17 unchanged sentences
We have no products approved for commercial sale and have generated only limited revenue to date.
−Removed: focus is now on advancing our DNase oncology platform via partnering opportunities or through regulatory approval and commercialization.
+Added: focus is now on advancing our DNase technology via partnering opportunities or through regulatory approval and commercialization.
We expect to continue to incur significant research and development and other expenses related to our ongoing operations.
87 unchanged sentences
Our business is substantially dependent
−Removed: on the success of the DNase oncology platform.
+Added: on the success of the DNase technology.
Our business will substantially depend on the
−Removed: successful clinical development, regulatory approval and commercialization of the DNase oncology platform.
+Added: successful clinical development, regulatory approval and commercialization of the DNase technology.
It will require substantial
201 unchanged sentences
Suspend or hold any of our ongoing clinical trials;
+Added: Require additional clinical trials;
Refuse to approve pending applications or supplements to approved applications submitted by us;
246 unchanged sentences
the implementation of legislation that would repeal portions of the ACA.
−Removed: In addition, on January 20, 2017, former President Trump signed
−Removed: an Executive Order directing federal agencies with authorities and responsibilities under the ACA to waive, defer, grant exemptions from,
−Removed: or delay the implementation of any provision of the ACA that would impose a fiscal or regulatory burden on states, individuals, healthcare
−Removed: providers, health insurers, or manufacturers of pharmaceuticals or medical devices.
−Removed: Further, on October 12, 2017, former President Trump
−Removed: issued another executive order requiring the Secretaries of HHA and the Departments of Labor and Treasury to consider proposing regulations
−Removed: or revising existing guidance to allow more employers to form association health plans that would be allowed to provide coverage across
−Removed: state lines, increase the availability of short-term, limited-duration health insurance plans, which are generally not subject to the
−Removed: requirements of the ACA, and increase the availability and permitted use of health reimbursement arrangements.
−Removed: On October 13, 2017, the
−Removed: Department of Justice announced that HHS was immediately stopping its cost sharing reduction payments to insurance companies based on
−Removed: the determination that those payments had not been appropriated by Congress.
−Removed: Furthermore, on December 22, 2017, former President Trump
−Removed: signed the Tax Cuts and Jobs Act (the “TCJA”) into law that, in addition to overhauling the federal tax system, also, effective
−Removed: as of January 1, 2019, repeals the penalties associated with the individual mandate.
−Removed: Congress or the President of the United States also
−Removed: could consider subsequent legislation or executive action to replace, eliminate or reaffirm elements of the ACA.
−Removed: We will continue to evaluate
−Removed: the effect that the ACA and any future measures to modify, repeal, replace or reaffirm the ACA have on our business.
+Added: In addition, on January 20, 2017, President Trump signed an executive
+Added: order directing federal agencies with authorities and responsibilities under the ACA to waive, defer, grant exemptions from, or delay
+Added: the implementation of any provision of the ACA that would impose a fiscal or regulatory burden on states, individuals, healthcare providers,
+Added: health insurers, or manufacturers of pharmaceuticals or medical devices.
+Added: Further, on October 12, 2017, President Trump issued another
+Added: executive order requiring the Secretaries of HHA and the Departments of Labor and Treasury to consider proposing regulations or revising
+Added: existing guidance to allow more employers to form association health plans that would be allowed to provide coverage across state lines,
+Added: increase the availability of short-term, limited-duration health insurance plans, which are generally not subject to the requirements
+Added: of the ACA, and increase the availability and permitted use of health reimbursement arrangements.
+Added: On October 13, 2017, the Department
+Added: of Justice announced that HHS was immediately stopping its cost sharing reduction payments to insurance companies based on the determination
+Added: that those payments had not been appropriated by Congress.
+Added: Furthermore, on December 22, 2017, President Trump signed the Tax Cuts and
+Added: Jobs Act (the “TCJA”) into law that, in addition to overhauling the federal tax system, also, effective as of January 1, 2019,
+Added: repealed the penalties associated with the individual mandate.
+Added: Congress or the President of the United States also could consider subsequent
+Added: legislation or executive action to replace, eliminate or reaffirm elements of the ACA.
+Added: We will continue to evaluate the effect that the
+Added: ACA and any future measures to modify, repeal, replace or reaffirm the ACA have on our business.
Additionally, the Inflation Reduction Act of 2022
1 unchanged sentence
In addition to other relevant provisions, the Inflation Reduction
−Removed: Act of 2022 allow the Medicare program to directly negotiate the price of certain high-expenditure prescription drugs covered under Medicare
+Added: Act of 2022 allows the Medicare program to directly negotiate the price of certain high-expenditure prescription drugs covered under Medicare
Parts B and D, starting in the year 2028 and 2026, respectively, by setting certain "maximum fair prices." Moreover, the Inflation
3 unchanged sentences
have on our business.
+Added: In a 2024 U.S.
+Added: Supreme Court ruling ( Loper
+Added: Bright Enterprises v.
+Added: Raimondo ) (the “ Loper decision”), the Supreme Court overturned the long-standing Chevron
+Added: doctrine, which had accorded deference to an agency’s interpretation of ambiguous laws since 1984.
+Added: Following the Loper decision,
+Added: the healthcare space may face increased judicial scrutiny of agency regulations, as courts are no longer required to defer to federal
+Added: agencies’ interpretations of ambiguous statutes.
+Added: This change could lead to significant alterations in how healthcare laws and regulations
+Added: are applied and enforced.
+Added: While the full impact of this reversal has yet to be examined, the Loper decision could lead to material
+Added: changes to the healthcare system, particularly concerning the FDA, CMS, HHS, and other agencies.
+Added: We will continue to evaluate the effects
+Added: that the Loper decision will have on our business.
We are not able to provide any assurance that
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the United States that is adverse to our business.
+Added: Moreover, we are not, at this time, able to evaluate any potential legislative, regulatory
+Added: or Executive Order actions that the new presidential administration may take which could have a material impact on our business.
Laws and other reform and cost containment measures
3 unchanged sentences
Risks Related to Our Reliance on Third-Parties
−Removed: We may seek to establish additional collaborations
−Removed: and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization
−Removed: Our drug candidate development programs and the
−Removed: potential commercialization of our drug candidates will require substantial additional cash to fund expenses.
−Removed: For some of our drug candidates,
−Removed: we may decide to collaborate with additional pharmaceutical and biotechnology companies for the development and potential commercialization
−Removed: of those drug candidates.
−Removed: We face significant competition in seeking appropriate
−Removed: collaborators.
−Removed: Whether we reach a definitive agreement for any additional collaborations will depend, among other things, upon our assessment
−Removed: of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s
−Removed: evaluation of a number of factors.
−Removed: Those factors may include the design or results of clinical trials, the likelihood of approval by FDA
−Removed: or similar regulatory authorities outside the U.S., the potential market for the subject drug candidate, the costs and complexities of
−Removed: manufacturing and delivering such drug candidate to patients, the potential of competing drugs, the existence of uncertainty with respect
−Removed: to our ownership of technology (which can exist if there is a challenge to such ownership without regard to the merits of the challenge)
−Removed: and industry and market conditions generally.
−Removed: The collaborator may also consider alternative drug candidates or technologies for similar
−Removed: indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for
−Removed: our drug candidate.
−Removed: The terms of any additional collaborations or other arrangements that we may establish may not be favorable to us.
−Removed: We may also be restricted under existing collaboration
−Removed: agreements from entering into future agreements on certain terms with potential collaborators.
−Removed: Collaborations are complex and time-consuming
−Removed: to negotiate and document.
−Removed: In addition, there have been a significant number of recent business combinations among large pharmaceutical
−Removed: companies that have resulted in a reduced number of potential future collaborators.
−Removed: We may not be able to negotiate additional collaborations
−Removed: on a timely basis on acceptable terms, or at all.
−Removed: If we are unable to do so, we may have to curtail the development of the drug candidate
−Removed: for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay
−Removed: its potential commercialization or reduce the scope of any sales or marketing activities or increase our expenditures and undertake development
−Removed: or commercialization activities at our own expense.
−Removed: If we elect to increase our expenditures to fund development or commercialization
−Removed: activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms, or at all.
−Removed: do not have sufficient funds, we may not be able to further develop our drug candidates or bring them to market and generate product revenue.
If conflicts arise between us and our collaborators
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Furthermore, facilities used by these third party CROs, clinical investigators and clinical study sites may be negatively affected by
−Removed: catastrophic events, such as pandemics, terrorist attacks, wars or other armed conflicts, geopolitical tensions, such as the ongoing conflict
−Removed: between Russia and Ukraine and related sanctions and other economic disruptions or concerns, natural disasters, such as floods or fire,
−Removed: or such facilities could face manufacturing issues, such as contamination or regulatory concerns following a regulatory inspection of
−Removed: such facility.
−Removed: In such instances, we may need to locate an appropriate replacement third-party facility and establish a contractual relationship,
−Removed: which may not be readily available or on acceptable terms, which would cause additional delay and increased expense, including as a result
−Removed: of additional required FDA approvals, and may have a material adverse effect on our business.
+Added: catastrophic events, such as pandemics, terrorist attacks, wars or other armed conflicts, geopolitical tensions, such as the ongoing conflicts
+Added: in the Ukraine and Middle East, and related sanctions and other economic disruptions or concerns, natural disasters, such as floods or
+Added: fire, or such facilities could face manufacturing issues, such as contamination or regulatory concerns following a regulatory inspection
+Added: of such facility.
+Added: In such instances, we may need to locate an appropriate replacement third-party facility and establish a contractual
+Added: relationship, which may not be readily available or on acceptable terms, which would cause additional delay and increased expense, including
+Added: as a result of additional required FDA approvals, and may have a material adverse effect on our business.
We, our clinical investigators, and our CROs are
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impact our revenues.
−Removed: If we enter into one or more collaborations,
−Removed: we may be required to relinquish important rights to and control over the development of our drug candidates or otherwise be subject to
−Removed: unfavorable terms.
−Removed: Any future collaborations we enter into could
−Removed: subject us to a number of risks, including:
+Added: We may seek to establish additional collaborations
+Added: and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization
+Added: Our drug candidate development programs and the
+Added: potential commercialization of our drug candidates will require substantial additional cash to fund expenses.
+Added: For some of our drug candidates,
+Added: we may decide to collaborate with additional pharmaceutical and biotechnology companies for the development and potential commercialization
+Added: of those drug candidates.
+Added: We face significant competition in seeking appropriate
+Added: collaborators.
+Added: Whether we reach a definitive agreement for any additional collaborations will depend, among other things, upon our assessment
+Added: of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s
+Added: evaluation of a number of factors.
+Added: Those factors may include the design or results of clinical trials, the likelihood of approval by FDA
+Added: or similar regulatory authorities outside the U.S., the potential market for the subject drug candidate, the costs and complexities of
+Added: manufacturing and delivering such drug candidate to patients, the potential of competing drugs, the existence of uncertainty with respect
+Added: to our ownership of technology (which can exist if there is a challenge to such ownership without regard to the merits of the challenge)
+Added: and industry and market conditions generally.
+Added: The collaborator may also consider alternative drug candidates or technologies for similar
+Added: indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for
+Added: our drug candidate.
+Added: The terms of any additional collaborations or other arrangements that we may establish may not be favorable to us.
+Added: We may also be restricted under existing collaboration
+Added: agreements from entering into future agreements on certain terms with potential collaborators.
+Added: Collaborations are complex and time-consuming
+Added: to negotiate and document.
+Added: In addition, there have been a significant number of recent business combinations among large pharmaceutical
+Added: companies that have resulted in a reduced number of potential future collaborators.
+Added: We may not be able to negotiate additional collaborations
+Added: on a timely basis on acceptable terms, or at all.
+Added: If we are unable to do so, we may have to curtail the development of the drug candidate
+Added: for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay
+Added: its potential commercialization or reduce the scope of any sales or marketing activities or increase our expenditures and undertake development
+Added: or commercialization activities at our own expense.
+Added: If we elect to increase our expenditures to fund development or commercialization
+Added: activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms, or at all.
+Added: do not have sufficient funds, we may not be able to further develop our drug candidates or bring them to market and generate product revenue.
+Added: We are a party to, and may enter into one
+Added: or more collaborations in the future, pursuant to which we may be required to relinquish important rights to and control over the development
+Added: of our drug candidates or otherwise be subject to unfavorable terms.
+Added: Any current and future collaborations we enter
+Added: into could subject us to a number of risks, including:
We may not be able to control the amount and timing of resources that our collaborators devote to the development or commercialization of our drug candidates;
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fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent
−Removed: agencies outside of the United States in several stages over the lifetime of the patents and/or applications.
+Added: agencies outside of the U.
+Added: in several stages over the lifetime of the patents and/or applications.
The USPTO and various non-U.S.
−Removed: governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during
−Removed: the patent application process.
−Removed: Non-compliance may result in abandonment or lapse of the patent or patent application, resulting in partial
−Removed: or complete loss of patent rights in the relevant jurisdiction.
−Removed: In such an event, our competitors might be able to enter the market, and
−Removed: this circumstance would have a material adverse effect on our business.
+Added: patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent
+Added: application process.
+Added: Non-compliance may result in abandonment or lapse of the patent or patent application, resulting in partial or complete
+Added: loss of patent rights in the relevant jurisdiction.
+Added: In such an event, our competitors might be able to enter the market, and this circumstance
+Added: would have a material adverse effect on our business.
Risks Related to Our Business Operations
−Removed: Market conditions and changing circumstances,
−Removed: some of which may be beyond our control, could impair our ability to access our existing cash, cash equivalents and investments and to
−Removed: timely pay collaborators and others.
−Removed: Market conditions and changing circumstances,
−Removed: some of which may be beyond our control, could impair our ability to access our existing cash, cash equivalents and investments and to
−Removed: timely pay key vendors and others.
−Removed: If banks and financial institutions with whom we have banking relationships enter receivership or become
−Removed: insolvent in the future, we may be unable to access, and we may lose, some or all of our existing cash, cash equivalents and investments
−Removed: to the extent those funds are not insured or otherwise protected by the FDIC.
−Removed: In addition, in such circumstances we might not be able
−Removed: to make timely payments to our collaborators or others.
−Removed: The Company maintains its primary banking relationship with one large financial
−Removed: institution and all cash on deposit is federally insured.
−Removed: The Company has not experienced any losses on its accounts, and does not believe
−Removed: it is exposed to any unusual credit risk beyond the normal credit risk currently associated with commercial banking relationships.
−Removed: any delay in our ability to access our cash, cash equivalents and investments or to timely pay our collaborators and others could have
−Removed: a material adverse effect on our operations and cause us to need to seek additional capital sooner than planned.
+Added: We operate in an extremely competitive
+Added: environment and there can be no assurances that competing technologies would not harm our business development.
+Added: We are engaged in a rapidly-evolving field.
+Added: from numerous pharmaceutical companies is intense and expected to increase.
+Added: The large and rapidly-growing market for oncology treatments
+Added: is likely to attract new entrants.
+Added: Numerous biotechnology and pharmaceutical companies are focused on developing cancer treatments and
+Added: immuno-oncology technologies.
+Added: Many, if not all, of these companies have greater financial and other resources and development capabilities
+Added: Many of our competitors also have greater collective experience in undertaking preclinical and clinical testing of products,
+Added: obtaining regulatory approvals and manufacturing and marketing prescription pharmaceutical products.
+Added: There can be no assurance that our
+Added: under-development drug candidates will be more effective or achieve greater market acceptance than competitive products or that our competitors
+Added: will not succeed in developing products and technologies that are more effective than those being developed by us or that would render
+Added: our products and technologies less competitive or obsolete.
+Added: Additionally, there can be no assurance that the development by others of
+Added: new or improved drugs will not make our pharmaceutical products superfluous or obsolete.
Our future success depends on our ability
12 unchanged sentences
and we may experience difficulties in managing this growth, which could disrupt our operations.
−Removed: As of December 31, 2023, we had four full-time
+Added: As of December 31, 2024, we had two full-time
As we mature, we may need to expand our full-time employee base and to hire more consultants and contractors.
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a material adverse effect on our business, financial condition and results of operations.
−Removed: We operate in an extremely competitive environment
−Removed: and there can be no assurances that competing technologies would not harm our business development.
−Removed: We are engaged in a rapidly-evolving field.
−Removed: from numerous pharmaceutical companies is intense and expected to increase.
−Removed: The large and rapidly-growing market for oncology treatments
−Removed: is likely to attract new entrants.
−Removed: Numerous biotechnology and pharmaceutical companies are focused on developing cancer treatments and
−Removed: immuno-oncology technologies.
−Removed: Many, if not all, of these companies have greater financial and other resources and development capabilities
−Removed: Many of our competitors also have greater collective experience in undertaking preclinical and clinical testing of products,
−Removed: obtaining regulatory approvals and manufacturing and marketing prescription pharmaceutical products.
−Removed: There can be no assurance that our
−Removed: under-development drug candidates will be more effective or achieve greater market acceptance than competitive products or that our competitors
−Removed: will not succeed in developing products and technologies that are more effective than those being developed by us or that would render
−Removed: our products and technologies less competitive or obsolete.
−Removed: Additionally, there can be no assurance that the development by others of
−Removed: new or improved drugs will not make our pharmaceutical products superfluous or obsolete.
+Added: Market conditions and changing circumstances,
+Added: some of which may be beyond our control, could impair our ability to access our existing cash, cash equivalents and investments and to
+Added: timely pay collaborators and others.
+Added: Market conditions and changing circumstances,
+Added: some of which may be beyond our control, could impair our ability to access our existing cash, cash equivalents and investments and to
+Added: timely pay key vendors and others.
+Added: If banks and financial institutions with whom we have banking relationships enter receivership or become
+Added: insolvent in the future, we may be unable to access, and we may lose, some or all of our existing cash, cash equivalents and investments
+Added: to the extent those funds are not insured or otherwise protected by the FDIC.
+Added: In addition, in such circumstances we might not be able
+Added: to make timely payments to our collaborators or others.
+Added: The Company maintains its primary banking relationship with one large financial
+Added: institution and all cash on deposit is federally insured.
+Added: The Company has not experienced any losses on its accounts, and does not believe
+Added: it is exposed to any unusual credit risk beyond the normal credit risk currently associated with commercial banking relationships.
+Added: any delay in our ability to access our cash, cash equivalents and investments or to timely pay our collaborators and others could have
+Added: a material adverse effect on our operations and cause us to need to seek additional capital sooner than planned.
Potential new accounting standards or legislative
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10 consecutive business days from May 15, 2023 through May 26, 2023 and that this matter was closed.
−Removed: The primary intent for the Reverse Stock Split
−Removed: was that the anticipated increase in the price of our common shares immediately following and resulting from a reverse stock split due
−Removed: to the reduction in the number of issued and outstanding common shares would help us meet the minimum bid price requirement.
−Removed: be assured that the Reverse Stock Split will result in any sustained proportionate increase in the market price of our common shares,
−Removed: which is dependent upon many factors, including the business and financial performance of the company, general market conditions, and
−Removed: prospects for future success, which are unrelated to the number of shares of our common shares outstanding.
−Removed: It is not uncommon for the
−Removed: market price of a company’s common shares to decline in the period following a reverse stock split.
−Removed: Thus, while we have regained
−Removed: compliance with the continued listing requirements for Nasdaq, it cannot be assured that we will continue to do so.
−Removed: If Nasdaq delists
−Removed: our common shares from trading on its exchange for failure to meet the listing standards, an investor would likely find it significantly
−Removed: more difficult to dispose of or obtain our shares, and our ability raise future capital through the sale of our shares could be severely
−Removed: Delisting could also have other negative results, including the potential loss of confidence by employees, the loss of institutional
−Removed: investor interest and fewer business development opportunities.
−Removed: The Reverse Stock Split may decrease the
−Removed: liquidity of our common shares.
−Removed: The liquidity of our common stock may be adversely
−Removed: affected by the reduced number of shares outstanding after the Reverse Stock Split.
−Removed: In addition, the Reverse Stock Split may have increased
−Removed: the number of shareholders who own odd lots (less than 100 shares) of our common shares, creating the potential for such shareholders
−Removed: to experience an increase in the cost of selling their shares and greater difficulty effecting such sales.
The market price of our securities may be
7 unchanged sentences
Our securities could be subject to wide fluctuations in price in response to a variety of factors, including the following:
−Removed: Failure to realize the anticipated potential of the DNase or PolyXen technologies;
+Added: Failure to realize the anticipated potential of the DNase technologies;
Adverse results, delays, or holds in pre-clinical or clinical studies;
19 unchanged sentences
Trading volume of our securities.
+Added: Actions of activist shareholders could
+Added: cause us to incur substantial costs, divert management's attention and resources, and have an adverse effect on our business.
+Added: We actively engage in discussions with our shareholders
+Added: regarding further strengthening our Company and creating long-term shareholder value.
+Added: Some shareholder activism, including potential proxy
+Added: contests, could result in substantial costs, such as legal fees and expenses, disrupt our operations, and divert management’s and
+Added: our Board of Directors’ attention and resources from our business and strategic plans.
+Added: Public shareholder activism can create perceived
+Added: uncertainties as to our future direction, strategy, or leadership and may result in the loss of potential business opportunities, harm
+Added: our ability to attract new employees, investors, collaborators and other partners, and cause our stock price to experience volatility.
+Added: These risks could adversely affect our financial performance.
Our preferred stockholders have rights,
14 unchanged sentences
As of March 7, 2025, we had approximately 1.5
−Removed: million shares of common stock outstanding, excluding 0.7 million of potentially dilutive common stock related to outstanding preferred
−Removed: stock, warrants, options, restricted stock and common stock awards.
+Added: million shares of common stock outstanding, excluding approximately 0.3 million of potentially dilutive common stock related to outstanding
+Added: preferred stock, warrants and options.
The issuance of these shares of common stock and
10 unchanged sentences
An active, liquid and orderly market for
−Removed: our common stock or purchase warrants may not develop.
−Removed: Our common stock and purchase warrants trade on
−Removed: the Nasdaq Capital Market.
−Removed: An active, liquid trading market for our common stock or purchase warrants may never develop or be sustained.
−Removed: If an active, liquid market for our common stock or purchase warrants does not continue to develop or is not sustained, it may be difficult
−Removed: for investors to sell shares or purchase warrants without depressing the market price, and investors may not be able to sell the shares
−Removed: or purchase warrants at all.
−Removed: An inactive or illiquid market may also impair our ability to raise capital by selling common stock or purchase
−Removed: warrants and may impair our ability to acquire other businesses, applications or technologies using our common stock or purchase warrants
−Removed: as consideration, which, in turn, could materially adversely affect our business.
−Removed: We have entered into several agreements
−Removed: with our stockholders.
+Added: our common stock may not develop.
+Added: Our common stock trades on the Nasdaq Capital
+Added: An active, liquid trading market for our common stock may never develop or be sustained.
+Added: If an active, liquid market for our common
+Added: stock does not continue to develop or is not sustained, it may be difficult for investors to sell shares or purchase warrants without
+Added: depressing the market price, and investors may not be able to sell the shares at all.
+Added: An inactive or illiquid market may also impair our
+Added: ability to raise capital by selling common stock and may impair our ability to acquire other businesses, applications or technologies
+Added: using our common stock or purchase warrants as consideration, which, in turn, could materially adversely affect our business.
+Added: We have entered into agreements with our
+Added: stockholders.
We have in the past, and may continue to enter
2 unchanged sentences
not have been negotiated at arm’s length and may contain terms and conditions that are not in our best interest.
−Removed: Actions of activist shareholders could cause
−Removed: us to incur substantial costs, divert management's attention and resources, and have an adverse effect on our business.
−Removed: We actively engage in discussions with our shareholders
−Removed: regarding further strengthening our Company and creating long-term shareholder value.
−Removed: Some shareholder activism, including potential proxy
−Removed: contests, could result in substantial costs, such as legal fees and expenses, disrupt our operations, and divert management’s and
−Removed: our Board of Directors’ attention and resources from our business and strategic plans.
−Removed: Public shareholder activism can create perceived
−Removed: uncertainties as to our future direction, strategy, or leadership and may result in the loss of potential business opportunities, harm
−Removed: our ability to attract new employees, investors, collaborators and other partners, and cause our stock price to experience volatility.
−Removed: These risks could adversely affect our financial performance.
We do not intend to pay dividends on our
16 unchanged sentences
General Risk Factors
+Added: We face potential product liability claims,
+Added: and, if successful claims are brought against us, we may incur substantial liability and costs.
+Added: If the use of our drug candidates harms
+Added: patients, or is perceived to harm patients even when such harm is unrelated to our drug candidates, our regulatory approvals could be
+Added: revoked or otherwise negatively impacted, and we could be subject to costly and damaging product liability claims.
+Added: The use of our drug candidates in clinical studies
+Added: and the sale of any products for which we obtain marketing approval exposes us to the risk of product liability claims.
+Added: Product liability
+Added: claims might be brought against us by consumers, healthcare providers, pharmaceutical companies or others selling or otherwise coming
+Added: into contact with our products.
+Added: There is a risk that our drug candidates may induce adverse events.
+Added: If we cannot successfully defend against
+Added: product liability claims, we could incur substantial liability and costs.
+Added: In addition, regardless of merit or eventual outcome, product
+Added: liability claims may result in, among other negative effects:
+Added: Impairment of our business reputation;
+Added: Withdrawal of clinical study participants;
+Added: Costs due to related litigation;
+Added: Distraction of management’s attention from our primary business;
+Added: Substantial monetary awards to patients or other claimants;
+Added: The inability to commercialize our drug candidates;
+Added: Decreased demand for our drug candidates, if approved for commercial sale,
+Added: all of which may have a material adverse effect
+Added: on our business, results of operations and prospects.
Our financial condition, results of operations,
6 unchanged sentences
public health epidemics and pandemics, or other outbreaks of communicable diseases, such as the COVID-19 pandemic, as well as from international
−Removed: conflicts, terrorism or other geopolitical events, such as the Russian invasion of Ukraine, and related sanctions and other economic disruptions
+Added: conflicts, terrorism or other geopolitical events, such as the conflicts in the Ukraine and the Middle East, and related sanctions and
+Added: other economic disruptions or concerns.
Additionally, the global economy and financial
markets may also be adversely affected by the current or anticipated impact of military conflict, terrorism or other geopolitical events,
−Removed: such as the wars in Ukraine and the Middle East.
+Added: such as the conflicts in Ukraine and the Middle East.
Sanctions imposed by the United States and other countries in response to such conflicts,
115 unchanged sentences
the imposition of civil monetary penalties, seizure of our products, or delay in approval or clearance of future products.
−Removed: We face potential product liability, and,
−Removed: if successful claims are brought against us, we may incur substantial liability and costs.
−Removed: If the use of our drug candidates harms patients,
−Removed: or is perceived to harm patients even when such harm is unrelated to our drug candidates, our regulatory approvals could be revoked or
−Removed: otherwise negatively impacted, and we could be subject to costly and damaging product liability claims.
−Removed: The use of our drug candidates in clinical studies
−Removed: and the sale of any products for which we obtain marketing approval exposes us to the risk of product liability claims.
−Removed: Product liability
−Removed: claims might be brought against us by consumers, healthcare providers, pharmaceutical companies or others selling or otherwise coming
−Removed: into contact with our products.
−Removed: There is a risk that our drug candidates may induce adverse events.
−Removed: If we cannot successfully defend against
−Removed: product liability claims, we could incur substantial liability and costs.
−Removed: In addition, regardless of merit or eventual outcome, product
−Removed: liability claims may result in, among other negative effects:
−Removed: Impairment of our business reputation;
−Removed: Withdrawal of clinical study participants;
−Removed: Costs due to related litigation;
−Removed: Distraction of management’s attention from our primary business;
−Removed: Substantial monetary awards to patients or other claimants;
−Removed: The inability to commercialize our drug candidates;
−Removed: Decreased demand for our drug candidates, if approved for commercial sale,
−Removed: all of which may have a material adverse effect
−Removed: on our business, results of operations and prospects.
If we fail to comply with environmental,
77 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.