−Removed: Factor Summary
+Added: of risk factors
We are subject to a number
77 unchanged sentences
For example, escalating geopolitical
−Removed: tensions, elevated interest rates and regulatory uncertainty have caused significant market volatility in recent months, and particularly
−Removed: in the biotechnology and biopharmaceutical industries, which such volatility can have an adverse effect on the ability to raise capital.
+Added: tensions, elevated interest rates and regulatory uncertainty have caused market volatility, and particularly in the biotechnology and
+Added: biopharmaceutical industries, which such volatility can have an adverse effect on the ability to raise capital.
Biopharmaceutical product
43 unchanged sentences
capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights.
−Removed: To the extent that we raise
−Removed: additional capital through the sale of equity securities or convertible debt securities, the ownership interest of our stockholders will
−Removed: be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of holders
−Removed: of our common stock.
−Removed: Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting
−Removed: or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends.
−Removed: For example, in September 2024, we entered into a Securities Purchase Agreement with certain new institutional and accredited investors,
−Removed: whereby the investors purchased an aggregate of 5,600,000 shares of common stock, 2,439 shares of Series A Preferred Stock and pre-funded
−Removed: warrants to purchase an aggregate of 680,000 shares of common stock for an aggregate purchase price of approximately $200.5 million.
−Removed: share of Series A Preferred Stock is convertible into 1,000 shares of common stock.
+Added: To the extent that we raise additional capital through the sale of
+Added: equity securities or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities
+Added: may include liquidation or other preferences that adversely affect the rights of holders of our common stock.
+Added: Debt financing and preferred
+Added: equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions,
+Added: such as incurring additional debt, making capital expenditures, or declaring dividends.
+Added: For example, in September 2024, we entered into
+Added: a Securities Purchase Agreement with certain institutional and accredited investors, whereby the investors purchased an aggregate of 5,600,000
+Added: shares of common stock, 2,439 shares of Series A Preferred Stock and pre-funded warrants to purchase an aggregate of 680,000 shares of
+Added: common stock and in November 2024, each outstanding share of Series A Preferred Stock converted into 1,000 shares of common stock.
+Added: in September 2025, we entered into a Securities Purchase Agreement with certain institutional and accredited investors, whereby the investors
+Added: purchased an aggregate of 10,933,405 shares of our common stock and pre-funded warrants to purchase 1,066,666 shares of common stock.
+Added: In addition, in October 2025, we entered into a sales agreement with TD Securities (USA) LLC acting as our sales agent pursuant to which
+Added: we may issue and sell shares of our common stock from time to time through an at-the-market equity offering program, for aggregate gross
+Added: proceeds of up to $200.0 million.
If we raise additional funds
50 unchanged sentences
of unforeseen events affecting our product development timeline, including the following:
−Removed: ● our clinical trials may fail to show safety or efficacy, produce
−Removed: negative or inconclusive results, or our product candidates may have undesirable side effects or unexpected characteristics, and we may
−Removed: decide, or regulators may require that we conduct additional preclinical studies or clinical trials or we may decide to abandon product
−Removed: development programs;
−Removed: ● the supply or quality of our clinical
−Removed: trial materials or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate;
+Added: our clinical trials may fail to show safety or efficacy, produce negative or inconclusive results, or our product candidates may have undesirable side effects or unexpected characteristics, and we may decide, or regulators may require that we conduct additional preclinical studies or clinical trials or we may decide to abandon product development programs;
+Added: the supply or quality of our clinical trial materials or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate;
regulators, Institutional Review Boards (“IRBs”), the FDA, or ethics committees may not authorize us or our investigators to commence or conduct a clinical trial at one or more prospective trial sites;
or may require that we or our investigators materially modify, suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding that the participants in our trials are being exposed to unacceptable health risks;
−Removed: ● our failure to establish an appropriate
−Removed: safety profile for a product candidate based on clinical or preclinical data as well as data emerging from other therapies in the same
−Removed: class as our product candidates;
+Added: our failure to establish an appropriate safety profile for a product candidate based on clinical or preclinical data as well as data emerging from other therapies in the same class as our product candidates;
the number of subjects required for clinical trials of any product candidates may be larger than we anticipate, especially if regulatory bodies require completion of non-inferiority or superiority trials;
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dependent on the success of our two most advanced programs, ORKA-001 and ORKA-002, and our clinical trials of such programs may not be
−Removed: Our future success is
−Removed: substantially dependent on our ability to develop and timely obtain marketing approval for, and then successfully commercialize, our
−Removed: two most advanced programs, ORKA-001 and ORKA-002.
−Removed: We are investing the majority of our efforts and financial resources into
−Removed: the research and development of these programs.
−Removed: We have initiated a Phase 1 clinical trial of ORKA-001 in healthy volunteers
−Removed: and have also initiated a Phase 2 clinical trial of ORKA-001 in patients with moderate-to-severe psoriasis in the third
−Removed: quarter of 2025.
−Removed: In addition, we have initiated a Phase 1
−Removed: clinical trial of ORKA-002 in healthy volunteers and plan to initiate a Phase 2 clinical trial of ORKA-002 in the first half of
−Removed: Currently, we believe that the success of our programs is dependent on observing a longer half-life of our product
−Removed: candidates in humans than mAbs currently marketed and in development as we believe this longer half-life has the potential to
−Removed: result in a more favorable dosing schedule for our product candidates, assuming they successfully complete clinical development and
−Removed: obtain marketing approval.
−Removed: This is based in part on the assumption that the longer half-life we have observed in non-human
−Removed: primates will translate into an extended half-life of our product candidates in humans.
−Removed: To the extent we do not observe this
−Removed: extended half-life in humans, it would significantly and adversely affect the clinical and commercial potential of our product
+Added: Our future success is substantially
+Added: dependent on our ability to develop and timely obtain marketing approval for, and then successfully commercialize, our two most advanced
+Added: programs, ORKA-001 and ORKA-002.
+Added: We are investing the majority of our efforts and financial resources into the research and development
+Added: of these programs.
+Added: Our Phase 1 clinical trial of ORKA-001 in healthy volunteers is ongoing and remains blinded and all subjects have remained
+Added: on trial through August 6, 2025.
+Added: Moreover, in the third quarter of 2025, we commenced dosing in a Phase 2a clinical trial of ORKA-001
+Added: in patients with moderate-to-severe psoriasis and furthermore, we expect to initiate a dose-ranging Phase 2b trial of ORKA-001 in moderate-to-severe
+Added: psoriasis in the first half of 2026.
+Added: In addition, we have initiated a Phase 1 clinical trial of ORKA-002 in healthy volunteers and plan
+Added: to initiate a Phase 2 clinical trial of ORKA-002 in the first half of 2026.
+Added: Currently, we believe that the success of our programs is dependent
+Added: on our product candidates demonstrating a longer half-life in humans than mAbs currently marketed and in development as we believe this
+Added: longer half-life has the potential to result in a more favorable dosing schedule for our product candidates, assuming they successfully
+Added: complete clinical development and obtain marketing approval.
+Added: To the extent we do not observe this extended half-life, it would significantly
+Added: and adversely affect the clinical and commercial potential of our product candidates.
If we do not achieve
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We plan to use the data
−Removed: from our Phase 1 trials of our ORKA-001 and ORKA-002 programs in healthy volunteers to support Phase 2 trials in PsO
−Removed: and potentially other I&I indications.
−Removed: If the FDA and/or comparable foreign regulatory authority requires us to materially modify
−Removed: our proposed trial designs, conduct additional trials or enroll additional participants, our development timelines may be delayed.
−Removed: cannot be sure that submission of an IND, Clinical Trial Application or similar application will result in the FDA or comparable foreign
−Removed: regulatory authorities, as applicable, allowing clinical trials to begin in a timely manner, if at all.
−Removed: Moreover, even if these trials
−Removed: begin, issues may arise that could suspend or terminate such clinical trials.
−Removed: Events that may prevent successful or timely initiation
−Removed: or completion of clinical trials include:
−Removed: inability to generate sufficient preclinical, toxicology or other in vivo or in
−Removed: vitro data to support the initiation or continuation of clinical trials;
−Removed: delays in reaching a consensus with regulatory authorities
−Removed: on trial design or implementation of the clinical trials;
+Added: from our current trials of our ORKA-001 and ORKA-002 programs to support further trials in PsO and potentially other I&I
+Added: If the FDA and/or comparable foreign regulatory authority requires us to materially modify our proposed trial designs, conduct
+Added: additional trials or enroll additional participants, our development timelines may be delayed.
+Added: We cannot be sure that submission of an
+Added: IND, Clinical Trial Application or similar application will result in the FDA or comparable foreign regulatory authorities, as applicable,
+Added: allowing clinical trials to begin in a timely manner, if at all.
+Added: Moreover, even if these trials begin, issues may arise that could suspend
+Added: or terminate such clinical trials.
+Added: Events that may prevent successful or timely initiation or completion of clinical trials include:
+Added: to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation or continuation
+Added: of clinical trials;
+Added: delays in reaching a consensus with regulatory authorities on trial design or implementation of the clinical trials;
delays or failure in obtaining regulatory authorization to commence a trial;
−Removed: delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;
−Removed: recruiting and training suitable clinical
−Removed: investigators;
+Added: delays in reaching agreement on acceptable terms with prospective
+Added: CROs and clinical trial sites;
+Added: recruiting and training suitable clinical investigators;
delays or difficulties in recruiting trial patients;
delays in obtaining required IRB approval at each clinical trial site;
−Removed: delays in manufacturing, testing, releasing, validating or importing/exporting sufficient stable quantities of our product candidates
−Removed: for use in clinical trials or the inability to do any of the foregoing;
−Removed: failure by our CROs, other third parties or us to adhere to clinical
−Removed: trial protocols;
−Removed: failure to perform in accordance with the FDA’s or any other regulatory authority’s current Good Clinical
−Removed: Practice (“GCP”) requirements or applicable regulatory guidelines in other countries;
+Added: delays in manufacturing, testing, releasing, validating or importing/exporting
+Added: sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing;
+Added: by our CROs, other third parties or us to adhere to clinical trial protocols;
+Added: failure to perform in accordance with the FDA’s or
+Added: any other regulatory authority’s current Good Clinical Practice (“GCP”) requirements or applicable regulatory guidelines
+Added: in other countries;
changes to the clinical trial protocols;
clinical sites deviating from trial protocol or dropping out of a trial;
−Removed: delays or failure by our third party vendors or us in the manufacturing,
−Removed: packaging, labeling and proper delivery of clinical trial materials;
−Removed: and third parties being unwilling or unable to satisfy their contractual
−Removed: obligations to us.
+Added: delays or failure by our third party vendors or us in the manufacturing, packaging, labeling and proper delivery of clinical trial materials;
+Added: and third parties being unwilling or unable to satisfy their contractual obligations to us.
We could also encounter delays
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Further, conducting clinical
−Removed: trials outside of the United States.
−Removed: presents additional risks that may delay completion of our clinical trials.
+Added: trials outside of the United States presents additional risks that may delay completion of our clinical trials.
These risks include the
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Disruptions at the
−Removed: FDA, the SEC and other government agencies and regulatory authorities caused by funding shortages or global health concerns could hinder
−Removed: their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized
−Removed: in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business
−Removed: may rely, which could negatively impact our business.
−Removed: The ability of the FDA to review regulatory filings and our ability
−Removed: to commence clinical trials can be affected by a variety of factors, including government budget and funding levels, ability to hire and
−Removed: retain key personnel and accept the payment of user fees, statutory, regulatory and policy changes, disruptions caused by government shutdowns
−Removed: and public health crises.
−Removed: There have been mass layoffs of federal government employees since the start of the Trump administration in
−Removed: January 2025, the full impact of which is unclear at this time.
−Removed: Average review times at the agency have fluctuated in recent years as
−Removed: In addition, government funding of the SEC, and other government agencies on which our operations may rely, including those
−Removed: that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
−Removed: the Trump administration has made and is expected to continue to make changes in the leadership of various U.S.
−Removed: federal regulatory agencies
−Removed: and changes to U.S.
−Removed: federal government policy that have led to, in some cases, legal challenges and uncertainty around the funding, functioning
−Removed: and policy priorities of the U.S.
+Added: FDA, the SEC and other government agencies and regulatory authorities could hinder their ability to hire and retain key leadership and
+Added: other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those
+Added: agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our
+Added: The ability of the FDA to
+Added: review regulatory filings and our ability to commence clinical trials can be affected by a variety of factors, including government budget
+Added: and funding levels, ability to hire and retain key personnel and accept the payment of user fees, statutory, regulatory and policy changes,
+Added: disruptions caused by government shutdowns and public health crises.
+Added: There have been mass layoffs of federal government employees since
+Added: the start of the Trump administration in January 2025, the full impact of which is unclear at this time.
+Added: Average review times at the agency
+Added: have fluctuated in recent years as a result.
+Added: In addition, government funding of the SEC, and other government agencies on which our operations
+Added: may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid
+Added: and unpredictable.
+Added: Furthermore, the Trump administration has made and is expected to continue to make changes in the leadership of various
+Added: federal regulatory agencies and changes to U.S.
+Added: federal government policy that have led to, in some cases, legal challenges and uncertainty
+Added: around the funding, functioning and policy priorities of the U.S.
federal regulatory agencies, including the FDA.
−Removed: Disruptions at the FDA and
−Removed: other agencies or comparable foreign regulatory authorities, may also slow the time necessary for the review and approval of applications
−Removed: for clinical trial or marketing authorization, which would adversely affect our business.
−Removed: For example, in recent years, including in 2018
−Removed: and 2019, the U.S.
−Removed: government shut down several times and certain regulatory agencies, such as the FDA and the SEC, had to furlough critical
−Removed: employees and stop critical activities.
+Added: Disruptions at the FDA and other agencies or comparable foreign regulatory authorities, may also slow the time necessary for the review and approval
+Added: of applications for clinical trial or marketing authorization, which would adversely affect our business.
+Added: For example, most recently in
+Added: October 2025, the U.S.
+Added: government shut down, during which time certain regulatory agencies, such as the FDA and the SEC, furloughed critical
+Added: employees and stopped critical activities.
Additionally, action by the Trump administration to limit federal agency budgets or personnel
3 unchanged sentences
our regulatory submissions, which could have a material adverse effect on our business.
−Removed: Further, future government shutdowns could impact
−Removed: our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
−Removed: We are unable to predict
−Removed: the extent to which the Trump administration may impose or seek to impose leadership or policy changes at the FDA or changes to rules
−Removed: and policies impacting our business and operations.
−Removed: It is unclear how these executive actions or other potential actions by the federal
−Removed: government will impact the FDA or other regulatory authorities that oversee our business.
−Removed: Government proposals to reduce or eliminate
−Removed: budgetary deficits may include reduced allocations to the FDA and other related government agencies.
−Removed: These budgetary pressures may reduce
−Removed: the FDA’s ability to perform its responsibilities, which could result in delays in our clinical trial timelines.
−Removed: If a significant
−Removed: reduction in the FDA’s workforce occurs, the FDA’s budget is significantly reduced or a prolonged government shutdown occurs,
+Added: Further, government shutdowns could impact our
+Added: ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
+Added: We are unable to predict the extent to which the Trump administration
+Added: may impose or seek to impose leadership or policy changes at the FDA or changes to rules and policies impacting our business and operations.
+Added: It is unclear how these executive actions or other potential actions by the federal government will impact the FDA or other regulatory
+Added: authorities that oversee our business.
+Added: Government proposals to reduce or eliminate budgetary deficits may include reduced allocations
+Added: to the FDA and other related government agencies.
+Added: These budgetary pressures may reduce the FDA’s ability to perform its responsibilities,
+Added: which could result in delays in our clinical trial timelines.
+Added: If a significant reduction in the FDA’s workforce occurs, the FDA’s
+Added: budget is significantly reduced or a prolonged government shutdown occurs,
it could significantly impact the ability of the FDA to timely review and process our regulatory submissions or take other actions critical
to the development or manufacturing of our product candidates, which could have a material adverse effect on our business.
−Removed: If a prolonged government
−Removed: shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections,
+Added: If a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections,
reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely
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and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations
−Removed: and customers will be subject to applicable healthcare regulatory laws, including conflicts of interest rules, which could expose us
−Removed: to penalties.
+Added: and customers will be subject to applicable healthcare regulatory laws, including conflicts of interest rules, which could expose us to
Our business operations and
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federal government and the states and the foreign governments in which we conduct our business.
−Removed: Restrictions under applicable laws and regulations include the following:
−Removed: privacy, data protection, and data security laws and regulations, such as the European Union’s
−Removed: General Data Protection Regulation (EU GDPR), which imposes comprehensive obligations on
−Removed: covered businesses to, among other things, make contractual privacy, data protection and
−Removed: data security commitments, cooperate with European data protection authorities, implement
−Removed: security measures, give data breach notifications, and keep records of personal information
−Removed: processing activities;
−Removed: Foreign Corrupt Practices Act of 1977, as amended, which prohibits, among other things,
−Removed: companies and their employees and agents from authorizing, promising, offering, or providing,
−Removed: directly or indirectly, corrupt or improper payments or anything else of value to foreign
−Removed: government officials, employees of public international organizations and foreign government
−Removed: owned or affiliated entities, candidates for foreign political office, and foreign political
−Removed: parties or officials thereof.
+Added: Restrictions under applicable laws and
+Added: regulations include the following:
+Added: foreign privacy, data protection, and data security laws and regulations, such as the European Union’s General Data Protection Regulation (EU GDPR), which imposes comprehensive obligations on covered businesses to, among other things, make contractual privacy, data protection and data security commitments, cooperate with European data protection authorities, implement security measures, give data breach notifications, and keep records of personal information processing activities;
+Added: Foreign Corrupt Practices Act of 1977, as amended, which prohibits, among other things, U.S.
+Added: companies and their employees and agents from authorizing, promising, offering, or providing, directly or indirectly, corrupt or improper payments or anything else of value to foreign government officials, employees of public international organizations and foreign government owned or affiliated entities, candidates for foreign political office, and foreign political parties or officials thereof.
Principal investigators for
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in obtaining or maintaining necessary rights to our programs through acquisitions and in-licenses.
−Removed: Because our development programs currently do and may in the future
−Removed: require the use of proprietary rights held by third parties, the growth of our business may depend in part on our ability to acquire, in-license, or
−Removed: use these third-party proprietary rights.
−Removed: It is possible that we may be unable to obtain licenses at a reasonable cost or on reasonable
−Removed: terms, if at all.
−Removed: Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same
−Removed: technologies licensed to us.
−Removed: We may be unable to acquire or in-license any compositions, methods of use, processes or other
−Removed: third-party intellectual property rights from third parties that we identify as necessary for our programs.
−Removed: The licensing and acquisition
−Removed: of third-party intellectual property rights is a competitive area, and a number of more established companies may pursue strategies
−Removed: to license or acquire third-party intellectual property rights that we may consider attractive or necessary.
−Removed: These established companies
−Removed: may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities.
−Removed: In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us.
−Removed: We also may be unable to
−Removed: license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment
−Removed: If we are unable to successfully obtain rights to required third-party intellectual property or maintain the existing
−Removed: intellectual property rights we do obtain, we may have to abandon development of the relevant program, which could have a material adverse
−Removed: effect on our business, financial condition, results of operations, and prospects.
+Added: Because our development programs
+Added: currently do and may in the future require the use of proprietary rights held by third parties, the growth of our business may depend
+Added: in part on our ability to acquire, in-license, or use these third-party proprietary rights.
+Added: It is possible that we may
+Added: be unable to obtain licenses at a reasonable cost or on reasonable terms, if at all.
+Added: Even if we are able to obtain a license, it may be
+Added: non-exclusive, thereby giving our competitors access to the same technologies licensed to us.
+Added: We may be unable to acquire or in-license any
+Added: compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify as
+Added: necessary for our programs.
+Added: The licensing and acquisition of third-party intellectual property rights is a competitive area, and
+Added: a number of more established companies may pursue strategies to license or acquire third-party intellectual property rights that
+Added: we may consider attractive or necessary.
+Added: These established companies may have a competitive advantage over us due to their size, capital
+Added: resources and greater clinical development and commercialization capabilities.
+Added: In addition, companies that perceive us to be a competitor
+Added: may be unwilling to assign or license rights to us.
+Added: We also may be unable to license or acquire third-party intellectual property
+Added: rights on terms that would allow us to make an appropriate return on our investment or at all.
+Added: If we are unable to successfully obtain
+Added: rights to required third-party intellectual property or maintain the existing intellectual property rights we do obtain, we may have
+Added: to abandon development of the relevant program, which could have a material adverse effect on our business, financial condition, results
+Added: of operations, and prospects.
While we plan to obtain the
546 unchanged sentences
among countries, or conflict with other rules.
−Removed: We are or may become subject to the terms of contractual
−Removed: obligations related to privacy, data protection and data security.
+Added: We are or may become subject to the terms of contractual obligations related to privacy,
+Added: data protection and data security.
Our obligations may also change or expand as our business grows.
−Removed: actual or perceived failure by us or third parties related to us to comply with such laws, regulations and obligations could increase
−Removed: our compliance and operational costs, expose us to regulatory scrutiny, actions, fines and penalties, result in reputational harm, lead
−Removed: to a loss of customers, result in litigation and liability, and otherwise cause a material adverse effect on our business, financial condition,
−Removed: and results of operations.
+Added: The actual or perceived failure by
+Added: us or third parties related to us to comply with such laws, regulations and obligations could increase our compliance and operational
+Added: costs, expose us to regulatory scrutiny, actions, fines and penalties, result in reputational harm, lead to a loss of customers, result
+Added: in litigation and liability, and otherwise cause a material adverse effect on our business, financial condition, and results of operations.
If we fail to comply
107 unchanged sentences
and financial condition.
−Removed: The global economy, including credit and financial markets, has experienced
−Removed: and may experience in the future extreme volatility and disruptions, including, among other things, diminished liquidity and credit availability,
−Removed: declines in consumer confidence, declines in economic growth, supply chain shortages, new or increased tariffs and other barriers to trade,
−Removed: especially in light of recent executive orders made by the Trump administration, trade and other international disputes, increases in
−Removed: inflation rates, fluctuation in interest rates, slower growth or recession, tighter credit, volatility in financial markets, high unemployment,
−Removed: labor availability constraints, public health crises, significant natural disasters, including as a result of climate change, changes
−Removed: to fiscal and monetary policy or government budget dynamics (particularly in the pharmaceutical and biotechnology areas), political and
−Removed: military conflict, and uncertainty about economic stability.
−Removed: In recent months, the U.S.
−Removed: has announced tariffs on imports from most countries,
−Removed: including significant tariffs on imports from China.
−Removed: Historically, tariffs have led to increased trade and political tensions.
−Removed: to tariffs, other countries have implemented retaliatory tariffs on U.S.
−Removed: Political tensions as a result of trade policies could
−Removed: reduce trade volume, investment, technological exchange and other economic activities between major international economies, resulting
−Removed: in a material adverse effect on global economic conditions and the stability of global financial markets.
−Removed: There is substantial uncertainty
−Removed: about the duration of existing tariffs and whether additional tariffs may be imposed, modified or suspended.
−Removed: Fluctuation in interest rates,
−Removed: coupled with reduced government spending and volatility in financial markets, may increase economic uncertainty and affect consumer spending.
−Removed: Similarly, the ongoing military conflict between Russia and Ukraine and in the Middle East and rising tensions with China have created
−Removed: extreme volatility in the global capital markets and may have further global economic consequences, including disruptions of the global
−Removed: supply chain.
−Removed: Any such volatility and disruptions may adversely affect our business or the third parties on whom we rely.
−Removed: If the equity
−Removed: and credit markets deteriorate, including as a result of economic or political uncertainty, political unrest or war, it may make any necessary
−Removed: debt or equity financing more costly, more dilutive, or more difficult to obtain in a timely manner or on favorable terms, if at all.
−Removed: Increased inflation rates can adversely affect us by increasing our costs, including materials, operational, labor and employee benefit
+Added: The global economy, including
+Added: credit and financial markets, has experienced and may experience in the future extreme volatility and disruptions, including, among other
+Added: things, diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, supply chain shortages,
+Added: new or increased tariffs and other barriers to trade, especially in light of recent executive orders made by the Trump administration,
+Added: trade and other international disputes, increases in inflation rates, fluctuation in interest rates, slower growth or recession, tighter
+Added: credit, volatility in financial markets, high unemployment, labor availability constraints, public health crises, significant natural
+Added: disasters, including as a result of climate change, changes to fiscal and monetary policy or government budget dynamics (particularly
+Added: in the pharmaceutical and biotechnology areas), political and military conflict, and uncertainty about economic stability.
+Added: In recent months,
+Added: has announced tariffs on imports from most countries, including significant tariffs on imports from China.
+Added: Historically, tariffs
+Added: have led to increased trade and political tensions.
+Added: In response to tariffs, other countries have implemented retaliatory tariffs on U.S.
+Added: Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange and other economic
+Added: activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability
+Added: of global financial markets.
+Added: There is substantial uncertainty about the duration of existing tariffs and whether additional tariffs may
+Added: be imposed, modified or suspended.
+Added: Fluctuation in interest rates, coupled with reduced government spending and volatility in financial
+Added: markets, may increase economic uncertainty and affect consumer spending.
+Added: Similarly, the ongoing military conflict between Russia and Ukraine
+Added: and in the Middle East and rising tensions with China have created extreme volatility in the global capital markets and may have further
+Added: global economic consequences, including disruptions of the global supply chain.
+Added: Any such volatility and disruptions may adversely affect
+Added: our business or the third parties on whom we rely.
+Added: If the equity and credit markets deteriorate, including as a result of economic or
+Added: political uncertainty, political unrest or war, it may make any necessary debt or equity financing more costly, more dilutive, or more
+Added: difficult to obtain in a timely manner or on favorable terms, if at all.
+Added: Increased inflation rates can adversely affect us by increasing
+Added: our costs, including materials, operational, labor and employee benefit costs.
We may in the future experience
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Among other things, these provisions:
−Removed: ● establish a classified board of
−Removed: directors such that all members of the board are not elected at one time;
+Added: establish a classified board of directors such that all members of the board are not elected at one time;
allow the authorized number of our directors to be changed only by resolution of our board of directors;
42 unchanged sentences
by existing stockholders could cause our stock price to decline.
−Removed: If our stockholders sell,
−Removed: or indicate an intention to sell, substantial amounts of our common stock in the public market after legal restrictions on resale lapse,
−Removed: the trading price of our common stock could decline.
−Removed: In addition, shares of our common stock that are subject to our outstanding options
−Removed: will become eligible for sale in the public market to the extent permitted by the provisions of various vesting agreements and Rules 144
−Removed: and 701 under the Securities Act.
+Added: If our stockholders sell, or indicate an intention to sell, substantial
+Added: amounts of our common stock in the public market, the trading price of our common stock could decline.
+Added: In addition, shares of our common
+Added: stock that are subject to our outstanding options will become eligible for sale in the public market to the extent permitted by the provisions
+Added: of various vesting agreements and Rules 144 and 701 under the Securities Act.
We do not anticipate
36 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.