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EDIT 10-K & 10-Q changes, risk factors and insider trading

Editas Medicine, Inc. · Nasdaq · Biological Products, (No Diagnostic Substances) · CIK 1650664 · All filings on SEC.gov

Everything below is quoted or computed from Editas Medicine, Inc.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

40 / 21risk-factor paragraphs added / removed in latest 10-K
4new risk-factor headings
0Form 4 filings reporting open-market purchases (last 180 days)
8Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparing 10-K filed 2026-03-09 (period ending 2025-12-31) with 10-K filed 2025-03-05 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

40new paragraphs
21removed paragraphs
86reworded paragraphs
40,140 → 41,849words in section

New heading “Unfavorable national or global economic conditions or political developments could adversely affect our business, financial condition or results of operations.”

New heading “We are dependent on the success of our lead product candidate, EDIT-401, which is in preclinical development. Development of product candidates may not be successful. If we are unable to commence and complete the clinical development of, obtain marketing approval for, or successfully commercialize EDIT-401, either alone or with a collaborator, or if we experience significant delays in doing so, our business would be substantially harmed.”

New heading “We currently plan to conduct and may in the future conduct clinical trials for our product candidates outside the U.S., and the FDA and comparable foreign regulatory authorities may not accept data from such trials.”

New heading “Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development programs and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business.”

Removed heading “Inadequate funding for the FDA, the SEC and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.”

Removed heading “We face risks related to health epidemics, pandemics and other widespread outbreaks of contagious disease, which could significantly disrupt our operations, impact our financial results or otherwise adversely impact our business.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: going concern, litigation, european commission
“The GDPR places restrictions on the cross-border transfer of personal data from the EU to countries that have not been found by the European Commission to offer adequate data protection legislation, such as the U.S. There are ongoing concerns about the ability of companies to transfer personal data from the EU to other countries. Following the July 2020 Court of Justice of the European Union judgment invalidating the so-called EU-U.S. Privacy Shield, the European Commission adopted an adequacy decision for the EU-U.S. Data Privacy Framework in July 2023. This adequacy decision permits U.S. …”
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New text topics: labor
“We are dependent on the success of our lead product candidate, EDIT-401, which is in preclinical development. Development of product candidates may not be successful. If we are unable to commence and complete the clinical development of, obtain marketing approval for, or successfully commercialize EDIT-401, either alone or with a collaborator, or if we experience significant delays in doing so, our business would be substantially harmed.”
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New text topics: litigation, lawsuit
“On June 6, 2023, Merck & Co., Inc., filed a lawsuit against HHS and CMS asserting that, among other things, the IRA’s Drug Price Negotiation Program for Medicare constitutes an uncompensated taking in violation of the Fifth Amendment of the U.S. Constitution. Subsequently, other parties, including the U.S. Chamber of Commerce, or Chamber of Commerce, Bristol Myers Squibb Company, the PhRMA, Astellas Pharma US, Inc., Novo Nordisk Inc., Janssen Pharmaceuticals, Inc., Novartis Pharmaceutical Corporation, AstraZeneca L.P. and Boehringer Ingelheim Pharmaceuticals, Inc. …”
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Removed text topics: pandemic
“We face risks related to health epidemics, pandemics and other widespread outbreaks of contagious disease, which could significantly disrupt our operations, impact our financial results or otherwise adversely impact our business.”
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Removed text topics: impairment, workforce reduction
“In December 2024, we announced the discontinuation of the clinical development of our ex vivo renizgamglogene autogedtemcel (“reni-cel”) program to treat sickle cell disease (“SCD”) and transfusion-dependent beta thalassemia (“TDT”) and a related employee workforce reduction. …”
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Removed text topics: litigation, lawsuit
“On June 6, 2023, Merck & Co. filed a lawsuit against the HHS and the CMS asserting that, among other things, the IRA’s Drug Price Negotiation Program for Medicare constitutes an uncompensated taking in violation of the Fifth Amendment of the Constitution. Subsequently, a number of other parties, including the U.S. Chamber of Commerce (the “Chamber”), Bristol Myers Squibb Company, the PhRMA, Astellas, Novo Nordisk, Janssen Pharmaceuticals, Novartis, AstraZeneca and Boehringer Ingelheim, also filed lawsuits in various courts with similar constitutional claims against the HHS and the CMS. …”
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Full comparison: every changed paragraph (147)

Green = added, red = removed. Unchanged paragraphs, 1 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

Since inception, we have incurred significant operating losses. Our net losses were $237.1$160.1 million, $153.2$237.1 million, and $220.4$153.2 million for the years ended December 31, 2024,2025, 20232024 and 2022,2023, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $1.47$1.6 billion. We have financed our operations primarily through public offerings of our common stock, our research collaboration with Bristol Myers Squibb Company (“BMS”) through its wholly owned subsidiary, Juno Therapeutics, Inc. (“Juno Therapeutics”),Inc., payments under our former strategic alliance with Allergan Pharmaceuticals International Limited (together with its affiliates, “Allergan”), which was terminated in August 2020, payments received under our purchase and sale agreement with DRI Healthcare Acquisitions LP, and payments under our license agreement with Vertex Pharmaceuticals, Inc.Incorporated (“Vertex”). We have devoted substantially all of our efforts to research and development. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter to quarter. We anticipate that our expenses will increase substantially if and as we:

Removed

•progress the preclinical development of our in vivo programs and seek to achieve our stated strategic priorities through 2027;

Reworded

•continue ourto currentsupport researchpreclinical programsstudies and ourprepare preclinicalfor andthe clinical development of product candidates from our current research programsEDIT-401;

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•initiate and conduct clinical trials of EDIT-401;

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•seekcontinue toour identify additionalcurrent research programs and additionalour preclinical development of product candidates from our current research programs;

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•seek to identify additional product candidates and research programs;

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•initiate preclinical testing and clinical trials for anyother product candidates we identify and develop;

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•further develop our genomegene editing platform;

Removed

In December 2024, we announced the discontinuation of the clinical development of our ex vivo renizgamglogene autogedtemcel (“reni-cel”) program to treat sickle cell disease (“SCD”) and transfusion-dependent beta thalassemia (“TDT”) and a related employee workforce reduction. We expect to incur substantial costs as we complete the wind-down of various activities related to clinical development of reni-cel, including contract termination costs, impairment charges and non-cash charges, and may also incur additional costs not currently contemplated due to events that may occur as a result of or that are associated with the discontinuation. We additionally expect to incur substantial costs related to the employee workforce reduction, primarily consisting of severance payments and employee benefit costs. The charges related to these activities are expected to be substantially incurred through the end of June 2025. The amounts and timing of these charges may be impacted by events that may occur as a result of, or that are associated with, these activities, which impacts could be material. We may not experience the expected benefits of the employee workforce reduction or the decision to discontinue clinical development of reni-cel.

Reworded

We expect our expenses to increase in connection with our ongoing activities, particularly as we identify, continue the research and development of, initiate preclinical studies and clinical trials of, and seek marketing approval for, product candidates.candidates, including EDIT-401. In addition, if we obtain marketing approval for any product candidates we develop, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution to the extent that such sales, marketing, manufacturing, and distribution are not the responsibility of a collaborator. We may also need to raise additional funds sooner if we choose to pursue additional indications or geographies for our product candidates or otherwise expand more rapidly than we presently anticipate. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce, or eliminate our research and product development programs or future commercialization efforts.

Reworded

We expect that our existing cash,cash and cash equivalents and marketable securities on December 31, 2024, together with the retained portions of the payments payable under our license agreement with Vertex,2025 will fund our operating expenses and capital expenditure requirements into the secondthird quarter of 2027. As of December 31, 2024,2025, our right to contingent payments under our collaboration agreements with BMS and our license agreement with Vor Bio,BMS, as well as the retained portions of the contingent upfront payment and other amounts under our license agreement with Vertex, are our only significant committed potential external source of funds. Our future capital requirements will depend on many factors, including:

Reworded

•the restructuring costs associatedof withprogressing the discontinuationpreclinical ofand clinical development of reni-celEDIT-401;

Reworded

Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive, and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, even if we successfully identify and develop product candidates and those are approved, we will require significant additional amountsfunding in order to launch and commercialize our product candidates and may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of medicines that we do not expect to be commercially available for years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all.

Reworded

Our limited operating history may make it difficult for our stockholders to evaluate the success of our business to date and to assess our future viability.

Reworded

We are currently a pre-clinical stage company and have neverlimited successfullyexperience completed aconducting clinical trial. Following our discontinuation of the clinical development of reni-cel, we have become an early-stage company.trials. We were founded and commenced operations in the second half of 2013. Our operations to date have beenconsisted limited toof organizing and staffing our company, business planning, raising capital, acquiring and developing our technology, identifying potential product candidates, undertaking preclinical studies and initiating and conducting clinical trials. All of our ongoing research programs are in the preclinical or research stage of development, and the risk of failure of all of our research programs is high. We have not yet demonstrated an ability to successfully complete any clinical trials, including large-scale, pivotal clinical trials, obtain marketing approvals, manufacture a commercial-scale medicine, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization. In addition, we may encounter unforeseen expenses, difficulties, complications, delays, and other known and unknown factors.

Reworded

Our limited operating history, particularly in light of the rapidly evolving genomegene editing field, may make it difficult to evaluate our current business and predict our future performance. Our relatively short history as an operating company and limited experience conducting clinical trials and commercializing products makes any assessment of our future success or viability subject to significant uncertainty. We will encounter risks and difficulties frequently experienced by other early-stage companies in rapidly evolving fields. If we do not address these risks successfully, our business will suffer.

Added

Unfavorable national or global economic conditions or political developments could adversely affect our business, financial condition or results of operations.

Added

Our results of operations could be adversely affected by general conditions in the national or global economy and financial markets. For example, governmental statements, actions or policies, political unrest and global financial crises can cause extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn, political unrest or additional global financial crises, could result in a variety of risks to our business, including weakened demand for our products, if approved, or our ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy or unfavorable political developments could also strain our suppliers, possibly resulting in supply disruption. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate, further political developments and financial market conditions could adversely impact our business.

Added

We are dependent on the success of our lead product candidate, EDIT-401, which is in preclinical development. Development of product candidates may not be successful. If we are unable to commence and complete the clinical development of, obtain marketing approval for, or successfully commercialize EDIT-401, either alone or with a collaborator, or if we experience significant delays in doing so, our business would be substantially harmed.

Added

We currently have no products approved for sale and are investing a significant portion of our efforts and financial resources in the development of EDIT-401, which is currently in preclinical development.

Added

Our prospects are substantially dependent on our ability, or that of any future collaborator, to develop, obtain marketing approval for and successfully commercialize EDIT-401. Because our business is significantly dependent upon this one product candidate, any setback in the preclinical or clinical development or the obtaining of regulatory approval for EDIT-401, or any delays in doing so, would have a material adverse effect on our business and prospects.

Added

The success of our EDIT-401 program will depend on several factors, including the following:

Added

•obtaining required regulatory approvals to commence clinical trials of EDIT-401, and the successful enrollment and completion of any such clinical trials;

Added

•safety, tolerability and efficacy profiles that are satisfactory to the FDA, or any comparable foreign regulatory authority for marketing approval;

Added

•timely receipt of marketing approvals from applicable regulatory authorities;

Added

•the performance of our future collaborators, if any;

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•the extent of any required post-marketing approval commitments to applicable regulatory authorities;

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•establishment and maintenance of supply arrangements with third-party raw materials suppliers and manufacturers for clinical development and, if approved, commercialization of our product candidates;

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•establishment and maintenance of arrangements with third-party manufacturers to obtain finished drug products that are appropriately packaged for sale;

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•successful development of internal manufacturing processes and transfer to larger-scale facilities operated by either a contract manufacturing organization or by us;

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•obtaining and maintaining patent, trade secret protection and regulatory exclusivity, both in the United States and internationally;

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•protection of our rights in our intellectual property portfolio;

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•successful launch of commercial sales following any marketing approval;

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•a continued acceptable safety profile following any marketing approval;

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•commercial acceptance by patients, the medical community and third-party payors following any marketing approval; and

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•our ability to compete with other therapies.

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Many of these factors are beyond our control, including the outcome of clinical development, the regulatory submission process, potential threats to our intellectual property rights, and the manufacturing, marketing and sales efforts of any future commercial partner. If we are unable to develop, receive marketing approval for and successfully commercialize EDIT-401, on our own or with any future collaborator, or experience delays as a result of any of these or other factors, our business would be substantially harmed.

Reworded

We intend to identify and develop product candidates based on a relatively novel genomegene editing technology, which makes it difficult to predict the time and cost of product candidate development. Only one therapeutic product that utilizes genomegene editing technology has been approved in the United States or in Europe.

Reworded

We have concentrated our research and development efforts on our genomegene editing platform, which uses CRISPR technology. Our future success depends on the successful development of this relatively novel genomegene editing therapeutic approach. In 2023, the first and, to date, only, approved therapeutic product that utilizes CRISPR-based gene editing, which is an ex vivo CRISPR-based genome editingtherapeutic, was approved in the United States and Europe. To date, in the United States, the FDA has not approved anyno in vivo CRISPR-based genomegene editing therapeutic.therapeutic has been approved in the United States or Europe. It is difficult for us to predict the time and cost of product candidate development, and we cannot predict whether the application of our genomegene editing platform, or any similar or competitive genomegene editing platforms, will result in the identification, development, and regulatory approval of any medicines. There can be no assurance that any development problems we experience in the future related to our genomegene editing platform or any of our research programs will not cause significant delays or unanticipated costs, or that such development problems can be solved. We may also experience delays in developing a sustainable, reproducible, and scalable manufacturing process or transferring that process to commercial partners. Any of these factors may prevent us from completing our preclinical studies or any clinical trials that we may initiate or commercializing any product candidates we develop on a timely or profitable basis, if at all.

Reworded

Regulatory requirements governing genetic and cellular medicines, and in particular any novel genetic medicine products we may develop, have changed frequently and may continue to change in the future. We are aware of a limited number of genetic medicines that have received marketing authorization from the FDA and EMA. Even with respect to more established products in the genetic medicine field, the regulatory landscape is still developing. For example, the FDA has established the Office of Therapeutic Products (“OTP”) to oversee the review of genetic medicines and related products. It has also established the Cellular, Tissue and Gene Therapies Advisory Committee to advise the Center for Biologics Evaluation and Research on its review of gene therapy products. The FDA has also issued guidance documents, including a January 2024 final guidance entitled “Human Gene Therapy Products Incorporating Human Genomegene Editingediting” outlining the agency’s current recommendations regarding information that should be provided in an Investigational New Drug application (“IND”) in order to assess the safety and quality of the investigational product. The FDA’s regulatory requirements governing genetic and cellular medicines continue to evolve and we will need to monitor and adapt to these requirements as they develop.

Reworded

The same is true for activities in the European Union (the “EU”). The EMA’s Committee for Advanced Therapies (“CAT”) is responsible for assessing the quality, safety and efficacy of advanced-therapy medicinal products. The role of the CAT is to prepare a draft opinion on an application for marketing authorization for a genetic medicinal candidate that is submitted to the Committee for Human Medicinal Products (“CHMP”) before it adopts its final opinion. In the EU, the development and evaluation of a genetic medicinal product must be considered in the context of the relevant European UnionEU guidelines. The EMA may issue new guidelines concerning the development and marketing authorization for genetic medicinal products and require that we comply with these new guidelines. As a result, the procedures and standards applied to genetic medicines and cell therapy products may be applied to any product candidates we may develop, but that remains uncertain at this point.

Reworded

The success of our business depends primarily upon our ability to identify, develop, and commercialize products based on our genomegene editing platform. All of our ongoing product development programs are in the preclinical or research stage of development. Our research programs, including those subject to our collaboration with BMS, may fail to identify potential product candidates for clinical development for a number of reasons. Our research methodology may be unsuccessful in identifying potential product candidates, or our potential product candidates may be shown to have smaller patient populations than initially estimated or may have harmful side effects or may have other characteristics or unforeseeable consequences that may make the products impractical to manufacture or commercialize, or unlikely to receive marketing approval.

Reworded

The occurrence of these events may force us to abandon our development efforts for a program or programs, which could have a material adverse effect on our business, financial condition, results of operations, and prospects. For example, we recently decided to discontinue clinical development of reni-cel to focus on our in vivo preclinical programs. Research programs to identify new product candidates require substantial technical, financial, and human resources. We may focus our efforts and resources on potential programs or product candidates that ultimately prove to be unsuccessful.unsuccessful or are otherwise discontinued due to unforeseen circumstances. For example, in December 2024,2024 we announced the discontinuation of our Phaseclinical 1/2/3 RUBY trialtrials of reni-cel for SCD and our Phase 1/2 EdiTHAL trial of reni-cel for TDT, following an extensive search to identify a commercial partner.reni-cel. Though reni-cel had demonstrated a favorable safety profile and promising preliminary efficacy, we determined not to pursue commercialization for reni-cel in order to optimize our cost structure and accelerate our in vivo pipeline development.

Reworded

The genomegene editing field is relatively new and is evolving rapidly. We are focusing our research and development efforts on CRISPR gene editing technology using Cas9 and Cas12a enzymes, but other genomegene editing technologies may be discovered that provide significant advantages over CRISPR/Cas9 or CRISPR/Cas12a, which could materially harm our business.

Reworded

To date, we have focused our efforts on genomegene editing technologies using CRISPR and the Cas9 and Cas12a (also known as Cpf1) enzymes. Other companies have previously undertaken research and development of genomegene editing technologies using zinc finger nucleases, engineered meganucleases, and transcription activator-like effector nucleases, but to date none has obtained marketing approval for a product candidate. There can be no certainty that these other genomegene editing technologies will not be considered better or more attractive for the development of medicines. Similarly, a new genomegene editing technology that has not been discovered yet may be determined to be more attractive than CRISPR. Moreover, if we decide to develop genome technologies other than CRISPR technology using a Cas9 or Cas12a enzyme, we cannot be certain we will be able to obtain rights to such technologies. Any of these factors could reduce or eliminate our commercial opportunity, and could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Reworded

All of our ongoing product development programs are at the preclinical or research stage. Preclinical testing and clinical trials of product candidatescandidates, including EDIT-401, may not be successful. If we are unable to commercialize any product candidates we develop or experience significant delays in doing so, our business will be materially harmed.

Reworded

•the performance of our future collaborators, if any;

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•successful development of our internal manufacturing processes and transfer to larger-scale facilities operated by either a contract manufacturing organization (“CMO”) or by us;

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If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize any product candidates we may identify and develop, which would materially harm our business. We currently generate no revenue from sales of any product and we may never be able to develop or commercialize a marketable product.

Reworded

In addition, if any product candidates encounter safety or efficacy problems, development delays, regulatory issues or other problems, our development plans and business could be significantly harmed. For the reasons described above, among others, regulatory authorities, particularly the FDA, have requested, and may request in the future, additional preclinical studies for genomegene editing products, such as additional studies related to toxicology, biodistribution or reproductive health, and/or preclinical studies earlier in clinical development compared to other therapeutic modalities. It is possible that the FDA may impose requirements that result in a delay of any of our programs or their regulatory approval of our product candidates. If we are unable to complete any required studies satisfactorily, the FDA or other regulatory authorities could require that we exclude certain patient populations from clinical studies, place our clinical studies on hold, or require us to cease further clinical studies or deny approval of such product candidates. Further, competitors that are developing ex vivo or in vivo products with similar technology may experience problems with their product candidates or programs that could in turn cause us to identify problems with our product candidates and programs, or cause the FDA or other regulatory authorities to impose additional requirements, that could cause us to delay or pause development of our product candidates. Any of these occurrences may harm our ability to identify and develop product candidates, and may harm our business, financial condition, results of operations and prospects significantly. We cannot guarantee that the FDA or other regulatory authorities will not change their requirements in the future or agree with our proposed regulatory strategies and filings.

Reworded

If serious adverse events, undesirable side effects, or unexpected characteristics are identified during the development of any product candidates we may develop, we may need to abandon or limit our further clinical development of those product candidates.

Reworded

We have limited experience in evaluating product candidates in human clinical trials, having dosed our first patient in a clinical trial in 2020, and our proposed delivery modes, combined with CRISPR technology, have a limited history of being tested clinically. It is impossible to predict when or if any product candidates we develop will ultimately prove safe in humans. In the genomic medicine field, there have been several significant adverse events from gene therapy treatments in the past, including reported cases of leukemia and death. There can be no assurance that genomegene editing technologies will not cause severe or undesirable side effects.

Reworded

A significant risk in any genomegene editing product is that the edit will be “off-target” and cause serious adverse events, undesirable side effects, or unexpected characteristics. For example, off-target cuts could lead to disruption of a gene or a genetic regulatory sequence at an unintended site in the DNA. We cannot be certain that off-target editing will not occur in any of our future clinical studies. There is also the potential risk of delayed adverse events following exposure to genomegene editing therapy due to the potential for persistent biological activity of the genetic material or other components of products used to carry the genetic material.

Reworded

We have not extensively tested any of our proposed delivery modesmodes, combined with our product candidates, in clinical trials and have not begun clinical trials in any of our current development programs.

Reworded

During the regulatory review process, we will need to identify success criteria and endpoints such that the FDA, the EMA, or other regulatory authorities will be able to determine the clinical efficacy and safety profile of our product candidates. As we are seeking to identify and develop product candidates to treat diseases in which there is little clinical experience using new technologies, there is heightened risk that the FDA, the EMA, or other regulatory authorities may not consider the clinical trial endpoints that we propose to provide clinically meaningful results. Even if thea FDAregulatory authority does find our success criteria to be sufficiently validated and clinically meaningful, we may not achieve the pre-specified endpoints to a degree of statistical significance. This may be a particularly significant risk for many of the genetically defined diseases for which we plan to develop product candidates because many of these diseases havewith small patient populations, andwhere designing and executing a rigorous clinical trial with appropriate statistical power is more difficult than with diseases that have larger patient populations. TheRegulatory FDAauthorities weighsweigh the benefits of a product against its risks, and the FDA may view the efficacy results in the context of safety as not being supportive of regulatory approval. Any product candidates we develop will be based on a novel technology that makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval. Only one genomegene editing therapeutic product has been approved in the United States or in Europe.

Added

We currently plan to conduct and may in the future conduct clinical trials for our product candidates outside the U.S., and the FDA and comparable foreign regulatory authorities may not accept data from such trials.

Added

We currently plan to conduct and may in the future conduct clinical trials for our product candidates outside the United States. The acceptance of data from clinical trials conducted outside the U.S. or another jurisdiction by the FDA or comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the U.S. or the applicable jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which could be costly and time-consuming, and which may result in product candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction.

Reworded

If we experience delays or difficulties in the enrollment of patients in clinical trials, our ability to conduct clinical trials on a timely basis or at all and receipt of necessary regulatory approvals could be delayed or prevented.

Reworded

We or our collaborators may not be able to initiate or continue clinical trials for any of our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or analogous regulatory authorities outside the United States, or as needed to provide appropriate statistical power for a given trial. In addition, if patients are unwilling to participate in our genomegene editing trials because of negative publicity from adverse events related to the biotechnology, gene therapy, or genomegene editing fields, competitive clinical trials for similar patient populations, clinical trials in competing products, or for other reasons, the timeline for recruiting patients, conducting studies, and obtaining regulatory approval of any product candidates we develop may be delayed. Moreover, some of our competitors may have approved products or ongoing clinical trials for product candidates that would treat the same indications as any product candidates we develop, and patients who would otherwise be eligible for our clinical trials may instead select the approved product or enroll in clinical trials of our competitors’ product candidates.

Reworded

•perceived risks and benefits of genomegene editing as a therapeutic approach;

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Management's Discussion & Analysis (MD&A) (10-K Item 7)

14new paragraphs
16removed paragraphs
53reworded paragraphs
7,258 → 7,421words in section

Removed heading “Comparison of Years Ended December 31, 2023 and 2022”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: impairment, restructuring
“The increase in restructuring and impairment charges for the year ended December 31, 2025 compared to the year ended December 31, 2024 was primarily attributable to reni-cel related contract costs recognized at the contract cease-use-date in 2025, accelerated expense recognized due to changes in useful life estimates for leasehold improvements, software, and a right-of-use asset, and impairment charges related to the sale of certain assets, resulting from the actions associated with the Discontinuation and the Reduction. …”
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Reworded topics: restructuring, workforce reduction

Paragraph as it now reads, with added and removed wording marked:

In December 2024, our board of directors approved the discontinuation of the clinical development of our ex vivo reni-cel program.program (the “Discontinuation”). As part of the discontinuation,Discontinuation, our boardBoard of Directors approved a reduction in our employee workforce by approximately 180 positions, or by approximately 65%.65% (the “Reduction”). Restructuring charges associated with the Discontinuation consist primarily of expenses in connection with the wind-down of various activities related to clinical development of reni-cel, including contract termination costs, impairment charges and non-cash charges, and expenses related to the employee workforce reduction,Reduction, primarily consisting of severance payments and employee benefit costs. WeThe may also incur additional costs not currently contemplated due to events that may occur as a result of or that areactions associated with the discontinuationDiscontinuation and headcountReduction reduction. We estimate that we will incur approximately $45.0 million to $55.0 millioncommenced in cashDecember costs to implement the discontinuation2024 and workforce reduction. We expect restructuring charges to bewere substantially incurredcompleted throughby theDecember end31, of June 2025, when the related activities are expected to be substantially complete.2025.
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New text topics: investigation, regulation
“In September 2025, we announced the nomination of our lead in vivo development candidate, EDIT-401, an experimental, potential best-in-class, one-time therapy to significantly reduce LDL-cholesterol (“LDL-C”) through upregulation of the LDL receptor (“LDLR”). EDIT-401 is designed to treat elevated levels of LDL-C, or hyperlipidemia, by directly editing the noncoding region of the LDLR gene to increase LDLR protein expression and reduce LDL-C levels. …”
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Removed text
“Comparison of Years Ended December 31, 2023 and 2022”
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New text topics: restructuring
“We record liabilities for costs associated with restructuring activities in the period in which the liability is incurred. Typical costs associated with restructuring activities include employee termination benefits, contract termination costs and on-going contract costs for which there is no economic benefit. For costs associated with employee terminations in which the employee is subject to an existing benefit arrangement, the post-employment benefits are recognized when probable and estimable. …”
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Removed text topics: regulation
“We previously demonstrated proof of concept of our functional upregulation strategy in our clinical trials of renizgamglogene autogedtemcel (“reni-cel”), an experimental ex vivo gene-edited medicine to treat sickle cell disease (“SCD”) and transfusion-dependent beta thalassemia (“TDT”). Despite the robust and clinically meaningful improvements observed in these trials, we determined in December 2024 not to pursue commercialization for reni-cel in order to optimize our cost structure and accelerate our intent to achieve in vivo human proof of concept in approximately two years. …”
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Reworded

Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K contains forward-looking statements that involve substantial risks and uncertainties. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “wouldwould,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. There are a number of important risks and uncertainties that could cause our actual results to differ materially from those indicated by forward-looking statements. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentionsintentions, and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Annual Report on Form 10-K, particularly in the section entitled “Risk Factors” in Part I, Item 1A that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make.

Reworded

You should read this Annual Report on Form 10-K and the documents that we have filed as exhibits to this Annual Report on Form 10-K completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this Annual Report on Form 10-K are made as of the date of this Annual Report on Form 10-K,and10-K, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Reworded

We are a pioneering gene editing company dedicated to developing potentially transformative genomic medicines to treat a broad range of serious diseases. We have developed a proprietary gene editing platform based on CRISPR technology and we continue to expand its capabilities. Our product development strategy is to target diseases where gene editing can be used to enable or enhance therapeutic outcomes for patients, while maximizing probability of technical, regulatory and commercial success. We are focused on the development of in vivo gene editing medicines utilizing functional upregulation, which aims to increase the expression and function of a normal gene copy and its normal protein function to treat diseases caused by genetic mutations that eliminate or disrupt normal function. We believe the ability to provide in vivo gene editing, in which the medicine is injected or infused into the patient to edit the cells inside their body, and functionally upregulates normal gene expression and normal protein function in the target tissues holds the potential to significantly expand the addressable therapeutic possibilities of CRISPR-based gene editing. To that end, our preclinical efforts are also focused on the creation of a “plug ‘n play” lipid nanoparticle (“LNP”) platform thatto enablesenable targeted delivery of thein vivo gene editing cargomedicines to multiple cells and tissues, including the liver, hematopoietic stem cells (“HSCs”), the liver and other cells and tissues.

Added

In September 2025, we announced the nomination of our lead in vivo development candidate, EDIT-401, an experimental, potential best-in-class, one-time therapy to significantly reduce LDL-cholesterol (“LDL-C”) through upregulation of the LDL receptor (“LDLR”). EDIT-401 is designed to treat elevated levels of LDL-C, or hyperlipidemia, by directly editing the noncoding region of the LDLR gene to increase LDLR protein expression and reduce LDL-C levels. This targeted approach has demonstrated an approximately 90% mean reduction of LDL-C in non-human primates (“NHPs”) in our preclinical studies with favorable tolerability data, and supports the potential of EDIT-401 to deliver meaningful clinical outcomes for patients underserved by current lipid-lowering therapies. We are on track to submit an investigational new drug application (“IND”) or foreign equivalent to conduct a clinical trial of EDIT-401 in patients with heterozygous familial hypercholesteremia by mid-2026 with the expectation of achieving early human proof-of-concept data for EDIT-401 by the end of 2026. We plan to complete enrolling the dose-finding portion of the first-in-human clinical trial with topline data results available in 2027. We expect to present additional preclinical data for EDIT-401 by mid-2026.

Added

Our discovery and development efforts further include HSCs and other cells and tissues. Building on our experience in our clinical trials of renizgamglogene autogedtemcel (“reni-cel”), we have achieved in vivo preclinical proof-of-concept data of HSC editing in NHPs. In addition, we previously announced in vivo delivery to two additional cell types in humanized mice using our proprietary LNP targeting platform, demonstrating the “plug ‘n play” potential of our proprietary extrahepatic LNP platform. We intend to continue optimizing candidates for our HSC program and exploring other cell types and tissues for development, but plan to focus our resources on the advancement of our lead EDIT-401 program to human proof-of-concept.

Removed

We previously demonstrated proof of concept of our functional upregulation strategy in our clinical trials of renizgamglogene autogedtemcel (“reni-cel”), an experimental ex vivo gene-edited medicine to treat sickle cell disease (“SCD”) and transfusion-dependent beta thalassemia (“TDT”). Despite the robust and clinically meaningful improvements observed in these trials, we determined in December 2024 not to pursue commercialization for reni-cel in order to optimize our cost structure and accelerate our intent to achieve in vivo human proof of concept in approximately two years. However, leveraging our differentiated approach and the insights gained from these trials, we are initially focused on pursuing next generation in vivo gene editing medicines targeting HSCs. In October 2024, we shared our achievement of in vivo preclinical proof of concept of hematopoietic stem and progenitor cell editing and fetal hemoglobin induction in humanized mice engrafted with human HSCs and lacking their own hematopoietic cells using a novel and proprietary targeted lipid nanoparticle (“tLNP”) formulation for non-liver, or extrahepatic, tissue delivery. Building on this achievement, in January 2025, we announced in vivo preclinical proof of concept of editing HSCs in non-human primates, a key step in developing a treatment for SCD and TDT. We are on track to declare a development candidate in HSCs for the in vivo treatment of SCD and TDT in mid-2025.

Removed

Beyond hemoglobinopathies, our discovery and development efforts are focused on in vivo gene editing medicines in liver cells and other cells and tissues. In preclinical studies for an undisclosed liver target, we have achieved an editing level of approximately 65% in non-human primates, near the theoretical maximum liver editing level of 70%, with minimal non-target tissue editing using AsCas12a and a liver targeted lipid nanoparticle (“LNP”). This editing resulted in robust serum biomarker reduction from the baseline of approximately 80%. We further announced in vivo delivery to two additional cell types in humanized mice using our proprietary LNP targeting platform. We are on track to declare a development candidate for an in vivo gene editing medicine in liver cells for an undisclosed indication in mid-2025 and to establish and disclose an extrahepatic, non-HSC target cell type or tissue by the end of 2025. We expect to present further in vivo HSC data and present further in vivo data in one liver indication by the end of 2025.

Reworded

We are pursuing the right combination of gene editing and targeted delivery tools through internal development and the in-licensing of complementary technologies to build our preclinical pipeline and accelerate the achievement of our goal of delivering lifesaving medicines to patients with previously untreatable diseases. Through in-licensing of complementary technologies, we can expand our existing gene editing platform and further drive the development of our in vivo pipeline. This was recently demonstrated with our entry in 2024 into a collaboration and license agreement to access LNPs targeting the liver, whichincluding the LNP we usedare using in our achievementEDIT-401 of in vivo editing of liver cells in non-human primates.program. We also actively seek opportunities to out-license and partner our robust intellectual property portfolio to drive the development of CRISPR-based medicines in therapeutic areas outside of our core focus and to provide non-dilutive capital. For example, in cellular therapy medicines, we are leveraging partnerships to progress engineered cell medicines to treat various cancers, including in our collaboration with Bristol Myers Squibb Company (“BMS”) through its wholly owned subsidiary, Juno Therapeutics, Inc. (“Juno Therapeutics”). This collaboration, which leverages our Cas9 and AsCas12a platform technologies, seeks to advance alpha-beta T-cell experimental medicines for the treatment of solid andtumors, liquid tumors, and autoimmune disease, and has resulted in 14 total programs to date.date, including BMS’ CD19 HD Allo CAR T program for the treatment of autoimmune disease currently in Phase I clinical development.

Reworded

In addition, in December 2023, we and Vertex Pharmaceuticals Incorporated (“Vertex”) entered into a license agreement,agreement (the “Vertex License Agreement”), under which Vertex obtained a non-exclusive license for our Cas9 gene editing technology for ex vivo gene editing medicines targeting the BCL11A gene in the fields of SCD and TDT, including Vertex’s CASGEVYTM (exagamglogene autotemcel). We received a $50.0 million upfront cash payment in the fourth quarter of 2023 and the 2024 annual license fee of $10.0 million in the first quarter of 2024. The licenseVertex agreementLicense Agreement further provides for the payment by Vertex of a potential additional $50.0 million contingent upfront payment and further future fixed and sales-based annual license fees, ranging from $10.0$5.0 million to $40.0 million annually, inclusive of certain sales-based annual license fee increases, through 2034. We are required to pay The Broad Institute, Inc. (“Broad”) and the President and Fellows of Harvard College (“Harvard”) a mid-double-digit percentage of amounts payable to us from Vertex under the licenseVertex agreementLicense Agreement as it relates to Cas9 technology licensed by us from Broad and Harvard. In October 2024, we entered into an agreement (the “DRI Agreement”) with a wholly owned subsidiary of DRI Healthcare Trust (“DRI”) providing for an upfront cash payment by DRI to us of $57.0 millionmillion. in exchange forUnder the acquisitionDRI byAgreement, DRI ofis purchasing up to 100% of certain offuture thefixed and sales-based annual license fees owedthat the Company is entitled to usreceive under the Vertex licenseLicense agreement,Agreement, which fees range from $5.0 million to $40.0 million per yearyear, (inclusiveincluding ofincreases certainbased sales-basedon annualsales. licenseIn feesaddition, thatDRI mayis become due), andpurchasing a mid-double-digit percentage of thea $50.0 million contingent upfront payment,payment inthat eachthe caseCompany aftermay subtractingreceive under the Vertex License Agreement. All amounts owedabove bywill usbe adjusted to exclude payments that the Company owes to Broad and Harvard. WeThe haveCompany has retained rights to ourcertain portions of certain other sales-based annual license fees and the contingent upfront payment that may become due under the licenseVertex agreementLicense with Vertex,Agreement, and the amounts that correspond to our licensor obligations.

Removed

In August 2023, we entered into a license agreement with Vor Biopharma, Inc. (“Vor Bio”), providing Vor Bio a non-exclusive license for the development of ex vivo Cas 9 gene edited HSC therapies for the treatment and/or prevention of hematological malignancies. Under this agreement, we received an upfront payment and will be eligible for future development, regulatory and commercial milestone payments, as well as royalties on medicines utilizing the related intellectual property.

Reworded

Since our inception in September 2013, ourOur operations to date have focused on organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio, assembling our core capabilities in gene editing, seeking to identify potential product candidates, and undertaking preclinical studies and clinical trials. All of our ongoing research programs are still in the preclinical or research stage of development and the risk of failure of all of our research programs is high. We have not generated any revenue from product sales. We have primarily financed our operations through various equity financings, payments received under our research collaboration with BMS through its wholly owned subsidiary Juno Therapeutics,BMS, our former strategic alliance with Allergan Pharmaceuticals International Limited (together with its affiliates, “Allergan”), which was terminated in August 2020, payments received under the DRI Agreement in connection with ourthe licenseVertex agreementLicense with Vertex,Agreement, and payments under the Vertex licenseLicense agreement.Agreement.

Reworded

Since inception, weWe have incurred significant operating losses.losses since inception. Our net losses were $237.1$160.1 million, $153.2 million,million and $220.4$237.1 million for the years ended December 31, 2024, 20232025 and 20222024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $1.5$1.6 billion. We expect to continue to incur significant expenses and operating losses for the foreseeable future. Our net losses may fluctuate significantly from quarter to quarter and from year to year. We anticipate that our expenses will increase substantially as we continue to support preclinical studies and prepare for the clinical development of EDIT-401; commence and conduct clinical trials of EDIT-401; continue our current research programs and our preclinical development activities; seek to identify additional research programs and additional product candidates; initiate preclinical testing and clinical trials for other product candidates we identify and develop; maintain, expand, and protect our intellectual property portfolio, including reimbursing our licensors for such expenses related to the intellectual property that we in-license from such licensors; further develop our genomegene editing platform; and hire additional clinical, quality control, and scientific personnel; and incur additional costs associated with operating as a public company.personnel. We do not expect to be profitable for the year ending December 31, 20252026 or for the foreseeable future.

Reworded

In connection with our collaboration with BMS, we have received an aggregate of $146.5$159.0 million in payments, which have primarily consisted of the initial upfront and amendment payments, development milestone payments andpayments, research funding support.support, and certain opt-in fees. We no longer receive research funding support. During the year ended December 31, 2024,2025, we recognized $18.1$23.2 million of revenue related to our collaboration with BMS of which $6.5$9.7 million was previously deferred revenue. As of December 31, 2024,2025, we had $50.2$40.5 million of deferred revenue related to BMS, all of which $50.2 million is classified as long-term deferred revenue on our consolidated balance sheet. Under this collaboration, we will recognize revenue upon delivery of option packages to BMS or whenupon milestonesreceipt areof achieved.development Asmilestone such,payments. weWe expect that our revenue will fluctuate from quarter-to-quarter and year-to-year as a result of the timing of when thesewe eventsdeliver occur.such option packages or receive such milestone payments.

Reworded

Pursuant to the licenseVertex agreementLicense with Vertex,Agreement, we received a $50.0 million upfront cash payment in the fourth quarter of 2023 upon execution of the agreement and the 2024 and 2025 annual license feefees of $10.0 million in each of the first quarterquarters of 2024.2024 and 2025. The license agreement further provides for the payment by Vertex of a potential additional $50.0 million contingent upfront payment and further future fixed and sales-based annual license fees, ranging from $10.0$5.0 million to $40.0 million annually, inclusive of certain sales-based annual license fee increases, through 2034. For the year ended, December 31, 2024,2025, we have recorded $10.0 million of revenue related to the annual license fee under the agreement.

Reworded

For the foreseeable future we expect substantially all of our revenue will be generated from our license agreements withthe Vertex andLicense VorAgreement, Bio,our collaboration with BMS, and any other collaborations or license agreements we may enter into.

Reworded

Operating Expenses

Added

•costs associated with our continued development of EDIT-401 as we progress EDIT-401 to IND and/or foreign equivalent submission and commence clinical trials;

Removed

•costs incurred under clinical trial agreements with investigative sites for our former reni-cel program;

Reworded

•costs associated with conducting our other preclinical, process and scale-up development, manufacturing, quality, clinical and regulatory activities, including fees paid to third-party professional consultants, service providers and suppliers;

Reworded

•successful initiation of, enrollment in, and completion of, clinical trials;

Reworded

Research and development activities are central to our business model. We expect research and development costsexpenses to increasedecrease significantlyin forfuture periods compared to prior periods, due to the foreseeablediscontinuation future as our development programs progress, including as we continue to support preclinical studies and prepare for theof clinical development of our researchex programs.vivo reni-cel program that contributed significantly to expense in prior periods.

Reworded

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation for personnel in executive, finance, investor relations, business development, legal, corporate affairs, information technology, facilitiesfacilities, and human resource functions. Other significant costs include corporate facility costs not otherwise included in research and development expenses, legal fees related to intellectual property and corporate matters, and fees for accounting and consulting services.

Reworded

We anticipate that our general and administrative expenses will decrease or remain flat in the near future tothat support continued research and development activities.activities will decrease in the near future. We anticipate that expenses associated with operating as a public company, including costs for audit, legal, regulatory, and tax-related services, director and officer insurance premiums, and investor relation costs will remain flat or decrease in the near future. With respect to reimbursement of third-party intellectual property-related expenses specifically, given the ongoing nature of the opposition and interference proceedings involving the patents licensed to us under our license agreement with Broad and Harvard, we anticipate general and administrative expenses associated with reimbursement of third-party intellectual property-related expense will continue to fluctuate as the interference proceedings continue.

Reworded

Restructuring and Impairment Charges

Reworded

In December 2024, our board of directors approved the discontinuation of the clinical development of our ex vivo reni-cel program.program (the “Discontinuation”). As part of the discontinuation,Discontinuation, our boardBoard of Directors approved a reduction in our employee workforce by approximately 180 positions, or by approximately 65%.65% (the “Reduction”). Restructuring charges associated with the Discontinuation consist primarily of expenses in connection with the wind-down of various activities related to clinical development of reni-cel, including contract termination costs, impairment charges and non-cash charges, and expenses related to the employee workforce reduction,Reduction, primarily consisting of severance payments and employee benefit costs. WeThe may also incur additional costs not currently contemplated due to events that may occur as a result of or that areactions associated with the discontinuationDiscontinuation and headcountReduction reduction. We estimate that we will incur approximately $45.0 million to $55.0 millioncommenced in cashDecember costs to implement the discontinuation2024 and workforce reduction. We expect restructuring charges to bewere substantially incurredcompleted throughby theDecember end31, of June 2025, when the related activities are expected to be substantially complete.2025.

Reworded

For the yearsyear ended December 31, 2024, and 2023,2025, other income (expense), net consisted primarily of changesinterest inincome on cash and cash equivalents and marketable securities as well as interest expense accretion related to the liability for the sale of future revenues. For the year ended December 31, 2024, other income (expense), net was primarily attributable to interest income and accretion of discounts associated with other marketable securities.

Reworded

While our significant accounting policies are described in more detail in the notes to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following accounting policies used in the preparation of our consolidated financial statements requiresrequire the most significant judgments and estimates.

Reworded

We recognize revenue in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”), Topic 606, Revenue Recognition (“ASC 606”). Accordingly, we recognize revenue following the five step model prescribed under Accounting Standards Updates No. 2014-09, Revenue from Contracts with Customers: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) we satisfy the performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations, and whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract and use judgementjudgment in the determination of the transaction price and the application of the constraint. The determination of standalone selling price has not had a significant impact on the accounting for our revenue arrangements given the nature of the performance obligations. We have also not been required to apply significant judgementjudgment in determining the transaction price given the nature of the variable consideration and the application of the constraint.

Added

Restructuring

Added

We record liabilities for costs associated with restructuring activities in the period in which the liability is incurred. Typical costs associated with restructuring activities include employee termination benefits, contract termination costs and on-going contract costs for which there is no economic benefit. For costs associated with employee terminations in which the employee is subject to an existing benefit arrangement, the post-employment benefits are recognized when probable and estimable. Other employee termination costs are measured and recognized on the communication date, unless there is a required future service period, in which case, the expense is recognized over the service period. Contract termination costs are recognized upon termination of the contract and costs for on-going contracts for which there is no future benefit are recognized at fair value on the cease-use date.

Added

We have made estimates and judgments regarding the amount and timing of our restructuring expense and liability, including current and future period termination benefits and other exit costs to be incurred when related actions take place. Restructuring charges are reflected in our consolidated statements of operations. Actual results may differ from these estimates.

Reworded

Collaboration and other research and development revenues decreasedincreased by $45.8$8.2 million, to $40.5 million for the year ended December 31, 2025, from $32.3 million for the year ended December 31, 2024, from $78.1 million for the year ended December 31, 2023.2024. The decreaseincrease was primarily attributable to recognition of the remaining deferred revenue recognizedupon the conclusion of a collaboration agreement with a strategic partner, as well as recognition of revenue related to a milestone achieved in 20232025 under our license agreementcollaboration with Vertex, which was executed in December 2023.BMS.

Reworded

Research and development expenses increaseddecreased by $21.5$109.2 million, to $90.0 million for the year ended December 31, 2025 from $199.2 million for the year ended December 31, 2024 from $177.7 million for the year ended December 31, 2023.2024. The following table summarizes our research and development expenses for the years ended December 31, 20242025 and December 31, 2023,2024, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Reworded

The increasedecrease in research and development expenses for the year ended December 31, 20242025 compared to the year ended December 31, 20232024 was primarily attributable to:

Reworded

•approximately $25.1$51.2 million in increaseddecreased external research and development expenses primarily relatedresulting tofrom reduced clinical and manufacturing costs relateddue to the progressionDiscontinuation, ofpartially ouroffset former reni-cel program as well asby costs attributable to in vivo research and discovery;

Reworded

•approximately $6.9$24.0 million in increaseddecreased employee related expenses related to increasedreduced headcount associated with the Reduction;

Removed

•approximately $5.0 million in increased facility expenses primarily related to increased rent expense incurred in connection with a lease commencement for manufacturing space in the second quarter of 2024; and

Removed

•approximately $1.9 million in increased other expenses attributable to consulting and external fees to support clinical and quality initiatives.

Removed

These increases were partially offset by the following decreases in research and development expenses:

Reworded

•approximately $16.1$11.5 million in decreased sublicense and license fees related to reduced licensing activity in 20242025 compared to 20232024; and

Reworded

•approximately $1.2$11.1 million in decreased stock-basedfacility compensationexpenses expenseprimarily due primarilyto the end of leases for manufacturing space due to a reduction in the market price of our common stock, resulting in a lower valuation of equity awards granted.Discontinuation;

Added

•approximately $5.8 million in decreased other expenses attributable to professional services to support our reni-cel program due to the Discontinuation; and

Added

•approximately $5.7 million in decreased stock-based compensation expense primarily related to expense in connection with the achievement of certain performance-based vesting milestones for restricted stock units recognized in 2024 for which there was no equivalent expense in 2025, a reduction in the market price of our common stock year-over-year resulting in lower fair value, and a reduction in headcount associated with the Reduction.

Reworded

General and administrative expenses increaseddecreased by approximately $2.3$22.1 million, to $49.9 million for the year ended December 31, 2025 from $72.0 million for the year ended December 31, 2024 from $69.7 million for the year ended December 31, 2023.2024. The following table summarizes our general and administrative expenses for the years ended December 31, 20242025 and December 31, 2023,2024, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Reworded

The increasedecrease in general and administrative expenses for the year ended December 31, 20242025 compared to the year ended December 31, 20232024 was primarily attributable to:

Reworded

•approximately $3.8$8.6 million in increaseddecreased employee related expenses related to increasedreduced headcount associated with the Reduction;

Removed

•approximately $2.8 million in increased stock-based compensation expense due primarily to the vesting of certain restricted stock units upon the achievement of performance-based milestones in 2024, along with an increased headcount;

Removed

•approximately $0.7 million in increased intellectual property and patent related fees for legal activity;

Removed

•approximately $0.3 million in increased facility and other expenses.

Reworded

These increases were partially offset by •approximately $5.3$6.0 million in decreased professional services expenses primarily related to one-timereduced expenseslicensing incurredand strategic business activities in 20232025 relative to support strategic initiatives and business development activities.2024;

Added

•approximately $5.7 million in decreased stock-based compensation expense primarily related to expense in connection with the achievement of certain performance-based vesting milestones for restricted stock units recognized in 2024 for which there was no equivalent expense in 2025, a reduction in the market price of our common stock year-over-year resulting in lower fair value, and a reduction in headcount associated with the Reduction; and

Added

•approximately $4.6 million in decreased facility and other expenses primarily related to the end of a lease.

Added

These decreases were partially offset by approximately $2.8 million in increased intellectual property and patent related fees for legal activity.

Reworded

Restructuring charges wereincreased by approximately $48.4 million, to $60.7 million for the year ended December 31, 2025, from $12.2 million for the year ended December 31, 2024, with no equivalent charges for the year ended December 31, 2023.2024. The following table summarizes our restructuring charges for the years ended December 31, 20242025 and December 31, 2023,2024, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Added

The increase in restructuring and impairment charges for the year ended December 31, 2025 compared to the year ended December 31, 2024 was primarily attributable to reni-cel related contract costs recognized at the contract cease-use-date in 2025, accelerated expense recognized due to changes in useful life estimates for leasehold improvements, software, and a right-of-use asset, and impairment charges related to the sale of certain assets, resulting from the actions associated with the Discontinuation and the Reduction. The increase was partially offset by decreased employee termination benefits due to the settlement of costs accrued as of December 31, 2024 during the year ended December 31, 2025. Refer to Note 17, Restructuring and Impairment Charges, for further information.

Removed

During the year ended December 31, 2024, we recorded $10.5 million and $1.8 million related to employee termination benefits and program-related contract termination costs, respectively, due to the discontinuation of the clinical development of our reni-cel program that we initiated in December 2024 and the related workforce reduction.

Reworded

Total Other Income,Income (Expense), Net

Reworded

For the years ended December 31, 2024,2025, and 2023, total2024, other income,income (expense), net was $0.1 million, which was primarily attributable to interest income and interest accretion related to the liability for the sale of future revenues. For the year ended December 31, 2024, other income (expense), net was $14.1 million and $16.0 million, respectively, which was primarily attributable to interest income and accretion of discounts associated with marketable securities. The decrease wasis attributable to reductionthe interest accretion related to the liability for the sale of future revenues and reductions in investment balancesincome offsetdue byto increaseda marketdecrease rates.in our investments.

Removed

Comparison of Years Ended December 31, 2023 and 2022

Removed

For a discussion of our results of operations for the year ended December 31, 2023 as compared to the year ended December 31, 2022, see Part II, Item 7, “Management's Discussion and Analysis of Financial Condition and Results of Operations” in our annual report on Form 10-K for the year ended December 31, 2023, which was filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 28, 2024.

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Risk Factors (10-Q Part II, Item 1A)

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On September 10, 2020, the PTAB granted Broad’s motion for priority benefit while denying CVC priority benefit to their two earliest provisional patent applications. As a result, Broad entered the priority phase of the interference as “Senior Party” while CVC remained the “Junior Party” for purposes of determining which entity was the first to invent the inventions at issue. On February 28, 2022, the PTAB issued a decision regarding the priority phase of the interference determining that Broad was the first entity to invent the claims at issue. This decision was appealed by CVC and the Broad cross-appealed. On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit (“CAFC”) affirmed-in-part and vacated-in-part the PTAB’s previous decision and remanded it back to the PTAB for further review. On March 26, 2026, the PTAB reaffirmed its previous decision favoring Broad. CVCThis retainsdecision by the rightPTAB tohas appealbeen theappealed PTAB’sby decision to the CAFC.CVC. It is uncertain if CVC will appeal and, if appealed, when or in what manner the CAFC will act on any suchthis appeal.
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Reworded

Certain U.S. patents and a U.S. patent application directed to CRISPR/Cas9 that are co-owned by the Broad Institute and the Massachusetts Institute of Technology (“MIT”), and in some cases Harvard (collectively referred to as “Broad”), and in-licensed by us were involved in a first interference with a U.S. patent application that is co-owned by the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively referred to as “CVC”). An interference is a proceeding in the USPTO before the Patent Trial and Appeal Board of the USPTO (“PTAB”) to determine priority of invention of the subject matter of patent claims filed by different parties. In this first interference, the PTAB made a judgment of no interference-in-fact in favor of the Broad, which was upheld on appeal. This decision was final and bars any further interference between the same parties for claims to the same invention that was considered in the interference. As a result of this decision, the U.S. patents and application that we in-license from the Broad and others were not modified or revoked.

Reworded

On September 10, 2020, the PTAB granted Broad’s motion for priority benefit while denying CVC priority benefit to their two earliest provisional patent applications. As a result, Broad entered the priority phase of the interference as “Senior Party” while CVC remained the “Junior Party” for purposes of determining which entity was the first to invent the inventions at issue. On February 28, 2022, the PTAB issued a decision regarding the priority phase of the interference determining that Broad was the first entity to invent the claims at issue. This decision was appealed by CVC and the Broad cross-appealed. On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit (“CAFC”) affirmed-in-part and vacated-in-part the PTAB’s previous decision and remanded it back to the PTAB for further review. On March 26, 2026, the PTAB reaffirmed its previous decision favoring Broad. CVCThis retainsdecision by the rightPTAB tohas appealbeen theappealed PTAB’sby decision to the CAFC.CVC. It is uncertain if CVC will appeal and, if appealed, when or in what manner the CAFC will act on any suchthis appeal.

Reworded

On December 14, 2020, the PTAB,PTAB declared two new interferences involving a pending U.S. patent application that is owned by ToolGen, Inc. (the “ToolGen application”). One of the two interferences is between the ToolGen application and certain U.S. patents and U.S. patent applications that are co-owned by Broad and in-licensed by us. Most of the Broad U.S. patents and patent applications that are involved in the interference with ToolGen are also part of the second interference with CVC. The other ToolGen interference is between the same ToolGen application and the U.S. patent applications that are co-owned by CVC and involved in the second interference with Broad. The claims in ToolGen’s patent application relate to a mammalian cell with a CRISPR/Cas system comprising a codon optimized nucleic acid encoding a Cas9 polypeptide with a nuclear localization signal and a single-molecule guide RNA that, together, are capable of forming a Cas9/RNA complex that mediates double stranded cleavage of a target nucleic acid sequence. On September 28, 2022, the PTAB suspended both of these interferences. Following the decision on remand by the PTAB in March 2026 in the second interference between Broad and CVC, the suspension in the interference between ToolGen and Broad has been lifted. We cannot predict with any certainty how long this interference proceeding will take. The interference between ToolGen and CVC remains suspended.

Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

43new paragraphs
9removed paragraphs
44reworded paragraphs
7,218 → 8,377words in section

New heading “Comparison of the Six Months ended June 30, 2026 and 2025”

New heading “Collaboration and Other Research and Development Revenues”

New heading “Research and Development Expenses”

New heading “General and Administrative Expenses”

New heading “Restructuring and Impairment Charges”

New heading “Other Income (Expense), Net”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: impairment, restructuring
“Restructuring and Impairment Charges”
see in full comparison
New text topics: impairment, restructuring
“During the six months ended June 30, 2026 we recorded a $1.3 million benefit related to restructuring and impairment compared to a $66.9 million expense for the six months ended June 30, 2025 due to the Discontinuation and the Reduction. The following table summarizes our restructuring charges for the six months ended June 30, 2026 and 2025, together with the changes in those items in dollars (in thousands) and the respective percentages of change:”
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New text topics: labor
“Collaboration and Other Research and Development Revenues”
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Removed text topics: impairment, restructuring
“The restructuring and impairment charges for the three months ended March 31, 2025 were primarily attributable to reni-cel related contract costs, accelerated expense recognized due to changes in useful life estimates for leasehold improvements, software, and a right-of-use asset, and impairment charges related to the sale of certain assets, resulting from the actions associated with the Discontinuation and the Reduction.”
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New text topics: impairment, restructuring
“The restructuring and impairment benefit for the three months ended June 30, 2026 is primarily attributable to favorable adjustments to prior estimated costs for contracts associated with the Discontinuation upon finalization of contract costs.”
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New text topics: impairment, restructuring
“The restructuring and impairment benefit for the six months ended June 30, 2026 is primarily attributable to favorable adjustments to prior estimated costs for contracts associated with the Discontinuation upon finalization of contract costs.”
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Full comparison: every changed paragraph (96)

Green = added, red = removed. Unchanged paragraphs, 1 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements addressing our future operating performance and development timelines that we expect or anticipate will occur in the future, as well as expectations for cash runway, are forward-looking statements. There are a number of important risks and uncertainties that could cause our actual results to differ materially from those indicated by forward-looking statements, including uncertainties inherent in the initiation and completion of pre-clinicalpreclinical studies and clinical development of our product candidates; availability and timing of results from pre-clinicalpreclinical studies; expectations for regulatory approvals to commence and conduct trials or to market products; and availability of fundingcash resources sufficient forto fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements.requirements for the periods anticipated. These and other risks are described in greater detail in the Annual Report under the captions “Risk Factor Summary” and Part I, “Item 1A. Risk Factors,” as updated by our subsequent filings with the SEC. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make.

Added

In September 2025, we announced the nomination of our lead in vivo development candidate, EDIT-401, an experimental, potential best-in-class, one-time therapy to significantly reduce LDL-cholesterol (“LDL-C”) through upregulation of the LDL receptor (“LDLR”). EDIT-401 is designed to treat elevated levels of LDL-C, or hyperlipidemia, by directly editing the noncoding region of the LDLR gene to increase LDLR protein expression and reduce LDL-C levels. In preclinical studies, a single dose of EDIT-401 achieved approximately 90% or greater mean reductions in LDL-C, lipoprotein(a) (Lp(a)), an independent risk factor for atherosclerotic cardiovascular disease (“ASCVD”), and apolipoprotein B (ApoB), a key measure of total plaque-causing cholesterol particles and predictive measure for ASCVD, with rapid and dose-dependent effect, in non-human primates (“NHPs”). LDL-C mean reduction of 90% or greater with a single dose of EDIT-401 in NHPs was durable through approximately six months. In addition, in our preclinical studies, including an ongoing Good Laboratory Practice (GLP) toxicology study in NHPs, a single dose of EDIT-401 of 1.5 mg/kg had no adverse clinical observations, no notable treatment-related liver enzyme elevations, and no liver histopathology findings in non-GLP toxicology.

Added

We continue to progress towards initiating a Phase 1/2 clinical trial of EDIT-401 in patients with Heterozygous Familial Hypercholesterolemia (“HeFH”). We have made a submission to the Human Research Ethics Committee in Australia for the trial and are on track to submit a Clinical Trial Notification in August 2026. The Phase 1/2 clinical trial will evaluate the safety, tolerability, and efficacy of a single dose of EDIT-401. The trial is designed in two parts. Part 1 is expected to be a single ascending dose, dose-finding study. Eligible patients will have a clinical diagnosis of HeFH with an elevated LDL-C despite treatment with two or more lipid lowering therapies. We plan to complete enrollment of Part 1 and have topline data results available in 2027. We expect that Part 2 of the trial will be a single-dose randomized, placebo-controlled expansion study, and that if the data from the Phase 1/2 trial warrant advancing EDIT-401, we would advance EDIT-401 into a single, pivotal randomized, placebo-controlled Phase 3 clinical trial in patients with HeFH, with or without existing ASCVD or coronary artery disease. These clinical trial plans are subject to further discussion and alignment with regulatory authorities. We have selected four clinical trial sites across Australia and New Zealand. We expect to report a data update in the first quarter of 2027 and share data from at least three patients in the EDIT-401 Phase 1/2 trial by the end of the third quarter of 2027.

Added

We have also received pre-IND feedback from the U.S. Food and Drug Administration on our nonclinical package, CMC plans, and study design to support an Investigational New Drug Application (“IND”) for EDIT-401, which we believe provides optionality for submitting an IND supportive of our anticipated clinical development strategy.

Removed

In September 2025, we announced the nomination of our lead in vivo development candidate, EDIT-401, an experimental, potential best-in-class, one-time therapy to significantly reduce LDL-cholesterol (“LDL-C”) through upregulation of the LDL receptor (“LDLR”). EDIT-401 is designed to treat elevated levels of LDL-C, or hyperlipidemia, by directly editing the noncoding region of the LDLR gene to increase LDLR protein expression and reduce LDL-C levels. This targeted approach has demonstrated a greater than 90% mean reduction of LDL-C in non-human primates (“NHPs”) in our preclinical studies with favorable tolerability data, and supports the potential of EDIT-401 to deliver meaningful clinical outcomes for patients underserved by current lipid-lowering therapies. We continue to advance our preclinical studies for EDIT-401, including the Good Laboratory Practice (GLP) toxicology study in NHPs to support advancement into a first-in-human clinical trial. We are preparing to initiate a first-in-human clinical trial of EDIT-401 in patients with heterozygous familial hypercholesterolemia later this year, and expect to have early human proof-of-concept data for EDIT-401 by the end of 2026. We plan to complete enrolling the dose-finding portion of the first-in-human clinical trial of EDIT-401 with topline data results available in 2027. We expect to present new EDIT-401 preclinical data at upcoming scientific meetings, including data showing significant reductions in NHPs in lipoprotein(a) and apolipoprotein B, both independent risk factors for atherosclerotic cardiovascular disease.

Reworded

Our discovery and development efforts further include HSCs and other cells and tissues. Building on our experience in our clinical trials of renizgamglogene autogedtemcel (“reni-cel”), we have achieved in vivo preclinical proof-of-concept data of HSC editing in NHPs. In addition, we previously announced in vivo delivery to two additional cell types in humanized mice using our proprietary LNP targeting platform, demonstrating the “plug ‘n play” potential of our proprietary extrahepatic LNP platform. We intend to continue optimizing candidates for our HSC program and exploring other cell types and tissues for development, but planare to focusfocusing our resources on the advancement of our lead EDIT-401 program to human proof-of-concept.program.

Reworded

We are pursuing the right combination of gene editing and targeted delivery tools through internal development and the in-licensing of complementary technologies to build our preclinical pipeline and accelerate the achievement of our goal of delivering lifesaving medicines to patients with previously untreatable diseases. Through in-licensing of complementary technologies, we can expand our existing gene editing platform and further drive the development of our in vivo pipeline. This was demonstrated with our entry in 2024 into a collaboration and license agreement to access LNPs targeting the liver, including the LNP we are using in our EDIT-401 program. We also actively seek opportunities to out-license and partner our robust intellectual property portfolio to drive the development of CRISPR-based medicines in therapeutic areas outside of our core focus and to provide non-dilutive capital. For example, we are leveraging partnerships to progress engineered cell medicines to treat various cancers, including in our collaboration with Bristol MyersBristol-Myers Squibb Company (“BMS”) through its wholly owned subsidiary, Juno Therapeutics, Inc. (“Juno Therapeutics”). This collaboration, which leverages our Cas9 and AsCas12a platform technologies, seeks to advance alpha-beta T-cell experimental medicines for the treatment of solid tumors, liquid tumors, and autoimmune disease, and has resulted in 14 total programs to date, including BMS’ CD19 HD Allo CAR T program for the treatment of autoimmune disease currently in Phase I clinical development. The term for BMS to opt-in to additional research programs expires in November 2026, but our collaboration with respect to those ongoing programs that have been selected will continue past that date.

Reworded

In addition, in December 2023, we and Vertex PharmaceuticalsPharmaceuticals, IncorporatedInc. (“Vertex”) entered into a license agreement (the “Vertex License Agreement”), under which Vertex obtained a non-exclusive license for our Cas9 gene editing technology for ex vivo gene editing medicines targeting the BCL11A gene in the fields of SCD and TDT, including Vertex’s CASGEVYTM (exagamglogene autotemcel). We received a $50.0 million upfront cash payment in the fourth quarter of 2023 and the 2024 annual license fee of $10.0 million in the first quarter of 2024. The Vertex License Agreement further provides for the payment by Vertex of a potential additional $50.0 million contingent upfront payment and further future fixed and sales-based annual license fees, ranging from $5.0 million to $40.0 million annually, inclusive of certain sales-based annual license fee increases, through 2034. We are required to pay The Broad Institute, Inc. (“Broad”) and the President and Fellows of Harvard College (“Harvard”) a mid-double-digit percentage of amounts payable to us from Vertex under the Vertex License Agreement as it relates to Cas9 technology licensed by us from Broad and Harvard (the “Cas9-I License Agreement”). In October 2024, we entered into an agreement (the “DRI Agreement”) with a wholly owned subsidiary of DRI Healthcare Trust (“DRI”) providing for an upfront cash payment by DRI to us of $57.0 million. Under the DRI Agreement, DRI is purchasing up to 100% of certain future fixed and sales-based annual license fees that thewe Company isare entitled to receive under the Vertex License Agreement, which fees range from $5.0 million to $40.0 million per year, including increases based on sales. In addition, DRI is purchasing a mid-double-digit percentage of a $50.0 million contingent upfront payment that we may receive under the Vertex License Agreement. All amounts above will be adjusted to exclude payments that we owe under the Cas9-I License Agreement. We have retained rights to certain portions of certain other sales-based annual license fees and the contingent upfront payment that may become due under the Vertex License Agreement, and the amounts that correspond to our licensor obligations.

Reworded

We have incurred significant operating losses since inception. Our net losses were $25.0$43.2 million and $76.1$129.3 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $1.7 billion. We expect to continue to incur significant expenses and operating losses for the foreseeable future. Our net losses may fluctuate significantly from quarter to quarter and from year to year. We anticipate that our expenses will increase as we continue to support preclinical studies and prepare for the clinical development of EDIT-401; commence and conduct our planned clinical trials of EDIT-401; continue our current research programs and our preclinical development activities; seek to identify additional research programs and additional product candidates; initiate preclinical testing for other product candidates we identify and develop; maintain, expand, and protect our intellectual property portfolio, including reimbursing our licensors for such expenses related to the intellectual property that we in-license from such licensors; further develop our gene editing platform; and hire personnel. We do not expect to be profitable for the year ending December 31, 2026 or for the foreseeable future.

Reworded

In connection with our collaboration with BMS, we have received an aggregate of $159.0 million in payments, which have primarily consisted of the initial upfront and amendment payments, development milestone payments, research funding support, and certain opt-in fees. We no longer receive research funding support. During the three and six months ended MarchJune 31,30, 2026,2026 and 2025, we did not recognize any revenue related to our collaboration with BMS. As of MarchJune 31,30, 2026, we had $40.5$32.3 million of deferred revenue related to BMS, all of which is classified as long-termshort-term deferred revenue on our condensed consolidated balance sheet. Under this collaboration, we recognize revenue upon delivery of option packages to BMS or upon receipt of development milestone payments. We expect that our revenue will fluctuate from quarter-to-quarter and year-to-year as a result of the timing of when we deliver such option packages or receive such milestone payments.

Reworded

Pursuant to ourthe licenseVertex agreementLicense with Vertex,Agreement, we received a $50.0 million upfront cash payment in the fourth quarter of 2023 upon execution of the agreement and the 2024, 2025 and 2026 annual license fees of $10.0 million in each of the first quarters of 2024, 2025 and 2026. The license agreement further provides for the payment by Vertex of a potential additional $50.0 million contingent upfront payment and further annual license fees, ranging from $5.0 million to $40.0 million annually, inclusive of certain sales-based annual license fee increases, through 2034.

Reworded

•costs associated with our continued development of EDIT-401 as we progressprepare EDIT-401 to an investigational new drug (“IND”) application and/or foreign equivalent submissionfor and commenceconduct clinical trialsdevelopment of EDIT-401;

Reworded

Research and development activities are central to our business model. We expect research and development expenses to increase in future periods to support our continued development of EDIT-401 preclinical activities and to fund our preclinical studies and clinical trials.

Reworded

Other Income,Income (Expense), Net

Reworded

For the threesix months ended MarchJune 31,30, 2026, other income, net consisted primarily of interest income on cash2026 and cash equivalents as well as interest expense accretion related to the liability for the sale of future revenues. For the three months ended March 31, 2025, other income,income (expense), net consisted primarily of interest income and the amortization of premiums or discounts on marketable securities and interest accretion related to the liability for the sale of future revenues.

Reworded

During the threesix months ended MarchJune 31,30, 2026, we had the following critical accounting policies and estimates as described in Part II, “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates” in the Annual Report.

Reworded

We recognize revenue in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”), Topic 606, Revenue Recognition (“ASC 606”). Accordingly, we recognize revenue following the five stepfive-step model prescribed under Accounting Standards UpdatesUpdate No. 2014-09, Revenue from Contracts with Customers: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) we satisfy the performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations, and whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract and use judgment in the determination of the transaction price and the application of the constraint. The determination of standalone selling price has not had a significant impact on the accounting for our revenue arrangements given the nature of the performance obligations. We have also not been required to apply significant judgment in determining the transaction price given the nature of the variable consideration and the application of the constraint.

Reworded

We record liabilities for costs associated with restructuring activities in the period in which the liability is incurred. Typical costs associated with restructuring activities include employee termination benefits, contract termination costs and on-goingongoing contract costs for which there is no economic benefit. For costs associated with employee terminations in which the employee is subject to an existing benefit arrangement, the post-employment benefits are recognized when probable and estimable. Other employee termination costs are measured and recognized on the communication date, unless there is a required future service period, in which case, the expense is recognized over the service period. Contract termination costs are recognized upon termination of the contract and costs for on-goingongoing contracts for which there is no future benefit are recognized at fair value on the cease-use date.

Reworded

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

Reworded

The following table summarizes our results of operations for the three months ended MarchJune 31,30, 2026 and 2025, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Reworded

Collaboration and other research and development revenues wereincreased $2.8by $8.3 million to $11.9 million for the three months ended MarchJune 31,30, 2026 compared to $4.7$3.6 million for the same period in 2025. The decreaseincrease from the three months ended March 31, 2025 iswas primarily attributable to the recognition of the remaining deferred revenue uponrelated conclusionto the expiration of acertain rights to opt-in to additional research programs under our collaboration agreement with a strategic partner in 2025.BMS.

Reworded

Research and development expenses decreasedincreased by $9.0$4.0 million to $17.6$20.2 million for the three months ended MarchJune 31,30, 2026 compared to $26.6$16.2 million for the same period in 2025. The following table summarizes our research and development expenses for the three months ended MarchJune 31,30, 2026 and 2025, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Reworded

The decreaseincrease in research and development expenses for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025 was primarily attributable to:

Removed

•approximately $5.9 million in decreased employee-related expenses related to reduced headcount associated with the Reduction;

Reworded

•approximately $4.0$4.6 million in decreasedincreased external research and development expenses,expenses primarily resulting from reduced clinical and manufacturing costs duerelated to the Discontinuation, partially offset by costs attributable to in vivoongoing research and discoverypreclinical efforts for EDIT-401;

Removed

•approximately $2.1 million in decreased facility expenses primarily due to the end of leases for manufacturing space due to the Discontinuation; and

Reworded

•approximately $0.4$1.5 million in decreasedincreased stock-basedsublicense compensationand expenses.license fees paid in connection with licensing activity; and

Added

•approximately $1.3 million in increased other expenses to support EDIT-401, including preclinical and regulatory consulting.

Added

These increases were partially offset by:

Added

•approximately $3.2 million in decreased employee-related expenses related to reduced headcount associated with the Reduction;

Added

•approximately $0.2 million in decreased stock-based compensation expenses; and

Added

•approximately $0.1 million in decreased facility expenses.

Removed

These decreases were partially offset by approximately $2.4 million in increased sublicense and license fees related to the achievement of certain milestones under a collaboration agreement in the three months ended March 31, 2026 for which there was no similar activity in the three months ended March 31, 2025 and $1.0 million in increased other expenses.

Reworded

General and administrative expenses decreased by $3.1$1.3 million to $10.2$11.6 million for the three months ended MarchJune 31,30, 2026 compared to $13.4$12.9 million for the three months ended MarchJune 31,30, 2025. The following table summarizes our general and administrative expenses for the three months ended MarchJune 31,30, 2026 and 2025, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Reworded

The decrease in general and administrative expenses for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025 was primarily attributable to:

Removed

•approximately $2.3 million in decreased employee-related expenses related to reduced headcount associated with the Reduction;

Reworded

•approximately $0.5$1.2 million in decreased stock-based compensationemployee-related expenses related to reduced headcount associated with the Reduction; and

Reworded

•approximately $0.4$0.3 million in decreased facilitystock-based and othercompensation expenses.

Reworded

These decreases were partially offset by approximately $0.9$1.3 million in increased intellectual property and patent related legal fees.fees due to increased legal activity related to intellectual property defense and $0.5 million in increased facility and other expenses.

Reworded

During the three months ended MarchJune 31,30, 2026 we recorded noa expense$1.3 million benefit related to restructuring and impairment compared to $40.9$26.1 million for the three months ended MarchJune 31,30, 2025 due to the Discontinuation and the Reduction. The following table summarizes our restructuring charges for the three months ended MarchJune 31,30, 2026 and 2025, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Added

The restructuring and impairment benefit for the three months ended June 30, 2026 is primarily attributable to favorable adjustments to prior estimated costs for contracts associated with the Discontinuation upon finalization of contract costs.

Removed

The restructuring and impairment charges for the three months ended March 31, 2025 were primarily attributable to reni-cel related contract costs, accelerated expense recognized due to changes in useful life estimates for leasehold improvements, software, and a right-of-use asset, and impairment charges related to the sale of certain assets, resulting from the actions associated with the Discontinuation and the Reduction.

Reworded

Other Income,Income (Expense), Net

Reworded

For the three months ended MarchJune 31,30, 2026, and MarchJune 31,30, 2025 other income,income (expense), net was lessa than $0.1$0.3 million net benefit and $0.1a million,$1.7 million net charge, respectively. The decreaseincrease is attributable to reductions inincreased investment income due to aan decreaseincrease in our investments for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025.

Added

Comparison of the Six Months ended June 30, 2026 and 2025

Added

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Added

Collaboration and Other Research and Development Revenues

Added

Collaboration and other research and development revenues increased by $6.5 million to $14.7 million for the six months ended June 30, 2026 compared to $8.2 million for the six months ended June 30, 2025. The increase was primarily attributable to the recognition of deferred revenue related to the expiration of certain rights to opt-in to additional research programs under our collaboration with BMS.

Added

Research and Development Expenses

Added

Research and development expenses decreased by $5.0 million to $37.8 million for the six months ended June 30, 2026 compared to $42.8 million for the six months ended June 30, 2025. The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Added

The decrease in research and development expenses for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was primarily attributable to:

Added

•approximately $9.1 million in decreased employee-related expenses related to reduced headcount associated with the Reduction;

Added

•approximately $2.2 million in decreased facility expenses primarily due to the end of leases for manufacturing space; and

Added

•approximately $0.6 million in decreased stock-based compensation expense.

Added

These decreases were partially offset by:

Added

•approximately $3.9 million in increased sublicense and license fees paid in connection with licensing activity;

Added

•approximately $2.3 million in increased other expenses related to professional services to support the progression of EDIT-401; and

Added

•approximately $0.6 million in increased external research and development expenses.

Added

General and Administrative Expenses

Added

General and administrative expenses decreased by $4.4 million to $21.8 million for the six months ended June 30, 2026 compared to $26.2 million for the six months ended June 30, 2025. The following table summarizes our general and administrative expenses for the six months ended June 30, 2026 and 2025, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Showing the first 60 of 96 changed paragraphs. The complete comparison will be part of Pro (coming soon). Meanwhile you can read the full text in the original filing.

EDIT insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 8 filings (3 insiders, 4 trade dates, 28,467 shares, about $78.8K; 8 of these filings say the sales were made under a Rule 10b5-1 trading plan). Net open-market shares: -28,467 (purchases minus sales); net value about -$78.8K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

Trade dateInsiderTransactionSharesPriceValueOwned afterFiling
2026-09-03Burkly Linda
EVP, CHIEF SCIENTIFIC OFFICER
Open-market sale
10b5-1 plan
709$3.04 $2.2K61,660 SEC
2026-09-03Parison Amy
SVP, Chief Financial Officer
Open-market sale
10b5-1 plan
453$3.04 $1.4K13,839 SEC
2026-09-03O'neill Gilmore Neil
Director, CEO
Open-market sale
10b5-1 plan
5,124$3.04 $15.6K243,189 SEC
2026-08-03Parison Amy
SVP, Chief Financial Officer
Open-market sale
10b5-1 plan
678$2.58 $1.7K14,292 SEC
2026-07-28Burkly Linda
EVP, CHIEF SCIENTIFIC OFFICER
Open-market sale
10b5-1 plan
4,928$2.67 $13.2K62,369 SEC
2026-06-03Parison Amy
SVP, Chief Financial Officer
Open-market sale
10b5-1 plan
464$2.70 $1.3K14,970 SEC
2026-06-03O'neill Gilmore Neil
Director, CEO
Open-market sale
10b5-1 plan
15,380$2.70 $41.5K248,313 SEC
2026-06-03Burkly Linda
EVP, CHIEF SCIENTIFIC OFFICER
Open-market sale
10b5-1 plan
731$2.70 $2.0K67,297 SEC

Well-known investors holding EDIT (13F)

InvestorQuarterSharesReported value% of their 13FChange vs prior quarter
Renaissance Technologies COM2026-06-302,468,919$8.0M0.01%Reduced 38%
D. E. Shaw & Co. COM2026-06-301,901,002$6.2M0.0%Reduced 2%
AQR Capital Management (Cliff Asness) COM2026-06-301,572,242$5.1M0.0%Added 15%
Two Sigma Investments COM2026-06-301,332,976$4.3M0.0%Reduced 14%
Millennium Management (Israel Englander) COM2026-06-30498,997$1.6M0.0%New position
Citadel Advisors (Ken Griffin) COM2026-06-30212,761$689.3K0.0%Reduced 68%
Point72 Asset Management (Steve Cohen) COM2026-06-30125,234$405.8K0.0%Added 7%

13F reports are filed up to 45 days after quarter end and show long U.S. equity positions only; options positions are omitted here.

Coming soon: email alerts when EDIT files, watchlists and downloadable comparisons.