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To date, we have financed our operations primarily with proceeds from our license and collaboration agreements and the issuance and sale of our capital stock, including most recently:
−Removed: (i) net proceeds of approximately $19.3 million, after deducting sales agent commissions, but before deducting any expenses related to such sales, from sales of our common stock under our “at-the-market” program in January 2024 and (ii) net proceeds of approximately $91.7 million, after deducting the underwriting discount and commissions and other estimated offering expenses, from the sale of our common stock and pre-funded warrants in an underwritten public offering in January 2024.
+Added: (i) net proceeds of approximately $19.3 million, after deducting sales agent commissions, but before deducting any expenses related to such sales, from sales of our common stock under our “at-the-market” program in January 2024;
+Added: (ii) net proceeds of approximately $91.7 million, after deducting the underwriting discount and commissions and other estimated offering expenses, from the sale of our common stock and pre-funded warrants in an underwritten public offering in January 2024;
+Added: and (iii) net proceeds of approximately $74.8 million, after deducting the underwriting discount and commissions and other estimated offering expenses, from the sale of our common stock and pre-funded warrants in an underwritten registered direct offering in October 2025.
For the year ended December 31, 2025, we recorded net loss of $116.8 million.
As of December 31, 2025, we had an accumulated deficit of $614.7 million.
−Removed: We expect to incur significant expenditures for the foreseeable future, and we expect these expenditures to increase as we continue our research and development of, and seek regulatory approvals for, product candidates based on our gamma delta T cell platform, including ADI-001 and ADI-270.
+Added: We expect to incur significant expenditures for the foreseeable future, and we expect these expenditures to increase as we continue our research and development of, and seek regulatory approvals for, product candidates based on our gamma delta T cell platform, including prula-cel and ADI-212.
Even if we succeed in commercializing one or more of our product candidates, we will continue to incur substantial research and development and other expenditures to develop and market additional product candidates.
−Removed: We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.
−Removed: The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue.
+Added: In addition, certain of our existing license and collaboration agreements require cash payments upon the achievement of milestone events, royalties and profit-sharing, or other cash payments.
+Added: These payment obligations, in addition to any payment obligations we may have under future arrangements with third parties, may have a substantial impact on our business, financial condition and profitability.
+Added: In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.
+Added: The size of our future net losses will depend, in part, on the rate of future
+Added: growth of our expenses and our ability to generate revenue.
Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital.
Further, even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
−Removed: Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product candidates or even continue our operations, any of which could have a material adverse effect on our
−Removed: business, financial condition, results of operations, and prospects and cause investors to lose all or part of their investments.
+Added: Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product candidates or even continue our operations, any of which could have a material adverse effect on our business, financial condition, results of operations, and prospects and cause investors to lose all or part of their investments.
Risks Related to Our Product Candidates
−Removed: Our business is highly dependent on the success of ADI-001 and ADI-270.
−Removed: If we are unable to obtain regulatory approval for ADI-001 and ADI-270 in one or more indications and effectively commercialize these product candidates for the treatment of patients in indications for which we receive approval (if any), our business would be significantly harmed.
−Removed: Our business and future success depends on our ability to obtain regulatory approval of, and then successfully commercialize ADI-001, our most advanced product candidate, and ADI-270.
−Removed: In November 2024, we dosed our first LN patient in our Phase 1 clinical study of ADI-001 in autoimmune diseases.
−Removed: We plan to report preliminary LN clinical data from this study in the first half of 2025, and data for other autoimmune diseases in the second half of 2025, subject to study site initiation and patient enrollment.
−Removed: In addition, we received FDA clearance for our IND application for ADI-270 in RCC in June 2024, and in December 2024, we dosed our first patient in our Phase 1 multicenter, open-label clinical trial to assess the safety and anti-tumor activity of ADI-270 in RCC patients.
−Removed: We plan to share preliminary clinical data from this trial in the first half of 2025.
−Removed: Our preclinical results or clinical results to date may not predict results for our planned or ongoing trials or any future studies of ADI-001, ADI-270 or any other allogeneic gamma delta T cell product candidate.
+Added: Our business is highly dependent on the success of prula-cel.
+Added: If we are unable to obtain regulatory approval for prula-cel in one or more indications and effectively commercialize this product candidate for the treatment of patients in indications for which we receive approval (if any), our business would be significantly harmed.
+Added: Our business and future success depends on our ability to obtain regulatory approval of, and then successfully commercialize prula-cel, our most advanced product candidate.
+Added: In November 2024, we dosed our first LN patient in our Phase 1 clinical study of prula-cel in autoimmune diseases.
+Added: In April 2025, we expanded enrollment to include patients with SLE in our Phase 1 clinical trial.
+Added: In July 2025, we reported that the first systemic sclerosis (SSc) patient had been dosed in the second cohort of the Phase 1 clinical trial evaluating prula-cel in autoimmune diseases and we anticipate providing a clinical update in SSc patients in the first half of 2026.
+Added: We have also opened enrollment for patients with IIM, SPS and AAV and RA.
+Added: In October 2025, we announced preliminary data from our prula-cel Phase 1 study in patients with LN and SLE.
+Added: Our preclinical results or clinical results to date may not predict results for our planned or ongoing trials or any future studies of prula-cel, ADI-212, or any other product candidates.
Because of the lack of evaluation of allogeneic products and gamma delta T cell therapy products in the clinic to date, any such product’s failure, or the failure of other allogeneic T cell therapies or gamma delta T cell therapies, may significantly influence physicians’ and regulators’ opinions in regards to the viability of our entire pipeline of allogeneic T cell therapies, which could have a material adverse effect on our reputation.
If our gamma delta T cell therapy is viewed as less safe or effective than autologous therapies or other allogeneic T cell therapies, our ability to develop other allogeneic gamma delta T cell therapies may be significantly harmed.
−Removed: All of our product candidates, including ADI-001 and ADI-270, will require additional clinical and non-clinical development, regulatory review and approval in multiple jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales.
−Removed: In addition, because ADI-001 is our most advanced product candidate, and because our other product candidates are based on similar technology, if ADI-001 encounters safety or efficacy problems, manufacturing problems, developmental delays, regulatory issues or other problems, our development plans and business would be significantly harmed, which could have a material adverse effect on our business, reputation and prospects.
+Added: All of our product candidates, including prula-cel and ADI-212, will require additional clinical and non-clinical development, regulatory review and approval in multiple jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales.
+Added: In addition, because prula-cel is our most advanced product candidate, and because our other product candidates are based on similar technology, if prula-cel encounters safety or efficacy problems, manufacturing problems, developmental delays, regulatory issues or other problems, our development plans and business would be significantly harmed, which could have a material adverse effect on our business, reputation and prospects.
Our gamma delta T cell candidates represent a novel approach to the treatment of autoimmune diseases and cancer indications that creates significant challenges for us.
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• establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy.
−Removed: The success of our business, including our ability to obtain financing and generate any revenue in the future, will primarily depend on the positive efficacy and safety profile and durability of our product candidates in our clinical trials, regulatory approval, successful development and commercialization of our novel product candidates, and our ability to build out our manufacturing capabilities, which may never occur.
+Added: The success of our business, including our ability to obtain financing and generate any revenue in the future, will primarily depend on the positive efficacy and safety profile and durability of our product candidates in our clinical trials, regulatory approval, successful development and commercialization of our novel product candidates, and our ability to build out our manufacturing capabilities, any of which may never occur.
We have not yet succeeded and may not succeed in demonstrating efficacy and safety or durability for any of our product candidates in clinical trials or in obtaining marketing approval thereafter.
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The regulatory approval process for novel product candidates such as ours can be more complex and consequently more expensive and take longer than for other, better known or extensively studied pharmaceutical or other product candidates.
−Removed: Allogeneic gamma delta T cell therapies are novel therapies, with no immunotherapies licensed to date in
+Added: Allogeneic gamma delta T cell therapies are novel therapies, with no T cell therapies licensed to date in
the United States or the European Union to treat autoimmune diseases.
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Also, while we expect reduced variability in our product candidates compared to autologous products, we do not have significant clinical data supporting any benefit of lower variability.
−Removed: More generally, approvals by any regulatory agency may not be indicative of what any other regulatory agency may require for approval or what such regulatory agencies may require for approval in connection with new product candidates.
+Added: More generally, approvals by any regulatory agency may not be indicative of what any other regulatory agencies may require for approval or what such regulatory agencies may require for approval in connection with new product candidates.
Our product candidates may also not perform successfully in clinical trials or may be associated with adverse events that distinguish them from the autologous CAR T-cell therapies that have previously been approved or alpha beta T cell therapies that may be approved in the future.
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Approved autologous CAR T-cell therapies and those under development have shown frequent rates of cytokine release syndrome and neurotoxicity, and adverse events have resulted in the death of patients.
−Removed: Additionally, in November 2023, the FDA announced an investigation into reports of T-cell malignancies in patients who had received B-cell maturation (BCMA)-directed or CD19-directed autologous CAR T cell immunotherapies.
In January 2024, the FDA determined that new boxed warning language related to T-cell malignancies should be included in the labeling for all BCMA- and CD19-directed genetically modified autologous T cell immunotherapies.
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This procedure causes side effects and, among other potential risks, can transiently compromise the patient’s immune system, known as neutropenia, and reduce blood clotting, known as thrombocytopenia.
−Removed: If we are unable to demonstrate that such adverse events were caused by the conditioning regimens used, administration process or related procedure, the FDA, the EMA or other regulatory authorities could order us to cease further development of, or deny approval of, any product candidates we may develop for any or all target indications.
−Removed: Even if we are able to demonstrate that adverse events are not related to our product candidate, such occurrences could affect patient recruitment, the ability
−Removed: of enrolled patients to complete the clinical trial or the commercial viability of any product candidates that obtain regulatory approval.
−Removed: If we are required by the FDA to obtain approval of a companion diagnostic in connection with approval of any of our product candidates, including in connection with our gamma delta T cell therapy targeting CD70, and we do not obtain, or face delays in obtaining, FDA approval of such companion diagnostic, we will not be able to commercialize such product candidate and our ability to generate revenue will be materially impaired.
+Added: If we are unable to demonstrate that such adverse events were caused by the conditioning regimens used, administration process or related procedure, or were otherwise unrelated to the therapy candidate being studied, the FDA, the EMA or other regulatory authorities could order us to cease further development of, or deny approval of, any product candidates we may develop for any or all target indications.
+Added: Even if we are able to demonstrate that adverse events are not related to our product candidate, such occurrences could affect patient recruitment, the ability of enrolled patients to complete the clinical trial or the commercial viability of any product candidates that obtain regulatory approval.
+Added: 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 such companion diagnostic, we will not be able to commercialize such product candidate and our ability to generate revenue will be materially impaired.
If the FDA believes that the safe and effective use of any of our product candidates depends on an in vitro diagnostic, then it may require approval or clearance of that diagnostic as a companion diagnostic at the same time that the FDA approves our product candidates, if at all.
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The process of obtaining or creating such diagnostic is time consuming and costly.
−Removed: Companion diagnostics are developed in conjunction with clinical programs for the associated product and are subject to regulation as medical devices by the FDA and comparable foreign regulatory authorities, and the FDA has generally required premarket approval of companion diagnostics for cancer therapies.
+Added: Companion diagnostics are developed in conjunction with clinical programs for the associated product and are subject to regulation as medical devices by the FDA and comparable foreign regulatory authorities.
In January 2024, FDA announced its intention to initiate the reclassification process for most in vitro diagnostics, including companion diagnostics.
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Any delay or failure by us or third party collaborators to develop or obtain regulatory approval or clearance of a companion diagnostic could delay or prevent approval or continued marketing of the relevant product.
−Removed: We or our collaborators may also experience delays in developing a sustainable, reproducible and scalable manufacturing process for the companion diagnostic or in transferring that process to commercial partners or negotiating insurance reimbursement plans, all of which may prevent us from completing our clinical trials or commercializing our product candidates, if approved, on a timely or profitable basis, if at all.
+Added: We or our collaborators may also experience delays in developing a sustainable, reproducible and scalable manufacturing process for the companion diagnostic or in transferring that process to commercial partners or negotiating insurance reimbursement plans, any of which may prevent us from completing our clinical trials or, if approved, commercializing our product candidates on a timely or profitable basis, if at all.
Risks Related to Clinical Trials
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A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy, insufficient durability of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials.
−Removed: Most product candidates that commence clinical trials are never approved as products.
−Removed: In addition, for the ongoing Phase 1 study of ADI-001 and any future trials that may be completed, we cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit our product candidates for approval.
−Removed: To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, approval of our product candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates.
+Added: Most product candidates that commence clinical trials are never approved.
+Added: In addition, for the ongoing Phase 1 study of prula-cel and any future clinical trials that may be completed, we cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit marketing applications for our product candidates.
+Added: To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application,
+Added: approval of our product candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates.
Any of the foregoing could have a material adverse effect on our business, prospects and financial condition.
−Removed: We may not be able to file IND applications to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.
−Removed: In December 2023, the IND for our lead product candidate, ADI-001, to treat patients with LN was cleared by the FDA.
−Removed: In the second quarter of 2024, we received clearance for our IND for ADI-001 to include SLE, SSc and AAV.
−Removed: In October 2024, we received clearance for our IND amendment to evaluate ADI-001 in IIM and SPS as part of the ongoing Phase 1 trial in autoimmune diseases.
−Removed: Our pipeline also includes ADI-270, an armored gamma delta CAR T cell product candidate targeting CD70+ cancers.
−Removed: In June 2024, our IND for ADI-270 in RCC was cleared by the FDA.
−Removed: We also have several additional internal gamma delta T cell therapy programs in preclinical development.
−Removed: We previously announced our plan to file one new IND every 12-18 months.
+Added: We may not be able to file IND applications, or comparable regulatory submissions outside the United States, to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA or analogous regulatory authorities may not permit us to proceed.
+Added: We have received clearance for INDs to evaluate prula-cel in clinical trials in a number of indications.
+Added: Our pipeline also includes ADI-212, an optimized next-generation gene-edited and armored clinical candidate targeting prostate specific membrane antigen (PSMA).
+Added: We expect to submit a regulatory filing for ADI-212, such as an IND application or comparable regulatory submission outside the United States, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the third quarter of 2026.
+Added: We aim to submit a new regulatory submission, such as an IND application or equivalent every 12-18 months.
We may not be able to make these filings on the timelines we expect, which may cause delays in commencing additional clinical trials.
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For example, we may experience manufacturing delays or other delays with IND-enabling studies or the FDA, the EMA or other regulatory authorities may require additional preclinical studies that we did not anticipate.
−Removed: Moreover, we cannot be assured that submission of an IND application will result in the FDA allowing clinical trials to begin, or that, once begun, issues will not arise that result in a decision by us, by IRBs, or independent ethics committees or by the FDA, the EMA or other regulatory authorities to suspend or terminate clinical trials, including as a result of a clinical hold.
−Removed: Additionally, even if such regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND application or clinical trial application, we cannot guarantee that such regulatory authorities will not change their requirements in the future.
−Removed: The inability to initiate clinical trials any of our product candidates on the timeline currently anticipated or at all could have a material adverse effect on our business, results of operations and prospects.
+Added: The inability to initiate clinical trials any of our product candidates on the timeline we currently anticipate or at all could have a material adverse effect on our business, results of operations and prospects.
We may encounter substantial delays in our clinical trials, or may not be able to conduct our trials on the timelines we expect.
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We cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all.
−Removed: Even if these trials begin as planned, issues may arise that could suspend or terminate such clinical trials.
−Removed: A failure of one or more clinical studies can occur at any stage of testing, and our future clinical studies may not be successful.
−Removed: Events that may prevent successful or timely completion of clinical development include:
+Added: Even if these trials begin as planned, issues may arise that could result in the suspension, or termination, or clinical hold of such clinical trials.
+Added: A failure of one or more clinical studies can occur at any stage of testing, and our ongoing or future clinical studies may not be successful.
+Added: Factors that may prevent successful or timely completion of clinical development include:
• inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation of clinical studies;
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as a result of a safety finding that presents unreasonable risk to clinical trial participants;
−Removed: a negative finding from an inspection of our clinical study operations or study sites;
+Added: a negative finding from
+Added: an inspection of our clinical study operations or study sites;
developments on trials conducted by competitors for related technology that raises FDA concerns about risk to patients of the technology broadly;
or if FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives;
−Removed: • delays in recruiting suitable patients to participate in our clinical studies;
+Added: • delays in recruiting eligible patients to participate in our clinical studies;
• difficulty collaborating with patient groups and investigators;
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• challenges in transferring manufacturing processes to any new contract development and manufacturing organizations (CDMOs) or our manufacturing facilities or any other development or commercialization partner for the manufacture of product candidates;
−Removed: • delays in having patients’ complete participation in a study or return for post-treatment follow-up;
+Added: • delays in having patients’ complete participation in a study or failure to return for post-treatment follow-up;
• developing and implementing processes and procedures with collaborators, if applicable, relating to the collection and transfer of patient samples and the timely performance of a companion diagnostic on such samples;
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• manufacturing challenges, including delays in testing, releasing, validating, or importing/exporting sufficient stable quantities of our product candidates for use in clinical studies or the inability to do any of the foregoing.
−Removed: Our timing of filing INDs for our product candidates is dependent on further preclinical and manufacturing success, which we work on with various third parties.
−Removed: We cannot be sure that we will be able to submit our INDs in a
−Removed: timely manner, if at all, or that submission of an IND application or IND amendment will result in the FDA allowing testing and clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate such clinical trials.
+Added: Timelines for filing INDs for our product candidates are dependent on further preclinical and manufacturing success, which we work on with various third parties.
+Added: We cannot be sure that we will be able to submit our INDs in a timely manner, if at all, or that submission of an IND application or IND amendment will result in the FDA allowing testing and clinical trials to begin, or that, once begun, issues will not arise that result in the suspension, termination, or clinical hold of such clinical trials.
Any inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenue.
In addition, if we make manufacturing or formulation changes to our product candidates, we may be required to or we may elect to conduct additional studies to bridge our modified product candidates to earlier versions.
−Removed: Clinical study delays could also shorten any periods during which our products have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.
+Added: Clinical study delays could also shorten any periods during which our products have
+Added: patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.
Monitoring safety of patients receiving our product candidates is challenging, which could adversely affect our ability to obtain regulatory approval and commercialize.
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Nonetheless, these centers and hospitals may have difficulty observing patients and treating toxicities, which may be more challenging due to personnel changes, inexperience, shift changes, house staff coverage or related issues.
−Removed: This could lead to more severe or prolonged toxicities or even patient deaths, which could result in us or the FDA delaying, suspending or terminating one or more of our clinical trials, and which could jeopardize regulatory approval.
−Removed: Medicines used at centers to help manage adverse side effects of ADI-001 and ADI-270 may not adequately control the side effects and/or may have a detrimental impact on the efficacy of the treatment.
+Added: Any such difficulties could lead to more severe or prolonged toxicities or even patient deaths, which could result in us or the FDA delaying, suspending, terminating, or issuing a clinical hold on one or more of our clinical trials, and which could jeopardize regulatory approval.
+Added: Medicines used at centers to help manage adverse side effects of prula-cel or our other product candidates may not adequately control the side effects and/or may have a detrimental impact on the efficacy of the treatment.
Use of these medicines may increase with new physicians and centers administering our product candidates, any of which could have a material adverse effect on our ability to obtain regulatory approval and commercialize on the timelines anticipated or at all, which could have a material adverse effect on our business and results of operations.
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The enrollment of patients depends on many factors, including:
−Removed: • the patient eligibility criteria defined in the protocol;
+Added: • the patient eligibility criteria and exclusion criteria defined in the protocol;
• the size of the patient population required for analysis of the trial’s primary endpoints;
• the proximity of patients to study sites;
+Added: • the number and location of clinical sites, including the potential impact of global or regional conflicts;
• the design of the trial;
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• the risk that patients enrolled in clinical trials will drop out of the trials before the infusion of our product candidates or trial completion.
−Removed: In addition, our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors.
+Added: In addition, our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition may reduce the number and types of patients available to us because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors.
Since the number of qualified clinical investigators is limited, some of our clinical trial sites are also being used by some of our competitors, which may reduce the number of patients who are available for our clinical trials in that clinical trial site.
Moreover, because our product candidates represent unproven methods for the treatment of autoimmune diseases and cancer, potential patients and their doctors may be inclined to use conventional therapies rather than enroll in our clinical trial.
−Removed: For cancer, they may use chemotherapy and hematopoietic cell transplantation or autologous CAR T cell
+Added: For cancer, they may use chemotherapy and hematopoietic cell transplantation or autologous CAR T cell therapies.
Patients eligible for allogeneic CAR T cell therapies but ineligible for autologous CAR T cell therapies due to aggressive cancer and inability to wait for autologous CAR T cell therapies may be at greater risk for complications and death from therapy.
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Human clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.
−Removed: Because our gamma delta T cell product candidates are based on new technologies and will require the creation of inventory of mass-produced, “off-the-shelf” products, we expect that we will require extensive research and development and have substantial manufacturing and processing costs.
+Added: Because our gamma delta T cell product candidates are based on novel technologies and will require the creation of inventory of mass-produced, “off-the-shelf” products, we expect that we will require extensive research and development and have substantial manufacturing and processing costs.
In addition, costs to treat patients with autoimmune diseases and cancer and to treat potential side effects that may result from our product candidates can be significant.
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As a result, because we have limited financial and managerial resources, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential.
−Removed: For example, in November 2023, we announced that we paused preclinical development of ADI-925 to prioritize corporate resources on ADI-270.
−Removed: In January 2024, we announced we had deprioritized enrollment of large B cell lymphoma patients in our Phase 1 clinical trial of ADI-001 in non-Hodgkin's lymphoma and in September 2024 we announced a strategic prioritization to focus ADI-001 development resources on autoimmune indications.
−Removed: Due to this prioritization, patient enrollment in the Phase 1 clinical study of ADI-001 in mantle cell lymphoma has been closed.
+Added: For example, in January 2024, we announced we had deprioritized enrollment of large B cell lymphoma patients in our Phase 1 clinical trial of prula-cel in non-Hodgkin's lymphoma and in September 2024 we announced a strategic prioritization to focus prula-cel development resources on autoimmune indications.
+Added: In July 2025, we also announced that we discontinued the development of ADI-270 for patients with metastatic/advanced clear renal cell carcinoma to prioritize corporate resources on prula-cel and ADI-212.
Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.
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We are currently conducting research and development activities outside of the United States, including in China, and plan to continue to globally develop our product candidates.
−Removed: Accordingly, we expect that our development programs will be subject to additional risks related to operating in foreign countries, including:
+Added: Accordingly, we expect that our development programs will be subject to additional risks related to operating in foreign countries, including but not limited to:
• differing and changing regulatory requirements in foreign countries, including for clinical trial activities and product approvals;
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• import and export requirements and restrictions;
−Removed: • economic weakness, including inflation, or political instability in particular foreign economies and markets;
+Added: • economic weakness, including inflation, or political instability and/or armed conflicts in particular foreign countries and markets;
• difficulties in compliance with different, complex and changing laws, regulations and court systems of multiple jurisdictions and compliance with a wide variety of foreign laws, treaties and regulations;
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• production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad.
−Removed: Furthermore, conducting clinical trials in countries outside the United States presents additional risks, including political and economic risks that are not present in the United States, such as armed conflict and economic embargoes or boycotts.
−Removed: We currently conduct and plan in the future to initiate clinical trials of ADI-001 at sites outside of the United States, which may be located in countries involved in or impacted by political unrest and conflicts.
+Added: Furthermore, conducting clinical trials in countries outside the United States presents additional risks, including political and economic risks, such as armed conflict and economic embargoes or boycotts.
+Added: We currently conduct and plan in the future to initiate clinical trials of prula-cel at sites outside of the United States, which may be located in countries involved in or impacted by political unrest and conflicts.
For example, while we currently do not expect armed conflicts, such as the conflicts between Russia and Ukraine or Israel and Hamas, or related developments to have a significant impact on our ability to obtain results from our clinical trials, further escalation (whether in these countries or surrounding areas) may adversely affect our ability to adequately conduct certain clinical trials and maintain compliance with relevant protocols due to, among other reasons, the prioritization of hospital resources away from clinical trials, reallocation or evacuation of site staff and subjects, or as a result of government-imposed curfews, warfare, violence, or other governmental action or other events that restrict movement.
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Such interruptions may delay our plans for clinical development and approvals for our product candidates.
+Added: We have conducted, and may in the future conduct, certain clinical trials for our product candidates outside of the U.S.
+Added: However, the FDA and comparable foreign regulatory authorities may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.
+Added: We conducted our Phase 1 clinical trial for prula-cel in RA outside the U.S., and may conduct one or more of our subsequent clinical trials for our product candidates outside the U.S.
+Added: Although the FDA may accept data from clinical trials conducted outside the U.S., acceptance of this data is subject to certain conditions imposed by the FDA.
+Added: Where data from foreign clinical trials are intended to serve as the basis for marketing approval in the U.S., the FDA will not approve the application on the basis of foreign data alone unless those data are applicable to the U.S.
+Added: population and U.S.
+Added: medical practice;
+Added: the studies were performed by clinical investigators of recognized competence;
+Added: and the data are considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means.
+Added: For studies that are conducted only at sites outside of the U.S.
+Added: and not subject to an IND, the FDA generally does not provide advance comment on the clinical protocols for the studies, and therefore there is an additional potential risk that the FDA could determine that the study design or protocol for a non-U.S.
+Added: clinical trial was inadequate, and require us to conduct additional clinical trials.
+Added: In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the study is well-designed and well-conducted in accordance with GCP and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary.
+Added: Many foreign regulatory authorities have similar approval requirements.
+Added: If the FDA does not accept data from our clinical trials of our product candidates, we would likely need to conduct additional clinical trials, which would be costly and time consuming and could delay or halt our development of our product candidates.
These and other risks associated with our potential international operations may materially adversely affect our ability to develop our product candidates and attain or maintain profitable operations, which could have a material adverse effect on our business and results of operations.
2 unchanged sentences
The FDA often approves new therapies initially only for use in patients who are currently not adequately treated with currently approved therapies.
−Removed: We expect to initially seek approval of ADI-001 and our other product candidates in this setting.
+Added: We expect to initially seek approval of prula-cel and our other product candidates in this setting.
Subsequently, for those products that prove to be sufficiently beneficial, if any, we would expect to seek approval in earlier lines of treatment and potentially as a first line therapy.
−Removed: There is no guarantee that our product candidates, even if approved, would be approved for earlier lines of therapy, and, prior to any such approvals, we will have to conduct additional clinical trials, including potentially comparative trials against approved therapies.
+Added: There is no guarantee that our product candidates, even if approved, would be approved for earlier lines of therapy, and, prior to any such approvals, we may have to conduct additional clinical trials, including potentially comparative trials against approved therapies.
We are also targeting a similar patient population as autologous CAR T-cell product candidates, including approved autologous CAR T-cell products.
1 unchanged sentence
Our projections of both the number of people who have the indications we are targeting, as well as the subset of people with these indications in a position to receive second or later lines of therapy and who have the potential to benefit from treatment with our product candidates, are based on our beliefs and estimates.
−Removed: These estimates have been derived from a variety of sources, including scientific literature, patient foundations or market research and may prove
−Removed: to be incorrect.
+Added: These estimates have been derived from a variety of sources, including scientific literature, patient foundations or market research and may prove to be incorrect.
Further, new studies may change the estimated incidence or prevalence of these indications.
3 unchanged sentences
If we fail to develop additional product candidates, our commercial opportunity will be limited.
−Removed: One of our core strategies is to pursue clinical development of additional product candidates beyond ADI-001.
−Removed: Our pipeline also includes ADI-270, an armored gamma delta CAR T-cell product candidate targeting CD70+ cancers, which has initiated clinical development.
−Removed: In addition, we have several additional internal gamma delta T cell therapy programs in preclinical development.
−Removed: We plan to submit one new IND to the FDA every 12-18 months.
+Added: One of our core strategies is to pursue clinical development of additional product candidates beyond prula-cel.
+Added: Our pipeline also includes ADI-212, an optimized next-generation gene-edited and armored clinical candidate targeting PSMA.
+Added: We plan to submit one new IND to the FDA every 12-18 months, including a regulatory filing for ADI-212 for the treatment of mCRPC in the third quarter of 2026.
Developing, obtaining regulatory approval for and commercializing additional gamma delta T cell product candidates will require substantial additional funding and is prone to the risks of failure inherent in medical product development.
8 unchanged sentences
We will have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel.
−Removed: If we are unable or decide not to establish internal sales, marketing and distribution capabilities, we will pursue collaborative arrangements regarding the sales and marketing of our products;
+Added: If we are unable or decide not to establish internal sales, marketing and distribution capabilities, we will pursue collaborative arrangements with third parties regarding the sales and marketing of our products;
however, there can be no assurance that we will be able to establish or maintain such collaborative arrangements, or if we are able to do so, that it will have effective sales forces.
3 unchanged sentences
There can be no assurance that we will be able to develop in-house sales and distribution capabilities or establish or maintain relationships with third-party collaborators to commercialize any product that receives regulatory approval in the United States or overseas.
−Removed: If we are unable to successfully market and distribute our products, our business, results of operations and prospects could be materially adversely affected.
+Added: If we are unable to successfully market and distribute our products, either on our own or in collaboration with third parties, our business, results of operations and prospects could be materially adversely affected.
We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
The biopharmaceutical industry is characterized by intense competition and rapid innovation.
−Removed: Our competitors may be able to develop other compounds or drugs that are able to achieve similar or better results.
+Added: Our competitors may be able to develop other compounds, drugs, or biological products that are able to achieve similar or better results.
Our potential competitors include major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research institutions.
3 unchanged sentences
Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.
−Removed: competitors, either alone or with collaborative partners, may succeed in developing, acquiring or licensing on an exclusive basis drug or biologic products that are more effective, safer, more easily commercialized or less costly than our product candidates or may develop proprietary technologies or secure patent protection that we may need for the development of our technologies and products.
+Added: Our competitors, either alone or with collaborative partners, may succeed in developing, acquiring or licensing on an exclusive basis drug or biologic products that are more effective, safer, more easily commercialized or less costly than our product candidates or may develop proprietary technologies or secure patent protection that we may need for the development of our technologies and products.
Specifically, engineered T cells face significant competition in both the CAR and T cell receptor (TCR) technology space from multiple companies.
2 unchanged sentences
Risks Related to Manufacturing
−Removed: Although we have commenced manufacturing operations at our manufacturing facility, we currently depend on the ability of our third-party suppliers and manufacturers with whom we contract to perform adequately, particularly with respect to the timely production and delivery of our product candidates, including ADI-001.
+Added: Although we have commenced manufacturing operations at our manufacturing facility, we currently depend on the ability of our third-party suppliers and manufacturers with whom we contract to perform adequately, particularly with respect to the timely production and delivery of our product candidates, including prula-cel.
This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
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We have experienced manufacturing delays due to these issues in the past and cannot assure you that any stability or other issues relating to the manufacture of our product candidates will not occur in the future.
−Removed: Our product candidates and any products that we may develop may compete with other product candidates and approved products for access to manufacturing facilities.
+Added: Our product candidates and any products that we may develop may compete with other companies’ product candidates and approved products for access to manufacturing facilities.
There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us.
9 unchanged sentences
The loss of the services of any of our executive officers, other key employees and other scientific and medical advisors, and our inability to find suitable replacements could result in delays in product development and harm our business.
+Added: Although we announced a workforce reduction in July 2025, we expect that we will have a need to recruit and hire qualified personnel as we advance our programs and expand operations.
+Added: Our recent workforce reduction could impede future recruiting and hiring efforts.
+Added: Failure to successfully recruit and retain personnel could impact our anticipated development plans and timelines.
We conduct substantially all of our operations at our facilities in the San Francisco Bay Area.
9 unchanged sentences
Despite our efforts to retain valuable employees, members of our management, scientific and development teams may terminate their employment with us on short notice.
−Removed: Although we have employment agreements with our key employees, these employment agreements provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice.
+Added: Although we have employment agreements with our
+Added: key employees, these employment agreements provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice.
We do not maintain “key person” insurance policies on the lives of these individuals or the lives of any of our other employees.
4 unchanged sentences
If we fail to obtain additional financing, we may be unable to complete the development and commercialization of our product candidates.
−Removed: We expect to spend a substantial amount of capital in the clinical development of our product candidates, including the ongoing and future clinical trials for ADI-001, the ongoing clinical trial for ADI-270 in RCC and IND-enabling activities for our additional internal gamma delta T cell therapy programs in preclinical development.
+Added: We expect to spend a substantial amount of capital for the clinical development of our product candidates, including the ongoing and future clinical trials for prula-cel and preparations for a regulatory filing for ADI-212.
We will need substantial additional financing to develop our products and implement our operating plans.
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We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives.
−Removed: Our license agreements may also be terminated if we are unable to meet the payment obligations under the agreements.
−Removed: We could be required to seek collaborators for our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to our product candidates in markets where we otherwise would seek to pursue development or commercialization ourselves.
+Added: In addition, certain of our license and collaboration agreements require us to make cash payments upon the achievement of certain milestone events.
+Added: In the event we are unable to meet the payment obligations under these agreements, the agreements may be terminated in accordance with the terms of such agreements.
+Added: Further, we could be required to seek collaborators for our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to our product candidates in markets where we otherwise would seek to pursue development or commercialization ourselves.
Additionally, United States and global economic uncertainty, higher interest rates and diminished credit availability may limit our ability to incur indebtedness on favorable terms.
2 unchanged sentences
We have grown rapidly and will need to continue to grow the size of our organization, and it may experience difficulties in managing this growth.
−Removed: As our development and commercialization plans and strategies develop, and as we have transitioned into operating as a public company, we have rapidly expanded our employee base and expect to continue to add managerial, operational, sales, research and development, marketing, financial and other personnel.
+Added: As our development and commercialization plans and strategies develop, and as we have transitioned into operating as a public company, we have rapidly expanded our employee base.
Current and future growth imposes significant added responsibilities on members of management, including:
3 unchanged sentences
Our future financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to effectively manage our growth, and our management may also have to divert a disproportionate amount of our attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.
−Removed: We currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants, pursuant to arrangements which expire after a certain period of time, to
−Removed: provide certain services, including certain research and development as well as general and administrative support.
+Added: We currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants, pursuant to arrangements which expire after a certain period of time, to provide certain services, including certain research and development as well as general and administrative support.
There can be no assurance that the services of independent organizations, advisors and consultants will continue to be available to us on a timely basis when needed, or that we can find qualified replacements.
12 unchanged sentences
We cannot be certain that, following a strategic transaction or license, we will achieve the results, revenue or specific net income that justifies such transaction, which could have a material adverse effect on our business and results of operations.
+Added: Our cash preservation activities, including the workforce reduction plan, may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.
+Added: In July 2025, we implemented our workforce reduction plan.
+Added: In connection with the workforce reduction plan, we expect to incur costs of approximately $2.3 million, which are primarily one-time severance benefits.
+Added: We may not realize, in full or in part, the anticipated benefits, savings and improvements in our cost structure from our restructuring efforts due to unforeseen difficulties, delays or unexpected costs.
+Added: If we are unable to realize the expected operational efficiencies and cost savings from the restructuring, our operating results and financial condition would be adversely affected.
+Added: Furthermore, our workforce reduction plan may be disruptive to our operations.
+Added: For example, headcount reductions could yield unanticipated consequences, such as increased difficulties in implementing our business strategy, including retention of remaining employees.
Risks Related to Doing Business in China and Our International Operations
1 unchanged sentence
The pharmaceutical industry in China is subject to comprehensive government regulation and supervision, encompassing the development, approval, registration, manufacturing, packaging, licensing and marketing of new drugs.
−Removed: For example, under the People's Republic of China (PRC) law, before we or our subsidiaries commence a clinical trial with Shanghai Adicet Biotechnology Co., Ltd., our variable interest entity (the Adicet VIE), an approval or filing, as the case may be, needs to be obtained in advance for any projects in respect of human genetic resources in order to collect any biological samples that contain the genetic material of Chinese human subjects.
+Added: For example, under the People's Republic of China (PRC) law, before we or our subsidiaries commence a clinical trial with Shanghai Adicet Biotechnology Co., Ltd., (Shanghai Adicet), an approval or filing, as the case may be, needs to be obtained in advance for any projects in respect of human genetic resources in order to collect any biological samples that contain the genetic material of Chinese human subjects.
Any failure to obtain such approval or filing could cause such projects to be suspended by governing authorities, and may result in fines.
4 unchanged sentences
In recent years, the regulatory framework in China regarding the pharmaceutical industry has undergone significant changes, and we expect that it will continue to undergo significant changes.
−Removed: Any such changes or amendments may result in increased
−Removed: compliance costs on our business or cause delays in or prevent the successful development or commercialization of our product candidates in China and reduce the current benefits we believe are available to us from developing and manufacturing drugs in China.
+Added: Any such changes or amendments may result in increased compliance costs on our business or cause delays in or prevent the successful development or commercialization of our product candidates in China and reduce the current benefits we believe are available to us from developing and manufacturing drugs in China.
PRC authorities have become increasingly vigilant in enforcing laws in the pharmaceutical industry and any failure by us or our partners to maintain compliance with applicable laws and regulations or obtain and maintain required licenses and permits may result in the suspension or termination of our business activities in China.
1 unchanged sentence
In addition, the Foreign Investment Law in China grants foreign invested entities the same treatment as PRC domestic entities, except for those foreign invested entities that operate in industries deemed to be either “restricted” or “prohibited” in the “negative list” published by the Ministry of Commerce, and the National Development and Reform Commission (2024 Negative List).
−Removed: We and our PRC subsidiary, Adicet (Shanghai) Biotechnology Co., Ltd.
−Removed: (Adicet Shanghai), a wholly foreign-owned enterprise (WFOE), are currently considered to be a foreign invested entity in China.
+Added: We and our PRC subsidiaries, Adicet (Shanghai) Biotechnology Co., Ltd.
+Added: (Adicet Shanghai), and Shanghai Adicet, each a wholly foreign-owned enterprise (WFOE), are currently considered to be a foreign invested entity in China.
The 2024 Negative List provides that foreign investment is prohibited in the development and application of human stem cell or gene diagnostic and therapeutic technologies.
−Removed: As of October 2024, there has been no official interpretation of the scope of “human stem cell or gene diagnostic and therapeutic technologies” and the application of this regulation remains unclear.
−Removed: If discovering and developing our allogeneic gamma delta T cell therapies are deemed by relevant PRC regulatory agencies as falling into the category of “human stem cell or gene diagnostic and therapeutic technologies,” Adicet Shanghai would be prohibited from engaging in the research or development of such technologies.
−Removed: To comply with the PRC laws and regulations, we conduct our research and development activities in PRC through the Adicet VIE.
−Removed: It is also noted that in September 2024, Ministry of Commerce, National Healthcare Commission and National Medical Products Administration of PRC jointly announce a pilot policy (2024 Pilot Policy) to allow foreign invested entities in Free Trade Zone of Beijing, Shanghai, Guangdong and Hainan to develop human stem cell or gene diagnostic and therapeutic technologies.
−Removed: However, the application of 2024 Pilot Policy remains unclear.
+Added: To date, there has been no official interpretation of the scope of “human stem cell or gene diagnostic and therapeutic technologies” and the application of this regulation remains unclear.
+Added: If discovering and developing our allogeneic gamma delta T cell therapies are deemed by relevant PRC regulatory agencies as falling into the category of “human stem cell or gene diagnostic and therapeutic technologies,” Adicet Shanghai and Shanghai Adicet would be prohibited from engaging in the research or development of such technologies.
+Added: It is also noted that in September 2024, Ministry of Commerce, National Healthcare Commission and National Medical Products Administration of PRC jointly announce a pilot policy (2024 Pilot Policy) to allow foreign invested entities in Free Trade Zone of Beijing, Shanghai, Guangdong and Hainan to develop human stem cell or gene diagnostic and therapeutic technologies, pursuant to which Shanghai Adicet, whose registered address is within the territory of Free Trade Zone of Shanghai, conduct our research and development activities in PRC.
Any of the above factors may affect the development, approval and commercialization of our product candidates, which could have a material adverse effect on our business and financial condition.
1 unchanged sentence
In May 2024, we formed Adicet Shanghai, located in Shanghai, PRC, as a wholly owned subsidiary of Adicet Therapeutics.
−Removed: Through Adicet Shanghai, we operate our business in PRC pursuant to a series of contractual arrangements between Adicet Shanghai and the Adicet VIE, and the Adicet VIE’s shareholders, which enable us to (i) direct the activities of the Adicet VIE that most significantly impact the Adicet VIE’s economic performance, (ii) receive substantially all of the economic benefits of the Adicet VIE and its subsidiary, and (iii) have an exclusive option to purchase all or part of the equity interests and assets in the Adicet VIE, when and to the extent permitted by PRC laws.
−Removed: As a result of these contractual arrangements, Adicet Therapeutics is considered the primary beneficiary of the Adicet VIE and the Adicet VIE’s subsidiaries for accounting purposes and is able to consolidate the financial results of the Adicet VIE in the consolidated financial statements in accordance with accounting principles generally accepted in the United States of America.
−Removed: Investors in our common stock do not hold any ownership interest, directly or indirectly, in the Adicet VIE in China, and we merely have a contractual relationship with the operating entity in China.
−Removed: Our PRC legal counsel based on its understanding of the relevant laws and regulations, is of the opinion that (i) the ownership structure of Adicet Shanghai and the Adicet VIE are in compliance with applicable PRC laws or regulations and (ii) such contractual arrangements constitute valid, legal and binding obligations enforceable against each party of such agreements in accordance with the terms of each agreement, and will not result in any violation of PRC laws or regulations currently in effect.
+Added: Through Adicet Shanghai, we operate our business in PRC pursuant to a series of contractual arrangements between Adicet Shanghai and Shanghai Adicet, and the Shanghai Adicet's shareholders, which enable us to (i) direct the activities of Shanghai Adicet that most significantly impact Shanghai Adicet’s economic performance, (ii) receive substantially all of the economic benefits of Shanghai Adicet and its subsidiary, and (iii)
+Added: have an exclusive option to purchase all or part of the equity interests and assets in Shanghai Adicet, when and to the extent permitted by PRC laws.
+Added: As a result of these contractual arrangements, Adicet Therapeutics is considered the primary beneficiary of Shanghai Adicet and Shanghai Adicet’s subsidiaries (if any) for accounting purposes and is able to consolidate the financial results of Shanghai Adicet in the consolidated financial statements in accordance with accounting principles generally accepted in the United States of America.
+Added: Investors in our common stock do not hold any ownership interest, directly or indirectly, in Shanghai Adicet in China, and we merely have a contractual relationship with the operating entity in China.
+Added: Our PRC legal counsel based on its understanding of the relevant laws and regulations, is of the opinion that (i) the ownership structure of Adicet Shanghai and Shanghai Adicet are in compliance with applicable PRC laws or regulations and (ii) such contractual arrangements constitute valid, legal and binding obligations enforceable against each party of such agreements in accordance with the terms of each agreement, and will not result in any violation of PRC laws or regulations currently in effect.
However, our PRC legal counsel has also advised us that there are substantial uncertainties regarding the interpretation and application of current and future PRC laws, regulations and rules.
Accordingly, the PRC regulatory authorities may take a view that is contrary to the opinion of our PRC legal counsel.
−Removed: If we, Adicet Shanghai or the Adicet VIE are found to be in violation of any existing or future PRC laws or regulations, or fail to obtain or maintain any of the required permits or approvals, the relevant PRC regulatory authorities would have broad discretion to take action in dealing with such violations or failures, including:
−Removed: • revoking the business licenses and/or operating licenses of such entities;
−Removed: • discontinuing or placing restrictions or onerous conditions on our operation through any transactions between the WFOE and the Adicet VIE;
−Removed: • imposing fines, confiscating the income from Adicet Shanghai or the Adicet VIE, or imposing other requirements with which we or the Adicet VIE may not be able to comply;
−Removed: • requiring us to restructure our ownership structure or operations, including terminating the contractual arrangements with the Adicet VIE and deregistering the equity pledges of the Adicet VIE, which in turn would affect our ability to consolidate or derive economic interests from the Adicet VIE;
−Removed: • restricting or prohibiting use of any of our offering proceeds to finance our business and operations in China, and taking other regulatory or enforcement actions that could be harmful to our business.
−Removed: The imposition of any of these penalties would result in a material and adverse effect on our ability to conduct our business.
−Removed: In addition, it is unclear what impact the PRC government actions would have on us and on our ability to consolidate the financial results of the Adicet VIE in our consolidated financial statements, if the PRC government authorities were to find our legal structure and contractual arrangements to be in violation of PRC laws and regulations.
−Removed: If the imposition of any of these government actions causes us to lose our right to direct the activities of the Adicet VIE or our right to receive substantially all the economic benefits and residual returns from the Adicet VIE and we are not able to restructure our ownership structure and operations in a satisfactory manner, we would no longer be able to be considered the primary beneficiary of the Adicet VIE for accounting purposes or consolidate the financial results of the Adicet VIE in our consolidated financial statements.
−Removed: Either of these results, or any other significant penalties that might be imposed on us in this event, would have a material adverse effect on our financial condition and results of operations.
−Removed: We rely on contractual arrangements with the Adicet VIE and its shareholders to undertake the activities of the Adicet VIE that most significantly impact the Adicet VIE’s economic performance, which may not be as effective as direct ownership in providing operational control.
−Removed: We have relied and expect to continue to rely on contractual arrangements with the Adicet VIE and its shareholders to operate our business in China.
−Removed: These contractual arrangements may not be as effective as direct ownership of the Adicet VIE.
−Removed: For example, the Adicet VIE and its shareholders could breach their contractual arrangements with us by, among other things, failing to conduct their operations in an acceptable manner or taking other actions that are detrimental to our interests.
−Removed: If we had direct ownership of the Adicet VIE, we would be able to exercise our rights as a shareholder to effect changes in the board of directors of the Adicet VIE, which in turn could implement changes, subject to any applicable fiduciary obligations, at the management and operational level.
−Removed: However, under the current contractual arrangements, we rely on the performance by the Adicet VIE and its shareholders of their respective obligations under the contracts to direct the activities of the Adicet VIE that most significantly impact the Adicet VIE’s economic performance.
−Removed: The shareholders of the Adicet VIE may not act in the best interests of our company or may not perform their obligations under these contracts.
−Removed: Such risks exist throughout the period in which we intend to operate certain portion of our business through the contractual arrangements with the Adicet VIE.
−Removed: If any dispute relating to these contracts remains unresolved, we will have to enforce our rights under these contracts through arbitration, litigation or other legal proceedings and therefore will be subject to uncertainties in the PRC legal system.
−Removed: Therefore, our contractual arrangements with the Adicet VIE may not be as effective in controlling our business operations as direct ownership.
−Removed: Our contractual arrangements with the Adicet VIE and its shareholders are governed by PRC law.
−Removed: Accordingly, these contracts would be interpreted in accordance with PRC law, and any disputes would be resolved in accordance with PRC legal procedures, which may not protect us as much as those of other jurisdictions, such as the United States.
−Removed: All the agreements under our contractual arrangements with the Adicet VIE and its shareholders are governed by PRC law and provide for the resolution of disputes through arbitration in China.
−Removed: Accordingly, these contracts would be interpreted in accordance with PRC law and any disputes would be resolved in accordance with PRC legal procedures.
−Removed: The legal system in the PRC is not as developed as in some other jurisdictions, such as the United States.
−Removed: As a result, uncertainties in the PRC legal system could limit our ability to enforce these contractual arrangements.
−Removed: Meanwhile, there are very few precedents and little formal guidance as to how contractual arrangements in the context of a variable interest entity should be interpreted or enforced under PRC law.
−Removed: There remain significant uncertainties
−Removed: regarding the ultimate outcome of such arbitration should legal action become necessary.
−Removed: In addition, under PRC law, rulings by arbitrators are final, parties cannot appeal the arbitration results in courts, and if the losing parties fail to carry out the arbitration awards within a prescribed time limit, the prevailing parties may only enforce the arbitration awards in PRC courts through arbitration award recognition proceedings, which would require additional expenses and delay.
−Removed: In the event we are unable to enforce these contractual arrangements, or if we suffer significant delay or other obstacles in the process of enforcing these contractual arrangements, our ability to conduct our business may be negatively affected.
+Added: Following the 2024 Pilot Policy which allows foreign invested entities in Free Trade Zone of Beijing, Shanghai, Guangdong and Hainan to develop human stem cell or gene diagnostic and therapeutic technologies, Adicet Therapeutics entered into an equity transfer agreement with the then-stockholders of Shanghai Adicet to acquire 100% equity interests of Shanghai Adicet from its then-stockholders (the Acquisition).
+Added: In connection with the Acquisition, tax filings and registration with the Administration for Market Regulation of Shanghai Adicet were completed in August 2025.
+Added: Upon completion of the registration, Shanghai Adicet is now a wholly owned subsidiary of Adicet Therapeutics and will continue to conduct research and development activities in China, and the contractual arrangements between Adicet Shanghai and Shanghai Adicet is terminated accordingly.
Changes in U.S.
13 unchanged sentences
Further, researchers conducting research funded, at least in part, by the PRC government may be required to submit relevant scientific data for management by the entity to which such researcher is affiliated before such data may be published in any foreign academic journal.
−Removed: Currently, as the term “state secret” is not clearly defined, there is no assurance that we can always obtain relevant approvals for sending scientific data (such as the results of our preclinical studies or clinical trials conducted within China) abroad, or to our foreign partners in China.
+Added: Currently, as the term “state secret” is not clearly defined, there is
+Added: no assurance that we can always obtain relevant approvals for sending scientific data (such as the results of our preclinical studies or clinical trials conducted within China) abroad, or to our foreign partners in China.
If we are unable to obtain the necessary approvals in a timely manner, or at all, our research and development of product candidates may be hindered, which may materially and adversely affect our business, results of operations, financial conditions and prospects.
1 unchanged sentence
Compliance with China’s Data Security Law, Cyber Security Law, Personal Information Protection Law, regulations and guidelines relating to the multi-level protection scheme on cyber security and any other future laws and regulations may entail significant expenses and could affect our business.
−Removed: China has implemented or will implement rules and is considering a number of additional proposals relating to data protection.
+Added: China has implemented an extensive legal framework governing data security, protection and privacy.
China’s Data Security Law took effect in September 2021 and provided that the data processing activities must be conducted based on “data classification and hierarchical protection system” for the purpose of data protection and prohibits entities in China from transferring data stored in China to foreign law enforcement agencies or judicial authorities without prior approval by the Chinese government.
10 unchanged sentences
Meanwhile, the State Council of the PRC promulgates the Regulations on the Administration of Network Data Security, which came into effect on January 1, 2025, and put forward a series of detailed requirements regarding data protection.
−Removed: With regard to the cross-border transfer of personal information, the Cyberspace Administration of China released the Regulations on Promoting and Regulating Cross-border Data Flows in 2024.
+Added: With regard to the cross-border transfer of personal information, the Cyberspace Administration of China (CAC) released the Regulations on Promoting and Regulating Cross-border Data Flows in 2024.
The Regulations on Promoting and Regulating Cross-border Data Flows establishes the latest regulatory framework for the cross-border transfer of personal information.
The personal information handler should pass the security assessment, submit the standard contract signed for the provision of personal information abroad, or be certified by a specialized agency for the protection of personal information authentication before the cross-border transfer of the personal information when certain threshold provided in the Regulations on Promoting and Regulating Cross-border Data Flows is reached.
+Added: Over the past year, the CAC has issued regulatory measures focused on data security and cross-border data flows, including the February 14, 2025, “Administrative Measures for Personal Information Protection Compliance Audits”, June 27, 2025, “Guidelines for the Declaration of Data Outbound Security Assessment (3 rd Edition)”, and September 11, 2025, “Measures for the Administration of National Cybersecurity Incident Reporting”.
+Added: In addition, the National Information Security Standardisation Technical
+Added: Committee (TC260) issued its finalized “Cybersecurity Standard Practice Guidelines:
+Added: Personal Information Protection Compliance Audit Requirements”.
+Added: The CAC has also increased its enforcement activity, including a regulatory sweep focused on app and SDK developers.
+Added: We expect the CAC and additional Chinese regulators to maintain a high level of scrutiny in the data security, cross-border data transfer and artificial intelligence space.
In addition, certain industry-specific laws and regulations affect the collection and transfer of data in the PRC.
6 unchanged sentences
There remain significant uncertainties as to how various provisions of the HGR Regulation and the related laws and regulations may be interpreted and implemented.
−Removed: Given such uncertainty, although we have made great efforts to comply with
−Removed: mandatory requirements of laws and government authorities in this regard, we cannot assure you that we will be deemed at all times in full compliance with the HGR Regulation, the Biosecurity Law of the PRC, the HGR Implementing Rules and other applicable laws in our utilizing of and dealing with China’s human genetic resources.
+Added: Given such uncertainty, although we have made great efforts to comply with mandatory requirements of laws and government authorities in this regard, we cannot assure you that we will be deemed at all times in full compliance with the HGR Regulation, the Biosecurity Law of the PRC, the HGR Implementing Rules and other applicable laws in our utilizing of and dealing with China’s human genetic resources.
As a result, we may be exposed to compliance risks under the HGR Regulation, the Biosecurity Law of the PRC and the HGR Implementing Rules.
8 unchanged sentences
The pharmaceutical industry in China is subject to extensive government regulation and supervision.
−Removed: The regulatory framework addresses all aspects of operating in the pharmaceutical industry, including product development activities, clinical trials, registration, production, distribution, packaging, labeling, storage and shipment, advertising, licensing and post-approval pharmacovigilance certification requirements and procedures, periodic renewal and reassessment processes, data security and data privacy protection requirements and compliance and environmental protection.
−Removed: Violation of applicable laws and regulations may materially and adversely affect our business by impacting the Adicet VIE through which we conduct certain research and development activities.
+Added: The regulatory framework addresses all aspects of operating in the pharmaceutical industry, including product
+Added: development activities, clinical trials, registration, production, distribution, packaging, labeling, storage and shipment, advertising, licensing and post-approval pharmacovigilance certification requirements and procedures, periodic renewal and reassessment processes, data security and data privacy protection requirements and compliance and environmental protection.
+Added: Violation of applicable laws and regulations may materially and adversely affect our business by impacting Shanghai Adicet through which we conduct certain research and development activities.
The regulatory framework governing the pharmaceutical industry in China is subject to change and amendment from time to time.
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government officials for the purpose of obtaining or retaining business or other advantage.
−Removed: We may engage third parties for clinical trials outside of the United States, to sell our products abroad once we enter a commercialization phase, and/or to obtain necessary permits, licenses, patent registrations and other regulatory
+Added: We may engage third parties for clinical trials outside of the United States, to sell our products abroad once we enter a commercialization phase, and/or to obtain necessary permits, licenses, patent registrations and other regulatory approvals.
We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations.
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In 2012, the State Administration of Foreign Exchange (SAFE) promulgated the Notices on Issues Concerning the Foreign Exchange Administration for Domestic Individuals Participating in Stock Incentive Plans of Overseas Publicly Listed Companies (the Stock Option Rules).
−Removed: In accordance with the Stock Option Rules and other relevant rules and regulations, Chinese citizens or non-Chinese citizens residing in China for a continuous period of not less than one year who participate in any stock incentive plan of an overseas publicly listed company, subject to a few exceptions, are required to register with SAFE through a domestic qualified agent, which could be a Chinese subsidiary of such overseas listed company, and complete certain procedures.
+Added: In accordance with the Stock Option Rules and other relevant rules and regulations, Chinese citizens or non-Chinese citizens residing in China for a continuous period of not less than one year who participate in any stock incentive plan of an overseas publicly listed company, subject to a few exceptions, are required to register with SAFE through a domestic qualified agent, which could be a Chinese subsidiary
+Added: of such overseas listed company, and complete certain procedures.
Our employees who are Chinese citizens or who reside in China for a continuous period of not less than one year and who participate in our stock incentive plans are subject to such regulation.
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The ultimate impact on us, our significant suppliers 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 operations and financial condition could suffer in the event of a major earthquake, fire or other natural disaster.
−Removed: Global conflicts may increase the likelihood of supply interruptions which could impact our ability to find the materials we need to make our product candidates.
−Removed: Ongoing conflicts, including conflicts between Russia and Ukraine and Israel and Hamas and a deterioration in the bilateral relationship between the United States and PRC, may increase the likelihood of supply interruptions and hinder our ability to find the materials we need to make our product candidates.
+Added: Global conflicts may increase the likelihood of supply or clinical trial interruptions which could impact our ability to find the materials we need to make our product candidates or conduct our clinical trials.
+Added: Ongoing conflicts, including conflicts between Russia and Ukraine and Israel and Hamas and a deterioration in the bilateral relationship between the United States and PRC, may increase the likelihood of supply or clinical trial interruptions and hinder our ability to find the materials we need to make our product candidates or conduct our clinical trials.
Supply disruptions make it more difficult for us to find favorable pricing and reliable sources for the materials we need, which increases pressure on our costs and increases the risk that we may be unable to acquire the necessary goods and services to successfully manufacture our product candidates.
−Removed: If we were to encounter any of these difficulties, our ability to provide our product candidates to patients in preclinical studies or clinical trials, such as our ongoing or planned clinical trials of ADI-001 and ADI-270, could be delayed or suspended.
−Removed: Any delay or interruption in the supply of trial materials could delay the completion of such trials, increase the costs associated with maintaining these research and development activities and, depending upon the period of delay, require us to commence new preclinical studies or clinical trials at additional expense or terminate such trials completely.
+Added: If we were to encounter difficulties related to global conflicts, our ability to provide our product candidates and to conduct our preclinical studies or clinical trials, such as our ongoing, planned, or future clinical trials of prula-cel, could be delayed or suspended.
+Added: Any delay or interruption in the supply of trial materials or disruption to the clinical trial itself could delay the completion of such trials, increase the costs associated with maintaining these research and development activities and, depending upon the period of delay, require us to commence new preclinical studies or clinical trials at additional expense or terminate such trials completely.
Changes in the political and economic policies or in relations between China and the United States may affect our business, financial condition, and results of operations.
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or other rules and regulations that place restrictions on capital raising or other activities by companies with operations in China could affect our business and results of operations.
−Removed: If the business environment in China deteriorates from the perspective of domestic or international investment, or if relations between China and the United States or other governments deteriorate and geopolitical tensions between China and the United States increase, our business in China and United States may also be affected.
−Removed: Inadequate funding for the FDA, the SEC and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the approval of our product candidates rely, which would negatively impact our business.
−Removed: Currently, federal agencies in the U.S.
−Removed: are operating under a continuing resolution that is set to expire on March 14, 2025.
−Removed: Without appropriation of additional funding to federal agencies, our business operations related to our product development activities for the U.S.
+Added: If the business environment in China deteriorates from the perspective of domestic or international investment, or if relations between China and the United
+Added: States or other governments deteriorate and geopolitical tensions between China and the United States increase, our business in China and United States may also be affected.
+Added: Inadequate funding and/or staffing for the FDA, the SEC and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the approval of our product candidates rely, which would negatively impact our business.
+Added: Without appropriation of necessary funding to federal agencies, our business operations related to our product development activities for the U.S.
market could be impacted.
−Removed: The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, adequate staffing, furloughs, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes.
+Added: The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, adequate staffing, furloughs, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, leadership and policy changes.
Average review times at the agency have fluctuated in recent years as a result.
+Added: For example, in 2025, changes and cuts in FDA staffing have been reported as resulting in delays in the FDA’s responsiveness or in its ability to review IND submissions or marketing applications.
In addition, government funding of other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
−Removed: Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved, which would adversely affect our business.
−Removed: For example, over the past decade, the U.S.
−Removed: government has shut down several times, and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities.
−Removed: If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business, including our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
+Added: For example, the U.S.
+Added: government has shut down several times, and certain regulatory agencies, such as the FDA and the SEC, in some instances have had to furlough critical employees and stop critical activities.
+Added: If a prolonged government shutdown occurs or a widespread freeze on federal funding continues or occurs in the future, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business, including our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue to fund our operations.
+Added: In addition, with the change in the U.S.
+Added: presidential administration in 2025, there is substantial uncertainty as to the extent and manner in which the U.S.
+Added: government will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain approval.
+Added: This uncertainty could present new challenges and/or opportunities as we navigate development and approval of our product candidates.
+Added: Additionally, the administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic candidates.
+Added: Also, state governments may seek to address or react to changes at the federal level with changes to their regualotry frameworks in a manner that could impact our operations.
Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations.
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federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations.
−Removed: For example, on February 1, 2025, the U.S.
−Removed: imposed a 25% tariff on imports from Canada and Mexico, which were subsequently suspended for a period of one month, and a 10% additional tariff on imports from China.
−Removed: Historically, tariffs have led to increased trade and political tensions.
−Removed: In response to tariffs, other countries have implemented retaliatory tariffs on U.S.
+Added: For example, the implementation of tariffs by the U.S.
+Added: government have led to increased trade and political tensions, between not only the U.S.
+Added: and China, but also between the U.S.
+Added: and other countries in the international community.
+Added: In response to tariffs, other countries have implemented and may in the future implement additional retaliatory tariffs on U.S.
Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets.
Any changes in political, trade, regulatory, and economic conditions, including U.S.
−Removed: trade policies, could have a material adverse effect on our financial condition or results of operations.
+Added: trade policies, could have a material adverse effect on our business, financial condition or results of operations.
Risks Related to Healthcare Regulation
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healthcare regulations, see the section entitled “ Business–Government Regulation and Product Approval—Other U.S.
−Removed: Healthcare Laws and Compliance Requirements ” in this Annual Report on Form 10-K.
+Added: Healthcare Laws and Compliance Requirements ” in our Annual Report on Form 10-K for the year ended December 31, 2025.
The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform.
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It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations.
−Removed: If any such actions are instituted against us, and we are not successful in defending themselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and/or oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws and
−Removed: curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
+Added: If any such actions are instituted against us, and we are not successful in defending themselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, disgorgement, debarment, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and/or oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
In addition, the approval and commercialization of any of our product candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.
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In addition, data protection, privacy and similar laws protect more than patient information and, although they vary by jurisdiction, these laws can extend to employee information, business contact information, provider information, and other information relating to identifiable individuals.
−Removed: For example, the California Consumer Privacy Act (CCPA) requires covered businesses to, among other things, provide notices to California consumers regarding the collection, use and disclosure of such consumers’ personal information and afford such consumers new rights with respect to their personal information, including the right to opt out of certain sales of personal information.
+Added: For example, the California Consumer Privacy Act (CCPA) requires covered businesses to, among other things, provide notices to California consumers regarding the collection, use and disclosure of such consumers’ personal information and afford such consumers new rights with respect to their personal information, including the right to opt out of certain sales of
+Added: personal information.
In addition, the California Privacy Rights Act (CPRA), which amended the CCPA, became effective on January 1, 2023 and imposed additional obligations on companies covered by the legislation.
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There are also states that are specifically regulating health information or specific types of information, such as biometric information, and regulators and legislators are continuing to propose and adopt new laws and regulations protecting privacy and certain types of personal information.
−Removed: For example, the Washington My Health My Data Law, and similar laws adopted and proposed in other states, regulate the collection and sharing of health information, and some such law include a private right of action, which further increases compliance risks.
−Removed: We believe that increased regulation in additional jurisdictions is likely in the area of data privacy.
−Removed: Any of the foregoing may have a material adverse effect on our ability to provide services to patients and, in turn, our results of operations.
−Removed: The collection and use of personal health data in the European Economic Area (EEA) is governed by the General Data Protection Regulation (GDPR).
+Added: For example, Washington’s My Health My Data Act (MHMDA) regulates the collection and sharing of consumer health information and includes a private right of action, which further increases compliance risks.
+Added: Given the breadth and depth of changes in privacy, data protection and consumer protection obligations, preparing for and complying with these requirements is rigorous and time intensive and requires significant resources and ongoing review of our technologies, systems and practices, as well as those of any third-party collaborators, service providers, contractors or consultants that store, process or transfer personal data on our behalf.
+Added: Compliance with such laws or regulations associated with the enhanced protection of certain types of sensitive data, such as healthcare data or other personal information from our clinical trials, could require us to change our business practices and put in place additional compliance mechanisms, may interrupt or delay our development, regulatory and commercialization activities and increase our cost of doing business.
+Added: Any failure or perceived failure by us to comply with such laws and regulations could lead to government enforcement actions, private litigation and significant fines and penalties against us and could have a material adverse effect on our business, financial condition or results of operations.
+Added: There is also the threat of consumer class actions related to these laws and the overall protection of personal data.
+Added: Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our reputation and our business.
+Added: The collection and use of personal health data in the European Economic Area (EEA) is governed by the General Data Protection Regulation (EU GDPR) and the United Kingdom’s General Data Protection Regulation (“UK GDPR”, together with the EU GDPR, “GDPR”).
The GDPR applies to any company established in the EEA and to companies established outside the EEA that process personal data in connection with the offering of goods or services to data subjects in the EEA or the monitoring of the behavior of data subjects in the EEA.
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The GDPR also imposes strict rules on the transfer of personal data outside of the EEA to countries that do not ensure an adequate level of protection, like the United States.
−Removed: Following the United Kingdom’s (UK) exit from the European Union (EU), the UK’s European Union (Withdrawal) Act 2018 incorporated the GDPR into UK law, referred to as the UK GDPR.
−Removed: The UK GDPR and the UK Data Protection Act 2018 set out the United Kingdom’s data protection regime, which is independent from but aligned to the European Union’s data protection regime.
−Removed: Although the GDPR and the UK GDPR currently impose substantially similar obligations, it is possible that over time the UK GDPR could become less aligned with the GDPR.
−Removed: The UK Government has introduced a Data Use and Access Bill (the UK Bill) into the UK legislative process with the intention for this bill to reform the UK’s data protection regime following Brexit.
−Removed: If passed, the UK Bill will have the effect of further altering the similarities between the UK and EU data protection regime.
+Added: Although the EU GDPR and the UK GDPR currently impose substantially similar obligations, it is possible that over time the UK GDPR could become less aligned with the GDPR.
+Added: On June 19, 2025, the UK Government adopted the Data (Use and Access) Act 2025 (the “DUAA”).
This may lead to additional compliance costs and could increase our overall risk.
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Non-compliance with the UK GDPR may result in monetary penalties of up to £17.5 million or 4% of worldwide revenue, whichever is higher.
−Removed: Although the UK is regarded as a third country under the European Union’s GDPR, the European Commission has issued a decision recognizing the UK as providing adequate protection under the EU GDPR and, therefore, transfers of personal data originating in the EU to the UK remain unrestricted (“UK Adequacy Decision”).
−Removed: However, the UK Bill may threaten the validity of this UK Adequacy Decision.
+Added: Although the UK is regarded as a third country under the EU GDPR, the European Commission issued a decision recognizing the UK as providing adequate protection under the EU GDPR and, therefore, transfers of personal data originating in the EU to the UK remain unrestricted (“UK Adequacy Decision”).
+Added: In December 2025, the European Commission adopted a decision to extend the validity of the UK adequacy decision for six years until December 2031, determining that the UK continues to offer a level of data protection that is “essentially equivalent” to the EU standards.
Like the EU GDPR, the UK GDPR restricts personal data transfers outside the United Kingdom to countries not regarded by the United Kingdom as providing adequate protection.
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The European Commission has issued forms of standard contractual clauses for data transfers from controllers or processors in the EU/EEA (or otherwise subject to the GDPR) to controllers or processors established outside the EU/EEA (and not subject to the GDPR).
−Removed: The UK is not subject to the EC’s new standard contractual clauses but has published the UK International Data Transfer Agreement and International Data Transfer Addendum to the new standard contractual clauses (the IDTA), which enable transfers from the UK.
−Removed: For new transfers, the IDTA already needs to be in place, and must be in place for all existing transfers from the UK from March 21, 2024.
−Removed: Following a ruling from the Court of Justice of the EU, in Data Protection Commissioner v Facebook Ireland Limited and Maximillian Schrems, Case C-311/18 (Schrems II), companies relying on standard contractual clauses to govern transfers of personal data to third countries (in particular the United States) will need to assess whether the data importer can ensure sufficient guarantees for safeguarding the personal data under GDPR.
+Added: The UK is not subject to
+Added: the EC’s new standard contractual clauses but has published the UK International Data Transfer Agreement and International Data Transfer Addendum to the new standard contractual clauses (the IDTA), which enable transfers from the UK.
+Added: For new transfers, the IDTA already needs to be in place, and must be in place for all existing transfers from the UK from March 21, 2024 Companies relying on standard contractual clauses to govern transfers of personal data to third countries (in particular the United States) will need to assess whether the data importer can ensure sufficient guarantees for safeguarding the personal data under GDPR.
This assessment includes assessing whether third party vendors can also ensure these guarantees.
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We are required to implement these new safeguards when conducting restricted data transfers under the GDPR and doing so will require significant effort and cost.
−Removed: Failure to comply with the requirements of the GDPR or UK GDPR and the related national data protection laws of the EEA Member States may result in fines up to €20 million or 4% of a company’s global annual revenues for the preceding financial year, whichever is higher.
−Removed: Moreover, the GDPR and UK GDPR grant data subjects the right to claim material and non-material damages resulting from infringement of the GDPR or UK GDPR.
−Removed: Given the breadth and depth of changes in data protection obligations, maintaining compliance with the GDPR and UK GDPR, will require significant time, resources and expense, and we may be required to put in place additional mechanisms ensuring compliance with the new data protection rules.
+Added: Failure to comply with the requirements of the GDPR and the related national data protection laws of the EEA Member States may result in fines up to €20 million (or £17.5 million in the UK) or 4% of a company’s global annual revenues for the preceding financial year, whichever is higher.
+Added: Moreover, the GDPR grants data subjects the right to claim material and non-material damages resulting from infringement of the GDPR or UK GDPR.
+Added: Given the breadth and depth of changes in data protection obligations, maintaining compliance with the GDPR, will require significant time, resources and expense, and we may be required to put in place additional mechanisms ensuring compliance with the new data protection rules.
This may be onerous and adversely affect our business, financial condition, results of operations and prospects.
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Failure to comply with these laws may result in, among other things, civil and criminal liability, negative publicity, damage to our reputation, and liability under contractual provisions.
−Removed: In addition, compliance with such laws may require increased costs to us or may dictate that wet not offer certain types of services in the future.
+Added: In addition, compliance with such laws may require increased costs to us or may dictate that we not offer certain types of services in the future.
Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data.
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For example, the EU’s Artificial Intelligence Act (AI Act) — the world’s first comprehensive AI law – which has entered into force on August 1, 2024 and most provisions of which will become effective on August 2, 2026.
−Removed: This legislation imposes
−Removed: significant obligations on providers and deployers of high risk artificial intelligence systems, and encourages providers and deployers of artificial intelligence systems to account for EU ethical principles in their development and use of these systems.
+Added: This legislation imposes significant obligations on providers and deployers of high risk artificial intelligence systems, and encourages providers and deployers of artificial intelligence systems to account for EU ethical principles in their development and use of these systems.
If we develop or use AI systems that are governed by the AI Act, it may necessitate ensuring higher standards of data quality, transparency, and human oversight, as well as adhering to specific and potentially burdensome and costly ethical, accountability, and administrative requirements.
−Removed: Furthermore, in the U.S., a number of states have proposed and passed laws regulating various uses of AI, and federal regulators have issued guidance affecting the use of AI in regulated sectors.
−Removed: We may adopt and integrate generative artificial intelligence tools into our systems for specific use cases reviewed by legal and information security.
+Added: Furthermore, in the U.S., a number
+Added: of states have proposed and passed laws regulating various uses of AI, and federal regulators have issued guidance affecting the use of AI in regulated sectors.
+Added: We may adopt and integrate generative artificial intelligence tools into our systems for specific use cases reviewed by legal and information security, including as informed by regulatory guidance.
Our vendors may incorporate generative artificial intelligence tools into their offerings without disclosing this use to us, and the providers of these generative artificial intelligence tools may not meet existing or rapidly evolving regulatory or industry standards with respect to privacy and data protection and may inhibit our or our vendors’ ability to maintain an adequate level of service and experience.
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Although we assess our banking relationships as we believe necessary or appropriate, our access to funding sources and other credit arrangements in amounts adequate to finance or capitalize our current and projected future business operations could be significantly impaired by factors that affect us, the financial institutions with which we have credit agreements or arrangements directly, or the financial services industry or economy in general.
−Removed: These factors could include, among others, events such as liquidity constraints or failures, the ability to perform obligations
−Removed: under various types of financial, credit or liquidity agreements or arrangements, disruptions or instability in the financial services industry or financial markets, or concerns or negative expectations about the prospects for companies in the financial services industry.
+Added: These factors could include, among others, events such as liquidity constraints or failures, the ability to perform obligations under various types of financial, credit or liquidity agreements or arrangements, disruptions or instability in the financial services industry or financial markets, or concerns or negative expectations about the prospects for companies in the financial services industry.
These factors could involve financial institutions or financial services industry companies with which we have financial or business relationships, but could also include factors involving financial markets or the financial services industry generally.
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Despite our efforts, from time to time we may not be able to conclude that our internal control over financial reporting is effective as required by Section 404.
−Removed: For example, our management concluded that our internal control over financial reporting was not
−Removed: effective at the reasonable assurance level as of December 31, 2024 due to the material weakness in our internal control over financial reporting described below.
−Removed: However, after giving full consideration to this material weakness, our management has concluded that the remediation steps taken have been sufficient to remediate this material weakness as of the date of this Annual Report on Form 10-K.
−Removed: Additional material weaknesses may arise in the future.
−Removed: Any additional material weakness in our internal control over financial reporting may, in the future, result in our management being unable to conclude that our disclosure controls and procedures were effective for the applicable period.
We expect to continue our efforts to improve our control processes, though there can be no assurance that our efforts will ultimately be successful or avoid potential future material weaknesses, and we expect to continue incurring additional costs as a result of these efforts.
−Removed: If we are unable to successfully remediate any future material weaknesses in our internal control over financial reporting, or if we identify any additional material weaknesses, the accuracy and timing of our financial reporting may be adversely affected, we may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports in addition to applicable stock exchange listing requirements, investors may lose confidence in our financial reporting, and our stock price may decline as a result.
+Added: If we are unable to successfully remediate any future material weaknesses in our internal control over financial reporting, or if we identify any additional material weaknesses, the accuracy and timing of our financial reporting may be adversely affected, we may be unable to maintain compliance with securities
+Added: law requirements regarding timely filing of periodic reports in addition to applicable stock exchange listing requirements, investors may lose confidence in our financial reporting, and our stock price may decline as a result.
We also could become subject to investigations by Nasdaq, the SEC or other regulatory authorities, which could harm our reputation and our financial condition, or divert financial and management resources from our core business.
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A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
−Removed: In connection with the audit of our consolidated financial statements as of and for the years ended December 31, 2024 and 2023, we identified a material weakness in our internal control over financial reporting which relates to cash disbursements.
−Removed: We have concluded that this material weakness in our internal control over financial reporting occurred due to our internal controls having not been adequately designed to prevent or timely detect unauthorized cash disbursements.
−Removed: We believe that the remediation steps taken have been sufficient to remediate this material weakness as of the date of this Annual Report on Form 10-K.
+Added: During the fourth quarter of 2024, we identified a material weakness in our internal control over financial reporting which relates to cash disbursements.
+Added: We concluded that this material weakness in our internal control over financial reporting occurred due to our internal controls having not been adequately designed to prevent or timely detect unauthorized cash disbursements.
+Added: We concluded that the remediation steps taken have been sufficient to remediate this material weakness as of the date of our Annual Report on Form 10-K for the year ended December 31, 2024.
We are focused on designing and implementing effective internal controls measures to improve our evaluation of disclosure controls and procedures, including internal control over financial reporting, and remediating the material weaknesses.
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We may have experienced such ownership changes in the past, and we may experience ownership changes in the future as a result of subsequent shifts in our stock ownership.
−Removed: As of December 31, 2024, we had federal net operating loss carryforwards of approximately $339.9 million, and our ability
−Removed: to utilize those net operating loss carryforwards could be limited by an “ownership change” as described above or subject to other limitations, which could potentially result in increased future tax liability to us.
+Added: As of December 31, 2025, we had federal net operating loss carryforwards of approximately $472.7 million, and our ability to utilize those net operating loss carryforwards could be limited by an “ownership change” as described above or subject to other limitations, which could potentially result in increased future tax liability to us.
Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
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Treasury Department.
+Added: For example, the One Big Beautiful Bill Act (OBBBA) was signed into law on July 4, 2025 and made significant changes to U.S.
+Added: federal tax law.
Changes to tax laws (which changes may have retroactive application) could adversely affect us or holders of our common stock.
−Removed: In recent years, many changes have been made and changes are likely to continue to occur in the future.
−Removed: In 2017, the U.S.
−Removed: Congress and the Trump administration made substantial changes to U.S.
−Removed: policies, which included comprehensive corporate and individual tax reform.
−Removed: In addition, the Trump administration called for significant changes to U.S.
−Removed: trade, healthcare, immigration and government regulatory policy.
−Removed: With the transition to the Biden administration in early 2021, changes to U.
−Removed: policy occurred and since the start of the Trump Administration in 2025, U.S.
+Added: For example, under Section 174 of the IRC, in taxable years beginning after December 31 2021, expenses that are incurred for research and development performed outside the U.S.
+Added: will be capitalized and amortized, which may have an adverse effect on our cash flow.
+Added: The OBBBA provides that for taxable years beginning after December 31, 2024, expenses that are incurred for research and development
+Added: performed in the U.S.
+Added: may, at the taxpayer’s election, be immediately deducted or capitalized and amortized.
+Added: In addition, the OBBBA provides that for taxable years beginning after December 31, 2021 and before January 1, 2025, certain eligible taxpayers generally may elect to retroactively deduct expenses for research and development performed in the U.S.
+Added: in such taxable years generally may elect to accelerate and deduct the remaining unamortized amounts of such research and development expenses (i) in the first taxable year beginning after December 31, 2024, or (ii) ratably over the two-taxable year period beginning with the first taxable year beginning after December 31, 2024.
+Added: In recent years, many changes to tax laws have been made and changes are likely to continue to occur in the future.
+Added: In addition, since the start of the Trump Administration in 2025, U.S.
policy changes have been implemented at a rapid pace and additional changes are likely.
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If we are unable to maintain any of these collaborations, or if these collaborations are not successful, our business could be adversely affected.
−Removed: We have entered, and plan to enter, into collaborations with other companies, including our collaboration agreement with Regeneron and discovery agreement with Twist Bioscience Corporation (Twist), that we believe can provide us with additional capabilities beneficial to our business.
−Removed: The collaboration with Regeneron has provided us with important technologies, expertise and funding for our programs and technology.
+Added: We have entered, and plan to enter, into collaborations with other companies, including our collaboration agreement with Regeneron, our discovery agreement with Twist Bioscience Corporation (Twist), our license and
+Added: collaboration agreement with CRISPR Therapeutics AG (CRISPR), and our license agreement with the City of Hope, that we believe can provide us with additional capabilities beneficial to our business.
+Added: For example, the collaboration with Regeneron has provided us with important technologies, expertise and funding for our programs and technology.
Under our discovery agreement with Twist, Twist will utilize its proprietary platform technology to assist us with the discovery of novel antibodies related to our gamma delta T cell therapy programs.
+Added: Further, our license and collaboration agreement with CRISPR provides us with certain propriety gene-editing technology, including the CRISPR/Cas platform, material to supporting the research, development and potential commercialization of ADI-212.
+Added: Additionally, our non-exclusive license with the City of Hope provides access to their proprietary cytokine expression technology for cellular immunotherapy, which may also be material to the research, development and potential commercialization of ADI-212.
We may receive additional technologies, expertise and funding under other collaborations in the future.
−Removed: Our existing therapeutic collaborations, and any future collaborations we enter into, may pose a number of risks, including the following:
+Added: If any of our existing or potential future collaboration partners does not perform in the manner that we expect or fulfill their responsibilities in a timely manner or at all, the research, clinical development, regulatory approval and commercialization efforts related to the product candidates that are the subject of such collaborations, or that potential future collaboration partner, could be delayed or terminated.
+Added: This could result in a limited potential to generate future revenue from such product candidates, and our business could be materially and adversely affected.
+Added: Our existing collaborations, and any future collaborations we enter into, may pose a number of additional risks, including the following:
• collaborators have significant discretion in determining the efforts and resources that they will apply;
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• collaborators could develop independently, or with third parties, products that compete directly or indirectly with our products and product candidates if the collaborators believe that the competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;
−Removed: • product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with our own product candidates or products, which may cause collaborators to cease to devote resources to the development or commercialization of our product candidates;
+Added: • product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the development or commercialization of our product candidates;
• collaborators may dispute ownership or rights in jointly developed technologies or intellectual property;
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• collaborations may be terminated by the collaborator, and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates, or potentially lose access to the collaborator’s intellectual property.
−Removed: If our therapeutic collaborations do not result in the successful discovery, development and commercialization of products or if one of our collaborators terminates our agreement with us, we may not receive any future research funding or milestone or royalty payments under the collaboration.
−Removed: If we do not receive the funding we expect under these agreements, our development and commercialization of our technology and product candidates could be delayed and we may need additional resources to develop product candidates and our technology.
+Added: If our collaborations do not result in the successful discovery, development and commercialization of products or if one of our collaborators terminates our agreement with us, we may not receive any future research funding or milestone or royalty payments under the collaboration.
+Added: If we do not receive the funding or support we expect under these agreements, our development and commercialization of our technology and product candidates could be delayed and we may need additional resources to develop product candidates and our technology.
All of the risks relating to product discovery, development, regulatory approval and commercialization described in these risk factors also apply to the activities of our therapeutic collaborators.
−Removed: In addition to the Regeneron collaboration described above, for some of our programs, we may in the future determine to collaborate with pharmaceutical and biotechnology companies for discovery, development and potential commercialization of therapeutic products.
+Added: In addition to existing collaborations, we may in the future determine to collaborate with pharmaceutical and biotechnology companies for discovery, development and potential commercialization of therapeutic products.
We face significant competition in seeking appropriate collaborators because, for example, third parties also have rights to allogeneic T cell technologies.
−Removed: For example, in April 2020, Johnson & Johnson entered into a collaboration agreement with Fate Therapeutics, a company that is also using allogeneic T cell technologies, for up to four CAR Natural Killer and CAR T-cell therapies.
Our ability to reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors.
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We are subject to certain exclusivity obligations under our agreement with Regeneron.
−Removed: During the five-year period following the effective date of the Regeneron Agreement, with certain limited exceptions, we may not directly or indirectly research, develop, manufacture or commercialize a gamma delta immune cell product (ICP) or grant a license to do the foregoing, except pursuant to the terms of the Regeneron Agreement.
−Removed: Both parties also have obligations not to research, develop, manufacture or commercialize an ICP with the same target as one being developed under a research program or commercialized by a party (and royalty bearing under the agreement), for so long as such activities are occurring.
+Added: Under the Regeneron Agreement, both parties have obligations not to research, develop, manufacture or commercialize an immune cell product (ICP) with the same target as one being developed under a research program or commercialized by a party (and royalty bearing under the agreement), for so long as such activities are occurring.
These exclusivity obligations are limited to engineered gamma delta immune cells to targets reasonably considered to have therapeutic relevance in cancer.
If our collaboration with Regeneron is not successful, including any failure caused by the risks listed in the preceding paragraphs, and the agreement and research programs are not terminated, we may not be able to enter into collaborations with other companies with respect to ICPs and our business could be adversely affected.
−Removed: The exclusivity obligations under the Regeneron Agreement expired on July 29, 2021.
−Removed: Prior to this expiration date, our ability to advance any gamma delta immune cell therapeutics outside of the scope of the research plan agreed on with Regeneron was limited.
The restrictions on internal development under the Regeneron Agreement could lead to delays in our ability to discover and develop gamma delta immune cell therapeutics for targets not covered by the collaboration with Regeneron and loss of opportunities to obtain additional research funding and advance our own technologies separately from the Regeneron collaboration.
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If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.
−Removed: We currently depend and will continue to depend upon independent investigators and collaborators, such as universities, medical institutions, CROs and strategic partners to conduct our preclinical and clinical trials under agreements with us.
+Added: We currently depend and will continue to depend upon independent investigators and collaborators, such as universities, medical institutions, CROs and strategic partners to conduct our preclinical studies and clinical trials under agreements with us.
We negotiate budgets and contracts with CROs and study sites, which may result in delays to our development timelines and increased costs.
−Removed: We will rely heavily on these third parties over the course of our clinical trials, and we control only certain aspects of their activities.
+Added: We rely heavily and expect to continue to rely heavily on these third parties over the course of our preclinical studies and clinical trials, and we control only certain aspects of their activities.
Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with applicable protocol, legal, regulatory and scientific standards, and our reliance on third parties does not relieve us of our regulatory responsibilities.
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We cannot assure you that, upon inspection, such regulatory authorities will determine that any of our clinical trials comply with the GCP regulations.
−Removed: In addition, our clinical trials must be conducted with biologic product produced under cGMPs and will require a large number of test patients.
+Added: In addition, our clinical trials must be conducted with biologic product produced under cGMPs requirements, and if applicable, cGTP requirements, and will require a large number of test patients.
Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the regulatory approval process.
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While we have implemented security measures designed to protect our systems and confidential and sensitive data, there can be no assurance that these measures will be effective.
+Added: Bad actors around the world use increasingly sophisticated methods, including the use of artificial intelligence, to engage in illegal activities involving the theft and misuse of personal information, confidential information and intellectual property.
+Added: In addition, the use of generative AI models in our internal or third-party systems may create new attack surfaces or methods for adversaries, which could impact us and our vendors.
+Added: Any of these effects could damage our reputation, result in the loss of valuable property and information, cause us to breach applicable laws and regulations, and adversely impact our business.
We and certain of our service providers have in the past and may in the future experience cybersecurity incidents, including incidents related to social engineering, business email compromise, and wire fraud.
−Removed: For example, in September and October 2024, certain employee business email accounts were compromised by an unauthorized third party, and as a result, payments intended for certain vendors were fraudulently re-directed into bank accounts presumably controlled by the unauthorized third party.
System failures and security breaches could cause interruptions in our operations, and could result in a disruption of our development programs and our business operations.
For example, the loss of clinical trial data from future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
−Removed: To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our product candidates could be delayed.
+Added: To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further
+Added: development and commercialization of our product candidates could be delayed.
Other consequences may include:
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litigation (including class claims);
−Removed: indemnification
+Added: indemnification obligations;
negative publicity;
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The FDA may also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to support licensure.
−Removed: The opinion of the Advisory Committee, although not binding, may have a significant impact on our ability to obtain licensure of the product candidates based on the completed clinical trials, as the FDA often adheres to the Advisory Committee’s recommendations.
+Added: The opinion of the Advisory Committee, although not binding, may have a significant impact on our ability to obtain marketing approval.
Accordingly, the regulatory approval pathway for our product candidates may be uncertain, complex, expensive and lengthy, and approval may not be obtained.
−Removed: We may also experience delays in obtaining regulatory approvals, including but not limited to:
−Removed: • obtaining regulatory authorization to begin a trial, if applicable;
−Removed: • redesigning our study protocols and need to conduct additional studies as may be required by a regulator;
+Added: We may also experience delays in obtaining regulatory approvals, including due to:
+Added: • delays in obtaining regulatory authorization to begin a trial, if applicable;
+Added: • the need to redesign our study protocols and/or conduct additional studies as may be required by a regulator;
• governmental or regulatory delays and changes in regulation or policy relating to the development and commercialization of our product candidate by the FDA, EMA or other comparable foreign regulatory authorities;
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• inability to recruit and enroll suitable patients to participate in a trial;
−Removed: • having patients complete a trial, including having patients enrolled in clinical trials dropping out of the trial before the product candidate is manufactured and returned to the site, or return for post-treatment follow-up;
−Removed: • difficulty in having patients complete a trial or return for post-treatment follow-up;
+Added: • having patients complete a trial, including patients enrolled in clinical trials dropping out of the trial before the product candidate is manufactured and returned to the site, or failure to return for post-treatment follow-up;
• addressing any patient safety concerns that arise during the course of a trial;
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• the cost and timing of establishing, expanding and scaling manufacturing capabilities;
−Removed: • inability to manufacture, or obtain from third parties, sufficient quantities of qualified materials under cGMPs, for the completion in preclinical and clinical studies;
+Added: • inability to manufacture, or obtain from third parties, sufficient quantities of qualified materials under cGMPs, or if applicable, cGTPs, for the completion of in preclinical studies and clinical trials;
• problems with biopharmaceutical product candidate storage, stability and distribution resulting in global supply chain disruptions;
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• potential unforeseen business disruptions or market fluctuations that delay our product development or clinical trials and increase our costs or expenses, such as business or operational disruptions, delays, or system failures due to malware, unauthorized access, terrorism, war, natural disasters, strikes, geopolitical conflicts, restrictions on trade, import or export restrictions, or public health crises.
−Removed: We could also encounter delays if physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of our product candidates in lieu of prescribing existing treatments that have established safety
−Removed: and efficacy profiles.
+Added: We could also encounter delays if physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of our product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles.
Further, a clinical trial may be suspended or terminated by us, the IRBs for the institutions in which such trials are being conducted or by the FDA, EMA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA, EMA or other regulatory authorities resulting in the imposition of a clinical hold, safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions, lack of adequate funding to continue the clinical trial, or based on a recommendation by the Data Safety Monitoring Committee.
−Removed: If we experience termination of, or delays in the completion of, any clinical trial of our product candidates, the commercial prospects for our product candidates will be harmed, and our ability to generate product revenue will be delayed.
+Added: If we experience termination of, or delays in the completion of, any clinical trial of our product candidates, the commercial prospects for our product candidates may be harmed, and our ability to generate product revenue may be delayed.
In addition, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue.
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We expect the product candidates we develop will be regulated as biological products, or biologics, and therefore they may be subject to competition from biosimilar products.
−Removed: The Biologics Price Competition and Innovation Act (BPCIA) was enacted as part of the Affordable Care Act to establish an abbreviated pathway for the approval of biosimilar and interchangeable biological products.
+Added: The Biologics Price Competition and Innovation Act (BPCIA) established an abbreviated pathway for the approval of biosimilar and interchangeable biological products.
The regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an approved biologic.
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However, there is a risk that this exclusivity could be shortened due to Congressional action or otherwise, potentially creating the opportunity for biosimilar competition sooner than anticipated.
−Removed: Moreover, the extent to which a biosimilar, once approved, will be substituted for any reference product in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors, including under state laws, that are still developing.
+Added: During this 12-year exclusivity period, a competing product may still be marketed if the FDA approves a full BLA containing the applicant’s own preclinical and clinical trial data demonstrating safety, purity and potency.
+Added: Moreover, the extent to which a biosimilar, once approved, will be substituted for any reference product in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors.
+Added: State pharmacy laws govern whether interchangeable products can be readily substituted for the reference product.
The regulatory landscape that will govern our product candidates is uncertain;
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ATMPs include somatic cell therapy products and tissue engineered products.
−Removed: These various regulatory review committees and advisory groups and new or revised guidelines that they promulgate from time to time may lengthen the regulatory review process, require us to perform additional studies, increase our development costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of our product candidates or lead to significant post-approval limitations or restrictions.
−Removed: Because the regulatory landscape for our gamma delta CAR T-cell product candidates is new, we may
−Removed: face even more cumbersome and complex regulations than those emerging for cell therapy products.
+Added: These various regulatory review committees and advisory groups and new or revised guidelines
+Added: that they promulgate from time to time may lengthen the regulatory review process, require us to perform additional studies, increase our development costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of our product candidates or lead to significant post-approval limitations or restrictions.
+Added: Because the regulatory landscape for our gamma delta CAR T-cell product candidates is new, we may face even more cumbersome and complex regulations than those emerging for cell therapy products.
Furthermore, even if our product candidates obtain required regulatory approvals, such approvals may later be withdrawn as a result of changes in regulations or the interpretation of regulations by applicable regulatory agencies.
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The FDA may disagree with our regulatory plan and we may fail to obtain regulatory approval of our product candidates.
−Removed: The general approach for FDA approval of a new biologic or drug is for the sponsor to provide dispositive data from two well-controlled, Phase 3 clinical studies of the relevant biologic or drug in the relevant patient population.
+Added: The general approach for FDA approval of a new biologic is for the sponsor to provide dispositive data from one or two well-controlled, Phase 3 clinical studies of the relevant biologic in the relevant patient population.
Phase 3 clinical studies typically involve hundreds of patients, have significant costs and take years to complete.
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A fast track designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval.
−Removed: We have received fast track designation for ADI-001 for the treatment of LN and for ADI-270 in metastatic/advanced clear cell RCC.
+Added: We have received fast track designation for prula-cel for the treatment of relapsed/refractory Class III or IV LN, refractory SLE with extrarenal involvement, and SSc.
If a drug or biologic is intended for the treatment of a serious or life-threatening condition and the product candidate demonstrates the potential to address unmet medical needs for this condition, the product candidate sponsor may apply for fast track designation for a particular indication.
We may seek fast track designation for certain of our product candidates, but there is no assurance that the FDA will grant this status to any of our product candidates.
−Removed: Marketing applications filed by sponsors of product candidate with fast track designation
−Removed: may qualify for priority review under the policies and procedures offered by the FDA, but the fast track designation does not assure any such qualification or ultimate marketing approval by the FDA.
+Added: Marketing applications filed by sponsors of product candidate with fast track designation may qualify for priority review under the policies and procedures offered by the FDA, but the fast track designation does not assure any such qualification or ultimate marketing approval by the FDA.
The FDA has broad discretion whether or not to grant fast track designation, so even if we believe a particular product candidate is eligible for this designation, there can be no assurance that the FDA would decide to grant it.
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In addition, the FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.
−Removed: In addition, the FDA may withdraw any fast track designation at any time.
Regenerative Medicine Advanced Therapy (RMAT) designation, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
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Data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.
−Removed: We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data.
+Added: We may also make assumptions, estimations, calculations and conclusions as part of our analyses of preliminary or top-line data, and we may not have received or had the opportunity to fully and carefully evaluate all data.
Preliminary or “top-line” data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously announced.
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Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development, and we cannot be certain that we will not face similar setbacks.
−Removed: These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway, or safety or efficacy observations made in preclinical studies and clinical trials, including
−Removed: previously unreported adverse events.
+Added: These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway, or safety or efficacy observations made in preclinical studies and clinical trials, including previously unreported adverse events.
Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their product candidate performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or similar regulatory approval.
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If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.
−Removed: Additionally, the UK formally left the EU on January 31, 2020.
−Removed: The EU and the UK have concluded a trade and cooperation agreement (TCA) which was provisionally applicable since January 1, 2021 and has been formally applicable since May 1, 2021.
−Removed: The TCA includes specific provisions concerning pharmaceuticals, which include the mutual recognition of GMP, inspections of manufacturing facilities for medicinal products and GMP documents issued, but does not provide for wholesale mutual recognition of UK and EU pharmaceutical regulations.
−Removed: At present, the UK has implemented EU legislation on the marketing, promotion and sale of medicinal products through the Human Medicines Regulations 2012.
−Removed: The regulatory regime in the UK therefore currently aligns in the most part with EU regulations, however it is possible that these regimes will diverge in future now that the UK’s regulatory system is independent from the EU and the TCA does not provide for mutual recognition of UK and EU pharmaceutical legislation.
−Removed: For example, the EU Clinical Trials Regulation, which became effective in the EU on January 31, 2022 and provides for a streamlined clinical trial application and assessment procedure covering multiple EU member states, has not been implemented into UK law, and a separate application will need to be submitted for clinical trial authorization in the UK.
−Removed: The separate, and potentially diverging, regulatory regimes between the UK and the EU may increase our regulatory burden of applying for and obtaining authorization in the UK and the EU.
Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
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The FDA may also require a risk evaluation and mitigation strategy (REMS), in order to approve our product candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.
−Removed: In addition, if the FDA or a comparable foreign regulatory authority approves our product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and record keeping for our product candidates will be subject to extensive and ongoing regulatory requirements.
+Added: In addition, if the FDA or a comparable foreign regulatory authority approves our product candidates, the manufacturing processes, quality control, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and record keeping for our
+Added: product candidates will be subject to extensive and ongoing regulatory requirements.
These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval.
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• restrictions on the marketing or manufacturing of our product candidates, withdrawal of the product from the market or voluntary or mandatory product recalls;
−Removed: • fines, warning letters or holds on clinical trials;
+Added: • fines, FDA Form 483s, untitled letters, warning letters or holds on clinical trials;
• refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;
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We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad.
−Removed: If we are slow or unable to adapt to changes in existing
−Removed: requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.
+Added: If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.
Even if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community, adversely affecting our ability to achieve our commercial and financial projections.
The use of engineered gamma delta T cells as potential treatments for autoimmune diseases and cancer is a recent development and may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers and others in the medical community.
−Removed: We expect physicians, including rheumatologists, nephrologists and oncologists, to be particularly important to the market acceptance of our products and we may not be able to educate them on the benefits of using our product candidates for many reasons.
+Added: We expect physicians, including rheumatologists, nephrologists and oncologists, to be particularly important to the market acceptance of our products and we may not be able to educate them on the
+Added: benefits of using our product candidates for many reasons.
Additional factors will influence whether our product candidates are accepted in the market, including:
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In addition, because our product candidates represent new approaches to the treatment of autoimmune diseases and cancer, we cannot accurately estimate the potential revenue from our product candidates.
−Removed: For further discussion on coverage and reimbursement matters, see the section entitled “Business—Government Regulation and Product Approval Coverage, Pricing and Reimbursement” in this Annual Report on Form 10-K.
+Added: For further discussion on coverage and reimbursement matters, see the section entitled “Business—Government Regulation and Product Approval Coverage, Pricing and Reimbursement” in our Annual Report on Form 10-K for the year ended December 31, 2025.
Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment.
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Increased efforts by governmental and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidate.
−Removed: obtain approval in one or more foreign jurisdictions for our product candidates, we will be subject to rules and regulations in those jurisdictions.
+Added: If we obtain approval in one or more foreign jurisdictions for our product candidates, we will be subject to rules and regulations in those jurisdictions.
In some foreign countries, particularly those in Europe, the pricing of biologics is subject to governmental control.
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In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our product candidates, if approved, profitably.
−Removed: For further discussion on healthcare reform matters, see the section entitled “ Business – Government Regulation and Product Approval – Healthcare Reform ” in this Annual Report on Form 10-K.
+Added: For further discussion on healthcare reform matters, see the section entitled “ Business – Government Regulation and Product Approval – Healthcare Reform ” in our Annual Report on Form 10-K for the year ended December 31, 2025.
There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare.
+Added: Additionally, there has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices, which has resulted in several U.S.
+Added: Congressional inquiries and federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs, and review the relationship between pricing and manufacturer patient programs.
+Added: The Inflation Reduction Act of 2022 (the “IRA”), for example, includes several provisions that may impact our business to varying degrees, including provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries to $2,000 starting in 2025, eliminating the prescription drug coverage gap;
+Added: impose new manufacturer financial liability on certain drugs under Medicare Part D, allow the U.S.
+Added: government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition;
+Added: require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation;
+Added: and delay until January 1, 2032 the implementation of an HHS rebate rule that would have limited the fees that pharmacy benefit managers can charge.
+Added: Further, under the IRA, orphan drugs were previously exempted from the Medicare drug price negotiation program;
+Added: however, this exemption was restricted to drugs with only one orphan designation and for which the only approved indication is for that disease or condition.
+Added: If a product received multiple orphan designations or had multiple approved indications, it would not qualify for the orphan drug exemption.
+Added: Under the One Big Beautiful Bill Act of 2025, this restriction was eliminated;
+Added: and effective for the 2028 initial price applicability year, all orphan drugs, regardless of the number of orphan designations or indications, are exempt from the Medicare drug price negotiation program.
+Added: The effects of the IRA on our business and the healthcare industry in general is not yet known.
+Added: On April 15, 2025, the Trump Administration published Executive Order 14273, “Lowering Drug Prices by Once Again Putting Americans First,” which generally directs the federal government to take measures to reduce drug prices, including eliminating the so-called “pill penalty” under the Inflation Reduction Act that creates a distinction between small molecule and large molecule products for purposes of determining when a drug may be eligible for drug price negotiation.
+Added: On May 12, 2025, the Trump Administration published Executive Order 14297, “Delivering MFN Prescription Drug Pricing to American Patients” which generally, among other things, directs the federal government to establish and communicate most-favored-nation price targets to pharmaceutical manufacturers to bring prices for American patients in line with comparably developed nations.
+Added: Further, the Executive Order directs the federal government to support regulatory paths to allow direct-to-patient sales for companies that meet these targets.
+Added: It also states that the Administration will take additional aggressive action (for example, examining whether marketing approvals should be modified or rescinded or opening the door for individual drug importation waivers) should manufacturers fail to offer American consumers the most-favored-nation lowest price.
+Added: It also directs the Secretary of Commerce and the U.S.
+Added: Trade Representative to “take all necessary and appropriate action to ensure foreign countries are not engaged in any act, policy, or practice that may be unreasonable or discriminatory or that may impair United States national security .
+Added: including by suppressing the price of pharmaceutical products below fair market value in foreign countries.” Notably, a similar “MFN” pricing rule enacted under the first Trump Administration was subject to an injunction resulting from judicial challenges to the rule, which was formally rescinded by the former Biden Administration in August 2021.
+Added: Recent CMS proposals, including the GLOBE, GUARD, and GENEROUS, could materially impact the Company’s revenue.
The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.
−Removed: Such reforms could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates.
+Added: Such reforms could have an adverse effect on
+Added: anticipated revenue from product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates.
Additionally, there has been heightened governmental scrutiny in the United States of pharmaceutical and biologics pricing practices in light of the rising cost of prescription drugs and biologics.
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The patent applications that we own or in-license may fail to result in issued patents with claims that cover our product candidates or uses thereof in the United States or in other foreign countries.
−Removed: Even if the patents do successfully issue, third parties may challenge the patentability, validity, enforceability or scope
−Removed: thereof, for example through inter partes review (IPR) post-grant review or ex parte reexamination before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions, which may result in such patents being cancelled, narrowed, invalidated or held unenforceable.
+Added: Even if the patents do successfully issue, third parties may challenge the patentability, validity, enforceability or scope thereof, for example through inter partes review (IPR) post-grant review or ex parte reexamination before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions, which may result in such patents being cancelled, narrowed, invalidated or held unenforceable.
Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property or prevent others from designing their products to avoid being covered by our claims.
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Our product candidates may also require specific formulations to work effectively and efficiently and these rights may be held by others.
−Removed: We may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify.
+Added: We may be unable to acquire or in-license any compositions, methods of use, processes or
+Added: other third-party intellectual property rights from third parties that we identify.
We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, which would harm our business.
12 unchanged sentences
Interference proceedings provoked by third parties or brought by the USPTO may be necessary to determine the priority of inventions with respect to our patents or patent applications or those of our licensors.
−Removed: An unfavorable outcome could result in a loss of our current patent rights and could require us to cease using the related technology
−Removed: or to attempt to license rights to it from the prevailing party.
+Added: An unfavorable outcome could result in a loss of our current patent rights and could require us to cease using the related technology or to attempt to license rights to it from the prevailing party.
Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms.
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Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation.
−Removed: Such mechanisms include IPR, ex parte re-examination and post grant review in the United States, and equivalent proceedings in foreign jurisdictions (e.g.,
−Removed: opposition proceedings).
+Added: Such mechanisms include IPR, ex parte re-examination and post grant review in the United States, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings).
Such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover and protect our product candidates.
6 unchanged sentences
We are dependent on patents, know-how and proprietary technology, both our own and licensed from others.
−Removed: We depend substantially on our license agreements with Regeneron.
+Added: We depend substantially on our license agreements with Regeneron, CRISPR and City of Hope.
These licenses may be terminated upon certain conditions.
15 unchanged sentences
Although we require all of our employees to assign their inventions to us, and require all of our employees and key consultants who have access to our proprietary know-how, information, or technology to enter into confidentiality agreements, we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques.
−Removed: Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States As a result, we may encounter significant problems
−Removed: in protecting and defending our intellectual property both in the United States and abroad.
+Added: Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad.
If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, we will not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results, and financial condition.
4 unchanged sentences
As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our product candidates may give rise to claims of infringement of the patent rights of others.
−Removed: We are aware of United States and foreign patents held by a third parties relating to gamma delta T cell expansion protocols and related compositions which, on information and belief, are invalid and/or not infringed.
−Removed: In the event that these patents are successfully asserted against our product candidates, such as ADI-001, ADI-270 and ADI-002, or the use of our precursor cells in manufacture of these product candidates, such litigation may negatively impact our ability to commercialize these product candidates in such jurisdictions.
+Added: We are aware of United States and foreign patents held by a third party relating to gamma delta T cell expansion protocols and related compositions which, on information and belief, are invalid and/or not infringed.
+Added: In the event that these patents are successfully asserted against our product candidates, such as prula-cel, or the use of our precursor cells in manufacture of these product candidates, such litigation may negatively impact our ability to commercialize these product candidates in such jurisdictions.
We are also aware of several United States and foreign patents held by third parties relating to certain CAR compositions of matter, methods of making and methods of use which, on information and belief, are invalid and/or not infringed.
1 unchanged sentence
Generally, conducting clinical trials and other development activities in the United States is not considered an act of infringement.
−Removed: If and when ADI-001, ADI-270, ADI-002 or another CAR-based product candidate is approved by the FDA, third parties may then seek to enforce their patents by filing a patent infringement lawsuit against us.
+Added: If and when prula-cel, or another CAR-based product candidate is approved by the FDA, third parties may then seek to enforce their patents by filing a patent infringement lawsuit against us.
Patents issued 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.
51 unchanged sentences
• announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments;
−Removed: • the timing and results of clinical trials of ADI-001;
−Removed: • our ability to obtain FDA clearance of additional INDs for ADI-001 in autoimmune indications;
+Added: • the timing and results of clinical trials of prula-cel;
+Added: • our ability to obtain FDA clearance of additional INDs for prula-cel in autoimmune indications;
• the initiation, timing and results of clinical studies of ADI-212;
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Even if the allegations against us are unfounded or we ultimately are not held liable, we may experience related negative publicity resulting in damage to our reputation.
−Removed: Further, the costs to defend ourselves may be significant and the litigation may subject us to
−Removed: substantial settlements, fines, penalties or judgments against us and may consume management’s bandwidth and attention, some or all of which may negatively impact our financial condition and results of operations.
+Added: Further, the costs to defend ourselves may be significant and the litigation may subject us to substantial settlements, fines, penalties or judgments against us and may consume management’s bandwidth and attention, some or all of which may negatively impact our financial condition and results of operations.
An active trading market for our common stock may not be sustained.
If an active trading market is not sustained, our ability to raise capital in the future may be impaired.
−Removed: Our common stock began trading on The Nasdaq Global Select Market on January 26, 2018 and now trades on The Nasdaq Global Market under the symbol “ACET.” Given the limited trading history of our common stock, there is a risk that an active trading market for our shares may not be sustained, which could put downward pressure on the market price of our common stock and thereby affect your ability to sell shares you purchased.
+Added: Our common stock began trading on The Nasdaq Global Market on January 26, 2018 and now trades on The Nasdaq Capital Market under the symbol “ACET.” Given the limited trading history of our common stock, there is a risk that an active trading market for our shares may not be sustained, which could put downward pressure on the market price of our common stock and thereby affect your ability to sell shares you purchased.
An inactive trading market for our common stock may also impair our ability to raise capital to continue to fund our operations by selling shares and impair our ability to acquire other companies or technologies by using our shares as consideration.
Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
−Removed: Our executive officers, directors, and 5% stockholders beneficially owned, in the aggregate, approximately 32.8% of our outstanding voting common stock as of December 31, 2024.
+Added: Our executive officers, directors, and 5% stockholders beneficially own a significant percentage of our outstanding stock.
Accordingly, these stockholders will have the ability to influence us through this ownership position and significantly affect the outcome of all matters requiring stockholder approval.
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The enforceability of similar choice of forum provisions in other companies’ bylaws or certificates of incorporation has been challenged in legal proceedings, and it is possible that, in connection with any applicable action brought against us, a court could find the choice of forum provisions contained in our amended and restated bylaws to be inapplicable or unenforceable in such action.
−Removed: If a court were to find the choice of forum provision contained in our amended and restated bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect our business, financial condition or results of operations.
+Added: If a court were to find the choice of forum provision contained in our amended and restated bylaws to be inapplicable or unenforceable
+Added: in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect our business, financial condition or results of operations.
General Risk Factors
14 unchanged sentences
We currently plan to retain all of our future earnings, if any, to finance the operation, development and growth of our business.
−Removed: In addition, the terms of any future
−Removed: debt or credit agreements may preclude us from paying dividends.
+Added: In addition, the terms of any future debt or credit agreements may preclude us from paying dividends.
As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.
8 unchanged sentences
Claims could also be asserted under state consumer protection acts.
−Removed: If we cannot successfully defend themselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates.
+Added: If we cannot successfully defend themselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product
Even successful defense would require significant financial and management resources.
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These sales, or the perception in the market that holders of a large number of shares intend to sell shares, could reduce the market price of our common stock.
−Removed: Certain holders of our common stock have rights, subject to conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may
−Removed: file for ourselves or other stockholders.
+Added: Certain holders of our common stock have rights, subject to conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders.
Registration of these shares under the Securities Act of 1933, as amended (Securities Act) would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares held by affiliates, as defined in Rule 144 under the Securities Act.
1 unchanged sentence
On March 6, 2025, we filed a registration statement on Form S-3 (File No.
−Removed: 333-263587) with the SEC, which was amended by the Amendment No.
−Removed: 1 to the Registration Statement on Form S-3, as filed with the SEC on March 16, 2022, declared effective on May 9, 2022 (2022 Shelf Registration Statement), in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof for the purposes of selling, from time to time, our common stock, debt securities or other equity securities in one or more offerings.
−Removed: Under the 2022 Shelf Registration Statement and a prospectus supplement filed on January 22, 2024, on January 25, 2024, we completed an underwritten public offering of 32,379,667 shares of our common stock, which included 5,325,000 shares sold and issued upon the exercise in full by the underwriters of their option to purchase additional shares of our common stock, and, in lieu of common stock to certain investors, pre-funded warrants to purchase 8,445,333 shares of common stock.
−Removed: The shares of common stock were sold at a public offering price of $2.40 per share and the pre-funded warrants were sold at a public offering price of $2.3999 per pre-funded warrant, which represents the per share public offering price of each share of common stock minus the $0.0001 per share exercise price for each pre-funded warrant.
+Added: 333-285609) with the SEC, which was declared effective on March 14, 2025 (2025 Shelf Registration Statement), in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof for the purposes of selling, from time to time, our common stock, debt securities or other equity securities in one or more offerings.
+Added: Under the 2025 Shelf Registration Statement and a prospectus supplement filed on October 7, 2025, we completed an underwritten registered direct offering of 4,375,062 shares of our common stock, and, in lieu of common stock to certain investors, pre-funded warrants to purchase 625,000 shares of common stock.
+Added: The shares of common stock were sold at a price of $16.00 per share and the pre-funded warrants were sold at a price of $15.9984 per pre-funded warrant, which represents the pre share price of each share of common stock minus the $0.0016 per share exercise price for each pre-funded warrant.
We received $80.0 million in aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses.
2 unchanged sentences
We have also filed registration statements on Form S-8 registering the issuance of shares of common stock issued or reserved for future issuance under our equity compensation plans.
−Removed: Shares registered under these registration statements on Form S-8 can be freely sold in the public market upon issuance and once vested, subject to volume limitations applicable to affiliates and the lock-up agreements described above.
+Added: Shares registered under these registration statements on Form S-8 can be freely sold in the public market upon issuance and once vested, subject to volume
+Added: limitations applicable to affiliates and the lock-up agreements described above.
If any of these additional shares are sold, or if it is perceived that they will be sold, in the public market, the market price of our common stock could decline.
4 unchanged sentences
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.