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Item 1A. Risk Factors

2026-03-05 compared with 2025-03-10 · 450 added, 465 removed, 1225 unchanged (43% of the section changed)

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You should carefully consider the following risks and uncertainties, together with all of the other information contained in this Annual Report on Form 10-K, including our financial statements and related notes, before making an investment decision.

The risks described below are not the only ones facing us.

These disclosures reflect our beliefs and opinions as to factors that could materially and adversely affect our company and its securities in the future.

References to past events are provided by way of example only and are not intended to be a complete listing or a representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the future.

Furthermore, the risks described below are not the only ones facing us.

The occurrence of any of the following risks, or of additional risks and uncertainties not presently known to us or that we currently believe to be immaterial, could materially and adversely affect our business, financial condition, results of operations and prospects, and reputation.

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In addition, we have not commercialized any products and have never generated any revenue from product sales.

We have devoted almost all of our financial resources to research and development, including our preclinical development activities.

We expect to continue to incur significant expenses and operating losses over the next several years and for the foreseeable future as we seek to advance product candidates through preclinical development, expand our research and development activities, develop new product candidates, initiate and complete clinical trials, seek regulatory approval and, if we receive approval from the FDA or foreign regulatory authorities, commercialize our products.

Furthermore, the costs of advancing product candidates into each succeeding clinical phase with greater number of patients increase substantially over time and, if we are to advance our CAR-T cell therapy product candidates into pivotal clinical trials, we will incur significant expenses in running large, multicenter trials in the United States and foreign jurisdictions.

We have devoted almost all of our financial resources to research and development, including our preclinical and clinical development activities.

We expect to continue to incur significant expenses and operating losses over the next several years and for the foreseeable future as we seek to advance product candidates through clinical development, and seek regulatory approval and, if we receive approval from the FDA or foreign regulatory authorities, commercialize our products.

Furthermore, the costs of advancing product candidates into each succeeding clinical phase with greater number of patients increase substantially over time and, if we advance vispa-cel into our planned pivotal clinical trial, we will incur significant expenses running a large, multicenter trial in the United States and foreign jurisdictions.

The total costs to advance any of our product candidates to marketing approval in even a single jurisdiction is substantial.

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We anticipate that our expenses will increase substantially if and as we:

• progress our clinical trials for our CAR-T product candidates, particularly as we advance product candidates into succeeding clinical phases;

• continue our current research programs and our preclinical and clinical development of our other current product candidates and any other product candidates we identify and choose to develop;

• hire additional employees;

• seek to identify additional research programs and additional product candidates;

• further develop our genome-editing technologies;

• acquire or in-license intellectual property or new technologies;

• progress our clinical trials for our vispa-cel and CB-011 product candidates, particularly as we advance our vispa-cel product candidate in our planned pivotal clinical trial;

• hire additional employees, as needed;

• acquire or in-license intellectual property, new technologies, and/or additional product candidates;

• expand, maintain, enforce, and defend our intellectual property estate;

• seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical trials, if any;

• establish and expand manufacturing capabilities and supply chain capacity for our product candidates;

• experience any delays, challenges or other issues associated with any of the above, including the failure of clinical trials meeting endpoints, the generation of unanticipated preclinical study results or clinical trial data subject to

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differing interpretations, or the occurrence of potential safety issues or other development or regulatory challenges;

• seek regulatory and marketing approvals for our vispa-cel or CB-011 product candidates if they successfully complete clinical trials;

• expand manufacturing capabilities and supply chain capacity for our vispa-cel and CB-011 product candidates;

• experience any delays, challenges or other issues associated with any of the above, including the failure of clinical trials meeting endpoints, the generation of clinical trial data subject to differing interpretations, or the occurrence of potential safety issues or other development or regulatory challenges;

• make royalty, milestone, or other payments under current, and any future, in-license or assignment agreements;

• establish a sales, marketing, and distribution infrastructure to commercialize any product candidates for which we obtain marketing approval;

• continue to operate as a public company, including defending against securities class action litigation.

• continue to operate as a public company, including defending against any future securities class action litigation.

We are unable to predict the extent of any future losses or when we will become profitable, if at all.

Even if we do become profitable, we may not be able to sustain or increase our profitability on a quarterly or annual basis.

We will need substantial additional financing to develop our product candidates and implement our operating plans.

If we fail to obtain additional financing, we may be delayed or unable to complete the development and commercialization of our product candidates.

We will need substantial additional financing to conduct our planned pivotal clinical trial for vispa-cel and to implement our operating plans.

If we fail to obtain additional financing, we will be unable to complete the development and commercialization of our vispa-cel and/or CB-011 product candidates.

We will continue to need additional capital beyond the proceeds received from our initial public offering (“IPO”), follow-on public financing, at-the-market equity offering program, and other historical sources of proceeds.

We expect to spend a substantial amount of capital in the research, development, and manufacture of our product candidates, particularly as we advance our CAR-T cell therapy product candidates through succeeding clinical phases with greater numbers of patients.

We expect our expenses to increase in connection with our ongoing activities, particularly as we initiate additional clinical trials for, and seek marketing approval of, our product candidates.

Because our allogeneic cell therapy product candidates are based on new technologies, they require extensive development.

The costs to treat patients with our product candidates in clinical trials are significant.

We expect to spend a substantial amount of capital in the clinical development and manufacture of our product candidates, particularly as we advance our CAR-T cell therapy product candidates through succeeding clinical phases with greater numbers of patients.

We currently do not have sufficient funds to conduct our planned pivotal clinical trial for vispa-cel, and we will need to raise additional funds in order to do so.

If we are unable to raise additional financing, we will be unable to initiate our planned pivotal clinical trial for vispa-cel or to develop CB-011 beyond dose expansion.

In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution to the extent that we do not obtain commercialization partners who will bear the costs for such activities.

We may also need to raise additional funds sooner if we choose to pursue additional indications or markets 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.

Because our allogeneic cell therapy product candidates are based on new technologies, they require extensive research and development and have substantial manufacturing costs.

In addition, clinical costs to treat patients with our product candidates, including treatment of any potential side effects that may arise, will be significant.

As of December 31, 2025, we had cash, cash equivalents, and marketable securities of $142.8 million.

We expect our cash, cash equivalents, and marketable securities to be sufficient to fund our current operating plan through at least the next 12 months from the date the consolidated financial statements included in this Annual Report on Form 10-K are issued.

We expect our cash, cash equivalents, and marketable securities to be sufficient to fund our current operating plan through at least the next 12 months from the date our consolidated financial statements included in this Annual Report on Form 10-K are filed.

Our expectation is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.

Our future capital requirements will depend on, and could increase significantly as a result of, many factors, including:

• costs, progress, and results of our product candidate preclinical studies and clinical trials;

• potential delays in our preclinical studies and clinical trials, whether current or planned, due to unforeseen events as well as other factors such as the economic or regulatory environment or pandemics or other public health crises;

• costs, progress, and results of clinical trials for our vispa-cel and CB-011 product candidates;

• potential delays in our clinical trials, whether current or planned, due to unforeseen events as well as other factors such as the economic or regulatory environment or pandemics or other public health crises;

• potential difficulties and delays in receiving regulatory clearances and/or approvals for our product candidates;

• costs and prioritization of our research and development programs as well as costs to acquire or in-license technologies or other product candidates;

• costs to acquire or in-license technologies or other product candidates;

• expansion of our workforce or our facilities;

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• our ability to establish and maintain collaborations on favorable terms;

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• costs of fulfilling our contractual obligations to reimburse certain parties for costs incurred in connection with the prosecution and maintenance of licensed patent rights, including reimbursements owed to The Regents of the University of California;

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• costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our product candidates;

• costs of operating as a public company, including defending against any class action securities litigation.

• costs of operating as a public company, including defending against any future class action securities litigation.

Changing circumstances may cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more money than expected because of circumstances beyond our control.

We may also need to raise additional capital sooner if we choose to expand programs, personnel, and facilities more rapidly than planned.

In any event, we will require additional capital for the further research, development, and commercialization of our product candidates, including potentially establishing our own internal manufacturing capabilities.

Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to research, develop, and commercialize our product candidates.

In any event, we will require additional capital for the further development and commercialization of our product candidates, including potentially establishing our own internal manufacturing capabilities.

Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates.

We cannot be certain that additional funding will be available when needed and on acceptable terms, or at all.

If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay, or discontinue one or more of our product candidate preclinical studies, clinical trials, or development and commercialization, or we may be unable to expand our operations or otherwise capitalize on our business opportunities, as desired.

If we are unable to obtain funding on a timely basis, we may be required to significantly delay initiation, curtail, or discontinue one or more of our product candidate clinical trials, or development and commercialization, or we may be unable to expand our operations or otherwise capitalize on our business opportunities, as desired.

Any of the above could significantly harm our business, financial condition, results of operations, and prospects and cause the price of our common stock to decline.

Raising additional capital may cause dilution to our stockholders, restrict our operations, and/or require us to relinquish rights to our technologies or product candidates.

Until such time, if ever, that we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, and strategic collaboration and licensing arrangements.

Raising additional capital may cause dilution to our stockholders, restrict our operations, and/or require us to relinquish rights to our genome-editing technologies or product candidates.

Until such time, if ever, that we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings (including our at-the-market equity offering program), debt financings, new strategic collaborations, structured or other non-dilutive financings, licensing arrangements, and/or other sources.

The terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our common stock to decline.

Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, licensing or assigning our intellectual property rights, declaring dividends, and possibly other restrictions.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, our existing stockholders’ interests will be diluted, perhaps substantially, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders and new investors could gain rights superior to our existing investors.

We may sell common stock, convertible securities, or other equity securities in one or more transactions at prices and in a manner we determine from time to time and investors may be substantially diluted by those issuances and sales.

Attempting to secure additional financing may also divert our management from our day-to-day activities, which could impair or delay our ability to develop our product candidates.

Furthermore, if, in the future, one or more banks or financial institutions enter receivership or become insolvent in response to financial conditions affecting the banking system or financial markets, our ability to access our existing cash, cash equivalents, and marketable securities may be threatened and could have a material impact on our business and financial condition.

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We may sell common stock, convertible securities, or other equity securities in one or more transactions at prices and in a manner we determine from time to time and existing investors may be substantially diluted by those issuances and sales.

The terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders and new investors could gain rights superior to those of our existing investors.

If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce, or terminate our product development or future commercialization efforts.

Alternatively, we could be required to seek collaborators for our product candidates at an earlier stage than would otherwise be desirable or on terms that are less favorable than might otherwise be available.

Alternatively, we could be required to seek funding for our product candidates through collaborations or structured or other non-dilutive financings at an earlier stage than would otherwise be desirable or on terms that are less favorable than might otherwise be available.

We might need to relinquish or license on unfavorable terms our rights to our product candidates in markets where we otherwise would seek to pursue development and commercialization ourselves, or to license our intellectual property to others who could develop products that will compete with our products.

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Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing cell therapy products.

Our ability to generate product revenue or profits, which we do not expect to occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of our product candidates, which may never occur.

Unless we receive approval from the FDA or other regulatory authorities for our product candidates, we will not have product revenues.

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In addition, our product candidates must be approved for marketing by the FDA before we may commercialize our products in the United States and, if we wish to commercialize our products outside the United States, by foreign regulatory agencies.

Furthermore, we will continue to incur costs associated with operating as a public company, including legal, accounting, insurance, investor relations, and other expenses.

Additionally, the rapidly evolving nature of the genome-editing and cell therapy fields may make it difficult to evaluate our technologies and product candidates as well as to predict our future performance.

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We will encounter risks and difficulties, known and unknown, that are frequently experienced by early-stage companies in rapidly evolving fields.

As we advance our product candidates, we must transition from a company with a research focus to a company capable of supporting clinical development and, if successful, commercial activities.

As we advance our product candidates, we must continue to transition from a company with a research focus to a company capable of supporting clinical development and, if successful, commercial activities.

We may not be successful in such transitions.

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Risks Relating to our Business, Government Regulation, Technology, and Industry

We are early in our product development efforts and it will be many years before we commercialize a product candidate, if ever.

If we are unable to advance our product candidates through clinical trials, obtain regulatory approval, and ultimately commercialize our product candidates, or we experience significant delays in doing so, our business will be materially harmed.

We are early in the development of our cell therapy product candidates and have focused our research and development efforts to date on various CRISPR genome-editing technologies, including our chRDNA genome-editing technology, as well as identifying our initial CAR-T cell product candidates.

Our future success depends heavily on the successful development of our product candidates.

Our ability to generate product revenue, which we do not expect will occur for many years, if ever, will be a result of the successful development and eventual commercialization of our product candidates, which may never occur.

Our product candidates may have expected or unexpected adverse side effects or fail to demonstrate safety and efficacy.

Additionally, our product candidates may have other characteristics that may make them

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impractical or prohibitively expensive for large-scale manufacturing.

Our CAR-T cell therapy product candidates are in clinical development and it will be many years before we commercialize a product candidate, if ever.

If we are unable to advance our product candidates through clinical trials, obtain regulatory approval, and ultimately commercialize our product candidates, or if we experience significant delays in doing so, our business will be materially harmed.

We initially focused our research and development efforts on various CRISPR genome-editing technologies, including our chRDNA genome-editing technology, as well as identifying and developing our CAR-T cell product candidates.

Our future success depends heavily on the successful clinical development of our vispa-cel and CB-011 product candidates.

These product candidates may have expected or unexpected adverse side effects or fail to demonstrate safety and efficacy.

In certain cases, CROs and clinical trial sites may fail to conduct the clinical trials as planned, may fail to comply with applicable requirements, or may deviate from the clinical trial protocols.

Furthermore, our product candidates may not receive regulatory approval or, if they do, they may not be accepted by the medical community or patients or may not be competitive with other products that become available.

Furthermore, our vispa-cel and/or CB-011 product candidates may not receive regulatory approval or, if they do, they may not be accepted by the medical community or patients or may not be competitive with other products that become available.

We currently have no product revenue and we may never be able to successfully develop or commercialize a marketable product.

We must submit IND applications to the FDA to initiate clinical trials in the United States.

The filing of future IND applications for our product candidates is subject to additional preclinical research, research-scale and clinical-scale manufacturing, exploration of possible other genome-editing systems, evaluation of potential targets, and other factors yet to be identified.

In addition, commencing any new clinical trial is subject to review by the FDA based on the acceptability and sufficiency of our CMC, and preclinical information provided to support our IND applications.

If the FDA or foreign regulatory authorities require us to complete additional preclinical studies or we are required to satisfy other requests for additional data or information, our clinical trials may be delayed.

We must submit an IND application to the FDA to initiate clinical trials in the United States.

The filing of any future INDs for product candidates we may develop will be subject to nonclinical research, research-scale and clinical-scale manufacturing, exploration of possible other genome-editing systems, evaluation of potential targets, and other factors yet to be identified.

In addition, commencing any new clinical trial is subject to review by the FDA based on the acceptability and sufficiency of our CMC, and nonclinical information provided to support our INDs.

If the FDA or foreign regulatory authorities require us to complete additional nonclinical studies or we are required to satisfy other requests for additional data or information, our clinical trials may be delayed.

Even after we receive and incorporate guidance from the FDA or foreign regulatory authorities, these regulatory authorities could disagree that we have satisfied all requirements to initiate our clinical trials or they may change their position on the acceptability of our trial design or the clinical endpoints selected.

They could impose a clinical hold, which may require us to complete additional preclinical studies or clinical trials.

The FDA and foreign regulatory authorities may refuse to clear our IND applications.

They could impose a clinical hold, which may require us to complete additional nonclinical studies or clinical trials.

The FDA and foreign regulatory authorities may refuse to clear our INDs.

The success of our product candidates will depend on several factors, including the following:

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• ability to develop and deploy armoring technologies so that our product candidates have a competitive edge;

• successful completion of preclinical studies;

• clearance of IND applications to initiate clinical trials;

• successful completion of any additional nonclinical studies;

• clearance of INDs to initiate clinical trials;

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

• data from our clinical trials that support an acceptable risk-benefit profile of our product candidates for our intended patient populations and indications and demonstrate safety and efficacy;

• data from our clinical trials that support an acceptable risk-benefit profile of our product candidates for our intended patient populations and indications and demonstrate acceptable safety and efficacy;

• establishment of agreements with CMOs for clinical and commercial supplies and scaling up of manufacturing processes and capabilities to support our clinical trials;

• successful development of our internal process development and transfer to larger-scale facilities;

• receipt of regulatory and marketing approvals from applicable regulatory authorities as well as receipt of regulatory exclusivity for our product candidates;

• receipt of regulatory and marketing approvals from applicable regulatory authorities as well as receipt of nonpatent regulatory exclusivity for our product candidates;

• establishment, maintenance, enforcement, and defense of patent and trade secret protection and other intellectual property rights;

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• entry into collaborations to further the development of our product candidates or for the development of new product candidates;

• establishment of sales, marketing, and distribution capabilities for commercialization of our product candidates if and when approved, whether by us or in collaboration with third parties;

• establishment of sales, marketing, and distribution capabilities for commercialization of our product candidates if approved, whether by us or in collaboration with third parties;

• identification and establishment of a stable supply chain that permits us to procure the necessary materials for our product candidates;

• legal and regulatory compliance by third parties that provide services to us or on our behalf, including but not limited to CMOs, suppliers, and clinical research organizations (“CROs”), some of which may be subject to regulatory investigations;

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• legal and regulatory compliance by third parties that provide services to us or on our behalf, including but not limited to CMOs, suppliers, and contract research organizations (“CROs”), some of which may be subject to regulatory investigations;

• the ability of CROs and clinical trial sites to conduct our clinical trials;

• maintenance of a continued acceptable safety profile of products post-approval;

• acceptance of product candidates, if and when approved, by patients, the medical community, and third-party payors;

• acceptance of product candidates, if approved, by patients, the medical community, and third-party payors;

• effective competition with other therapies and treatment options, including but not limited to autologous CAR-T cell therapies, small molecules, and antibody treatment;

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• expanding indications and patient populations for our products post-approval.

Our product candidates are cell therapies generated by our novel CRISPR chRDNA genome-editing technologies, which make it difficult to predict the time and cost of developing these product candidates and obtaining regulatory approval.

To date, no other products that use these chRDNA genome-editing technologies have advanced into clinical trials or received marketing approval in the United States.

We are concentrating our initial research, development, and manufacturing efforts on our allogeneic CAR-T cell therapies that are intended to treat patients with certain cancers.

Before obtaining regulatory approval for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex, and expensive preclinical studies and clinical trials that our product candidates are both safe and effective for their intended use.

Our product candidates are cell therapies generated by our novel CRISPR chRDNA genome-editing technology, which makes it difficult to predict the time and cost of developing these product candidates and obtaining regulatory approval.

To date, no other products that use these chRDNA genome-editing technology have advanced into clinical trials or received marketing approval in the United States.

We are concentrating our development and manufacturing efforts on our allogeneic CAR-T cell therapies that are intended to treat patients with certain cancers.

Before obtaining regulatory approval for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex, and expensive nonclinical studies and clinical trials that our product candidates are both safe and effective for their intended use.

The clinical trial requirements of the FDA and other regulatory authorities, and the criteria these regulators use to determine the safety and efficacy of a product candidate, vary substantially according to the type, complexity, novelty, intended use, and target population of our product candidates.

The outcome of preclinical studies and clinical trials is inherently uncertain.

Preclinical results in animals may not be predictive of safety or efficacy in humans.

Failure can occur at any time during the preclinical study and clinical trial processes and because we have never successfully commercialized a product and our first product candidate is in an early stage of clinical development, there is a high risk of failure.

The outcome of nonclinical studies and clinical trials is inherently uncertain.

Nonclinical results in animals may not be predictive of safety or efficacy in humans.

Failure can occur at any time during the nonclinical study and clinical trial processes and because we have never successfully commercialized a product and our first product candidate is in an early stage of clinical development, there is a high risk of failure.

We may never succeed in developing marketable products.

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If significant GvHD or other SAEs are observed with the administration of our product candidates, or if any of our product candidates are viewed as less safe or effective than autologous therapies or other allogeneic therapies, our ability to develop other allogeneic therapies may be adversely affected.

We use our CRISPR chRDNA genome-editing platform to generate our product candidates, and we believe our chRDNA guides significantly improve the specificity of CRISPR genome editing (e.g., by reducing the number of off-target events).

We use our CRISPR chRDNA genome-editing technology to generate our product candidates, and we believe our chRDNA guides significantly improve the specificity of CRISPR genome editing (e.g., by reducing the number of off-target events).

CRISPR genome editing generally is relatively new;

to date, only one cell therapy product using CRISPR-Cas9 genome editing has been approved in the United States although clinical trials of additional product candidates based on CRISPR-Cas9 and other genome-editing technologies are underway.

As a result, the regulatory approval process for cell

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therapy product candidates such as ours is uncertain and may be more expensive and take longer than the approval process for product candidates based on better known or more extensively studied technologies.

As such, it is difficult to accurately predict the developmental challenges we may face as we progress our product candidates through preclinical studies and clinical trials.

There may be long-term adverse effects from treatment with our product candidates resulting from the use of our chRDNA genome-editing technologies that we cannot predict with the knowledge we have today.

Also, animal models may not exist for some of the diseases we choose to pursue in our programs, which may complicate and increase the cost of preclinical research.

As a result of these factors, it is difficult for us to predict the time and cost of our product candidate development, and we cannot predict whether the application of our chRDNA technologies, or other genome-editing technologies we may use in the future, will result in the identification, development, preclinical studies, and clinical trials to support regulatory approval of any of our cell therapy product candidates.

There can be no assurance that any development problems we experience in the future related to our chRDNA technologies or any of our research programs will not cause significant delays or unanticipated costs, or that such development problems can be solved.

As a result, the regulatory approval process for cell therapy product candidates such as ours is uncertain and may be more expensive and take longer than the approval process for product candidates based on better known or more extensively studied technologies.

As such, it is difficult to accurately predict the developmental challenges we may face as we progress our product candidates through clinical trials.

There may be long-term adverse effects from treatment with our product candidates resulting from the use of our chRDNA genome-editing technology that we cannot predict with the knowledge we have today.

Also, animal models may not exist for some of the diseases we choose to pursue in the future, which may complicate and increase the cost of nonclinical research.

As a result of these factors, it is difficult for us to predict the time and cost of our product candidate development, and we cannot predict whether the application of our chRDNA technology, or other genome-editing technologies we may use in the future, will result in the identification, development, nonclinical studies, and clinical trials to support regulatory approval of any future cell therapy product candidates.

We cannot provide any assurance that any development problems we experience in the future related to our chRDNA technology will not cause significant delays or unanticipated costs, or that such development problems can be solved.

We may not achieve the desired safety and efficacy of our product candidates.

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Currently, we have only manufactured our CAR-T cell therapy product candidates for clinical trials.

In addition, since we are in the early stages of clinical development, we do not know the doses to be used in later phase 2 or pivotal phase 3 clinical trials necessary to evaluate the efficacy of our product candidates, which will affect the manufacturing requirements for our product candidates.

Finding a suitable dose, such as a MTD or, as applicable, a RP2D, for our cell therapy product candidates may delay our anticipated clinical development timelines and prolong our clinical trials.

Accordingly, our expectations regarding our costs of manufacturing may vary significantly as we develop our product candidates and understand these critical factors.

Such factors may delay or keep us from bringing a product candidate to market and could decrease our ability to generate sufficient product revenue, which could harm our business, financial condition, results of operations, and prospects.

Manufacturing our product candidates is complex and we could experience manufacturing problems during our clinical trials, which could delay or limit commercialization of our product candidates.

The manufacturing processes used to produce our cell therapy product candidates are and will be complex, as our product candidates are new products.

Manufacturing our product candidates is complex and we could experience manufacturing problems during our clinical trials, which could delay or limit development and/or commercialization of our product candidates.

The manufacturing processes used to produce our cell therapy product candidates are complex, as our product candidates are new biologics.

Several factors could cause production interruptions including facility contaminations;

shortages or quality problems;

contamination of healthy donor cells, chRDNA guides, Cas9 and Cas12a proteins, viruses, iPSC master cell banks or working cell banks;

contamination of healthy donor cells, chRDNA guides, Cas9 and Cas12a proteins, AAV6 viruses, and other materials used in the manufacturing of our product candidates;

natural disasters, including pandemics and other public health crises;

labor shortages and strikes;

lack of experienced scientific, quality control, and manufacturing personnel;

lack or loss of experienced clinical, quality control, process development, and manufacturing personnel;

or other disruptions in the operations of our suppliers and CMOs.

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We may encounter problems achieving adequate quantities and quality of clinical grade materials that meet FDA or other applicable standards or specifications with consistent and acceptable production yields and costs.

As our product candidates proceed through preclinical studies to clinical trials to regulatory review, and potential marketing approval and commercialization, it is common that various aspects of our manufacturing methods will be altered along the way to optimize processes and results.

As our product candidates proceed through clinical trials to regulatory review, and potential marketing approval and commercialization, it is common that various aspects of our manufacturing methods will be altered along the way to optimize processes and results.

Such changes carry the risk that intended objectives will not be achieved.

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Slight deviations in the manufacturing process, including those affecting quality attributes and stability, may result in unacceptable changes in the product that could result in lot failures or product recalls.

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Problems in our manufacturing processes could restrict our ability to meet market demand for our products.

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If we are unable to advance our clinical trials and obtain regulatory approval for, and successfully commercialize, our product candidates for the treatment of patients in approved indications, or if we are substantially delayed in doing so, our business will be materially harmed.

Our business and future success depends on our ability to advance our product candidates through preclinical studies and clinical trials, obtain regulatory approval for, and successfully commercialize, our product candidates.

The failure of our product candidates in clinical trials, or the failure of other companies’ allogeneic anti-CD19 CAR-T and allogeneic anti-BCMA CAR-T cell therapies, including for reasons due to safety, efficacy, or the durability of response, may impede our ability to develop our CAR-T cell therapy programs and product candidates and may significantly influence physicians’ and regulatory authorities’ opinions with regard to the viability of our entire pipeline of allogeneic cell therapies.

In order to submit IND applications for our other product candidates, we will need to complete many objectives, such as our preclinical research of product candidates still in discovery and advancement of cGMP conditions for our product candidates.

If we are unable to achieve any of these objectives, we may not be able to submit other IND applications in a timely manner or at all, which would significantly harm our business.

We may not be successful in our efforts to identify and successfully research and develop additional product candidates and may expend our limited resources to pursue particular product candidates or indications while failing to capitalize on other product candidates or indications that may be more profitable, or for which there is a greater likelihood of commercial success.

Part of our business strategy involves identifying and developing new cell therapy product candidates.

Our business and future success depends on our ability to advance our product candidates through clinical trials, obtain regulatory approval for, and successfully commercialize, our product candidates.

We are not currently researching and developing additional product candidates;

if we choose to do so in the future, we may not be successful in our efforts to identify and successfully research and develop additional product candidates.

In the future, we may choose to identify and develop new product candidates, either internally or through acquisition from, or a partnership with, a third party.

The process by which we identify product candidates may fail to yield successful product candidates for a number of reasons, including:

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We have limited financial and managerial resources.

We are focused initially on allogeneic CAR-T cell therapies and, as a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential.

We are currently focused on two allogeneic CAR-T cell therapy product candidates and, as a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential.

Our resource allocation decisions may cause us to fail to timely capitalize on viable commercial products or profitable market opportunities.

Our spending on current and future product candidates for specific indications may not yield any commercially viable products.

If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing, or other royalty arrangements when it would have been more advantageous for us to retain sole development and commercialization rights to that product candidate.

Our spending on current product candidates may not yield any commercially viable products.

If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing, or structured or other non-dilutive financings when it would have been more advantageous for us to retain sole development and commercialization rights to that product candidate.

In the event that we are unable to continue to fund the clinical development of one or both of our product candidates, and/or if one or both of our clinical-stage product candidates is not clinically successful, does not receive regulatory approval, and/or is not commercially competitive, we currently do not have a research pipeline from which to generate new product candidates.

On July 16, 2024, we announced that we had discontinued preclinical research activities associated with our allogeneic CAR-NK platform and reduced our workforce by 21 positions, or approximately 12% of our workforce, primarily in the research group and, on April 24, 2025, we announced a strategic pipeline prioritization, including reduction of our workforce by 47 positions, or approximately 32% of our workforce, primarily in the preclinical research group.

Additionally, as part of the strategic pipeline prioritization announced in April 2025, we disclosed that we had discontinued our AMpLify phase 1 clinical trial of CB-012.

In the event that we are unable to continue to fund the clinical development of our vispa-cel and/or CB-011 product candidates, and/or one or both of our clinical-stage product candidates are not clinically successful, do not receive regulatory approval, and/or are not commercially competitive, we do not have any product candidates other than vispa-cel and CB-011 to advance into the clinic.

Additionally, we do not currently have a scientific workforce to research and develop such new product candidates, and we would need to either reestablish a preclinical research and development workforce to internally develop additional product candidates or acquire one or more new product candidates from a third party, both of which would be time-consuming and costly.

We cannot provide any assurance that we would be able to research and develop new product candidates, or acquire such new product candidates from a third party.

If we experience delays or difficulties enrolling patients in the clinical trials for our product candidates, our ability to advance our product candidates through clinical development and the regulatory process could be delayed or prevented.

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For our current clinical trials, we have entered into contracts with CROs, as well as clinical trial agreements with the sites participating in our clinical trials.

Patient selection and enrollment may be

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additionally, the protocols for our ongoing clinical trials specifically exclude patients with certain prior treatments as well as other conditions.

Patient selection and enrollment may be challenging;

additionally, the protocols for our clinical trials specifically exclude patients with certain prior treatments as well as other conditions.

Additionally, even after the FDA clears an IND for one of our product candidates, our clinical trials may not commence immediately if we are negotiating clinical trial agreements with clinical sites, conducting site initiation visits, or waiting for the sites to receive IRB approval.

Due to competition from other clinical trials within the same therapeutic area at clinical sites, particularly with autoimmune diseases, sites may drop out or take longer to start up and enroll trials.

Due to competition from other clinical trials within the same therapeutic area at clinical sites, sites may drop out or take longer to start up and enroll trials.

Thus, we may not treat the first patient in a clinical trials for several months, or even for a year, after IND clearance.

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Additionally, since the number of qualified and experienced clinical investigators for therapeutic areas is limited, some of our clinical trial sites may be also conducting clinical trials for some of our competitors, which may reduce the number of patients who are available for our clinical trials at that clinical trial site.

Our allogeneic CAR-T cell therapy product candidates can be administered not only in academic centers of excellence but also in community hospital settings;

however, recruitment of community sites for participation in the trial may be challenging due to hesitancy to adopt a CAR-T cell therapy in a center that has not previously administered this type of therapy or to administer our clinical trial protocol.

Moreover, because our product candidates represent a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy, HSC transplantation, or autologous CAR-T cell therapies, rather than refer patients to our clinical trials.

Because our cell therapy product candidates are edited with CRISPR chRDNA guides, our products may be perceived to have additional or greater safety risks.

Additionally, because our cell therapy product candidates are edited with CRISPR chRDNA guides, our products may be perceived to have additional or greater safety risks.

Patients eligible for allogeneic CAR-T cell therapies but ineligible for autologous CAR-T cell therapies may be difficult to treat due to advanced and aggressive cancers and may fail to experience improved outcomes and be at greater risk for complications and death from our product candidates.

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• interruptions, delays, or staffing shortages resulting from pandemics or other public health crises.

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Enrollment delays in our clinical trials may result in increased development costs for any product candidates we may develop, which may cause our stock price to decline and limit our ability to obtain additional financing.

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• failure to manufacture sufficient quantities of our product candidates for use in our clinical trials;

• failure by CMOs, suppliers, CROs, or clinical trial sites to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

• imposition of a temporary or permanent clinical hold by us, IRBs for the institutions at which such trials are being conducted, or by the FDA or other regulatory authorities for safety or other reasons, such as a result of a new safety finding in a clinical trial on a similar product by one of our competitors, that presents unreasonable risk to clinical trial participants;

• failure by CMOs, suppliers, CROs, or clinical trial sites to comply with regulatory requirements and clinical trial protocols or to meet their contractual obligations to us in a timely manner, or at all;

• imposition of a temporary or permanent partial or full clinical hold by us, IRBs for the institutions at which such trials are being conducted, or by the FDA or other regulatory authorities for safety or other reasons, such as a result of a new safety finding in a clinical trial on a similar product by one of our competitors, that presents unreasonable risk to clinical trial participants;

• changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;

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• clinical trials of our product candidates producing negative or inconclusive results, which may result in our deciding, or regulators requiring us, to conduct additional clinical trials or abandon development of our product candidates;

• inability to establish clinical trial endpoints that applicable regulatory authorities consider clinically meaningful, or, if we seek accelerated approval, that applicable regulatory authorities consider likely to predict clinical benefit;

• regulators withdrawing their approval of a product or imposing restrictions on its distribution;

• interruptions, delays, or staffing shortages resulting from pandemics or other public health crises.

If (i) we are required to extend the duration of any clinical trials or to conduct additional preclinical studies or clinical trials or other testing of our product candidates beyond those that we currently contemplate;

(ii) we are unable to successfully complete preclinical studies or clinical trials of our product candidates or other testing;

(iii) the results of these

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trials, studies, or tests are negative or produce inconclusive results;

If (i) we are required to extend the duration of any clinical trials or to conduct additional nonclinical studies or clinical trials or other testing of our product candidates beyond those that we currently contemplate;

(ii) we are unable to successfully complete additional nonclinical studies or clinical trials of our product candidates or other testing;

(iii) the results of these trials, studies, or tests are negative or produce inconclusive results;

(iv) there are safety concerns;

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• obtain marketing approval for indications or patient populations that are not as broad as we intended or designed;

• obtain marketing approval with labeling that includes significant use restrictions or safety warnings, including black box warnings;

• obtain marketing approval with labeling that includes significant use restrictions or safety warnings, including boxed warnings;

• be subject to additional post-marketing requirements;

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Our clinical trials may fail to adequately demonstrate the safety and efficacy of any of our product candidates and, if this happens, the development of our product candidates may be delayed or unsuccessful, which could prevent or delay regulatory approval and commercialization.

Our product candidates are in various stages of preclinical and clinical development.

Our product candidates are in various stages of clinical development.

If we encounter safety or efficacy problems in our ongoing or future studies, our developmental plans and business could be materially harmed.

Product candidates in later stages of clinical trials may fail to show the desired safety profiles and efficacy results despite having progressed through initial clinical trials.

A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials.

Based upon negative or inconclusive results, we may decide, or regulatory agencies may require us, to conduct additional clinical trials or preclinical studies.

Although we recently incorporated partial HLA matching in our ANTLER and GALLOP phase 1 clinical trials, after a retrospective analysis of all patient data in our ANTLER phase 1 trial demonstrated that patients who received a dose of CB-010 manufactured from a donor with at least four matching HLA alleles with the patient resulted in improved PFS compared to patients who received a single dose of CB-010 from a donor with fewer than four matching HLA alleles, there can be no assurances that partial HLA matching will increase efficacy and/or durability and there may be other donor characteristics that prove to be more relevant.

A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of sufficient efficacy or adverse safety profiles, notwithstanding promising results in earlier trials.

Based upon negative or inconclusive results, we may decide, or regulatory agencies may require us, to conduct additional clinical trials or nonclinical studies.

In addition, data obtained from clinical trials are susceptible to varying interpretations, and regulatory agencies may not interpret our data as favorably as we do, which may delay, limit, or prevent regulatory approval.

In addition, the design of a clinical trial can determine whether its results will support approval of our product candidates, and flaws in the design of a clinical trial may not be apparent until the clinical trial is well advanced.

The design of a clinical trial can determine whether its results will support approval of our product candidates, and flaws in the design of a clinical trial may not be apparent until the clinical trial is well advanced.

We have limited experience designing clinical trials and may be unable to design and execute a clinical trial that will support regulatory approval.

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These data also remain subject to audit and verification procedures that may result in the final data being materially different from the data we previously published.

The information that we choose to disclose publicly regarding preclinical studies or clinical trials is typically a summary of extensive information, and others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities, or otherwise regarding a particular product candidate or our product candidates generally.

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a result, initial, interim, and preliminary data should be viewed with caution until the final data are available.

The information that we choose to disclose publicly regarding nonclinical studies or clinical trials is typically a summary of extensive information, and others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities, or otherwise regarding a particular product candidate or our product candidates generally.

As a result, initial, interim, and preliminary data should be viewed with caution until the final data are available.

Moreover, initial, interim, and preliminary data are subject to the risk that one or more of the clinical outcomes may materially and adversely change as more patient data become available when patients mature on study, dose levels change, patient enrollment continues, or, for final data, as other ongoing or future clinical trials with a product candidate further develop.

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If we are unable to advance our product candidates through clinical trials to seek marketing approval, our business, financial condition, results of operations, and prospects will be materially harmed.

If our product candidates cause serious adverse events or undesirable side effects, including injury and death, or have other properties that could delay or prevent regulatory approval, they would have limited or no commercial potential.

If our product candidates cause serious adverse events or undesirable side effects, including injury and death, or have other properties that could delay or prevent regulatory approval, our product candidates could have limited or no commercial potential.

Product candidates we develop may be associated with undesirable or unacceptable side effects, unexpected characteristics, or other SAEs, including death.

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If any undesirable or unacceptable side effects, unexpected characteristics, or other SAEs occur, our clinical trials could be suspended or terminated, and our business and reputation could suffer substantial harm.

There can be no assurance that we will resolve any adverse event related to any of our products to the satisfaction of the FDA or any regulatory agency in a timely manner or at all.

We cannot provide any assurance that we will resolve any adverse event concerns related to any of our products to the satisfaction of the FDA or any regulatory agency in a timely manner or at all.

If we are unable to demonstrate that such adverse events were caused by factors other than our product candidates, the FDA or other regulatory authorities could order us to cease further clinical trials of, or deny approval of, our product candidates.

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Any of these occurrences may harm our business, financial condition, results of operations, and prospects.

The FDA or other regulatory agencies may disagree with our regulatory plans and we may fail to obtain regulatory approval of our cell therapy product candidates.

If and when each of our phase 1 clinical trials for our CAR-T product candidates is completed and, assuming positive data, we will propose to the FDA that such product candidate advance to a pivotal phase 3 clinical trial.

Although the FDA has found substantial evidence to support approval outside of the traditional phase 1, phase 2, and phase 3 framework for the approved autologous anti-CD19 and anti-BCMA CAR-T cell therapies, the general approach for FDA approval of a new biologic is for the sponsor to provide dispositive data from at least two adequate and well-controlled clinical trials of the relevant biologic in the applicable patient population.

The FDA or other regulatory agencies may disagree with our regulatory plans and we may fail to obtain regulatory approval of our CAR-T cell therapy product candidates.

Although the FDA has found substantial evidence of effectiveness to support approval outside of the traditional phase 1, phase 2, and phase 3 framework for the approved autologous anti-CD19 and anti-BCMA CAR-T cell therapies, the general approach for FDA approval of a new biologic is for the sponsor to provide dispositive data from adequate and well-controlled clinical trials of the relevant biologic in the applicable patient population.

Such clinical trials typically involve hundreds of patients, have significant costs, and take years to complete.

We do not have agreement or guidance from the FDA that our regulatory development plans will be sufficient for submission of a BLA.

In the event that the FDA requires us to conduct clinical trials with more patients than planned or to add additional clinical trials for our product candidates or to compare our product candidates against certain approved therapies, we may not have the funding to enlarge or conduct such trials and we may not be able to raise sufficient funding to do so, which could delay or prevent commercialization of our product candidates.

We are in ongoing engagement with the FDA regarding the design of our pivotal trial for vispa-cel;

however, we cannot provide any assurance that our proposed pivotal trial design will ultimately meet FDA requirements and/or recommendations or lead to regulatory approval.

For example, in the event that the FDA requires us to conduct clinical trials with more patients than planned and/or to conduct clinical trials with designs or endpoints other than those we currently anticipate, we may not have the funding to enlarge or conduct such trials and we may not be able to raise sufficient funding to do so, which could delay or prevent commercialization of our product candidates.

Additionally, the FDA may change its views and/or issue new guidance on aspects of clinical programs, including clinical trial designs, or the ability of trials as designed to support approval of a product candidate.

Furthermore, we may experience changes in FDA personnel that alter the FDA’s advice with respect to the development strategy of our vispa-cel and/or CB-011 product candidate.

Changes in FDA leadership, personnel, policies, priorities, and regulations have affected our industry and may affect our product candidates.

For example, FDA policies and practices concerning cell and gene therapies may change in a way that disparately impacts our product candidates.

Additionally, decreases in FDA staff could lead to increases in newly hired, inexperienced staff with less expertise relevant in our industry and with our product candidates, which may negatively impact the review of our product candidate regulatory submissions and/or approval of our product candidates.

If we are unable to effectively and efficiently resolve and comply with the inquiries and requests of the FDA or other comparable international regulatory authorities, the approval of our product candidates may be delayed, which would impact future commercialization of our product candidates.

In addition, the standard of care may change with the approval of new products in the same indications to which our cell therapy product candidates are directed.

This may result in the FDA or other regulatory authorities requesting additional studies to show that our product candidate is comparable or superior to the new products.

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Our clinical trial results may also not support marketing approval.

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• the approval policies or regulations of the FDA or other regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

Even if we comply with all FDA requests, we may still fail to obtain regulatory approval.

Even if we comply with all FDA requests and requirements, we may still fail to obtain regulatory approval.

We cannot be sure that we will ever obtain regulatory clearance for our product candidates.

Failure to obtain FDA approval of our product candidates will severely undermine our business by leaving us without a commercially marketable product in the United States, and therefore without any source of revenues from product sales in the United States, until another product candidate can be developed or obtained and ultimately approved.

In June 2024, in Loper Bright Enterprises v.

Raimondo , U.S.

Supreme Court overruled the 1984 Chevron USA v.

National Resources Defense Council doctrine, which gave deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, where the law is ambiguous.

This landmark Loper decision may invite various stakeholders to bring lawsuits against the FDA to challenge longstanding decisions and policies of the FDA, including the FDA’s statutory interpretations of market exclusivities and the “substantial evidence” requirements for drug approvals, which could undermine the FDA’s authority, lead to uncertainty in the industry, and disrupt the FDA’s normal operations.

Furthermore, there is substantial uncertainty as to how, if at all, the new Administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates.

Changes at the FDA may hinder the agency’s ability to hire and retain key leadership and other personnel, slow the time necessary for new product candidates to be reviewed and/or approved, or otherwise prevent these agencies from performing normal business functions on which our operations rely, which would adversely affect our business.

There continues to be substantial uncertainty regarding the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates.

We are reliant on regulators having the resources necessary to evaluate and approve our product candidates.

In the United States, a partial federal government shutdown halted the work of many federal agencies and their employees from late December 2018 through late January 2019.

A subsequent extended shutdown or, pursuant to the new Administration’s actions in early 2025 to freeze or reduce the federal workforce, significant reductions of, or disruptions to, staffing and resources available to government agencies could result in reductions or delays of FDA’s activities, including with respect to our ongoing clinical trials, the manufacturing of our product candidates, and regulatory approvals for our product candidates.

Changes at the FDA may slow the time necessary for our product candidates to be reviewed and/or approved, which would adversely affect our business.

For example, starting in January 2025, the current administration has reduced the number of federal employees, including those at the FDA, by establishing voluntary termination programs, position eliminations, or involuntary terminations.

Decreases in FDA staffing could result in delays in the FDA’s responsiveness or in its ability to review submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all.

In the United States, there have been recent federal government shutdowns that halted the work of many federal agencies and their employees.

For example, over the last several years, the U.S.

government has shut down several times, and certain regulatory agencies, such as the FDA, had to furlough critical employees and stop critical activities.

Any extended government shutdown or significant reductions of, or changes to, staffing and resources available to government agencies could result in reductions or delays of FDA’s activities, including with respect to our ongoing clinical trials, the manufacturing of our product candidates, and regulatory review and approvals for our product candidates.

There is currently substantial volatility and uncertainty surrounding the role and activities of federal regulatory agencies and their future, including potential workforce reductions.

Although it is impossible to predict what governmental changes may occur, the impending uncertainty could present new challenges or potential opportunities as we navigate the clinical development and approval process for our product candidates.

Any delay in obtaining, or inability to obtain, applicable regulatory approval would delay or prevent commercialization of our products.

Even if we complete the necessary preclinical studies and clinical trials, the regulatory approval process is expensive, time-consuming, and uncertain, and we may be unable to obtain the regulatory approvals necessary for the commercialization of our product candidates;

furthermore, if there are delays in obtaining regulatory approvals, we

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may not be able to commercialize our products, may lose competitive lead time, and our ability to generate revenues will be materially impaired.

Any delay in obtaining, or inability to obtain, applicable regulatory approvals would delay or prevent commercialization of our products.

Even if we complete the necessary clinical trials, the regulatory approval process is expensive, time-consuming, and uncertain, and we may be unable to obtain the regulatory approvals necessary for the commercialization of our product candidates;

furthermore, if there are delays in obtaining regulatory approvals, we may not be able to commercialize our products, may lose competitive lead time, and our ability to generate revenues will be materially impaired.

The process of obtaining marketing approvals, both in the United States and in other jurisdictions, is expensive, may take many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity, and novelty of the product candidates involved.

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The risk of failure through the development process is high.

Any product candidates we may develop, and the activities associated with their development and commercialization, including their manufacture, preclinical and clinical development, safety, efficacy, recordkeeping, labeling, storage, advertising, promotion, sale, and distribution, are subject to comprehensive regulation by the FDA and other regulatory authorities.

Any product candidates we may develop, and the activities associated with their development and commercialization, including their manufacture, nonclinical and clinical development, safety, efficacy, recordkeeping, labeling, storage, advertising, promotion, sale, and distribution, are subject to comprehensive regulation by the FDA and other regulatory authorities.

Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate in a given jurisdiction.

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We have not previously submitted a BLA to the FDA or made a similar submission to any foreign regulatory authority.

A BLA must include extensive preclinical and clinical data and supporting information to establish our product candidate’s safety and efficacy for each desired indication.

The BLA must also include significant information regarding the chemistry, manufacturing, and controls for our product.

A BLA must include extensive nonclinical and clinical data and supporting information to establish our product candidate’s safety and efficacy for each desired indication.

A BLA must also include significant information regarding the chemistry, manufacturing, and controls for our product.

Any product candidates we develop may not be effective;

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or may prove to have undesirable or unintended side effects, toxicities, or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use.

The FDA and other regulatory authorities have substantial discretion in the approval process and may refuse to accept our BLA applications and decide that our data are insufficient and require additional preclinical studies or clinical trials.

The same may happen with review of our product candidates by foreign regulatory authorities.

In addition, varying interpretations of the data obtained from preclinical studies and clinical trials could delay, limit, or prevent marketing approval of our product candidates.

In addition, varying interpretations of the data obtained from nonclinical studies and clinical trials could delay, limit, or prevent marketing approval of our product candidates.

Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render our approved product not commercially viable.

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We expect the innovative nature of our product candidates to create further challenges in obtaining regulatory approval.

For example, the FDA has limited experience with the development of allogeneic T cell cell therapies for cancer and other diseases.

For example, the FDA has limited experience with the development of allogeneic T cell therapies for cancer and other diseases.

We may also request regulatory approval of future CAR-T cell therapy product candidates by target, regardless of cancer type or origin, which the FDA may have difficulty accepting if our clinical trials have only involved cancers of certain types or origins.

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Although the FDA decides whether individual gene therapy protocols may proceed, review processes and determinations of other reviewing bodies can impede or delay the initiation of a clinical trial, even if the FDA has reviewed the study and cleared its initiation.

Conversely, the FDA can place an IND application on clinical hold even if such other entities have provided a favorable review.

Conversely, the FDA can place an IND on clinical hold even if such other entities have provided a favorable review.

In addition, regulatory agencies, including the FDA, develop and issue guidance documents with which we, in practice, must comply, even if the agencies state that the documents only represent the current thinking of the agencies and are not binding.

These documents may provide

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additional guidance and recommendations regarding the testing, design, development, and manufacturing of cell therapy products.

These documents may provide additional guidance and recommendations regarding the testing, design, development, and manufacturing of cell therapy products.

Failure to comply with such regulatory agency guidance could delay or prevent regulatory approval of our product candidates.

The content of such guidance documents may change in the future, which could add to the cost, time, and resources that are required for completion of our preclinical studies, clinical trials, or regulatory approvals.

There is substantial uncertainty regarding the new Administration’s initiatives and how these might impact the FDA, its implementation of laws, regulations, policies, and guidance, and its personnel.

Similar initiatives may also be directed toward other government agencies.

These initiatives could prevent, limit, or delay development and regulatory approval of our product candidates, which would adversely affect our business.

As a result of efforts under the new Administration, FDA-regulated industries, such as ours, face substantial uncertainty with regard to the regulatory environment we will face as we proceed with research and development, and, if our product candidates receive regulatory approval, during future commercialization.

Some of these efforts have manifested to date in the form of workforce reduction measures that could impact the FDA’s ability to hire and retain key personnel, which could result in delays or limitations on our ability to obtain guidance from the FDA on our product candidates in development and obtain the requisite regulatory approvals in the future.

Moreover, the new Administration has proposed action to freeze or reduce the budget of the National Institutes of Health (“NIH”) related to funding for medical research, which could negatively impact the ability of facilities that rely on NIH funding to enroll and conduct clinical trials or could increase the costs to us of conducting clinical trials on our product candidates.

There remains general uncertainty regarding other government agencies under the new Administration, such as the SEC, USPTO, DOJ, Federal Trade Commission (“FTC”), and Internal Revenue Service (“IRS”), among others.

The new Administration could issue or promulgate executive orders, regulations, policies, or guidance that adversely affect us or create a more challenging or costly environment to conduct business and to pursue the development of our product candidates and research programs.

We could be negatively impacted by future governmental orders, regulations, policies, or guidance of the new Administration, which could have a material adverse effect on us and our business.

Additionally, court challenges to the new Administration’s changes may delay certainty around such executive orders, regulations, policies, guidance, and workforce reductions, and different courts may issue conflicting rulings.

The content of such guidance documents may change in the future, which could add to the cost, time, and resources that are required for completion of additional nonclinical studies, clinical trials, or regulatory approvals.

In June 2024, in Loper Bright Enterprises v.

Raimondo , U.S.

Supreme Court overruled the 1984 Chevron USA v.

This landmark Loper decision may invite various stakeholders to bring lawsuits against the FDA to challenge longstanding decisions and policies of the FDA, including the FDA’s statutory interpretations of market exclusivities and the “substantial evidence” requirements for regulatory approvals, which could undermine the FDA’s authority, lead to uncertainty in the industry, and disrupt the FDA’s normal operations.

There is currently substantial uncertainty regarding governmental agencies, including the implementation of laws, regulations, policies, and guidance, and personnel.

Such uncertainties could adversely affect our business.

Currently, there is general uncertainty regarding many government agencies, such as the SEC, USPTO, DOJ, Federal Trade Commission (“FTC”), and Internal Revenue Service (“IRS”), as well as the FDA.

New executive orders, regulations, policies, or guidance could adversely affect us or create a more challenging or costly environment to conduct business and to pursue the development of our product candidates.

Moreover, recent reductions to the budgets of the National Institutes of Health (“NIH”) for medical research could negatively impact the ability of facilities that rely on NIH funding to enroll and conduct clinical trials or could increase the costs to us of conducting clinical trials on our product candidates.

We could be negatively impacted by future governmental orders, regulations, policies, or guidance, which could have a material adverse effect on us and our business.

Additionally, court challenges to these changes may delay certainty around such executive orders, regulations, policies, guidance, and workforce reductions, and different courts may issue conflicting rulings.

If we are required by the FDA to obtain approval of a companion diagnostic in connection with approval of any of our product candidates, and we do not obtain, or face delays in obtaining, FDA approval of the companion diagnostic, we will not be able to commercialize our product candidates.

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The process of obtaining or developing such a diagnostic is time consuming and costly and we may not be able to either develop such a diagnostic or receive appropriate and timely regulatory approval.

Furthermore, the classification, approval, or clearance of a companion diagnostic as part of the therapeutic product’s further labeling limits the use of the therapeutic product to only those patients who fit the criteria and indications that are reviewed and authorized by FDA.

We may not receive additional priority review, such as RMAT designation, breakthrough therapy designation, or fast track designation, by the FDA for our allogeneic CAR-T cell therapies.

Furthermore, the classification, approval, or clearance of a companion diagnostic as part of the therapeutic product’s further labeling limits the approved use of the therapeutic product to only those patients who fit the criteria and indications that are reviewed and authorized by FDA.

We may not receive additional designations for expedited programs, such as priority review, RMAT designation, breakthrough therapy designation, or fast track designation, by the FDA for our allogeneic CAR-T cell therapies.

We may continue to apply for certain expedited programs in the United States, such as RMAT, breakthrough therapy, fast track, or priority review programs.

The FDA granted RMAT designation for our CB-010 product candidate for r/r LBCL as well as fast track designation for r/r B-NHL and SLE.

Additionally, the FDA granted fast track designation for our CB-011 product candidate in r/r MM and our CB-012 product candidate in r/r AML.

Although obtaining each of these designations has specific and different criteria, they are reserved for therapeutic products that are intended for serious diseases, and each designation offers certain benefits to prioritize the review and approval of such therapeutic option, which may include rolling reviews, intensive guidance, or approval based on surrogate endpoint or an intermediate clinical endpoint that is reasonably likely to predict a drug’s clinical benefit.

However, there is no assurance that we will be able to obtain such designations in the future and, even with expedited designation, we may ultimately fail to obtain FDA’s full approval for our product candidates, or the approved indication may be narrower than the indication covered by the designation.

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We may continue to seek orphan drug designation for our allogeneic CAR-T cell therapy product candidates across various indications, but we may not be able to obtain such designations or to maintain the benefits associated with orphan drug designation, including market exclusivity, which may cause our revenue, if any, to be reduced.

The FDA granted RMAT designation for our vispa-cel product candidate for r/r LBCL as well as fast track designation for r/r B-NHL.

Additionally, the FDA granted fast track designation for our CB-011 product candidate in r/r MM.

Although obtaining each of these designations has specific and different criteria, these designations are reserved for therapeutic products that are intended for serious diseases, and each designation offers certain benefits to expedite the development, review, and potential approval of such therapeutic option, which may include rolling reviews, intensive guidance, or approval based on surrogate endpoint or an intermediate clinical endpoint that is reasonably likely to predict the clinical benefit of a biologic.

However, we cannot provide any assurance that we will be able to obtain such designations in the future and, even with expedited designation, we may ultimately fail to obtain FDA approval for our product candidates on an expedited basis or at all, or the approved indication may be narrower than the indication covered by the designation.

We may continue to seek orphan drug designation for our allogeneic CAR-T cell therapy product candidates across various indications, but we may not be able to obtain such designations or to maintain the benefits associated with orphan drug designation, including potential exclusivity, which may cause our revenue, if any, to be reduced.

We may submit applications to FDA for additional orphan drug designation for our allogeneic CAR-T cell therapy product candidates in specific orphan indications in which there is a medically plausible basis for the use of these products.

Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is intended to treat a rare disease or condition, defined as a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States.

Although we received orphan drug designation from the FDA for our CB-010 product candidate in FL, for our CB-011 product candidate in the treatment of r/r MM, and for our CB-012 product candidate in the treatment of r/r AML, we may not be able to obtain additional designations for other indications or for our other product candidates as the FDA may decline future requests if it determines that our product candidates and the proposed indications do not meet the threshold for the orphan drug designation.

Even if we obtain additional orphan drug designations, we may not be the first company to obtain FDA approval for the orphan drug indication, in which case exclusive marketing rights would not be available to us.

Under the Orphan Drug Act, the FDA may designate a drug or biologic as an orphan drug if it is intended to treat a rare disease or condition, defined as a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug or biologic will be recovered from sales in the United States.

Although we received orphan drug designation from the FDA for our vispa-cel product candidate in FL and for our CB-011 product candidate in the treatment of r/r MM, we may not be able to obtain additional designations for other indications as the FDA may decline future requests if it determines that our product candidates and the proposed indications do not meet the criteria for the orphan drug designation.

Even if we obtain additional orphan drug designations, we may not be the first company to obtain FDA approval of a product for the orphan drug indication, in which case exclusive marketing rights would not be available to us, and approval of our product candidate would be blocked until expiration of the first company’s orphan drug exclusivity for the indication for which we are seeking approval, unless we demonstrate that our product is clinically superior to the licensed product.

In addition, exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective, we are unable to ensure sufficient quantities of the product to meet the needs of patients with the rare disease or condition, or if a subsequent applicant demonstrates clinical superiority over our products.

In addition, there remains some uncertainty regarding the legal and regulatory framework for orphan drug exclusivity.

In September 2021, the U.S.

Court of Appeals for the Eleventh Circuit agreed with a pharmaceutical company’s position that once an orphan drug is approved for a disease or condition, the FDA may not approve another drug for the same disease or condition, even if for different uses or indications that the FDA has not approved.

However, in January 2023, the FDA stated that it will continue to tie the applicability of the orphan drug exclusivity to the specific uses or indications, rather than diseases or conditions, despite the loss.

Thus, any future orphan drug exclusivity may be blocked if another company receives approval before us for an indication for a disease or a condition, even if our orphan drug designation was for a different indication.

Our allogeneic CAR-T cell therapy product candidates will be regulated as biological products, or biologics, and therefore may be subject to uncertainty regarding regulatory exclusivity or maintaining regulatory approval.

Our allogeneic CAR-T cell therapy product candidates will be regulated as biologics, and therefore may be subject to uncertainty regarding nonpatent regulatory exclusivity or maintaining regulatory approval.

Under the BPCIA, the FDA has the authority to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an approved biologic.

An application for a biosimilar product cannot be approved by the FDA until 12 years after the reference product was approved under a BLA.

We believe that our product candidates should qualify for the 12-year period of exclusivity.

However, some uncertainty over interpretation of the law remains, and there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our product candidates to be reference products for competing products, potentially creating the opportunity for biosimilar competition sooner than anticipated.

An application for a biosimilar product cannot be approved by the FDA until 12 years after its reference product was first licensed under a BLA.

We believe that our product candidates, if approved, should qualify for the 12-year period of exclusivity.

However, some uncertainty over interpretation of the law remains, and there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our product candidates eligible for reference product exclusivity, potentially creating the opportunity for biosimilar competition sooner than anticipated.

Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of the reference products in a way that is similar to traditional generic substitution for drug products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

In addition, critics of the 12-year exclusivity period in the biosimilar pathway law may continue to seek to shorten the data exclusivity period and/or to encourage the FDA to interpret narrowly the law’s provisions regarding which new products receive data exclusivity.

Also, the FDA is considering whether subsequent changes to a licensed biologic would be protected by the remainder of the reference product’s original 12-year exclusivity period (a concept known in the generic drug context as “umbrella exclusivity”).

If the FDA were to decide that umbrella exclusivity does not apply to biological reference products or were to make other changes to the exclusivity period, this could expose us to biosimilar competition at an earlier time.

If the FDA or Congress were to make changes to the 12-year exclusivity period, this could expose us to biosimilar competition at an earlier time.

There also have been, and may continue to be, legislative and regulatory efforts to promote competition through policies enabling easier generic and biosimilar approval and commercialization, including efforts to lower standards for demonstrating biosimilarity or interchangeability, eliminate the standard for interchangeability and declare by law that all biosimilars are de facto interchangeable with their reference products, limit patents that may be litigated and/or patent settlements, implement preferential reimbursement policies for biosimilars, and pass new laws requiring more disclosure in the FDA’s Purple Book.

Even if we obtain marketing approvals for our product candidates, the terms of such approvals and ongoing regulation of our products could require substantial expenditure of resources and may limit how we manufacture and market our products, which could materially impair our ability to generate revenues.

Any product candidate for which we obtain marketing approval could be subject to restrictions or withdrawal from the market, and we may be subject to

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substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.

Any product candidate for which we obtain marketing approval could be subject to restrictions or withdrawal from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.

Even if we receive marketing approval for a product candidate, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval or contain requirements for costly post-marketing testing and studies to further assess the safety or efficacy of the product.

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Accordingly, we will need to continue to expend time, money, and effort on regulatory compliance activities.

If we are not able to comply with post-approval regulatory requirements, we could have the marketing approval for our products withdrawn by regulatory authorities and our ability to market any product candidates could be limited, which could adversely affect our ability to achieve or sustain profitability.

If we are not able to comply with post-approval regulatory requirements, we could have the marketing approval for our products withdrawn by regulatory authorities and our ability to market such products could be limited, which could adversely affect our ability to achieve or sustain profitability.

Furthermore, the cost of compliance with post-approval regulations, including REMS, may have a negative effect on our business, financial condition, results of operations, and prospects.

The FDA and other regulatory authorities closely regulate the post-approval marketing and promotion of biologics to ensure that they are marketed only for the approved indications and in accordance with the provisions of the approved labeling.

The FDA and other regulatory authorities impose stringent restrictions on off-label promotion, and if we market our products for unapproved indications, including off-label indications, we may be subject to enforcement action for off-label marketing by the FDA and other federal and state enforcement agencies, including the DOJ.

The FDA and other regulatory authorities impose stringent restrictions on off-label promotion, and if we market our products for unapproved indications, we may be subject to enforcement action for off-label marketing by the FDA and other federal and state enforcement agencies, including the DOJ.

Violation of the FDCA and other statutes, including the federal False Claims Act, relating to the promotion and advertising of prescription products, may also lead to investigations or allegations of violations of federal and state healthcare fraud and abuse laws and state consumer protection laws.

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• product seizure;

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• injunctions or the imposition of civil or criminal penalties.

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We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our product candidates in multiple jurisdictions, which could materially impair our ability to generate revenue.

Following the United Kingdom’s exit from the EU in 2020 (commonly referred to as “Brexit”), the EU and United Kingdom entered into the EU-UK Trade and Cooperation Agreement, which was entered into force permanently on May 1, 2021.

The agreement provides details on how some aspects of the United Kingdom and the EU’s relationship regarding pharmaceutical products will operate;

Following the United Kingdom (“UK”)’s exit from the EU in 2020 (commonly referred to as “Brexit”), the EU and the UK entered into the EU-UK Trade and Cooperation Agreement, which was entered into force permanently on May 1, 2021.

The agreement provides details on how some aspects of the relationship between the UK and the EU regarding pharmaceutical products will operate;

however, there are still many uncertainties.

Since the regulatory framework in the United Kingdom covering pharmaceutical products is derived from EU directives and regulations, Brexit could materially impact the future regulatory requirements for product candidates and products in the United Kingdom as there is now potential for the UK regulations to diverge from the EU regulations.

In the meantime, the Medicines and Healthcare products Regulatory Agency (“MHRA”), the medicines and medical devices regulator in the United Kingdom, has published detailed guidance for industry and organizations to follow as of January 1, 2021, which is updated as necessary.

Since the regulatory framework in the UK covering pharmaceutical products is derived from EU directives and regulations, Brexit could materially impact the future regulatory requirements for product candidates and products in the UK as there is now potential for the UK regulations to diverge from the EU regulations.

In the meantime, the Medicines and Healthcare products Regulatory Agency (“MHRA”), the medicines and medical devices regulator in the UK, has published detailed guidance for industry and organizations to follow as of January 1, 2021, which is updated as necessary.

A number of new marketing authorization routes have been introduced post-Brexit under the UK Human Medicines Regulations 2012 (SI 2012/1916) to allow for quick recognition of products that are approved in the EU and to allow greater flexibility in the UK procedures (such as a “rolling review” that permits the submission of an application in modules).

As of January 1, 2024, the MHRA is applying its new International Recognition Procedure (“IRP”) to medicines approved in other jurisdictions (including by the FDA and EMA) that meet certain criteria to undergo a fast-tracked MHRA review to obtain and/or update a marketing authorization in the UK.

Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of Brexit or otherwise, may force us to restrict or delay efforts to seek regulatory approval in the United Kingdom for our product candidates, which could harm our business.

Since January 1, 2024, the MHRA is applying its new International Recognition Procedure (“IRP”) to medicines approved in other jurisdictions (including by the FDA and EMA) that meet certain criteria to undergo a fast-tracked MHRA review to obtain and/or update a marketing authorization in the UK.

Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of Brexit or otherwise, may force us to restrict or delay efforts to seek regulatory approval in the UK for our product candidates, which could harm our business.

Negative public opinion and increased regulatory scrutiny of genetic research and therapies involving genome editing may damage public perception of our product candidates generated through genome editing or adversely affect our ability to conduct our business or obtain regulatory approvals for our product candidates.

The CRISPR chRDNA genome-editing technologies that we use are novel, and public perception may be influenced by claims that genome editing is unsafe, and therapeutic products generated through genome editing may not gain the acceptance of the public or the medical community.

The CRISPR chRDNA genome-editing technology that we use is novel, and public perception may be influenced by claims that CRISPR genome editing is unsafe, and therapeutic products generated through CRISPR genome editing may not gain the acceptance of the public or the medical community.

In particular, our success will depend upon physicians specializing in our targeted diseases prescribing our product candidates, if approved for marketing, as treatments in lieu of, or in addition to, existing, more familiar treatments for which greater clinical data may be available.

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Increased negative public opinion or more restrictive government regulations, either in the United States or internationally, could have a negative effect on our business or financial condition and may delay or impair the commercialization of our product candidates or demand for such products.

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In particular, genome-editing technology is subject to public debate and heightened regulatory scrutiny due to ethical concerns relating to the potential application of genome-editing technology to human embryos or the human germline.

In particular, CRISPR genome-editing technology is subject to public debate and heightened regulatory scrutiny due to ethical concerns relating to the potential application of genome-editing technology to human embryos or the human germline.

We do not apply genome-editing technologies to human embryos or the human germline.

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Similarly, the NIH has announced that it would not fund any use of genome-editing technologies in human embryos, noting that there are multiple existing legislative and regulatory prohibitions against such work, including the Dickey-Wicker Amendment, which prohibits the use of appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed.

Although we do not use our CRISPR chRDNA genome-editing technologies to edit human embryos or the human germline, such public debate about the use of genome-editing technologies in human embryos and heightened regulatory scrutiny could prevent or delay our development of our product candidates and, if approved, the market acceptance of our products.

Recently, however, the Wall Street Journal reported on at least three companies that are planning to genome edit human embryos, in apparent violation of such prohibitions.

Although we do not use our CRISPR chRDNA genome-editing technology to edit human embryos or the human germline, such public debate about the use of genome-editing technologies in human embryos and heightened regulatory scrutiny could prevent or delay our development of our product candidates and, if approved, the market acceptance of our products.

More restrictive government regulations or negative public opinion would have a negative effect on our business or financial condition.

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• the inability of medical affairs personnel to negotiate arrangements for reimbursement and other acceptance by payors;

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• the inability to price our products at a sufficient price point to ensure an adequate and attractive level of profitability;

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• potential product liability claims.

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If our product candidates are approved but fail to achieve market acceptance among physicians, patients, hospitals, cancer treatment centers, or others in the medical community, we will not be able to generate significant revenue.

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Even if we are able to commercialize our product candidates, such products may be subject to unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives, which could harm our business.

The regulations that govern marketing approvals, pricing, and reimbursement for new biologic products vary widely from country to country.

The regulations that govern marketing approvals, pricing, and reimbursement for new biologics vary widely from country to country.

Some countries require approval of the sale price of a product before it can be marketed.

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Significant uncertainty exists as to the coverage and reimbursement status of any of our products for which we obtain regulatory approval.

In the United States, although private third-party payors tend to follow Medicare practices, no uniform or consistent policy of coverage and reimbursement for drugs and biologics exists among third-party payors.

Therefore, coverage and reimbursement for drugs and biologics can differ significantly from payor to payor as well as from state to state.

Consequently, the coverage determination process is often a time-consuming and costly process that must be played out across many jurisdictions and different entities and that will require us to provide scientific, clinical, and health economics support for the use of our products compared to current alternatives and do so to each payor separately, and we cannot provide any assurance that coverage and adequate reimbursement will be obtained and in what time frame.

Additionally, reimbursement coverage may be more limited than the indications for which our products are approved.

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Third-party payors, whether domestic or foreign, governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs.

In both the United States and certain foreign jurisdictions, there have

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been a number of legislative and regulatory changes to healthcare systems that could impact our ability to sell our product candidates, if approved, profitably.

In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to healthcare systems that could impact our ability to sell our product candidates, if approved, profitably.

There have been, and likely will continue to be, legislative and regulatory proposals at the federal and state levels directed at broadening the availability of, and containing or lowering the cost of, healthcare.

The implementation of cost containment measures that third-party payors and healthcare providers are instituting and any other healthcare reforms may prevent us from being able to generate, or may reduce, our revenues from the sale of our product candidates, if approved, and our product candidates may not be profitable.

Such reforms could have an adverse effect on anticipated revenue from product candidates for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates.

Even if our product candidates are successful in clinical trials and receive marketing approval, we cannot provide any assurances that we will be able to obtain and maintain third-party payor coverage or adequate reimbursement for our product candidates in whole or in part.

Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain approval of and commercialize our product candidates and could adversely affect our business.

The Affordable Care Act and Inflation Reduction Act brought significant changes to the way healthcare is financed by both the government and private insurers, and significantly impacted the U.S.

pharmaceutical industry, including expanding the list of covered entities eligible to participate in the 340B drug pricing program and establishing a new Medicare Part D coverage gap discount program.

We expect that these and other healthcare reform measures in the future, may result in more rigorous coverage criteria and lower reimbursement, and in addition, exert downward pressure on the price that we receive for any approved product.

Any reduction in reimbursement from Medicare or other government-funded programs may result in a similar reduction in payments from private payors.

The implementation of cost containment measures or other healthcare reforms may hinder us in generating revenue, attaining profitability, or commercializing our cell therapy products once, and if, marketing approval is obtained.

In the EU, coverage and reimbursement status of any product candidates for which we obtain regulatory approval are provided for by the national laws of EU member states.

The requirements may differ across the EU member states.

In markets outside the United States and the EU, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings or other price controls on specific products and therapies.

We cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation or administrative action in the United States, the EU, or any other jurisdiction.

If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or those third parties are not able to maintain regulatory compliance, our product candidates may lose any regulatory approval that we may have obtained and we may not achieve or sustain profitability.

Such reforms could have an adverse effect on anticipated revenue from products for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates.

Even if our product candidates are successful in clinical trials and receive marketing approval, we cannot provide any assurance that we will be able to obtain and maintain third-party payor coverage or adequate reimbursement for our products in whole or in part.

Healthcare and other reform measures could hinder or prevent the commercial success of our product candidates, if approved.

Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit, or delay regulatory approval of any future product candidates we may develop, or affect pricing and third-party payment for our product candidates, which could negatively affect our business, financial condition and prospects.

In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs.

For example, in 2010, the ACA was enacted to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for health care and health insurance industries, impose new taxes and fees on the health industry, and impose additional health policy reforms.

Additionally, there has been increasing legislative and enforcement interest in the United States with respect to pharmaceutical pricing practices since the ACA was enacted.

Several healthcare reform initiatives culminated in the enactment of the IRA in 2022, which, among other things, eliminated, beginning in 2025, the coverage gap under Medicare Part D by significantly lowering the enrollee maximum out-of-pocket costs and requiring manufacturers to subsidize, through a newly established manufacturer discount program, 10% of Part D enrollees’ prescription costs for brand drugs below the out-of-pocket limit, and 20% once the out-of-pocket limit has been reached.

The IRA also requires HHS to directly negotiate the selling price of a statutorily specified number of drugs and biologics each year that CMS reimburses under Medicare Part B and Part D.

The negotiated price may not exceed a statutory ceiling price.

Only high-expenditure single-source biologics that have been approved for at least 11 years (seven years for single-source drugs) are eligible to be selected by CMS for negotiation, with the negotiated price taking effect two years after the selection year.

For 2026, the first year in which negotiated prices become effective, CMS selected 10 high-cost Medicare Part D products in 2023, negotiations began in 2024, and the negotiated maximum fair price for each product has been announced.

These negotiations resulted in significant price reductions for the products from their 2023 list prices, ranging from 38% to 79%, with an average price reduction of 59.4%.

In addition, CMS has selected and announced the negotiated maximum fair price for 15 additional Medicare Part D drugs which will become effective in 2027 for negotiated maximum fair pricing in 2027.

For 2028, CMS has selected an additional 15 drugs comprised of drugs covered under Medicare Part D and, for the first time, drugs payable under Medicare Part B.

For 2029 and subsequent years, 20 Part B or D drugs will be selected.

The negotiated prices have represented, and will continue to represent, a significant discount from average prices to wholesalers and direct purchasers.

The IRA also imposes rebates on Medicare Part B and Part D drugs whose prices have increased at a rate greater than the rate of inflation, and in 2024, CMS finalized regulations for the Medicare Part B and Part D inflation rebates.

The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties.

These provisions may be subject to legal challenges.

For example, the provisions related to the negotiation of selling prices of high-expenditure single-source drugs and biologics have been challenged in multiple lawsuits brought by pharmaceutical manufacturers.

Although full economic effect of the IRA on our business and the pharmaceutical industry in general is unknown at this time, it will likely have a significant impact on the pharmaceutical industry and the pricing of our product candidates, if approved.

Similarly, the adoption of restrictive price controls in new jurisdictions, more restrictive controls in existing jurisdictions, or the failure to obtain or maintain timely or adequate pricing could also reduce our profitability.

We expect pricing pressures will continue globally.

The current administration is pursuing policies to reduce regulations and expenditures across government including at HHS, which include the FDA and CMS, and related agencies.

For example, on May 12, 2025, an executive order was issued that, among other things, required HHS, within 30 days, to establish and communicate to drug manufacturers MFN price targets designed to bring drug prices for American patients in line with those in comparably developed nations.

If significant progress towards MFN pricing is not achieved, the executive order requires HHS to propose a rulemaking to implement MFN pricing.

Recently, on December 23, 2025, CMS issued proposed regulations to establish, under the Center for Medicare and Medicaid Innovation, two mandatory MFN demonstration models under Medicare Parts B and D, respectively.

If these rules or other MFN pricing rules are finalized, they are likely to reduce prices of at least some drugs in the United States, if they are also sold in comparator countries.

Even if we do not market our products in such countries, we will be indirectly affected if our products compete with products whose prices were reduced as a result of MFN pricing initiatives.

At the state level, legislatures are increasingly enacting legislation and implementing regulations designed to control pharmaceutical pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

In addition, the FDA issued a final rule in 2020 providing guidance for states to build and submit importation proposals for drugs from Canada, and the FDA authorized the first such plan in Florida in 2024, but implementation of Florida’s plan has been extended until May 6, 2026.

It is unclear how this program will be implemented, including which drugs will be chosen, and whether it will be subject to legal challenges in the United States or Canada.

Other states have also submitted proposals that are pending review by the FDA.

We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our product candidates if approved or additional pricing pressures.

We face significant competition from other biotechnology and pharmaceutical companies, which may result in other companies developing or commercializing products before, or more successfully than, we do, thus rendering our product candidates non-competitive or reducing the size of the market for our product candidates.

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Our potential competitors include major multi-national pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, and universities and other research institutions.

Furthermore, the field of cell and gene therapy faces increasing competition from entities outside of the United States, in particular from China due to a more flexible regulatory environment that facilitates faster translation of ideas to initial human clinical data.

Many of our competitors have substantially greater financial, technical, and other resources, such as larger research and development staffs, established manufacturing capabilities and facilities, clinical trial expertise, and marketing organizations with well-established sales forces.

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Competition may increase further as a result of advances in the commercial applicability of genome editing or other new technologies and greater availability of capital for investment in these industries.

These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient enrollment for participation in clinical trials, as well as in acquiring technologies complementary to, or necessary for, our development programs.

These competitors also compete with us in recruiting and retaining qualified clinical and management personnel and establishing clinical trial sites and patient enrollment for participation in clinical trials, as well as in acquiring technologies complementary to, or necessary for, our development programs.

In addition, due to the intense research and development taking place in the genome-editing field, including by us and our competitors, the intellectual property landscape is in flux and highly competitive.

There may be significant intellectual property-related litigation and proceedings relating to our owned and in-licensed, and other third-party, intellectual property rights in the future.

There may be significant intellectual property-related litigation and proceedings relating to third-party intellectual property rights, as well as to intellectual property owned or controlled by us, in the future.

Our commercial opportunities could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient to administer, have broader acceptance and higher rates of reimbursement by third-party payors, or are less expensive than any product candidates that we may develop.

Our competitors also may

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obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

Delays in the initiation and/or execution of our planned pivotal clinical trial for vispa-cel could result in us entering a more competitive market with vispa-cel, if approved, than what we have anticipated.

Additionally, genome-editing technologies developed by our competitors may render our product candidates uneconomical or obsolete, and we may not be successful in marketing any product candidates we may develop against competitor products.

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Our focus is on the development of cell therapies using our chRDNA genome-editing technology.

Our allogeneic CAR-T cell therapy product candidates face significant competition from multiple companies developing allogeneic cell therapies as well as developing and marketing autologous cell therapies.

Our allogeneic CAR-T cell therapy product candidates face significant competition from multiple companies developing allogeneic cell therapies and bispecific antibody therapies as well as developing and marketing autologous cell therapies.

Autologous T cell therapies directed at CD19 have been commercialized by Novartis AG (Kymriah®), Kite Pharma, Inc., a Gilead Sciences, Inc.

company (Yescarta®, Tecartus®), and Bristol-Myers Squibb Company (Breyanzi®) and are witnessing increased adoption in the marketplace.

Autologous cell therapies directed at BCMA have been commercialized by 2seventy bio, Inc., with their partner Bristol-Myers Squibb Company, (Abecma®) and Legend Biotech Corporation with their partner, Janssen Biotech Inc., a Johnson & Johnson company, (Carvykti®).

Both Abecma and Carvykti cell therapies have succeeded in pivotal trials in earlier lines of r/r MM and are expected to gain label extensions into this market.

There are numerous preclinical- and clinical-stage autologous and allogeneic anti-CD19 and anti-BCMA CAR-T programs and product candidates, some of which will be competitive with our CB-010 and CB-011 product candidates, respectively.

Additionally, other companies are developing allogeneic CAR-T cell therapies for AML.

Allogeneic T cell therapies are being developed by Allogene Therapeutics, Inc., Atara Biotherapeutics, Inc., AvenCell Therapuetics, Inc., Cellectis S.A., Celyad Oncology SA, CRISPR Therapeutics AG, Fate Therapeutics, Inc., Gracell Biotechnologies, an AstraZeneca PLC company, Imugene Limited, Kite Pharma, Inc.( a Gilead Sciences, Inc.

company (Yescarta®, Tecartus®), and Bristol-Myers Squibb Company (Breyanzi®).

Autologous cell therapies directed at BCMA have been commercialized by Bristol-Myers Squibb Company (Abecma®) and Legend Biotech Corporation with their partner Johnson & Johnson (Carvykti®).

There are numerous preclinical- and clinical-stage allogeneic and autologous anti-CD19 and anti-BCMA CAR-T programs and product candidates, some of which will be competitive with our vispa-cel and CB-011 product candidates, respectively.

Companies developing allogeneic T cell therapies include, but are not limited to, Allogene Therapeutics, Inc., Atara Biotherapeutics, Inc., AvenCell Therapuetics, Inc., Cellectis S.A., CRISPR Therapeutics AG, Fate Therapeutics, Inc., Gracell Biotechnologies (an AstraZeneca PLC company), Imugene Limited, Kite Pharma, Inc.

(a Gilead Sciences, Inc.

company), Legend Biotech Corporation, March Biosciences, Inc., F.

Hoffman-La Roche Ltd (through its acquisition of Poseida Therapeutics, Inc.), Sana Biotechnology, Inc., and Vor Biopharma Inc., among others.

Autologous T cell therapies are being developed by a number of additional companies, including but not limited to, 2seventy bio, Inc., Adaptimmune Therapeutics PLC, Alaunos Therapeutics, Inc., Arcellx, Inc., Arsenal Biosciences, Inc., Astellas Pharma Inc.

Autolus Therapeutics plc, AvenCell Therapeutics, Inc., Bristol-Myers Squibb Company, Cabaletta Bio, Inc., CARGO Therapeutics, Inc., Eureka Therapeutics, Inc., Gracell Biotechnologies Inc., (an AstraZeneca PLC company), Iovance Biotherapeutics, Inc., Janssen Biotech, Inc., Kite Pharma, Inc.

Hoffman La-Roche Ltd (through its acquisition of Poseida Therapeutics, Inc.), and Sana Biotechnology, Inc.

Companies developing additional autologous T cell therapies include, but are not limited to, AbelZeta Pharma Inc., Arcellx, Inc., Arsenal Biosciences, Inc., Astellas Pharma Inc., Autolus Therapeutics plc, AvenCell Therapeutics, Inc., Bristol-Myers Squibb Company, Cabaletta Bio, Inc., Eureka Therapeutics, Inc., Gracell Biotechnologies Inc., an AstraZeneca PLC company, Iovance Biotherapeutics, Inc., Johnson & Johnson, Kite Pharma, Inc.

(a Gilead Sciences Inc.

company), Kyverna Therapeutics, Inc., Legend Biotech Corporation, Lyell Immunopharma, Inc., March Biosciences, Inc., Miltenyi Biotec, Mustang Bio, Inc., Novartis AG, Precigen, Inc., Regeneron Pharmaceuticals, Inc.

(through its acquisition of 2seventy bio, Inc.

(through its acquisition of the 2seventy bio, Inc.

research pipeline), F.

Hoffman-La Roche Ltd (through its acquisition of Poseida Therapeutics, Inc.), TCR² Therapeutics Inc., Triumvira Immunologics Inc., TScan Therapeutics, Inc., and Vor Biopharma Inc.

Multiple biotechnology and pharmaceutical companies are developing other directly competitive technologies, such as small molecule, antibody, bi-specific antibody, and antibody-drug conjugates.

Several companies are also exploring the use of CAR-T cell therapies for the treatment of autoimmune diseases, often including against the same targets as in the oncology field (e.g., CD19, BCMA).

Such autoimmune disorders include LN, SLE, pemphigus vulgaris, myasthenia gravis, and multiple sclerosis.

These companies include, but are not limited to, BRL Medicine Inc., Fate Therapeutics, Inc., Kite Pharma, Inc.

(a Gilead Sciences, Inc.

company), Kyverna Therapeutics, Inc., Luminary Therapeutics, Inc., Nkarta, Inc., and Sana Biotechnology, Inc.

in allogeneic cell therapies;

and Atara Biotherapeutics, Inc., Autolus Therapeutics plc, Bristol-Myers Squibb Company, Cabaletta Bio, Inc., Cartesian Therapeutics, Inc., Century Therapeutics, Inc., iCell Gene Therapeutics Inc., JW (Cayman) Therapeutics, Co.

Ltd, Kyverna Therapeutics, Inc., Lyell Immunopharma, Inc., and Novartis AG in autologous cell therapies.

We also face competition from non-cell-based treatments for autoimmune diseases offered by companies such as Amgen Inc., AstraZeneca PLC, Bristol-Myers Squibb Company, F.

Hoffman-La Roche Ltd., GlaxoSmithKline Capital plc, Merck & Co., Inc., and Pfizer Inc.

Although we believe that our scientific expertise, novel technologies, and intellectual property position in genome editing offer competitive advantages, we face competition from multiple other genome-editing technologies and companies.

Other companies developing CRISPR-based technologies include, among others, Arbor Biotechnologies, Inc., Beam Therapeutics Inc., CRISPR Therapeutics AG, Editas Medicine, Inc., Intellia Therapeutics, Inc., Mammoth Biosciences, Inc., Metagenomi, Inc., and Scribe Therapeutics, Inc.

Hoffman-La Roche Ltd (through its acquisition of Poseida Therapeutics, Inc.), TCR² Therapeutics Inc., Triumvira Immunologics Inc., and TScan Therapeutics, Inc.

Additionally, multiple companies are developing other directly competitive technologies, such as small molecules, antibodies, bispecific antibodies, trispecific antibodies, and antibody-drug conjugates, and such companies include, but are not limited to, AbbVie Inc.

(Epkinly®), F.

Hoffman-La Roche Ltd (Columnvi® and Lunsumio®), Johnson & Johnson (Tecvayli® and Talvey®), Pfizer (Elrexfio®), and Regeneron Pharmaceuticals, Inc.

(Lynozyfic®).

Compared to first-generation genome-editing approaches, our chRDNA genome-editing technology has shown improved specificity, a reduction in off-target edits and translocations and, when paired with Cas12a, an advanced capability to perform multiplexed edits, in particular multiplexed insertions.

Although we believe that our novel technologies and intellectual property position offer competitive advantages, we face competition from multiple other genome-editing technologies and companies.

Companies developing other genome-editing technologies include, among others, Allogene Therapeutics, Inc., Cellectis S.A., Precision BioSciences, Inc., Prime Medicine, Inc., Sangamo Therapeutics, Inc., and Wave Life Sciences Ltd.

To become and remain profitable, we must develop and eventually commercialize product candidates with significant market potential, which will require us to be successful in a range of challenging activities.

These activities may include completing preclinical studies and clinical trials of our product candidates;

obtaining marketing and reimbursement

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approval for these product candidates;

To become and remain profitable, we must continue to develop and eventually commercialize product candidates with significant market potential, which will require us to be successful in a range of challenging activities.

These activities include completing clinical trials of our product candidates;

obtaining marketing and reimbursement approval for these product candidates;

manufacturing, marketing, and selling those products that are approved;

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If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.

Our failure to become and remain profitable would decrease the price of our common stock and could impair our ability to raise capital, maintain our research and development efforts, expand our business, or continue our operations.

Our failure to become and remain profitable would decrease the price of our common stock and could impair our ability to raise capital, maintain our development efforts, expand our business, or continue our operations.

A decline in the price of our common stock also could cause stockholders to lose all or part of their investments.

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therefore, if our product candidates receive regulatory approval, our dealings with these prescribers and purchasers will be subject to regulation under the FCPA.

We may engage third parties to sell our product candidates outside the United

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States if we receive regulatory approval in such jurisdictions for our product candidates.

We may engage third parties to sell our product candidates outside the United States if we receive regulatory approval in such jurisdictions for our product candidates.

We may also have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations.

The SEC and the DOJ have increased their FCPA enforcement activities with respect to biotechnology and pharmaceutical companies.

For these reasons, we may be required to expend resources related to training and compliance under FCPA and other anti-corruption laws.

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Some state health information privacy laws carry a private right of action in addition to regulatory enforcement actions that can be brought by state attorneys general.

We cannot assure you that we, our CROs, our clinical trial sites, and our clinical trial principal investigators with access to personally identifiable and other sensitive or confidential information relating to the patients in our clinical trials will not breach contractual obligations, or that we or they will not experience data security breaches or attempts thereof.

We cannot provide any assurance that we, our CROs, our clinical trial sites, and our clinical trial principal investigators with access to personally identifiable and other sensitive or confidential information relating to the patients in our clinical trials will not breach contractual obligations, or that we or they will not experience data security breaches or attempts thereof.

This could have a corresponding effect on our business, including putting us in breach of our obligations under federal and state privacy laws and regulations as discussed above, which could in turn adversely affect our business, financial condition, results of operations, and prospects.

We cannot assure you that our contractual measures and our own privacy and security-related safeguards will protect us from the risks associated with the third-party processing, storage, and transmission of such information.

We cannot provide any assurance that our contractual measures and our own privacy and security-related safeguards will protect us from the risks associated with the third-party processing, storage, and transmission of such information.

Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could subject us to significant fines and penalties, which could have a material adverse effect on our business, financial condition, results of operations, or prospects.

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New laws also are being considered at both the state and federal levels.

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example, the CCPA, which went into effect on January 1, 2020, provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation.

For example, the CCPA, which went into effect on January 1, 2020, provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation.

Many other states are considering similar legislation.

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The GDPR has expanded the definition of personal data to include coded data and requiring changes to informed consent practices and more detailed notices for clinical trial patients and investigators.

In addition, the GDPR also imposes strict rules on the transfer of personal data to countries outside the EU, including the United States and, as a result, increases the scrutiny that clinical trial sites located in the European Economic Area should apply to transfers of personal data from such sites to countries that are considered to lack an adequate level of data protection, such as the United States.

In addition, the GDPR also imposes strict rules on the transfer of personal data to countries outside the EU, including the United States and, as a result, increases the scrutiny that clinical trial sites located in the European Economic Area (“EEA”) should apply to transfers of personal data from such sites to countries that are considered to lack an adequate level of data protection, such as the United States unless such transfer is covered under the EU-US Data Privacy Framework.

The GDPR also permits data protection authorities to require destruction of improperly gathered or used personal information or impose substantial fines for violations of the GDPR, which can be up to 4% of global revenues or €20 million, whichever is greater, and it also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.

In addition, the GDPR provides that EU member states may make their own additional laws and regulations limiting the processing of personal data, including genetic, biometric, or health data.

Furthermore, since the United Kingdom is no longer part of the EU, its data protection regulatory regime will be independent of the EU.

From January 1, 2021, companies have had to comply with the GDPR and also the United Kingdom GDPR (“UK GDPR”), which, together with the amended United Kingdom Data Protection Act 2018, retains the GDPR in UK national law.

The relationship between the United Kingdom and the EU in relation to certain aspects of data protection law remains unclear.

In addition, the longer term economic, legal, political, regulatory, and social framework to be put in place between the United Kingdom and the EU has had, and may continue to have, a material and adverse effect on global economic conditions and the stability of global financial markets and may significantly reduce global market liquidity and restrict the ability of key market participants to operate in certain financial markets.

Furthermore, since the UK is no longer part of the EU, its data protection regulatory regime is independent of the EU.

From January 1, 2021, companies have had to comply with the GDPR and also the UK GDPR (“UK GDPR”), which, together with the amended UK Data Protection Act 2018, retains the GDPR in UK national law.

The relationship between the UK and the EU in relation to certain aspects of data protection law remains unclear.

In June 2021, the European Commission granted the UK an adequacy decision under the GDPR, permitting the free flow of personal data from the EU/EEA into the UK without additional safeguards.

This adequacy decision was renewed in December 2025, although it remains subject to periodic review and could be revoked if the UK’s data protection standards are deemed to have diverged materially from EU standards.

In addition, the longer term economic, legal, political, regulatory, and social framework to be put in place between the UK and the EU has had, and may continue to have, a material and adverse effect on global economic conditions and the stability of global financial markets and may significantly reduce global market liquidity and restrict the ability of key market participants to operate in certain financial markets.

Any of these factors could depress economic activity and restrict our access to capital, which could materially and adversely affect our business, financial condition, and results of operations.

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Our use of artificial intelligence and challenges with properly managing its use could adversely affect our business.

We incorporate certain artificial intelligence (“AI”) solutions into our business, and applications of AI may become more important in our operations over time.

Although we scrutinize the AI platforms we use, there are significant risks involved in deploying AI.

For example, any AI-related efforts, particularly those related to generative AI, could subject us to risks related to harmful content, inaccuracies, bias, discrimination, infringement of third-party intellectual property, or misappropriation, defamation, data privacy, cybersecurity, or sanctions and export controls, among others.

AI’s rapid development is the subject of evolving review by various U.S.

and foreign governmental and regulatory agencies.

The rapid evolution of AI may require us to apply resources to help ensure that AI is implemented in accordance with applicable law and regulation and in a socially responsible manner and to minimize any real or perceived unintended harmful impacts.

Our vendors may in turn incorporate AI tools into their own offerings, and the providers of these AI tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data security.

Further, bad actors around the world use increasingly sophisticated methods, including the use of AI, to engage in illegal activities involving the theft and misuse of confidential information and intellectual property.

Any of these effects could damage our reputation, result in the loss of valuable intellectual property and confidential information, cause us to breach applicable laws and regulations, and adversely impact our business.

Risks Relating to Intellectual Property

If we do not possess the necessary intellectual property rights covering our CRISPR chRDNA genome-editing technologies, our product candidates, or other proprietary technologies, we may not be able to block competitors or to compete effectively in the market.

Our industry is subject to rapid technological change and our success depends in large part on our ability to obtain and maintain intellectual property protection in the United States and other jurisdictions with respect to our CRISPR chRDNA platform technologies and product candidates.

If we do not possess the necessary intellectual property rights covering our CRISPR chRDNA genome-editing technology, our product candidates, or other proprietary technologies, we may not be able to block competitors or to compete effectively in the market.

We rely upon a combination of patents, owned by us or in-licensed from third parties, and trade secrets to protect our technology and product candidates.

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We also rely on know-how and continuing technological innovation to develop and maintain our competitive position.

If we are unable to obtain or maintain intellectual property protection with respect to our CRISPR chRDNA genome-editing platform technologies and product candidates, our business, financial condition, results of operations, and prospects will be materially harmed.

If we are unable to obtain or maintain intellectual property protection with respect to our CRISPR chRDNA genome-editing technology and product candidates, our business, financial condition, results of operations, and prospects will be materially harmed.

The strength of patents in the biotechnology and pharmaceutical fields generally, and the genome-editing field in particular, involves complex legal and scientific questions and can be uncertain.

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rather, our chRDNA guides are used in manufacturing our CAR-T cell therapy product candidates.

It is virtually impossible to determine whether a competitor has infringed our

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chRDNA patents in making their products.

It is virtually impossible to determine whether a competitor has infringed our chRDNA patents in making their products.

Thus, even if we obtain patent protection on certain aspects of our technologies, such protection may not be enough to block our competitors from entering the market.

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Furthermore, patent rights are granted jurisdiction-by-jurisdiction, and our freedom to practice certain genome-editing technologies, including our ability to research, develop, and commercialize our product candidates, may differ by country.

Additionally, AI resources that are publicly available also present a risk that we may inadvertently obtain, incorporate, or use third-party intellectual property, thus possibly subjecting us to future litigation.

Numerous third-party U.S.

and foreign granted patents and pending patent applications exist in the fields of cell therapy and CRISPR genome editing, including those relating to CAR and CAR-T cell therapy compositions, components (including specific co-stimulatory regions), and methods of use as well as those relating to CRISPR-Cas9 and CRISPR-Cas12a systems and methods of use.

Our CB-010 product candidate uses Cas9 chRDNAs to insert the CD19-specific CAR into the T cell genome and for an additional edit.

Our vispa-cel product candidate uses Cas9 chRDNAs to insert the CD19-specific CAR into the T cell genome and for an additional edit.

Numerous third parties have intellectual property relating to RNA-guided Cas9 genome editing.

See Risk Factors - “Our ability to continue to receive licensing revenue and to enter into new licensing arrangements related to the foundational CRISPR-Cas9 intellectual property will be substantially impaired if such intellectual property is limited by administrative patent proceedings or other patent challenges,” in Item 1A of this Annual Report on Form 10-K.

Our CB-011 product candidate and our CB-012 product candidate both use Cas12a chRDNAs to insert the CAR into the T cell genome and to make additional edits.

Our CB-011 product candidate uses Cas12a chRDNAs to insert the CAR into the T cell genome and to make additional edits.

We are aware of certain third-party patents relating to CRISPR-Cas12a genome-editing systems.

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However, third parties may claim that certain of our activities are outside of the safe harbor provision because, for example, such activities are allegedly not reasonably related to the development and submission of information to the FDA for regulatory approval.

Upon regulatory approval, third parties may assert infringement claims based on existing patents or patents that may be granted prior to our BLA filing, regardless of the merit of such claims.

Even if we believe third-party intellectual property claims are without merit, there is no assurance that a court would find in our favor on questions of infringement, validity, enforceability, ownership, or priority.

Upon regulatory approval, third parties may assert infringement claims based on existing patents or patents that may be granted prior to our BLA, regardless of the merit of such claims.

Even if we believe third-party intellectual property claims are without merit, a court may not find in our favor on questions of infringement, validity, enforceability, ownership, or priority.

Patents in the United States by law enjoy a presumption of validity that can be rebutted only with evidence that is “clear and convincing,” a heightened standard of proof.

In order to successfully challenge the validity of any U.S.

patent in federal court, we would need to overcome this presumption of validity, and there can be no assurance that a court of competent jurisdiction would invalidate the patent.

A court of competent jurisdiction could hold that these third-party patents are valid, enforceable, and infringed, which could materially and adversely affect our ability to commercialize any product candidates we may develop, including CB-010, CB-011, and CB-012, as well as any other product candidates or technologies covered by the asserted third-party patents.

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patent in federal court, we would need to overcome this presumption of validity, and we cannot provide any assurance that a court of competent jurisdiction would invalidate the patent.

If any third-party patents were held by a court of competent jurisdiction to cover our genome-editing technology used in manufacturing our product candidates or any product candidate itself or its indication, the holders of those patents may be able to block our ability to commercialize the product candidate unless and until we obtained a license under the applicable patents, or the patents expire, or are held to be not infringed, unpatentable, invalid, or unenforceable.

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Accordingly, we may choose not to seek patent protection in certain jurisdictions or countries, and we will not have the benefit of patent protection in such jurisdictions or countries.

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We may be subject to claims challenging the inventorship of our patents and other intellectual property.

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Recent decisions by the U.S.

Supreme Court have either narrowed the scope of patent protection available in certain

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circumstances or weakened the rights of patent owners in particular situations.

Supreme Court have either narrowed the scope of patent protection available in certain circumstances or weakened the rights of patent owners in particular situations.

For example, in Association for Molecular Pathology v.

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If the breadth or strength of protection provided by our patents and patent applications to our product candidates is threatened, it could dissuade companies from collaborating with us to develop, and threaten our or their ability to commercialize, our product candidates.

Litigation or other legal proceedings relating to intellectual property claims, with or without merit, is unpredictable and generally expensive and time-consuming and likely to divert significant resources from our core business, including distracting our management and scientific personnel from their normal responsibilities, and generally harm our business.

Litigation or other legal proceedings relating to intellectual property claims, with or without merit, is unpredictable and generally expensive and time-consuming and likely to divert significant resources from our core business, including distracting our management and personnel from their normal responsibilities, and generally harm our business.

Additionally, a defendant could counterclaim that our patent is invalid or unenforceable.

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A loss of patent protection could have a material adverse impact on our business.

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We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings.

Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources.

There can be no assurance that we will have sufficient financial or other resources for such litigation or proceedings, which may continue for several years.

We cannot provide any assurance that we will have sufficient financial or other resources for such litigation or proceedings, which may continue for several years.

Accordingly, despite our efforts, we may not be able to prevent third parties from infringing or misappropriating or successfully challenging our intellectual property rights.

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Through an amendment to the Pioneer Agreement, dated December 18, 2020, Pioneer assigned the chRDNA patent family to us in exchange for an upfront payment and potential future milestones.

As part of this amendment, Pioneer also granted a covenant not to sue for our licensees of our chRDNA technologies under certain other Pioneer intellectual property (to which we already have a license that, in this situation, we cannot sublicense to licensees of our chRDNA technologies in the field of human therapeutics) that might cover our chRDNA genome-editing technology, provided that we make the required payments.

As part of this amendment, Pioneer also granted a covenant not to sue for our licensees of our chRDNA technology under certain other Pioneer intellectual property (to which we already have a license that, in this situation, we cannot sublicense to licensees of our chRDNA technology in the field of human therapeutics) that might cover our chRDNA genome-editing technology, provided that we make the required payments.

Thus, if we do not make such payments, our licensees could be sued by Pioneer, which could result in our licensees suing us for breach of contract.

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Additionally, under the Pioneer Agreement, we licensed certain Pioneer background CRISPR-Cas9 intellectual property, particularly a patent family owned by Vilnius University and exclusively licensed to Pioneer, that we have sublicensed to several third parties as part of our CRISPR-Cas9 out-licensing program.

Although the Vilnius patent family does not cover our chRDNA genome-editing technologies or product candidates, if we were to materially breach the Pioneer Agreement and not cure the breach, Pioneer could terminate the Pioneer Agreement, which would expose us to possible lawsuits from a number of our sublicensees to the Vilnius University patent family.

Although the Vilnius patent family does not cover our chRDNA genome-editing technology or product candidates, if we were to materially breach the Pioneer Agreement and not cure the breach, Pioneer could terminate the Pioneer Agreement, which would expose us to possible lawsuits from a number of our sublicensees to the Vilnius University patent family.

For our CB-011 product candidate, an allogeneic anti-BCMA CAR-T cell therapy, we took assignment of an anti-BCMA scFv from ProMab under the ProMab Agreement.

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If this were to happen prior to regulatory approval, we would not be able to continue the development of CB-011 and, if this were to happen after regulatory approval, we would lose all future revenues from CB-011.

The scFv in our CB-012 product candidate, an allogeneic anti-CLL-1 CAR-T cell therapy, is exclusively licensed to us in the field of allogeneic cell therapy by MSKCC.

To maintain the license, we are required to pay annual license fees and to meet certain diligence milestones within specified periods of time.

We may extend these periods by a certain number of months upon payment of additional fees.

If we materially breach, and do not cure, the MSKCC Agreement, MSKCC may terminate the MSKCC Agreement, in which case we would not be able to continue the development of CB-012 or any other licensed CLL-1 product candidate.

Thus, we are reliant upon the above licenses to and assignments of certain intellectual property from third parties that is important or necessary to the development of our genome-editing technologies and product candidates.

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We may need to cease development of a future product candidate covered by such third-party intellectual property rights.

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The licensing and acquisition of third-party intellectual property rights is a competitive area, and companies that may be more established or have greater resources than we do may also be pursuing strategies to license or acquire third-party intellectual property rights that we may consider necessary or attractive in order to develop product candidates.

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We also may be unable to license or acquire third party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all.

There can be no assurance that we will be able to successfully complete such negotiations and ultimately acquire the rights to the intellectual property surrounding the additional product candidates or new genome-editing or other technologies that we may seek to acquire.

We cannot provide any assurance that we will be able to successfully complete such negotiations and ultimately acquire the rights to the intellectual property surrounding the additional product candidates or new genome-editing or other technologies that we may seek to acquire.

If we are unable to successfully obtain rights to required third party intellectual property rights, we may not be able to expand our product pipeline, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

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Doudna, Emmanuelle Charpentier, Martin Jinek, and Krzysztof Chylinski.

We have entered into over 30 sublicenses, both exclusive and non-exclusive, to this CRISPR-Cas9 intellectual property in combination with licenses to our own Cas9 intellectual property (and sometimes in combination with a sublicense to the Vilnius Cas9 patent family we licensed from Pioneer) in a variety of fields (e.g., human therapeutics, forestry, agriculture, research reagents, transgenic animals, certain livestock targets, internal research, bioproduction, cell lines, and microbial applications, etc.).

We have entered into over 30 sublicenses, both exclusive and non-exclusive, to this CRISPR-Cas9 intellectual property in combination with licenses to our own Cas9 intellectual property (and sometimes in combination with a sublicense to the Vilnius Cas9 patent family we licensed from Pioneer) in a variety of fields (e.g., human therapeutics, animal therapeutics, agriculture, forestry, research reagents, transgenic animals, certain livestock targets, internal research, bioproduction, cell lines, and microbial applications, etc.).

We are also required to share with UC/Vienna a percentage of sublicensing revenue we receive including cash and equity.

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Furthermore, in the United States, each co-owner is required to be joined as a party to any claim or action we may wish to bring to enforce those patent rights.

Although we have entered into the IMA, which provides for, among other things, notice of and coordination in the event of third-party infringement of the patent rights within the CVC IP, there can be no assurance that all parties will cooperate in any future infringement.

Although we have entered into the IMA, which provides for, among other things, notice of and coordination in the event of third-party infringement of the patent rights within the CVC IP, we cannot provide any assurance that all parties will cooperate in any future infringement.

In addition, the parties to the IMA may dispute certain provisions and the resolution of any contract interpretation disagreement could increase what we believe to be our financial obligations to UC/Vienna.

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Following appeal by the CVC group, in September 2018, the U.S.

Court of Appeals for the Federal Circuit (“CAFC”), affirmed the PTAB’s

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decision to terminate the interference proceeding without determining which inventors actually invented the use of the CRISPR-Cas9 genome-editing technology in eukaryotic cells.

Court of Appeals for the Federal Circuit (“Federal Circuit”), affirmed the PTAB’s decision to terminate the interference proceeding without determining which inventors actually invented the use of the CRISPR-Cas9 genome-editing technology in eukaryotic cells.

In June 2019, the PTAB declared another interference (Interference No.

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In February 2022, the PTAB issued its decision that the Broad inventors were the first to invent the use of CRISPR-Cas9 genome editing in eukaryotic cells.

The owners of the CVC IP appealed this decision to the CAFC, which held an oral hearing on May 7, 2024, and the parties are waiting for a decision from the CAFC.

The owners of the CVC IP appealed this decision to the Federal Circuit, which issued its decision on May 12, 2025, ruling that the PTAB incorrectly applied the legal standard for conception of the invention and remanded the case to the PTAB for further proceedings to reconsider the issue of conception in a manner consistent with the Federal Circuit’s decision.

The parties have completed briefing on the remand and are waiting for a decision from the PTAB.

In addition to the Broad, ToolGen, Inc., MilliporeSigma (a subsidiary of Merck KGaA), and Harvard University, each filed patent applications claiming CRISPR-Cas9-related inventions after the CVC IP was first filed (October 23, 2012 in the case of ToolGen patent family;

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patent applications in the CVC IP that are involved in the appeal of the ’115 interference.

The motions phase of this interference has concluded, and the priority phase is suspended until the CAFC appeal is decided.

The motions phase of this interference has concluded, and the priority phase is suspended until the remand from the Federal Circuit appeal in the ‘115 interference is decided.

Additionally, the PTAB declared an interference (Interference No.

106,126) at the same time between the same ToolGen patent application and the Broad patents and patent application in the appeal of the ’115 interference;

the motions phase has concluded, and this interference is also suspended until the CAFC appeal is decided.

the motions phase has concluded, and this interference is also suspended until the remand from the Federal Circuit appeal in the ‘115 interference is decided.

In June 2021, the PTAB declared an interference (Interference No.

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applications in the CVC IP that are involved in the ‘115 and ‘127 interferences.

This interference completed the motions phase and is also suspended until the CAFC appeal is decided.

This interference completed the motions phase and is also suspended until at least the remand from the Federal Circuit appeal in the ‘115 interference is decided.

Also in June 2021, the PTAB declared an interference (Interference No.

106,133) between the same MilliporeSigma patent application and the Broad patents and patent applications in the ‘115 and ‘126 interferences;

the motions phase has concluded, and this interference is also suspended until the CAFC appeal is decided.

We do not know the impact of a decision by the CAFC in the appeal of the ‘115 interference on these suspended interferences.

the motions phase has concluded, and this interference is also suspended until at least the remand from the Federal Circuit appeal in the ‘115 interference is decided.

We do not know the impact on these suspended interferences of a decision by the PTAB on remand from the Federal Circuit appeal in the ‘115 interference.

Opposition and appeal proceedings in the EPO are ongoing against patents owned by the Broad, ToolGen, and MilliporeSigma as well as against the CVC IP.

Additionally, invalidation trials or appeals thereof of the CVC IP are ongoing in China, India, and Japan.

Additionally, invalidation trials or appeals thereof of the CVC IP are ongoing in China and India.

Such proceedings are often lengthy and can lead to the revocation of a patent in its entirety, the maintenance of the patent as granted, or, depending upon the jurisdiction, the maintenance of a patent in amended form.

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Although we have confidence in these individuals, organizations, and systems, agreements or security measures may be breached, and we may not have adequate remedies for any breaches.

Monitoring unauthorized uses and disclosures is difficult, and we do

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not know whether the steps we have taken to protect our confidential information will be effective.

Monitoring unauthorized uses and disclosures is difficult, and we do not know whether the steps we have taken to protect our confidential information will be effective.

Our trade secrets and other confidential information may be inadvertently or illegally disclosed and competitors may gain access to our trade secrets.

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If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, or misappropriation of our intellectual property by third parties, we may not be able to establish or maintain a competitive advantage in our markets, which could materially adversely affect our business, operating results, financial condition, and prospects.

Additionally, it is possible that our genome-editing technology platform, our trade secrets, and our know-how will over time be disseminated within the industry through the publication of journal articles and the movement of personnel from our company into academia or into other companies that may be our competitors.

Additionally, it is possible that our CRISPR chRDNA genome-editing technology, our trade secrets, and our know-how will over time be disseminated within the industry through the publication of journal articles and the movement of personnel from our company into academia or into other companies that may be our competitors.

Furthermore, others may independently discover our trade secrets or other confidential information.

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In addition, there could be potential trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our unregistered trademarks.

Over the long term, if we are unable to successfully register our trademarks and establish name recognition based on our trademarks,

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then we may not be able to compete effectively and our business may be adversely affected.

Over the long term, if we are unable to successfully register our trademarks and establish name recognition based on our trademarks, then we may not be able to compete effectively and our business may be adversely affected.

Our efforts to enforce or protect our trademarks, domain names, copyrights, or other intellectual property rights may be ineffective and could result in substantial costs and diversion of resources and could adversely impact our business, financial condition, results of operations, and prospects.

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thus, we must rely on third-party CMOs to manufacture clinical supplies for our product candidates.

We currently rely on five different CMOs to supply materials to additional CMOs that manufacture CB-010, CB-011, and CB-012 product candidates for our phase 1 clinical trials.

We currently rely on five different CMOs to supply materials to additional CMOs that manufacture vispa-cel and CB-011 product candidates for our phase 1 clinical trials.

We anticipate that we may need to engage other suppliers and CMOs for our clinical trials with our product candidates.

We receive the CRISPR chRDNA guides used for genome editing from one CMO, the Cas proteins (Cas9 in the case of CB-010 and Cas12a in the case of CB-011 and CB-012) from another CMO, the virus used to insert the CAR into the T cell genome from another CMO located outside the United States, and our healthy donor cells from multiple sources.

We receive the CRISPR chRDNA guides used for genome editing from one CMO, the Cas proteins (Cas9 in the case of vispa-cel and Cas12a in the case of CB-011) from another CMO, the virus used to insert the CAR into the T cell genome and the virus used to insert the B2M-HLA-E-peptide fusion into the T cell genome from another CMO located outside the United States, and our healthy donor cells from multiple sources.

The CMO that supplies the virus receives plasmid from another supplier used in the manufacture of the viral material.

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The manufactured CAR-T products then undergo a series of release testing.

There can be no assurance that we will not experience supply or manufacturing issues in the future;

We cannot provide any assurance that we will not experience supply or manufacturing issues in the future;

particularly, given our reliance on single-source suppliers, some of which are small companies with limited resources and experience to support clinical, and ultimately commercial, products.

We cannot ensure that these suppliers will remain in business or that they will not be purchased by one of our competitors or another company that is not interested in continuing to produce these materials for our intended purposes.

We cannot ensure that these suppliers will remain in business, will not experience reductions in force, or that they will not be purchased by one of our competitors or another company that is not interested in continuing to produce these materials for our intended purposes.

In addition, the lead time needed to establish a relationship with a new supplier can be lengthy, and we may experience delays in meeting demand if we must switch to a new supplier or CMO.

The time and effort to qualify a new supplier or CMO, including to meet any regulatory requirements for such qualification, could result in additional costs, diversion of resources, or reduced manufacturing yields, any of which would negatively impact our operating results.

The time and effort to qualify a new supplier or CMO, including to meet any regulatory requirements for such qualification, could result in additional costs, diversion of resources, reduced manufacturing yields, or delays, any of which would negatively impact our operating results.

Furthermore, we may be unable to enter into agreements with a new supplier on commercially reasonable terms, which could have a material adverse impact on our business, financial condition, results of operations, and prospects.

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If the FDA or a foreign regulatory authority inspects these third-party facilities for compliance with regulations for the manufacture and testing of materials or product candidates and, if these facilities fail inspection and cannot adequately correct deficiencies, we may need to find alternative CMOs, which would significantly impact our ability to develop and obtain regulatory approval for our product candidates, and if approved, to market our products.

One of our CMOs that manufacturers our CAR-T cell therapy product candidates is a company that currently has ties to China, and we expect to continue to use this CMO for some of our manufacturing in the near future.

lawmakers have urged the U.S.

government to investigate CMOs and CROs that have ties to China to ensure that sensitive U.S.

biotechnology intellectual property is not transferred to China.

Any such investigations or other regulatory actions could affect the ability of this CMO to provide services to us in a timely manner.

Although the BIOSECURE Act was not passed by Congress, given the current uncertain political and legislative environment, particularly under the new Administration, it is unclear what form the BIOSECURE Act or similar legislation will take in the future and whether or when it will be enacted into law.

As a result, we may need to seek additional alternative CMOs.

Although we believe we will be able to identify and contract with one or more alternative CMOs, we cannot predict the terms of any such alternative arrangement nor what actions may ultimately be taken with respect to trade relations between the United States and China or other countries, what products and services may be subject to such actions or what actions may be taken by China or the other countries in retaliation.

Additionally, any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, new legislation or regulations, renegotiation of existing trade agreements, or any retaliatory trade actions due to recent or future trade tension, may impede, delay, limit, or increase the cost of manufacturing our CAR-T

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cell therapy product candidates, including recently imposed tariffs by the new Administration.

Any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, new legislation or regulations, renegotiation of existing trade agreements, or any retaliatory trade actions due to recent or future trade tension, may impede, delay, limit, or increase the cost of manufacturing our CAR-T cell therapy product candidates, including recently imposed tariffs.

Such events could result in a lack of supply for our clinical trials, which could harm our business.

In addition, if our CMOs and suppliers are unable to timely perform or have operations temporarily halted as a result of inspection or enforcement actions taken by the FDA or other regulatory authorities, or as a result of pandemics or other public health crises, we may experience manufacturing delays or delays in receiving healthy donor cells used in manufacturing our product candidates or may need to find alternative CMOs or suppliers, which in each case would significantly impact our ability to develop, obtain regulatory approval for, and market our product candidates, if approved.

We do not yet have sufficient information to reliably estimate the cost of manufacturing our product candidates for commercialization, and the actual cost to manufacture and process our product candidates could materially and adversely affect the commercial viability of our product candidates.

Our product candidates have not been manufactured at commercial scale, may not be able to achieve commercial manufacturing, and we may be unable to create a product inventory necessary to satisfy demands for any of our product candidates following approval.

Our product candidates have not been manufactured for commercialization and we may not be able to achieve commercial manufacturing;

additionally, we may be unable to create a product inventory necessary to satisfy demands for any of our product candidates following regulatory approval.

As a result, we may never be able to develop a commercially viable product.

We recently incorporated partial HLA matching in our ANTLER phase 1 clinical trial and we believe that we will be able to manufacture sufficient materials to support this effort;

however, there can be no assurances that we will be successful in manufacturing additional batches in a timely manner in order to supply our clinical trials.

In addition, our current reliance on a limited number of CMOs and suppliers exposes us to a variety of risks, each of which could delay our preclinical studies, clinical trials, the approval, if any, of our product candidates by the FDA or foreign regulatory authorities, or the commercialization of our product candidates or result in higher costs or deprive us of potential product revenue.

We incorporated partial HLA matching in our ANTLER phase 1 clinical trial and we believe that we will be able to manufacture sufficient materials to support this effort;

however, we cannot provide any assurance that we will be successful in manufacturing additional batches in a timely manner in order to supply our clinical trials.

In addition, our current reliance on a limited number of CMOs and suppliers exposes us to a variety of risks, each of which could delay our clinical trials, the approval, if any, of our product candidates by the FDA or foreign regulatory authorities, or the commercialization of our product candidates or result in higher costs or deprive us of potential product revenue.

These risks include:

• our CMOs and suppliers may be unable to timely manufacture our product candidates or produce the quantity and quality required to meet our preclinical, clinical, and commercial needs, if any;

• our CMOs and suppliers may be unable to timely manufacture our product candidates or produce the quantity and quality required to meet our clinical, and commercial needs, if any;

• our CMOs and suppliers may not be able to execute our manufacturing procedures appropriately;

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• our CMOs and suppliers may not perform as agreed or may not remain in business for the time required to supply our clinical trials or to successfully manufacture, store, and distribute our commercial products;

• our CMOs and suppliers may experience reductions in force, and employees who are familiar with our product candidates and processes at such CMOs and suppliers may be impacted, resulting in employees who are not familiar with our product candidates and processes causing errors and/or delays;

• our CMOs and suppliers could breach or terminate their agreements with us;

• we face competition for supplies from other gene and cell therapy companies, which may make it difficult for us to secure materials or the testing of such materials on commercially reasonable terms or in a timely manner;

• we face competition for supplies from other cell and gene therapy companies, which may make it difficult for us to secure materials or the testing of such materials on commercially reasonable terms or in a timely manner;

• our CMOs may fail to adequately store the various components received from our suppliers and any damage or loss of such materials could materially impact our ability to manufacture and supply our product candidates;

• our product candidates may be damaged or otherwise made unfit for use in clinical trials during shipment from our CMOs to clinical trial sites;

• our product candidates may be damaged or otherwise made unfit for use in clinical trials during shipments from our CMOs to clinical trial sites;

• we rely on third parties to perform release tests on our product candidates prior to delivery to clinical trial sites.

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• as a result of pandemics or other public health crises, our CMOs and suppliers may experience production delays and shutdowns.

Our CMO that supplies the virus we use to insert the CAR into our CAR-T product candidates is located outside the United States.

To date, our virus CMO has not been audited by the FDA, but it has received the cGMP certification for

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the manufacture of recombinant viral vectors from an EU national regulatory authority.

Our CMO that supplies the virus we use to insert the CAR into our CAR-T product candidates and the virus to insert the B2M-HLA-E-peptide fusion into CB-011 is located outside the United States.

To date, our virus CMO has not been audited by the FDA, but it has received the cGMP certification for the manufacture of recombinant viral vectors from an EU national regulatory authority.

There are additional risks with using a non-U.S.

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• workforce uncertainty in countries where labor unrest is more common than in the United States.

In addition, although we do not currently utilize Chinese CMOs, certain Chinese biotechnology companies may become subject to trade restrictions, sanctions, other regulatory requirements, or proposed legislation by the U.S.

government, which could restrict or even prohibit our ability to work with such entities, thereby potentially disrupting the supply of material to us.

For example, the BIOSECURE Act, which was recently signed into law in December 2025, prohibits U.S.

federal agencies from entering into or renewing any contract with any entity that uses biotechnology equipment or services produced or provided by a “biotechnology company of concern” to perform that contract as well as authorize the U.S.

government to name additional Chinese “biotechnology companies of concern.” Although prior versions of the BIOSECURE Act explicitly named “biotechnology companies of concern,” the revised version defines a “biotechnology company of concern” as an entity that is identified on the annual 1260H List of Chinese military companies (the “1260H List”) issued by the U.S.

Department of Defense, any entity designated by the U.S.

government as such, and certain affiliates of the foregoing.

In addition, the BIOSECURE Act provides a grandfathering period of five years for entities that are designated by the U.S.

however, entities identified on the 1260H List are not eligible for such grandfathering period.

None of our suppliers is currently designated on the 1260H List, but such list is subject to periodic updates by the U.S.

It is possible for the legislation to be amended.

If this law, or similar laws that are passed impact Chinese biotechnology manufacturing companies that may provide biotechnology equipment or services in the manufacture of our product candidates, we may be restricted in our ability to work with such Chinese biotechnology manufacturing companies to the extent we would contract with, or otherwise receive funding from, the U.S.

As a result, we may need to seek alternative suppliers.

Although we believe we will be able to identify and contract with such alternative suppliers, we cannot predict the terms of any such alternative arrangement nor what actions may ultimately be taken with respect to trade relations between the United States and China or other countries, what products and services may be subject to such actions, or what actions may be taken by China or the other countries in retaliation.

In addition, any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, new legislation or regulations, renegotiation of existing trade agreements, or any retaliatory trade actions due to recent or future trade tension, may impede, delay, limit, or increase the cost of manufacturing our product candidates.

Such events could result in our clinical supply of our product candidates being interrupted or limited, which could harm our business.

For our allogeneic CAR-T product candidates, we rely on receiving safe and healthy donor material to manufacture our product candidates.

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We have strict specifications for donor material, which include specifications required by regulatory authorities as well as requirements for additional screening, for example, HLA matching and donor age and health.

We recently incorporated partial HLA matching in our ANTLER and GALLOP phase 1 clinical trials and there may be other beneficial donor characteristics that could affect the efficacy and durability of our product candidates, which we may need to incorporate into our screening processes.

We have incorporated partial HLA matching and donor age restrictions (<30 years of age) in both our ANTLER phase 1 clinical trial and our CaMMouflage phase 1 clinical trial, and there may be other beneficial donor characteristics that could affect the efficacy and durability of our product candidates, which we may need to incorporate into our screening processes.

If we are unable to (i) identify and obtain donor material that satisfies specifications, (ii) agree with regulatory authorities on appropriate specifications, or (iii) address variability of donor T cells, there may be insufficient material or we may be unable to initiate or continue clinical trials on the timelines we expect, which could harm our reputation and adversely impact our business and prospects.

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Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the protocol and applicable legal, regulatory, and scientific standards and regulations, and our reliance on third parties does not relieve us of our regulatory responsibilities.

We and these third parties are required to comply with cGCPs, which are regulations and guidelines

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enforced by the FDA and comparable foreign regulatory authorities for the conduct of clinical trials on product candidates in clinical development.

We and these third parties are required to comply with cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for the conduct of clinical trials on product candidates in clinical development.

Regulatory authorities enforce cGCPs through periodic inspections and for-cause inspections of clinical trial principal investigators and trial sites.

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Communicating with third parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities.

Any third parties conducting our clinical trials are not, and will not be, our employees and, except for remedies available to us under our agreements with these third parties, we cannot control whether they devote sufficient time and resources to our ongoing preclinical, clinical, and nonclinical programs.

These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug and biologic development activities, which could affect their performance on our behalf.

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Failure to do so can result in fines, adverse publicity, and civil and criminal sanctions.

Our ANTLER phase 1 clinical trial for our CB-010 product candidate, our CaMMouflage phase 1 clinical trial for our CB-011 product candidate, and our AMpLIFY phase 1 clinical trial for our CB-012 product candidate are posted on www.ClinicalTrials.gov.

For any violations of laws and regulations during the conduct of our preclinical studies and clinical trials, we could be subject to warning letters or enforcement action that may include civil and other penalties, up to and including criminal prosecution.

We may form or seek collaborations or strategic alliances in the future for the development and commercialization of one or more of our product candidates or for new product candidates.

Our ANTLER phase 1 clinical trial for our vispa-cel product candidate and our ongoing CaMMouflage phase 1 clinical trial for our CB-011 product candidate are posted on www.ClinicalTrials.gov.

For any violations of laws and regulations during the conduct of our clinical trials, we could be subject to warning letters or enforcement action that may include civil and other penalties, up to and including criminal prosecution.

We may form or seek new strategic collaborations in the future for the development and commercialization of one or more of our product candidates or for new product candidates.

We may not be successful in those efforts and, even if we do enter into any collaborations, they may not be successful.

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To date, we have not partnered with a third party with respect to commercializing of any of our product candidates.

We have entered into agreements with Pfizer with respect to certain

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information rights and rights of first negotiation with Pfizer regarding a BCMA Product Candidate, including our CB-011 product candidate.

We have entered into agreements with Pfizer with respect to certain information rights and rights of first negotiation with Pfizer regarding a BCMA Product Candidate, including our CB-011 product candidate, which rights will expire on June 29, 2026.

In the future, we may choose to partner with third parties for one or more of our product candidates.

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• collaborators may not properly obtain, maintain, enforce, or defend our intellectual property if we grant such rights or may use our intellectual property in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or expose us to potential litigation;

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• we may lose certain valuable rights under circumstances identified in our collaborations, including if we undergo a change in control;

• disputes may arise between our collaborator and us that may cause the collaborator to act in a manner adverse to us and could result in the delay or termination of the research, development, or commercialization of our product candidates or that result in costly litigation or arbitration that diverts our management’s attention and resources;

• disputes may arise between our collaborator and us that may cause the collaborator to act in a manner adverse to us and could result in the delay or termination of the development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts our management’s attention and resources;

• collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner, if at all.

For example, if a collaborator were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program under such collaboration could be delayed, diminished, or terminated;

• collaboration agreements may be terminated and, if terminated, we may find it more difficult to find a suitable replacement collaborator or attract new collaborators, resulting in a need for additional capital to pursue further development or commercialization of the applicable product candidates we may develop.

• collaboration agreements may be terminated and, if terminated, it may be more difficult for us to find a suitable replacement collaborator or attract new collaborators, resulting in a need for additional capital to pursue further development or commercialization of the applicable product candidates we may develop.

We may not realize the benefits of acquired assets or other strategic transactions.

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• retention of key employees;

• diversion of management’s time and focus from operating our business to management of strategic alliances or joint ventures or acquisition integration challenges;

• diversion of management’s time and focus from operating our business to management of new strategic collaborations or joint ventures or acquisition integration challenges;

• increases in our expenses and reductions in our cash available for operations and other uses;

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Haurwitz, Ph.D., as well as other members of our senior management team.

Although we have entered into

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employment agreements with all our executive officers, each of them may terminate their employment with us at any time, which could result in disruption to our business while we find, negotiate with, and hire an executive officer to serve in the same function or while we reorganize our departmental reporting structures.

Although we have entered into employment agreements with all our executive officers, each of them may terminate their employment with us at any time, which could result in disruption to our business while we find, negotiate with, and hire an executive officer to serve in the same function or while we reorganize our departmental reporting structures.

All our non-officer employees are “at will,” which means that any of our employees could leave our employment at any time, with or without notice.

We conduct substantially all our research activities at our facilities in Berkeley, California.

Our corporate headquarters are in Berkeley, California.

The San Francisco Bay Area is headquarters to many other biopharmaceutical companies and many academic and research institutions.

Competition for skilled personnel in our industry is intense and may limit our ability to hire and retain highly qualified personnel on acceptable terms, if at all.

Certain of our scientists have greatly contributed to our intellectual property and are critical as we move our CRISPR-Cas12a chRDNA technology platform forward.

Many of the biotechnology companies and research institutions that we compete against for qualified personnel and consultants have greater financial and other resources, different risk profiles, and a longer history in the industry than we do.

Recruiting and retaining qualified research, development, manufacturing, regulatory, and clinical personnel is critical to our success.

Our success also depends on our ability to continue to attract, retain, and motivate entry-level, mid-level, and senior scientific personnel as well as managers.

Recruiting and retaining qualified development, manufacturing, regulatory, and clinical personnel is critical to our success.

Our success also depends on our ability to continue to attract, retain, and motivate entry-level, mid-level, and senior personnel.

We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies, as well as academic and research institutions, for similar personnel.

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To induce employees to remain at our company, in addition to salary and cash incentives, we provide equity awards that vest over time, the value of which may be significantly affected by movements in our stock price that are beyond our control and may be insufficient to counteract more lucrative offers from other companies.

Since the COVID pandemic, many of our non-researchers work remotely or on a hybrid work schedule.

Since the COVID pandemic, many of our employees work remotely or on a hybrid work schedule.

This may lead to employees not feeling as connected to our company and thus more inclined to pursue other opportunities.

This reduction in force, as well as any others we may need to implement in the future, may have a detrimental impact on company culture and employee morale, which may hurt our ability to retain employees.

We rely on consultants and advisors, including our co-founders and SAB, to assist us in formulating our research and development and commercialization strategy.

Additionally, on July 16, 2024, we announced that we had discontinued preclinical research activities associated with our allogeneic CAR-NK platform and reduced our workforce by 21 positions, or approximately 12% of our workforce, primarily in the research group and, on April 24, 2025, we announced a strategic pipeline prioritization, including reduction of our workforce by 47 positions, or approximately 32% of our workforce, primarily in the preclinical research group.

These reductions in force, as well as any others we may need to implement in the future, may have a detrimental impact on company culture and employee morale, which may hurt our ability to retain employees.

We rely on consultants and advisors, including our co-founders and SAB, to assist us in formulating our development and commercialization strategy.

Our consultants and advisors, including Drs.

Doudna and Martin Jinek, who are among our founders and who are pioneers in CRISPR genome-editing technology, are not employed by us, are employed by employers other than us, and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us.

The inability to recruit or retain certain executive officers, key employees, consultants, or advisors may impede the progress of our research, development, and commercialization objectives and have a material adverse effect on our business, intellectual property, financial condition, results of operations, and prospects.

The inability to recruit or retain certain executive officers, key employees, consultants, or advisors may impede the progress of our development and commercialization objectives and have a material adverse effect on our business, intellectual property, financial condition, results of operations, and prospects.

We must continue developing and expanding our company, and we may encounter difficulties in managing this development and expansion, which could disrupt our operations.

As of March 1, 2025, we had 147 full-time employees, and we expect to continue to increase our number of employees and the scope of our operations in 2025 and beyond as we seek to advance development, and if successful, commercialization, of our product candidates.

As of February 27, 2026, we had 97 full-time employees, and we expect to continue to increase our number of employees and the scope of our operations in 2026 and beyond as we seek to advance development, and if successful, commercialization, of our product candidates.

To manage our anticipated development and expansion, we must continue to implement and improve our managerial, operational, and financial systems;

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Due to our limited resources, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel.

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This may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees, and reduced productivity among our remaining employees.

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Our future financial performance and our ability to commercialize our product candidates, if approved, and compete effectively will depend, in part, on our ability to effectively manage the continuing development and expansion of our company.

Our internal computer systems, or those of third parties with which we interact, may fail or suffer security breaches, which could result in a material disruption of the development of our product candidates and research programs, compromise sensitive information related to our business, or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.

Our internal computer systems, or those of third parties with which we interact, may fail or suffer security breaches, which could result in a material disruption of the development of our product candidates, compromise sensitive information related to our business, or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.

Our internal computer systems, and those of third parties with which we interact, including our clinical sites, governmental agencies, CMOs, suppliers, CROs, clinical sites, and the like, are vulnerable to damage from computer viruses, ransomware, malware, data corruption, cyber-based attacks, phishing attacks, unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failures.

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In addition, we could be subject to regulatory actions or claims made by individuals and groups in litigation involving privacy issues related to data collection and use practices and other data privacy laws and regulations, including claims for misuse or inappropriate disclosure of data, as well as unfair or deceptive practices.

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monitoring and updating as technologies change and efforts to overcome security measures become increasingly sophisticated.

Although we develop and maintain systems and controls designed to prevent these events from occurring, and we have a process to identify and mitigate threats, the development and maintenance of these systems, controls, and processes is costly and requires ongoing monitoring and updating as technologies change and efforts to overcome security measures become increasingly sophisticated.

Moreover, despite our efforts, the possibility of these events occurring cannot be eliminated entirely.

As we outsource more of our information systems to vendors, engage in more electronic transactions with clinical sites and collaborators, and rely more on cloud-based information systems, the related security risks will increase and we will need to expend additional resources to protect our technology and information systems.

In addition, there can be no assurance that our internal information technology systems, or those of third parties with which we conduct business, will be sufficient to protect us against breakdowns, service disruption, data deterioration, or loss in the event of a system malfunction, or prevent data from being stolen or corrupted in the event of a cyberattack, security breach, industrial espionage attacks, or insider threat attacks, which could result in financial, legal, business, or reputational harm.

In addition, we cannot provide any assurance that our internal information technology systems, or those of third parties with which we conduct business, will be sufficient to protect us against breakdowns, service disruption, data deterioration, or loss in the event of a system malfunction, or prevent data from being stolen or corrupted in the event of a cyberattack, security breach, industrial espionage attacks, or insider threat attacks, which could result in financial, legal, business, or reputational harm.

Our employees, clinical trial principal investigators, and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.

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We are subject to numerous federal, state, and local environmental, health, and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment, and disposal of hazardous materials and wastes.

Our operations involve the use of hazardous and flammable materials, including chemicals and

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biological materials.

Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials.

Our operations also produce hazardous waste products.

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In addition, we may incur substantial costs to comply with current or future environmental, health, and safety laws and regulations.

These current or future laws and regulations may impair our product candidate development and research program efforts.

These current or future laws and regulations may impair our product candidate development efforts.

Moreover, there is increasing stakeholder pressure on companies to diligence environmental, social, and governance matters in the supply chain.

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• diversion of our management’s time and resources;

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• substantial monetary awards to clinical trial patients;

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As a result, our effective tax rate is derived from a combination of applicable tax rates in the locations in which we operate.

In preparing our financial statements, we estimate the amount of tax that will become payable in each jurisdiction using enacted tax rates as of the balance sheet date.

In preparing our financial statements, we estimate the amount of tax, if any, that will become payable in each jurisdiction using enacted tax rates as of the balance sheet date.

Nevertheless, our effective tax rate may change from year to year due to numerous factors, including changes in the mix of our profitability, if any, from jurisdiction to jurisdiction, the results of examinations and audits of our tax filings, our inability to secure or sustain acceptable agreements with tax authorities, and changes in tax laws.

For example, the new Administration and Congress are discussing various proposals that would renew, modify, or eliminate the international and other corporate provisions of the 2017 Tax Act and federal tax laws more generally.

Any of these factors could result in an effective tax rate significantly different from previous periods and may result in tax obligations in excess of amounts accrued in our financial statements.

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

We have generated, and expect to continue to generate in the future, significant federal and state net operating loss (“NOL”) carryforwards that are available to offset taxable income in future years, if any.

In particular, new income or other tax laws or regulations could be enacted at any time, which could adversely affect our business operations and financial performance.

Furthermore, existing tax laws and regulations could be interpreted, modified, or applied adversely to us.

government may enact additional significant changes to the taxation of business entities, and we are currently unable to predict whether such changes will occur and what the ultimate impact of any such changes would be;

thus, we cannot provide any assurance that such changes will not adversely affect our business.

Recently, on July 4, 2025, the U.S.

government enacted The One Big Beautiful Bill Act (the “OBBBA”), which includes a broad range of tax reform provisions, including the allowance of immediate expensing of qualifying domestic research and development expenses and permanent extensions of certain provisions within the Tax Cuts and Jobs Act of 2017 (“TCJA”).

We have evaluated the impact of the guidance provided to date and determined that there is no material impact to our financial statements for the year ended December 31, 2025.

We will continue to address and evaluate the impact of changes in tax laws and legislation as such changes could affect our income tax payable and deferred tax assets and liabilities.

Our ability to use our net operating loss (“NOL”) carryforwards and certain other tax attributes may be limited.

We have generated, and expect to continue to generate in the future, significant federal and state NOL carryforwards that are available to offset taxable income in future years, if any.

We have also generated, and expect to continue to generate in the future, significant federal and state research and development tax credit carryforwards, and, beginning in 2022, we began to generate orphan drug credit carryforwards that are available to potentially offset federal and state income taxes, respectively, in future years, if any.

Under the Tax Cuts and Jobs Act of 2017 (“TCJA”), as modified by the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), our federal NOLs incurred in taxable years beginning after December 31, 2017 may be carried forward indefinitely.

Additionally, for tax years beginning after December 31, 2020, the deductibility of federal NOLs incurred in taxable years beginning after December 31, 2017 is limited to 80% of our taxable income.

Under the TCJA, as modified by the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), our federal NOLs incurred in taxable years beginning after December 31, 2017 may be carried forward indefinitely but are limited to 80% of our taxable income.

It is uncertain if and to what extent various states will conform to the NOL changes contained in the TCJA and the CARES Act.

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As a result, they may be unavailable to offset future taxes.

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In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (“Tax Code”), and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50 percentage point change, by value, in its equity ownership by certain stockholders over a rolling three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes (such as research and development tax credits) to offset its post-change income or taxes may be limited.

We have experienced prior ownership changes in 2014, 2016, and most recently in July 2021 upon our IPO.

We have experienced prior ownership changes in 2014, 2016, and 2021.

We do not expect any permanent limitations on our tax attributes.

We have recorded a full valuation allowance for deferred tax assets, including NOLs and tax credits as of December 31, 2025.

The issuance of common stock in the future, or shifts in the ownership of our common stock among certain stockholders, either separately or in combination, over time may result in a limitation under Sections 382 and 383 of the Code.

In addition, at the state level, there may be periods during which the use of NOL carryforwards is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed.

For example, California imposed limits on the use of California state NOLs and tax credits to offset California taxable income in years beginning after 2019 and before 2022.

If an ownership change occurs and we earn taxable income in future years, the limitation on our ability to use our NOLs and other tax attribute carryforwards could adversely affect our future operating results by increasing our future income tax liabilities.

See Note 13 to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional information.

Pandemics or other public health crises may adversely impact our business, financial condition, and results of operations, including our preclinical studies and clinical trials, and may cause substantial disruption in the financial markets and adversely impact economies worldwide.

We may experience disruptions related to pandemics or other public health crises that could severely impact our business, preclinical studies, clinical trials, and commercialization activities, including:

See Note 12 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional information.

Pandemics or other public health crises may adversely impact our business, financial condition, and results of operations, including our clinical trials, and may cause substantial disruption in the financial markets and adversely impact economies worldwide.

We may experience disruptions related to pandemics or other public health crises that could severely impact our business, clinical trials, and commercialization activities, including:

• halting or suspending enrollment in our clinical trials;

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• interruption of key clinical trial activities, such as clinical trial site data monitoring and efficacy, safety and translational data collection, and processing and analyses, due to limitations on travel imposed or recommended by federal, state, or local governments, employers and others or interruption of clinical trial subject visits, which may impact the collection and integrity of subject data and clinical trial endpoints;

• requirements to change the ways in which our preclinical studies and clinical trials are conducted due to governmental regulations as part of a response to pandemics or other public health crises, which may result in unexpected costs, delays, or discontinuation of our preclinical studies and clinical trials altogether;

• requirements to change the ways in which our clinical trials are conducted due to governmental regulations as part of a response to pandemics or other public health crises, which may result in unexpected costs, delays, or discontinuation of our clinical trials altogether;

• increased adverse events and deaths in our clinical trials due to pandemic-related infections;

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• significant disruptions and volatility in the financial markets.

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The extent to which pandemics or other public health crises may impact our business, research, preclinical studies and clinical trials, productivity of our employees, supply chains, and access to capital or business development activities will depend on future developments, which are highly uncertain at this time.

The extent to which pandemics or other public health crises may impact our business and clinical trials, productivity of our employees, supply chains, and access to capital or business development activities will depend on future developments, which are highly uncertain at this time.

To the extent pandemics or other public health crisis adversely affects our business, financial condition, results of operations, and prospects, it may also have the effect of amplifying many of the other risks described in this “Risk Factors” section, such as those relating to the timing and results of our current and future clinical trials and our financing needs.

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The ultimate impact on us and our general infrastructure of being located near major earthquake faults and fire zones and being consolidated in certain geographical areas is unknown, but our business, financial condition, results of operations, and prospects could suffer in the event of a major earthquake, fire, or other natural disaster.

Furthermore, our preclinical work involves studies in mice.

In the past, vivarium sites have been shut down by animal activists, and any disturbance or shut down at sites where our preclinical work is being conducted could jeopardize our data and affect our product candidate timelines.

Furthermore, we interact with the FDA and other federal, state, and regulatory agencies, and lack of funding for such agencies or temporary shutdowns can affect our operations.

Over the last several years, the U.S.

government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, and has had to furlough critical government employees and stop critical activities.

government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical government employees and stop critical activities.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels;

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were each put into receivership.

Although the U.S.

Department of Treasury, FDIC, and Federal Reserve Board have implemented a program to provide up to $25 billion of loans to financial institutions secured by certain of such government securities held by financial institutions to mitigate the risk of potential losses on the sale of such instruments, widespread demands for customer withdrawals or other liquidity needs of financial institutions for immediate liquidity may exceed the capacity of such program, there is no guarantee that such programs will be sufficient.

Additionally, it is uncertain whether the U.S.

The Federal Reserve Board subsequently announced that account holders would be made whole;

however, it is uncertain whether the U.S.

Department of Treasury, FDIC, and Federal Reserve Board will provide access to uninsured funds in the future in the event of the closure of other banks or financial institutions, or that they would do so in a timely fashion.

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Any loss or limitation on our cash, cash equivalents, or marketable securities would adversely affect our business.

In addition, if any of the third parties on which we rely to conduct our preclinical studies or clinical trials are unable to access funds pursuant to a failure at a financial institution, the ability for such party to fulfill its obligations to us could be adversely affected.

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In addition, if any of the third parties on which we rely to conduct our clinical trials are unable to access funds pursuant to a failure at a financial institution, the ability for such party to fulfill its obligations to us could be adversely affected.

Although we assess our banking relationships as we believe necessary or appropriate, our access to cash in amounts adequate to finance our current and projected future business operations could be significantly impaired by factors that affect the financial institutions with which we have banking relationships.

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We maintain our cash at financial institutions, often in balances that exceed federally insured limits.

We maintain the majority of our cash and cash equivalents in accounts at banking institutions in the United States that we believe are of high quality.

We maintain the majority of our cash and cash equivalents in accounts at four banking institutions in the United States that we believe are of high quality.

Cash held in these accounts often exceed the FDIC insurance limits.

If such banking institutions were to fail, we could lose all or a portion of amounts held in excess of such insurance limitations.

As noted above, the FDIC recently took control of certain banks.

In the event of failure of any of the financial institutions where we maintain our cash and cash equivalents, there can be no assurance that we would be able to access uninsured funds in a timely manner or at all.

As noted above, the FDIC took control of certain banks.

In the event of failure of any of the financial institutions where we maintain our cash and cash equivalents, we cannot provide any assurance that we would be able to access uninsured funds in a timely manner or at all.

Any inability to access or delay in accessing these funds could adversely affect our business and financial position.

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Our business, financial condition, results of operations, or prospects could be adversely affected by general conditions in the global economy and in the global financial markets.

A severe or prolonged economic downturn, including as a result of pandemics or other public health crises, the ongoing war between Russia and Ukraine, conflict in the Middle East, and tension between China and Taiwan, interest rate fluctuations, rising inflation, recession, or other global financial, geopolitical crises or macroeconomic factors, could result in a variety of risks to our business, including weakened demand for our product candidates, if approved, or our ability to raise additional capital when needed on acceptable terms, if at all.

A severe or prolonged economic downturn, including as a result of pandemics or other public health crises, the ongoing war between Russia and Ukraine, conflicts in the Middle East, including the recent hostilities involving Iran, tension between China and Taiwan, geopolitical tensions in Europe, South America, and elsewhere, interest rate fluctuations, rising inflation, recession, or other global financial, geopolitical crises or macroeconomic factors, could result in a variety of risks to our business, including weakened demand for our product candidates, if approved, or our ability to raise additional capital when needed on acceptable terms, if at all.

Recent global events such as supply chain constraints have led to higher inflation, which, if sustained, could have a negative impact on our product development and operations.

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A significant worsening of global economic conditions could precipitate or materially amplify the other risks described herein.

Furthermore, the range of actions the new Administration has taken, and may take, around tariffs and trade and the associated uncertainty of how such actions may be implemented, may have adverse effects on the global economic environment and could also amplify such other risks.

Furthermore, the range of actions taken to date, as well as those that may occur in the future, around tariffs and trade and the associated uncertainty of how such actions may be implemented, may have adverse effects on the global economic environment and could also amplify such other risks.

Global conflicts or a weak or declining economy may increase the likelihood disruptions of our clinical trials or manufacturing and supply of our product candidates.

We are currently conducting our ANTLER clinical trial at sites in Israel and, although we have not experienced delays or interruptions to date, given the conflict in the Middle East, we may experience disruptions at these sites in the future.

Additionally, any supply disruptions could make it more difficult for us to find favorable pricing and reliable sources for the materials we need, which would increase pressure on our costs and increase the risk that we may be unable to acquire the necessary materials to successfully manufacture our product candidates.

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Similarly, these macroeconomic factors could affect the ability of our third-party suppliers and CMOs to manufacture clinical trial materials for our product candidates.

Furthermore, we currently conduct some clinical trials

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outside of the United States, and unfavorable global conditions could affect these trials.

Furthermore, we currently conduct some clinical trials outside of the United States, and unfavorable global conditions could affect these trials.

Any of the foregoing could harm our business and we cannot anticipate all of the ways in which such conditions could adversely impact our business.

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Some of the factors that may cause the market price of our common stock to fluctuate include:

• the timing and results of preclinical studies and clinical trials for any product candidates that we develop;

• delay, failure, or discontinuation of any of our product candidates or research programs;

• results of preclinical studies, clinical trials, or regulatory approvals of product candidates of our competitors, or announcements about new research programs or product candidates of our competitors;

• the timing and results of our clinical trials;

• delay, failure, or discontinuation of any of our product candidates;

• results of nonclinical studies, clinical trials, or regulatory approvals of product candidates of our competitors, or announcements about new research programs or product candidates of our competitors;

• adverse regulatory decisions, including failure to receive regulatory approval of one or more of our product candidates;

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• acceptance or lack of acceptance of allogeneic CAR-T cell therapies as compared with autologous CAR-T cell therapies and perceptions that allogeneic CAR-T cell therapies do not maintain a durable response;

• inability to obtain collaboration partners;

• inability to obtain and maintain collaboration partners;

• the recruitment and retention of key personnel;

• the level of expenses related to any of our product candidates, including preclinical studies and clinical trials, as well as the level related to our research programs;

• the level of expenses related to any of our product candidates, including clinical trials;

• the results of our efforts to develop additional product candidates or technologies;

• actual or anticipated changes in estimates as to financial results, development timelines, or recommendations by securities analysts;

• announcements or expectations of additional financing efforts;

• announcements, expectations, or structures of additional financing efforts;

• significant lawsuits, including contract disputes with our licensors, licensees, assignors, assignees, suppliers, CMOs, CROs, clinical sites, or securities class action litigation;

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• market conditions in the pharmaceutical and biotechnology sectors;

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• general economic and political conditions such as recessions, inflationary pressures, interest rates, fuel prices, elections, drug pricing policies, international currency fluctuations, acts of war or terrorism, geopolitical events, and public health crises;

• general economic and political conditions such as recessions, inflationary pressures, interest rates, fuel prices, elections, drug and biologic pricing policies, international currency fluctuations, acts of war or terrorism, geopolitical events, and public health crises;

• the other factors described in this “Risk Factors” section.

Our failure to meet the continued listing requirements of Nasdaq could result in the delisting of our common stock.

Our common stock is currently listed on the Nasdaq Global Select Market.

The trading price of our common stock has been volatile and has traded between $1.00 and below $2.00 for the past three months and at various times over the past nine months.

On March 7, 2025, the closing price of our stock was $1.16.

In order to maintain our listing on the Nasdaq Global Select Market, we must continue to satisfy minimum financial and other continued listing requirements and standards, including a minimum closing bid price of $1.00 per share.

A failure to meet the minimum closing bid price requirement occurs when a company’s security has a closing bid price below $1.00 for a period of 30 consecutive trading days.

There can be no assurance that we will continue to be able to comply with the applicable Nasdaq Global Select listing requirements, or, if transferred, the Nasdaq Capital Market listing standards.

If we fail to comply with the continued listing requirements of Nasdaq, Nasdaq may take steps to delist our common stock.

If we fail to meet the minimum closing bid price requirement, we may need to implement a reverse stock split, which would require stockholder approval;

there is no guarantee that such approval could be obtained and, even if it is obtained, we may fail to comply with applicable listing requirements thereafter.

In the event that our common stock is delisted from Nasdaq and is not eligible for quotation or listing on another market or exchange, trading of our common stock could be conducted only in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board.

If this were to occur, it could become more difficult to dispose of, or obtain accurate price quotations for, our common stock and there would likely also be a reduction in our coverage by securities analysts and the news media, which could cause the price of our common stock to decline further.

Furthermore, if we were to be delisted from Nasdaq, our common stock would cease to be recognized as “covered securities” and we would be subject to regulation in each state in which we offer our securities.

Additionally, if Nasdaq delists our securities from trading on its exchange, we and our stockholders could face significant negative consequences, including reduced liquidity for our securities, a determination that shares of our common stock are “penny stock,” which will require brokers to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities, and a decreased ability to issue additional securities or obtain additional financing in the future.

We are subject to securities class action litigation, and our officers and directors may be subject to shareholder derivative lawsuits, which may result in substantial costs and a diversion of management's attention and resources, which could harm our business.

In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities, and we recently settled one such class action and are currently defending another in the U.S.

District Court for the Northern District of California, filed by purported stockholders against us and certain of our current and former officers.

Additionally, a shareholder derivative complaint has been filed against our directors and certain of our current and former officers in the same court relating to the pending securities class action litigation.

See Legal Proceedings in Item 3 of this Annual Report on Form 10-K for additional information.

There is no guarantee that we will be able to settle this new securities class action litigation and, if we are able to settle, for what amount.

We may face additional securities class action litigation, and our officers and directors may be subject to shareholder derivative suits, in the future.

We may not remain in compliance with the continued listing requirements of Nasdaq, and, if we are not able to remain in compliance, our common stock will be subject to delisting.

Our common stock is currently listed for trading on the Nasdaq Global Select Market under the symbol “CRBU.” The continued listing of our common stock on Nasdaq is subject to our compliance with a number of listing standards.

On May 7, 2025, we received a letter from the Listing Qualifications Staff (“Staff”) of The Nasdaq Stock Market LLC notifying us that, for the prior 30 consecutive business days, the bid price for our shares of common stock had closed below $1.00 per share, which is the minimum bid price required to maintain continued listing on the Nasdaq Global Select Market under Nasdaq Listing Rule 5450(a)(1) (“Minimum Bid Price Rule”).

On June 18, 2025, we received a written notice (“Compliance Notice”) from the Staff notifying us that, from June 3, 2025, to June 17, 2025, the closing bid price of the our common stock had been $1.00 per share or greater and, accordingly, we had regained compliance the Minimum Bid Price Rule.

We cannot provide any assurance that, in the future, we will remain in compliance with the Minimum Bid Price Rule, and the bid price of our shares of common stock may again close below $1.00 per share for 30 consecutive business days.

In such event, we will have 180 calendar days to regain compliance as long as we have not implemented a reverse stock split within the one-year period before we fail to be in compliance with the Minimum Bid Price Rule.

To regain compliance during a compliance period, the closing bid price of our common stock must be at least $1.00 per share for a minimum of 10 consecutive business days during this 180-calendar day period, at which time the Staff will provide written notification to us that our stock complies with the Minimum Bid Price Rule, unless the Staff exercises its discretion to extend this 10-business day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H).

We cannot provide any assurance that our common stock will regain compliance with the Minimum Bid Price Rule by any compliance deadline.

Even if the market price per post-reverse stock split share of our common stock remains in excess of $1.00 per share, we may be delisted due to a failure to meet other continued listing requirements, including Nasdaq requirements related to the minimum number of shares that must be in the public float, the minimum market value of the public float, and the minimum number of market makers, among others.

If we are unable to satisfy the Nasdaq criteria for continued listing, our common stock would be subject to delisting.

A delisting of our common stock could negatively impact us by, among other things, (i) reducing the liquidity and market price of our common stock;

(ii) reducing the number of investors willing to hold or acquire our common stock, which could negatively impact our ability to raise equity financing;

(iii) decreasing the amount of news and analyst coverage of us;

(iv) limiting our ability to issue additional securities or obtain additional financing in the future;

(v) limiting the number of shares we could sell under a registration statement to offer and sell freely tradable securities, thereby reducing the amount of capital we could raise in the public capital markets;

and (vi) impairing our ability to provide equity incentives to our employees.

In addition, delisting from Nasdaq may negatively impact our reputation and, consequently, our business.

If this happens, we cannot provide any assurance that we will be able to regain compliance with the applicable Nasdaq Global Select listing requirements, or, if our listing is transferred to the Nasdaq Capital Market, that we will meet the continued listing requirement for the market value of publicly held shares and all other initial listing standards of the Nasdaq Capital Market, with the exception of the Minimum Bid Price Rule.

Our stockholders have approved an amendment to our amended and restated certificate of incorporation to effect a reverse stock split at the discretion of our board of directors.

We cannot provide any assurance that a reverse stock split, if implemented, will increase our stock price for a sustained period or will cause our stock to maintain compliance with Nasdaq continued listing requirements.

At our 2025 Annual Meeting of Stockholders held on June 12, 2025, our stockholders approved a proposal to adopt an amendment to our amended and restated certificate of incorporation to effect a reverse stock split at a ratio ranging from any whole number between 1-for-5 and 1-for-50 inclusive (“Split Ratio Range”), as determined by our board of directors in its discretion, subject to our board of directors’ authority to abandon such amendment.

Our board of directors has the sole authority to elect, at any time on or prior to June 12, 2026, whether or not to effect a reverse stock split.

Our board of directors could decide to implement a reverse stock split for a variety of business reasons, including but not limited to, regaining compliance with Nasdaq continued listing requirements in the event we are not in compliance with the Minimum Bid Price Rule;

increasing the marketability of our common stock since investors, brokerage firms, and market makers consider low-priced stocks as unduly speculative in nature, in part due to the trading volatility often associated with stocks below certain prices, and, as a matter of policy, avoid investment and trading in such stocks;

decreasing price volatility as currently small changes in the price of our common stock result in relatively large percentage changes in the stock price;

and, providing more authorized shares available for issuance in capital-raising transactions by reducing the number of issued and outstanding shares.

If a reverse stock split is implemented, we expect that a reverse stock split will increase the market price of our common stock.

However, the effect of a reverse stock split on the market price of our common stock cannot be predicted with any certainty, and the history of similar reverse stock splits for companies in like circumstances is varied, particularly since some investors may view a reverse stock split negatively.

It is possible that the per share price of our common stock after a reverse stock split will not rise in proportion to the reduction in the number of shares of our common stock outstanding resulting from the reverse stock split, and the reverse stock split may not result in a per share price that would attract brokers and investors who do not trade in lower-priced stocks.

Even if a reverse stock split is implemented, the market price of our common stock may decrease due to factors unrelated to the reverse stock split.

The market price of our common stock may also be based on other factors that may be unrelated to the number of shares outstanding, including the timing and content of disclosures about our clinical trials for our product candidates.

If a reverse stock split is effected and the trading price of our common stock declines, the percentage decline as an absolute number and as a percentage of our overall market capitalization may be greater than would occur in the absence of the reverse stock split.

Even if we implement a reverse stock split, we cannot provide any assurance that we will maintain compliance with the Minimum Bid Price Rule, or otherwise be in compliance with other applicable Nasdaq listing rules.

Moreover, under a recent change in Nasdaq rules, if we effect a reverse stock split and we fail to be in compliance with the Minimum Bid Price Rule within one year of that previous reverse stock split, we would not be eligible for any 180-day compliance period and we may be subject to immediate delisting.

Nasdaq’s position is that this applies to a company even if the company was in compliance with the Minimum Bid Price Rule at the time of its prior reverse stock split.

Accordingly, if we effect a reverse stock split, whether for the purpose of regaining compliance with the Minimum Bid Price Rule or other business reasons, and subsequently the closing bid price of our common stock drops below $1.00 long enough to no longer be in compliance with the Minimum Bid Price Rule within one year of a previous reverse stock split, we may suffer immediate delisting without an opportunity to regain compliance.

The effective increase in the number of authorized shares of our common stock as a result of a reverse stock split may result in dilution to existing stockholders from future issuances of shares.

Under the stockholder proposal approved at our 2025 Annual Meeting, if a reverse stock split is implemented, it would not change the total authorized number of shares of our common stock, which would remain at 300,000,000 authorized shares of common stock and 10,000,000 authorized shares of preferred stock.

However, the reduction in the issued and outstanding shares would, in effect, provide more authorized shares available for future issuance.

These additional shares would be available for issuance from time to time for corporate purposes such as issuances of common stock in connection with capital-raising transactions and acquisitions of other companies or assets, as well as for issuance upon conversion or exercise of securities such as convertible debt, warrants, or options convertible into, or exercisable for, common stock.

Although we believe that the availability of the additional shares will provide us with flexibility to meet business needs as they arise, to take advantage of favorable opportunities, and to respond effectively in a changing corporate environment, if we issue additional shares for any of these purposes, the aggregate ownership interest of our current stockholders, and the interest of each existing stockholder, would be diluted, possibly substantially.

In the past, we have conducted public and private offerings of our securities, and we will require additional capital to develop our product candidates and fund our operations.

As a result, it is foreseeable that we will seek to issue additional shares of common stock in connection with capital raising activities or any of the other activities described above, which would result in dilution of the interests of existing stockholders.

We may be subject to securities class action litigation, and our officers and directors may be subject to shareholder derivative lawsuits, which will result in substantial costs and a diversion of management's attention and resources, which could harm our business.

Securities class action litigation is often been brought against a company following a decline in the market price of its securities, and, in the past, we have had such securities class action litigation brought against us as well as shareholder derivative complaints filed against our directors and certain of our current and former officers relating to securities class action litigation.

In the future, we may face additional securities class action litigation, and our officers and directors may be subject to shareholder derivative suits.

This risk is especially relevant for us because biotechnology and pharmaceutical companies have experienced significant stock price volatility in recent years, and we expect to experience continued stock price volatility.

Defending against the current litigation and any future litigation could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

We cannot provide any assurance that we will be able to have such lawsuits dismissed or, if not, that we will be able to settle the cases.

Defending against future litigation could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.

We currently have research coverage by several biotechnology research analysts.

We currently have coverage by several biotechnology research analysts.

If any of those analysts discontinue coverage, we could lose visibility in the market for our stock, which in turn could cause our stock price to decline.

If one or more of the analysts covering our business downgrade or adjust the price target as part of their evaluations of our stock, the price of our stock could decline.

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We are an “emerging growth company” under the JOBS ACT and a “smaller reporting company” and the reduced disclosure requirements and exemptions from certain governance requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.

We are an “emerging growth company,” as defined in the JOBS Act, and may remain an emerging growth company for up to five years following our IPO (until the end of 2026).

We are an “emerging growth company,” as defined in the JOBS Act, and may remain an emerging growth company until the last day of our fiscal year following the fifth anniversary of the closing of our IPO (i.e., December 31, 2026).

For as long as we remain an emerging growth company, we are permitted and plan to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies.

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Even after we no longer qualify as an emerging growth company, we may still qualify as a smaller reporting company and would be permitted to continue to take advantage of many of the same reporting exemptions, including the exemption from the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act as long as we do not otherwise also qualify as an “accelerated filer” or “large accelerated filer” for SEC reporting purposes, and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.

In addition, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K.

In addition, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Reports on Form 10-K.

We cannot predict if investors will find our common stock less attractive if we rely on emerging growth company or smaller reporting company exemptions.

If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

If some investors determine that our common stock is less attractive, there may be a less active trading market for our common stock and our stock price may be more volatile.

We have incurred, and will continue to incur, increased costs as a result of operating as a public company, and our management will continue to devote substantial time to compliance initiatives and corporate governance practices.

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As a public company, we are subject to Section 404 of the Sarbanes-Oxley Act and the related rules of the SEC, which generally require our management and independent registered public accounting firm to report on the effectiveness of our internal control over financial reporting.

However, for so long as we remain an emerging growth company as defined in the JOBS Act or a smaller reporting company, we intend to take advantage of certain exemptions from various reporting requirements that are applicable to public companies that are not emerging growth companies or smaller reporting companies, including, but not limited to, not being required to comply with the auditor attestation requirements of

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Once we are no longer either an emerging growth company or a smaller reporting company or, if prior to such date, we opt to no longer take advantage of the applicable exemption, we will be required to include an opinion from our independent registered public accounting firm on the effectiveness of our internal control over financial reporting.

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• require supermajority votes of the holders of our common stock to amend our amended and restated bylaws and specified provisions of our amended and restated certificate of incorporation.

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These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management.

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In February 2024, the California state court granted our motion to dismiss on the grounds that our amended and restated certification of incorporation mandates that Securities Act claims against us be brought in federal court.

Although we were successful in the Lowry Case and we will vigorously assert the validity and enforceability of our exclusive federal forum provision in any future litigation in other jurisdictions, this may require significant additional costs associated with resolving the action and there can be no assurance that the federal forum provision will be enforced by a court in the future or in other jurisdictions.

Although we were successful in the Lowry Case and we will vigorously assert the validity and enforceability of our exclusive federal forum provision in any future litigation in other jurisdictions, this may require significant additional costs associated with resolving the action, and we cannot provide any assurance that the federal forum provision will be enforced by a court in the future or in other jurisdictions.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors