies they will pay for and establish coverage conditions and reimbursement levels.

While no uniform policy for coverage and reimbursement exists in the United States, third-party commercial payors may rely upon Medicare or Medicaid coverage policy and payment limitations in setting their own coverage and reimbursement policies.

However, decisions regarding the extent of coverage and amount of reimbursement to be provided for any product candidates that we develop will be made on a payor-by-payor basis and may be delayed, particularly with regard to new drugs, and subject to change.

Additionally, a third-party payor’s decision to provide coverage for a therapy does not imply that an adequate reimbursement rate will be approved.

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.

Patients who are prescribed treatments for their conditions and providers prescribing such services generally rely on third-party payors to reimburse all or part of the associated healthcare costs.

Patients are unlikely to use our products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products.

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

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

Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications.

We cannot be sure that coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement will be.

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.

Patients who are prescribed treatments for their conditions and healthcare professionals prescribing such services generally rely on third-party payors to reimburse all or part of the associated healthcare costs.

Patients may be less likely to use our products if coverage is limited, including through utilization management and/or high cost-sharing requirements.

In addition, because certain of our product candidates are physician-administered, physicians that purchase products must receive sufficient reimbursement to cover their acquisition costs.

In such physician-administered settings, separate reimbursement for the product itself may or may not be available, and, if it is not, the administering physician may only be reimbursed for providing the treatment or procedure in which our product is used.

Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications, including through utilization management or other restrictions on coverage of a product.

We cannot be sure that adequate coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement will be.

Inadequate coverage and reimbursement may impact the demand for, or the price of, any product for which we obtain marketing approval.

If coverage and adequate reimbursement are not available, or are available only at limited levels, we may not be able to successfully commercialize any product candidates that we develop.

Healthcare legislative reform measures may have a negative impact on our business, financial condition, results of operations and prospects.

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 order for our products to be eligible for coverage under certain government health care programs, we will be required to enter into agreements with the government and provide complex pricing calculations that, in turn, may influence government reimbursement rates.

For instance, reimbursement for our products under Medicaid and Medicare Part B will require participation in the Medicaid Drug Rebate Program and payment of a rebate for each unit of product reimbursed by state Medicaid programs.

We will also be required to participate in the 340B Drug Pricing Program and an agreement with the U.S.

Department of Veterans Affairs.

Changes to these programs may impact government program reimbursement for our products and in turn could adversely affect our business, results of operations, financial condition and prospects.

Healthcare legislative, administrative and other reform measures may have a negative impact on our business, financial condition, results of operations and prospects.

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.

In particular, there have been and continue to be a number of initiatives at the U.S.

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federal government will pay for healthcare products and services, which could result in reduced demand for our current or any future product candidates or additional pricing pressures.

While it is currently unclear how 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.

In addition, 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.

For additional information regarding other healthcare legislative reform measures, see the sections titled “Government Regulation and Product Approval—Healthcare Reform” and “Government Regulation and Product Approval—Pharmaceutical Prices” in “Part I, Item 1.

Business” in this Annual Report on Form 10-K.

It is currently unclear how certain new measures, including the drug pricing provisions of the Inflation Reduction Act of 2022 (and subsequent rulemaking and guidance) and changes to Medicaid eligibility requirements in the OBBBA, will ultimately be effectuated.

Accordingly, we cannot predict with certainty what impact these or any other federal or state health reforms will have on us, including whether finalized rules will be implemented or withstand judicial review.

Any 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, financial condition and prospects.

In addition, it is unclear whether the new Trump Administration will reverse or modify any existing regulatory requirements, pursue the reform initiatives outlined in various executive orders and administrative proposals (such as the May 12, 2025 executive order supporting a "most favored nation" approach to drug pricing and related price reduction agreements with certain manufacturers) or otherwise influence the overall healthcare regulatory environment, and even if proposed, whether such changes or modifications would be implemented or withstand potential litigation.

For additional information regarding healthcare legislative, administrative and other reform measures, see the sections titled “ Part I, Item 1.

Business—Government Regulation and Product Approval—Healthcare Reform ” and “ Part I, Item 1.

Business—Government Regulation and Product Approval—Pharmaceutical Prices ” in this Annual Report on Form 10-K.

Should we seek and obtain regulatory approval in the United States, we expect that these and other healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product, which could have an adverse effect on demand for our product candidates.

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors.

The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our products.

Any reduction in reimbursement from Medicare, Medicaid or other government programs may result in a similar reduction in payments from private payors.

The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue or attain profitability from commercializing our products.

We are subject to anti-corruption, anti-bribery, anti-money laundering, and similar laws, and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.

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While we have policies and procedures to address compliance with such laws in the United States, we cannot assure you that all of our employees and agents will not take actions in violation of our policies and applicable law, for which we may be ultimately held responsible.

Detecting, investigating and resolving actual or alleged violations can require a significant diversion of time, resources and attention from senior management.

Detecting, investigating and resolving actual or alleged violations can be expensive and time-consuming, and could divert resources and management ’ s attention from our core business.

In addition, noncompliance with anti-corruption, anti-bribery or anti-money laundering laws could subject us to whistleblower complaints, investigations, sanctions, settlements, prosecution, other enforcement actions, disgorgement of profits, significant fines, damages, other civil and criminal penalties or injunctions, suspension and/or debarment from contracting with certain persons, the loss of export privileges, reputational harm, adverse media coverage and other collateral consequences.

If any subpoenas or investigations are launched, or governmental or other sanctions are imposed, or if we do not prevail in any possible civil or criminal litigation, our business, financial condition, results of operations and prospects could be materially harmed.

In addition, responding to any action will likely result in a materially significant diversion of management’s attention and resources and significant defense costs and other professional fees.

In addition, responding to any action will likely divert resources and management’s attention from our core business, as well as cause us to incur significant defense costs and other professional fees.

Enforcement actions and sanctions could further harm our business, reputation, financial condition, results of operations and prospects.

Risks Related to Our Dependence on Third Parties

We rely on third parties to produce clinical supplies of our product candidates.

There could be delays or supply shortages beyond our control limiting our access to clinical supplies.

We are currently conducting process development and manufacturing material for product candidates of three different therapeutic modalities:

mAbs, siRNAs and TCEs.

Except for limited early-clinical phase process, analytical and formulation development, cell line development, small-scale non-GMP manufacturing for preclinical studies, and quality control testing capabilities in certain of our facilities that is either established or is currently being built, we do not own or operate facilities for full process development or product manufacturing, storage and distribution, or testing.

We are dependent on third parties, including strategic collaborators and CDMOs, to develop the large-scale manufacturing process and manufacture the clinical supplies of our current and any future product candidates.

We have established relationships with multiple third parties that have developed the large-scale manufacturing processes and produced material to support our preclinical, Phase 1, 2, and 3 clinical studies.

We do not yet have sufficient information to reliably estimate the cost of the commercial manufacturing of our future product candidates.

Certain of our product candidates may have to compete with existing and future products that may have a lower price point.

The actual cost to manufacture our product candidates could materially and adversely affect the commercial viability of our product candidates.

The facilities used by our CDMOs to develop and manufacture our product candidates must be approved by the FDA or other regulatory authorities pursuant to inspections that will be conducted after we submit our NDA or BLA to the FDA or foreign marketing application to the appropriate regulatory authority.

We do not control the manufacturing process of, and are completely dependent on, our CDMOs for compliance with cGMP requirements.

If our CDMOs cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or other health authorities, we will not be able to secure and/or maintain regulatory approval for our product candidates.

In addition, we have no control over the ability of our CDMOs to maintain adequate quality control, quality assurance, qualified personnel or oversight of their subcontractors.

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.

Any significant delay in the supply of a product candidate, or the raw material components thereof, for an ongoing clinical trial due to the need to replace a CDMO could considerably delay completion of our clinical studies, product testing and potential regulatory approval of our product candidates.

We rely on third parties to produce clinical and future commercial supplies of our product candidates.

There could be delays or supply shortages beyond our control limiting our access to clinical and future commercial supplies.

We are currently conducting process development and manufacturing materials for product candidates of three different therapeutic modalities:

monoclonal antibodies, siRNAs and TCEs.

Except for process, analytical and formulation development, cell line development, non-cGMP manufacturing and quality control testing for preclinical studies, we do not own or operate facilities for large-scale process development or product manufacturing, storage and distribution, or testing.

We are dependent on multiple third parties, including strategic collaborators and CDMOs, to obtain product raw materials and components, develop large-scale manufacturing processes for and manufacture clinical and future commercial supplies of our product candidates.

The actual cost to manufacture our product candidates, including the requisite scale-up activities for commercial supplies, is difficult to estimate and could affect the commercial viability and competitive position of our product candidates.

Additionally, scaling up a biologic manufacturing process is a difficult and uncertain task and involves additional risks, including cost overruns, process reproducibility, stability issues, cGMP compliance, lot consistency and timely availability of sufficient quantity of raw materials.

The facilities used by our CDMOs to develop and manufacture our product candidates must be inspected and approved by the FDA or other regulatory authorities.

We do not control the day-to-day operations of, and are completely dependent on, our CDMOs for compliance with cGMP requirements.

If our CDMOs cannot successfully manufacture materials that conform to the requirements of the FDA or other health authorities, we will not be able to secure or maintain regulatory approval for our product candidates.

In addition, we have limited control over the oversight of personnel or subcontractors of our CDMOs.

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.

Any significant delay in the supply of a product candidate, or its raw material components, for an ongoing clinical trial could considerably delay completion of our clinical studies, product testing and potential regulatory approval.

We also intend to rely on CDMOs to supply us with sufficient quantities of our product candidates to be used, if approved, for commercialization.

There is, however, no assurance that our CDMOs will have sufficient manufacturing capacity to meet demand for our product candidates, meet our working assumptions of manufacturing titer and yield per batch of our product candidates or consistently manufacture product meeting our quality requirements.

Any shortfall in manufacturing capacity or reduction in anticipated manufacturing titer, yield per batch or batch success rates may adversely impact our ability to meet market demand for any approved product.

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.

Any shortfall in a CDMO ’ s manufacturing capacity or reduction in anticipated manufacturing titer, yield per batch or batch success rates may adversely impact our ability to meet market demand.

Furthermore, if we are not able to produce supply at low enough costs, it could negatively impact our ability to generate revenue, harm our reputation, and could have a material adverse effect on our business, financial condition, results of operations and prospects.

In addition, we currently rely on strategic collaborators and third-party suppliers and CDMOs that operate outside the United States and will likely continue to rely on these organizations in the future.

Such third-party suppliers and CDMOs may be subject to trade restrictions and other foreign regulatory requirements which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material or have an adverse effect on our ability to secure significant commitments from governments to purchase our potential therapies.

For example, the biopharmaceutical industry in China is strictly regulated by the Chinese government.

Changes to Chinese regulations or government policies affecting biopharmaceutical companies are unpredictable and may have a material adverse effect on our strategic collaborators, third-party suppliers and CDMOs operating in China which could have an adverse effect on our business, financial condition, results of operations and prospects.

Evolving changes in China’s public health, economic, political, and social conditions and the uncertainty around China’s relationship with other governments, such as the United States and the U.K., could also negatively impact our ability to manufacture or supply our product candidates for our planned clinical studies or have an adverse effect on our ability to secure government funding, which could adversely affect our financial condition and cause us to delay our clinical development programs.

Further, our reliance on third-party suppliers and CDMOs entails risks to which we would not be exposed or that may be reduced if we conducted process development or manufactured product candidates ourselves, including:

• delay or inability to procure or expand sufficient manufacturing capacity;

• delays in process development;

• issues related to scale-up of manufacturing;

• excess manufacturing capacity or excess raw materials due to insufficient market demand for our product candidates and responsibility for the associated costs;

Such third-party suppliers and CDMOs may be subject to trade restrictions and other foreign regulatory requirements which could increase the cost or reduce the supply of materials available to us, delay the procurement or supply of such materials or adversely affect our ability to secure significant commitments from governments to purchase our potential therapies.

Our reliance on third-party suppliers and CDMOs exposes us to other risks, including:

• the commitment of excess manufacturing capacity or excess raw materials due to insufficient market demand for our product candidates and responsibility for the associated costs;

• costs and validation of new equipment and facilities required for scale-up;

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

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

• inability to negotiate development and manufacturing agreements with third parties under commercially reasonable terms, if at all;

• greater costs and competition for access to an increasingly smaller pool of potential CDMOs as a result of consolidation in the contract manufacturing industry;

• greater costs and competition for access to an increasingly smaller pool of potential CDMO as a result of consolidation in the contract manufacturing industry;

• breach, termination or nonrenewal of development and manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;

• reliance on single sources for product raw materials or components;

• lack of qualified backup suppliers for those raw materials or components that are currently purchased from a sole or single-source supplier;

• lack of ownership to the intellectual property rights to any improvements made by our third parties in the manufacturing process for our product candidates;

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

• limited ownership to the intellectual property rights to any improvements made by our third parties in the manufacturing process for our product candidates;

• price increases or decreased availability of product raw materials or components;

• disruptions to operations of our third-party suppliers and CDMO by conditions unrelated to our business or operations, including supply chain issues, capacity constraints, transportation and labor disruptions, global competition for resources, the bankruptcy of the supplier or CDMO and/or general economic conditions interest rate and currency rate fluctuations, and economic slowdown or recession;

• disruptions caused by geopolitical events, including civil or political unrest, terrorism, insurrection or war (such as the ongoing conflicts in the Middle East and Eastern Europe), as well as man-made or natural disasters, or public health pandemics or epidemics;

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

We may be unable to obtain product raw materials or components for an indeterminate period of time if any of our third-party suppliers and CDMOs were to cease or interrupt production or otherwise fail to supply these materials or components to us for any reason, including due to regulatory requirements or actions (including recalls), adverse financial developments at or affecting the supplier or CDMO, failure by the supplier or CDMO to comply with cGMP, facility outages (including due to contamination), business interruptions, or labor shortages or disputes.

• disruptions to operations of our third-party suppliers and CDMO by conditions unrelated to our business or operations, including supply chain issues, capacity constraints, facility outages (including due to contamination), transportation and labor disruptions, global competition for resources, regulatory requirements or actions (including recalls or failure by the supplier or CDMO to comply with cGMP), adverse financial developments or the bankruptcy of the supplier or CDMO, or general economic conditions;

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

Suppliers and CDMOs may extend lead times, limit supplies, change manufacturing schedules, increase prices, or require significant upfront fees due to capacity and material supply constraints or other factors beyond our control.

For example, recent increased demand for GLP-1 therapeutics could result in increased competition for our CDMOs’ services and limited capacity, which could limit our access to, and increase our costs for, manufacturing production and potentially harm our business and results of operations.

We cannot be sure that single source suppliers for our product raw materials or components will remain in business or that they will not be purchased by one of our competitors or another company that is not interested in continuing to produce our product raw materials or components for our intended purpose.

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.

The time and effort to technology transfer to a new CDMO or qualify a new supplier or CDMO could result in manufacturing delays, additional costs, diversion of resources or reduced manufacturing capacity or yields, any of which would negatively impact our operating results.

Due to limited knowledge of the manufacturing process during development stages, potential product loss and contaminations could lead to batch failures.

Furthermore, we currently rely on a limited number of third-party suppliers and CDMOs that are able to meet our supply requirements for synthetic siRNAs.

There are risks inherent in pharmaceutical manufacturing that could affect the ability of our CDMOs to meet our delivery time requirements or provide adequate amounts of synthetic siRNAs to meet our needs.

Included in these risks are potential extended lead times, delays or shortages of raw materials and components, synthesis and purification failures and/or contamination during the manufacturing process, as well as other issues with the CDMO’s facility and ability to comply with the applicable manufacturing requirements, including cGMP requirements, which could result in unusable product.

This would cause delays in our manufacturing timelines and ultimately delay our clinical studies and potentially put at risk commercial supply, as well as result in additional expense to us.

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.

Our CDMOs could face risks in meeting our delivery time requirements or provide adequate amounts of synthetic siRNAs to meet our needs, which may include extended lead times, delays or shortages of raw materials and components, synthesis and purification failures and/or contamination during the manufacturing process, or difficulty complying with the applicable manufacturing requirements.

To fulfill our siRNA supply requirements, we may need to secure alternative suppliers of synthetic siRNAs or key raw materials and components, and such alternative third-party suppliers are limited and may not be readily available, or we may be unable to enter into agreements with them on reasonable terms and in a timely manner.

Further, alternative suppliers would require filing and regulatory approvals.

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and international trade policies.

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.

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.

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.

If any new tariffs, export controls, legislation and/or regulations are implemented, or if existing trade agreements are renegotiated or if the U.S.

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Failure to comply with these environmental, health and safety laws and regulations may result in substantial fines, penalties or other sanctions.

We do not currently carry hazardous waste insurance coverage.

We do not currently carry hazardous waste insurance coverage, and our financial condition could be negatively impacted should such risks come to fruition.

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.

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While we expect to control only certain aspects of our CROs’ activities, we will nevertheless be responsible for ensuring that each of our preclinical and clinical studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on the CROs does not relieve us of our regulatory responsibilities.

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.

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.

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.

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.

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.

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.

Accordingly, if our CROs fail to comply with these regulations or fail to recruit a sufficient number of subjects, we may be required to repeat clinical studies, which would delay the regulatory approval process.

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Obtaining and maintaining our patent rights depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.

Patent and Trademark Office (USPTO) and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.

In addition, periodic maintenance fees, renewal fees, annuity fees and various other government fees on patents and/or patent applications will have to be paid to the USPTO and various government patent agencies outside of the United States over the lifetime of our owned and licensed patents and/or applications and any patent rights we may own or license in the future.

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In addition, if we are responsible for patent prosecution and maintenance of patent rights in-licensed to us or out-licensed by us, any of the foregoing could expose us to liability to the applicable patent owner or licensee, respectively.

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.

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.

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We may also have to redesign our products, which may not be commercially or technically feasible or require substantial time and expense.

In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent or other intellectual property right.

We may be required to indemnify collaborators or contractors against such claims.

Even if we are successful in defending against such claims, litigation can be expensive and time-consuming and would divert management’s attention from our core business.

In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent or other intellectual property right, and we may also be required to indemnify collaborators or contractors against such claims.

Even if we are successful in defending against such claims, litigation can be expensive and time-consuming and could divert resources and management’s attention from our core business.

Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

There could also be public announcements of the results of hearings, motions or other interim proceedings or developments.

If securities analysts or investors perceive these results to be negative, it could have an adverse effect on the price of our common stock.

Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business, financial condition, results of operations and prospects.

There could also be public announcements of the results of hearings, motions or other interim proceedings or developments, and if research analysts or investors perceive these results to be negative, it could have an adverse effect on the price of our common stock.

Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar material adverse effect on our business, financial condition, results of operations and prospects.

We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.

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If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.

Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.

Even if we are successful in defending against such claims, litigation can be expensive and time-consuming and could divert resources and management ’ s attention from our core business.

In addition, we may in the future be subject to claims by our former employees or consultants asserting an ownership right in our patents or patent applications because of the work they performed on our behalf.

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The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection to the same degree as in the United States, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our intellectual property and proprietary rights generally.

Proceedings to enforce our intellectual property and proprietary rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, could put our patent applications at risk of not issuing, and could provoke third parties to assert claims against us.

Proceedings to enforce our intellectual property and proprietary rights in foreign jurisdictions can be expensive and time-consuming and could divert resources and management ’ s attention from our core business, could put our patents at risk of being invalidated or interpreted narrowly, could put our patent applications at risk of not issuing, and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate outside the United States, and the damages or other remedies awarded, if any, may not be commercially meaningful.

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In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent.

If we or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely affected.

If we or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired and have a material adverse effect on our business, financial condition, results of operations and prospects.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

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We rely and expect to continue to rely on trademarks as one means to distinguish any of our products and product candidates that are approved for marketing from the products of our competitors.

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.

Once we select trademarks and apply to register them, our trademark applications may not be approved.

Third parties may oppose our trademark applications in certain jurisdictions, as in a currently pending opposition filed against the Portuguese registration of our VIR Pharmaceuticals house mark and logo by Industria Quimica y Farmaceutica Vir.

Third parties may oppose our trademark applications in certain jurisdictions, as in currently pending oppositions filed against the Portuguese applications for our Vir Biotechnology house mark and logo by Industria Quimica y Farmaceutica Vir.

S.A., a Spanish company which claims exclusive rights in the term VIR in Spain and Portugal.

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The potential exercise by the Gates Foundation of its licenses to certain of our intellectual property and its development and commercialization of products that we are also developing and commercializing could have an adverse impact on our market position.

We entered into the Gates Agreement in January 2022, which amends and restates the original letter agreement with the Gates Foundation that we entered into in December 2016.

In connection with the original letter agreement, the Gates Foundation purchased $20.0 million of shares of our convertible preferred stock which converted to shares of our common stock after our initial public offering and purchased $40.0 million of shares of our common stock.

In January 2022, we entered into the Gates Agreement, which amended and restated the original letter agreement with the Gates Foundation that we entered into in December 2016.

In connection with the Gates Agreement, the Gates Foundation purchased an aggregate of $20.0 million of shares of our convertible preferred stock (which later converted to shares of our common stock after our initial public offering) and purchased $40.0 million of shares of our common stock in January 2022.

We are obligated to use the proceeds of the Gates Foundation’s investment in furtherance of its charitable purposes to perform certain activities set forth in the Gates Agreement.

For additional information regarding our obligations under the Gates Agreement, see the section titled “Our Collaboration, License and Grant Agreements—Amended and Restated Letter Agreement with the Gates Foundation” in “Part I, Item 1.

Business” in this Annual Report on Form 10-K.

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.

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.

For additional information regarding our obligations under the Gates Agreement, see the section titled “ Part I, Item 1.

Business—Our Collaboration, License and Grant Agreements—Amended and Restated Letter Agreement with the Gates Foundation ” in our Annual Report on Form 10-K.

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.

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.

The exercise by the Gates Foundation of any of its non-exclusive licenses to certain of our intellectual property (or its right to obtain such licenses), and its development and commercialization of product candidates and products that we are also developing and commercializing, could have an adverse impact on our market position.

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The loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives.

We have in the past undergone leadership changes, and such management transitions may create uncertainty and divert resources and management ’ s attention from our core business, be disruptive to our daily operations or impact public or market perception, any of which could negatively impact our ability to operate effectively or execute our strategies.

Additionally, we do not currently maintain “key person” life insurance on the lives of our executives or any of our employees.

We have recently announced several leadership changes, including a new Chief Medical Officer and Chief Financial Officer in 2024.

Management transitions may create uncertainty and involve a diversion of resources and management attention, be disruptive to our daily operations or impact public or market perception, any of which could negatively impact our ability to operate effectively or execute our strategies.

Recruiting, integrating and retaining other senior executives, qualified scientific and clinical personnel and, if we progress the development of any of our product candidates, commercialization, manufacturing and sales and marketing personnel, will be critical to our success.

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.

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.

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.

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.

We have in the past and may in the future seek to acquire or invest in additional businesses and/or technologies that we believe complement or expand our product candidates, enhance our technical capabilities or otherwise offer growth opportunities in the United States and internationally.

The pursuit of potential acquisitions and investments may divert the attention of management and cause us to incur various expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they are consummated.

In addition, we are exposed to market risks related to our investments, including changes in fair value of equity securities we hold, which is discussed in greater detail in “Part I, Item 3.

The pursuit of potential acquisitions and investments could divert management ’ s attention from our core business and cause us to incur various expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they are consummated.

In addition, we are exposed to market risks related to our investments, including changes in fair value of equity securities we hold, which is discussed in greater detail in “ Part II, Item 7A.

Quantitative and Qualitative Disclosures About Market Risk ” in this Annual Report on Form 10-K.

For example, we acquired numerous biotechnology companies between 2016 and 2018.

Realizing the benefits of these acquisitions will depend upon the successful integration of the acquired technology into our existing and future product candidates.

We also may not realize the anticipated benefits from any acquired business.

We may not successfully integrate and realize the anticipated benefits from any acquired business.

We face many risks in connection with acquisitions and investments, whether or not consummated.

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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.

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.

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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.

The expansion of our operations may lead to significant costs and could divert business development resources and management ’ s attention.

We may not be able to effectively manage any further expansion of our operations, recruit and train additional qualified personnel, or succeed at effectively integrating employees into our operations.

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Our operations, and those of our CDMOs, clinical trial sites, CROs and other contractors and consultants, could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, public health pandemics or epidemics, geopolitical events, including civil or political unrest in any of our business locations, terrorism, insurrection or war (such as the ongoing conflicts in the Middle East and Eastern Europe), as well as other business interruptions, for which we are predominantly self-insured.

The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses.

Our existing business continuity preparations may not sufficiently mitigate the occurrence of any of these business disruptions, which could seriously harm our operations and financial condition and increase our costs and expenses.

Our ability to develop our product candidates could be disrupted if our operations or those of our suppliers are affected by such geopolitical events, disasters or other business interruptions.

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and other adverse effects on our business, financial condition, results of operations and prospects.

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.

We may also experience server malfunction, software or hardware failures, supply-chain cyber-attacks, loss of data or other computer assets and other similar issues.

We have experienced minor or inconsequential security breaches of our information technology systems, such as through attempted business email compromises.

Our computer and information technology systems, cloud-based computing services and those of our current and any future collaborators, service providers and other parties upon whom we rely can be vulnerable to malware, computer viruses, denial-of-service attacks, ransomware attacks, user error or malfeasance, data corruption, cyber-based attacks, natural disasters, public health pandemics or epidemics, geopolitical events, including civil or political unrest, terrorism, war and telecommunication and electrical failures that can result in damage to or the interruption or impairment of key business processes, or the loss or corruption of our information, including intellectual property, proprietary business information and personal information.

We have in the past and may in the future experience server malfunction, software or hardware failures, supply-chain cyber-attacks, loss of data or other computer assets and other similar issues.

In addition, we have in the past and may in the future experience security events affecting our information technology systems, such as through business email compromises or other network intrusions, including threats to exfiltrate and disclose proprietary information;

however, none of these attacks to date, either individually or in the aggregate, have had a material adverse effect on our business, financial condition, results of operations or prospects.

The techniques used to sabotage or to obtain unauthorized access to information systems, and networks in which cyber threat actors store data or through which they transmit data change frequently and we may be unable to implement adequate preventative measures.

For example, attackers have used AI to launch more automated, targeted and coordinated attacks against targets.

Any significant system failure, accident or security breach could have a material adverse effect on our business, financial condition and operations.

For example, attackers have used AI to launch more automated, targeted and coordinated attacks against various targets.

Any significant system failure, accident or security breach could have a material adverse effect on our business, financial condition, results of operations and prospects.

We may be required to expend significant resources, fundamentally change our business activities and practices, or modify our operations, including our clinical trial activities, or information technology in an effort to protect against security breaches and to detect, investigate (including performing required forensics), mitigate and remediate actual and potential vulnerabilities.

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Although we maintain cybersecurity insurance coverage, such insurance may not be adequate to cover all liabilities that we may incur.

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.

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.

Securities and Exchange Commission adopted rules in 2023 requiring us to publicly disclose certain cybersecurity incidents.

Such notices may be costly and could harm our reputation and our ability to compete, and our ultimate disclosure or failure to comply with such requirements could lead to a material adverse effect on our reputation, business or financial condition.

Additionally, federal, state and foreign laws and regulations can expose us to enforcement actions and investigations by regulatory authorities, and potentially result in regulatory penalties and significant legal liability, if our information technology security efforts fail.

We and the third parties with whom we work are subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, contractual obligations and failure by us or the third parties with whom we work to comply with such requirements could subject us to significant fines and penalties, investigations and/or reputational harm, which may have a material adverse effect on our business, financial condition or results of operations.

Such requirements include rules adopted by the SEC in 2023, pursuant to which we must publicly disclose certain cybersecurity incidents.

These notices may be costly and could harm our reputation and our ability to compete, and our ultimate disclosure or failure to comply with such requirements could lead to a material adverse effect on our reputation, business, or financial condition.

Moreover, federal, state and foreign laws and regulations can expose us to enforcement actions and investigations by regulatory authorities, and potentially result in regulatory penalties and significant legal liability, if our information technology security efforts fail.

We and the third parties with whom we work are subject to stringent and evolving laws, regulations, policies and contractual obligations related to data privacy and security, and failure by us or the third parties with whom we work to comply with such requirements could subject us to significant fines, penalties, investigations and/or reputational harm.

We and the third parties with whom we work are subject to local, state, federal and international data privacy and protection laws and regulations that apply to the collection, transmission, storage and use of personally identifying information, which among other things, impose certain requirements relating to the privacy, security and transmission of personal information, including comprehensive regulatory systems in the United States, EU and the U.K.

The legislative and regulatory landscape for privacy and data protection continues to evolve in jurisdictions worldwide, and there has been an increasing focus on privacy and data protection issues with the potential to affect our business.

Additionally, our use of AI and machine learning may be subject to laws and evolving regulations regarding the use of AI, controlling for data bias, and anti-discrimination.

Implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact future laws, regulations, standards, or perception of their requirements may have on our business.

Failure by us or any of the third parties with whom we work to comply with any of these laws and regulations could result in investigations or enforcement action against us, including fines, claims for damages by affected individuals, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations or prospects.

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 fail to comply with applicable privacy laws, we could face civil and criminal penalties, and claims that we failed to comply with privacy laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time consuming to defend, result in adverse publicity and have a material adverse effect on our business, financial condition and results of operations.

Numerous states in the U.S., including California, Colorado, Oregon, Texas, Utah and Virginia, among others, have passed comprehensive privacy laws and other states are considering passing such laws.

The legislative and regulatory landscape for privacy and data protection continues to evolve in jurisdictions worldwide, and our use of AI and machine learning may subject us to additional laws and evolving regulations.

Numerous U.S.

states, including California where our headquarters is located, have passed comprehensive privacy laws, and other states are considering passing similar laws.

These laws create obligations related to the processing of personal information, as well as special obligations for the processing of “sensitive” data (which includes health data in some cases).

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

Congress has also considered passing a federal privacy law.

These laws may impact our business activities, including our identification of research subjects, relationships with business partners and ultimately the marketing and distribution of our products.

Similar to the laws in the United States, there are significant privacy and data security laws that apply in Europe and other countries.

The collection, use, disclosure, transfer or other processing of personal data, including personal health data, regarding individuals who are located in the EEA and the processing of personal data that takes place in the EEA, is regulated by the GDPR, which imposes obligations on companies that operate in our industry with respect to the processing of personal data and the cross-border transfer of such data.

These laws may impact our business activities, including our identification of clinical research subjects, relationships with business partners and ultimately the marketing and distribution of our products.

The collection, use, disclosure, transfer or other processing of personal data, including personal health data, regarding individuals who are located in the EEA, and the processing of personal data that takes place in the EEA, is regulated by the GDPR.

The GDPR imposes onerous accountability obligations requiring data controllers and processors to maintain a record of their data processing and policies.

If our or our collaboration partners’ or service providers’ privacy or data security measures fail to comply with the GDPR requirements, we may be subject to litigation, regulatory investigations, enforcement notices requiring us to change the way we use personal data and/or fines of up to €20 million or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, as well as compensation claims by affected individuals, negative publicity, reputational harm and a potential loss of business and goodwill.

and Switzerland, as well as other countries outside of Europe, have adopted privacy and data security laws that are comparable to the GDPR.

In addition, we may be unable to transfer personal data from EEA countries and other jurisdictions to the United States or other countries due to data localization requirements or limitations on cross-border data flows.

Although there are various mechanisms that may be used in some cases to lawfully transfer personal data to the United States or other countries, these mechanisms are subject to legal challenges and may not be available to us.

An inability or material limitation on our ability to transfer personal data to the United States or other countries could materially impact our business operations.

While we continue to address the implications of the recent changes to data privacy regulations, data privacy remains an evolving landscape at both the domestic and international level, with new regulations coming into effect and continued legal challenges, and our efforts to comply with the evolving data protection rules may be unsuccessful.

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.

We must devote significant resources to understanding and complying with this changing landscape.

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.

Similarly, such failures could result in government-imposed orders requiring that we change our practices, private lawsuits asserting claims for damages or other liabilities, and potentially significant costs for remediation, any of which could adversely affect our business.

Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our business, financial condition, results of operations or prospects.

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.

Claims that we failed to comply with privacy laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend, result in adverse publicity and have a material adverse effect on our business, financial condition, results of operations or prospects.

Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, insider trading laws, or contractual obligations.

We are exposed to the risk of fraud or other misconduct by our employees, principal investigators, consultants and commercial partners.

Misconduct by these parties could include intentional failures, reckless and/or negligent conduct or unauthorized activities that violates (i) the laws and regulations of FDA and other regulatory authorities, including those laws requiring the reporting of true, complete and accurate information to such authorities, (ii) manufacturing standards, (iii) federal and state data privacy, security, fraud and abuse and other healthcare laws and regulations in the United States and abroad, (iv) laws that require the true, complete and accurate reporting of financial information or data, (v) insider trading laws that restrict the buying and selling of shares of securities while in possession of material non-public information, (vi) federal and state data privacy laws and regulations and (vii) contractual obligations of VirBio or such parties.

In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices.

Such misconduct also could involve the improper use of individually identifiable information, including, without limitation, information obtained in the course of clinical studies, creating fraudulent data in our preclinical lor clinical studies or illegal misappropriation of drug product, which could result in regulatory sanctions and cause serious harm to our reputation.

Such misconduct also could involve the improper use of individually identifiable information, including, without limitation, information obtained in the course of clinical studies, creating fraudulent data in our preclinical or clinical studies or illegal misappropriation of drug product, which could result in regulatory sanctions and cause serious harm to our reputation.

It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from government investigations or other actions or lawsuits stemming from a failure to comply with these contractual provisions, laws or regulations.

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Our ability to use our net operating losses, or NOLs, to offset future taxable income may be subject to certain limitations.

As of December 31, 2024, we had net operating loss carryforwards of $645.3 millio n for federal tax purposes $450.2 million for state tax purposes.

As of December 31, 2025, we had net operating loss carryforwards of $1.2 billion for federal tax purposes and $446.4 million for state tax purposes.

If not utilized, federal carryforwards will begin expiring in 2036 and state carryforwards will begin expiring in 2037.

Our ability to use our federal and state NOLs to offset potential future taxable income is dependent upon our generation of future taxable income before any expiration dates of the NOLs, and we cannot predict with certainty when, or whether, we will generate sufficient taxable income to use all of our NOLs.

Beginning in 2022, the Tax Cuts and Jobs Act of 2017 eliminated the option to deduct research and development expenditures currently and requires taxpayers to capitalize and amortize them over five or fifteen years pursuant to Section 174 of the Internal Revenue Code of 1986, as amended, or the Code.

Although Congress is considering legislation that could repeal such requirement or defer the amortization requirement to later years, it is not certain that the provision will be repealed or otherwise modified.

If the requirement is not modified, it will continue to reduce our anticipated net operating losses over the next several years.

Beginning in 2022, the Tax Cuts and Jobs Act of 2017 eliminated the option to deduct research and development expenditures and required taxpayers to capitalize and amortize them over five or fifteen years pursuant to Section 174 of the Internal Revenue Code of 1986, as amended (the Code), which reduced our net operating losses.

The OBBBA suspends the requirement to capitalize and amortize domestic “research or experimental expenditures” (as defined in the OBBBA) over five years and instead allows taxpayers to immediately deduct such expenses for tax years beginning after December 31, 2024.

In addition, with respect to domestic research or experimental expenditures incurred in a taxable year beginning after December 31, 2021 and before January 1, 2025, taxpayers may elect to accelerate the remaining unamortized amounts of such expenses over a one- or two-year period.

Both aforementioned changes under the OBBBA to the treatment and deductibility of such expenses could potentially increase our anticipated net operating losses.

The treatment of foreign research and development expenses remains unchanged, requiring amortization over 15 years.

We are continuing to evaluate the future impacts of the OBBBA as additional information is provided.

Risks Related to Ownership of Our Common Stock

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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.

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.

As a result, currency fluctuations among our reporting currency, the U.S.

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The stock market in general and the market for biopharmaceutical and pharmaceutical companies in particular, has experienced extreme volatility that has often been unrelated to the operating performance of particular companies.

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.

As a result of this volatility, you may not be able to sell your common stock at or above the price you paid for your shares.

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Any such negative outcome could result in payments of substantial damages or fines, damage to our reputation or adverse changes to our business practices.

Defending against litigation is costly and time-consuming and could divert our management’s attention and our resources.

Defending against litigation can be expensive and time-consuming and could divert resources and management’s attention from our core business.

Furthermore, during the course of litigation, there could be negative public announcements of the results of hearings, motions or other interim proceedings or developments, which could have a negative effect on the market price of our common stock.

Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.

Our executive officers, directors and stockholders who own more than 5% of our outstanding common stock beneficially own a significant percentage of our outstanding common stock.

If these persons acted together, they may be able to significantly influence all matters requiring stockholder approval, including the election and removal of directors and approval of any merger, consolidation or sale of all or substantially all of our assets.

The concentration of voting power and transfer restrictions could delay or prevent an acquisition of our company on terms that other stockholders may desire or result in the management of our company in ways with which other stockholders disagree.

If research analysts publish unfavorable research or reports about us, our business or our market, our stock price and trading volume could decline.

The trading market for our common stock may be influenced by research and reports that industry or financial analysts publish about us, our business or the potential markets for our products or product candidates.

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.

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.

Similarly, if analysts publish favorable reports about our competitors or unfavorable comparisons of our products or product candidates relative to competing products, our stock price could also 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.

Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.

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We have incurred and we will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.

As a public company, we are subject to the reporting requirements of the Exchange Act, the listing standards of Nasdaq, the Sarbanes-Oxley Act and other applicable securities rules and regulations.

As a public company, we are subject to the reporting requirements of the Exchange Act, the listing standards of Nasdaq, the Sarbanes-Oxley Act and other applicable securities rules and regulations, which are subject to change and new rulemaking.

Stockholder activism and litigation can also increase the costs of being a public company, such as by making it more difficult and expensive to obtain director and officer liability insurance.

We have incurred and will continue to incur significant legal, accounting, investor relations and other expenses to comply with these rules and regulations.

Stockholder activism, the current political environment and the current high level of U.S.

government intervention and regulatory reform may also lead to substantial new regulations and disclosure obligations, which may in turn lead to additional compliance costs and impact the manner in which we operate our business in ways we do not currently anticipate.

Our management and other personnel will need to devote a substantial amount of time to comply with these requirements.

Moreover, these requirements will increase our legal and financial compliance costs and will make some activities more time-consuming and costly.

For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance.

We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements.

If we fail to develop or maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in us and the trading price of our common stock may decline.

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Deficiencies in the preparation of financial statements, could lead to litigation claims against us.

The defense of any such claims may cause the diversion of management’s attention and resources, and we may be required to pay damages if any such claims or proceedings are not resolved in our favor.

Any litigation, even if resolved in our favor, could cause us to incur significant legal and other expenses.

Even if resolved in our favor, the defense of any such claims can be expensive and time-consuming and could divert resources and management’s attention from our core business, and we may further be required to pay damages if any such claims or proceedings are not resolved in our favor.

Such events could also affect our ability to raise capital to fund future business initiatives.

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Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.

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.

These provisions also could limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock.

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What changed 10-K

Item 1A. Risk Factors