What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2026-08-05 compared with 2026-05-07 · 47 added, 50 removed, 755 unchanged (11% of the section changed)

1 unchanged sentence

An investment in shares of our common stock involves a high degree of risk.

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

The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations 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.

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

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

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

15 unchanged sentences

• Interim, “top line” and preliminary data from our clinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

• Although the combination of tobevibart and elebsiran has received Fast Track and Breakthrough Therapy designation from the U.S.

• Although the combination of elebsiran and tobevibart has received Fast Track and Breakthrough Therapy designation from the U.S.

Food and Drug Administration (FDA), as well as PRIME designation from the EMA and European orphan drug designation, in each case for the treatment of CHD, there can be no assurance that any of our product candidates that receive such designations in the United States or similar designations in any other regulatory jurisdictions will maintain such designations or receive regulatory approval any sooner than other product candidates that do not have such designations, or at all.

3 unchanged sentences

• Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval.

• We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments upon achievement of milestone events and, in certain cases, have relinquished important rights over the development and commercialization of certain current and future product candidates.

• We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments to fund our share of development activities, upon achievement of milestone events and, in certain cases, have relinquished important rights over the development and commercialization of certain current and future product candidates.

We may explore additional strategic collaborations, which may never materialize or may require that we spend significant additional capital or that we relinquish rights to and control over the development and commercialization of our product candidates.

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

• The deployment of AI in our or our collaborators’ efforts to discover, develop and engineer next-generation antibodies or other investigational products or components, could have a material adverse effect on our business 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.

10 unchanged sentences

We have incurred net losses and anticipate that we will continue to incur net losses in the foreseeable future.

Although we recorded net income for the years ended December 31, 2022, and 2021, we have otherwise incurred net losses since inception in April 2016.

We had net loss of $125.7 million and $121.0 million for the three months ended March 31, 2026 and 2025 , respectively.

As of March 31, 2026, we had an accumulated deficit of $1.3 billion.

Although we recorded net income for the years ended December 31, 2022 and 2021 and for the three months ended June 30, 2026, we have otherwise incurred net losses since inception in April 2016.

We had net loss of $45.6 million and $231.9 million for the six months ended June 30, 2026 and 2025 , respectively.

As of June 30, 2026, 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.

There is substantial uncertainty around the future development and commercialization of our product candidates, and we may not ultimately commercialize any of our product candidates on the timelines we expect, or at all.

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

12 unchanged sentences

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 March 31, 2026, we had cash, cash equivalents and investments of $809.3 million.

As of June 30, 2026, we had cash, cash equivalents and investments of approximately $1.01 billion.

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

14 unchanged sentences

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

For example, on February 19, 2026, we and Astellas entered into a Collaboration and License Agreement (the Astellas Agreement).

On April 15, 2026, this global strategic collaboration to co-develop and co-commercialize VIR-5500 for the treatment of prostate cancer became effective, and we will receive a $240 million upfront cash payment pursuant to the Astellas Agreement.

On the same date, we sold 7,239,382 shares of our common stock to Astellas for an aggregate purchase price of approximately $75 million pursuant to a separate Stock Purchase Agreement related to the Astellas Agreement.

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.

40 unchanged sentences

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 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.

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

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

In our early-stage oncology programs, we are evaluating each of VIR-5818 and VIR-5525 in combination with pembrolizumab in Phase 1 basket studies across multiple tumor types, including metastatic breast cancer and metastatic colorectal cancer (CRC) for VIR-5818 and non-small cell lung cancer (NSCLC), CRC, head and neck squamous cell carcinoma (HNSCC) and cutaneous squamous cell carcinoma (cSCC) for VIR-5525.

We are also evaluating VIR-5500 in combination with enzalutamide in mCRPC and with darolutamide in mHSPC in a Phase 1 study with plans to initiate the combination dose-expansion cohorts in both early-line mCRPC and mHSPC in the coming months.

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.

In our early-stage oncology programs, we are evaluating each of VIR-5500, VIR-5818 and VIR-5525 in combination with existing cancer therapies.

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

Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or comparable foreign regulatory authorities could revoke approval of the therapy used in combination with our product candidate.

13 unchanged sentences

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.

From time to time, we may publish interim, “top-line” or preliminary data from our clinical studies.

From time to time, we have published, and may in the future publish, interim, “top-line” or preliminary data from our clinical studies.

Interim data from clinical studies that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.

1 unchanged sentence

As a result, interim and preliminary data should be viewed with caution until the final data is available.

Differences between preliminary or interim data and final data could significantly harm our business prospects and may cause the 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 .

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

Although the combination of elebsiran and tobevibart 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 elebsiran and tobevibart for the treatment of CHD .

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

We can provide no assurances that the combination of 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.

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

The FDA, EMA or other foreign regulatory authorities may also withdraw or revoke any such designation or elect to treat designated candidates in a manner different from what was originally indicated, if determined that any such product candidates that receive such designations no longer meet the relevant criteria.

22 unchanged sentences

• be subject to lawsuits, investigations or other legal or regulatory proceedings;

• experience damage to our reputation.

• experience reputational harm.

Furthermore, our product candidates are based on certain innovative technology platforms, which makes it even more difficult to predict the time and cost of product candidate development and regulatory approval.

16 unchanged sentences

If additional clinical experience indicates that any of our product candidates have side effects or cause serious or life-threatening side effects, the development of the product candidate may fail or be delayed, or, if the product candidate has received regulatory approval, such approval may be revoked, which would harm our business, financial condition, results of operations and prospects.

We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments upon achievement of milestone events and, in certain cases, have relinquished important rights over the development and commercialization of certain current and future product candidates.

We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments to fund our share of development activities, upon achievement of milestone events and, in certain cases, have relinquished important rights over the development and commercialization of certain current and future product candidates.

We 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.

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

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.

3 unchanged sentences

We have in the past and may in the future need to renegotiate such arrangements from time to time, and we may not be able to negotiate these arrangements on acceptable terms, or at all.

If we are unable to enter into new strategic collaborations or licenses related to our current or potential product candidates in certain geographies for certain indications, or if we are unable to maintain our current strategic collaborations or license on acceptable terms, we may not be able to develop and commercialize certain of our product candidates, which would harm our business prospects, financial condition and results of operations.

If we are unable to enter into new strategic collaborations or licenses related to our current or potential product candidates in certain geographies for certain indications, or if we are unable to maintain our current strategic collaborations or license on acceptable terms or remain aligned with our collaborators on particular development or commercialization strategies, we may not be able to realize the full value of certain of our product candidates or successfully develop and commercialize them at all, which would harm our business prospects, financial condition and results of operations.

Our current and future strategic collaborations and licenses could subject us to a number of risks, including the following:

2 unchanged sentences

• 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;

• certain strategic collaborations may require us to fund a portion of future development or commercialization costs to maintain our participation in any profit-sharing or other economic arrangements for a product candidate, and if we are unable to satisfy those funding obligations, or determine that doing so no longer aligns with our business strategy, we may exercise opt-out rights or otherwise forego our participation in such profit-sharing or other arrangements, which could reduce our ultimate participation in the future value of that product candidate;

• strategic collaborators may select dosages or indications, or design clinical studies, in a way that may be less successful than if we were doing so or in a way that may differ from our strategy, which could negatively impact our development, manufacturing and commercialization of the same or a similar product candidate;

6 unchanged sentences

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 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.

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

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

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

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

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

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

8 unchanged sentences

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.

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

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

10 unchanged sentences

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 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.

For example, in May 2026, the FDA approved a therapy for the treatment of CHD in adults, the first such approved therapy in the United States.

We are pursuing development of the combination of elebsiran and tobevibart as a treatment for CHD in registrational trials, and the availability of an approved therapy for CHD in the United States could affect the standard of care, physician adoption, patient expectations, the market size and the competitive landscape for our CHD program.

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

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

70 unchanged sentences

• the inability to commercialize any product candidate that we may develop;

• injury to our reputation and significant negative media attention.

• reputational harm and/or significant negative media attention.

Any such outcomes could negatively impact our business, financial condition, results of operations and prospects.

29 unchanged sentences

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.

45 unchanged sentences

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.

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.

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.

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, reputation, financial condition, results of operations and prospects could be materially harmed.

Risks Related to Our Dependence on Third Parties

6 unchanged sentences

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.

6 unchanged sentences

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.

Furthermore, if we are not able to produce supply at low enough costs, it could negatively impact our ability to generate revenue and/or lead to reputational harm, 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.

7 unchanged sentences

• 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 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;

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

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

16 unchanged sentences

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.

Any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, may affect the demand for our product candidates, the competitive position of our product candidates, and import or export of raw materials and product used in our drug development, clinical manufacturing and future commercial activities.

While the tariffs imposed under the International Emergency Economic Powers Act were overturned by the U.S.

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

government takes retaliatory trade actions due to the ongoing trade tensions, such changes could have an adverse effect on our business, financial condition and results of operations.

Supreme Court, the Trump Administration has used other statutory authorities to implement temporary import surcharges and has proposed additional tariffs on multiple trading partners, and related court challenges remain pending, contributing to ongoing uncertainty around the scope and duration of U.S.

tariff measures.

Our business involves the use of hazardous materials, and we and our third-party suppliers and CDMOs must comply with environmental, health and safety laws and regulations, which can be expensive and restrict how we do, or interrupt our, business.

102 unchanged sentences

and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing our product candidates.

We may in the future become party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to our current and any future product candidates and technology, including interference proceedings, derivation proceedings, post grant review, inter partes review before the USPTO, or as counterclaims in litigation initiated by us.

We have in the past and may in the future become party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to our current and any future product candidates and technology, including interference proceedings, derivation proceedings, post grant review, inter partes review before the USPTO, or as counterclaims in litigation initiated by us.

If we are found to infringe a third party’s valid and enforceable intellectual property rights, we could be required to obtain a license from such third party to continue developing, manufacturing and marketing our product candidate(s) and technology.

8 unchanged sentences

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

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

87 unchanged sentences

Our success depends on our ability to manage our growth.

We have in the past experienced, and expect to continue to experience, growth in the scope of our operations, particularly in the areas of research, development and regulatory affairs.

We have in the past experienced, and expect to continue to experience, growth in the scope of our operations, particularly in the areas of research, clinical development and regulatory affairs as we continue to advance the clinical programs for our product candidates.

In addition, if any of our product candidates receives marketing approval, we will need to build out our sales and marketing capabilities, either on our own or with others.

3 unchanged sentences

Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

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

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

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

Our existing business continuity preparations may not sufficiently mitigate the occurrence of any of these business disruptions, which could 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 have a material adverse impact on 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.

16 unchanged sentences

In addition, such a breach or cybersecurity incident may require public disclosure or notification to governmental agencies, supervisory bodies, credit reporting agencies, the media, individuals, collaborators or others pursuant to various federal, state and foreign data protection, privacy and security laws, regulations and guidelines, industry standards, our policies and our contracts, if applicable.

These notices may be costly and could 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.

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

24 unchanged sentences

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

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

10 unchanged sentences

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

22 unchanged sentences

We also may decide to settle lawsuits on unfavorable terms.

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

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

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

55 unchanged sentences

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

What changed 10-Q

Item 1A. Risk Factors