11 unchanged sentences
We expect to incur losses over the next several years and may never achieve or maintain profitability.
−Removed: • We may not realize the expected benefits from our business restructuring and workforce reduction and we may incur additional costs implementing it or other difficulties.
+Added: • We have a pipeline that is primarily composed of early-stage and mid-stage programs, and clinical proof of concept has not yet been established for any of our product candidates.
+Added: Our ability to advance these molecules into clinical development, and successfully progress them through preclinical, clinical, and regulatory milestones, is highly uncertain.
+Added: The inherent risks of early-stage drug discovery and development, including challenges in translation from preclinical data to human studies, may prevent us from achieving meaningful clinical results, obtaining regulatory approval, or realizing the value of our pipeline assets.
• We require substantial additional funding to meet our financial needs and to pursue our business objectives.
14 unchanged sentences
• If we are unable to obtain and maintain patent and other intellectual property protection for our technology, or for our product candidates, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and drugs similar or identical to ours, and our ability to successfully commercialize our technology and product candidates may be impaired.
+Added: • We may not realize the expected benefits from our business restructuring and workforce reduction and we may incur additional costs or other difficulties.
• If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired.
8 unchanged sentences
In addition, we have limited experience as a company and have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biopharmaceutical industry.
−Removed: On August 8, 2024, we announced topline results from the Phase 2 part of the EBO-301 Phase 2/3 study evaluating epetraborole on top of optimized background regimen (“OBR”) in treatment-refractory MAC lung disease.
−Removed: The Phase 2 part of the study met its primary objective of demonstrating the potential validation of a novel patient-reported outcome (PRO) tool and a higher PRO-based clinical response rate in the epetraborole + OBR arm (39.5%) vs.
+Added: For example, in August 2024, we announced topline results from the Phase 2 part of the EBO-301 Phase 2/3 study evaluating epetraborole on top of OBR in treatment-refractory MAC lung disease.
+Added: The Phase 2 part of the study met its primary objective of demonstrating the potential validation of a novel PRO tool and a higher PRO-based clinical response rate in the epetraborole + OBR arm (39.5%) vs.
placebo + OBR (25.0%;
treatment difference 13.9%, p=0.19).
−Removed: Sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs.
+Added: However, sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs.
10.0% placebo + OBR;
treatment difference 3.4%, p=0.64).
−Removed: Epetraborole was generally well tolerated in the trial.
+Added: In May 2025, we announced that the truncated Phase 3 portion of the EBO-301 study did not meet its primary endpoint of demonstrating an improvement on the QOL-B respiratory domain PRO instrument (change from baseline to month 6), though epetraborole was generally well tolerated in the trial.
+Added: Based on these results, we decided to suspend further development of epetraborole for treatment-refractory MAC lung disease.
Our net loss was $35.2 million and $51.3 million for the years ended December 31, 2025 and 2024, respectively.
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Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
−Removed: We commenced active operations in November 2019, and our operations to date have been largely focused on raising capital, developing epetraborole, broadening our expertise in the development of epetraborole, undertaking preclinical and nonclinical studies, manufacturing clinical trial material, preparing for and initiating clinical trials, and general and administrative operations.
+Added: We commenced active operations in November 2019, and our operations to date have been largely focused on raising capital, developing epetraborole and other product candidates, broadening our expertise in the development of epetraborole, and other product candidates, undertaking preclinical and nonclinical studies, manufacturing clinical trial material, preparing for and initiating clinical trials, and general and administrative operations.
As a company, we have not yet demonstrated an ability to successfully complete pivotal clinical trials, obtain regulatory approvals, manufacture a commercial product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization.
1 unchanged sentence
We have and may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives.
−Removed: For example, in August 2024, we announced topline data from the Phase 2 portion of our Phase 2/3 clinical trial evaluating our initial product candidate, epetraborole, in patients with treatment-refractory MAC lung disease.
−Removed: Although the Phase 2 part of the study met its primary objective in demonstrating the potential validation of a novel patient-reported outcome (PRO) tool and a higher PRO-based clinical response rate in the epetraborole + OBR arm (39.5%) vs.
−Removed: placebo + OBR (25.0%;
−Removed: treatment difference 13.9%, p=0.19), sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs.
−Removed: 10.0% placebo + OBR;
−Removed: treatment difference 3.4%, p=0.64).
−Removed: Given these results, we decided to close out the trial and are in the process of planning to unblind the Phase 3 part of the study and meet with the FDA to determine next steps.
+Added: For example, in May 2025, we decided to discontinue our development of epetraborole for treatment-refractory MAC lung disease following the failure of the truncated Phase 3 portion of the EBO-301 study to meet its primary endpoint.
In addition, we will need to transition successfully at some point from a company with a research and development focus to a company capable of supporting commercial activities.
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Accordingly, you should not rely upon the results of any quarterly or annual periods as indications of future operating performance.
−Removed: We may not realize the expected benefits from our business restructuring and workforce reduction and we may incur additional costs implementing it or other difficulties.
−Removed: In August 2024, we announced a business restructuring plan and implemented a workforce reduction.
−Removed: The objective of these initiatives was to focus the organization and our resources on product candidates and development compounds to treat Chagas diseases, NTM, melioidosis, other infectious diseases, and oncology while we continue to evaluate the TR-MAC program.
−Removed: However, the changes to our business strategy and the reduction in workforce may yield unintended consequences and costs, such as the loss of institutional knowledge and expertise, attrition beyond our intended workforce reduction, a reduction in morale among our remaining employees, and the risk that we may not achieve the anticipated benefits, all of which may have an adverse effect on our development activities, ability to progress our product candidate development, and results of operations or financial condition.
−Removed: As a result of the workforce reduction, we have recognized severance and other charges of $2.2 million as of December 31, 2024, primarily consisting of severance payments and other employee termination-related expenses.
−Removed: We may also incur other charges, costs, future cash expenditures or impairments not currently contemplated due to events that may occur as a result of, or in connection with, the revised business strategy and workforce reduction.
−Removed: In addition, we may be unsuccessful in distributing the duties and obligations of departed employees among our remaining employees.
−Removed: We may also discover that the workforce reduction and cost cutting measures will make it difficult for us to pursue new opportunities and initiatives and require us to hire qualified replacement personnel, which may require us to incur additional and unanticipated costs and expenses.
−Removed: Moreover, there is no assurance we will be successful in our pursuit of any of our new goals.
−Removed: Our failure to successfully accomplish any of the above activities and goals may have a negative impact on our business, financial condition, results of operations and growth prospects.
We require substantial additional funding to meet our financial needs and to pursue our business objectives.
1 unchanged sentence
We believe that our existing cash, cash equivalents, and investments will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months.
−Removed: However, we will need to obtain substantial additional funding in connection with our continuing operations and planned activities.
+Added: However, in addition to the $40.0 million financing completed in March 2026, we will need to obtain substantial additional funding in connection with our continuing operations and planned activities.
Our future capital requirements will depend on many factors, including:
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We currently have no products approved for sale and have historically invested a significant portion of our efforts and financial resources on the development of our initial product candidate, epetraborole, as a treatment for treatment-refractory MAC lung disease.
−Removed: Although we have discontinued our development efforts with respect to epetraborole in the treatment-refractory MAC population studied in the EBO-301 trial until completion of discussions with the FDA to align on potential next steps, our business remains heavily dependent on the successful development, regulatory approval, and, if approved, commercialization of our product candidates.
−Removed: We cannot be certain that any product candidate will receive regulatory approval or will be successfully commercialized even if it receives regulatory approval.
+Added: Although we have discontinued our development efforts with respect to epetraborole in the treatment-refractory MAC population, our business remains heavily dependent on the successful development, regulatory approval, and, if approved, commercialization of our product candidates.
+Added: We cannot be certain that any product candidate will advance through each of the various stages of drug development and receive regulatory approval or will be successfully commercialized even if it receives regulatory approval.
The research, development, manufacturing, safety, efficacy, labeling, approval, sale, marketing and distribution of our product candidates are, and will remain, subject to comprehensive regulation by the FDA and other comparable foreign regulatory authorities.
2 unchanged sentences
These delays or failures could be caused by a variety of factors, including but not limited to, toxicity, safety, tolerability, efficacy, problems with clinical trial enrollment, drug product availability, stability, and impurity issues related to drug product manufacturing.
−Removed: For example, in August 2024, we announced topline data from the Phase 2 portion of EBO-301, our Phase 2/3 clinical trial evaluating epetraborole in patients with treatment-refractory MAC lung disease.
−Removed: Although the Phase 2 part of the study met its primary objective in demonstrating the potential validation of a novel patient-reported outcome (“PRO”) tool and a non-significant, but numerically higher PRO-based clinical response rate in the epetraborole + OBR arm (39.5%) vs.
−Removed: placebo + OBR (25.0%;
−Removed: treatment difference 13.9%, p=0.19), sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs.
−Removed: 10.0% placebo + OBR;
−Removed: treatment difference 3.4%, p=0.64).
−Removed: Given these topline results, we decided to close out the Phase 3 portion of the trial and commence a review of data to help inform further development.
−Removed: Although we believe that to date our ongoing data review supports the continued development of epetraborole in patients with treatment-refractory MAC lung disease, it is possible that we will determine to defer or discontinue development of epetraborole in NTM, whether due to further FDA feedback or otherwise.
−Removed: Failure to obtain regulatory approval for our product candidates in the United States or other territories will prevent us from commercializing and marketing such product candidates.
+Added: For example, in May 2025, we decided to discontinue our development of epetraborole for treatment-refractory MAC lung disease following the failure of the truncated Phase 3 portion of the EBO-301 study to meet its primary endpoint.
+Added: Failure to obtain regulatory approval for our product candidates in the U.S.
+Added: or other territories will prevent us from commercializing and marketing such product candidates.
The success of our product candidates will depend on several additional factors, including:
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• maintaining a continued acceptable safety and tolerability profile of our drugs following approval;
−Removed: • allowance to proceed with clinical trials under future investigational new drug applications ("INDs"), or under comparable applications submitted outside the United States.
+Added: • allowance to proceed with clinical trials under future INDs, or under comparable applications submitted outside the U.S.
If we do not achieve these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product candidates, which would harm our business.
We may not be successful in our efforts to build a pipeline of product candidates.
−Removed: A key element of our strategy is to develop our AN2 drug discovery platform, build a pipeline of product candidates and progress these product candidates through clinical development for the treatment of Chagas disease, NTM, melioidosis, other infectious diseases, and in oncology.
+Added: A key element of our strategy is to develop our AN2 drug discovery platform, build a pipeline of product candidates and progress these product candidates through clinical development for the treatment of PV, M.
+Added: abscessus lung disease, Chagas disease, melioidosis, tuberculosis, other infectious diseases, and in oncology.
+Added: Our pipeline is primarily composed of early-stage and mid-stage programs, and clinical proof of concept has not yet been established for any of our product candidates.
We may not be able to develop product candidates that are safe and effective for any proposed use.
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There can be no assurance that any clinical trials we conduct will be sufficient for product approval.
−Removed: Prior to marketing any product candidate in the United States, we must demonstrate that such product candidate is safe and provide substantial evidence of effectiveness for its intended uses.
+Added: Prior to marketing any product candidate in the U.S., we must demonstrate that such product candidate is safe and provide substantial evidence of effectiveness for its intended uses.
The FDA has generally interpreted the “substantial evidence” requirements as requiring sponsors to conduct two adequate and well-controlled Phase 3 clinical trials.
However, in some circumstances, the FDA may conclude that substantial evidence of efficacy has been demonstrated through the conduct of one adequate and well-controlled clinical trial, plus confirmatory evidence (whether obtained prior to or after such trial).
−Removed: Regardless of the clinical development plans we decide to pursue with respect to our product candidates, there can be no assurance that the FDA will not require additional clinical trials for approval of such product candidates beyond the trials that we currently plan to conduct, even if we successfully complete the trial and believe the results are sufficiently positive.
−Removed: As a company, we have limited experience designing and conducting clinical trials in the United States or other geographies and may be unable to design and execute a clinical trial to support regulatory approval.
+Added: Regardless of the clinical development plans we decide to pursue with respect to our product candidates, there can be no assurance that the FDA will not require additional clinical trials for approval of such product candidates beyond the trials that we currently plan to conduct, including in other geographies, even if we successfully complete the trial and believe the results are sufficiently positive.
+Added: As a company, we have limited experience designing and conducting clinical trials in the U.S.
+Added: or other geographies and may be unable to design and execute a clinical trial to support regulatory approval.
In addition, the design and results of our clinical trials may not be sufficient to support approval, since factors such as an inappropriate dosage or flaws in the design of a clinical trial may not become apparent until the clinical trial is in progress or data are available.
1 unchanged sentence
Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in later-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage clinical trials.
−Removed: For example, in August 2024, we announced topline data from the Phase 2 portion of our Phase 2/3 clinical trial evaluating epetraborole in patients with treatment-refractory MAC lung disease.
−Removed: Although we believe the Phase 2 part of the study met its primary objective in demonstrating the potential validation of a novel patient-reported outcome (PRO) tool and a higher PRO-based clinical response rate in the epetraborole + OBR arm (39.5%) vs.
−Removed: placebo + OBR (25.0%;
−Removed: treatment difference 13.9%, p=0.19), sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs.
−Removed: 10.0% placebo + OBR;
−Removed: treatment difference 3.4%, p=0.64).
−Removed: Given these results, we decided to close the Phase 3 portion of the trial and to commence a review of data to help inform further development.
−Removed: Although we believe that our ongoing data review to date supports the continued development of epetraborole in patients with treatment-refractory MAC lung disease, it is possible that we will defer or discontinue development of epetraborole in NTM, whether due to further FDA feedback or otherwise.
−Removed: For example, based on the results from the Phase 2 portion of the EBO-301 trial, we submitted an amended statistical analysis plan for the EBO-301 trial selecting the Quality of Life – Bronchiectasis (QOL-B) respiratory domain patient reported outcome (PRO) instrument as the revised primary efficacy endpoint.
−Removed: However, the FDA may not consider the data from the Phase 3 portion of the trial to be clinically meaningful or otherwise supportive for regulatory decision-making purposes, even if the Phase 3 data show a statistically significant outcome with respect to QOL-B.
+Added: For example, in May 2025, we announced that the truncated Phase 3 portion of the EBO-301 study did not meet its primary endpoint of demonstrating an improvement on the QOL-B respiratory domain PRO instrument (change from baseline to month 6), though epetraborole was generally well tolerated in the trial.
+Added: Based on these results, we decided to suspend further development of epetraborole for treatment-refractory MAC lung disease.
+Added: There is no guarantee that we will not experience similar setbacks with respect to our other product candidates.
If clinical trials of our product candidates fail to demonstrate safety and/or efficacy of such product candidates to the satisfaction of the FDA or other comparable regulatory authorities, or do not otherwise produce favorable results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
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If we are not successful in discovering, developing and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired.
−Removed: Although a substantial amount of our effort will focus on potential clinical testing and potential regulatory approval of our current and future product candidates, including the development of AN2-502998, a boron-based small molecule therapeutic candidate for the treatment of Chagas disease, epetraborole for NTM or melioidosis, and other development compounds, an element of our strategy is to discover, develop and commercialize a portfolio of product candidates to treat diseases with high unmet need.
+Added: Although a substantial amount of our effort will focus on potential clinical testing and potential regulatory approval of our product candidates, an element of our strategy is to discover, develop and commercialize a portfolio of product candidates to treat diseases with high unmet need.
We are seeking to do so by utilizing our targeted-design AN2 drug discovery platform, which uses bacterial genomics and state-of-the-art molecular and dynamic models to design active new compounds that target known mechanisms.
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• product candidates we develop may nevertheless be covered by third parties’ patents or other exclusive rights;
−Removed: • a product candidate may on further study be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;
+Added: • a product candidate may reveal harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;
• a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all;
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• the risk that patients enrolled in clinical trials will drop out of the trials before completion.
−Removed: In particular, we may face delays and difficulties in enrollment in our planned trials of certain of our product candidates because Chagas disease and certain other conditions we may target include rare diseases (i.e., the size of the targeted patient population is small).
+Added: In particular, we may face delays and difficulties in enrollment in our planned trials of certain of our product candidates because PV, M.
+Added: abscessus, Chagas disease and certain other conditions we may target include rare diseases (i.e., the size of the targeted patient population is small).
Because of this, we may experience difficulties in recruiting sufficient patients into certain of our planned clinical trials.
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If the interim, topline or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, financial condition, operating results, growth prospects.
−Removed: We may conduct clinical trials for our product candidates outside of the United States, and the FDA may not accept data from such trials, in which case our development plans may be delayed, which could materially harm our business.
−Removed: We conduct and may in the future conduct one or more of our clinical trials or a portion of our clinical trials for our product candidates outside the United States.
−Removed: The acceptance of study data from clinical trials conducted outside the United States or another jurisdiction by the FDA or comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all.
−Removed: In cases where data from foreign clinical trials are intended to serve as the sole basis for regulatory approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S.
+Added: We may conduct clinical trials for our product candidates outside of the U.S., and the FDA may not accept data from such trials, in which case our development plans may be delayed, which could materially harm our business.
+Added: We conduct and may in the future conduct one or more of our clinical trials or a portion of our clinical trials for our product candidates outside the U.S.
+Added: For instance, we will be initiating a PV Phase 2 study in India.
+Added: The acceptance of study data from clinical trials conducted outside the U.S.
+Added: or another jurisdiction by the FDA or comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all.
+Added: In cases where data from foreign clinical trials are intended to serve as the sole basis for regulatory approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S.
population and U.S.
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Moreover, we and our CROs are required to comply with regulations and comply with good laboratory practice requirements for the conduct of certain preclinical studies and GCP requirements for clinical trials, which are regulations and guidelines enforced by the FDA, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected.
−Removed: Similar regulatory requirements apply outside the United States, including the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use.
+Added: Similar regulatory requirements apply outside the U.S., including the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use.
Regulatory authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators and trial sites.
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Our current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to develop product candidates and commercialize any products that receive regulatory approval on a timely and competitive basis.
+Added: Evaluation of our product candidates in investigator-initiated clinical trials (“IITs”) may expose us to additional risks that could impair the development of our product candidates.
+Added: We are currently supporting an IIT evaluating epetraborole in patients with M.
+Added: abscessus lung disease, and may in the future support other IITs for our product candidates that are designed and managed by independent investigators or institutions.
+Added: While we believe these clinical trials have the potential to provide supportive data that may further the development of our product candidates, we do not directly control the clinical development process, including, but not limited to, the initiation, enrollment, safety reporting, or conduct of these trials.
+Added: As a result, investigator-sponsored trials may be subject to significant delays.
+Added: fail to comply with GCP or other regulatory requirements.
+Added: be terminated prematurely by the investigator or applicable IRBs or ethics committees, or produce data that is not useful for, or acceptable to, regulatory authorities for purposes of obtaining regulatory approval.
+Added: IITs may also identify safety or tolerability concerns that could adversely affect the development of our product candidates, including through the imposition of clinical holds, or otherwise subject us to liability.
+Added: Moreover, if the data from IITs differ from the data we have observed in our sponsored clinical studies, such differences could potentially require us to conduct additional clinical trials or otherwise delay or prevent regulatory approval from the FDA or other regulatory authorities.
+Added: Any of these factors could adversely impact our reputation, delay our development timelines, or negatively affect our ability to obtain regulatory approval.
Risks Related to the Commercialization of Our Product Candidates
−Removed: Even if any of our product candidates receives regulatory approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community necessary for commercial success.
+Added: Even if any of our product candidates receive regulatory approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community necessary for commercial success.
Even if we obtain approvals from the FDA or other comparable regulatory agencies and are able to initiate commercialization of any of our product candidates, such product candidates may not achieve market acceptance among physicians, patients and third-party payors and, ultimately, may not be commercially successful.
2 unchanged sentences
• the potential and perceived advantages and disadvantages of the product candidates, including cost and clinical benefit relative to alternative treatments;
−Removed: • the convenience and ease of once-a-day oral administration compared to alternative treatments (e.g., inhaled drug through nebulizer);
+Added: • the convenience and ease of once-a-day oral administration compared to alternative treatments;
• the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
22 unchanged sentences
These third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
−Removed: In addition, following the announcement of topline data from the Phase 2 portion of our Phase 2/3 clinical trial evaluating epetraborole, we effected a restructuring resulting in the elimination of a significant portion of the workforce and could result in additional unplanned loss of personnel.
+Added: In addition, following the August 2024 announcement of topline data from the Phase 2 portion of our Phase 2/3 clinical trial evaluating epetraborole, we effected a restructuring resulting in the elimination of a significant portion of the workforce and could result in additional unplanned loss of personnel.
Continued disruption caused by the transition or by the loss of ongoing services of any qualified scientific and management personnel could delay or prevent the successful development of our current and future product candidates.
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To achieve commercial success for any product candidate for which we may obtain regulatory approval, we will need to establish a sales and marketing organization or enter into collaboration, distribution and other marketing arrangements with one or more third parties to commercialize such product candidate.
−Removed: In the United States and other key markets, we intend to build a commercial organization to target areas with the greatest incidence of conditions for which we may at some point obtain regulatory approval and recruit experienced sales, marketing and distribution professionals.
+Added: and other key markets, we intend to build a commercial organization to target areas with the greatest incidence of conditions for which we may at some point obtain regulatory approval and recruit experienced sales, marketing and distribution professionals.
The development of sales, marketing and distribution capabilities will require substantial resources, will be time-consuming and could delay any product launch.
−Removed: We may decide to work with regional specialty pharmacies, distributors, and/or multi-national pharmaceutical companies to leverage their commercialization capabilities to commercialize any product candidate for which we may obtain regulatory approval outside of the United States.
+Added: We may decide to work with regional specialty pharmacies, distributors, and/or multi-national pharmaceutical companies to leverage their commercialization capabilities to commercialize any product candidate for which we may obtain regulatory approval outside of the U.S.
If the commercial launch of a product candidate for which we recruit a sales force and establish marketing and distribution capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization costs.
This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.
−Removed: In addition, we may not be able to hire a sales force in the United States that is sufficient in size or has adequate expertise to target the areas that we intend to target.
+Added: In addition, we may not be able to hire a sales force in the U.S.
+Added: that is sufficient in size or has adequate expertise to target the areas that we intend to target.
If we are unable to establish a sales force and marketing and distribution capabilities, our operating results may be adversely affected.
5 unchanged sentences
• unforeseen costs and limitations with regard to setting up a distribution network.
−Removed: If we are unable to establish our own sales, marketing and distribution capabilities in the United States and other jurisdictions in which any of our product candidates are approved and, instead, enter into arrangements with third parties to perform these services, our revenues and profitability, if any, are likely to be lower than if we were to sell, market and distribute any product candidates that we develop ourselves.
+Added: If we are unable to establish our own sales, marketing and distribution capabilities in the U.S.
+Added: and other jurisdictions in which any of our product candidates are approved and, instead, enter into arrangements with third parties to perform these services, our revenues and profitability, if any, are likely to be lower than if we were to sell, market and distribute any product candidates that we develop ourselves.
We may not be successful in entering into arrangements with third parties to sell, market and distribute our product candidates or may be unable to do so on terms that are favorable to us.
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There are a variety of risks associated with marketing our product candidates internationally, which could affect our business.
−Removed: We may seek regulatory approval for our product candidates outside of the United States and, accordingly, we expect that we will be subject to additional risks related to operating in foreign countries if we obtain the necessary approvals, including:
+Added: We may seek regulatory approval for our product candidates outside of the U.S.
+Added: and, accordingly, we expect that we will be subject to additional risks related to operating in foreign countries if we obtain the necessary approvals, including:
• differing regulatory requirements and reimbursement landscapes in foreign countries;
6 unchanged sentences
• difficulties staffing and managing foreign operations;
−Removed: • workforce uncertainty in countries where labor unrest is more common than in the United States;
+Added: • workforce uncertainty in countries where labor unrest is more common than in the U.S.;
• potential liability under the U.S.
Foreign Corrupt Practices Act of 1977, as amended (the “FCPA”), or comparable foreign regulations;
−Removed: • challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;
+Added: • challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the U.S.;
• production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;
3 unchanged sentences
We operate with a small team and our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
−Removed: We are highly dependent on the management, research and development, financial and business development expertise of Eric Easom, our co-founder, president, and chief executive officer, Sanjay Chanda, Ph.D., our chief development officer, Lucy Day, our chief financial officer, Josh Eizen, J.D., our chief legal and operating officer, Michael R.K.
−Removed: (Dickon) Alley, Ph.D., our co-founder and SVP research fellow and head of biology, Stephen Prior, Ph.D., our chief strategy officer, and Vincent Hernandez, our senior vice president research and head of chemistry, as well as the other members of our research, development, and business teams.
+Added: We are highly dependent on the management, research and development, financial and business development expertise of our key executives, as well as the other members of our research, development, and business teams.
Each may terminate employment with us at any time.
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Similarly, volatility and disruptions in global markets and supply chains, tariffs, and global conflicts may adversely affect our business or the third parties on whom we rely.
−Removed: If the equity and credit markets deteriorate, including as a result of political unrest or war, or new tariffs, it may make any necessary debt or equity financing more difficult to obtain in a timely manner or on favorable terms, more costly or more dilutive.
+Added: If the equity and credit markets deteriorate, including as a result of political unrest or war, or new tariffs and any retaliatory trade protection measures or trade wars that ensue, it may make any necessary debt or equity financing more difficult to obtain in a timely manner or on favorable terms, more costly or more dilutive.
Increased inflation rates can adversely affect us by increasing our costs, including labor and employee benefit costs.
43 unchanged sentences
If we are unable to obtain and maintain patent and other intellectual property protection for our technology, or for our product candidates, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and drugs similar or identical to ours, and our ability to successfully commercialize our technology and product candidates may be impaired.
−Removed: Our success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries with respect to our product candidates.
−Removed: We seek to protect our proprietary position by developing and in-licensing intellectual property relating to our product candidates including patent applications in the United States and abroad related to our technology and product candidates that are important to our business.
+Added: Our success depends in large part on our ability to obtain and maintain patent protection in the U.S.
+Added: and other countries with respect to our product candidates.
+Added: We seek to protect our proprietary position by developing and in-licensing intellectual property relating to our product candidates including patent applications in the U.S.
+Added: and abroad related to our technology and product candidates that are important to our business.
If we or our licensors do not adequately protect the intellectual property we in-license or own, competitors may be able to use our technologies and erode or negate any competitive advantage that we may have, which could harm our business and ability to achieve profitability.
−Removed: To protect our proprietary positions, we and our licensors file patent applications in the United States and abroad related to our novel technologies and product candidates that are important to our business.
+Added: To protect our proprietary positions, we and our licensors file patent applications in the U.S.
+Added: and abroad related to our novel technologies and product candidates that are important to our business.
The patent application and prosecution process is expensive and time-consuming.
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The patent position of biotechnology and pharmaceutical companies generally is highly uncertain and has been the subject of much litigation in recent years.
−Removed: Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection.
−Removed: In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States.
−Removed: No consistent policy regarding the breadth of claims allowed in biotechnology and pharmaceutical patents has emerged to date in the United States or in many foreign jurisdictions.
+Added: Changes in either the patent laws or interpretation of the patent laws in the U.S.
+Added: and other countries may diminish the value of our patents or narrow the scope of our patent protection.
+Added: In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the U.S.
+Added: No consistent policy regarding the breadth of claims allowed in biotechnology and pharmaceutical patents has emerged to date in the U.S.
+Added: or in many foreign jurisdictions.
In addition, the determination of patent rights with respect to pharmaceutical compounds and technologies commonly involves complex legal and factual questions, which has in recent years been the subject of much litigation.
As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain.
−Removed: Furthermore, recent changes in patent laws in the United States, including the America Invents Act of 2011, and future changes in patent laws in or outside the United States may affect the scope, strength and enforceability of our patent rights or the nature of proceedings that may be brought by us related to our patent rights.
+Added: Furthermore, recent changes in patent laws in the U.S., including the America Invents Act of 2011, and future changes in patent laws in or outside the U.S.
+Added: may affect the scope, strength and enforceability of our patent rights or the nature of proceedings that may be brought by us related to our patent rights.
We may not be aware of all third-party intellectual property rights potentially relating to our product candidates.
−Removed: Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all.
+Added: Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the U.S.
+Added: and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all.
Therefore, we cannot be certain that we or our licensors were the first to make the inventions claimed in patents or pending patent applications that we in-license or own, or that we or our licensors were the first to file for patent protection of such inventions.
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Moreover, we or our licensors may be subject to a third-party pre-issuance submission of prior art to the U.S.
−Removed: Patent and Trademark Office (“USPTO”), or become involved in opposition, derivation, reexamination, inter partes review, or interference proceedings, in the United States or elsewhere, challenging our patent rights or the patent rights of others.
+Added: Patent and Trademark Office (“USPTO”), or become involved in opposition, derivation, reexamination, inter partes review, or interference proceedings, in the U.S.
+Added: or elsewhere, challenging our patent rights or the patent rights of others.
An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or product candidates, and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize product candidates without infringing third-party patent rights.
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In any of these types of proceedings, a court, or other agency with jurisdiction may find our in-licensed patents or any owned patents, should such patents issue in the future, not infringed, invalid and/or unenforceable.
−Removed: The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability, and our in-licensed patents or patents we may own in the future may be challenged in the courts or patent offices in the United States and abroad.
+Added: The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability, and our in-licensed patents or patents we may own in the future may be challenged in the courts or patent offices in the U.S.
Such challenges may result in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and product candidates, or limit the duration of the patent protection of our technology and product candidates.
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Anacor has relied upon, our other licensors may have relied upon, and any future licensors may rely upon, third-party companies, consultants or collaborators, or on funds from third parties such that our licensors are not the sole and exclusive owners of the patents we in-licensed.
−Removed: We have sublicensed certain patents from Anacor that are owned, maintained and prosecuted by GSK.
+Added: We have sublicensed certain patents from Anacor that are owned, maintained and prosecuted by GlaxoSmithKline plc (“GSK”).
If third-party companies such as GSK fail to prosecute, maintain, enforce and defend such patents, or lose rights to those patents, the rights we have licensed may be reduced or eliminated, and our right to develop and commercialize our product candidates that are the subject of such licensed rights could be adversely affected.
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In addition, our in-licensed patents may become involved in inventorship or priority disputes.
−Removed: Third parties may raise challenges to the validity of certain of our in-licensed patent claims and may in the future raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation.
+Added: Third parties may raise challenges to the validity of certain of our in-licensed patent claims and may in the future raise similar claims before administrative bodies in the U.S.
+Added: or abroad, even outside the context of litigation.
For example, we may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in derivation, revocation, reexamination, post-grant review (“PGR”), inter partes review (“IPR”), interference proceedings and equivalent proceedings in foreign jurisdictions, such as opposition proceedings challenging any patents that we may own or in-license.
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Our competitors may infringe our trademarks and we may not have adequate resources to enforce our trademarks and may not be able to prevent such third parties from using and marketing any such trademarks.
−Removed: In addition, any proprietary name we propose to use with any product candidate in the United States must be approved by the FDA, regardless of whether we have registered it, or applied to register it, as a trademark.
+Added: In addition, any proprietary name we propose to use with any product candidate in the U.S.
+Added: must be approved by the FDA, regardless of whether we have registered it, or applied to register it, as a trademark.
The FDA typically conducts a review of proposed product names, including an evaluation of the potential for confusion with other product names.
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Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, distracting to management, and time-consuming, and the outcome is unpredictable and varied depending on the jurisdiction.
−Removed: In addition, some courts inside and outside the United States, in countries in which we operate or intend to operate, are less willing, or unwilling, to protect trade secrets, know-how and other proprietary information.
+Added: In addition, some courts inside and outside the U.S., in countries in which we operate or intend to operate, are less willing, or unwilling, to protect trade secrets, know-how and other proprietary information.
Any claims or litigation could cause us to incur significant expenses.
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Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
−Removed: Periodic maintenance fees, renewal fees, annuity fees and various other government fees on patents and patent applications will be due to be paid to the USPTO and various government patent agencies outside of the United States over the lifetime of our owned or in-licensed patents and patent applications.
+Added: Periodic maintenance fees, renewal fees, annuity fees and various other government fees on patents and patent applications will be due to be paid to the USPTO and various government patent agencies outside of the U.S.
+Added: over the lifetime of our owned or in-licensed patents and patent applications.
In certain circumstances, we rely on our licensing partners to pay these fees due to U.S.
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We may not be able to protect our intellectual property rights throughout the world.
−Removed: Filing, prosecuting, enforcing and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States could be less extensive than those in the United States.
−Removed: In some cases, we or our licensors may not be able to obtain patent protection for certain licensed technology outside the United States.
−Removed: In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States, even in jurisdictions where we or our licensors do pursue patent protection.
−Removed: Consequently, we may not be able to prevent third parties from practicing our in-licensed inventions in all countries outside the United States, even in jurisdictions where our licensors do pursue patent protection or from selling or importing products made using our inventions in and into the United States or other jurisdictions.
−Removed: In addition, geo-political actions in the United States and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications or those of any current or future licensors and the maintenance, enforcement or defense of our issued patents or those of any current or future licensors.
−Removed: For example, the United States and foreign government actions related to Russia’s conflict in Ukraine may limit or prevent filing, prosecution, and maintenance of patent applications in Russia.
+Added: Filing, prosecuting, enforcing and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the U.S.
+Added: could be less extensive than those in the U.S.
+Added: In some cases, we or our licensors may not be able to obtain patent protection for certain licensed technology outside the U.S.
+Added: In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the U.S., even in jurisdictions where we or our licensors do pursue patent protection.
+Added: Consequently, we may not be able to prevent third parties from practicing our in-licensed inventions in all countries outside the U.S., even in jurisdictions where our licensors do pursue patent protection or from selling or importing products made using our inventions in and into the U.S.
+Added: or other jurisdictions.
+Added: In addition, geo-political actions in the U.S.
+Added: and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications or those of any current or future licensors and the maintenance, enforcement or defense of our issued patents or those of any current or future licensors.
+Added: For example, the U.S.
+Added: and foreign government actions related to Russia’s conflict in Ukraine may limit or prevent filing, prosecution, and maintenance of patent applications in Russia.
Government actions may also prevent maintenance of issued patents in Russia.
These actions could result in abandonment or lapse of our patents or patent applications, resulting in partial or complete loss of patent rights in Russia.
−Removed: In addition, a decree was adopted by the Russian government in March 2022, allowing Russian companies and individuals to exploit inventions owned by patentees from the United States without consent or compensation.
+Added: In addition, a decree was adopted by the Russian government in March 2022, allowing Russian companies and individuals to exploit inventions owned by patentees from the U.S.
+Added: without consent or compensation.
Consequently, we would not be able to prevent third parties from practicing our inventions in Russia or from selling or importing products made using our inventions in and into Russia.
Accordingly, our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely affected.
−Removed: Competitors may use our technologies in jurisdictions where we or our licensors have not pursued and obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States.
+Added: Competitors may use our technologies in jurisdictions where we or our licensors have not pursued and obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the U.S.
These products may compete with our product candidates and our preclinical programs.
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If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired.
−Removed: Our product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, record-keeping, labeling, storage, approval, advertising, promotion, sale, import, export and distribution, are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable foreign regulatory authorities, with regulations differing from country to country.
+Added: Our product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, record-keeping, labeling, storage, approval, advertising, promotion, sale, import, export and distribution, are subject to comprehensive regulation by the FDA and other regulatory agencies in the U.S.
+Added: and by comparable foreign regulatory authorities, with regulations differing from country to country.
Failure to obtain regulatory approval for a product candidate will prevent us from commercializing the product candidate.
We currently do not have any products approved for sale in any jurisdiction.
−Removed: For example, we are not permitted to market any product candidate in the United States until we receive regulatory approval of an NDA from the FDA.
+Added: For example, we are not permitted to market any product candidate in the U.S.
+Added: until we receive regulatory approval of an NDA from the FDA.
We as a company only have limited experience in filing and supporting the applications necessary to gain regulatory approvals and may rely on third-party contract research organizations to assist us in this process.
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We have not sought or obtained regulatory approval for any product candidate, and it is possible that any product candidates we may seek to develop will never obtain regulatory approval.
−Removed: In order to obtain approval to commercialize a product candidate in the United States or abroad, we or our collaborators must demonstrate to the satisfaction of the FDA or foreign regulatory agencies, that such product candidates are safe and effective for their intended uses.
+Added: In order to obtain approval to commercialize a product candidate in the U.S.
+Added: or abroad, we or our collaborators must demonstrate to the satisfaction of the FDA or foreign regulatory agencies, that such product candidates are safe and effective for their intended uses.
Results from nonclinical studies and clinical trials can be interpreted in different ways.
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• refusals by regulators to accept a submission due to, among other reasons, the content or formatting of the submission;
−Removed: • changes in a policies, requirements, or regulations rendering our clinical data insufficient for approval.
+Added: • changes in policies, requirements, or regulations rendering our clinical data insufficient for approval.
Of the large number of drugs in development, only a small percentage complete the FDA or foreign regulatory approval processes and are successfully commercialized.
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Any delay in obtaining, or inability to obtain, applicable regulatory approval would delay or prevent commercialization of that product candidate and would materially adversely impact our business and prospects.
−Removed: Disruptions at the FDA and other government agencies caused by the transition to a new administration with different philosophies, funding shortages, staffing limitations, or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, prevent new or modified products from being developed, reviewed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
+Added: Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations, or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, prevent new or modified products from being developed, reviewed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
The ability of the FDA and foreign regulatory authorities to review and approve new products can be affected by a variety of factors, including the transition to a new administration, government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s or foreign regulatory authorities’ ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s or foreign regulatory authorities’ ability to perform routine functions.
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We may not be able to obtain or maintain orphan drug designations for any product candidates, and we may be unable to take advantage of the benefits associated with orphan drug designation, including the potential for market exclusivity.
−Removed: Regulatory authorities in some jurisdictions, including the United States, may designate drugs for relatively small patient populations as orphan drugs.
−Removed: Under the Orphan Drug Act of 1983, the FDA may designate a product as an orphan product if it is intended to treat a rare disease or condition, which is generally defined as a diagnosed patient population of fewer than 200,000 individuals in the United States, or a patient population of greater than 200,000 individuals in the United States, but for which there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States.
+Added: Regulatory authorities in some jurisdictions, including the U.S., may designate drugs for relatively small patient populations as orphan drugs.
+Added: Under the Orphan Drug Act of 1983, the FDA may designate a product as an orphan product if it is intended to treat a rare disease or condition, which is generally defined as a diagnosed patient population of fewer than 200,000 individuals in the U.S., or a patient population of greater than 200,000 individuals in the U.S., but for which there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the U.S.
Similar laws exist in Europe and Japan.
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There can be no assurance that any regulatory authority will grant any orphan drug designations.
−Removed: In the United States, orphan designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers.
−Removed: In addition, if a product candidate that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, it is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications, including an NDA, to market the same drug for the same disease or condition for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or where the manufacturer is unable to assure sufficient product quantity.
−Removed: More than one product may be approved by the FDA for the same orphan disease or condition, as long as the products are different drugs, as determined by the FDA.
−Removed: As a result, if any of our product candidates is approved by the FDA and receives orphan drug exclusivity, absent other applicable exclusivities, the FDA can still approve other drugs for use in treating the same indication or disease, which could create a more competitive market for us.
+Added: In the U.S., orphan designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers.
+Added: In addition, if a product candidate that has orphan drug designation subsequently receives the first FDA approval for the rare disease or condition for which it has such designation, it is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications, including an NDA, to market the same drug for the same approved use or indication within the relevant rare disease or condition for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity within the relevant approved use or indication or where the manufacturer is unable to assure sufficient product quantity.
+Added: More than one product may be approved by the FDA for the same use or indication within the orphan disease or condition, as long as the products are different drugs, as determined by the FDA.
+Added: As a result, if any of our product candidates is approved by the FDA and receives orphan drug exclusivity, absent other applicable exclusivities, the FDA can still approve other drugs for use in treating the same indication or use within the applicable rare disease or condition, which could create a more competitive market for us.
The failure to successfully obtain orphan drug exclusivity would adversely affect our business.
−Removed: Even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs can be approved for the same disease or condition.
−Removed: Even after an orphan drug is approved, the FDA or comparable foreign regulatory authority can subsequently approve the same drug for the same disease or condition if such regulatory authority concludes that the later drug is clinically superior if it is shown to be safer, more effective, or makes a major contribution to patient care.
+Added: Even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs can be approved for the same use or indication within the same rare disease or condition.
+Added: Even after an orphan drug is approved, the FDA or comparable foreign regulatory authority can subsequently approve the same drug for the same use or indication within the relevant rare disease or condition if such regulatory authority concludes that the later drug is clinically superior if it is shown to be safer, more effective, or makes a major contribution to patient care.
Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process.
−Removed: We may attempt to seek accelerated approval in the United States for certain of our product candidates.
+Added: We may attempt to seek accelerated approval in the U.S.
+Added: for certain of our product candidates.
If we are not able to use that pathway, we may be required to conduct additional clinical trials beyond those that are contemplated, which would increase the expense of obtaining, and delay the receipt of, necessary regulatory approvals, if we receive them at all.
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If such post-approval studies fail to confirm the drug’s clinical benefit or are not completed in a timely manner, the FDA may withdraw its approval of the drug on an expedited basis.
−Removed: In addition, the Food and Drug Omnibus Reform Act of 2022, provided the FDA new statutory authority to mitigate potential risks to patients from continued marketing of ineffective drugs previously granted accelerated approval.
+Added: In addition, the Food and Drug Omnibus Reform Act of 2022, provided the FDA additional statutory authority to mitigate potential risks to patients from continued marketing of ineffective drugs previously granted accelerated approval.
Under these provisions, the FDA may require a sponsor of a product seeking accelerated approval to, among other things, have a confirmatory trial underway prior to such approval being granted.
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Failure to obtain regulatory approval in foreign jurisdictions would prevent our product candidates from being marketed in these territories.
−Removed: Any approval we are granted for our product candidates in the United States would not assure approval of such product candidates in foreign jurisdictions.
+Added: Any approval we are granted for our product candidates in the U.S.
+Added: would not assure approval of such product candidates in foreign jurisdictions.
In order to market and sell our product candidates in Japan, the European Union, United Kingdom, other areas of Asia, Australia, and any other jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements.
1 unchanged sentence
The time required to obtain approval may differ substantially from that required to obtain approval from the FDA.
−Removed: The regulatory approval process outside the United States generally includes all of the risks associated with obtaining approval from the FDA.
−Removed: In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before the product can be approved for sale in that country.
−Removed: We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all.
−Removed: Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and data from clinical studies approved by the FDA may not be accepted by foreign regulatory agencies, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.
+Added: The regulatory approval process outside the U.S.
+Added: generally includes all of the risks associated with obtaining approval from the FDA.
+Added: In addition, in many countries outside the U.S., it is required that the product be approved for reimbursement before the product can be approved for sale in that country.
+Added: We may not obtain approvals from regulatory authorities outside the U.S.
+Added: on a timely basis, if at all.
+Added: Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and data from clinical studies approved by the FDA may not be accepted by foreign regulatory agencies, and approval by one regulatory authority outside the U.S.
+Added: does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.
However, failure to obtain approval in one jurisdiction may impact our ability to obtain approval elsewhere.
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The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be promulgated that could prevent, limit or delay marketing authorization of any product candidates we develop.
−Removed: We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad.
+Added: We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the U.S.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be subject to enforcement action and we may not achieve or sustain profitability.
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For example, any regulatory approval that the FDA grants is limited to those specific diseases and indications for which a product is deemed to be safe and effective by the FDA.
−Removed: While physicians in the United States may choose, and are generally permitted, to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical trials and approved by the regulatory authorities, our ability to promote any products will be narrowly limited to those indications that are specifically approved by the FDA.
+Added: While physicians in the U.S.
+Added: may choose, and are generally permitted, to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical trials and approved by the regulatory authorities, our ability to promote any products will be narrowly limited to those indications that are specifically approved by the FDA.
If we are found to have promoted such off-label uses, we may become subject to significant liability.
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If we become subject to these reporting requirements, we will be liable for errors associated with our submission of pricing data, for failure to report pricing data in a timely manner, and for overcharging government payers, which can result in civil monetary penalties under the Medicaid statute, the federal civil False Claims Act, and other laws and regulations.
−Removed: Our current and future relationships with healthcare professionals, principal investigators, consultants, customers, and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency and other healthcare laws and regulations, which could expose us to penalties.
−Removed: Healthcare providers, physicians, and third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription of any product candidates for which we obtain regulatory approval.
+Added: Our current and future relationships with healthcare professionals, principal investigators, consultants, customers, and third-party payors in the U.S.
+Added: and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency and other healthcare laws and regulations, which could expose us to penalties.
+Added: Healthcare providers, physicians, and third-party payors in the U.S.
+Added: and elsewhere will play a primary role in the recommendation and prescription of any product candidates for which we obtain regulatory approval.
Our current and future arrangements with healthcare professionals, principal investigators, consultants, customers, and third-party payors may expose us to broadly applicable fraud and abuse and other healthcare laws that may constrain the business or financial arrangements and relationships through which we research, sell, market, and distribute any product candidates for which we obtain regulatory approval.
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• the federal civil monetary penalties statute, which imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent;
−Removed: • HIPAA which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of whether the payor is public or private, knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters.
+Added: • the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of whether the payor is public or private, knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
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Changes in healthcare policies, laws, and regulations may impact our ability to obtain approval for, or commercialize our product candidates, if approved.
−Removed: In the United States and some foreign jurisdictions there have been, and continue to be, several legislative and regulatory changes and proposed reforms of the healthcare system in an effort to contain costs, improve quality, and expand access to care.
−Removed: In the United States, there have been and continue to be a number of healthcare-related legislative initiatives, as well as executive, judicial, and Congressional challenges to existing healthcare laws that have significantly affected, and could continue to significantly affect, the healthcare industry.
+Added: and some foreign jurisdictions there have been, and continue to be, several legislative and regulatory changes and proposed reforms of the healthcare system in an effort to contain costs, improve quality, and expand access to care.
+Added: In the U.S., there have been and continue to be a number of healthcare-related legislative initiatives, as well as executive, judicial, and Congressional challenges to existing healthcare laws that have significantly affected, and could continue to significantly affect, the healthcare industry.
For example, on June 17, 2021, the U.S.
−Removed: Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress.
−Removed: On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 (the “IRA”) into law, which among other things, extended enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.
+Added: Supreme Court dismissed a challenge on procedural grounds that argued the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (the “ACA”), is unconstitutional in its entirety because the “individual mandate” was repealed by Congress.
+Added: On August 16, 2022, the Inflation Reduction Act of 2022 (the “IRA”) was signed into law, which among other things, extended enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.
The IRA also eliminated the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program.
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These provisions took effect progressively starting in fiscal year 2023.
−Removed: CMS published the negotiated prices for the initial ten drugs, which will first be effective in 2026, and the list of the subsequent 15 drugs that will be subject to negotiation, although the Medicare drug price negotiation program is currently subject to legal challenges.
+Added: CMS published the negotiated prices for the initial ten drugs, which went into effect in 2026, and the subsequent 15 drugs, which will first be effective in 2027, as well as the next set of 15 drugs that will be subject to negotiation, although the Medicare drug price negotiation program is currently subject to legal challenges.
HHS has and will continue to issue and update guidance as these programs are implemented.
It is currently unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical industry.
+Added: In July 2025, the One Big Beautiful Bill Act (the “OBBBA”) was enacted and imposes significant reductions in the funding of the Medicaid program.
+Added: Such reductions are expected to decrease the number of persons enrolled in Medicaid and reduce the services covered by Medicaid, which could adversely affect the sales of any product candidate that we may commercialize.
+Added: The Trump administration is pursuing a two-fold strategy to reduce drug costs in the U.S.
+Added: While it is unclear whether and how the Trump proposals will be implemented, the Trump policies are likely to have a negative impact on the pharmaceutical industry and on our ability to receive adequate revenues for any product candidate that we commercialize.
+Added: On the one hand, President Trump has threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the U.S.
+Added: to the lowest price in a group of other countries.
+Added: In response, multiple manufacturers have reportedly entered into confidential pricing agreements with the federal government.
+Added: On the other hand, the Trump administration is pursuing traditional regulatory pathways to impose drug pricing policies, and published two proposed regulations in December 2025, referred to as Globe and Guard.
+Added: If finalized, these regulations would implement mandatory payment models under which manufacturers of eligible drugs would be required to pay rebates to the federal government on a portion of the units of their drugs that are reimbursed by Medicare, with the rebate amount based on most favored nation pricing.
+Added: While the impact of the Globe and Guard proposed regulations, if finalized, cannot yet be determined, it is likely to be significant.
+Added: Even regulatory proposals or executive actions that are ultimately deemed unlawful could negatively impact the U.S.
+Added: pharmaceutical sector and our business.
We expect that additional U.S.
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Some states have enacted legislation creating so-called prescription drug affordability boards, which ultimately may attempt to impose price limits on certain drugs in these states.
−Removed: Outside of the United States, particularly in the European Union, the pricing of prescription pharmaceuticals is subject to governmental control.
+Added: Outside of the U.S., particularly in the European Union, the pricing of prescription pharmaceuticals is subject to governmental control.
In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of regulatory approval for a product.
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If reimbursement of our product candidates is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed.
−Removed: Government Downsizing Initiatives Could Adversely Impact FDA Operations, Leading to Potential Delays in Regulatory Review and Approval
−Removed: Recent government downsizing initiatives, including efforts to reduce the size and scope of federal agencies such as the U.S.
−Removed: Food and Drug Administration (“FDA”), could negatively impact the agency’s ability to efficiently review and approve new drug applications.
−Removed: These initiatives may lead to staff reductions, voluntary resignations, and resource constraints that could slow down regulatory processes, including clinical trial oversight, new drug application reviews, and post-market surveillance activities.
−Removed: In addition, future agency cost-cutting measures, budget reductions, or structural changes remain uncertain and could further disrupt the FDA operations.
−Removed: Any prolonged delays or unpredictability in regulatory timelines may adversely affect our ability to bring our product candidates to market in a timely manner, which could have a material impact on our business, financial condition, and future growth prospects.
−Removed: Disruptions at the FDA and other government agencies caused by funding shortages, staff reductions or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
−Removed: The ability of the FDA and foreign regulatory authorities to review and/or approve new products can be affected by a variety of factors, including government budget and funding levels, staff reductions, statutory, regulatory, and policy changes, the FDA’s or foreign regulatory authorities’ ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s or foreign regulatory authorities’ ability to perform routine functions.
−Removed: Average review times at the FDA and foreign regulatory authorities have fluctuated in recent years as a result.
−Removed: In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
−Removed: Disruptions at the FDA and other agencies such as the EMA, following its relocation to Amsterdam and resulting staff changes, may also slow the time necessary for new drugs and biologics or modifications to approved drugs or biologics to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.
−Removed: For example, over the last several years, the U.S.
−Removed: government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.
−Removed: If a prolonged government shutdown occurs, or if staffing reductions or 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 review and process our regulatory submissions, which could have a material adverse effect on our business.
We are subject to privacy and data security laws, rules, regulations, policies, industry standards, and contractual obligations, and our failure to comply with them could harm our business.
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As such, we are subject to laws and regulations governing the privacy and security of such information.
−Removed: In the United States, there are numerous federal and state privacy and data security laws and regulations governing the collection, use, disclosure, and protection of personal information that apply or could apply to our operations or the operations of our partners, including federal and state health information privacy laws, federal and state security breach notification laws, and federal and state consumer protection laws.
+Added: In the U.S., there are numerous federal and state privacy and data security laws and regulations governing the collection, use, disclosure, and protection of personal information that apply or could apply to our operations or the operations of our partners, including federal and state health information privacy laws, federal and state security breach notification laws, and federal and state consumer protection laws.
The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues, in particular in relation to health information, which may affect our business and is expected to increase our compliance costs and exposure to liability.
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Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector.
−Removed: We may engage third parties to sell any approved product candidates outside the United States, to conduct clinical trials, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals.
+Added: We may engage third parties to sell any approved product candidates outside the U.S., to conduct clinical trials, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals.
We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations.
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These sales, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our common stock.
+Added: In addition, after our March 2026 Private Placement, there are pre-funded warrants currently exercisable for 8,741,473 shares of our common stock, 2,952,000 of which were outstanding and exercisable as of December 31, 2025.
+Added: The exercise of these warrants will cause us to issue additional shares of our common stock, which will result in dilution to our stockholders, increase the number of shares of common stock eligible for resale in the public market, and could adversely affect the market price of our common stock.
Provisions in our corporate charter documents and under Delaware law, and the adoption of a rights plan, could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
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These provisions may also prevent changes in our management or limit the price that investors are willing to pay for our stock.
−Removed: Additionally, in August 2024, we entered into a Rights Agreement, which was previously approved by the Board.
−Removed: In connection with the Rights Agreement, a dividend was declared of one preferred stock purchase right for each share of the Common Stock of the Company outstanding at the Record Date (individually, a “Right” and collectively, the “Rights”).
−Removed: Each Right entitles the registered holder thereof, after the Rights become exercisable and until August 15, 2025 (or the earlier redemption, exchange or termination of the Rights), to purchase from the Company one one-thousandth of a share of Series A Preferred, of the Company at a price of $6.50 per one one-thousandth of a share of Series A Preferred, subject to adjustment.
−Removed: The Rights will expire on August 15, 2025, subject to the Company’s right to extend such date, unless earlier redeemed or exchanged by the Company or terminated.
−Removed: The Rights Agreement could have the effect of discouraging, delaying or preventing a change in management or control over us.
−Removed: While there is no plan to do so at this time, our Board may choose to extend the current Rights Agreement or adopt a new rights agreement in the future.
−Removed: Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States will be the exclusive forums for substantially all disputes between us and our stockholders, including claims under the Securities Act, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
+Added: Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the U.S.
+Added: will be the exclusive forums for substantially all disputes between us and our stockholders, including claims under the Securities Act, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for:
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• any action asserting a claim against us or any of our directors, officers, employees, or agents that is governed by the internal-affairs doctrine.
−Removed: Furthermore, our amended and restated certificate of incorporation also provides that unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act.
+Added: Furthermore, our amended and restated certificate of incorporation also provides that unless we consent in writing to the selection of an alternative forum, the federal district courts of the U.S.
+Added: shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act.
However, these provisions would not apply to suits brought to enforce a duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction.
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Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
−Removed: As of December 31, 2024, we had federal and state net operating loss (“NOLs”) carryforwards of approximately $81.3 million and $166.3 million, respectively.
−Removed: Under the Tax Cuts and Jobs Act of 2017 (“the Tax Act”), as modified by the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), our NOLs generated in tax years beginning after December 31, 2017 may be carried forward indefinitely, but the deductibility of such federal NOLs in tax years beginning after December 31, 2020, is limited to 80% of taxable income.
−Removed: There is variation in how states have responded and may continue to respond to the Tax Act or the CARES Act.
+Added: Under the Tax Cuts and Jobs Act of 2017 (the “TCJA”), as modified by the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), our net operating losses (“NOLs”) generated in tax years beginning after December 31, 2017 may be carried forward indefinitely, but the deductibility of such federal NOLs in tax years beginning after December 31, 2020, is limited to 80% of taxable income.
+Added: There is variation in how states have responded and may continue to respond to the TCJA or the CARES Act.
In addition, under Sections 382 and 383 of the U.S.
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As a result of this volatility, investors may not be able to sell their shares at or above the price paid for the shares.
−Removed: In addition to the factors discussed in this “Risk Factors” section and elsewhere in this Annual Report Form 10-K, these factors include:
+Added: In addition to the factors discussed in this “Risk Factors” section and elsewhere in this Form 10-K, these factors include:
• the commencement, enrollment or results of our planned and future clinical trials;
• the sufficiency of our existing cash to fund our future operating expenses and capital expenditure requirements;
−Removed: • the results of our testing and clinical trials;
+Added: • the results of our nonclinical testing and clinical trials;
• unanticipated safety, tolerability or efficacy concerns;
• the loss of any of our key research, development or management personnel;
−Removed: • regulatory or legal developments in the United States and other countries;
+Added: • regulatory or legal developments in the U.S.
+Added: and other countries;
• the success of competitive products or technologies;
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• sales of our common stock by us, our executive officers and directors or our stockholders or the anticipation that such sales may occur in the future;
−Removed: • general economic, political, and market conditions and overall fluctuations in the financial markets in the United States or other countries where we conduct critical business;
+Added: • general economic, political, market, and industry conditions, including economic slowdowns, recessions, inflationary pressures, rising interest rates, tariffs, trade wars, and reduced credit availability, and overall fluctuations in the financial markets in the U.S.
+Added: or other countries where we conduct critical business;
• stock market price and volume fluctuations of comparable companies and, in particular, those that operate in the biopharmaceutical industry;
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If one or more equity research analysts ceases coverage of us or fails to publish reports on us regularly, demand for our shares could decrease, which in turn could cause the trading price or trading volume of our common stock to decline.
−Removed: We are incurring significantly increased costs as a result of operating as a company whose common stock is publicly traded in the United States, and our management is devoting substantial time to new compliance initiatives.
−Removed: As a public company in the United States, we are incurring significant legal, accounting, and other expenses.
+Added: We are incurring significantly increased costs as a result of operating as a company whose common stock is publicly traded in the U.S., and our management is devoting substantial time to new compliance initiatives.
+Added: As a public company in the U.S., we are incurring significant legal, accounting, and other expenses.
These expenses will likely be even more significant after we no longer qualify as an emerging growth company.
−Removed: The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq Global Select Market and other applicable securities rules and regulations impose various requirements on public companies in the United States, including the establishment and maintenance of effective disclosure and financial controls and corporate governance practices.
+Added: The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq Global Select Market and other applicable securities rules and regulations impose various requirements on public companies in the U.S., including the establishment and maintenance of effective disclosure and financial controls and corporate governance practices.
Our senior management and other personnel devote a substantial amount of time to these compliance initiatives.
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As a result, the information we provide stockholders will be different than the information that is available with respect to other public companies.
−Removed: We have taken advantage of reduced reporting burdens in this Annual Report on Form 10-K.
−Removed: In particular, in this Annual Report on Form 10-K, we have provided only two comparative periods of audited financial statements.
+Added: We have taken advantage of reduced reporting burdens in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q.
+Added: In particular, in our Annual Reports on Form 10-K, we have provided only two comparative periods of audited financial statements.
We also have not provided all of the executive compensation related information that would be required if we were not an emerging growth company.
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If our common stock is delisted from Nasdaq, we could be required to list on the over-the-counter market, which may adversely affect the price and trading liquidity of our common stock.
−Removed: Delisting from the Nasdaq may have other negative results, including the potential loss of confidence in us by employees and partners, the loss of institutional investor interest, fewer business development opportunities and greater difficulty in obtaining financing on favorable terms or at all.
+Added: Delisting from Nasdaq may have other negative results, including the potential loss of confidence in us by employees and partners, the loss of institutional investor interest, fewer business development opportunities and greater difficulty in obtaining financing on favorable terms or at all.
Recent and potential future changes to U.S.
tax laws could materially adversely affect our company.
−Removed: Existing, new, or future changes in tax laws, regulations, and treaties, or the interpretation thereof, in addition to tax policy initiatives and reforms under consideration in the United States or internationally and other initiatives could have an adverse effect on the taxation of international businesses.
−Removed: Furthermore, countries where we are subject to taxes, including the United States, are independently evaluating their tax policy and we may see significant changes in legislation and regulations concerning taxation.
−Removed: For example, the Tax Act, the CARES Act and the recently enacted IRA made many significant changes to the U.S.
−Removed: The Tax Act made broad and complex changes to the Code, including, among other things, reducing the federal corporate tax rate.
−Removed: Additionally, beginning in 2022, the Tax Act required the capitalization of research and experimentation expenses with amortization periods over five and fifteen years pursuant to Code Section 174 (“Section 174”), which could impact our effective tax rate and cash flow.
+Added: Existing, new, or future changes in tax laws, regulations, and treaties, or the interpretation thereof, in addition to tax policy initiatives, reforms and other initiatives under consideration in the U.S.
+Added: and internationally could have an adverse effect on the taxation of international businesses.
+Added: Furthermore, countries where we are subject to taxes, including the U.S., are independently evaluating their tax policies and we may see significant changes in legislation and regulations concerning taxation.
+Added: For example, the TCJA, the CARES Act and the IRA made many significant changes to the U.S.
Future guidance from the U.S.
Internal Revenue Service and other tax authorities with respect to any such tax legislation may affect us, and certain aspects of the previously enacted legislation could be repealed or modified in future legislation.
−Removed: In addition, it is uncertain if and to what extent various states will conform to the Tax Act, the CARES Act, the IRA, or any newly enacted federal tax legislation.
+Added: In addition, it is uncertain if and to what extent various states will conform to the TCJA, the CARES Act, the IRA, or any newly enacted federal tax legislation.
Other legislative changes could also affect the taxation of holders of our common stock.
−Removed: We are unable to predict what tax reform may be proposed or enacted in the future or what effect such changes would have on our business, but such changes, to the extent they are brought into tax legislation, regulations, policies or practices, could affect our effective tax rates in the future in countries where we are subject to tax and have an adverse effect on our overall tax rate in the future, along with increasing the complexity, burden, and cost of tax compliance.
−Removed: We urge our stockholders to consult with their legal and tax advisors with respect to any such legislative changes and the potential tax consequences of investing in or holding our common stock.
+Added: We are unable to predict what tax reform may be proposed or enacted in the future or what effect such changes would have on our business, but such changes could affect our effective tax rates in the future in countries where we are subject to tax and have an adverse effect on our overall tax rate in the future, along with increasing the complexity, burden, and cost of tax compliance.
+Added: In July 2025, the U.S.
+Added: government enacted the OBBBA, which includes several changes to U.S.
+Added: federal income tax law, including the temporary and permanent extension of expiring provisions of the TCJA.
+Added: Adoption of the OBBBA did not have a material impact to our financial statements and related disclosures.
+Added: We will continue to monitor the impact of the OBBBA in future periods.
Indemnity provisions in various agreements potentially expose us to substantial liability for intellectual property infringement, data protection, and other losses.
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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.