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Other events that we do not currently anticipate or that we currently deem immaterial may also affect our business, prospects, financial condition and results of operations.
−Removed: Risks Related to our Financial Position and Need for Additional Capital
−Removed: We are a development-stage company and have incurred significant losses since our inception.
−Removed: We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
−Removed: Since inception, we have incurred significant operating losses in every year.
−Removed: Our net losses were $25.7 million for the year ended December 31, 2021, and $68.9 million and $55.4 million for each of the years ended December 31, 2020 and 2019, respectively.
−Removed: As of December 31, 2021, we had an accumulated deficit of $430.3 million.
−Removed: To date, we have financed our operations primarily through public offerings and private placements of our securities, funding received from collaboration and license arrangements and our credit facility.
−Removed: We currently have no source of product revenue, and we do not expect to generate product revenue for the foreseeable future.
−Removed: We have devoted substantially all of our financial resources and efforts to developing our ImmTOR platform, identifying potential product candidates and conducting preclinical studies and our clinical
−Removed: We are in the early stages of development of most of our product candidates, and we have not completed development of any ImmTOR-enabled therapies.
−Removed: We expect to continue to incur significant expenses and operating losses for the foreseeable future.
−Removed: We expect that our expenses will increase substantially as we:
−Removed: • continue the research and development of our product candidates;
−Removed: • seek to enhance and evolve our ImmTOR platform and discover and develop additional product candidates;
−Removed: • seek to maintain and enter into collaboration, licensing and other agreements, including, but not limited to research and development, and/or commercialization agreements;
−Removed: • seek regulatory approvals for any product candidates that successfully complete clinical trials;
−Removed: • potentially establish a sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any products for which we may obtain regulatory approval;
−Removed: • maintain, expand and protect our intellectual property portfolio, including through licensing arrangements;
−Removed: • add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and potential future commercialization efforts;
−Removed: • experience any delays or encounter any issues with any of the above, including, but not limited to, failed studies, complex results, safety issues or other regulatory, manufacturing or scale-up challenges;
−Removed: • are exposed to broad macroeconomic conditions including inflation and supply chain tightness which could result in us paying more, or being unable, to access goods and services.
−Removed: To become and remain profitable, we must succeed in developing and eventually commercializing products that generate significant revenue.
−Removed: This will require us to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of our product candidates, discovering additional product candidates, obtaining regulatory approval and securing reimbursement for these product candidates, manufacturing, marketing and selling any products for which we may obtain regulatory approval, and establishing and managing our collaborations at various stages of a product candidate’s development.
−Removed: We are only in the preliminary stages of most of these activities.
−Removed: We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability.
−Removed: Because of the numerous risks and uncertainties associated with pharmaceutical and biological product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability.
−Removed: If we are required by the FDA or other regulatory authorities to perform studies in addition to those currently expected, or if there are any delays in completing our clinical trials or the development of any of our product candidates, our expenses could increase and product revenue could be further delayed.
−Removed: Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
−Removed: Our failure to become and remain profitable would depress our value and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or continue our operations.
−Removed: We will need substantial additional funding in order to complete development of our product candidates and commercialize our products, if approved.
−Removed: If we are unable to raise capital when needed and on terms favorable to us, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts .
−Removed: We expect our expenses to increase in connection with our ongoing activities, particularly as we continue to develop our gene therapy pipeline, including our collaboration with AskBio, research and develop our autoimmune programs and advance the evolution of our ImmTOR platform in combination with IL-2, and continue research and development for other product candidates.
−Removed: Additionally, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution.
−Removed: Accordingly, we will need to obtain substantial additional funding to continue operations.
−Removed: If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our clinical trials, our other research and development programs or any future commercialization efforts.
−Removed: We believe that our existing cash, cash equivalents and restricted cash as of December 31, 2021 will enable us to fund our current planned operations into the third quarter of 2023, though we may realize additional cash resources upon the achievement of certain contingent collaboration milestones or it may pursue additional cash resources through public or private equity or debt financings or by establishing collaborations with other companies.
−Removed: Management’s expectations with respect to our ability to fund current and long-term planned operations are based on estimates that are subject to risks and uncertainties.
−Removed: If actual results are different from management’s estimates, we may need to seek additional strategic or financing opportunities sooner than would otherwise be expected.
−Removed: However, there is no guarantee that any collaboration milestones will be achieved or that any of these strategic or financing opportunities will be executed on favorable terms, and some could be dilutive to existing stockholders.
−Removed: If we are unable to obtain additional funding on a timely basis, we may be forced to significantly curtail, delay, or
−Removed: discontinue one or more of its planned research or development programs or be unable to expand our operations, meet long-term obligations or otherwise capitalize on our commercialization of our product candidates.
−Removed: We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.
−Removed: Our future capital requirements will depend on many factors, including:
−Removed: • the scope, progress, results and costs of our clinical trials, preclinical development, and laboratory testing;
−Removed: • the number of product candidates that we pursue and the speed with which we pursue development;
−Removed: • our collaboration agreements remaining in effect, our entering into additional collaboration agreements and our ability to achieve milestones under these agreements;
−Removed: • our headcount growth and associated costs;
−Removed: • the costs, timing and outcome of regulatory review of our product candidates;
−Removed: • the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;
−Removed: • the revenue, if any, from commercial sales of our product candidates for which we receive marketing approval;
−Removed: • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;
−Removed: • the effect of competing technological and market developments;
−Removed: • the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for product candidates.
−Removed: Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates.
−Removed: In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all.
−Removed: Market volatility resulting from the COVID-19 pandemic or other factors could also adversely impact our ability to access capital as and when needed.
−Removed: Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders, and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline.
−Removed: The sale of additional equity or convertible securities would dilute all of our stockholders.
−Removed: The incurrence of indebtedness could result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
−Removed: We could also be required to seek funds through arrangements with collaborators or others at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.
−Removed: If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs, including our clinical trial programs, or the commercialization of any product candidates, or be unable to sustain or expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations.
−Removed: The terms of our credit facility place restrictions on our operating and financial flexibility.
−Removed: If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.
−Removed: On August 31, 2020, we entered into a term loan, or the 2020 Term Loan, of up to $35.0 million, consisting of term loans in an aggregate amount of $25.0 million, or the Term A Loan, and term loans in an aggregate amount of $10.0 million, or the Term B Loan, governed by a loan and security agreement among us and Oxford Finance LLC, or Oxford, as collateral agent and a lender, and Silicon Valley Bank, or SVB, as a lender.
−Removed: The Term A Loan was funded in full on August 31, 2020, the proceeds of which were used to repay our previously existing 2017 term loan and for general corporate and working capital purposes, and the draw period relating to the Term B Loan expired on September 30, 2021.
−Removed: The 2020 Term Loan is secured by a lien on substantially all of our assets, other than intellectual property, provided that such lien includes any rights to payments and proceeds from the sale, licensing or disposition of intellectual property.
−Removed: We also granted Oxford a negative pledge with respect to our intellectual property.
−Removed: Failure to satisfy our current and future debt obligations, including covenants to take or avoid specific actions, under the 2020 Term Loan could result in an event of default, our lenders could accelerate all of the amounts due.
−Removed: If we raise any additional debt financing, the terms of such additional debt could further restrict our operating and financial flexibility.
−Removed: Our ability to use our net operating loss and research and development tax credit carryforwards to offset future taxable income may be subject to certain limitations.
−Removed: We have net operating loss carryforwards, or NOLs, for federal and state income tax purposes that may be available to offset our future taxable income, if any.
−Removed: In general, under Sections 382 and 383 of the U.S.
−Removed: Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to use its pre-change NOLs to offset future taxable income.
−Removed: Internal Revenue Service, or IRS, challenges our analysis that existing NOLs will not expire before utilization due to previous ownership changes, or if we undergo an ownership change in connection with or after a public offering, our ability to use our NOLs could be limited by Section 382 of the Code.
−Removed: Future changes in our stock ownership, some of which are outside of our control, could result in an ownership change under Sections 382 and 383 of the Code.
−Removed: Furthermore, our ability to use NOLs of companies that we may acquire in the future may be subject to limitations.
−Removed: As a result, we may not be able to use a material portion of the NOLs reflected on our balance sheet, even if we attain profitability.
−Removed: The reduction of the corporate tax rate under the TCJA may cause a reduction in the economic benefit of our NOLs and other deferred tax assets available to us.
−Removed: Under current law, NOLs that arose before January 1, 2018, will begin to expire in 2041.
−Removed: NOLs that arose after 2017 may be used to offset at most 80% of our taxable income to the extent not offset by pre-2018 NOLs.
−Removed: As a result, we may become required to pay federal income taxes in future years despite having generated losses for federal income tax purposes in prior years.
Risks Related to the Development of our Product Candidates
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The occurrence of any of the foregoing would effectively prevent or delay approval of our lead and other product candidates.
−Removed: The outbreak of COVID-19 may continue to adversely impact our business, including our preclinical studies and clinical trials.
−Removed: The ongoing COVID-19 pandemic has impacted our business and we expect it to continue to do so.
−Removed: In response to the spread of COVID-19, we closed our principal executive office with our administrative employees continuing their work outside of our office and limited the number of staff in any given research and development laboratory.
−Removed: As COVID-19 continues to spread in the United States and elsewhere, we may experience disruptions that could severely impact our business, preclinical studies and clinical trials, including:
−Removed: • delays in receiving approval from local regulatory authorities to initiate our planned clinical trials;
−Removed: • delays or difficulties in enrolling or sustaining patients in our clinical trials;
−Removed: • delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;
−Removed: • delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials, such as ImmTOR including interruption in global shipping that may affect the transport of clinical trial materials;
−Removed: • changes in local regulations as part of a response to the COVID-19 pandemic which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;
−Removed: • diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals and clinics serving as our clinical trial sites and hospital and clinic staff supporting the conduct of our clinical trials;
−Removed: • interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others, or interruption of clinical trial subject visits and study procedures, or the closing of clinical trial sites due to the virus, the occurrence of which could affect the integrity of clinical trial data;
−Removed: • risk that participants enrolled in our clinical trials will contract COVID-19 while the clinical trial is ongoing, or will withdraw from the clinical trial due to concerns over COVID-19, which could impact the results of the clinical trial, including by increasing the number of observed adverse events, or reducing the statistical power of the clinical trials;
−Removed: • interruptions or delays in preclinical studies due to restricted or limited operations at our research and development laboratory facility;
−Removed: • delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees;
−Removed: • limitations in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;
−Removed: • refusal of the FDA to accept data from clinical trials in affected geographies;
−Removed: • changes to the clinical endpoints, statistical analysis plan, or enrollment plans for ongoing clinical trials due to limitations in patients, resources, or sites due to COVID-19;
−Removed: • interruption or delays to our sourced discovery and clinical activities;
−Removed: • impacts from prolonged remote work arrangements, such as increased cybersecurity risks and strains on our business continuity plans.
−Removed: The extent to which the COVID-19 pandemic impacts our business, preclinical studies and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence.
+Added: The ongoing COVID-19 pandemic may continue to adversely impact our business, including our preclinical studies and clinical trials.
We are applying our ImmTOR platform to antigen-specific immune tolerance for gene therapy involving gene augmentation, replacement or editing.
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Since we are developing novel treatments for diseases in which there is little clinical experience with new endpoints and methodologies, there is heightened risk that the FDA, the European Medicines Agency, or the EMA, or comparable regulatory bodies may not consider the clinical trial endpoints to provide clinically meaningful results, and the resulting clinical data and results may be more difficult to analyze.
−Removed: This may be a particularly significant risk for many of the genetically defined diseases for which we may develop
−Removed: product candidates alone or with collaborators due to small patient populations for those diseases, and designing and executing a rigorous clinical trial with appropriate statistical power is more difficult than with diseases that have larger patient populations.
+Added: This may be a particularly significant risk for many of the genetically defined diseases for which we may develop product candidates alone or with collaborators due to small patient populations for those diseases, and designing and executing a rigorous clinical trial with appropriate statistical power is more difficult than with diseases that have larger patient populations.
Regulatory agencies administering existing or future regulations or legislation may not allow production and marketing of products utilizing genome editing technology in a timely manner or under technically or commercially feasible conditions.
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Changes in applicable regulatory guidelines may lengthen the regulatory review process for our product candidates, require additional studies or trials, increase development costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of such product candidates, or lead to significant post-approval limitations or restrictions.
−Removed: Additionally, adverse developments in clinical trials conducted by others of gene therapy products or products created using genome editing technology, or adverse public perception of the field of genome editing, may cause the FDA, the EMA and other regulatory bodies to revise the requirements for approval of any product candidates we may develop or limit the use of products utilizing genome editing technologies, either of which could materially harm our business.
+Added: Additionally, adverse developments in clinical trials conducted by others of gene therapy products or products created using genome editing technology, or adverse public perception of the field of genome editing, may cause the FDA, the EMA and other regulatory bodies to revise the requirements for approval of any product candidates we may develop or limit the
+Added: use of products utilizing genome editing technologies, either of which could materially harm our business.
Furthermore, regulatory action or private litigation could result in expenses, delays or other impediments to our research programs or the development or commercialization of current or future product candidates.
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If any product candidate that we may choose to develop is associated with SAEs or other unexpected properties, we may need to abandon development or limit development of that product candidate to certain uses or subpopulations in which those undesirable characteristics would be expected to be less prevalent, less severe or more tolerable from a risk-benefit perspective.
−Removed: In the SEL-212 Phase 1/2 clinical program, we have observed multiple SAEs, and future SAEs may occur causing us to incur additional costs or experience delays in completing, or causing us to ultimately be unable to complete, the development and commercialization of our product candidates, and delay or prevent our ability to
−Removed: obtain FDA approval.
+Added: In the SEL-212 Phase 1/2 clinical program, we have observed multiple SAEs, and future SAEs may occur causing us to incur additional costs or experience delays in completing, or causing us to ultimately be unable to complete, the development and commercialization of our product candidates, and delay or prevent our ability to obtain FDA approval.
Moreover, preclinical and clinical data is often susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or other regulatory authority approval.
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• have a product removed from the market after obtaining marketing approval.
−Removed: In addition, disruptions caused by the COVID-19 pandemic may increase the likelihood that we encounter such difficulties or delays in initiating, enrolling, conducting or completing our planned and ongoing clinical trials.
We could also encounter delays if a clinical trial is suspended or terminated.
−Removed: Authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or comparable foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.
+Added: Authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or comparable foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a
+Added: benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.
In addition, changes in regulatory requirements and policies may occur, and we may need to amend clinical trial protocols to comply with these changes.
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We filed an IND to conduct a Phase 1/2 clinical trial of our SEL-302 product candidate in pediatric patients with methylmalonic acidemia in the third quarter of 2021.
−Removed: On November 23, 2021, this trial was placed on clinical hold by the FDA, with questions specifically relating to CMC of the AAV vector.
−Removed: On February 9, 2022, we submitted a written response to the FDA to answer its questions.
−Removed: On March 9, 2022, we received a letter from the FDA indicating the clinical hold was removed and the trial may proceed.
ImmTOR manufacturing continues to proceed in accordance with our expectations, and we have not observed any impact to any of our ImmTOR programs.
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In addition, from time to time our competitors have ongoing clinical trials for product candidates that treat the same indications as our product candidates, and patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product candidates.
−Removed: For example, SEL-212 is being developed for the treatment of chronic refractory gout, which affects a small patient population.
−Removed: Accordingly, there is a limited number of patients who could enroll in our clinical studies for SEL-212.
−Removed: Additionally, the DISSOLVE II trial of SEL-212 has enrolled subjects at clinical sites located in Russia and Ukraine.
−Removed: As a result of the ongoing and rapidly evolving situation in the region, we may remove those patients from the trial, which as a result could potentially result in delays in the full enrollment of the study and/or the release of top-line results.
The safety of our patients and investigators continues to be our utmost priority.
−Removed: Additionally, the COVID-19 pandemic has affected our ability to enroll and sustain patients in our clinical trials, and could result in the inability of some patients to complete our clinical trials.
−Removed: Additionally, we have enrolled subjects in countries where patient populations have less or limited access to COVID-19 vaccines, which could result in further delays in enrollment or a patient’s inability to complete our clinical trials.
Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether.
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For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with good clinical practices, or GCPs, and the FDA must be able to validate the data from the trial through an onsite inspection, if necessary.
−Removed: Generally, the patient population for any clinical trials conducted
−Removed: outside the United States must be representative of the population for which we intend to seek approval in the United States.
+Added: Generally, the patient population for any clinical trials conducted outside the United States must be representative of the population for which we intend to seek approval in the United States.
In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the data will be dependent upon its determination that the trials also complied with all applicable U.S.
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From time to time, we may publish interim, top-line or preliminary data from our clinical studies, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a full analyses of all data related to the particular trial.
−Removed: For example, we and AskBio announced top-line data from the Phase 1 trial for SEL-399 in November 2021.
We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data.
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Interim data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.
−Removed: Interim, top-line or preliminary data
−Removed: may not be representative of final data.
+Added: Interim, top-line or preliminary data may not be representative of final data.
If final data is not as positive as earlier interim, top-line or preliminary we have released, our business prospects would be significantly harmed.
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Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials, could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities and could result in decreased market acceptance of any of our product candidates, if approved.
−Removed: Further, therapies such as those we are developing involve unique side effects that could be more significant than side effects from other types of therapies with singular components.
+Added: Further, therapies such as those we are developing involve unique side effects that could be more significant than side effects
+Added: from other types of therapies with singular components.
Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects.
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business operations, including those of our CMOs and suppliers, we could face additional disruptions to our supply chain that could affect the supply of drug product for our preclinical studies and clinical trials.
−Removed: Additionally, as our CMOs are producers of drug substances and drug products, including vaccines and therapeutics, they could be compelled by a national government, or choose themselves, to shift their resources to the production of a COVID-19 vaccine and/or therapeutics for COVID-19, which could disrupt any scheduled drug substance or drug product batches we may have and may prevent us from obtaining supplies for our programs in a timely manner to meet our development timelines.
Any of these matters could materially and adversely affect our business and results of operations.
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• a collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product or products;
−Removed: • disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization
−Removed: of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive;
+Added: • disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive;
• collaborators 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 potential litigation;
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Moreover, eligibility for reimbursement does not imply that a product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution.
−Removed: Interim reimbursement levels for new products,
−Removed: if applicable, may also not be sufficient to cover our costs and may not be made permanent.
+Added: Interim reimbursement levels for new products, if applicable, may also not be sufficient to cover our costs and may not be made permanent.
Reimbursement rates may vary according to the use of the product and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost products and may be incorporated into existing payments for other services.
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A product liability claim or series of claims brought against us could cause our share price to decline and, if judgments exceed our insurance coverage, could adversely affect our results of operations and business, including preventing or limiting the commercialization of any product candidates we develop.
−Removed: Our relationships with healthcare providers, customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties,
−Removed: exclusion from government healthcare programs, contractual damages, reputational harm and diminished profits and future earnings.
+Added: Our relationships with healthcare providers, customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm and diminished profits and future earnings.
Arrangements with physicians, others who may be in a position to generate business for us, and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that constrain the business or financial arrangements and relationships through which we market, sell and distribute any products for which we obtain marketing approval.
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It is possible that governmental authorities will conclude that our business practices, including our relationships with physicians and other healthcare providers, some of whom may recommend, purchase and/or prescribe our product candidates, if approved, may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
−Removed: If our operations are found to be in violation of any of these laws or
−Removed: any other governmental laws and regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of products from government funded healthcare programs, such as Medicare and Medicaid, disgorgement, contractual damages, reputational harm, diminished profits and the curtailment or restructuring of our operations.
+Added: If our operations are found to be in violation of any of these laws or any other governmental laws and regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of products from government funded healthcare programs, such as Medicare and Medicaid, disgorgement, contractual damages, reputational harm, diminished profits and the curtailment or restructuring of our operations.
If any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.
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Average review times at the agency have fluctuated in recent years as a result.
−Removed: In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
+Added: In addition, government funding of
+Added: other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
Disruptions at the FDA and other agencies may also slow the time necessary for new drugs and biologics to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.
−Removed: Separately, in response to the COVID-19 pandemic, the FDA has periodically modified its regular practices with respect to inspection of manufacturing facilities.
If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
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Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors and other partners from authorizing, promising, offering or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector.
−Removed: We may engage third parties for clinical trials outside of the United States, to sell our product candidates abroad once we enter a commercialization phase, and/or to obtain necessary
−Removed: permits, licenses, patent registrations, and other regulatory approvals.
+Added: We may engage third parties for clinical trials outside of the United States, to sell our product candidates abroad once we enter a commercialization phase, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals.
We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations.
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The failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.
+Added: Risks Related to our Financial Position and Need for Additional Capital
+Added: We are a development-stage company and have incurred significant losses since our inception.
+Added: We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
+Added: Except for the year ended December 31, 2022, we have incurred significant operating losses since our inception.
+Added: Our net income was $35.4 million for the year ended December 31, 2022, and net losses were $25.7 million and $68.9 million for each of the years ended December 31, 2021 and 2020, respectively.
+Added: As of December 31, 2022, we had an accumulated deficit of $394.9 million.
+Added: To date, we have financed our operations primarily through public offerings and private placements of our securities, funding received from collaboration and license arrangements and our credit facility.
+Added: We currently have no source of product revenue, and we do not expect to generate product revenue for the foreseeable future.
+Added: We have devoted substantially all
+Added: of our financial resources and efforts to developing our ImmTOR platform, identifying potential product candidates and conducting preclinical studies and our clinical trials.
+Added: We are in the early stages of development of most of our product candidates, and we have not completed development of any ImmTOR-enabled therapies.
+Added: We expect to continue to incur significant expenses and operating losses for the foreseeable future.
+Added: We expect that our expenses will increase substantially as we:
+Added: • continue the research and development of our product candidates;
+Added: • seek to enhance and evolve our ImmTOR platform and discover and develop additional product candidates;
+Added: • seek to maintain and enter into collaboration, licensing and other agreements, including, but not limited to research and development, and/or commercialization agreements;
+Added: • seek regulatory approvals for any product candidates that successfully complete clinical trials;
+Added: • potentially establish a sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any products for which we may obtain regulatory approval;
+Added: • maintain, expand and protect our intellectual property portfolio, including through licensing arrangements;
+Added: • add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and potential future commercialization efforts;
+Added: • experience any delays or encounter any issues with any of the above, including, but not limited to, failed studies, complex results, safety issues or other regulatory, manufacturing or scale-up challenges;
+Added: • are exposed to broad macroeconomic conditions including inflation and supply chain tightness which could result in us paying more, or being unable, to access goods and services.
+Added: To become and remain profitable, we must succeed in developing and eventually commercializing products that generate significant revenue.
+Added: This will require us to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of our product candidates, discovering additional product candidates, obtaining regulatory approval and securing reimbursement for these product candidates, manufacturing, marketing and selling any products for which we may obtain regulatory approval, and establishing and managing our collaborations at various stages of a product candidate’s development.
+Added: We are only in the preliminary stages of most of these activities.
+Added: We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability.
+Added: Because of the numerous risks and uncertainties associated with pharmaceutical and biological product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability.
+Added: If we are required by the FDA or other regulatory authorities to perform studies in addition to those currently expected, or if there are any delays in completing our clinical trials or the development of any of our product candidates, our expenses could increase and product revenue could be further delayed.
+Added: We may not be able to sustain or increase profitability on a quarterly or annual basis.
+Added: Our failure to remain profitable would depress our value and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or continue our operations.
+Added: We will need substantial additional funding in order to complete development of our product candidates and commercialize our products, if approved.
+Added: If we are unable to raise capital when needed and on terms favorable to us, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts .
+Added: We expect our expenses to increase in connection with our ongoing activities, particularly as we continue to develop our gene therapy pipeline, including our collaboration with AskBio, research and develop our autoimmune programs and advance the evolution of our ImmTOR platform in combination with IL-2, and continue research and development for other product candidates.
+Added: Additionally, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution.
+Added: Accordingly, we will need to obtain substantial additional funding to continue operations.
+Added: If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our clinical trials, our other research and development programs or any future commercialization efforts.
+Added: We believe that our existing cash, cash equivalents and restricted cash as of December 31, 2022 will enable us to fund our current planned operations into mid-2024, though we may realize additional cash resources upon the achievement of certain contingent collaboration milestones and we may pursue additional cash resources through public or private equity or debt financings, by establishing collaborations with other companies or through the monetization of potential royalty and/or milestone payments pursuant to our existing collaboration and license arrangements.
+Added: Management’s expectations with respect to our ability to fund current and long-term planned operations are based on estimates that are subject to risks and uncertainties.
+Added: If actual results are different from management’s estimates, we may need to seek additional strategic or financing opportunities
+Added: sooner than would otherwise be expected.
+Added: However, there is no guarantee that any collaboration milestones will be achieved or that any of these strategic or financing opportunities will be executed on favorable terms, and some could be dilutive to existing stockholders.
+Added: If we are unable to obtain additional funding on a timely basis, we may be forced to significantly curtail, delay, or discontinue one or more of our planned research or development programs or be unable to expand our operations, meet long-term obligations or otherwise capitalize on our commercialization of our product candidates.
+Added: We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.
+Added: Our future capital requirements will depend on many factors, including:
+Added: • the scope, progress, results and costs of our clinical trials, preclinical development, and laboratory testing;
+Added: • the number of product candidates that we pursue and the speed with which we pursue development;
+Added: • our collaboration agreements remaining in effect, our entering into additional collaboration agreements and our ability to achieve milestones under these agreements;
+Added: • our headcount growth and associated costs;
+Added: • the costs, timing and outcome of regulatory review of our product candidates;
+Added: • the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;
+Added: • the revenue, if any, from commercial sales of our product candidates for which we receive marketing approval;
+Added: • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;
+Added: • the effect of competing technological and market developments;
+Added: • the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for product candidates.
+Added: Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates.
+Added: In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all.
+Added: Market volatility resulting from the COVID-19 pandemic, the ongoing conflict in Ukraine and current global macroeconomic conditions or other factors could also adversely impact our ability to access capital as and when needed.
+Added: Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders, and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline.
+Added: The sale of additional equity or convertible securities would dilute all of our stockholders.
+Added: The incurrence of indebtedness could result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
+Added: We could also be required to seek funds through arrangements with collaborators or others at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.
+Added: If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs, including our clinical trial programs, or the commercialization of any product candidates, or be unable to sustain or expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations.
+Added: The terms of our credit facility place restrictions on our operating and financial flexibility.
+Added: If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.
+Added: On August 31, 2020, we entered into a term loan, or the 2020 Term Loan, of up to $35.0 million, consisting of term loans in an aggregate amount of $25.0 million, or the Term A Loan, and term loans in an aggregate amount of $10.0 million, or the Term B Loan, governed by a loan and security agreement among us and Oxford Finance LLC, or Oxford, as collateral agent and a lender, and Silicon Valley Bank, or SVB, as a lender.
+Added: The Term A Loan was funded in full on August 31, 2020, the proceeds of which were used to repay our previously existing 2017 term loan and for general corporate and working capital purposes, and the draw period relating to the Term B Loan expired on September 30, 2021.
+Added: The 2020 Term Loan is secured by a lien on substantially all of our assets, other than intellectual property, provided that such lien includes any rights to payments and proceeds from the sale, licensing or disposition of intellectual property.
+Added: We also granted Oxford a negative pledge with respect to our intellectual property.
+Added: Failure to satisfy our current and future debt obligations, including covenants to take or avoid specific actions, under the 2020 Term Loan could result in an event of default, our lenders could accelerate all of the amounts due.
+Added: If we raise any additional debt financing, the terms of such additional debt could further restrict our operating and financial flexibility.
+Added: Our ability to use our net operating loss and research and development tax credit carryforwards to offset future taxable income may be subject to certain limitations.
+Added: We have net operating loss carryforwards, or NOLs, for federal and state income tax purposes that may be available to offset our future taxable income, if any.
+Added: In general, under Sections 382 and 383 of the U.S.
+Added: Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to use its pre-change NOLs to offset future taxable income.
+Added: Internal Revenue Service, or IRS, challenges our analysis that existing NOLs will not expire before utilization due to previous ownership changes, or if we undergo an ownership change in connection with or after a public offering, our ability to use our NOLs could be limited by Section 382 of the Code.
+Added: Future changes in our stock ownership, some of which are outside of our control, could result in an ownership change under Sections 382 and 383 of the Code.
+Added: Furthermore, our ability to use NOLs of companies that we may acquire in the future may be subject to limitations.
+Added: As a result, we may not be able to use a material portion of the NOLs reflected on our balance sheet, even if we attain profitability.
+Added: The reduction of the corporate tax rate under the TCJA may cause a reduction in the economic benefit of our NOLs and other deferred tax assets available to us.
+Added: Under current law, NOLs that arose before January 1, 2018, will begin to expire in 2041.
+Added: NOLs that arose after 2017 may be used to offset at most 80% of our taxable income to the extent not offset by pre-2018 NOLs.
+Added: As a result, we may become required to pay federal income taxes in future years despite having generated losses for federal income tax purposes in prior years.
Risks Related to our Intellectual Property
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We may not be able, alone or with our licensors or potential collaborators, to prevent misappropriation of our proprietary rights, particularly in countries where the laws may not protect such rights as fully as in the United States.
−Removed: Furthermore, because of the substantial amount of discovery required in connection with
−Removed: intellectual property litigation or other proceedings, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation or other proceedings.
−Removed: In addition, during the course of this kind of litigation or proceedings, there could be public announcements of the results of hearings, motions or other interim proceedings or developments or public access to related documents.
+Added: Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or other proceedings, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation or other proceedings.
+Added: In addition, during the course of this kind of litigation or proceedings, there could be public announcements of the results of hearings, motions or other interim proceedings
+Added: or developments or public access to related documents.
If investors perceive these results to be negative, the market price for our common stock could be adversely affected.
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Grounds for unenforceability assertions include allegations that someone connected with the prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution.
−Removed: Third parties may
−Removed: also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation.
−Removed: Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings and equivalent proceedings in foreign jurisdictions, such as opposition proceedings.
+Added: Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation.
+Added: Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings and equivalent
+Added: proceedings in foreign jurisdictions, such as opposition proceedings.
Such proceedings could result in revocation or amendment of our patents in such a way that they no longer cover our product candidates or competitive products.
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Because we may find that our programs require the use of proprietary rights held by third parties, the growth of our business may depend in part on our ability to acquire, in-license or use these proprietary rights.
−Removed: We may be unable to acquire or in-license compositions, methods of use, processes or other third-party
−Removed: intellectual property rights from third parties that we identify as necessary for our product candidates.
−Removed: The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies are also pursuing strategies to license or acquire third-party intellectual property rights that we may consider attractive.
+Added: We may be unable to acquire or in-license compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify as necessary for our product candidates.
+Added: The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies are also
+Added: pursuing strategies to license or acquire third-party intellectual property rights that we may consider attractive.
These established companies may have a competitive advantage over us due to their size, financial resources and greater clinical development and commercialization capabilities.
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As a public company, we have incurred and expect to continue to incur significant legal, accounting and other expenses.
−Removed: In particular, beginning with this Annual Report, we will be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.
If we are unable to maintain effective internal control over financial reporting, we may not have adequate, accurate or timely financial information, and we may be unable to meet our reporting obligations as a public company or comply with the requirements of the SEC or Section 404.
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operations, we maintain a wholly owned subsidiary in Russia, Selecta (RUS).
−Removed: However, we plan to wind down these operations.
−Removed: We may face risks associated with maintaining our subsidiary in Russia, or with any international operations, including possible unfavorable regulatory, pricing and reimbursement, legal, political, tax and labor conditions, and risks associated with our compliance with evolving international sanctions, which could harm our business.
−Removed: We may also rely
−Removed: on collaborators to commercialize any approved product candidates outside of the United States.
+Added: However, we are in the process of winding down these operations.
+Added: We may face risks associated with winding down the operations of our subsidiary in Russia, or with any international operations, including possible unfavorable regulatory, pricing and reimbursement, legal, political, tax and labor conditions, and risks associated with our compliance with evolving international sanctions, which could harm our business.
+Added: We may also rely on collaborators to commercialize any approved product candidates outside of the United States.
Doing business internationally involves a number of risks, including but not limited to:
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Any of these factors could significantly harm our future international expansion and operations and, consequently, our results of operations.
−Removed: Our business and operations would suffer in the event of system failures or unauthorized or inappropriate use of or access to our systems.
−Removed: Despite the implementation of security measures, our internal computer systems and those of our current and future contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.
−Removed: While we are not aware of any such material system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations.
−Removed: Likewise, we rely on third parties to manufacture our product candidates and conduct clinical trials, and similar events relating to their computer systems could also have a material adverse effect on our business.
−Removed: To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our product candidates could be delayed.
+Added: Our business and operations, including our development programs, could be materially disrupted in the event of system failures, security breaches, violations of data protection laws or data loss or damage by us or third parties on which we rely, including our CROs or other contractors or consultants.
+Added: Our internal computer systems and those of third parties on which we rely, including our CROs and other contractors and consultants, are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.
+Added: If such an event were to occur and cause interruptions in our operations, it could have a material adverse effect on our business operations, including a material disruption of our development programs.
+Added: Unauthorized disclosure of sensitive or confidential patient or employee data, including personally identifiable information, whether through breach of computer systems, systems failure, employee negligence, fraud or misappropriation, or otherwise, or unauthorized access to or through our information systems and networks, whether by our employees or third parties, could result in negative publicity, legal liability and damage to our reputation.
+Added: Unauthorized disclosure of personally identifiable information could also expose us to sanctions for violations of data privacy laws and regulations around the world.
+Added: To the extent that any disruption or security breach resulted in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of our product candidates could be delayed.
+Added: For example, the loss of or damage to clinical trial data, such as from completed or ongoing clinical trials, for any of our product candidates would likely result in delays in our marketing approval efforts and significantly increased costs in an effort to recover or reproduce the data.
+Added: We have previously been, and expect to remain, the target of cyber-attacks.
+Added: As we become more dependent on information technologies to conduct our operations, cyber incidents, including deliberate attacks, such as ransomware attacks, and attempts to gain unauthorized access to computer systems and networks, may increase in frequency and sophistication.
+Added: These incidents pose a risk to the security of our systems and networks, the confidentiality and the availability and integrity of our data and these risks apply both to us, and to third parties on whose systems we rely for the conduct of our business.
+Added: While we do not believe the effect of these incidents has historically been material to our results of operations, financial condition or prospects, cyber threats are persistent and constantly evolving.
+Added: Such threats have increased in frequency, scope and potential impact in recent years, which increases the difficulty of detecting and successfully defending against them.
+Added: As cyber threats continue to
+Added: evolve, we may be required to incur additional expenses in order to enhance our protective measures or to remediate any information security vulnerability.
+Added: There can be no assurance that we or our third-party providers will be successful in preventing cyber-attacks or mitigating their effects.
+Added: Similarly, there can be no assurance that our collaborators, CROs, third-party logistics providers, distributors and other contractors and consultants will be successful in protecting our clinical and other data that is stored on their systems.
+Added: Any cyber-attack or destruction or loss of data could have a material adverse effect on our business and prospects.
+Added: In addition, we may suffer reputational harm or face litigation or adverse regulatory action as a result of cyber-attacks or destruction or loss of data and may incur significant additional expense to implement further data protection measures.
+Added: It is also possible that unauthorized access to data may be obtained through inadequate use of security controls by our suppliers or other vendors.
+Added: Although we have general liability insurance coverage, our insurance may not cover all claims, continue to be available on reasonable terms or be sufficient in amount to cover one or more large claims.
+Added: Additionally, the insurer may disclaim coverage as to any claim.
+Added: The successful assertion of one or more large claims against us that exceed or are not covered by our insurance coverage or changes in our insurance policies, including premium increases or the imposition of large deductible or co-insurance requirements, could have a material adverse effect on our business, prospects, operating results and financial condition.
Acquisitions or joint ventures could disrupt our business, cause dilution to our stockholders and otherwise harm our business.
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We may not have the funds necessary to fulfill our obligation to repurchase certain warrants.
−Removed: Under certain circumstances, holders of certain warrants issued in December 2019 may require us to repurchase the remaining unexercised portion of such warrants for an amount of cash equal to the value of the warrant as determined in accordance with the Black-Scholes option pricing model and the terms of the warrants.
+Added: Under certain circumstances, holders of certain warrants may require us to repurchase the remaining unexercised portion of such warrants for an amount of cash equal to the value of the warrant as determined in accordance with the Black-Scholes option pricing model and the terms of the warrants.
Our ability to repurchase the warrants depends on our ability to generate cash flow in the future.
9 unchanged sentences
However, the provision may have the effect of discouraging lawsuits against our directors, officers, employees and agents as it may limit any stockholder’s ability to bring a claim in a judicial forum that such stockholder finds favorable for disputes with us or our directors, officers, employees or agents.
−Removed: We are involved in two securities class action lawsuits.
+Added: We have been in the past and may in the future be subject to securities class action lawsuits.
In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities.
9 unchanged sentences
On April 12, 2021, the Court of Chancery in the State of Delaware granted a motion to stay the litigation pending a review by a Special Committee appointed by the Company’s Board of Directors.
−Removed: While the litigation was stayed, the parties reached an agreement in principle to settle the matter, and they expect to submit documentation to the Court for its approval of the settlement in the near future.
+Added: While the litigation was stayed, the parties reached an agreement in principle to settle the matter, and on March 18, 2022, they submitted a Stipulation and Agreement of Settlement and other documentation to the Court for its approval of the settlement.
+Added: On July 21, 2022, the Court held a settlement hearing, at which the settlement was approved.
+Added: On August 1, 2022, the Court entered an Order and Final Judgment which dismissed the action, and all claims contained therein, with prejudice.
We could receive other demands or be subject to other litigation.
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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.