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Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations.
+Added: Summary of Principal Risks Associated with Our Business
+Added: We are an early-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale.
+Added: We have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future, which, together with our limited operating history, makes it difficult to assess our future viability;
+Added: We are very early in our development efforts.
+Added: Our business is dependent on the successful development of our product candidates, future product candidates, and companion diagnostics for biomarkers associated with our product candidates and future product candidates;
+Added: In connection with the Collaboration, Option and License Agreement with GSK, if GSK does not exercise its option or if it terminates any development program under its collaborations with us, whether as a result of our inability to meet milestones or otherwise, any potential revenue from those collaborations will be significantly reduced or eliminated, and our results of operations and financial condition will be materially and adversely affected.
+Added: As an organization, we have never conducted a clinical trial, and may be unable to do so for any of our product candidates;
+Added: The successful development of targeted therapeutics, including therapeutics involving direct targeting of an oncogenic pathway and synthetic lethality therapeutics, including our portfolio of synthetic lethality small molecule inhibitors, as well as any related diagnostics, is highly uncertain;
+Added: Preclinical and clinical drug development is a lengthy and expensive process with an uncertain outcome.
+Added: We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of any product candidates, which could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our business, financial condition, results of operations and prospects.
+Added: Furthermore, results of earlier studies and trials may not be predictive of future trial results;
+Added: We may find it difficult to enroll patients in our clinical trials given the limited number of patients who have the diseases for which our product candidates are being developed.
+Added: If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected;
+Added: If we are unable to successfully develop molecular diagnostics for biomarkers that enable patient selection and/or that demonstrate drug-target interaction, or experience significant delays in doing so, we may not realize the full commercial potential of our product candidates;
+Added: We rely on third parties for the manufacture of our product candidates for preclinical and clinical development and expect to continue to do so for the foreseeable future.
+Added: This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts;
+Added: We face significant competition in an environment of rapid technological and scientific change, and our failure to effectively compete may prevent us from achieving significant market penetration.
+Added: Most of our competitors have significantly greater resources than we do and we may not be able to successfully compete;
+Added: If we fail to attract and retain senior management and key scientific personnel, our business may be materially and adversely affected;
+Added: The COVID-19 pandemic, or any other pandemic, epidemic or outbreak of an infectious disease may materially and adversely affect our business and operations, including the pace of enrollment in current or future clinical trials;
+Added: Our success depends on our ability to obtain and maintain protection for our intellectual property and our proprietary technologies and to avoid infringing the rights of others;
+Added: Our stock price has been and may continue to be volatile and you may not be able to resell shares of our common stock at or above the price you paid.
Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements
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We have had significant operating losses since our inception.
−Removed: Our net losses for the six months ended June 30, 2020 and June 30, 2019 were $24.4 million and $20.2 million, respectively.
−Removed: As of June 30, 2020, we had an accumulated deficit of $116.9 million.
+Added: Our net losses for the nine months ended September 30, 2020 and September 30, 2019 were $29.4 million and $31.2 million, respectively.
+Added: As of September 30, 2020, we had an accumulated deficit of $121.9 million.
Substantially all of our losses have resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.
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Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ deficit and working capital.
−Removed: We will require substantial additional financing to achieve our goals, and failure to obtain additional capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
+Added: Our operating results may fluctuate significantly, which will make our future results difficult to predict and could cause our results to fall below expectations.
+Added: Our quarterly and annual operating results may fluctuate significantly, which will make it difficult for us to predict our future results.
+Added: These fluctuations may occur due to a variety of factors, many of which are outside of our control and may be difficult to predict, including:
+Added: the timing and cost of, and level of investment in, research, development and commercialization activities, which may change from time to time;
+Added: the timing and status of enrollment for our clinical trials;
+Added: the timing of regulatory approvals, if any, in the United States and internationally;
+Added: the cost of manufacturing, as well as building out our supply chain, which may vary depending on the quantity of productions, and the terms of any agreements we enter into with third-party suppliers;
+Added: timing and amount of any option exercise, milestone, royalty or other payments we may or may not receive pursuant to any current or future collaboration or license agreement, including under the Collaboration, Option and License Agreement with GSK;
+Added: timing and amount of any milestone, royalty or other payments due under any current or future collaboration or license agreement, including the License Agreement with Novartis or the Option and License Agreement with Cancer Research UK and University of Manchester;
+Added: coverage and reimbursement policies with respect to any future approved products, and potential future drugs that compete with our products;
+Added: expenditures that we may incur to acquire, develop or commercialize additional products and technologies;
+Added: the level of demand for any future approved products, which may vary significantly over time;
+Added: future accounting pronouncements or changes in our accounting policies;
+Added: the timing and success or failure of preclinical studies and clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or collaboration partners.
+Added: The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results.
+Added: As a result, comparing our operating results on a period-to-period basis may not be meaningful.
+Added: Investors should not rely on our past results as an indication of our future performance.
+Added: This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period.
+Added: If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially.
+Added: Such a stock price decline could occur even when we have met any previously publicly stated revenue or earnings guidance we may provide.
+Added: We will require substantial additional financing to achieve our goals, and failure to obtain additional capital when needed on accep table terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
Since our inception, we have invested a significant portion of our efforts and financial resources in research and development activities for our precision medicine target and biomarker discovery platform and our initial preclinical and clinical product candidates.
Preclinical studies and clinical trials and additional research and development activities will require substantial funds to complete.
−Removed: As of June 30, 2020, we had cash, cash equivalents and marketable securities of $172.0 million.
+Added: As of September 30, 2020, we had cash, cash equivalents and marketable securities of $288.8 million.
We believe that we will continue to expend substantial resources for the foreseeable future in connection with the research and development of our precision medicine target and biomarker discovery platform, clinical and preclinical product candidates, and any other future product candidates we may choose to pursue, as well as other corporate uses.
−Removed: Specifically, in the near term, we expect to incur substantial expenses as we advance our synthetic lethality product candidates through preclinical studies, advance IDE196 through clinical development, seek regulatory approval, prepare for and, if approved, proceed to commercialization, and continue our research and development efforts.
+Added: Specifically, in the near term, we expect to incur substantial expenses as we advance our synthetic lethality product candidates through preclinical studies, advance IDE196 through clinical development, begin clinical development for IDE397, seek regulatory approval, prepare for and, if approved, proceed to commercialization, and continue our research and development efforts.
These expenses will include our cost sharing obligations with GSK for research and development for our WRN program and MAT2A program (if GSK exercises its exclusive option to obtain an exclusive license to continue development of and commercialize MAT2A products).
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the scope, progress, results and costs of developing, in collaboration with certain diagnostic companies, diagnostics for biomarkers associated with our product candidates or any other future product candidates in support of our preclinical studies and clinical trials, including our ongoing Phase 1/2 clinical trial for IDE196 in solid tumors harboring GNAQ or GNA11 mutations;
−Removed: the cost of coordinating and/or collabor ating with certain diagnostic companies for manufacturing and supply of companion diagnostics for biomarkers associated with our product candidates and any future product candidates;
+Added: the cost of coordinating and/or collaborating with cert ain diagnostic companies for manufacturing and supply of companion diagnostics for biomarkers associated with our product candidates and any future product candidates;
our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the Collaboration, Option and License Agreement with GSK, the License Agreement with Novartis and the Option and License Agreement with Cancer Research United Kingdom, or Cancer Research UK, and University of Manchester;
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We also could be required to seek funds through arrangements with collaborators or others that may require us to relinquish rights or jointly own some aspects of our technologies or product candidates that we would otherwise pursue on our own.
−Removed: Our operating results may fluctuate significantly, which will make our future results difficult to predict and could cause our results to fall below expectations.
−Removed: Our quarterly and annual operating results may fluctuate significantly, which will make it difficult for us to predict our future results.
−Removed: These fluctuations may occur due to a variety of factors, many of which are outside of our control and may be difficult to predict, including:
−Removed: the timing and cost of, and level of investment in, research, development and commercialization activities, which may change from time to time;
−Removed: the timing and status of enrollment for our clinical trials;
−Removed: the timing of regulatory approvals, if any, in the United States and internationally;
−Removed: the cost of manufacturing, as well as building out our supply chain, which may vary depending on the quantity of productions, and the terms of any agreements we enter into with third-party suppliers;
−Removed: timing and amount of any option exercise, milestone, royalty or other payments we may or may not receive pursuant to any current or future collaboration or license agreement, including under the Collaboration, Option and License Agreement with GSK;
−Removed: timing and amount of any milestone, royalty or other payments due under any current or future collaboration or license agreement, including the License Agreement with Novartis or the Option and License Agreement with Cancer Research UK and University of Manchester;
−Removed: coverage and reimbursement policies with respect to any future approved products, and potential future drugs that compete with our products;
−Removed: expenditures that we may incur to acquire, develop or commercialize additional products and technologies;
−Removed: the level of demand for any future approved products, which may vary significantly over time;
−Removed: future accounting pronouncements or changes in our accounting policies;
−Removed: the timing and success or failure of preclinical studies and clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or collaboration partners.
−Removed: The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results.
−Removed: As a result, comparing our operating results on a period-to-period basis may not be meaningful.
−Removed: Investors should not rely on our past results as an indication of our future performance.
−Removed: This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any per iod.
−Removed: If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price o f our common stock could decline substantially.
−Removed: Such a stock price decline could occur even when we have met any previously publicly stated revenue or earnings guidance we may provide.
Risks Related to Our Business
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our ability to compete with other approved therapies, if any;
−Removed: acceptance by physicians, payors and patients of the benefits, safety and efficacy of our product candidate or any future product candidates, if approv ed, including relative to alternative and competing treatments;
+Added: acceptance by physicians, payors and patients of the benefits, safety and efficacy of our prod uct candidate or any future product candidates, if approved, including relative to alternative and competing treatments;
patient demand for any approved products;
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exercise the Option.
−Removed: Further, in the event that GSK is required to obtain HSR Clearance after exercising t he Option, and such HSR Clearance is not obtained, GSK will not participate in further development of any MAT2A products and the product rights would revert to us.
−Removed: We would then have worldwide rights to those assets and be responsible for funding the devel opment of the assets.
−Removed: GSK may terminate the entire GSK Collaboration Agreement or any collaboration program on a target-by-target basis for any or no reason upon written notice to us after expiration of a defined notice period.
−Removed: The GSK Collaboration Agreem ent or any program under the GSK Collaboration Agreement may also be terminated by either party for the other party’s insolvency or certain uncured breaches.
−Removed: We may terminate the GSK Collaboration Agreement if GSK or any of its sublicensees or affiliates c hallenge certain of our patents.
−Removed: Depending on the timing of any such termination we may not be entitled to receive the option exercise fees, or potential milestone payments, as these payments terminate with termination of the GSK Collaboration Agreement .
+Added: Further, in the event that GSK is required to obtain HSR Clearance after exercising the Option, and such HSR Clearance is not obtained, GSK will not participate in further development of any MAT2A products and the product rights would revert to us.
+Added: We would then have worldwide rights to those assets and be responsible for funding the development of the assets.
+Added: GSK may terminate the entire GSK Collaboration Agreement or any collaboration program on a target-by-targe t basis for any or no reason upon written notice to us after expiration of a defined notice period.
+Added: The GSK Collaboration Agreement or any program under the GSK Collaboration Agreement may also be terminated by either party for the other party’s insolvency or certain uncured breaches.
+Added: We may terminate the GSK Collaboration Agreement if GSK or any of its sublicensees or affiliates challenge certain of our patents.
+Added: Depending on the timing of any such termination we may not be entitled to receive the option ex ercise fees, or potential milestone payments, as these payments terminate with termination of the GSK Collaboration Agreement .
If GSK does not exercise the Option with respect to any MAT2A product (or HSR Clearance thereof is not obtained), or terminates its rights and obligations with respect to a program or the entire GSK Collaboration Agreement, then depending on the timing of such event:
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this may not be possible, or we may not be able to do so on terms which are acceptable to us, in which case it may be necessary for us to limit the size or scope of one or more of our programs or increase our expenditures and seek additional funding by other means.
−Removed: Any of these events would have a material adverse effect on our results of operations and financial condition.
+Added: Any of these events would have a material adverse effect on o ur results of operations and financial condition.
Clinical development of our lead product candidate, IDE196, depends, in part, on data from Novartis’ ongoing Phase 1 clinical trial of IDE196 in patients with metastatic uveal melanoma.
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difficult or impossible for us to rely on Novartis’ clinical data in regulatory filings as planned.
−Removed: Furthermore, although the agreement requires Novartis to provide us with certain data at specified intervals, if Nova rtis does not make data available to us, our IDE196 development program may be significantly delayed and we may need to conduct additional studies or trials independently.
+Added: Furthermore, although the agreement requires Novartis to provide us with certain data at specified intervals, if Novartis does not make data available to us, our IDE196 development program may be significantly delayed and we may need to conduct additional studies or trials independently.
As a result, we may not be able to obtain regulatory approval for IDE196 in a timely fashion, at the expected cost to us, or at all, and our business, financial position, results of operations and prospects may be adversely affected.
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As an organization, we have not yet completed any clinical trials for any of our product candidates.
−Removed: Our lead product candidate, IDE196, is currently in a Phase 1 clinical trial being conducted by Novartis.
−Removed: IDE196 is also in a Phase 1/2 clinical trial that we are conducting.
+Added: Our lead product candidate, IDE196, is in a Phase 1/2 clinical trial that we are conducting.
We have limited experience in preparing, submitting and prosecuting regulatory filings, and have not previously submitted any NDA or other comparable foreign regulatory submission for any product candidate.
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Additionally, particular patient genetic alterations, such as mutations, deletions or fusions may not be functionally active genetic drivers of the disease.
−Removed: Further, whether a genetic alteration is functionally active may be difficult to ascertain from pre clinical cancer models, may be tissue-type dependent and may vary from patient to patient within a specific indication.
−Removed: If that was the case, we would need to functionally validate such genetic alterations, for example, using in vitro and in vivo models, p otentially across more than one tumor-tissue type and across multiple cell lines.
−Removed: If some of the genetic alterations are not functionally validated, this would reduce the size of our addressable patient population.
−Removed: Even if genetic alterations are preclinic ally validated, the relevance of these alterations may not translate into a human clinical setting, which could adversely impact our clinical trial results and our commercial opportunities.
+Added: Further, whether a genetic a lteration is functionally active may be difficult to ascertain from preclinical cancer models, may be tissue-type dependent and may vary from patient to patient within a specific indication.
+Added: If that was the case, we would need to functionally validate such genetic alterations, for example, using in vitro and in vivo models, potentially across more than one tumor-tissue type and across multiple cell lines.
+Added: If some of the genetic alterations are not functionally validated, this would reduce the size of our ad dressable patient population.
+Added: Even if genetic alterations are preclinically validated, the relevance of these alterations may not translate into a human clinical setting, which could adversely impact our clinical trial results and our commercial opportunit ies.
Targeted therapeutics that appear promising in the early phases of development may fail to reach the market for several reasons, including:
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Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a potential product candidate to market would adversely affect our business, financial condition, results of operations and prospects.
−Removed: Even if we are successful in obtaining regulatory approval, commercial success of any approved products will also depend in large part on the availability of insurance coverage and adequate reimbursement from third-party payors, including government payors, such as the Medicare and Medicaid programs, and managed care organizations, which may be affected by existing and future healthcare reform measures designed to reduce the cost of healthcare.
−Removed: Third-party payo rs could require us to conduct additional studies, including post-marketing studies related to the cost-effectiveness of a product, to qualify for reimbursement, which could be costly and divert our resources.
+Added: Even if we are successful in obtaining regulatory approval, commercial success of any approved products will also depend in large part on the availability of insurance coverage and adequate reimbursement from third-party payors, including government payors, such as the Medicare and Me dicaid programs, and managed care organizations, which may be affected by existing and future healthcare reform measures designed to reduce the cost of healthcare.
+Added: Third-party payors could require us to conduct additional studies, including post-marketing studies related to the cost-effectiveness of a product, to qualify for reimbursement, which could be costly and divert our resources.
If government and other healthcare payors were not to provide adequate insurance coverage and reimbursement levels for one any of our products once approved, market acceptance and commercial success would be limited.
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Before we can initiate clinical trials for our product candidates, we must submit the results of preclinical studies to the FDA or a comparable foreign regulatory authority along with other information, including information about product candidate chemistry, manufacturing and controls, diagnostics for biomarkers for our product candidates and our proposed clinical trial protocol, as part of an IND application or similar regulatory filing.
+Added: We anticipate submitting an IND to the FDA for our IDE397 development candidate in the fourth quarter of 2020.
Before obtaining marketing approval from regulatory authorities for the sale of any products, we, or our collaboration partners, such as GSK, must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidates in humans.
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In either case, our development costs would increase.
−Removed: Our clinical trial collaboration and supply agreement with Pfizer for the supply of their MEK inhibitor, binimetinib, supports our plans to evaluate the safety and efficacy of IDE196 in combination with binimetinib in a Phase 1/2 clinical trial which we initiated in June 2020.
−Removed: If Pfizer delays or fails to supply binimetinib in support of the combination arm of the IDE196 clinical trial, the development program as perta ining to combination of IDE196 and a MEK inhibitor may be significantly delayed, and our development costs may increase.
−Removed: Subject to completion of and satisfactory results from preclinical studies, we may evaluate IDE196 in combination with one or more anti-cancer agent(s) in addition to binimetinib, such as a different inhibitor of MEK or an inhibitor of FAK, mTOR and/or CDK4/6, in a Phase 1/2 clinical trial in patients with metastatic uveal melanoma.
−Removed: This may require us to establish additional supply agreements and rely upon third parties for supply of such combination agents, or if such combination agents are commercially available, in the absence of a supply agreement, we may incur the cost of purchasing such combination agents and may be at risk of having insufficient supply.
−Removed: We may initiate clinical trials in which our product candidates, including IDE196, are combined with one or more other pharmaceutical agents that have not yet been approved by the FDA or comparable foreign regulatory authorities;
−Removed: in such situations, we may be relying on third parties for obtaining appropriate regulatory approvals and we may have no or limited influence over whether or not such regulatory approvals are achieved for such combination agents.
−Removed: We and our strategic collaborators , such as GSK, also may experience numerous unforeseen events during, or as a result of, any preclinical studies or clinical trials that could delay or prevent us or our strategic collaborators from successfully developing our product candidat es, including:
+Added: Our clinical trial collaboration and supply agreement with Pfizer for the supply of their MEK inhibitor, binimetinib, and their cMET inhibitor, crizotinib, supports our plans to evaluate the safety and efficacy of IDE196 in combination with binimetinib and in combination with crizotinib in Phase 1/2 clinical trial arms that we initiated in June 2020 and that we plan to initiate in late 2020 to early 2021, respectively.
+Added: If Pfizer delays or fails to supply binimetinib or crizotinib in support of the combination arms of the IDE196 clinical trial, the development program as pertaining to combination of IDE196 with either a MEK inhibitor or a cMET inhibitor may be significantly delayed, and our development costs may increase.
+Added: Subject to completion of and satisfactory results from preclinical studies, we may evaluate IDE196 in combination with one or more anti-cancer agent(s) in addition to binimetinib and crizotinib, such as a different inhibitor of MEK or cMET or an inhibitor of FAK, mTOR and/or CDK4/6, in a Phase 1/2 clinical trial in patients with metastatic uveal melanoma.
+Added: This may require us to establish additional supply agreements and rely upon third parties for supply of such combination agents, or if such combination agents
+Added: are commercially available, in the absence of a supply agreement, we may incu r the cost of purchasing such combination agents and may be at risk of having insufficient supply.
+Added: We may initiate clinical trials in which our product candidates, including IDE196, are combined with one or more other pharmaceutical agents that have not ye t been approved by the FDA or comparable foreign regulatory authorities;
+Added: in such situations, we may be relying on third parties for obtaining appropriate regulatory approvals and we may have no or limited influence over whether or not such regulatory appro vals are achieved for such combination agents.
+Added: We and our strategic collaborators, such as GSK, also may experience numerous unforeseen events during, or as a result of, any preclinical studies or clinical trials that could delay or prevent us or our strategic collaborators from successfully developing our product candidates, including:
we may be unable to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials;
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we or our third-party contractors may fail to comply with regulatory requirements, fail to maintain adequate quality controls, or be unable to produce sufficient product supply to conduct and complete preclinical studies or clinical trials of our product candidates in a timely manner, or at all;
−Removed: we or our investigators might have to suspend or terminate clinical trials of our product candidates for various reasons, including non-compliance with regulatory requirements, a finding that our product candidates have undesirable side effects or other unexpected characteristics, or a finding that the participants are being exposed to unacceptable health risks;
+Added: we or our investigators might have to suspend or terminate clinical trials of our product candidates for various reasons, including non-compliance with regulatory requirements, a finding that our product candidates have undesirable side effects or other un expected characteristics, or a finding that the participants are being exposed to unacceptable health risks;
the cost of clinical trials of our product candidates may be greater than we anticipate;
−Removed: the quality of our product candida tes or other materials necessary to conduct preclinical studies or clinical trials of our product candidates may be insufficient or inadequate;
+Added: the quality of our product candidates or other materials necessary to conduct preclinical studies or clinical trials of our product candidates may be insufficient or inadequate;
regulators may revise the requirements for approving our product candidates, or such requirements may not be as we anticipate;
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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.
−Removed: If these relationships and any related compensation result in perceived or actual conflicts of interest, or a regulatory authority concludes that the financial relationship may have affected the interpretation of the clinical trial, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection of the marketing application we submit.
+Added: If these relationships and any related compensation result in perceived or actual conflicts of interest, or a regulatory authority concludes that the financial relationship may have affected the interpretation of the clinical trial, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection of the marketing application w e submit.
Any such delay or rejection could prevent or delay us from commercializing our current or future product candidates.
−Removed: If any of our preclinical studies or clinical trials of our product candidates are delayed or terminated, the commercial prospects of our product candidates may be harmed, and our ability to ultimately generate revenues from any of these product candidates will be delayed or not realized a t all.
+Added: If any of our preclinical studies or clinical trials of our product candidates are delayed or terminated, the commercial prospects of our product candidates may be harmed, and our ability to ultimately generate revenues from any of these product candidates will be delayed or not realized at all.
In addition, any delays in completing our clinical trials may increase our costs, slow down our product candidate development and regulatory approval process and jeopardize our ability to commence product sales and generate revenues.
−Removed: Any of these oc currences may significantly harm our business, financial condition, results of operations and prospects.
−Removed: In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the d enial of regulatory approval of our product candidates.
−Removed: If our product candidates and any future product candidates prove to be ineffective, unsafe or commercially unviable, our entire platform and approach would have little, if any, value, which would hav e a material adverse effect on our business, financial condition, results of operations and prospects.
+Added: Any of these occurrences may significantly harm our business, financial condition, results of operations and prospects.
+Added: In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.
+Added: If our product candidates and any future product candidates prove to be ineffective, unsafe or commercially unviable, our entire platform and approach would have little, if any, value, which would have a material adverse effect on our business, financial condition, results of operations and prospects.
Furthermore, the results of preclinical studies and clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials.
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More restrictive statutory regimes, government regulations, or negative public opinion would have an adverse effect on our business, financial condition, results of operations, and prospects, and may delay or impair the development of our product candidates and commercialization of any approved products or demand for any products we may develop.
−Removed: Tissue-type agnostic basket trials are an emerging clinical appr oach, that may result in delays in clinical development, additional regulatory requirements and delays in, or the prevention of, our ability to obtain regulatory approval or commercialize our product candidates.
+Added: Tissue-type agnostic basket trials are an emerging clinical approach, that may result in delays in clinical development, additional regulatory requirements and delays in, or the prevention of, our ability to obtain regulatory approval or commercialize our product candidates.
We initiated a Phase 1/2 tissue-type agnostic basket trial with IDE196 in June 2019, and may also utilize a basket trial approach in clinical trials for other product candidates.
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In addition, the process of finding and diagnosing patients may prove costly.
−Removed: In addition, our clinical trials may compete with other clinical trials for product candidates that are in the same therapeutic areas as our product ca ndidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors.
−Removed: As a result of t he COVID-19 pandemic, competition for potential patients in our trials is further exacerbated as a result of multiple clinical site closures .
−Removed: Since the number of qualified clinical investigators is already limited, we may conduct some of our clinical trial s at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial site.
+Added: In addition, our clin ical trials may compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might h ave opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors.
+Added: As a result of the COVID-19 pandemic, competition for potential patients in our trials is further exacerbated as a result of multiple clinical site closures .
+Added: Since the number of qualified clinical investigators is already limited, we may conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are availabl e for our clinical trials in such clinical trial site.
Furthermore, certain conditions for which we plan to evaluate our current development candidates are rare diseases, such as metastatic uveal melanoma, with limited patient pools from which to draw for clinical trials.
−Removed: For example, our lead product candidate, IDE196, is currently being evaluated in a Phase 1 clinical trial in patients with metastatic uveal melanoma conducted by Novartis.
−Removed: We initiated our own Phase 1/2 basket trial in June 2019 to evaluate IDE196 in solid tumors harboring GNAQ/GNA11 hotspot mutations in metastatic uveal melanoma, and potentially in other solid tumors such as cutaneous melanoma and colorectal cancer.
+Added: For example, our lead product candidate, IDE196, is currently being evaluated in a Phase 1/2 basket trial that we initiated in June 2019 to evaluate IDE196 in solid tumors harboring GNAQ/GNA11 hotspot mutations in metastatic uveal melanoma, and potentially in other solid tumors such as cutaneous melanoma and colorectal cancer.
The timing of our clinical trials depends, in part, on the speed at which we can recruit patients to participate in our trials, as well as completion of required follow-up periods.
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Results of our clinical trials could reveal a high and unacceptable severity and prevalence of these or other side effects.
−Removed: Furthermore, certain of our product candidates, such as IDE196, may be co-administered with third-party approved or experimental therapies, such as binimetinib in the combination arm of our Phase 1/2 clinical trial.
+Added: Furthermore, certain of our product candidates, such as IDE196, may be co-administered with third-party approved or experimental therapies, such as binimetinib or crizotinib in the combination arms of our Phase 1/2 clinical trial.
These combinations may have additional side effects.
The uncertainty resulting from the use of our product candidates in combination with other therapies may make it difficult to accurately predict side effects in future clinical trials.
−Removed: To date, only one of our product candidates, IDE196, has been tested in clinical trials, including an ongoing Phase 1 clinical trial and an ongoing Phase 1/2 clinical trial, and has been observed to be generally well tolerated, with the most common AEs report ed being hypotension, GI toxicities, and fatigue.
−Removed: If unacceptable side effects arise in the further development of IDE196 , including in combination with binimetinib, or in the development of any of our other product candidates, we, the FDA, or the IRBs at the institutions in which the clinical trials are being conducted could suspend or terminate our clinical trials or the FDA or a comparable foreign regulatory authority could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications.
−Removed: Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete any of our clinical trials or result in potential product liability claims.
−Removed: In addition, these side effect s may not be appropriately recognized or managed by the treating medical staff.
−Removed: We expect to have to train medical personnel using our product candidates to understand the side effect profiles for our clinical trials and upon any commercialization of any o f our product candidates.
+Added: To date, only one of our product candidates, IDE196, has been tested in clinical trials, including an ongoing Phase 1 clinical trial and an ongoing Phase 1/2 clinical trial, and has been observed to be generally well tolerated, with the most common AEs reported being hypotension, GI toxicities, and fatigue.
+Added: If unacceptable side effects arise in the further development of IDE196 , including in combination with binimetinib or crizotinib , or in the developme nt of any of our other product candidates, we, the FDA, or the IRBs at the institutions in which the clinical trials are being conducted could suspend or terminate our clinical trials or the FDA or a comparable foreign regulatory authority could order us t o cease clinical trials or deny approval of our product candidates for any or all targeted indications.
+Added: Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete any of our clinical trials or resul t in potential product liability claims.
+Added: In addition, these side effects may not be appropriately recognized or managed by the treating medical staff.
+Added: We expect to have to train medical personnel using our product candidates to understand the side effect p rofiles for our clinical trials and upon any commercialization of any of our product candidates.
Inadequate training in recognizing or managing the potential side effects of our product candidates could result in patient injury or death.
−Removed: Any of these occurrences may harm our business, financial condition, results of operation s and prospects significantly.
+Added: Any of these occur rences may harm our business, financial condition, results of operations and prospects significantly.
In addition, even if we successfully advance our product candidates or any future product candidates into and through clinical trials, such trials will likely only include a limited number of patients and limited duration of exposure to our product candidates.
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We may have difficulty in establishing or maintaining such development relationships, and we will face competition from other companies in establishing these collaborations.
−Removed: There are also several risks assoc iated with biomarker identification and validation.
−Removed: We, in collaboration with any diagnostic partners, may not be able to identify predictive biomarkers or pharmacodynamic biomarkers for one or more of our programs.
+Added: There are also several risks associated with biomarker identification and validation.
+Added: We, in collaboration with any diagnostic partners, may not be able to identify pre dictive biomarkers or pharmacodynamic biomarkers for one or more of our programs.
We may not be able to validate potential biomarkers (e.g., certain genetic mutations) or their functional relevance preclinically in relevant in vitro or in vivo models.
−Removed: Data analytics and information from databases that we rely on for identifying or validating some of our biomarker-target relat ionships may not accurately reflect potential patient populations.
−Removed: Potential biomarkers, even if validated preclinically, may not be functionally effective or validated in human clinical trials.
+Added: Data analytics and information from databases that we rely on for identifying or validating some of our biomarker-target relationships may not accurately reflect potential patient populations.
+Added: Potential biomarkers, even if validated preclinically, may not be f unctionally effective or validated in human clinical trials.
If we, in collaboration with these parties, are unable to successfully develop companion diagnostics for our product candidates, or experience delays in doing so, the development of our product candidates may be adversely affected.
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such authorities could question the integrity of data obtained in our current or future clinical trials, for example, due to missed protocol procedures due to the impact of the COVID-19 pandemic;
−Removed: such authorities may not agree that the data collected from clinical trials of our product candidates are acceptable or sufficient to support the submission of an NDA or other s ubmission or to obtain regulatory approval in the United States or elsewhere, and such authorities may impose requirements for additional preclinical studies or clinical trials;
+Added: such authorities may not agree that the data collected from clinical trials of our product candidates are acceptable or sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere, a nd such authorities may impose requirements for additional preclinical studies or clinical trials;
such authorities may disagree regarding the formulation, labeling and/or the specifications of our product candidates;
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The occurrence of any of these risks could result in our own products, if approved, being removed from the market or being less successful commercially.
−Removed: We may also evaluate our product candidates in combination with one or more cancer therapies that have not yet been approved for marketing by the FDA or a similar regulatory authority outside of the United States.
+Added: We may also eva luate our product candidates in combination with one or more cancer therapies that have not yet been approved for marketing by the FDA or a similar regulatory authority outside of the United States.
We may be unable to effectively identify and collaborate with third parties for the evaluation of our product candidates in combination with their therapies.
−Removed: We will not be able to market and sell any product candidate we develop in combination with any such unappr oved cancer therapies that do not ultimately obtain marketing approval.
+Added: We will not be able to market and sell any product candidate we develop in combination with any such unapproved cancer therapies that do not ultimately obt ain marketing approval.
The regulations prohibiting the promotion of products for unapproved uses are complex and subject to substantial interpretation by the FDA and other government agencies.
−Removed: In addition, t here are additional risks similar to the ones described for our products currently in development and clinical trials that result from the fact that such cancer therapies are unapproved, such as the potential for serious adverse effects, delay in their cli nical trials and lack of FDA approval.
+Added: In addition, there are additional risks similar to the ones de scribed for our products currently in development and clinical trials that result from the fact that such cancer therapies are unapproved, such as the potential for serious adverse effects, delay in their clinical trials and lack of FDA approval.
If the FDA or a similar regulatory authority outside of the United States does not approve these other drugs or revokes approval of, or if safety, efficacy, manufacturing, or supply issues arise with, the drugs we choose to evaluate in combination with any product candidate we develop, we may be unable to obtain approval of or market such product.
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Our competitors include larger and better funded biopharmaceutical, biotechnological and oncology therapeutics companies, as well as universities and other research institutions.
−Removed: Our commercial opportunity and success will be reduced or eliminated if competing products emerge that are safer, more effective, or less expensive than the therapeutics we develop.
−Removed: Our competitors may develop drugs that are more effective, more convenient, more widely used and less costly or have a better safety profile than our products and these competitors may also be more successful than us in manufacturing and marketin g their products.
+Added: Our commercial opportunity and success will be reduced or eliminated if competing products emerge that are safer, more effective, or less expensive t han the therapeutics we develop.
+Added: Our competitors may develop drugs that are more effective, more convenient, more widely used and less costly or have a better safety profile than our products and these competitors may also be more successful than us in man ufacturing and marketing their products.
Although we believe that IDE196 is currently the most advanced small molecule PKC inhibitor for genetically-defined cancers having GNAQ or GNA11 gene mutations in clinical trials, others may receive approval for competitive products before we do.
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Such competitors could also recruit our employees, which could negatively impact our level of expertise and our ability to execute our business plan.
−Removed: We expect to expand our development and regulatory capabi lities and potentially implement sales and distribution capabilities, and as a result, we will need to increase the size of our organization, and we may experience difficulties in managing growth.
−Removed: As of June 30, 2020, we had 46 employees.
+Added: We expect to expand our developmen t and regulatory capabilities and potentially implement sales and distribution capabilities, and as a result, we will need to increase the size of our organization, and we may experience difficulties in managing growth.
+Added: As of September 30, 2020, we had 58 employees.
We will need to continue to expand our managerial, operational, finance and other resources in order to manage our operations and clinical trials, continue our development activities, submit for regulatory approval and, if approved, commercialize our lead product candidate or any future product candidates.
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The loss of services of any of these individuals could delay or prevent the successful development of any products, initiation or completion of our planned clinical trials or the commercialization of our lead product candidate or any other product candidates.
−Removed: Competition for qualified personnel in the biotechnology and biopharmaceutical fields is intense due to the limited number of individuals who possess the skills and experience required by our industry.
−Removed: We will need to hire additional personnel as we exp and our clinical development and if we initiate commercial activities.
+Added: Competition f or qualified personnel in the biotechnology and biopharmaceutical fields is intense due to the limited number of individuals who possess the skills and experience required by our industry.
+Added: We will need to hire additional personnel as we expand our clinical development and if we initiate commercial activities.
We may not be able to attract and retain quality personnel on acceptable terms, or at all.
−Removed: In addition, to the extent we hire personnel from competitors, we may be subject to allegation s that they have been improperly solicited or that they have divulged proprietary or other confidential information, or that their former employers own their research output.
−Removed: We depend on our information technology systems, and any failure of these systems could harm our business.
−Removed: Security breaches, loss of data or financial assets, and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business, results of operations and financial condition.
−Removed: We collect and maintain information in digital form that is necessary to conduct our business, and we are increasingly dependent on information technology systems and infrastructure to operate our business.
−Removed: In the ordinary course of our business, we collect, store and transmit large amounts of confidential information, including intellectual property, proprietary business information and personal information.
−Removed: It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information, including both our own and that of third parties.
−Removed: We have established physical, electronic and organizational measures to safeguard and secure our systems to prevent a data compromise, and rely on commercially available systems, software, tools, and monitoring to provide security for our information technology systems and the processing, transmission and storage of digital information.
−Removed: We have also outsourced elements of our information technology infrastructure, and as a result a number of third-party vendors may or could have access to our confidential information.
−Removed: Our internal information technology systems and infrastructure, and those of our current and any future collaborators, contractors and consultants and other third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization.
−Removed: The risk of a security breach or disruption or data loss, particularly through cyber-attacks or cyber-intrusion, including by computer hackers, foreign governments and cyber-terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.
−Removed: In addition, the pervasive use of mobile devices that access confidential information increases the risk of data security breaches, which could lead to the loss of confidential information or other intellectual property, including both our own and that of third parties.
−Removed: The costs to us to mitigate network security problems, bugs, viruses, worms, malicious software programs and security vulnerabilities could be significant, and while we have implemented security measures to protect our data security and information technology systems, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service and other harm to our business and our competitive position.
−Removed: If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our product development programs.
−Removed: For example, the loss of clinical trial data could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
−Removed: Moreover, if a computer security breach affects our systems or results in the unauthorized release of personally identifiable information, our reputation could be materially damaged.
−Removed: In addition, such a breach may require notification to governmental agencies, the media or individuals pursuant to various federal and state privacy and security laws, if applicable, including the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Clinical Health Act of 2009, or HITECH, and its implementing rules and regulations, as well as regulations promulgated by the Federal Trade Commission and state breach notification laws.
−Removed: We would also be exposed to a risk of loss, including financial assets or litigation and potential liability, which could materially adversely affect our business, financial condition, results of operations and prospects.
−Removed: Our employees and independent contractors, including principal investigators, consultants, colla borators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
+Added: In addition, to the extent we hire personnel from competitors, we may be subject to allegations that they have been improperly solicited or that they have divulged proprietary or other confidential information, or that their former employers own their research output.
+Added: Our employees and independent contractors, including principal investigators, consultants, collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
We are exposed to the risk that our employees and independent contractors, including principal investigators, consultants, collaborators, service providers and other vendors may engage in misconduct or other illegal activity.
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We cannot predict the impact of such changes and cannot be certain of our future compliance.
−Removed: Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws a nd regulations may impair our research, product development and manufacturing efforts.
+Added: Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may i mpair our research, product development and manufacturing efforts.
In addition, we cannot entirely eliminate the risk of accidental injury or contamination from these materials or wastes.
−Removed: Although we maintain workers’ compensation insur ance 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.
−Removed: We do not carry specific biological or haza rdous waste insurance coverage, and our property, casualty, and general liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination.
−Removed: Accordingly, in the event of cont amination or injury, we could be held liable for damages or be penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended, which could have a material adverse effect on our business, financ ial condition, results of operations and prospects.
+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.
+Added: We do not carry specific biological or hazardous waste insuranc e coverage, and our property, casualty, and general liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination.
+Added: Accordingly, in the event of contamination or injury, we could be held liable for damages or be penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended, which could have a material adverse effect on our business, financial condition, resul ts of operations and prospects.
We attempt to distribute our technology, biology, execution and financing risks across a range of therapeutic classes, disease states, programs and technologies.
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All of these risks may relate to our current or future precision medicine programs or companion diagnostics, and in the event material decisions in any of these areas turn out to have been incorrect or under-optimized, we may experience a material adverse impact on our business, financial condition, results of operations and prospects.
−Removed: The COVID-19 pandemic, or any other pandemic, epidemic or outbreak of an infectious disease may materially and adversely affect our business and operations.
+Added: The COVID-19 pandemic, or any other pandemic, epidemic or outbreak of an infectious disease may materially and adversely affect our business and operations, including the pace of enrollment in current or future clinical trials.
Outbreaks of epidemic, pandemic, or contagious diseases, such as the current novel coronavirus or, historically, the Ebola virus, Middle East Respiratory Syndrome, Severe Acute Respiratory Syndrome, or the H1N1 virus, could disrupt our business.
For example, beginning in late 2019, the outbreak of a novel strain of virus named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), or coronavirus, which causes coronavirus disease 2019, or COVID-19, has evolved into a global pandemic.
−Removed: On January 30, 2020, the World Health Organization declared the outbreak of COVID-19 a “Public Health Emergency of International Concern,” and on March 11, 2020, the World Health Organization characterized the outbreak as a “pandemic”.
+Added: On January 30, 2020, the World Health Organization declared the outbreak of COVID-19 a “Public Health Emergency of International Concern,” and on March 11, 2020, the
+Added: World Health Organization characterized the outbreak as a “pandemic”.
The governors of California and over forty other states, as well as mayors of many cities, ordered their residents to cease traveling to non-essential jobs and to curtail all unnecessary travel, and to stay in their homes as much as possible.
−Removed: As of late July 2020, the coronavirus has spread to most regions of the world and the United States continues to experience escalating COVID-19 outbreaks, particularly in certain states, such as California.
−Removed: If the current economic conditions worsen or last for an extended period of time, we will be forced to significantly scale back our business and growth plans, which could have a material adverse effect on our business.
−Removed: The COVID-19 pandemic is affecting the United States and global economies and may affect our opera tions and those of third parties on which we rely.
−Removed: Some of these third parties are experiencing shut-downs, supply chain and experimental study interruptions or slow-downs, and more third parties could experience such shut-downs, interruptions or slow-dow ns.
+Added: As of late October 2020, the coronavirus has spre ad to most regions of the world and the United States continues to experience significant COVID-19 outbreaks, particularly in certain state s, such as California .
+Added: If the current economic conditions worsen or last for an extended period of time, we will be f orced to significantly scale back our business and growth plans, which could have a material adverse effect on our business.
+Added: The COVID-19 pandemic is affecting the United States and global economies and may affect our operations and those of third parties on which we rely.
+Added: Some of these third parties have experienced shut-downs, supply chain and experimental study interruptions or slow-downs, and more third parties could experience such shut-downs, interruptions or slow-downs.
Individuals at our company or at such third parties could become ill, quarantined, or otherwise unable to work and/or travel due to health reasons or governmental restrictions.
−Removed: In response to the COVID-19 pandemic, San Mateo County, California, in whic h our primary office resides, issued a “shelter in place” order in March 2020 , which was issued in accordance with the March 2020 Proclamation of a State of Emergency issued by the Governor of California .
−Removed: We have closed our offices and requested that most of our personnel, including all of our administrative employees, work remotely, restricted on-site staff to only those personnel and contractors who must perform essential activities that must be completed on-site and limited the number of staff in any giv en research and development laboratory.
+Added: In response to the COVID-19 pandemic, San Mateo County, California, in which our primary office resides, issued a “shelter in place” order in March 2020, which was issued in accordance with the March 2020 Proclamation of a State of Emergency issued by the Governor of California.
+Added: We have closed our offices and requested that most of our personnel, including all of our administrative employees, work remotely, restricted on-site staff to only those personnel and contractors who must perform essential activities that must be completed on-site and limited the number of staff in any given research and development laboratory.
While the San Mateo County “shelter in place” order was rescinded on June 17, 2020 and replaced with a “reopening plan” order, we have continued to restrict our personnel as outlined above.
−Removed: The COVID-19 pandemic coul d disrupt our ability to secure supplies for our facilities and to provide personal protective equipment for our employees.
+Added: The COVID-19 pandemic could disrupt our ability to secure supplies for our facilities and to provide personal protective equipment for our employees.
The safety, health and well-being of our workforce is of primary concern and we may need to enact further precautionary measures to help minimize the risk of our employees being exposed to the novel coronavirus.
−Removed: In addition, the COVID-19 pandemic may affect the operations of the FDA and other health authorities, which could result in delays of reviews and approvals, including with resp ect to our product candidates.
+Added: In addition, the COVID-19 pandemic may affect the operations of the FDA and other health authorities, which could result in delays of reviews and approvals, including with respect to our product candidates.
The evolving COVID-19 pandemic may also, directly or indirectly, impact the pace of enrollment in current or future clinical trials.
−Removed: While the COVID-19 pandemic did not materially adversely affect our business operations in the quarter ended June 30, 2020, economic and health conditions in the United States and across most of the globe have changed rapidly since the end of the quarter and may materially affect us economically.
+Added: While the COVID-19 pandemic did not materially adversely affect our business operations in the quarter ended September 30, 2020, economic and health conditions in the United States and across most of the globe have changed rapidly since the end of the quarter and may materially affect us economically.
While the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, a continuing widespread pandemic could result in significant disruption of global financial markets, reducing our ability to access capital, which could in the future negatively affect our liquidity.
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We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which, particularly when taken together with our lack of earthquake insurance, could have a material adverse effect on our business.
−Removed: Furthermore, the third parties on which we depend, including suppliers, contract manufacturers and CROs are similarly vulnerable to natural disasters or other sudden, unforeseen and serious adverse events.
−Removed: If such an event were to affect our supply chain, manufacturing arrangements or interfere with a preclinical study or clinical trial, it could have a material adverse effect on our business.
+Added: Furthermore, the third parties on which we depend, including suppliers, contract manufacturers and CROs are similarly vulnerable to natural disasters or o ther sudden, unforeseen and serious adverse events .
+Added: If such a n event were to affect our supply chain, manufacturing arrangements or interfere with a preclinical study or clinical trial, it could have a material adverse effect on our business.
Risks Related to Our Dependence on Third Parties
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Further, some of these agreements may also be terminated by such third parties on short notice, or under certain circumstances, including our insolvency.
−Removed: If the third parties conducting our preclinical studies or our clinical trials do not adequately perform their contractual duties or obligations, experience significant business challenges, disruptions or failures, do not meet expected deadlines, terminate their agreements with us or need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to our protocols or to GCPs, or for any other reason, we may need to enter into new arrangements with alternative third parties.
+Added: If the third parties conducting our preclinical studies or our clinical trials do not adequately perform their contractual duties or obligations, experience significant business challenges, disruptions or failures, do not meet expected deadlines, terminate their agreements
+Added: with us or need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to our protocols or to GCPs, or for any other reason, we may need to enter into new arrangements with alternative third parties.
This could be difficult, costly or impossible, and our preclinical studies or clinical trials may need to be extended, delayed, terminated or repeated.
As a result, we may not be able to obtain regulatory approval in a timely fashion, or at all, for the applicable product candidate, and our business, financial position, results of operations and prospects may be adversely affected.
−Removed: We rely on third parties for the manufacture of our product candidates for preclinical and clinical development and expect to continue to do so for the foreseeab le future.
−Removed: This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercializati on efforts.
+Added: We rely on third parties for the manufacture of our product candidates for preclinical and clinical development and expect to continue to do so for the foreseeable future.
+Added: This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
We do not own or operate manufacturing facilities and have no plans to build our own clinical or commercial scale manufacturing capabilities.
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If these third-party manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, including requirements related to the manufacturing of high potency compounds, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities.
+Added: These third-party manufacturers may be delayed in their manufacture or shipment of our product candidates due to the COVID-19 pandemic.
+Added: Additionally, our ability to audit these third-party manufacturers for compliance with cGMP requirements and our specifications may be hindered or delayed due to the COVID-19 pandemic.
In addition, we have no control over the ability of third-party manufacturers to maintain adequate quality control, quality assurance and qualified personnel.
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If our current third-party manufacturers cannot perform as agreed, we may be required to replace such manufacturers and we may be unable to replace them on a timely basis or at all.
−Removed: We rely on, and in the future may rely on, third-party databases and collaborations with third parties to inform patient selection and drug target identification for our existing product candidates and any future product candidates and for the supply of biomarker comp anion diagnostics .
+Added: We rely on, and in the future may rely on, third-party databases and collaborations with third parties to inform patient selection and drug target identification for our existing product candidates and any future product candidates and for the supply of biomarker companion diagnostics .
We are using bioinformatics, including data analytics, biostatistics, and computational biology, to identify new target and biomarker opportunities.
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a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.
−Removed: If we engage in future acquisitions or strategic collaborations, it may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject us to other risks.
−Removed: We may evaluate various acquisitions and strategic collaborations, including licensing or acquiring complementary products, intellectual property rights, technologies, or businesses.
−Removed: Any potential acquisition or strategic partnership may entail numerous risks, including:
−Removed: increased operating expenses and cash requirements;
−Removed: the assumption or incurrence of additional indebtedness or contingent liabilities;
−Removed: the issuance of our equity securities;
−Removed: assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new personnel;
−Removed: the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition;
−Removed: loss of key personnel, and uncertainties in our ability to maintain key business relationships;
−Removed: uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals;
−Removed: our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.
−Removed: In addition, if we undertake acquisitions, we may incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense.
−Removed: Moreover, we may not be able to locate suitable acquisition opportunities and this inability could impair our ability to grow or obtain access to technology or products that may be important to the development of our business.
Risks Related to Commercialization of Our Product Candidates
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If one of our product candidates is approved, it will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, and other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities.
−Removed: For example, the FDA may impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly and time-consuming post-approval studies, post-market surveillance or clinical trials to monitor the safety and efficacy of the product candidate.
−Removed: The FDA may also require a REMS as a condition of approval of our product candidates, which could include requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.
−Removed: In addition, if the FDA or a comparable foreign regulatory authority approves our product candidates, the manufacturing processes, labeling, packaging, distribution, AE reporting, storage, advertising, promotion, import, export and recordkeeping for our product candidates will be subject to extensive and ongoing regulatory requirements.
−Removed: These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and GCP requirements for any clinical trials that we conduct post-approval.
+Added: For example, the FDA may impose significa nt restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly and time-consuming post-approval studies, post-market surveillance or clinical trials to monitor the safety and efficacy of the product candida te.
+Added: The FDA may also require a REMS as a condition of approval of our product candidates, which could include requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution meth ods, patient registries and other risk minimization tools.
+Added: In addition, if the FDA or a comparable foreign regulatory authority approves our product candidates, the manufacturing processes, labeling, packaging, distribution, AE reporting, storage, advertis ing, promotion, import, export and recordkeeping for our product candidates will be subject to extensive and ongoing regulatory requirements.
+Added: These requirements include submissions of safety and other post-marketing information and reports, registration, a s well as continued compliance with cGMPs and GCP requirements for any clinical trials that we conduct post-approval.
Later discovery of previously unknown problems with our product candidates, including AEs of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:
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injunctions or the imposition of civil or criminal penalties.
−Removed: The occurrence of any event or penalty described above may inhibit our ability to commercialize any future approved product and generate revenue and could require us to expend significant time and re sources in response and could generate negative publicity.
+Added: The occurrence of any event or penalty described above may inhibit our ability to commercialize any future approved product and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity.
In addition, if any of our product candidates is approved, our product labeling, advertising and promotion will be subject to regulatory requirements and continuing regulatory review.
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For example, certain policies of the Trump Administration may impact our business and industry.
−Removed: Namely, the Trump Administration has taken several executive actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications.
−Removed: It is difficult to predict how these executive actions, including the Executive Orders will be implemented, and the extent to which they will impact the FDA’s ability to exercise its regulatory authority.
−Removed: If these executive actions impose constraints on FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.
+Added: Namely, the Trump Administration has taken several executive actions, including the issuance of a number of Executive Orders, that could impose significant
+Added: burdens on, or otherwise materially delay, the FDA’s abilit y to engage in routine regulatory and oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications.
+Added: It is difficult to predict how these executive actions, including the Exec utive Orders will be implemented, and the extent to which they will impact the FDA’s ability to exercise its regulatory authority.
+Added: If these executive actions impose constraints on FDA’s ability to engage in oversight and implementation activities in the no rmal course, our business may be negatively impacted.
The incidence and prevalence of our target patient populations are estimations.
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In addition, upon treatment with our product candidates, patients may have or develop resistance to our product candidates, reducing the addressable patient population and the duration of treatment.
−Removed: Even if our product candidates or any future product candidate obtains regulatory approval, they may fail to achieve the broad degree of physician and patient ado ption and use necessary for commercial success.
+Added: Even if our product candidates or any future product candidate obtains regulatory approval, they may fail to achieve the broad degree of physician and patient adoption and use necessary for commercial success.
Even if our product candidates or any future product candidate receives FDA or other regulatory approvals, the commercial success of any product will depend significantly on the broad adoption and use of the resulting product by physicians and patients for approved indications.
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Any failure by our product candidates that obtain regulatory approval to achieve market acceptance or commercial success would adversely affect our business, financial condition, results of operations and prospects.
−Removed: The successful commercialization of any products will depend in part on the extent to which governmental authorities, p rivate health insurers, managed care plans and other third-party payors provide coverage, adequate reimbursement levels and implement pricing policies favorable for any products.
−Removed: Failure to obtain or maintain coverage and adequate reimbursement for product s, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
+Added: The successful commercialization of any products will depend in part on the extent to which governmental authorities, private health insurers, managed care plans and other third-party payors provide coverage, adequate reimbursement levels and implement pricing policies favorable for any products.
+Added: Failure to obtain or maintain coverage and adequate reimbursement for products, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
The availability of coverage and adequacy of reimbursement by governmental healthcare programs, such as Medicare and Medicaid, private health insurers, managed care plans and other third-party payors are essential for most patients to be able to afford medical services and pharmaceutical products such as our product candidates that receive FDA approval.
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Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost-containment initiatives in Europe and other countries has and will continue to put pressure on the pricing and usage of our products, if any.
−Removed: In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems.
+Added: In many countries, the prices of med ical products are subject to varying price control mechanisms as part of national health systems.
Other countries allow companies to fix their own prices for medical products but monitor and control company profits.
−Removed: Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our products.
−Removed: Accordingly, in markets outside the United States, the reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenue and profits.
−Removed: Moreover, increasing efforts by governmental and 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 rei mbursement for newly approved products, and, as a result, they may not cover or provide adequate payment for our products.
−Removed: We expect to experience pricing pressures in connection with the sale of our product candidates due to the trend toward managed healt h care, the increasing influence of health maintenance organizations and additional legislative changes.
−Removed: The downward pressure on healthcare costs in general, particularly prescription drugs and biologics and surgical procedures and other treatments, has b ecome intense.
+Added: Additional foreign price controls or oth er changes in pricing regulation could restrict the amount that we are able to charge for our products.
+Added: Accordingly, in markets outside the United States, the reimbursement for our products may be reduced compared with the United States and may be insuffic ient to generate commercially reasonable revenue and profits.
+Added: Moreover, increasing efforts by governmental and 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 products.
+Added: We expect to experience pricing pressures in connection with the sale of our product candidates due to the trend toward managed health care, the increasing influence of health maintenance organizations and additional legislative changes.
+Added: The downward pressure on healthcare costs in general, particularly prescription drugs and biologics and surgical procedures and other treatments, has become intense.
As a result, increasingly high barriers are being erected to the entry of new products.
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Our commercial success depends in part on our ability to obtain and maintain patent, trade secret and other intellectual property protection for our product candidates and proprietary technologies as well as our ability to operate without infringing upon the proprietary rights of others.
−Removed: We and our licensors have applied, and we i ntend to continue applying, for patents covering important aspects of our product candidates, proprietary technologies and their uses as we deem appropriate.
−Removed: However, the patent prosecution process is expensive, time-consuming and complex, and we may not b e able to apply for patents on certain aspects of our current or future product candidates and proprietary technologies in a timely fashion, at a reasonable cost, in all jurisdictions, or at all.
+Added: We and our licensors have applied, and we intend to continue applying, for patents covering important aspects of our product candidates, proprietary technologies and their uses as we deem appropriate.
+Added: However, the patent prosecution process is expensive, time-consuming and complex, and we may not be able to apply for patents on certain aspects of our current or future product candidates and proprietary technologies in a timely fashion, at a reasonable cost, in all jurisdictions, or at all.
Our patent applications cannot be enforced against third parties practicing the inventions claimed in such applications unless, and until, patents issue from such applications, and then only to the extent the issued claims cover the invention as claimed.
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The patent position of biopharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years.
−Removed: It is possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection.
−Removed: And although we enter into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of our research and development output, such as our employees, corporate collaborators, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors and other third parties, any of these parties may breach such agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection.
+Added: It i s possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection.
+Added: And although we enter into non-disclosure and confidentiality agreements with parties who have access to p atentable aspects of our research and development output, such as our employees, corporate collaborators, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors and other third parties, any of these parties may breach such ag reements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents or the patent rights that we license from others, may be challenged in the courts or patent offices in the United States and abroad.
Once granted, patents may remain open to opposition, interference, re-examination, post-grant review, inter partes review, nullification or derivation action or similar proceedings in court or before patent offices in the United States or foreign jurisdictions for a given period after allowance or grant, during which time third parties can raise objections against such patents.
−Removed: Such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated or held unenforceable, all of which co uld limit our ability to stop others from using or commercializing similar or identical product candidates, or limit the duration of the patent protection of our product candidates.
+Added: Such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated or held unenforceable, all of which could limit our ability to stop others from using or commercializing similar or identical product candidates, or limit the duration of the patent protection of our product candidates.
The degree of future protection for our patent rights is uncertain, and we cannot ensure that:
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As a result, the government may have certain rights, or march-in rights, to such patent rights and technology.
−Removed: When new technologies are developed with government funding, the government generally obtains certain rights in any resulting pat ents, including a non-exclusive license authorizing the government to use the invention for non-commercial purposes.
−Removed: These rights may permit the government to disclose our confidential information to third parties and to exercise march-in rights to use or allow third parties to use our licensed technology.
−Removed: The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to U.S.
−Removed: In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the United States.
+Added: When new technologies are developed with government funding, the government generally obtains certain rights in a ny resulting patents, including a non-exclusive license authorizing the government to use the invention for non-commercial purposes.
+Added: These rights may permit the government to disclose our confidential information to third parties and to exercise march-in r ights to use or allow third parties to use our licensed technology.
+Added: The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, because acti on is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to U.S.
+Added: In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying su ch inventions in the United States.
Any exercise by the government of such rights could harm our competitive position, business, financial condition, results of operations, and prospects.
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The launch of a generic version of one of our products in particular would be likely to result in an immediate and substantial reduction in the demand for that product, which could have a material adverse effect on our business, financial condition, results of operations and prospects.
−Removed: Our rights to develop and commercialize our product candidates are subject in part to the terms and conditions of licenses granted to us by others, and the patent protection, prosecution and enforcement for some of our pr oduct candidates may be dependent on our licensors.
+Added: Our rights to develop and commercialize our product candidates are subject in part to the terms and conditions of licenses granted to us by others, and the patent protection, prosecution and enforcement for some of our product candidates may be dependent on our licensors.
We currently are reliant upon licenses of certain intellectual property rights and proprietary technology from third parties that are important or necessary to the development of our proprietary technology, including technology related to our product candidates.
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Any of these events could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.
−Removed: We may fail to comply with any of our obligations under existing or future agreements pursuant to which we license or have otherwise acquired intellectual property rights o r technology, which could result in the loss of rights or technology that are material to our business.
+Added: We may fail to comply with any of our obligations under existing or future agreements pursuant to which we license or have otherwise ac quired intellectual property rights or technology, which could result in the loss of rights or technology that are material to our business.
We are party to various agreements that we depend on to operate our business, including intellectual property rights relating to IDE196, in particular, our agreement with Novartis.
13 unchanged sentences
If we fail to comply with our obligations under current or future license agreements, these agreements may be terminated or the scope of our rights under them may be reduced and we might be unable to develop, manufacture or market any product that is licensed under these agreements.
−Removed: We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
−Removed: Our programs may require the use of intellectual property rights held by third parties to which we do not have rights.
−Removed: In such a case, the growth of our business will depend in part on our ability to acquire, in-license or use these rights.
−Removed: However, we may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify as necessary for our product candidates on reasonable terms and conditions or at all.
−Removed: The acquisition or licensing of intellectual property rights for pharmaceutical products is very competitive.
−Removed: If we seek to acquire or license additional intellectual property rights, we may face substantial competition from a number of more established companies, some of which have acknowledged strategies to license or acquire products, and many of which have more institutional experience and greater financial and other resources than we have.
−Removed: These established companies may have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities, as may other emerging companies taking similar or different approaches to product licenses and/or acquisitions.
−Removed: In addition, a number of established research-based pharmaceutical and biotechnology companies may acquire products in late stages of development to augment their internal product lines, which may provide those companies with an even greater competitive advantage.
−Removed: Furthermore, companies that perceive us to be a competitor may be unwilling to assign or license rights to us or may interfere with our acquisition or licensing of rights from others.
−Removed: We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment.
−Removed: We have collaborated with U.S.
−Removed: academic institutions and may in the future collaborate with U.S.
−Removed: and foreign academic institutions to accelerate our preclinical research or development under written agreements with these institutions.
−Removed: These institutions ma y provide us with an option to negotiate a license to any of the institution’s rights in technology resulting from the collaboration.
−Removed: Regardless of such option, we may be unable to negotiate a license within the specified timeframe or under terms that are acceptable to us.
−Removed: If we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have on reasonable terms, we may have to abandon development of that program and our competitive position, business, financial condition, results of operations, and prospects could suffer.
Third-party claims of intellectual property infringement could require us to spend significant time and money and could prevent us from selling our products.
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Our competitors in both the United States and abroad, many of which have substantially greater resources and have made substantial investments in patent portfolios and competing technologies, may have applied for or obtained or may in the future apply for and obtain, patents that will prevent, limit or otherwise interfere with our ability to make, use and sell our product candidates.
−Removed: There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions, reexaminations, inter partes review proceedings and post-grant review proceedings before the USPTO and/or corresponding foreign patent offices.
−Removed: Numerous third-party U.S.
+Added: There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions, reexaminations, inter partes review proceedings and post-grant review proceedings before the USPTO
+Added: and/or corresponding foreign patent offices.
+Added: Numerous third-part y U.S.
and foreign issued patents and pending patent applications exist in the fields in which we are developing product candidates.
−Removed: There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates.
+Added: There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or m ethods for treatment related to the use or manufacture of our product candidates.
For example, we are aware of an international patent application published as PCT WO 2017/096165 A1.
−Removed: If a patent issues from such patent application with claims similar to those published, our ability to commercialize a product candidate for our MAT2A program may be adversely affected if we do not obtain a license under such patent.
+Added: If a patent issues from such patent application with claims similar to th ose published, our ability to commercialize a product candidate for our MAT2A program may be adversely affected if we do not obtain a license under such patent.
Furthermore, the scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history and can involve other factors such as expert opinion.
5 unchanged sentences
Furthermore, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our technologies, our product candidates or the use of our product candidates.
−Removed: These applications may later result in issued patents, or the revival of previously abandoned patents, that will prevent, limit
−Removed: or otherwise interfere with our ability to make, use or sell our products.
−Removed: As a result, we may be unaware of third-party patents that may be infringed by commercialization of IDE196 or our other product candidates, and cannot be certain that we were the f irst to file a patent application related to a product candidate or proprietary technology.
−Removed: In addition, identification of third-party patent rights that may be relevant to our technology is difficult because patent searching is imperfect due to difference s in terminology among patents, incomplete databases and the difficulty in assessing the meaning of patent claims.
−Removed: Although no third party has asserted a claim of patent infringement against us as of June 30, 2020, others may hold proprietary rights that could prevent IDE196, our other product candidates or any future product candidates from being marketed.
+Added: These applications may later result in issued patents, or the revival of previously abandoned patents, that will prevent, limit or otherwise interfere with our ability to make, use or sell our products.
+Added: As a result, we may be unaware of third-party patents that may be infringed by commercialization of IDE196 or our other product candidates, and cannot be certain that we were the first to file a patent application related to a product candidate or proprietary technology.
+Added: In addition, identification of third-party patent rights that may be relevant to our technology is difficult because patent searching is imperfect due to differences in terminology among patents, incomplete databases and the difficulty in assessing the meaning of patent claims.
+Added: Although no third party has asserted a claim of patent infringement against us as of September 30, 2020, others may hold proprietary rights that could prevent IDE196, our other product candidates or any future product candidates from being marketed.
Any patent-related legal action against us claiming damages and seeking to enjoin commercial activities relating to our product candidates or proprietary technologies could subject us to potential liability for damages, including treble damages if we were determined to willfully infringe or attorney’s fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing, and require us to obtain a license to manufacture or market IDE196, our other product candidates or any future product candidates.
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In addition, intellectual property litigation, regardless of its outcome, may cause negative publicity or the disclosure of confidential information, and the perceived value of our product candidates or intellectual property could be diminished correspondingly.
−Removed: Additionally, our collaborators, such as GSK or any third parties with which we collaborate in the future, may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to litigation or potential liability.
+Added: Additionally, our collaborators , such as GSK or any third parties with which we collaborate in the future, may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way a s to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to litigation or potential liability.
Further, collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability.
−Removed: Also, we may be obligated under our agreements with our collaborators, licensors, suppliers and others to indemnify and hold them harmless for damages arising from intellectual property infringement by us.
+Added: Also, we may be obligated under our agreements with our collaborators, licensors, suppliers and others to indemnify and hold them harmless for damages arising from intellectual property infringement by u s.
Any of the foregoing could harm our competitive position, business, financial condition, results of operations, and prospects.
13 unchanged sentences
Such a loss of patent protection would have a material adverse impact on our business, financial condition, results of operations and prospects.
−Removed: Additionally, interference or derivation proceedings provoked by third parties or brought by us or declared by t he USPTO, or equivalent actions brought in foreign jurisdictions, may be necessary to determine the priority of invention with respect to our patents or patent applications or those of our licensors.
−Removed: Our defense of litigation or interference proceedings ma y fail and, even if successful, may result in substantial costs and distract our management and other employees.
+Added: Additionally, interference or derivation proceedings provoked by third parties or brought by us or declared by the USPTO, or equivalent actions brought in foreign jurisdictions, may be necessary to determine the priority of invention with respect to our patents or patent applications or those of our licensors.
+Added: Our defense of litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees.
An unfavorable outcome could require us to cease using the covered technology or to attempt to license rights to it from the prevailing party.
Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms or at all, or if a non-exclusive license is offered and our competitors gain access to the same technology.
−Removed: These and other uncertainties asso ciated with litigation could have a material adverse effect on our ability to raise the funds necessary to continue our clinical trials, continue our research programs, license necessary technology from third parties or enter into development or manufactur ing partnerships that would help us bring our product candidates to market.
+Added: These and other uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to continue our clinical trials, continue our research programs, license necessary technology from third parties or enter into development or manufacturing partnerships that would help us bring our product candidates to market.
Even if resolved in our favor, litigation or other legal proceedings relating to our intellectual property rights may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities.
8 unchanged sentences
Any of the foregoing could harm our business, financial condition, results of operations and prospects.
−Removed: We may be subject to claims that we have wrongfully hired an employee, consultant, advisor or other third party from a competitor or that we or our employees, consultants, advisors or other third parties have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
+Added: We may be subject to claims that we have wrongfully hir ed an employee, consultant, advisor or other third party from a competitor or that we or our employees, consultants, advisors or other third parties have wrongfully used or disclosed alleged confidential information or trade secrets of their former employe rs.
As is common in the biotechnology and biopharmaceutical industries, in addition to our employees, we engage the services of consultants, advisors and other third parties to assist us in the development of our product candidates.
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Enforcing a claim that a party illegally disclosed or misappropriated a trade secret can be difficult, expensive and time-consuming, and the outcome is unpredictable.
−Removed: Even though we use commonly accepted security measures, the criteria for protection of trade secrets can vary among different jurisdictions.
+Added: Even though we us e commonly accepted security measures, the criteria for protection of trade secrets can vary among different jurisdictions.
Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable.
4 unchanged sentences
In addition, if any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position.
−Removed: Despite employing the contractual and other security precautions described above, the need to share trade secrets increases the risk that such trade secrets become known by our
−Removed: competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements.
+Added: Despite employing the contractual and other security precautions described above, the need to share trade secrets increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements.
If any of these events occurs or if we otherwise lose protection for our trade secrets, the value of this information may be greatly reduced and our competitive position, business, financial condition, results of operations, and prospects would be harmed.
If we do not apply for patent protection prior to such publication or if we cannot otherwise maintain the confidentiality of our proprietary technology and other confidential information, then our ability to obtain patent protection or to protect our trade secret information may be jeopardized.
−Removed: If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
−Removed: Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
−Removed: We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential collaborators or customers in our markets of interest.
−Removed: At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion.
−Removed: In addition, there could be potential trade name or trademark infringement claims brought by owners of other trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names.
−Removed: Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.
−Removed: We may license our trademarks and trade names to third parties, such as distributors.
−Removed: Though these license agreements may provide guidelines for how our trademarks and trade names may be used, a breach of these agreements or misuse of our trademarks and tradenames by our licensees may jeopardize our rights in or diminish the goodwill associated with our trademarks and trade names.
−Removed: Our efforts to enforce or protect our proprietary rights related to trademarks, trade names, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results of operations and prospects.
−Removed: Changes in patent law in the United States or in other countries could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
−Removed: Our patent rights may be affected by developments or uncertainty in the United States’ or other jurisdictions’ patent statutes, patent case law, USPTO rules and regulations or the rules and regulations of other jurisdictions’ patent offices.
−Removed: There are a number of recent changes to U.S.
−Removed: patent laws that may have a significant impact on our ability to protect our technology and enforce our intellectual property rights.
−Removed: For example, on September 16, 2011, the Leahy-Smith America Invents Act, or Leahy-Smith Act, was signed into law.
−Removed: The Leahy-Smith Act includes a number of significant changes to U.S.
−Removed: These include provisions that affect the way patent applications will be prosecuted and may also affect patent litigation.
−Removed: In particular, under the Leahy-Smith Act, the United States transitioned in March 2013 to a “first to file” system in which the first inventor to file a patent application is typically entitled to the patent.
−Removed: Third parties are allowed to submit prior art before the issuance of a patent by the USPTO, and may become involved in post-grant proceedings including opposition, derivation, reexamination, inter partes review or interference proceedings challenging our patent rights or the patent rights of others.
−Removed: An adverse determination in any such submission, proceeding or litigation could reduce the scope or enforceability of, or invalidate, our patent rights, which could adversely affect our competitive position.
−Removed: In addition, the U.S.
−Removed: congress may pass additional patent reform legislation that is unfavorable to us.
−Removed: The Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations.
−Removed: In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents once obtained.
−Removed: Depending on decisions by the U.S.
−Removed: Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents we might obtain in the future.
−Removed: Similarly, statutory or judicial changes to the patent laws of other countries may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents.
−Removed: We may not be able to protect our intellectual property r ights throughout the world.
−Removed: Filing, prosecuting and defending all current and future patents in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States.
−Removed: In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States.
−Removed: Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions.
−Removed: Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection but enforcement is not as strong as that in the United States.
−Removed: These products may compete with our product candidates, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
−Removed: The legal systems of many foreign countries do not favor the enforcement of patents and other intellectual property protection, 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.
−Removed: For example, some foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties.
−Removed: In addition, some countries limit the enforceability of patents against third parties, including government agencies or government contractors.
−Removed: In these countries, patents may provide limited or no benefit.
−Removed: Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us.
−Removed: We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.
−Removed: Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
−Removed: If we or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations, and prospects may be adversely affected.
−Removed: Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
−Removed: The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process.
−Removed: Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications.
−Removed: We employ reputable professionals and rely on such third parties to help us comply with these requirements and effect payment of these fees with respect to the patents and patent applications that we own, and if we license intellectual property we may have to rely upon our licensors to comply with these requirements and effect payment of these fees with respect to any patents and patent applications that we license.
−Removed: In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules.
−Removed: However, there are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
−Removed: In such an event, competitors might be able to enter the market earlier than would otherwise have been the case.
Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
21 unchanged sentences
establishment of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services, or CMS, to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.
−Removed: Since its enactment, there have been judicial and cong ressional challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future.
−Removed: By way of example, the Tax Cuts and Jobs Act of 2017, or the Tax Act, which includes a provision that entered int o effect on January 1, 2019, that repeals the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandat e.” On December 14, 2018, a U.S.
−Removed: District Court Judge in the Northern District of Texas ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part of the Tax Act, the remaining provisi ons of the ACA are invalid as well.
+Added: Since its enactment, there have been judicial and congressional challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future.
+Added: By way of example, the Tax Cuts and Jobs Act of 2017, or the Tax Act, which includes a provision that entered into effect on January 1, 2019, that repeals the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” On December 14, 2018, a U.S.
+Added: District Court Judge in the Northern District of Texas ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part of the Tax Act, the remaining provisions of the ACA are invalid as well.
On December 18, 2019, the U.S.
−Removed: Court of Appeals for the 5th Circuit upheld the District Court’s decision that the individual mandate was unconstitutional but remanded the case back to the District Court to determine whet her the remaining provisions of the ACA are invalid as well.
+Added: Court of Appeals for the 5th Circuit upheld the District Court’s decision that the individual mandate was unconstitutional but remanded the case back to the District Court to determine whether the remaining provisions of the ACA are invalid as well.
It is unclear how these decisions, subsequent appeals, if any, or other efforts to challenge, repeal or replace the ACA will impact the ACA or our business.
−Removed: In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted.
+Added: In addition, other legislative changes have been proposed and adopted in th e United States since the ACA was enacted.
In August 2011, the Budget Control Act of 2011, among other things, led to aggregate reductions of Medicare payments to providers of 2% per fiscal year.
These reductions went into effect in April 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2029 unless additional action is taken by Congress.
−Removed: In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
−Removed: These new laws or any other similar laws introduced in the future may result in additional reductions in Medicare and other health care funding, which could negatively affect our customers and accordingly, our financial operations.
+Added: In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Me dicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
+Added: These new la ws or any other similar laws introduced in the future may result in additional reductions in Medicare and other health care funding, which could negatively affect our customers and accordingly, our financial operations.
Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives.
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In addition to continuing pressure on prices and cost containment measures, legislative developments at the European Union or member state level may result in significant additional requirements or obstacles that may increase our operating costs.
−Removed: The delivery of healthcare in the E uropean Union, including the establishment and operation of health services and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than European Union, law and policy.
−Removed: National governments and health service pro viders have different priorities and approaches to the delivery of health care and the pricing and reimbursement of products in that context.
−Removed: In general, however, the healthcare budgetary constraints in most European Union member states have resulted in re strictions on the pricing and reimbursement of medicines by relevant health service providers.
−Removed: Coupled with ever-increasing European Union and national regulatory burdens on those wishing to develop and market products, this could prevent or delay marketin g approval of our product candidates, restrict or regulate post-approval activities and affect our ability to commercialize our product candidates, if approved.
−Removed: In markets outside of the United States and European Union, reimbursement and healthcare paymen t systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies.
+Added: The delivery of healthcare in the European Union, including the establishment and operation of health services and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than European Union, law and policy.
+Added: National governments and health service providers have different priorities and approaches to the delivery of health care and the pricing and reimbursement of products in that context.
+Added: In general, however, the healthcare budgetary constraints in most European Union member states have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers.
+Added: Coupled with ever-increasing European Union and national regulatory burdens on those wishing to develop and market products, this could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to commercialize our product candidates, if approved.
+Added: In markets outside of the United States and European Union, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies.
We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action in the United States, the European Union or any other jurisdiction.
−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: 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 regu latory compliance, our product candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.
Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
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federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the healthcare fraud statute implemented under HIPAA or specific intent to violate it in order to have committed a violation;
−Removed: the Federal Food Drug or Cosmetic A ct, or FDCA, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices;
+Added: the Federal Food Drug or Cosmetic Act, or FDCA, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices;
Physician Payments Sunshine Act and its implementing regulations, which requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually to the government information related to certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other health care professionals beginning in 2022, and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members;
2 unchanged sentences
state laws and regulations, including:
−Removed: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers;
+Added: stat e anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers;
state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S.
federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources;
−Removed: and state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities;
+Added: and state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other r emuneration and items of value provided to healthcare professionals and entities;
state and local laws requiring the registration of pharmaceutical sales representatives;
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federal and state laws and non-U.S.
−Removed: regulations governing the protection of personal and confidential information of our clinical subjects, clinical investigators, employees and vendors/business contacts, including in relation to medical records, credit card data and financial information.
+Added: regulations governing the protection of personal and confidential information of our clinical patients, clinical investigators, employees and vendors/business contacts, including in relation to medical records, credit card data and financial information.
For example, on May 25, 2018, the GDPR became effective, implementing more stringent requirements in relation to our use of personal data.
The GDPR repeals the Data Protection Directive (95/46/EC) and is directly applicable in all E.U.
−Removed: member states and will also remain law in the United Kingdom until the end of the transition period on
−Removed: December 31, 2020 provided for in the Withdrawal Agreement between the EU and the U.K.
+Added: member states and will also remain law in the United Kingdom until the end of the transition period on December 31, 2020 provided for in the Withdrawal Agreement between the EU and the U.K.
The GDPR significantly increased fines to up to 4% total worldwide annual turnover or up to €20 million (whichever is higher) for non-compliance with its requirements.
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providing expanded disclosures about how their personal data will be used;
−Removed: higher standards for organizations to demonstrate that they have obtained valid consent or have another legal basis in place to justify their data processing activities;
+Added: higher standards for organizations to demonstrate that they have obtained vali d consent or have another legal basis in place to justify their data processing activities;
the obligation to appoint data protection officers in certain circumstances;
2 unchanged sentences
the new mandatory data breach regime.
−Removed: In particular, medical or health data, genetic data and biometric data where the latter is used to uniquely identify an individual (even, in certain situations, where such data is key coded) are all classified as “special category” data under GDPR and afford greater protection and require additional compliance obligations.
+Added: In particular, medical or health data, genetic data and b iometric data where the latter is used to uniquely identify an individual (even, in certain situations, where such data is key coded) are all classified as “special category” data under GDPR and afford greater protection and require additional compliance o bligations.
Further, E.U.
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This is because the GDPR allows E.U.
−Removed: member states to derogate from the requirements of the GDPR mainly in regard to specific processing situations (including special category data and processing for scientific or statistical purposes).
−Removed: member states reframe their national legislation to harmonize with the GDPR, we will need to monitor compliance with all relevant E.U.
+Added: member states to derogate from the requirements of the GDPR mainly in regar d to specific processing situations (including special category data and processing for scientific or statistical purposes).
+Added: member states reframe their national legislation to harmonize with the GDPR, we will need to monitor compliance with al l relevant E.U.
member states' laws and regulations, including where permitted derogations from the GDPR are introduced.
15 unchanged sentences
Some observers have noted that the CCPA could mark the beginning of a trend toward more stringent privacy legislation in the United States, which could increase our potential liability and adversely affect our business.
−Removed: If any person, including any of our employees, clinical trial collaborators or those with whom we share such information, negligently disregards or intentionally breaches our established controls with respect to clinical subject, clinical investigator or employee data, or otherwise mismanages or misappropriates that data, we could be subject to significant monetary damages, regulatory enforcement actions, fines and/or criminal prosecution in one or more jurisdictions.
−Removed: In addition, a data breach could result in negative publicity which could damage our reputation and have an adverse effect on our business, financial condition or results of operations.
+Added: If any person, including any of our employees, clinical trial collaborators or those with whom we share such information, negligently disregards or intentionally breaches our established controls with respect to clinical subject, clinical inv estigator or employee data, or otherwise mismanages or misappropriates that data, we could be subject to significant monetary damages, regulatory enforcement actions, fines and/or criminal prosecution in one or more jurisdictions.
+Added: In addition, a data breac h could result in negative publicity which could damage our reputation and have an adverse effect on our business, financial condition or results of operations.
Risks Related to Our Common Stock
25 unchanged sentences
general economic conditions in the United States and abroad.
−Removed: In addition, the stock markets in general, and the markets for biopharmaceutical and biotechnology stocks in particular, have experienced extreme volatility , particularly in response to the COVID-19 pandemic.
−Removed: In particular, the market prices of securities of smaller biotechnology have experienced dramatic fluctuations that often have been unrelated or disproportionate to the operating results of these companies .
+Added: In addition, the st ock markets in general, and the markets for biopharmaceutical and biotechnology stocks in particular, have experienced extreme volatility , particularly in response to the COVID-19 pandemic.
+Added: In particular, the market prices of securities of smaller biotechn ology have experienced dramatic fluctuations that often have been unrelated or disproportionate to the operating results of these companies .
These broad market fluctuations may adversely affect the trading price or liquidity of our common stock.
−Removed: In the past, when the market price of a st ock has been volatile, holders of that stock have sometimes instituted securities class action litigation against the issuer.
−Removed: If any of our stockholders were to bring such a lawsuit against us, we could incur substantial costs defending the lawsuit and the attention of our management would be diverted from the operation of our business.
−Removed: An active, liquid and orderly market for our common stock may not develop, and you may not be able to resell your common stock at or above the public offering price.
+Added: In the pas t, when the market price of a stock has been volatile, holders of that stock have sometimes instituted securities class action litigation against the issuer.
+Added: If any of our stockholders were to bring such a lawsuit against us, we could incur substantial cos ts defending the lawsuit and the attention of our management would be diverted from the operation of our business.
+Added: An active, liquid and orderly market for our common stock may not be maintained, and you may not be able to resell your common stock.
Prior to our initial public offering, or IPO, in May 2019, there was no public market for shares of our common stock.
−Removed: An active trading market may not develop or, if it is developed, may not be sustained.
+Added: Our stock recently began trading on the Nasdaq Global Select Market, but we can provide no assurance that we will be able to maintain an active trading market on the Nasdaq Global Select Market or any other exchange in the future.
The lack of an active market may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable.
−Removed: An inactive market may also impair our ability to raise capital and may impair our ability to acquire other businesses or technologies using our shares as consideration.
−Removed: If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
+Added: An inactive market may also impair our ability to raise capital by selling shares and may impair our ability to acquire other businesses, applications, or technologies using our shares as consideration.
+Added: Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
+Added: If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the trading price of our common stock could decline.
+Added: As of September 30, 2020, we have outstanding a total of 29.1 million shares of common stock, of which the holders of approximately 5.0 million shares of our common stock are entitled to rights with respect to the registration of their shares under the Securities Act.
+Added: Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares purchased by affiliates.
+Added: Any sales of securities by these stockholders could have a material adverse effect on the trading price of our common stock.
+Added: In addition, as of September 30, 2020, approximately 4.0 million shares of common stock that are either subject to outstanding options or reserved for future issuance under our existing equity incentive plan will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules, Rule 144 and Rule 701 under the Securities Act.
+Added: If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline.
+Added: General Risks
+Added: We depend on our information technology systems, and any failure of these systems could harm our business.
+Added: Security breaches, loss of data or financial assets, and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business, results of operations and financial condition.
+Added: We collect and maintain information in digital form that is necessary to conduct our business, and we are increasingly dependent on information technology systems and infrastructure to operate our business.
+Added: In the ordinary course of our business, we collect, store and transmit large amounts of confidential information, including intellectual property, proprietary business information and personal information.
+Added: It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information, including both our own and that of third parties.
+Added: We have established physical, electronic and organizational measures to safeguard and secure our systems to prevent a data compromise, and rely on commercially available systems, software, tools, and monitoring to provide security for our information technology systems and the processing, transmission and storage of digital information.
+Added: We have also outsourced elements of our information technology infrastructure, and as a result a number of third-party vendors may or could have access to our confidential information.
+Added: Our internal information technology systems and infrastructure, and those of our current and any future collaborators, contractors and consultants and other third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization.
+Added: The risk of a security breach or disruption or data loss, particularly through cyber-attacks or cyb er - intrusion, including by computer hackers, foreign governments and cyber - terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.
+Added: In addition, the pervasive use of mobile devices that access confidential information increases the risk of data security breaches, which could lead to the loss of confidential information or other intellectual property, including both our own and that of third parties.
+Added: The costs to us to mitigate network security problems, bugs, viruses, worms, malicious software programs and security vulnerabilities could be significant, and while we have implemented security measures to protect our data security and information technology systems, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service and other harm to our business and our competitive position.
+Added: If such an event were to occur and cause in terruptions in our operations, it could result in a material disruption of our product development programs.
+Added: For example, the loss of clinical trial data could result in delays in our regulatory approval efforts and significantly increase our costs to reco ver or reproduce the data.
+Added: Moreover, if a computer security breach affects our systems or results in the unauthorized release of personally identifiable information, our reputation could be materially damaged.
+Added: In addition, such a breach may require notific ation to governmental agencies, the media or individuals pursuant to various federal and state privacy and security laws, if applicable, including the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Informati on Technology for Clinical Health Act of 2009, or HITECH, and its implementing rules and regulations, as well as regulations promulgated by the Federal Trade Commission and state breach notification laws.
+Added: We would also be exposed to a risk of loss, includi ng financial assets or litigation and potential liability, which could materially adversely affect our business, financial condition, results of operations and prospects.
+Added: If we engage in future acquisitions or strategic collaborations, it may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject us to other risks.
+Added: We may evaluate various acquisitions and strategic collaborations, including licensing or acquiring complementary products, intellectual property rights, technologies, or businesses.
+Added: Any potential acquisition or strategic partnership may entail numerous risks, including:
+Added: increased operating expenses and cash requirements;
+Added: the assumption or incurrence of additional indebtedness or contingent liabilities;
+Added: the issuance of our equity securities;
+Added: assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new personnel;
+Added: the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition;
+Added: loss of key personnel, and uncertainties in our ability to maintain key business relationships;
+Added: uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals;
+Added: our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.
+Added: In addition, if we undertake acquisitions, we may incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense.
+Added: Moreover, we may not be able to locate suitable acquisition opportunities and this inability could impair our ability to grow or obtain access to technology or products that may be important to the development of our business.
+Added: We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
+Added: Our programs may require the use of intellectual property rights held by third parties to which we do not have rights.
+Added: In such a case, the growth of our business will depend in part on our ability to acquire, in-license or use these rights.
+Added: However, we may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify as necessary for our product candidates on reasonable terms and conditions or at all.
+Added: The acquisition or licensing of intellectual property rights for pharmaceutical products is very competitive.
+Added: If we seek to acquire or license additional intellectual property rights, we may face substantial competition from a number of more established companies, some of which have acknowledged strategies to license or acquire products, and many of which have more institutional exper ience and greater financial and other resources than we have.
+Added: These established companies may have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities, as may other emerging companies taking similar or different approaches to product licenses and/or acquisitions.
+Added: In addition, a number of established research-based pharmaceutical and biotechnology companies may acquire products in late stages of development to augment their int ernal product lines, which may provide those companies with an even greater competitive advantage.
+Added: Furthermore, companies that perceive us to be a competitor may be unwilling to assign or license rights to us or may interfere with our acquisition or licens ing of rights from others.
+Added: We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment.
+Added: We have collaborated with U.S.
+Added: academic institutions and may in the future collaborate with U.S.
+Added: and foreign academic institutions to accelerate our preclinical research or development under written agreements with these institutions.
+Added: These institutions may provide us with an option to negotiate a license to any of the institution’s rights in technology resulting from the collaboration.
+Added: Regardless of such option, we may be unable to negotiate a license within the specified timeframe or under terms that are acceptable to us.
+Added: If we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have on reasonable terms, we may have to abandon development of that program and our competitive position, business, financial condition, results of operations, and prospects could suffer.
+Added: If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
+Added: Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
+Added: We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential collaborators or customers in our markets of interest.
+Added: At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion.
+Added: In addition, there could be potential trade name or trademark infringement claims brought by owners of other trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names.
+Added: Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.
+Added: We may license our trademarks and trade names to third parties, such as distributors.
+Added: Though these license agreements may provide guidelines for how our trademarks and trade names may be used, a breach of these agreements or misuse of our trademarks and tradenames by our licensees may jeopardize our rights in or diminish the goodwill associated with our trademarks and trade names.
+Added: Our efforts to enforce or protect our proprietary rights related to trademarks, trade names, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results of operations and prospects.
+Added: Changes in patent law in the United States or in other countries could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
+Added: Our patent rights may be affected by developments or uncertainty in the United States’ or other jurisdictions’ patent statutes, patent case law, USPTO rules and regulations or the rules and regulations of other jurisdictions’ patent offices.
+Added: There are a number of recent changes to U.S.
+Added: patent laws that may have a significant impact on our ability to protect our technology and enforce our intellectual property rights.
+Added: For example, on September 16, 2011, the Leahy-Smith America Invents Act, or Leahy-Smith Act, was signed into law.
+Added: The Leahy-Smith Act includes a number of significant changes to U.S.
+Added: These include provisions that affect the way patent applications will be prosecuted and may also affect patent litigation.
+Added: In particular, under the Leahy-Smith Act, the United States transitioned in March 2013 to a “first to file” system in which the first inventor to file a patent application is typically entitled to the patent.
+Added: Third parties are allowed to submit prior art before the issuance of a patent by the
+Added: USPTO, and may become involved in post-grant proceedings including opposition, derivation, reexamination, inter partes review or interference proceedings challenging our patent rights or the patent rights of others.
+Added: An adverse determination in any such submission, proceeding or litigation could reduce the scope or enforceability of, or invalidate, our patent rights, which could adversely affect our competitive position.
+Added: In addition, the U.S.
+Added: congress may pass additional patent reform legislation that is unfavorable to us.
+Added: The Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations.
+Added: In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents once obtained.
+Added: Depending on decisions by the U.S.
+Added: Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents we might obtain in the future.
+Added: Similarly, statutory or judicial changes to the patent laws of other countries may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents.
+Added: We may not be able to protect our intellectual property rights throughout the world.
+Added: Filing, prosecuting and defending all current and future patents in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States.
+Added: In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States.
+Added: Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions.
+Added: Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection but enforcement is not as strong as that in the United States.
+Added: These products may compete with our product candidates, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
+Added: The legal systems of many foreign countries do not favor the enforcement of patents and other intellectual property protection, 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.
+Added: For example, some foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties.
+Added: In addition, some countries limit the enforceability of patents against third parties, including government agencies or government contractors.
+Added: In these countries, patents may provide limited or no benefit.
+Added: Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us.
+Added: We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.
+Added: Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
+Added: If we or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations, and prospects may be adversely affected.
+Added: Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
+Added: The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process.
+Added: Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications.
+Added: We employ reputable professionals and rely on such third parties to help us comply with these requirements and effect payment of these fees with respect to the patents and patent applications that we own, and if we license intellectual property we may have to rely upon our licensors to comply with these requirements and effect payment of these fees with respect to any patents and patent applications that we license.
+Added: In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules.
+Added: However, there are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
+Added: In such an event, competitors might be able to enter the market earlier than would otherwise have been the case.
+Added: If securities or industry analysts do not publish research or reports about our b usiness, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about us or our business.
14 unchanged sentences
However, for so long as we remain an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012, or JOBS Act, we intend to take advantage of certain exemptions from various reporting requirements that are applicable to public companies that are not emerging growth companies, including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404.
−Removed: Once we are no longer an emerging growth company or, if prior to such date, we opt to no longer take advantage of the applicable exemption, we will be required to include an opinion from our
−Removed: ind ependent registered public accounting firm on the effectiveness of our internal control over financial reporting.
+Added: Once we are no longer an emerging growth company or, if prior to such date, we opt to no longer take advantage of the applicable exemption, we will be required to include an opinion from our independent registered public accounting firm on the effectiveness of our internal control over financial reporting.
We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of our IPO, (b) in which we have total annual gross revenue of at least $1.07 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
6 unchanged sentences
Any failure to report our financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from the Nasdaq Global Market or other adverse consequences that would materially harm to our business.
−Removed: If we are unable to maintain effective internal controls, our business, financial position, results of operations and prospects could be adversely affected.
+Added: If we are unable to maintain effective internal controls, ou r business, financial position, results of operations and prospects could be adversely affected.
As a public company, we are subject to reporting and other obligations under the Exchange Act, including Section 404, which require annual management assessments of the effectiveness of our internal control over financial reporting.
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In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards.
−Removed: This allows an emerging growth company to delay the adoption of cer tain accounting standards until those standards would otherwise apply to private companies.
−Removed: We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards, and, therefore, we are subject to the same new or rev ised accounting standards as other public companies that are not emerging growth companies.
−Removed: The closing of the private placement of $20.0 million of shares of our common stock by Glaxo Group Limited, an entity affiliated with GSK, or the Private Placement, has resulted in substantial dilution to our stockholders.
+Added: This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
+Added: We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards, and, therefore, we are subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
If we sell shares of our common stock in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline.
−Removed: The closing of the Private Placement has resulted in substantial dilution to our stockholders.
−Removed: Immediately following the closing for $20.0 million of shares in the Private Placement, the holders of our common stock immediately prior to the closing of the Private Placement held approximately 95% of our outstanding common stock.
−Removed: If the common equity closing had occurred on June 30, 2020, the holders of our common stock prior to the Private Placement would have held approximately 95% of our outstanding common stock as of that date.
We may from time to time issue additional shares of common stock at a discount from the current trading price of our common stock.
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If we issue common stock or securities convertible into common stock, our common stockholders would experience additional dilution and, as a result, our stock price may decline.
−Removed: Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
−Removed: If our stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after the lock-up entered into in connection with our IPO and other legal restrictions on resale lapse, the trading price of our common stock could decline.
−Removed: As of June 30, 2020, we have a total of 27.2 million outstanding shares of our common stock.
−Removed: The lock-up agreements pertaining to our IPO expired on November 18, 2019.
−Removed: After the expiration of the lock-up agreements, up to approximately 14.6 million additional shares of common stock became eligible for sale in the public market, approximately 6.7 million of which shares were held by directors, executive officers and other affiliates and are be subject to Rule 144 under the Securities Act of 1933, as amended, or the Securities Act.
−Removed: In addition, as of June 30, 2020, approximately 4.0 million shares of common stock that are either subject to outstanding options or reserved for future issuance under our equity incentive plans will become eligible for sale in the public market.
−Removed: If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline.
−Removed: The holders of approximately 5.0 million shares of our common stock, or approximately 18% of our total outstanding common stock as of June 30, 2020, are entitled to rights with respect to the registration of their shares under the Securities Act.
−Removed: Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act.
−Removed: Any sales of securities by these stockholders could have a material adverse effect on the trading price of our common stock.
−Removed: Our ability to use our net operating loss carryforwa rds and certain other tax attributes may be limited.
+Added: Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
We have incurred substantial losses during our history and do not expect to become profitable in the near future, and we may never achieve profitability.
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We are also subject to the anti-takeover provisions contained in Section 203 of the Delaware General Corporation Law.
−Removed: Under Section 203, a corporation may not, in general, engage in a business combination with any holder of 15% or more of its capital stock unless the holder has held the stock for three years or, among other exceptions, the board of directors has approved the transaction.
+Added: Under Section 203, a corporation may not, in general, engage in a business combination with any holder of 15% or m ore of its capital stock unless the holder has held the stock for three years or, among other exceptions, the board of directors has approved the transaction.
Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
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The cost of D&O insurance policy premiums is expected to continue to increase.
−Removed: If the costs of maintaining adequate D&O insurance coverage i ncrease significantly in the future, our operating results could be materially adversely affected.
−Removed: Likewise, if any of our current D&O insurance coverage should become unavailable to us or become economically impractical, we may need to decrease our covera ge limits or increase our self-insured retention or we may be unable to renew such insurance at all.
+Added: If the costs of maintaining adequate D&O insurance coverage increase significantly in the future, our operating results could be materially adversely affected.
+Added: Likewise, if any of our current D&O insurance coverage should become unavailable to us or become economically impractical, we may need to decrease our coverage limits or increase our self-insured retention or we may be unable to renew such insurance at all.
If we incur liabilities that exceed our coverage or incur liabilities not covered by our insurance, we would have to self-fund any indemnification amounts owed to our directors and officers and employees in which case our results of operations and financial condition could be materially adversely affected.
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Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for any state law derivative action or proceeding brought on our behalf, any action asserting a breach of fiduciary duty, any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our amended and restated certificate of incorporation or our amended and restated bylaws, any action to interpret, apply, enforce, or determine the validity of our amended and restated certificate of incorporation or amended and restated bylaws, or any action asserting a claim against us that is governed by the internal affairs doctrine.
−Removed: The choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and other employees.
+Added: The choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and other employees and result in increased costs for investors to bring a claim.
We do not intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.