1 unchanged sentence
Investing in our common stock involves a high degree of risk.
−Removed: You should carefully consider the risks described below together with all of the other information in this Annual Report on Form 10-K ("Form 10-K"), including our financial statements and the related notes and the information described in the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,”
−Removed: and in our other filings with the SEC.
+Added: You should carefully consider the risks described below together with all of the other information in this Annual Report on Form 10-K ("Form 10-K"), including our financial statements and the related notes and the information described in the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in our other filings with the SEC.
If any of the events described below actually occurs, our business, results of operations, financial conditions, cash flows or prospects could be harmed.
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Since our founding in 2014, we have incurred significant net losses with an accumulated deficit of $315 million as of December 31, 2023.
−Removed: We have funded our operations to date primarily with proceeds from private placements of preferred and common equity, an underwritten public offering, a PIPE offering and borrowings under the 2018 loan and security agreement with Pacific Western Bank (“the 2018 Credit Facility”), which has since been terminated.
+Added: We have funded our operations to date primarily with proceeds from private placements of preferred and common equity, an underwritten public offering and a PIPE offering, as well as sales under our at-the-market offering program pursuant to an Open Market Sale Agreement SM with Jefferies LLC.
Since commencing operations, we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, identifying business development opportunities, raising capital, securing intellectual property rights related to our product candidates, conducting discovery, and research and development activities, including clinical development, for our product candidates.
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continue to advance the preclinical and clinical development of our existing product candidates and our research programs;
−Removed: leverage our research and development capabilities, including our proprietary StitchMabs TM  technology, to advance additional product candidates into preclinical and clinical development;
+Added: leverage our research and development capabilities, including our proprietary StitchMabs TM technology, to advance additional product candidates into preclinical and clinical development;
seek regulatory approvals for any product candidates that successfully complete clinical trials;
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We do not anticipate generating revenue from product sales for the next several years, if ever.
−Removed: Our ability to generate future revenue from product sales depends heavily on our, or our existing or future collaborators’, success in:
+Added: Our ability to generate future revenue from product sales depends heavily on our, or our existing or future collaborators’, success in:
completing preclinical studies and clinical trials of our product candidates;
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We anticipate incurring significant costs associated with commercializing any product candidate that is approved for commercial sale.
−Removed: Our expenses could increase beyond expectations if we are required by the FDA or other regulatory agencies to perform clinical trials or studies in addition to those that we currently anticipate, or if there are any delays in establishing appropriate manufacturing arrangements for or in completing our clinical trials for the development of any of our product candidates, for example, as a result of any setbacks or delays due to the ongoing COVID-19 pandemic.
+Added: Our expenses could increase beyond expectations if we are required by the FDA or other regulatory agencies to perform clinical trials or studies in addition to those that we currently anticipate, or if there are any delays in establishing appropriate manufacturing arrangements for or in completing our clinical trials for the development of any of our product candidates.
Even if we are able to generate revenue from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations.
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Because the designs and outcomes of our planned and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development of and commercialize any product candidate we develop.
−Removed: Additionally, any COVID-19 related program setbacks or delays due to changes in federal, state, or local laws and regulations or clinical site policies could impact our programs and increase our expenditures.
+Added: Additionally, any delays due to changes in federal, state, or local laws and regulations or clinical site policies could impact our programs and increase our expenditures.
Our future capital requirements depend on many factors, including:
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the costs of manufacturing our current and any future product candidates for preclinical studies and clinical trials and in preparation for marketing approval and commercialization;
−Removed: the impact of COVID-19 on the initiation or completion of preclinical studies or clinical trials, the third-parties on whom we rely, and the supply of our product candidates;
the costs of commercialization activities, including marketing, sales and distribution costs, for our products and any future product candidates we develop, whether alone or with a collaborator, if any of these product candidates are approved for sale;
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As of December 31, 2023, we had $152.5 million in cash, cash equivalents and marketable securities.
−Removed: Based on our research and development plans, we expect that these cash resources will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2024.
+Added: Based on our research and development plans, we expect that these cash resources will enable us to fund our operating expenses and capital expenditure requirements into mid-2026.
This estimate is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we expect.
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If we raise additional capital through marketing, sales and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, future revenue streams or research programs, technologies or grant licenses on terms that may not be favorable to us.
−Removed: If we raise additional capital through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’
−Removed: Further, to the extent that we raise additional capital through additional sales of common stock or securities convertible or exchangeable into common stock, investors’
−Removed: ownership interest will be diluted.
+Added: If we raise additional capital through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights.
+Added: Further, to the extent that we raise additional capital through additional sales of common stock or securities convertible or exchangeable into common stock, investors’ ownership interest will be diluted.
If we raise additional capital through debt financing, we would be subject to fixed payment obligations and may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
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sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials;
−Removed: our plans to successfully submit investigational new drug ("IND"), applications with the FDA for our current and future product candidates;
+Added: our plans to successfully submit new INDs with the FDA for our current and future product candidates;
our ability to complete preclinical studies for current or future product candidates;
−Removed: successful enrollment in, including maintaining or reaching target enrollment levels during the COVID-19 pandemic, and completion of clinical trials;
+Added: successful enrollment in, and completion of clinical trials;
successful data from our clinical program that supports an acceptable risk-benefit profile of our product candidates in the intended patient populations;
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maintaining a continued acceptable safety, tolerability and efficacy profile of the product candidates following approval;
−Removed: our compliance with any post-approval requirements imposed on our products, such as post-marketing studies, a Risk Evaluation and Mitigation Strategy ("REMS"), or additional requirements that might limit the promotion, advertising, distribution or sales of our products or make the products cost prohibitive;
+Added: our compliance with any post-approval requirements imposed on our products, such as post-marketing studies, REMS or additional requirements that might limit the promotion, advertising, distribution or sales of our products or make the products cost prohibitive;
competing effectively with other therapies;
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Further, the FDA or other regulatory authorities may disagree with our clinical trial design and our interpretation of data from clinical trials.
−Removed: For example, we are conducting and may in the future conduct additional “open-label”
−Removed: clinical trials.
−Removed: An “open-label”
−Removed: clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate or either an existing approved drug or placebo.
+Added: For example, we are conducting and may in the future conduct additional “open-label” clinical trials.
+Added: An “open-label” clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate or either an existing approved drug or placebo.
Most typically, open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels.
−Removed: Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients may be subject to a “patient bias”
−Removed: where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment.
+Added: Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment.
Moreover, patients selected for early clinical trials often include the most severe sufferers and their symptoms may have been bound to improve notwithstanding the new treatment.
−Removed: In addition, open-label clinical trials may be subject to an “investigator bias”
−Removed: where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge.
+Added: In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge.
Principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and may receive cash or equity compensation in connection with such services.
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Any such delay or rejection could prevent or delay us from commercializing our current or future product candidates.
−Removed: If we experience delays in the completion, or termination, of any clinical trial of our product candidates, including as a result of the ongoing COVID-19 pandemic, the commercial prospects of our product candidates will be harmed and our ability to generate product revenues from any of these product candidates will be delayed.
+Added: If we experience delays in the completion, or termination, of any clinical trial of our product candidates, the commercial prospects of our product candidates will be harmed and our ability to generate product revenues from any of these product candidates will be delayed.
In addition, any delays in completing our clinical trials will increase our costs, slow down the development and approval process for our product candidates and jeopardize our ability to commence product sales and generate revenues.
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The commencement and rate of completion of preclinical studies and clinical trials for a product candidate may be delayed by many factors, including but not limited to:
−Removed: an inability to generate sufficient preclinical or other in vivo  or in vitro  data to support the initiation of clinical trials;
+Added: an inability to generate sufficient preclinical or other in vivo or in vitro data to support the initiation of clinical trials;
delays in reaching a consensus with regulatory agencies on trial design;
−Removed: any setbacks or delays on account of the ongoing COVID-19 pandemic;
the FDA or foreign regulatory authorities not permitting the reliance on preclinical or other data from published scientific literature.
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Although our current and future product candidates have undergone and will undergo safety testing to the extent possible and, where applicable, under such conditions discussed with regulatory authorities, not all adverse effects of drugs can be predicted or anticipated.
−Removed: Antibody therapeutics and bispecifics and their method of action of harnessing the body’s immune system are powerful and could lead to serious side effects that we only discover in clinical trials or during commercial marketing.
+Added: Antibody therapeutics and bispecifics and their method of action of harnessing the body’s immune system are powerful and could lead to serious side effects that we only discover in clinical trials or during commercial marketing.
Unforeseen side effects could arise either during clinical development or after our product candidates have been approved by regulatory authorities and the approved product has been marketed, resulting in the exposure of additional patients.
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additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof;
−Removed: regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication;
+Added: regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication;
we may be required to implement a REMS or create a medication guide outlining the risks of such side effects for distribution to patients;
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We also expect to continue to rely on third parties to conduct our clinical trials.
−Removed: See “—
−Removed: Risks Related to Reliance on Third Parties —
−Removed: We rely or will rely on third parties to help conduct our ongoing and planned preclinical studies and clinical trials for our current product candidates and any future product candidates we develop.
−Removed: If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize for our current product candidates or future product candidates we develop and our business could be materially harmed .”
−Removed: Consequently, we may be unable to successfully and efficiently execute and complete clinical trials that are required for BLA submission and FDA approval of our current or future product candidates.
+Added: See “— Risks Related to Reliance on Third Parties — We rely or will rely on third parties to help conduct our ongoing and planned preclinical studies and clinical trials for our current product candidates and any future product candidates we develop.
+Added: If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize for our current product candidates or future product candidates we develop and our business could be materially harmed .” Consequently, we may be unable to successfully and efficiently execute and complete clinical trials that are required for BLA submission and FDA approval of our current or future product candidates.
We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approvals of product candidates that we develop.
If we or our collaborators encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise be adversely affected.
−Removed: The successful and timely completion of clinical trials in accordance with their protocols depends on, among other things, our ability to enroll a sufficient number of patients who remain in the trial until the trial’s conclusion, including any follow-up period.
+Added: The successful and timely completion of clinical trials in accordance with their protocols depends on, among other things, our ability to enroll a sufficient number of patients who remain in the trial until the trial’s conclusion, including any follow-up period.
We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons.
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the patient eligibility criteria defined in the protocol;
−Removed: the nature and size of the patient population required for analysis of the trial’s primary endpoints and the process for identifying patients;
+Added: the nature and size of the patient population required for analysis of the trial’s primary endpoints and the process for identifying patients;
the number and location of participating clinical sites or patients;
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our ability to recruit clinical trial investigators with the appropriate competencies and experience;
−Removed: clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating;
−Removed: the availability of competing commercially available therapies and other competing drug candidates’ clinical trials;
+Added: clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating;
+Added: the availability of competing commercially available therapies and other competing drug candidates’ clinical trials;
our ability to obtain and maintain patient informed consents for participation in our clinical trials;
−Removed: the impact of the ongoing COVID-19 pandemic or future pandemics or similar events on patients’ willingness and ability to participate in clinical trials or on trial site policies;
the risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may be late-stage cancer patients, will not survive the full terms of the clinical trials.
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Moreover, because our current and potential future product candidates may represent a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy, rather than enroll patients in our ongoing or any future clinical trial.
−Removed: Additionally, the ongoing COVID-19 pandemic may have an impact on our ability to recruit and follow-up with patients either due to continued or renewed restrictions on travel or shelter-in-place orders or policies, or due to changes in patient willingness to participate in trials or travel to trial sites in the wake of the pandemic.
−Removed: Additionally, COVID-19 related trial site policies may create delays or setbacks in our ability to continue to enroll or to dose patients.
Delays of difficulties in patient enrollment may result in increased costs or may affect the timing, outcome or completion of clinical trials, which would adversely affect our ability to advance the development of the product candidates we develop.
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If we conduct any future clinical trials, we may not achieve a statistically significant result or the same level of statistical significance seen, if any, in our clinical trials.
−Removed: We have chosen to prioritize certain product candidates for development as described in this form 10-K.
+Added: We have chosen to prioritize certain product candidates for development as described in this Annual Report on Form 10-K.
We may expend our limited resources on product candidates or indications that do not yield a successful product and fail to capitalize on other candidates or indications for which there may be a greater likelihood of success or may be more profitable .
−Removed: Because we have limited resources, we have strategically determined to prioritize development of certain product candidates as described in this form 10-K, rather than other product candidates.
+Added: Because we have limited resources, we have strategically determined to prioritize development of certain product candidates as described in this Annual Report on Form 10-K, rather than other product candidates.
This decision is based, in part, on the significant resources required for developing and manufacturing antibody therapeutics and bispecifics.
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As a result, we may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of opportunities with other product candidates or other diseases and disease pathways that may later prove to have greater commercial potential than those we choose to pursue, or relinquish valuable rights to such product candidates through collaboration, licensing or other royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain development and commercialization rights.
−Removed: We may experience increased costs, disruptions or other difficulties with the integration of TRIGR.
−Removed: On June 25, 2021, we consummated the acquisition of all outstanding shares of TRIGR.
−Removed: As a result of this acquisition, we also acquired certain assets of TRIGR, including CTX-009 (a.k.a.
−Removed: ABL001), an anti-DLL4 x VEGF-A bispecific antibody that is undergoing clinical development in patients with advanced solid tumors in South Korea.
−Removed: While we have invested, and continue to invest, significant resources in due diligence, planning and integration of TRIGR, it is possible that significant issues and potential unknown liabilities may arise during the course of the integration and ongoing development of CTX-009, which may result in increased costs, delays in the initiation of clinical trials and other difficulties that are not presently contemplated.
−Removed: We have not historically developed the product candidate we acquired in our recent acquisition of TRIGR and are relying on TRIGR ’
−Removed: s prior research to advance this product candidate and intellectual property obtained by TRIGR.
−Removed: The product candidate that was acquired in the TRIGR acquisition, CTX-009, was initially developed by TRIGR and its licensor ABL Bio.
−Removed: We have not yet demonstrated an ability to develop, advance, or run clinical trials with this product candidate.
−Removed: In addition, our intellectual property rights covering the product candidate that was acquired in the TRIGR acquisition, CTX-009, were developed by TRIGR and its licensor, ABL Bio.
−Removed: We were not responsible for obtaining, maintaining or enforcing such intellectual property rights and we are relying on the previous work of TRIGR and its licensor to have adequately protected such intellectual property.
−Removed: We are relying on TRIGR’s previous work to continue our development of this product candidate.
−Removed: We are dependent on TRIGR having conducted their research and development in accordance with the applicable protocols, legal and regulatory requirements, and scientific standards;
−Removed: having accurately reported the results of all preclinical studies and clinical trials conducted with respect to such product candidates and having correctly collected and interpreted the data from these studies and trials.
−Removed: If these activities were not compliant, accurate or correct, the clinical development, regulatory approval or commercialization of CTX-009 will be adversely affected.
−Removed: As a result, we cannot ensure that we will be able to successfully advance this product candidate going forward or that the intellectual property rights were protected at a level comparable to our previously disclosed intellectual property.
Certain of our clinical trials are conducted in overseas jurisdictions, which may subject us to delays and expenses.
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The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities.
−Removed: In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions.
+Added: In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions.
We have not obtained regulatory approval for any product candidate.
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the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
−Removed: we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
+Added: we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from clinical trials or preclinical studies;
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our inability to demonstrate to the satisfaction of the FDA or a comparable foreign regulatory authority that our product candidates are safe and effective for the requested indication;
−Removed: the FDA or a comparable foreign regulatory authority’s disagreement with our trial protocol or the interpretation of data from preclinical studies or clinical trials;
+Added: the FDA or a comparable foreign regulatory authority’s disagreement with our trial protocol or the interpretation of data from preclinical studies or clinical trials;
our inability to demonstrate that the clinical and other benefits of our product candidates outweigh any safety or other perceived risks;
−Removed: the FDA or a comparable foreign regulatory authority’s requirement for additional preclinical studies or clinical trials;
−Removed: the FDA or a comparable foreign regulatory authority’s non-approval of the formulation, labeling, or specifications of our product candidates;
−Removed: the FDA or a comparable regulatory authority’s failure to approve our manufacturing processes and facilities or the manufacturing processes and facilities of third-party manufacturers upon which we rely;
+Added: the FDA or a comparable foreign regulatory authority’s requirement for additional preclinical studies or clinical trials;
+Added: the FDA or a comparable foreign regulatory authority’s non-approval of the formulation, labeling, or specifications of our product candidates;
+Added: the FDA or a comparable regulatory authority’s failure to approve our manufacturing processes and facilities or the manufacturing processes and facilities of third-party manufacturers upon which we rely;
potential for approval policies or regulations of the FDA or a comparable foreign regulatory authority to significantly change in a manner rendering our clinical data insufficient for approval.
1 unchanged sentence
The FDA or comparable foreign regulatory authorities also may approve any of our product candidates for a more limited indication or a narrower patient population than we originally requested, and the FDA or comparable foreign regulatory authorities may not approve any of our product candidates with the labeling that we believe is necessary or desirable for the successful commercialization of any such product candidates.
−Removed: Of the large number of biopharmaceutical products in development, only a small percentage successfully complete the FDA or other regulatory bodies’
−Removed: approval processes and are commercialized.
+Added: Of the large number of biopharmaceutical products in development, only a small percentage successfully complete the FDA or other regulatory bodies’ approval processes and are commercialized.
Any delay in obtaining, or inability to obtain, applicable regulatory approval would delay or prevent commercialization of our product candidates and would materially harm our business.
Disruptions at the FDA and other government agencies caused by funding shortages 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 to review and approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions.
+Added: The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions.
Average review times at the agency have fluctuated in recent years as a result.
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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: Separately, since March 2020 when foreign and domestic inspections of facilities were largely placed on hold, the FDA has been working to resume pre-pandemic levels of inspection activities, including routine surveillance, bioresearch monitoring and pre-approval inspections.
−Removed: Should the FDA determine that an inspection is necessary for approval and an inspection cannot be completed during the review cycle due to restrictions on travel, and the FDA does not determine a remote interactive evaluation to be adequate, the agency has stated that it generally intends to issue, depending on the circumstances, a complete response letter or defer action on the application until an inspection can be completed.
−Removed: During the COVID-19 public health emergency, a number of companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications.
−Removed: Regulatory authorities outside the United States may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic.
−Removed: If a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the trials are not well designed.
−Removed: Clinical trials must be conducted in accordance with the FDA’s current good clinical practices requirements ("cGCP"), or analogous requirements of applicable foreign regulatory authorities.
+Added: Clinical trials must be conducted in accordance with the FDA’s current good clinical practices requirements ("cGCP"), or analogous requirements of applicable foreign regulatory authorities.
Clinical trials are subject to oversight by the FDA, other foreign governmental agencies and IRBs or ethical committees at the trial sites where the clinical trials are conducted.
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These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMP and cGCP, for any clinical trials that we may conduct post-approval.
−Removed: Later discovery of previously unknown problems with any approved candidate, including adverse events of unanticipated severity or frequency, or with our or our third-party manufacturers’
−Removed: manufacturing processes or facilities, or failure to comply with regulatory requirements, may result in, among other things:
+Added: Later discovery of previously unknown problems with any approved candidate, including adverse events of unanticipated severity or frequency, or with our or our third-party manufacturers’ manufacturing processes or facilities, or failure to comply with regulatory requirements, may result in, among other things:
suspension of, or imposition of restrictions on, the marketing or manufacturing of the product, withdrawal of the product from the market, or product recalls;
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Moreover, the FDA strictly regulates the promotional claims that may be made about drug and biological products.
−Removed: In particular, an approved product may not be promoted for uses that are not approved by the FDA as reflected in the product’s approved labeling, or off-label uses.
+Added: In particular, an approved product may not be promoted for uses that are not approved by the FDA as reflected in the product’s approved labeling, or off-label uses.
The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
−Removed: The FDA has issued guidance on the factors that it will consider in determining whether a firm’s product communication is consistent with the FDA-required labeling for that product, and those factors contain complexity and potential for overlap and misinterpretation.
+Added: The FDA has issued guidance on the factors that it will consider in determining whether a firm’s product communication is consistent with the FDA-required labeling for that product, and those factors contain complexity and potential for overlap and misinterpretation.
A company that is found to have improperly promoted off-label uses of their products may be subject to significant civil, criminal and administrative penalties.
−Removed: The FDA and other regulatory authorities’
−Removed: policies may change and additional government regulations may be enacted that could prevent, limit or delay marketing approval of a product.
+Added: The FDA and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay marketing approval of a product.
We 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.
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Accelerated approval by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive regulatory approval.
−Removed: We may seek accelerated approval of our current or future product candidates using the FDA’s accelerated approval pathway.
+Added: We may seek accelerated approval of our current or future product candidates using the FDA’s accelerated approval pathway.
A product may be eligible for accelerated approval if it treats a serious or life-threatening condition.
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These confirmatory trials must be completed with due diligence.
−Removed: Under the Food and Drug Omnibus Reform Act (“FDORA”) the FDA is empowered to take action, such as issuing fines, against companies that fail to conduct with due diligence any post-marketing confirmatory trial or submit timely reports to the agency on their progress.
+Added: Under the FDORA, the FDA is empowered to take action, such as issuing fines, against companies that fail to conduct with due diligence any post-marketing confirmatory trial or submit timely reports to the agency on their progress.
In addition, the FDA currently requires, unless otherwise informed by the agency, as a condition for accelerated approval pre-approval of promotional materials for products being considered for accelerated approval, which could adversely impact the timing of the commercial launch of the product.
−Removed: Even if we do receive accelerated approval, we may not experience a faster development, regulatory review or approval process, and receiving accelerated approval does not assure that the product’s accelerated approval will eventually be converted to a traditional approval.
+Added: Even if we do receive accelerated approval, we may not experience a faster development, regulatory review or approval process, and receiving accelerated approval does not assure that the product’s accelerated approval will eventually be converted to a traditional approval.
Risks Related to the Commercialization of Our Product Candidates
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CMS decides whether and to what extent our products will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree.
−Removed: See the section entitled, “Business —
−Removed: Government Regulation —
−Removed: Pharmaceutical Coverage, Pricing and Reimbursement”.
+Added: See the section entitled, “Business — Government Regulation — Pharmaceutical Coverage, Pricing and Reimbursement”.
Our ability to successfully commercialize our product candidates, whether as a single agent or combination therapy, will depend in part on the extent to which coverage and adequate reimbursement for our products and related treatments will be available from third-party payors.
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In the United States and in some foreign jurisdictions, there have been and likely will continue to be a number of legislative and regulatory changes regarding the healthcare system directed at broadening the availability of healthcare, improving the quality of healthcare, and containing or lowering the cost of healthcare.
−Removed: For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, was passed, which substantially changes the way healthcare is financed by both governmental and private insurers, and significantly impacts the U.S.
+Added: For example, in 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, was passed, which substantially changes the way healthcare is financed by both governmental and private insurers, and significantly impacts the U.S.
pharmaceutical industry.
−Removed: See the section entitled, “Business —
−Removed: Government Regulation —
−Removed: Current and future healthcare reform legislation”.
+Added: See the section entitled, “Business — Government Regulation — Current and future healthcare reform legislation”.
Moreover, increasing efforts by governmental and other third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates.
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We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action in the United States.
−Removed: If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties are not able to maintain regulatory compliance, our product candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.
+Added: The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:
+Added: the demand for our product candidates, if we obtain regulatory approval;
+Added: our ability to set a price that we believe is fair for our approved products;
+Added: our ability to generate revenue and achieve or maintain profitability;
+Added: the level of taxes that we are required to pay;
+Added: the availability of capital.
Our relationships with customers, third-party payors and others may be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
1 unchanged sentence
Our current and future arrangements with healthcare providers, third-party payors, customers, and others may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations, which may constrain the business or financial arrangements and relationships through which we research, as well as sell, market and distribute any products for which we obtain marketing approval.
−Removed: See the section entitled, “Business —
−Removed: Government Regulation —
−Removed: Other Healthcare Laws and Compliance Requirements”.
+Added: See the section entitled, “Business — Government Regulation — Other Healthcare Laws and Compliance Requirements”.
It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
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Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs.
−Removed: Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.
+Added: Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.
The shifting compliance environment and the need to build and maintain robust and expandable systems to comply with multiple jurisdictions with different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.
Risks Related to Manufacturing of Our Product Candidates
−Removed: The loss of our third-party manufacturing partners or our, or our partners ’
−Removed: , failure to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.
+Added: The loss of our third-party manufacturing partners or our, or our partners ’ , failure to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.
We have contracted with qualified third-party contract development manufacturing organizations ("CDMOs"), to manufacture our product candidates for preclinical and clinical trials.
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If the FDA or a comparable foreign regulatory authority finds our facilities or those of our CDMOs inadequate for the manufacture of our product candidates or if such facilities are subject to enforcement action in the future or are otherwise inadequate, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates.
−Removed: Additionally, our CDMOs may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstable political environments or on account of global pandemics or similar events, including the ongoing COVID-19 pandemic.
+Added: Additionally, our CDMOs may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstable political environments or on account of global pandemics or similar events.
If our CDMOs were to encounter any of these difficulties, our ability to provide our product candidate to patients in clinical trials, or to provide product for the treatment of patients once approved, would be jeopardized.
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If we are unable to obtain and maintain patent protection for our product candidates, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our product candidates may be adversely affected.
−Removed: Our success depends, in large part, on our and in a few cases, our licensors’
−Removed: ability to obtain and maintain patent protection in the United States and other countries with respect to our product candidates and platform.
+Added: Our success depends, in large part, on our and in a few cases, our licensors’ ability to obtain and maintain patent protection in the United States and other countries with respect to our product candidates and platform.
We and our licensors have sought, and intend to seek, to protect our proprietary position by filing patent applications in the United States and abroad related to our product candidates and technology that are important to our business.
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On February 1, 2019 the government of Venezuela, in response to certain U.S.
−Removed: sanctions, began to require that foreign entities pay all official fees, including patent fees (either for pending matters or new petitions), in PETRO, a “cryptocurrency”
−Removed: created by the Nicolás Maduro administration in February 2018 as a way to collect U.S.
+Added: sanctions, began to require that foreign entities pay all official fees, including patent fees (either for pending matters or new petitions), in PETRO, a “cryptocurrency” created by the Nicolás Maduro administration in February 2018 as a way to collect U.S.
dollars while avoiding American financial sanctions issued under an Executive Order of then-President Trump on March 19, 2018.
−Removed: The Executive Order banned transactions involving “any digital currency, digital coin, or digital token, that was issued by, for, or on behalf of the Government of Venezuela on or after January 9, 2018.”
−Removed: The prohibition is applicable to any U.S.
+Added: The Executive Order banned transactions involving “any digital currency, digital coin, or digital token, that was issued by, for, or on behalf of the Government of Venezuela on or after January 9, 2018.” The prohibition is applicable to any U.S.
entity unless exempted by license.
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The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biotechnology products or methods of treatment, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally.
−Removed: For example, with “Brexit”, there is uncertainty associated with obtaining, defending, and enforcing intellectual property rights in the United Kingdom.
+Added: For example, with “Brexit”, there is uncertainty associated with obtaining, defending, and enforcing intellectual property rights in the United Kingdom.
International treaties and regulations promulgated as a result of this transition could impede or eliminate our ability to obtain or maintain meaningful intellectual property rights in the United Kingdom.
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The Hatch Waxman Act permits a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process.
−Removed: A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval or more than five years beyond the patent’s natural expiration date, only one patent may be extended per FDA-approved product, and only those claims covering the approved drug, a method for using it or a method for manufacturing it may be extended.
+Added: A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval or more than five years beyond the patent’s natural expiration date, only one patent may be extended per FDA-approved product, and only those claims covering the approved drug, a method for using it or a method for manufacturing it may be extended.
Further, certain of our licenses currently or in the future may not provide us with the right to control decisions the licensor or its other licensees on Orange Book listings or patent term extension decisions under the Hatch-Waxman Act.
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The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process.
−Removed: A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval or more than five years beyond the patent’s natural expiration date, only one patent per product may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended.
+Added: A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval or more than five years beyond the patent’s natural expiration date, only one patent per product may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended.
However, even if we were to seek a patent term extension, it may not be granted because of, for example, the failure to exercise due diligence during the testing phase or regulatory review process, the failure to apply within applicable deadlines, the failure to apply prior to expiration of relevant patents, or the failure to otherwise satisfy applicable requirements.
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Even if we believe such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could materially and adversely affect our ability to commercialize any of our product candidates or technologies covered by the asserted third-party patents.
−Removed: If we are found to infringe a third party’s valid and enforceable intellectual property rights, we could be required to obtain a license from such third party to continue developing, manufacturing and marketing our product candidates and technology.
+Added: If we are found to infringe a third party’s valid and enforceable intellectual property rights, we could be required to obtain a license from such third party to continue developing, manufacturing and marketing our product candidates and technology.
However, we may not be able to obtain any required license on commercially reasonable terms or at all.
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We could be forced, including by court order, to cease developing, manufacturing and commercializing the infringing technology or product candidates.
−Removed: In addition, we could be found liable for monetary damages, including treble damages and attorneys’
−Removed: fees, if we are found to have willfully infringed a patent or other intellectual property right.
+Added: In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent or other intellectual property right.
A finding of infringement could prevent us from manufacturing and commercializing our product candidates or force us to cease some of our business operations, which could materially harm our business.
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While we are presently unaware of any claims or assertions by third parties with respect to our patents or other intellectual property, we cannot guarantee that a third party will not assert a claim or an interest in any of such patents or intellectual property.
−Removed: For example, a third party may claim an ownership interest in one or more of our, or our licensors’, patents or other proprietary or intellectual property rights.
+Added: For example, a third party may claim an ownership interest in one or more of our, or our licensors’, patents or other proprietary or intellectual property rights.
A third party could bring legal actions against us to seek monetary damages or enjoin clinical testing, manufacturing or marketing of the affected product candidate or product.
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To maintain the confidentiality of trade secrets and proprietary information, we enter into confidentiality agreements with our employees, consultants, collaborators and others upon the commencement of their relationships with us.
−Removed: These agreements require that all confidential information developed by the individual or made known to the individual by us during the course of the individual’s relationship with us be kept confidential and not disclosed to third parties.
+Added: These agreements require that all confidential information developed by the individual or made known to the individual by us during the course of the individual’s relationship with us be kept confidential and not disclosed to third parties.
Our agreements with employees and our personnel policies also provide that any inventions conceived by the individual in the course of rendering services to us shall be our exclusive property.
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To the extent that our employees, consultants or contractors use technology or know-how owned by third parties in their work for us, disputes may arise between us and those third parties as to the rights in related inventions.
−Removed: To the extent that an individual who is not obligated to assign rights in intellectual property to us is rightfully an inventor of intellectual property, we may need to obtain an assignment or a license to that intellectual property from that individual, or a third party or from that individual’s assignee.
+Added: To the extent that an individual who is not obligated to assign rights in intellectual property to us is rightfully an inventor of intellectual property, we may need to obtain an assignment or a license to that intellectual property from that individual, or a third party or from that individual’s assignee.
Such assignment or license may not be available on commercially reasonable terms or at all.
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Many of our directors, employees, consultants, and advisors are currently, or were previously, employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors.
−Removed: Although we try to ensure that our employees, consultants and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that these individuals, or we, have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer, or that patents and applications we have filed to protect inventions of these employees, even those related to one or more of our product candidates, are rightfully owned by their former or current employer.
+Added: Although we try to ensure that our employees, consultants and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that these individuals, or we, have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer, or that patents and applications we have filed to protect inventions of these employees, even those related to one or more of our product candidates, are rightfully owned by their former or current employer.
Litigation may be necessary to defend against these claims.
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We may sometimes collaborate with non-profit and academic institutions to accelerate our preclinical research or development under written agreements with these institutions.
−Removed: Typically, these institutions provide us with an option to negotiate a license to any of the institution’s rights in technology resulting from the collaboration.
+Added: Typically, these institutions provide us with an option to negotiate a license to any of the institution’s rights in technology resulting from the collaboration.
Regardless of such option, we may be unable to negotiate a license within the specified timeframe or under terms that are acceptable to us.
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Should any of these events occur, they could significantly harm our business, financial condition, results of operations and prospects.
−Removed: Changes to national patent laws and diminished or limited access to U.S.
−Removed: and/or foreign patent counsel and the courts in response to the ongoing COVID 19 pandemic may compromise our ability to pursue, obtain, enforce or defend our intellectual property patent protections throughout the world.
−Removed: Following the discovery of a novel strain of coronavirus in Wuhan, China in December 2019, and the subsequent spread of the virus around the world, including the declaration of a public health emergency in January 2020 by the World Health Organization, many national patent offices promulgated emergency measures and alternative procedures for filing, prosecuting and adjudicating disputes regarding intellectual property.
−Removed: While some of these new rules involve the provision of extensions for certain filing deadlines, none of these emergency-situation rules have been tested in a litigation setting or for their harmonization with the laws of other countries.
−Removed: Access to the USPTO and other patent offices has been restricted by government mandated shelter-in-place or stay-home orders thereby limiting our ability to appear before any tribunal in support of our intellectual property.
−Removed: Should the remaining electronic access to these tribunals be interrupted or non-existent, we may not be able to secure, defend or enforce patent protections in all jurisdictions.
−Removed: We also rely on U.S.
−Removed: and foreign patent counsel in the management of our intellectual property.
−Removed: Should our access to counsel be diminished or lost due to effects of COVID-19 on these service providers and their organizations, we may not be able to manage, maintain or secure our intellectual property position.
Risks Related to Information Technology and Data Privacy
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The collection, use, storage, disclosure, transfer, or other processing of personal data regarding individuals in the EEA, including personal health data, is subject to the EU General Data Protection Regulation (“EU GDPR”).
−Removed: Following the U.K.’s withdrawal from the EU on January 31, 2020 and the end of the transitional arrangements agreed between the U.K.
−Removed: and EU as of January 1, 2021, the EU GDPR has been incorporated into U.K.
−Removed: domestic law by virtue of section 3 of the European Union (Withdrawal) Act 2018 and amended by the Data Protection, Privacy and Electronic Communications (Amendments etc.) (EU Exit) Regulations 2019 (“U.K.
−Removed: GDPR”, together with the EU GDPR referred to as “GDPR”).
−Removed: The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive data, obtaining consent of the individuals to whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, where required providing notification of data breaches, and taking certain measures when engaging third-party processors.
+Added: EU GDPR has been incorporated into U.K.
+Added: domestic law by virtue of section 3 of the European Union (Withdrawal) Act 2018 and amended by the Data Protection, Privacy and Electronic Communications (Amendments etc.) (EU Exit) Regulations 2019 (“U.K.
+Added: GDPR”, together with the EU GDPR referred to as “GDPR”).
+Added: The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to the processing of sensitive data (such as health data), obtaining consent of the individuals to whom the personal data relates or ensuring another legal basis or condition applies to the processing of personal data, providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, where required providing notification of data breaches, requiring data protection impact assessments for high risk processing and taking certain measures when engaging third-party processors.
The GDPR also imposes strict rules on the transfer of personal data to countries outside the EEA or the U.K.
−Removed: (see below), including the United States, and permits data protection authorities to impose large penalties for violations of the GDPR, including potential fines of up to €20 million (£17.5 million) or 4% of annual global revenues, whichever is greater.
+Added: (see below), including the United States, and permits data protection authorities to impose large penalties for violations of the GDPR, including potential fines of up to €20 million (£17.5 million) or 4% of annual global revenues, whichever is greater.
The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.
1 unchanged sentence
Compliance with the GDPR will be a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with our European activities.
−Removed: Further, the U.K.’s decision to leave the EU, often referred to as Brexit, has created uncertainty with regard to data protection regulation in the U.K., as the country’s future laws may deviate from the GDPR.
−Removed: The UK Government has announced plans to reform its data protection legal framework but those have been put on hold.
+Added: has announced plans to reform the country’s data protection legal framework in its Data Reform Bill, which will introduce significant changes from the EU GDPR.
+Added: This may lead to additional compliance costs and could increase our overall risk exposure as we may no longer be able to take a unified approach across the EU and the U.K.
The GDPR includes restrictions on cross-border data transfers.
1 unchanged sentence
data protection laws.
−Removed: On June 4, 2021, the European Commission (“EC”) issued new forms of standard contractual clauses for data transfers from controllers or processors in the EEA (or otherwise subject to the EU GDPR) to controllers or processors established outside the EEA (and not subject to the EU GDPR).
−Removed: The new standard contractual clauses replace the standard contractual clauses that were adopted previously under the Data Protection Directive.
−Removed: is not subject to the EC’s new standard contractual clauses but has published its own version of standard clauses, referred to as “International Data Transfer Agreement”
−Removed: which entered into force on 21 March 2022 and enables transfers originating from the U.K.
−Removed: Transfers made pursuant to these new mechanisms need to be assessed on a case-by-case basis to ensure the law in the recipient country provides “essentially equivalent”
−Removed: protections to safeguard the transferred personal data as the EU, and businesses are required to adopt supplementary measures if such standard is not met.
−Removed: We will be required to implement these new safeguards when conducting restricted data transfers under the GDPR and doing so will require significant effort and cost.
−Removed: On June 28, 2021, the EC announced a decision of “adequacy”
−Removed: concluding that the U.K.
−Removed: ensures an equivalent level of data protection to the GDPR, which provides some relief regarding the legality of continued personal data flows from the EEA to the U.K.
−Removed: Some uncertainty remains, however, as this adequacy determination must be renewed after four years and may be modified or revoked in the interim.
+Added: On June 4, 2021, the European Commission (“EC”) issued new forms of standard contractual clauses for data transfers from controllers or processors in the EEA (or otherwise subject to the EU GDPR) to controllers or processors established outside the EEA (and not subject to the EU GDPR).
+Added: is not subject to the EC’s new standard contractual clauses but has published its own version of standard clauses, referred to as “International Data Transfer Agreement” which entered into force on 21 March 2022 and enables transfers originating from the U.K.
Government has confirmed that transfers from the U.K.
to the EEA may currently continue to flow freely.
−Removed: Changes with respect to any of these matters may lead to additional costs and increase our overall risk exposure.
+Added: Transfers made pursuant to these new mechanisms need to be assessed on a case-by-case basis to ensure the law in the recipient country provides “essentially equivalent” protections to safeguard the transferred personal data as the EU, and businesses are required to adopt supplementary measures if such standard is not met.
+Added: Further, the EU and United States have adopted its adequacy decision for the EU-U.S.
+Added: Data Privacy Framework ("Framework"), which entered into force on July 11, 2023.
+Added: This Framework provides that the protection of personal data transferred between the EU and the U.S.
+Added: is comparable to that offered in the EU.
+Added: This provides a further avenue to ensuring transfers to the United States are carried out in line with GDPR.
+Added: There has been an extension to the Framework to cover U.K.
+Added: transfers to the United States.
+Added: The Framework could be challenged like its predecessor frameworks.
+Added: We will be required to implement these new safeguards when conducting restricted data transfers under the GDPR and doing so will require significant effort and cost.
Risks Related to Our Work with Third Parties
34 unchanged sentences
We face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex.
−Removed: Whether we reach a definitive agreement for other collaborations will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the collaborator’s evaluation of a number of factors.
+Added: Whether we reach a definitive agreement for other collaborations will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the collaborator’s evaluation of a number of factors.
Those factors may include the design or results of clinical trials, the progress of our clinical trials, the likelihood of approval by the FDA or similar regulatory authorities outside the United States, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge and industry and market conditions generally.
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There are a large number of companies developing or marketing treatments for cancer, including many major pharmaceutical and biotechnology companies.
−Removed: Currently marketed oncology drugs and therapeutics range from traditional cancer therapies, including chemotherapy, to antibody-drug conjugates, such as Genentech’s Kadcyla, to immune checkpoint inhibitors targeting CTLA-4, such as BMS’
−Removed: Yervoy, and PD-1/PD-L1, such as BMS’
−Removed: Opdivo, Merck & Co.’s Keytruda and Genentech’s Tecentriq, to T cell-engager antibody therapeutics, such as Amgen’s Blincyto.
+Added: Currently marketed oncology drugs and therapeutics range from traditional cancer therapies, including chemotherapy, to antibody-drug conjugates, such as Genentech’s Kadcyla, to immune checkpoint inhibitors targeting CTLA-4, such as BMS’ Yervoy, and PD-1/PD-L1, such as BMS’ Opdivo, Merck & Co.’s Keytruda and Genentech’s Tecentriq, to T cell-engager antibody therapeutics, such as Amgen’s Blincyto.
In addition, numerous compounds are in clinical development for cancer treatment.
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The loss of the services of any of them may adversely impact the achievement of our objectives.
−Removed: Any of our executive officers—Thomas J.
−Removed: Schuetz, our co-founder and Chief Executive Officer, and Vered Bisker-Leib, our President and Chief Operating Officer—could leave our employment at any time, as all of our employees are “at-will”
+Added: Any of our executive officers— Vered Bisker-Leib, our Chief Executive Officer and Thomas J.
+Added: Schuetz, our co-founder and President of R&D —could leave our employment at any time, as all of our employees are “at-will” employees.
The loss of the services of Dr.
−Removed: Schuetz or Dr.
−Removed: Bisker-Leib could impede the achievement of our research, development and commercialization objectives.
+Added: Bisker-Leib or Dr.
+Added: Schuetz could impede the achievement of our research, development and commercialization objectives.
Historically, we have experienced significant turnover in our research and development workforce and have operated with a limited team of scientific and technical personnel.
5 unchanged sentences
Pursuant to Section 404 of the Sarbanes-Oxley Act, our management is required to annually report upon the effectiveness of our internal control over financial reporting.
−Removed: When we lose our status as an “emerging growth company”
−Removed: and reach an accelerated filer threshold, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting.
+Added: When we lose our status as an “emerging growth company” and reach an accelerated filer threshold, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting.
The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation.
6 unchanged sentences
Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.
−Removed: Our business, results of operations and future growth prospects could be materially and adversely affected by the ongoing COVID-19 pandemic or the future outbreak of other highly infectious or contagious diseases.
+Added: Our business, results of operations and future growth prospects could be or continue to be affected by global pandemics, such as the COVID-19 pandemic, or the future outbreak of other highly infectious or contagious diseases.
Our business could be adversely affected by health epidemics in regions where we have concentrations of clinical trial sites or other business activities and could cause significant disruption in the operations of third-parties on which we rely.
−Removed: We cannot precisely determine or quantify the impact the COVID-19 pandemic, or the future outbreak of any other highly infectious our contagious diseases, will have on our business operations in the future, which will depend on a variety of factors and future developments, which are highly uncertain and cannot be predicted with confidence, including the ultimate geographic spread of the disease, the duration, scope and severity of the pandemic, the duration and extent of travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and the pandemic.
+Added: We cannot precisely determine or quantify the impact the future outbreak of any highly infectious our contagious diseases, such as the COVID-19 pandemic, will have on our business operations in the future, which will depend on a variety of factors and future developments, which are highly uncertain and cannot be predicted with confidence, including the ultimate geographic spread of the disease, the duration, scope and severity of the pandemic, the duration and extent of travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and the pandemic.
Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
1 unchanged sentence
For taxable years beginning after December 31, 2020, the deductibility of such federal net operating losses is limited to 80% of our taxable income in any future taxable year.
−Removed: In addition, in general, under Sections 382 and 383 of the Code, a corporation that undergoes an “ownership change,”
−Removed: which is generally defined as a greater than 50% change, by value, in its equity ownership by certain stockholders over a three-year period, is subject to limitations on its ability to utilize its pre-change net operating losses and research and development tax credit carryforwards to offset future taxable income.
+Added: In addition, in general, under Sections 382 and 383 of the Code, a corporation that undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in its equity ownership by certain stockholders over a three-year period, is subject to limitations on its ability to utilize its pre-change net operating losses and research and development tax credit carryforwards to offset future taxable income.
We may have experienced such ownership changes in the past and may experience such ownership changes in the future (which may be outside our control).
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Any provision of our amended and restated certificate of incorporation, our amended and restated bylaws or Delaware law that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our common stock and could also affect the price that some investors are willing to pay for our common stock.
−Removed: Our amended and restated bylaws designate certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders ’
−Removed: ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
+Added: Our amended and restated bylaws designate certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, 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 bylaws provide that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for any state law claims for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of fiduciary duty owed by any of our directors, officers and employees to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the DGCL, our amended and restated certificate of incorporation or our bylaws (in each case, as they may be amended form time to time) or (iv) any action asserting a claim that is governed by the internal affairs doctrine, in each case subject to the Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein;
4 unchanged sentences
We recognize that the forum selection clause in our bylaws may impose additional litigation costs on stockholders in pursuing any such claims, particularly if the stockholders do not reside in or near the State of Delaware or the Commonwealth of Massachusetts, as applicable.
−Removed: Additionally, the forum selection clause in our bylaws may limit our stockholders’
−Removed: ability to bring a claim in a forum that they find favorable for disputes with us or our directors, officers or employees, which may discourage such lawsuits against us and our directors, officers and employees even though an action, if successful, might benefit our stockholders.
+Added: Additionally, the forum selection clause in our bylaws may limit our stockholders’ ability to bring a claim in a forum that they find favorable for disputes with us or our directors, officers or employees, which may discourage such lawsuits against us and our directors, officers and employees even though an action, if successful, might benefit our stockholders.
The Court of Chancery of the State of Delaware or the United States District Court for the District of Massachusetts may also reach different judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgments may be more or less favorable to us than our stockholders.
3 unchanged sentences
Instead, we plan to retain any earnings to maintain and expand our operations.
−Removed: In addition, any future debt financing arrangement we enter into may contain, terms prohibiting or limiting the amount of dividends that may be declared or paid on our common stock.
+Added: In addition, any future debt financing arrangement we enter into may contain, terms prohibiting or limiting the amount of dividends that may be declared or paid on our common stock.
Accordingly, investors must rely on sales of their common stock after price appreciation, which may never occur, as the only way to realize any return on their investment.
29 unchanged sentences
We also could incur significant costs associated with civil or criminal fines and penalties.
−Removed: Although we maintain workers’
−Removed: compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.
+Added: Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.
We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials.
26 unchanged sentences
If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.
−Removed: Even after we no longer qualify as an “emerging growth company,”
−Removed: we may still qualify as a “smaller reporting company,”
−Removed: which would allow us to take advantage of many of the same exemptions from disclosure requirements, including not being required to comply with the independent auditor attestation requirements of Section 404 and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
+Added: Even after we no longer qualify as an “emerging growth company,” we may still qualify as a “smaller reporting company,” which would allow us to take advantage of many of the same exemptions from disclosure requirements, including not being required to comply with the independent auditor attestation requirements of Section 404 and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions.
3 unchanged sentences
As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
−Removed: We are also a “smaller reporting company,”
−Removed: meaning that the market value of our stock held by non-affiliates is less than $700.0 million and our annual revenue is less than $100.0 million during the most recently completed fiscal year.
−Removed: We may continue to be a “smaller reporting company”
−Removed: until (i) the market value of our stock held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million as of the prior June 30.
−Removed: If we are a “smaller reporting company”
−Removed: at the time we cease to be an “emerging growth company,”
−Removed: we may continue to rely on exemptions from certain disclosure requirements that are available to “smaller reporting companies.”
−Removed: Specifically, as a “smaller reporting company”
−Removed: we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, “smaller reporting companies”
−Removed: have reduced disclosure obligations regarding executive compensation.
−Removed: The designation of our common stock as “
−Removed: penny stock ”
−Removed: would limit the liquidity of our common stock.
−Removed: Our common stock may be deemed a “penny stock”
−Removed: (as that term is defined under Rule 3a51-1 of the Exchange Act) in any market that may develop in the future.
−Removed: Generally, a “penny stock”
−Removed: is a common stock that is not listed on a securities exchange and trades for less than $5.00 a share.
+Added: We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700.0 million and our annual revenue is less than $100.0 million during the most recently completed fiscal year.
+Added: We may continue to be a “smaller reporting company” until (i) the market value of our stock held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million as of the prior June 30.
+Added: If we are a “smaller reporting company” at the time we cease to be an “emerging growth company,” we may continue to rely on exemptions from certain disclosure requirements that are available to “smaller reporting companies.” Specifically, as a “smaller reporting company” we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, “smaller reporting companies” have reduced disclosure obligations regarding executive compensation.
+Added: The designation of our common stock as “ penny stock ” would limit the liquidity of our common stock.
+Added: Our common stock may be deemed a “penny stock” (as that term is defined under Rule 3a51-1 of the Exchange Act) in any market that may develop in the future.
+Added: Generally, a “penny stock” is a common stock that is not listed on a securities exchange and trades for less than $5.00 a share.
Prices often are not available to buyers and sellers and the market may be very limited.
2 unchanged sentences
The document provides information about penny stock and the nature and level of risks involved in investing in the penny stock market.
−Removed: A broker must also provide purchasers with bid and offer quotations and information regarding broker and salesperson compensation and make a written determination that the penny stock is a suitable investment for the purchaser and obtain the purchaser’s written agreement to the purchase.
+Added: A broker must also provide purchasers with bid and offer quotations and information regarding broker and salesperson compensation and make a written determination that the penny stock is a suitable investment for the purchaser and obtain the purchaser’s written agreement to the purchase.
Many brokers choose not to participate in penny stock transactions.
−Removed: If our common stock is deemed “penny stock”, because of penny stock rules, there may be less trading activity in any market that develops for our common stock in the future and stockholders are likely to have difficulty selling their shares.
−Removed: FINRA sales practice requirements may limit a stockholder ’
−Removed: s ability to buy and sell our common stock.
−Removed: The Financial Industry Regulatory Authority (“FINRA”) has adopted rules requiring that, in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer.
−Removed: Prior to recommending speculative or low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information.
+Added: If our common stock is deemed “penny stock”, because of penny stock rules, there may be less trading activity in any market that develops for our common stock in the future and stockholders are likely to have difficulty selling their shares.
+Added: FINRA sales practice requirements may limit a stockholder ’ s ability to buy and sell our common stock.
+Added: The Financial Industry Regulatory Authority (“FINRA”) has adopted rules requiring that, in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer.
+Added: Prior to recommending speculative or low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information.
Under interpretations of these rules, FINRA has indicated its belief that there is a high probability that speculative or low-priced securities will not be suitable for at least some customers.
7 unchanged sentences
the timing of the release of results of our clinical trials;
−Removed: results of clinical trials of our competitors’ products;
−Removed: safety issues with respect to our products or our competitors’ products;
−Removed: regulatory actions with respect to our products or our competitors’ products;
+Added: results of clinical trials of our competitors’ products;
+Added: safety issues with respect to our products or our competitors’ products;
+Added: regulatory actions with respect to our products or our competitors’ products;
actual or anticipated fluctuations in our financial condition and operating results;
publication of research reports by securities analysts about us or our competitors or our industry;
−Removed: our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market;
+Added: our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market;
additions and departures of key personnel;
10 unchanged sentences
changes in general market and economic conditions.
−Removed: In addition, the stock market has recently experienced significant volatility, including as a result of the ongoing COVID-19 pandemic and particularly with respect to pharmaceutical, biotechnology and other life sciences company stocks.
−Removed: The volatility of pharmaceutical, biotechnology and other life sciences company stocks often does not relate to the operating performance of the companies represented by the stock.
+Added: In addition, the volatility of pharmaceutical, biotechnology and other life sciences company stocks often does not relate to the operating performance of the companies represented by the stock.
As we operate in a single industry, we are especially vulnerable to these factors to the extent that they affect our industry or our products, or to a lesser extent our markets.
In the past, securities class action litigation has often been initiated against companies following periods of volatility in their stock price.
−Removed: This type of litigation could result in substantial costs and divert our management’s attention and resources, and could also require us to make substantial payments to satisfy judgments or to settle litigation.
+Added: This type of litigation could result in substantial costs and divert our management’s attention and resources, and could also require us to make substantial payments to satisfy judgments or to settle litigation.
Changes in tax law could adversely affect our business and financial condition.
6 unchanged sentences
We urge investors to consult with their legal and tax advisers regarding the implications of potential changes in tax laws on an investment in our common stock.
−Removed: Unresolved Staff Comments.
−Removed: Not applicable.
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.