What changed in this filing

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Item 1. Business

2026-03-12 compared with 2025-03-13 · 229 added, 216 removed, 776 unchanged (36% of the section changed)

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We believe this key difference will enable us to deliver readily available treatments faster, more reliably, at greater scale, and to more patients.

Last year we executed our 2024 Platform Vision, which we believe will redefine the future of chimeric antigen receptor (CAR) T therapy by leveraging the unique attributes of allogeneic CAR T products.

In furtherance of that vision, we continue to focus on three core programs:

After nearly eight years of platform development and treatment of more than 200 patients across six clinical studies, multiple anticipated clinical readouts are expected in the second quarter of 2026.

These readouts could begin to validate several key scientific and clinical assumptions underlying off-the-shelf CAR T therapy, including biologic activity, safety, and the feasibility of standardized, readily available cell therapy across oncology and autoimmune indications.

We continue to focus on three core programs:

Large B-Cell Lymphoma (LBCL) :

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Renal Cell Carcinoma (RCC) :

TRAVERSE trial with ALLO-316 seeks to advance scientific innovation underlying the Dagger® technology to optimize CAR T cell expansion and persistence, thereby maximizing the potential of allogeneic CAR T in solid tumors while mitigating treatment-associated inflammatory response.

Our allogeneic approach involves engineering healthy donor T cells, which we believe will allow for the creation of an inventory of off-the-shelf products that can be delivered to a larger portion of eligible patients throughout the world.

These potential benefits led our Executive Chair, Arie Belldegrun, M.D., who was previously the Chair and Chief Executive Officer at Kite Pharma (Kite, now a Gilead company), and our President and Chief Executive Officer, David Chang, M.D., Ph.D., previously Chief Medical Officer and Executive Vice President of Research and Development at Kite, to found our company with the driving purpose of accelerating the development of allogeneic CAR T cell therapies.

Although we are currently focusing on our three core development programs noted above, we continue to have a deep pipeline to further the research and development of allogeneic CAR T cell product candidates in both hematological malignancies and solid tumors.

Although we are currently focusing on our three core development programs noted above, we continue to build a pipeline to further the research and development of allogeneic CAR T cell product candidates in both hematological malignancies and solid tumors, as well as in autoimmune diseases.

We believe our technology platform combined with our management team’s experience in immuno-oncology and specifically in CAR T cell therapy will help drive the rapid development and, if approved, the commercialization of potentially curative therapies for patients with aggressive cancer or who suffer from autoimmune diseases.

Our allogeneic CAR T cell development strategy has four key pillars:

(1) engineering product candidates to minimize the risk of graft-versus-host disease (GvHD), a condition where allogeneic T cells can recognize the patient’s normal tissue as foreign and cause damage, (2) creating a window of persistence that may enable allogeneic T cells to expand and eradicate cancer cells in patients or pathogenic autoreactive cells in patients, (3) building a leading manufacturing platform to enable consistent and high quality production and (4) leveraging next generation technologies to improve the functionality of allogeneic CAR T cells.

For our oncology programs we use Cellectis, S.A.

(Cellectis), TALEN® gene-editing technology to limit the risk of GvHD by engineering T cells to lack functional T cell receptors (TCRs), thereby preventing them from recognizing a patient’s normal tissue as foreign.

With the goal of enhancing the expansion and persistence of our engineered allogeneic T cells, we use TALEN® technology to inactivate the CD52 gene in donor T cells and an anti-CD52 monoclonal antibody to deplete CD52 expressing T cells in patients while sparing the therapeutic allogeneic T cells.

We believe this enables a window of persistence for the infused allogeneic T cells to actively target and destroy cancer cells.

We are also developing ALLO-647, our own anti-CD52 monoclonal antibody, which is designed to be used prior to infusing our other product candidates as part of a

lymphodepletion regimen.

(1) engineering product candidates to minimize the risk of graft-versus-host disease (GvHD), a condition where allogeneic T cells can recognize the patient’s normal tissue as foreign and cause damage, (2) creating a window of persistence that may enable allogeneic T cells to expand and eradicate cancer cells or pathogenic autoreactive cells in patients, (3) building a leading manufacturing platform to enable consistent and high quality production and (4) leveraging next generation technologies to improve the functionality of allogeneic CAR T cells.

We use Cellectis, S.A.

(Cellectis), TALEN® gene-editing technology and Arbor Biotechnologies CRISPR-based gene-editing technology in our oncology and autoimmune programs, respectively, to limit the risk of GvHD by engineering T cells to lack functional T cell receptors (TCRs), thereby preventing them from recognizing a patient’s normal tissue as foreign.

We also utilize either standard lymphodepletion (e.g., fludarabine and cyclophosphamide (Flu/Cy)) and/or our Dagger® technology in our oncology and autoimmune programs to potentially enhance the expansion and persistence of our engineered allogeneic T cells.

The Dagger® technology incorporates an anti-CD70 CAR engineered to eliminate CD70-expressing activated host T cells (including alloreactive host T cells) that can mediate premature rejection of infused allogeneic CAR T

We believe these approaches could enable a window of persistence for the infused allogeneic T cells to actively target and destroy cancer cells or to eliminate pathogenic autoreactive immune cells in autoimmune disease.

Our off-the-shelf approach is dependent on state-of-the-art manufacturing processes, and we believe we have built a technical operations organization with fully integrated in-house expertise in clinical and commercial engineered T cell manufacturing.

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We have built our own current good manufacturing practices (cGMP) manufacturing facility in Newark, California, that we call Cell Forge 1 (CF1).

We are currently utilizing CF1 for clinical manufacturing of our product candidates.

Finally, we plan to leverage next generation technologies to develop more potent product candidates and to develop product candidates to overcome premature rejection of allogeneic CAR T cells by the patient’s immune system.

We believe next generation technologies will also allow us to further develop allogeneic T cell therapies for the treatment of solid tumors, which to date have been difficult to treat because of, among other factors, the lack of validated targets and tumor microenvironments that can impair the activity of T cells.

We exclusively utilize CF1 for manufacturing of our product candidates for use in clinical studies.

We are currently developing a pipeline of multiple allogeneic CAR T cell product candidates utilizing protein engineering, gene editing, gene insertion and advanced proprietary T cell manufacturing technologies.

Our most advanced product candidate, cemacabtagene ansegedleucel, referred to as cema-cel (previously ALLO-501A), is an engineered allogeneic CAR T cell product candidate that targets CD19, a protein expressed on the cell surface of B cells and a validated target for B cell driven hematological malignancies.

We are currently focused on developing cema-cel for LBCL.

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• Cemacabtagene ansegedleucel (cema-cel).

We are enrolling a pivotal Phase 2 clinical trial (ALPHA3) for cema-cel as part of a 1L treatment plan for newly diagnosed and treated LBCL patients who are likely to relapse and need further therapy.

We continue to enroll our pivotal Phase 2 clinical trial (ALPHA3) for cema-cel as part of a 1L treatment plan for newly diagnosed and treated LBCL patients who are likely to relapse and need further therapy.

(Foresight Diagnostics) that we believe will identify patients who have achieved remission by standard disease assessment but who have minimal residual disease (MRD) at the completion of 1L chemoimmunotherapy.

The ALPHA3 trial is designed to study the impact of treating MRD positive patients with cema-cel.

The study will randomize

approximately 240 patients who achieve a complete response or partial response to 1L therapy, but who are MRD positive.

Patients will be randomized to receive either consolidation with cema-cel or the current standard of care, which is observation.

The study design, which has event free survival (EFS) as its primary endpoint, initially includes two lymphodepletion arms:

standard fludarabine and cyclophosphamide plus ALLO-647

standard fludarabine and cyclophosphamide without ALLO-647

One of these lymphodepletion arms will be discontinued following a planned interim analysis designed to identify the most appropriate regimen for this patient population.

An initial safety and futility interim analysis will occur once 12 patients in each arm have been enrolled and followed for MRD conversion.

If both treatment arms perform better than the control arm according to the futility criteria, but neither treatment arm shows a trend toward superiority relative to the other in this interim analysis, additional patients may be enrolled and analyzed before we select the final lymphodepletion regimen.

The selection of the lymphodepletion regimen is anticipated around mid-2025, depending on the interim analyses results and overall trial progress.

(Foresight Diagnostics), which was acquired by Natera, Inc.

(Natera) in December 2025.

We believe the Foresight Diagnostics assay will identify patients who have achieved remission by standard disease assessment but who have minimal residual disease (MRD) at the completion of 1L chemoimmunotherapy.

The ALPHA3 trial is designed to

evaluate whether treating MRD positive LBCL patients with cema-cel will improve clinical outcomes.

The study will randomize approximately 220 patients who achieve a complete response or partial response to 1L therapy, but who are MRD positive.

Patients are being randomized to receive either consolidation with cema-cel or the current standard of care, which is observation.

The study design has event free survival (EFS) as its primary endpoint.

Originally, the study design also included two lymphodepletion arms, FCA (standard fludarabine and cyclophosphamide plus ALLO-647) and FC (standard fludarabine and cyclophosphamide without ALLO-647).

Following a Grade 5 treatment-related serious adverse event observed in the FCA arm, in August 2025 we announced the discontinuation of dosing in the FCA arm, and we terminated further development of ALLO-647.

Thereafter, the trial design was amended and ALPHA3 is now proceeding with the FC arm and the control arm (observation).

An interim futility analysis will occur once 12 patients in each arm have been enrolled and followed for MRD conversion.

We plan to announce MRD clearance data from the interim futility analysis in April 2026, and anticipate that enrollment in ALPHA3 will be completed by the end of 2027.

We have completed enrollment in a Phase 1 clinical trial (TRAVERSE) of ALLO-316, an allogeneic CAR T cell product candidate targeting CD70, in adult patients with advanced or metastatic RCC.

We presented interim results from the TRAVERSE trial at the International Kidney Cancer Symposium (IKCS) and The Society for Immunotherapy of Cancer's (SITC) Annual Meeting in November 2024.

See “—Product Pipeline and Development Strategy—Anti-CD70 Development Program—Results from the Phase 1 ALLO-316 TRAVERSE Trial” for information regarding the results.

We presented updated results from the TRAVERSE trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in June 2025.

Refer to “—Product Pipeline and Development Strategy—Anti-CD70 Development Program—Results from the Phase 1 ALLO-316 TRAVERSE Trial” for information regarding the results.

In October 2024, we announced that we received Regenerative Medicine Advanced Therapy (RMAT) designation for ALLO-316 for adult patients with advanced or metastatic RCC.

The RMAT designation was based on Phase 1 clinical data from the TRAVERSE trial indicating the potential of ALLO-316 to address the unmet need for patients with difficult-to-treat RCC who have failed multiple standard RCC therapies, including an immune checkpoint inhibitor and a VEGF-targeting therapy.

Once we have obtained additional follow-up data on the enrolled patients, we plan to engage with FDA to establish the next steps for this development program.

Following the clearance of an IND in January 2025, we plan to initiate a Phase 1 clinical trial (the RESOLUTION trial) of ALLO-329, an allogeneic CAR T cell product candidate targeting both CD19 and CD70, in adult patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis in mid-2025.

We are currently exploring partnering opportunities to advance the asset.

During 2025, we initiated a Phase 1 clinical trial (the RESOLUTION trial) of ALLO-329, an allogeneic CAR T cell product candidate targeting both CD19 and CD70, in adult patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis.

Inclusion of an anti-CD70 CAR in ALLO-329 incorporates the Dagger® technology, which is designed to reduce or eliminate the need for standard chemotherapy by preventing premature rejection while targeting CD19+ B-cells and CD70+ activated T-cells, both of which play a role in autoimmune diseases.

The RESOLUTION trial will include two distinct lymphodepletion arms:

The RESOLUTION trial includes two distinct lymphodepletion arms:

one using a dose of cyclophosphamide alone which is used by rheumatologists, and another that eliminates lymphodepletion entirely.

We plan to announce initial proof-of-concept data in June 2026.

• Other Product Candidates:

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The design of the ALPHA3 1L consolidation trial builds upon the results demonstrated in the Phase 1 ALPHA2 trial and leverages an investigational diagnostic test developed by Foresight Diagnostics to identify patients who have MRD at the completion of 1L chemoimmunotherapy for treatment with cema-cel.

The ALPHA3 trial was initiated in June 2024 and now has 40 sites activated and screening for patients with MRD.

An interim analysis is anticipated around mid-2025 depending on the analyses and overall trial progress, and based thereon, the lymphodepletion regimen for the remainder of the trial will be selected.

The ALPHA3 trial was initiated in June 2024 and now has over 60 sites activated and screening for patients with MRD.

We plan to announce MRD clearance data from the interim futility analysis in April 2026, and anticipate that enrollment in ALPHA3 will be completed by the end of 2027.

• Expand our allogeneic CAR T platform into the treatment of autoimmune disease (AID).

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ALLO-329 incorporates our Dagger® technology.

In January 2025, we announced that the FDA has cleared our IND for a rheumatology basket study of ALLO-329, our RESOLUTION trial.

Incorporation of the Dagger® technology into an “off-the-shelf” CD19 product for use in AID is designed to reduce or eliminate the need for standard chemotherapy while targeting CD19+ B-cells and CD70+ activated T-cells, both of which play a role in AID.

Initiation of the RESOLUTION trial is targeted for mid-2025 with initial proof-of-concept data available anticipated around year-end 2025.

During 2025 we initiated a rheumatology basket study of ALLO-329, our RESOLUTION trial.

The RESOLUTION trial includes two parallel cell dose escalation arms that differ in the lymphodepletion regimen used.

One arm uses cyclophosphamide alone at a dose used by rheumatologists, and the other does not incorporate lymphodepletion.

We plan to announce initial proof-of-concept data in June 2026.

• Build state-of-the-art gene engineering and cell manufacturing capabilities .

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• Expand into solid tumor indications with high unmet need and leverage next generation technologies to advance our platform.

We plan to continue to advance the research and development of ALLO-316, which targets CD70, for the treatment of clear cell renal cell carcinoma (ccRCC) as part of our TRAVERSE trial.

We plan to continue to advance the research and development of ALLO-316, which targets CD70, for the treatment of clear cell renal cell carcinoma (ccRCC).

We are investigating next-generation technologies incorporated in the design of ALLO-316 which seek to better control rejection of allogeneic CAR T cells by the patient's immune system.

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CARs are engineered molecules that, when present on the surface of a T cell, enable the T cell to recognize specific proteins or antigens that are present on the surface of other cells.

More than one type of CAR can be included in a CAR T cell,

imparting multi-antigen targeting capability.

More than one type of CAR can be included in a CAR T cell, imparting multi-antigen targeting capability.

The CAR molecule(s) in our product candidates are comprised of a single chain protein that contains the following elements:

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This domain extends out onto the surface of the engineered T cell, where it can recognize the target antigens.

The target binding domain consists of a single-chain variable fragment (scFv) of an antibody comprising variable domains of heavy and light chains joined by a short linker.

binding domain consists of a single-chain variable fragment (scFv) of an antibody comprising variable domains of heavy and light chains joined by a short linker.

• Transmembrane Domain and Hinge:

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The Next Revolution

There are two primary approaches to engineered T cell therapy:

There are two primary ex vivo approaches to engineered T cell therapy:

autologous and allogeneic.

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In part due to these logistics, autologous treatment is currently only available at select centers.

In addition to these ex vivo approaches, a third approach has emerged that is referred to as in vivo CAR T or in situ CAR T.

This in vivo approach seeks to generate CAR expressing T cells directly inside the patient by administering engineered delivery systems (such as viral vectors or targeted lipid nanoparticles (LNP)) that introduce CAR encoding genetic material into endogenous T cells.

We believe that in vivo approaches face limitations/challenges, including:

• CAR expression and transduction efficiency are dose dependent and difficult to titrate (unpredictable pharmacology).

• Potential immunogenicity to LNP components or viral proteins may hinder repeat dosing or retreatment.

• Reduced activity in patients with exhausted or otherwise unhealthy T cells.

• Risk of off target delivery and insertional mutagenesis in progenitor cells arising from stochastic viral vector integration, warranting monitoring.

Allogeneic engineered T cells are manufactured in a similar manner as autologous, but our manufacturing has two key differences:

(1) our allogeneic T cells are derived from healthy donors, not cancer patients, and (2) our allogeneic T cells are genetically engineered to minimize the risk of GvHD and enable a window of persistence in the patient.

(1) our allogeneic T cells are derived from healthy donors, not the patients themselves, and (2) our allogeneic T cells are genetically engineered to minimize the risk of GvHD.

Our approach is designed to provide the same intended curative outcome as autologous therapy, while offering the following potential key advantages:

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Our manufacturing process produces therapies from selected, screened and tested healthy donors.

Healthy donor T cells are potentially superior for engineered cellular therapy as compared to T cells from patients who have undergone prior chemotherapy or hematopoietic stem-cell transplant, which can damage or weaken T cells.

In addition, greater consistency of the product may yield more predictable treatment outcomes.

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Next, we use gene editing tools to edit the T cell genome to inactivate TCRα, and in the case of our oncology products, to also inactivate CD52.

Inactivation of TCRα and CD52 is intended to reduce the risk of GvHD and enable the use of ALLO-647, a proprietary CD52 monoclonal antibody, as part of lymphodepletion to allow the allogeneic T cells to expand and persist in patients, respectively.

Inactivation of TCRα is intended to reduce the risk of GvHD.

Inactivation of CD52 was intended to enable the use of ALLO-647, a proprietary CD52 monoclonal antibody, as part of lymphodepletion.

Although the CD52 inactivation remains in certain of our product candidates, we have now discontinued the use of ALLO-647 as we now do not believe it is a necessary component of the lymphodepletion regimen for our product candidates in the clinical settings selected for development.

For oncology products the transduction and genetic editing steps are separate, but for our autoimmune disease product candidate, ALLO-329, the steps are combined and utilize different gene editing technology.

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On September 15, 2022, Servier sent us a notice of discontinuation of its involvement in the development of all CD19 Products pursuant to the Servier Agreement.

On May 10, 2024, the we entered into an Amendment and Settlement Agreement (the Servier Amendment) with Servier which restructures our relationship under the Servier Agreement.

On May 10, 2024, we entered into an Amendment and Settlement Agreement (the Servier Amendment) with Servier which restructures our relationship under the Servier Agreement.

Under the Servier Amendment the parties agreed that co-development performed by the Company and Servier under the Servier Agreement, including co-development relating to CD19 Products, ceased as of December 15, 2022.

UCART19 was our first CD19 product candidate, and Servier led its manufacturing and clinical development.

UCART19 was manufactured to express a CAR that is designed to target CD19 and gene edited to lack TCRα and CD52 to minimize the risk of GvHD and enable use of anti-CD52 monoclonal antibodies to create a window of CAR T cell persistence in the patient.

In addition, UCART19 cells were engineered to express a small protein on the cell surface called RQR8, which consists of two rituximab recognition domains.

This allowed for recognition and elimination of the CAR T cells by rituximab if silencing of CAR T cell activity is desired.

Servier sponsored two Phase 1 clinical trials of UCART19 in patients with R/R CD19 positive B-cell acute lymphoblastic leukemia (ALL), both of which were completed in 2020.

Patients from both studies are continuing the long-term follow-up as planned.

We have been, and continue to be, responsible for the manufacture and clinical development of ALLO-501 and cema-cel.

ALLO-501 is identical to UCART19 in molecular design, however several modifications were introduced by us to the manufacturing process for ALLO-501.

These modifications are designed to facilitate more efficient manufacturing scale-up for the larger patient population targeted by ALLO-501.

Like UCART19, ALLO-501 also co-expresses a small protein on the cell surface called RQR8, which consists of two rituximab recognition domains.

This is intended to allow for destruction of the CAR T by rituximab.

Prior treatment with rituximab is typical for patients with Non-Hodgkin Lymphoma (NHL) and, depending on the lag time between the rituximab administration and the CAR T infusion, prior administration of rituximab may interfere with any CAR T that includes RQR8.

As a result, we have removed RQR8 in cema-cel, which is illustrated below, to facilitate treatment of patients who were recently treated with rituximab.

In December 2025, the Centre de Médiation et d'Arbitrage de Paris issued a decision in an arbitration between Cellectis and Servier relating to Servier’s discontinuation of development.

In that decision, the arbitration panel terminated Servier’s license to UCART19v1 and ALLO-501, which were essentially the same product, and as a result our license to ALLO-501 was also terminated.

We had previously in 2021 terminated further development of ALLO‑501 in favor of ALLO‑501A, now known as cema‑cel, in view of ALLO‑501A’s optimized construct and manufacturing process, including removal of the rituximab-activated safety switch and promoter modifications that improved CAR expression, product consistency, and clinical scalability without altering the CAR itself.

This termination of our rights with respect to ALLO-501 does not impact our license with respect to cema-cel, and we continue to have no plans to further develop ALLO-501.

We have been, and continue to be, responsible for the manufacture and clinical development of cema-cel.

Cema-cel is manufactured to express a CAR that is designed to target CD19 and gene edited to lack TCRα and CD52 to minimize the risk of GvHD and enable use of anti-CD52 monoclonal antibodies to create a window of CAR T cell persistence in the patient, which is illustrated below.

Lead Target Indication:

Non-Hodgkin Lymphoma (NHL)

NHL is a hematologic cancer originating from malignant lymphocytes.

NHL is a hematologic cancer originating from lymphocytes.

It is the most common hematological malignancy in the United States, with 80,620 new cases estimated to be diagnosed and 20,140 deaths estimated in 2024, according to the American Cancer Society.

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NHL can be rapidly growing (aggressive), such as LBCLs, or it can be slow growing, or indolent, such as follicular lymphoma (FL).

The R-CHOP chemotherapy combination (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) introduced in the early 2000s remains the standard of care for newly diagnosed LBCL, and can yield five-year survival rates of 55-60%.

Unfortunately, approximately 30% of LBCL patients relapse or have treatment-refractory disease and require second-line therapy.

Subsequent therapy for fit patients is commonly high-dose therapy followed by autologous stem-cell therapy or autologous anti-CD19 CAR T therapy.

Two previous randomized controlled trials evaluated anti-CD19 CAR T cell therapies, Yescarta® and Breyanzi® compared to high dose chemotherapy followed by autologous stem cell rescue.

Yescarta® and Breyanzi® improved event-free-survival versus stem cell transplant (8.3 months vs.

2.0 months and 10.1 months vs.

2.3 months, respectively).

A retrospective analysis of patients with R/R LBCL, who were not treated with autologous CAR T therapy, found that outcomes in this population are poor, with an objective response rate of 26% (complete response (CR):

The R-CHOP chemotherapy combination (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), introduced in the early 2000s, remains the standard of care for newly diagnosed LBCL and can yield five-year survival rates of approximately 55-60%.

Unfortunately, the remaining LBCL patients relapse or have treatment-refractory disease and require additional therapy.

Historically, treatment options have included salvage chemotherapy followed by high-dose therapy and autologous stem-cell transplantation in eligible patients, as well as autologous anti-CD19 CAR T therapy.

A retrospective analysis of patients with R/R LBCL, who were not treated with autologous CAR T therapy reported an objective response rate of 26% (complete response (CR):

7%, partial response:

18%) and median overall survival of 6.3 months.

In recent years, additional therapies have been approved for patients with relapsed or refractory disease, including antibody-drug conjugates such as polatuzumab vedotin and loncastuximab tesirine, the CD19-directed antibody tafasitamab in combination with lenalidomide, and CD20-directed bispecific antibodies such as epcoritamab and glofitamab.

Despite these advances, outcomes for many patients with relapsed or refractory LBCL remain poor.

Autologous CAR T therapy has made significant advances in addressing R/R NHL, and has moved to earlier lines of therapy, as further described below under — "Competition".

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In the fourth quarter of 2022, we proceeded to the Phase 2 portion of the ALPHA2 trial in adult patients with R/R LBCL.

We have also sponsored the EXPAND trial of ALLO-647, which was intended to demonstrate the overall contribution of ALLO-647 to the benefit to risk ratio of the lymphodepletion regimen for cema-cel.

We are the sponsor of the EXPAND trial of ALLO-647, which was intended to demonstrate the overall contribution of ALLO-647 to the risk-benefit ratio of the lymphodepletion regimen for cema-cel.

In January 2024 we announced that we would deprioritize the ALPHA2 R/R LBCL and EXPAND trials to focus on our ALPHA3 trial, which seeks to embed cema-cel as part of a 1L consolidation strategy.

We have deprioritized the ALPHA2 R/R LBCL trial primarily because the ALPHA3 trial, if successful, could significantly impact the need for cell therapy in later lines of treatment, including the third line (3L) patients being studied in our ALPHA2 trial.

The ALPHA3 trial is an open-label, Phase 2, multicenter clinical trial evaluating the safety and efficacy of cema-cel in adult patients with LBCL who have completed R-CHOP and have attained a remission, but who test positive for MRD.

The ALPHA3 trial is an open-label, Phase 2, multicenter clinical trial evaluating the safety and efficacy of cema-cel in adult patients with LBCL who have completed R-CHOP for other standard regimen and have attained a remission, but who test positive for MRD.

The ALPHA3 trial will randomize approximately 220 patients who achieve a complete or partial response to 1L therapy, but who test positive for MRD at their end-of-therapy PET/CT assessment.

The patients will be randomized to either treatment with cema-cel or the current standard of care, which is observation.

The design, with a primary endpoint of EFS, will initially include two lymphodepletion arms (one with standard fludarabine and cyclophosphamide plus ALLO-647 and one without ALLO-647).

One lymphodepletion arm will be discontinued following a planned interim analysis around mid-2025 designed to select the most appropriate regimen for this patient population.

The design, with a primary endpoint of EFS, initially included two lymphodepletion arms (one with standard fludarabine and cyclophosphamide plus ALLO-647 (FCA) and one without ALLO-647 (FC)).

Thereafter, the trial design was amended and ALPHA3 is now proceeding with just the FC arm and the control arm (observation).

The ALPHA3 trial leverages an investigational diagnostic test developed by Foresight Diagnostics to identify patients who have MRD at the completion of 1L chemoimmunotherapy.

Although 1L R-CHOP is curative for many with

LBCL, as noted above, approximately 30% of patients treated will relapse.

Although 1L R-CHOP is curative for many with LBCL, as noted above, approximately 30% of patients treated will relapse.

Under the current standard of care, there is no way to determine which patients are at greater risk of relapse after initially responding to 1L treatment, and so the standard of care has been simply to “watch and wait” for the disease to relapse.

Foresight Diagnostics, however, has developed a liquid biopsy testing platform for the measurement of MRD.

Foresight Diagnostics, however, has developed a liquid biopsy

testing platform for the measurement of MRD.

Based on Foresight Diagnostics’ published data, we believe that the Foresight Diagnostics’ assay is highly sensitive and predictive of which patients are likely to relapse.

By incorporating the Foresight Diagnostics assay into our ALPHA3 trial design, we believe that we can identify the patient population most at risk for relapse and treat those patients with cema-cel.

In February 2025, we entered into an Amended and Restated Strategic Collaboration Agreement with Foresight Diagnostics which expands our collaboration to enable the development of Foresight Diagnostics’ CLARITY TM MRD assay as a companion diagnostic in the EU, UK, Canada and Australia in support of Allogene’s clinical development of cema-cel.

In December 2025, Foresight Diagnostics was acquired by Natera;

however, it continues to operate as a standalone division of Natera and to execute its role in the ALPHA3 trial.

To date, the acquisition has not impacted Foresight Diagnostics’ ability to meet its testing commitments or had any negative effect on the execution of the ALPHA3 trial, including enrollment and trial timelines.

ALPHA3 takes advantage of cema-cel as a one-time, off-the-shelf treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP, potentially positioning cema-cel to become the standard “7th cycle” of frontline treatment available to all eligible patients with MRD.

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Cema-cel’s Phase 1 safety profile, with low rates of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS), already permits its use in the outpatient setting in R/R patients and may further improve in patients with no radiological evidence of disease.

The ALPHA3 trial was initiated in 2024 and enrollment is currently ongoing with 40 sites activated in the United States.

Assuming favorable outcomes and subject to FDA discussions, we plan to seek FDA approval of cema-cel, and possibly ALLO-647, based on the ALPHA3 trial.

Additionally, assuming favorable outcomes, we anticipate that the ALPHA3 data set could be used to support EU regulatory approval.

The ALPHA3 trial was initiated in 2024 and enrollment is currently ongoing with over 60 sites activated in the United States and Canada.

We expect to activate additional sites in Australia and South Korea in mid-2026.

We have met with European Union (EU) regulatory authorities and have received scientific advice to assist us with finalizing our regulatory strategy for opening the trial in the EU, and operational feasibility assessments for the EU remain ongoing.

An interim futility analysis is expected to occur in April 2026 which will compare MRD clearance rates between cema-cel after standard fludarabine and cyclophosphamide (FC) lymphodepletion versus observation (12 patients in each arm).

The update will also include a summary of safety outcomes and additional information about screening and treatment patterns across the trial site footprint.

Clearance of MRD in 25–30% more patients assigned to the cema-cel arm compared to those in the observation arm may indicate a proof of concept that early treatment of MRD+ disease could meaningfully improve long term outcomes.

We anticipate that enrollment in ALPHA3 will be completed by the end of 2027.

Assuming favorable outcomes and subject to FDA discussions, we plan to seek FDA approval of cema-cel based on the ALPHA3 trial.

Additionally, assuming favorable outcomes, we anticipate that the ALPHA3 data set could be used to support EU regulatory approval regardless of whether the ALPHA3 trial is expanded into the EU.

The EMA has granted Marketing Authorizations for products, even when their clinical development programs did not involve any European sites.

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This practice encompasses a wide range of indications and modalities, including those classified as Advanced Therapy Medicinal Products by the EMA.

Later this year, we plan to seek scientific advice from the EMA to assist us with finalizing our regulatory strategy for the EU and the UK.

Additionally, in February 2025, we entered into an Amended and Restated Strategic Collaboration Agreement with Foresight Diagnostics which expands our collaboration to enable the development of Foresight Diagnostics’ MRD assay as a companion diagnostic in the EU, UK, Canada and Australia in support of Allogene’s clinical development of cema-cel.

Anti-CD70 Oncology Development Program

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Accordingly, we believe progressing allogeneic CAR T cell products directed against CD70 could be promising in solid tumor indications as well as hematological malignancies.

ALLO-316 is manufactured to express a CAR that is designed to target CD70 and gene edited to lack expression of the TCR and CD52 to both minimize the risk of GvHD and to enable use of CD52 monoclonal antibodies to permit a window of persistence of CAR T cells in the patient.

ALLO-316 is manufactured to express a CAR that is designed to target CD70 and gene edited to lack expression of the TCR to minimize the risk of GvHD.

We also inactivated CD52, which was intended to enable use of CD52 monoclonal antibodies to potentially permit a window of persistence of CAR T cells in the patient.

Although the CD52 edit remains in ALLO-316, we have discontinued dosing ALLO-316 in combination with an anti‑CD52 monoclonal antibody as we now do not believe it is a necessary component of the lymphodepletion regimen for ALLO-316.

In addition, rituximab and CD34 recognition domains have been incorporated in between the scFv and the linker domain, as illustrated below.

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Results from the Phase 1 ALLO-316 TRAVERSE Trial

On November 7, 2024, we announced interim results from the Phase 1 TRAVERSE trial of ALLO-316 in patients with advanced or metastatic RCC who have progressed on or who are intolerant to standard therapies, including an immune checkpoint inhibitor and a VEGF-targeting therapy.

Data from dose escalation cohorts and the ongoing Phase 1b expansion cohort were included.

The Phase 1b expansion cohort is evaluating safety and efficacy of ALLO-316 at DL2 (80M CAR T cells) following a standard FC500 (fludarabine (30 mg/m2/day) and cyclophosphamide (500 mg/m2/d) for 3 days) lymphodepletion regimen.

The interim results provide proof-of-concept demonstrating the promise of an allogeneic CAR T product candidate to treat CD70-expressing RCC with ALLO-316.

As of the data extract date of October 14, 2024, 39 patients had been enrolled in the ongoing Phase 1 trial, of which 26 were confirmed to have CD70 positive RCC and were evaluable for efficacy outcomes.

Following a single infusion of ALLO-316 in heavily pretreated patients, the trial demonstrated best Overall Response Rate (ORR) of 50% and Confirmed Response Rate of 33% in those patients with CD70 Tumor Proportion Score (TPS) of ≥50% who received DL2.

Patients with a TPS of ≥50% comprise the majority of patients with advanced or metastatic RCC.

Of those with a TPS ≥50, 76% (16/21) experienced a reduction in tumor burden.

Two of six (33%) patients with high TPS who received the Phase 1b expansion regimen showed durable responses ongoing at ≥4 months.

Response Rates by CD70 Status and Dose

Patients Evaluable for Disease Outcomes a (N=34)

CD70 Positive (N=26) CD70 Negative or Unknown (N=8)

Best overall response, d n/N (%)

High TPS (≥50)

Low TPS (<50)

0/5 (0) 1/8 (13)

0/2 (0) 6/18 (33)

0/3 (0) 3/8 (38)

0/2 (0) 0/8 (0)

Confirmed ORR, e n/N (%)

High TPS (≥50)

Low TPS (<50)

0/5 (0) 1/8 (13)

0/2 (0) 4/18 (22)

0/3 (0) 2/8 (25)

0/2 (0) 0/8 (0)

a Patients evaluable for disease outcome includes those who received ALLO-316 and had at least one tumor assessment.

b Standard fludarabine and cyclophosphamide plus ALLO-647

c Includes FC300 and FC500

d Best overall response across visits did not require confirmation for CR/PR.

e Confirmed overall response of CR/PR required confirmation at the subsequent visit.

Regarding safety data, the most common all-grade adverse events were CRS (with only one grade ≥3), fatigue (59%), neutropenia (56%), decreased white blood cell count (54%), anemia (51%) and nausea (51%).

ICANS was minimal at 8% and no GvHD occurred.

Most Prevalent Treatment-Emergent Adverse Events (TEAEs) (>40% Any Grade Incidence) and

On June 1, 2025, we announced updated data from the Phase 1 TRAVERSE trial of ALLO-316 in patients with advanced or metastatic RCC whose tumors had progressed on or who are intolerant to standard therapies, including an immune checkpoint inhibitor and a VEGF-targeting therapy.

The data were presented at the 2025 ASCO Annual Meeting and focused on the Phase 1b expansion cohort evaluating ALLO-316 at DL2 (80 million CAR T cells) following a standard lymphodepletion regimen of fludarabine (30 mg/m2/day) and cyclophosphamide (500 mg/m2/day) for three days.

The median time from enrollment to the start of therapy was four days.

In the Phase 1b expansion cohort, 22 patients whose tumors had progressed on multiple prior therapies were treated with lymphodepletion and 20 were treated with ALLO-316.

All patients had tumors resistant to immune checkpoint blockers and at least one tyrosine kinase inhibitor (TKI), 82% had ≥2+ prior TKIs, and 41% had prior belzutifan.

Sixteen of the ALLO-316 treated patients had a high CD70 Tumor Proportion Score (TPS >50%).

A single dose of ALLO-316 stabilized or reversed disease progression in the majority of patients.

In the 16 patients with CD70 TPS ≥50%, the trial demonstrated a Confirmed Overall Response Rate (ORR) of 31%.

Of the five confirmed responders, four maintain ongoing responses, with one in sustained remission for over 12 months.

The median duration of response (mDOR) has not yet been reached, indicating the potential for long-term disease control.

The updated results continue to demonstrate the potential of an allogeneic CAR T product candidate to treat CD70-expressing RCC and highlight the impact of our proprietary Dagger® technology in enabling robust CAR T-cell expansion and persistence in solid tumors.

Response Rates by CD70 Status

Response Rates by CD70 Status CD70+ patients Phase 1b

ORR (confirmed CR or PR per RECIST v1.1), n/N (%)

CD70 TPS ≥ 50%

CD70 TPS <50%

Across the overall Phase 1 TRAVERSE study population, treatment-emergent adverse events were common and primarily hematologic in nature.

Adverse events commonly associated with CAR T-cell therapy and lymphodepleting chemotherapy, including infections, CRS, ICANS and hyperinflammatory syndromes such as IEC-HS, were observed.

In earlier dose-finding cohorts outside the Phase 1b expansion cohort, fatal treatment-related adverse events were reported, including Grade 5 cardiogenic shock, Grade 5 sepsis and Grade 5 failure to thrive.

Following review of these events, the study protocol was amended to incorporate additional diagnostic criteria and management guidance for IEC-HS and enrollment resumed with the regimen subsequently evaluated in the Phase 1b expansion cohort.

The safety profile of ALLO-316 in the Phase 1b cohort was generally consistent with lymphodepletion and an active CAR T product.

The most frequent Grade ≥3 events were hematologic and there were no treatment-related Grade 5 events reported in the Phase 1b cohort.

The most common all-grade adverse events were cytokine release syndrome (CRS) (68%;

with no Grade ≥3 events), neutropenia (68%), decreased white blood cell count (68%), anemia (59%), and thrombocytopenia (55%).

Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 18% of patients (with no Grade ≥3 events) and no graft-versus-host disease (GvHD) occurred.

Improved recognition of immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) led to diagnosis in 36% of patients, with two patients (9%) experiencing a Grade 3 (one patient) or Grade 4 (one patient) event that subsequently improved with management.

No treatment-related Grade 5 events were reported in patients treated in the Phase 1b cohort.

Most Prevalent Treatment-Emergent Adverse Events (TEAEs)

(>20% Any Grade Incidence) and

Adverse Events of Special Interest (AESI)

Adverse Event, n(%)

All Patients (N=39)

DL2 FC500 (N=11)

TEAEs ≥20% incidence in Phase 1b, n (%)

Phase 1b (n = 22)†

White blood cell count decreased

Thrombocytopenia

ALT increased

Peripheral edema

AST increased

AEs of Special Interest

Viral infections

Neurotoxicity c

Any Grade Grade ≥3

Graft-versus-host disease

a TEAE included all AEs that started from the first dose date of study drug in each treatment period up to start of another treatment period, death, or the date prior to initiation of another anti-cancer agent, whichever occurred first.

b Infection events (62%) were primarily low grade;

the most common was viral infections (33%) with cytomegalovirus infection and COVID-19 (any grade, 18% and 15%;

Grade ≥3, 0% and 5%, respectively).

c Neurotoxicity includes system organ class of nerve system disorders and psychiatric disorders with onset date up to Study Day 30 post ALLO-316 infusion.

d IEC-HS includes the preferred terms IEC-HS, HLH, Hemophagocytic lymphohistiocytosis, and atypical HLH.

Two patients developed an inflammatory syndrome prior to the existence of IEC-HS as a term in MedDRA, which has been updated as of September 2023.

Two dose-limiting toxicity (DLT) events of autoimmune hepatitis and cardiogenic shock were reported.

Each event occurred in two separate participants who received FCA (FC300 plus ALLO-647) lymphodepletion and DL2 of ALLO-316.

Three Grade 5 treatment-related adverse events were reported:

1) cardiogenic shock, which was one of the two DLT events;

2) sepsis from multi-drug resistant Klebsiella pneumoniae in a participant who received DL4 of ALLO-316.

This participant had a prior episode of muscle abscess and bacteremia from the same multi-drug resistant Klebsiella and was receiving anakinra and dexamethasone for hyperinflammation;

3) failure to thrive in a participant 16 months after treatment with ALLO-316.

This subject had tumor response of stable disease (SD) at month 12 and no interval scans to evaluate disease status prior to death.

IEC-HS includes the preferred terms immune effector cell-associated HLH-like syndrome and Hemophagocytic lymphohistiocytosis.

†Includes 2 patients who received lymphodepletion but did not receive ALLO-316

†† One patient experienced G4 IEC-HS based on GI bleeding with subsequent improvement and 1 patient experienced G3 IEC-HS based on hypotension managed without pressors with subsequent improvement.

Clinical Development Plan

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We have developed an investigational in vitro companion diagnostic (IVD) assay designed for use in determining CD70 expression levels for patient selection in TRAVERSE.

The trial is now deploying the IVD assay for the purposes of identifying patients most likely to benefit from ALLO-316.

The trial deployed the IVD assay for the purposes of identifying patients most likely to benefit from ALLO-316.

During the advancement of the TRAVERSE trial with ALLO-316, we have observed allogeneic CAR T cell expansion and persistence driven by CD70 CAR that allows elimination of alloreactive host lymphocytes.

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Enrollment in the Phase 1b cohort has been completed and we are now pausing further standard dosing pending durability results for the enrolled patients.

Additional data from the Phase 1b expansion cohort is expected to be announced in mid-2025.

We continue to actively explore strategic opportunities, including potential partnerships, to advance this program.

Anti-CD19/CD70 Autoimmune Disease Development Program

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B cells and T cells are two key components of the immune system, each playing distinct roles in the body’s defense against pathogens and in maintaining immune tolerance.

Effective collaboration between B cells and T cells results in the sustained production of autoantibodies, which are antibodies that mistakenly target and react with a person’s own tissues or organs resulting in AID.

Occasionally, B cells and T cells work together to generate production of pathogenic autoantibodies, which are antibodies that target and react with a person’s own tissues or organs and can contribute to AID.

Autoantibodies are critical to the pathogenesis of many AIDs.

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As noted above, CD19 is an antigen expressed on the surface of B cells, including pathogenic autoreactive B cells.

Activated T cells, which upregulate CD70, induce sustained production of autoantibodies by B cells from patients affected by AID.

Moreover, CD70 expression is elevated on T cells of patients in certain AIDs, suggesting a pathogenic role for CD70+ T cells in AID.

Activated T cells, which upregulate CD70, may contribute to B-cell autoantibody production and can cause direct tissue damage via an autoreactive T cell receptor.

Indeed, CD70 expression has been shown to be elevated on some T cells of patients in certain AIDs, suggesting a pathogenic role for CD70+ T cells in AID.

Accordingly, we believe progressing allogeneic CAR T cell therapies directed against CD19 and CD70 could be promising in AID indications.

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Lupus Nephritis, Idiopathic Inflammatory Myopathies, and Systemic Sclerosis

In January 2025 we announced that the FDA has cleared our IND for a rheumatology basket study of ALLO-329.

In January 2025 we announced that the FDA had cleared our IND for a rheumatology basket study of ALLO-329, which we initiated in 2025.

Our RESOLUTION trial will evaluate the safety and efficacy of ALLO-329 across multiple autoimmune diseases, including systemic lupus erythematosus (SLE) (including lupus nephritis), idiopathic inflammatory myopathies, and systemic sclerosis.

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Inclusion of an anti-CD70 CAR in ALLO-329 is designed to reduce or eliminate the need for standard chemotherapy by preventing premature rejection while also targeting CD70+ activated lymphocytes, which may play a direct role in AID pathogenesis.

Following the clearance of an IND in January 2025, we plan to initiate a Phase 1 clinical trial (the RESOLUTION trial) of ALLO-329 in adult patients with systemic lupus erythematosus (including lupus nephritis), idiopathic inflammatory myopathies, and systemic sclerosis in mid-2025.

The Phase 1 RESOLUTION trial is a 3+3 dose-escalation study enrolling patients across SLE, IIMs, and SSc.

The trial is evaluating up to four dose levels, beginning at 20 million CAR T cells, in two parallel dose escalation pathways:

one receiving low-intensity lymphodepletion and one receiving no lymphodepletion.

For context, competitive CAR T programs are evaluating dose levels ranging from approximately 150 million cells (autologous) to nearly 1 billion cells (allogeneic) and several utilize multi-drug (eg cyclophosphamide + fludarabine) lymphodepletion.

On April 27, 2025, we announced that ALLO-329 had received three Fast Track Designations (FTD) from the FDA for the treatment of adult patients with SLE, IIM, and SSc.

Initial proof-of-concept data from the first patients treated in the first dosing cohorts in both dose escalation pathways are expected in June 2026.

The planned data update is expected to include early clinical outcomes and supporting translational data, including disease-related biomarkers, CAR T expansion, and immune reconstitution.

Future Opportunities

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As we advance those programs, we may seek to utilize our allogeneic platform to pursue additional targets of interest, particularly through strategic partnerships.

These include the additional targets currently in our pipeline as well as other targets that might be validated in the future.

These include the additional targets currently in our pipeline as well as other targets that might be validated in the future, either of which we may seek to combine with our Dagger® technology.

For example, we have been developing allogeneic CAR T cell product candidates targeting B-cell maturation antigen (BCMA) for treatment of multiple myeloma (ALLO-715), FLT3 for the treatment of acute myeloid leukemia (ALLO-819), DLL3 for the treatment of small cell lung cancer (ALLO-213), and Claudin 18.2 for the treatment of gastric and pancreatic cancer (ALLO-182).

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Although we are utilizing CF1 for clinical manufacturing, we may continue to rely on CDMOs and other third parties for the manufacturing and processing of our product candidates in the future.

We also utilize a CDMO in the United States for the manufacture and supply of ALLO-647 and we plan to continue to rely on the CDMO for future production of ALLO-647.

We believe the use of contract manufacturing and testing for our first clinical product candidates has allowed us to rapidly prepare for clinical trials in accordance with our development plans.

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Under the License Amendment, we continue to grant Allogene Overland PRC an exclusive license to develop, manufacture, and commercialize the JV Licensed Products in the JV Territory, with us retaining exclusive rights to the JV Licensed Products outside the JV Territory

We have also entered into multiple additional strategic agreements and collaborations, including an Asset Contribution Agreement with Pfizer (the Pfizer Agreement), a License Agreement with Cellectis (the Cellectis Agreement), the Servier Agreement, a Collaboration and License Agreement (the Notch Agreement) with Notch Therapeutics Inc.

(Notch), a License and Collaboration Agreement with Antion, and a Strategic Collaboration Agreement with Foresight Diagnostics.

For additional information regarding our significant agreements, see Note 6 to our consolidated financial statements appearing elsewhere in this Annual Report.

Agreement, a Collaboration and License Agreement (the Notch Agreement) with Notch Therapeutics Inc.

(Notch), and a Strategic Collaboration Agreement with Foresight Diagnostics.

For additional information regarding our significant agreements refer to Note 6 in our consolidated financial statements appearing elsewhere in this Annual Report.

Intellectual Property

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These licensed assets include rights to the Cellectis TALEN ® gene-editing technology to engineer T cells that lack functional TCRs and to inactivate the CD52 gene in donor cells.

We have exclusive worldwide rights to these patents for certain antigen targets, including BCMA, CD70, FLT3, DLL3 and Claudin 18.2, and have U.S., EU, and UK rights to these patents for CD19.

We have exclusive worldwide rights to these patents for certain antigen targets, including BCMA, CD70, FLT3, DLL3 and Claudin 18.2, and have U.S., EU, and UK rights to these patents for cema-cel.

We also have rights to Cellectis intellectual property for technology covering an engineered T cell therapy combining CD52 gene knockout in combination with an anti-CD52 antibody for certain products directed against certain antigen targets.

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Our patent portfolio includes protection for our clinical-stage product candidates, ALLO-501, cema-cel, ALLO-316, ALLO-329, ALLO-715, and ALLO-605, as well as our research-stage candidates.

With respect to ALLO-501 and cema-cel, we have an exclusive license from Servier to patent rights in the United States covering compositions of matter of and methods of making and using ALLO-501 and cema-cel.

With respect to cema-cel, we have an exclusive license from Servier to patent rights in the United States covering compositions of matter of and methods of making and using cema-cel.

With respect to ALLO-715, ALLO-605 and ALLO-316, we have an exclusive license from Pfizer to patent rights covering ALLO-715, ALLO-605, and ALLO-316 in the United States and in foreign jurisdictions.

These rights cover compositions of matter of and methods of making and using ALLO-715, ALLO-605 and ALLO-316.

We also have patent rights to the TurboCAR™ technology solely owned by us, including technology that covers the TurboCAR™ construct that is part of ALLO-605.

We also have patent rights to the TurboCAR™ and Dagger ® technologies solely owned by us, including technology that covers the TurboCAR™ construct that is part of ALLO-605, and the Dagger ® construct that is part of ALLO-329.

More generally, our patent portfolio and filing strategy is designed to provide multiple layers of protection by pursuing claims directed toward, for example:

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The length of the patent term extension involves a complex calculation based on the length of time it takes for regulatory review.

A patent term extension under the Hatch-Waxman Act cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only one patent applicable to an approved drug may be extended.

A patent term extension under the Hatch-Waxman Act cannot extend the remaining term of a patent beyond a total of 14 years from the date

of product approval and only one patent applicable to an approved drug may be extended.

Moreover, a patent can only be extended once, and thus, if a single patent is applicable to multiple products, it can only be extended based on one product.

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We also anticipate competition from other therapeutic modalities, including antibodies, bispecific T cell engagers, antibody drug conjugates, and small molecule therapeutics.

In particular, the rapid development and commercialization of bispecific antibodies and other “off-the-shelf” immune oncology products may reduce the number of patients eligible for, or willing to receive, cell therapy, may shift treatment sequencing and standards of care, and may intensify pricing and reimbursement pressures, any of which could adversely affect enrollment in our clinical trials and, if approved, the commercial adoption of our product candidates.

Autologous T cell therapies directed at CD19 have been commercialized by Novartis, Kite/Gilead and Bristol-Myers Squibb Company (BMS) and are witnessing increased adoption in the marketplace.

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In February 2021, BMS obtained FDA approval for its anti-CD19 autologous T cell therapy, Breyanzi® for the treatment of adults with 3rd-line LBCL.

The label of Breyanzi® label was extended to 2nd-line LBCL in June 2022, R/R Chronic Lymphocytic Leukemia (CLL) in March 2024, R/R FL in May 2024, and R/R Mantle Cell Lymphoma (MCL) in May 2024.

Autologous cell therapies directed at BCMA have been commercialized by BMS and Jannsen, a Johnson & Johnson company.

The Breyanzi® label was extended to 2nd-line LBCL in June 2022, R/R Chronic Lymphocytic Leukemia (CLL) in March 2024, R/R FL in May 2024, and R/R Mantle Cell Lymphoma (MCL) in May 2024.

In November 2024, Autolus Therapeutics obtained FDA approval for its anti-CD19 autologous T cell therapy, Aucatzyl® (obecabtagene autoleucel), for adults with relapsed or refractory B-cell precursor ALL.

Autologous cell therapies directed at BCMA have been commercialized by BMS and Janssen, a Johnson & Johnson company.

In March 2021, BMS and partner 2seventy bio, Inc.

received FDA approval of Abecma®, an anti-BCMA autologous T cell therapy, for the treatment of adult patients with multiple myeloma who have received at least four prior therapies.

Jannsen and partner Legend Bio received approval for Carvykti®, an anti-BCMA autologous T cell therapy, for the same indication in February 2022.

Janssen and partner Legend Bio received approval for Carvykti®, an anti-BCMA autologous T cell therapy, for the same indication in February 2022.

Both Abecma® and Carvykti® have succeeded in pivotal trials in earlier lines of R/R myeloma and have gained label extensions into this market in 2024.

Eureka Therapeutics, Inc., Galapagos NV, Gilead Sciences, Inc., ImmPACT Bio, USA Inc., Instil Bio, Inc., Iovance Biotherapeutics, Inc., Legend Biotech Corp., Lyell Immunopharma Inc., Mustang Bio, Inc., Triumvira Immunologics, and TScan Therapeutics, Inc.

Autologous T cell therapies are being developed by a number of additional companies, including but not limited to 2seventy bio, Inc., Adaptimmune Therapeutics PLC, Alaunos Therapeutics, Inc., Arcellx, Inc., Arsenal Biosciences, Inc., AstraZeneca plc, Autolus Therapeutics plc, Eureka Therapeutics, Inc., Galapagos NV, Gilead Sciences, Inc., Instil Bio, Inc., Iovance Biotherapeutics, Inc., Legend Biotech Corp., Lyell Immunopharma Inc., Mustang Bio, Inc., Triumvira Immunologics, and TScan Therapeutics, Inc.

Autologous CAR T therapy has made significant advances in addressing R/R NHL, and has moved to earlier lines of therapy, as further described above.

We do not, however, believe that autologous CAR T therapy will be a viable option in the 1L consolidation setting because of the lengthy lead time for the individualized manufacturing process for autologous CAR T.

We do not, however, believe that autologous CAR T therapy will be a viable option in the 1L consolidation setting because of the reduced T cell counts in patients who have recently completed 1L therapy as well as lengthy lead time for the individualized manufacturing process for autologous CAR T.

Once it is determined that a patient is MRD positive following standard 1L treatment, we believe that the speed at which a patient is treated with CAR T therapy will enhance response rates.

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As a result, we believe that it will be important that patients receive CAR T therapy as soon as possible following an MRD positive diagnosis, which will not allow for the lengthy manufacturing process of autologous CAR T.

In addition, a number of companies are developing in vivo approaches intended to generate CAR T cells inside the patient by delivering genetic payloads (for example, mRNA encoding a CAR) to immune cells using delivery systems such as targeted lipid nanoparticles, with the goal of avoiding ex vivo cell collection and individualized manufacturing.

approaches are early-stage and face significant development challenges (including targeted delivery, control of CAR expression and persistence, safety, and scalability of delivery platforms), but if successful, they could broaden use of CAR T therapy in both oncology and autoimmune disease and therefore may compete with our programs.

Allogeneic T cell products have yet to receive FDA approval though the number of companies developing allogeneic product candidates is substantial.

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For instance, we may experience competition from companies, such as AbbVie, Inc., Amgen Inc., BMS, Compass Therapeutics, Inc., F.

Hoffmann-La Roche

AG, Genmab A/S, GlaxoSmithKline plc, Immunocore Holdings plc, Johnson & Johnson, MacroGenics, Inc., Merck & Co.

Hoffmann-La Roche AG, Genmab A/S, GlaxoSmithKline plc, Immunocore Holdings plc, Johnson & Johnson, MacroGenics, Inc., Merck & Co.

Inc., Merus N.V., Pfizer, Regeneron Pharmaceuticals, Inc., and Xencor Inc., that are pursuing bispecific T cell engagers that target both the cancer antigen and T cell receptor, thus bringing both cancer cells and T cells in close proximity to maximize the likelihood of an immune response to the cancer cells.

Multiple bi-specific T cell engagers targeting BCMA for myeloma and CD20 for lymphoma are advancing rapidly in development and the first products in each category gained FDA approval in 2022.

Additionally, companies, such as ADC Therapeutics SA, Amgen Inc., Daiichi Sankyo Company, Limited, Gilead Sciences, Inc., GlaxoSmithKline plc, ImmunoGen, Inc., Pfizer Inc., and Sutro Biopharma, Inc.

Bi-specific T cell engagers targeting BCMA for myeloma and CD20 for lymphoma have advanced rapidly in development, with initial FDA approvals beginning in 2022, and additional products approved since that time.

These therapies may be administered without individualized cell collection and manufacturing, and in some settings may be used before, after, or instead of cell therapies.

As a result, bispecific therapies may reduce the addressable patient population for our product candidates, compete for physician and patient preference based on convenience or risk-benefit profile, and contribute to increased pricing and reimbursement pressure.

Additionally, companies, such as ADC Therapeutics SA, Amgen Inc., Daiichi Sankyo Company, Limited, Gilead Sciences, Inc., GlaxoSmithKline plc, ImmunoGen, Inc., Pfizer Inc., Regeneron Pharmaceuticals, Inc., and Sutro Biopharma, Inc.

are pursuing antibody drug conjugates, which utilize the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells.

In addition to the significant competition noted above in oncology markets, as early data in the use of CAR T cell therapy for the treatment of autoimmune disease has been emerging since 2022, there have been many companies initiating autologous and/or allogeneic cell therapy development programs that would be in direct competition to our autoimmune program.

For example, we may experience competition in these markets from companies such as Adicet Bio, Inc., Arcellx, Inc., Atara Biotherapeutics, Inc., Autolus Therapeutics plc, BMS, Cabaletta Bio, Inc., Caribou Biosciences, Inc., Cartesian Therapeutics, Inc., CRISPR Therapeutics AG, Fate Therapeutics, Inc., Gracell Biotechnologies, Inc., ImmPACT Bio USA, Inc., Kyverna Therapeutics, Inc., Nkarta, Inc., Novartis, Sana Biotechology, Inc., and TG Therapeutics Inc.

Many of our competitors, either alone or with their collaboration partners, have significantly greater financial resources and expertise in research and development, pre-clinical testing, clinical trials, manufacturing, and marketing than we do.

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With this classification, commercial production of our products will need to occur in registered facilities in compliance with cGMP for biologics.

The FDA categorizes human cell- or tissue-based products as either minimally manipulated or more than minimally manipulated, and has determined that more than minimally manipulated products require clinical trials to demonstrate product safety and efficacy and the submission of a BLA for marketing authorization.

Our products are considered more than minimally manipulated and will require evaluation in clinical trials and the submission and approval of a BLA before we can market them.

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Failure to comply with the applicable U.S.

requirements at any time during the product development process, approval process or after approval, may subject an applicant to

administrative or judicial sanctions.

requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions.

FDA sanctions could include, among other actions, refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

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Before testing any biological product candidate, including our product candidates, in humans, the product candidate enters the preclinical testing stage.

Preclinical tests, also referred to as nonclinical studies, include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies to assess the potential safety and activity of the product candidate.

Preclinical tests, also referred to as nonclinical studies, include laboratory evaluations of

product chemistry, toxicity and formulation, as well as animal studies to assess the potential safety and activity of the product candidate.

The conduct of the preclinical tests must comply with federal regulations and requirements including GLPs.

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Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all.

The FDA or the sponsor or its data safety monitoring board may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk, including risks inferred from other unrelated immunotherapy trials.

The FDA or the sponsor or its data safety monitoring board may suspend or terminate a clinical trial at any time on various

grounds, including a finding that the research patients are being exposed to an unacceptable health risk, including risks inferred from other unrelated immunotherapy trials.

Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the biological product has been associated with unexpected serious harm to patients.

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Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.

The FDA has continued to issue guidance specific to cellular and gene therapy (CGT) products.

For example, in November 2024, the FDA issued draft guidance providing frequently asked questions on CGT product development, including common regulatory, chemistry, manufacturing and controls (CMC), and clinical issues, and in December 2023, the FDA issued draft guidance on potency assurance for CGT products that discusses a science- and risk-based strategy to help assure potency across the product lifecycle.

Review and Approval Processes

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Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the BLA.

The FDA reviews the BLA to determine, among other things, whether the proposed product is safe, potent, and/or effective for its intended use, and has an acceptable purity profile, and whether the product is being manufactured in accordance with cGMP to assure and

preserve the product’s identity, safety, strength, quality, potency and purity.

The FDA may refer applications for novel biological products or biological products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions.

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These are FDA regulations and guidance documents that govern the methods used in, and the facilities and controls used for, the manufacture of human cells, tissue, and cellular and tissue-based products (HCT/Ps), which are human cells or tissue intended for implantation, transplant, infusion, or transfer into a human recipient.

The primary intent of the GTP requirements is to ensure that cell and tissue-based products are manufactured in a manner designed to prevent the introduction, transmission and spread of communicable disease.

The primary intent of the GTP requirements is to ensure that cell and tissue-based products are manufactured in a manner designed to prevent the introduction,

transmission and spread of communicable disease.

FDA regulations also require tissue establishments to register and list their HCT/Ps with the FDA and, when applicable, to evaluate donors through screening and testing.

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The orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.

If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a full BLA, to market the same biologic for the same indication for seven years, except in limited

circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity.

Orphan drug exclusivity does not prevent FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition.

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In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.

Congress expanded FDA’s authorities regarding accelerated approval in 2023, including authority to require that confirmatory trials be underway prior to approval or within a specified time period after approval, and the FDA issued draft guidance in January 2025 describing factors it intends to consider when determining whether a confirmatory trial is “underway.”

Regenerative Medicine Advanced Therapy (RMAT) designation was established by FDA to facilitate an efficient development program for, and expedite review of, any drug that meets the following criteria:

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In addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after approval to ensure the long-term stability of the product.

cGMP regulations require among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP.

cGMP regulations require among other things,

quality control and quality assurance as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP.

Manufacturers and other entities involved in the manufacture and distribution of approved products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws.

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Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our products under development.

Given the potential for long-lasting effects of CGT products, the FDA issued draft guidance in September 2025 describing methods and approaches for capturing post-approval safety and efficacy data for CGT products, including through approaches such as registries and other real-world data sources.

Marketing Exclusivity

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Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms.

This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric trial in

accordance with an FDA-issued “Written Request” for such a trial.

This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric trial in accordance with an FDA-issued “Written Request” for such a trial.

FDA Approval and Regulation of Medical Devices and Companion Diagnostics

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Approval or clearance of the companion diagnostic device will ensure that the device has been adequately evaluated and has adequate performance characteristics in the intended population.

The review of in vitro companion diagnostics in conjunction with the review of our product candidates in development for cancer will, therefore, likely involve coordination of review by the FDA’s Center for Drug Evaluation and Research and the FDA’s Center for Devices and Radiological Health Office of In Vitro Diagnostics and Radiological Health.

The review of in vitro

companion diagnostics in conjunction with the review of our product candidates in development for cancer will, therefore, likely involve coordination of review by the FDA’s Center for Drug Evaluation and Research and the FDA’s Center for Devices and Radiological Health Office of In Vitro Diagnostics and Radiological Health.

Under the FDCA, in vitro diagnostics, including companion diagnostics, are regulated as medical devices.

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Approval of a PMA is not guaranteed, and the FDA may ultimately respond to a PMA submission with a not approvable determination based on deficiencies in the application and require additional clinical trial or other data that may be expensive and time-consuming to generate and that can substantially delay approval.

If the FDA’s evaluation of the PMA application is favorable, the FDA typically issues an approvable letter requiring the applicant’s agreement to specific conditions, such as changes in labeling, or specific additional information, such as submission of final labeling, in order to

secure final approval of the PMA.

If the FDA’s evaluation of the PMA or manufacturing facilities is not favorable, the FDA will deny approval of the PMA or issue a not approvable letter.

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Device manufacturers must also establish registration and device listings with the FDA.

A medical device manufacturer’s manufacturing processes and those of its suppliers are required to comply with the applicable portions of the QSR, which cover the methods and documentation of the design, testing, production, processes, controls, quality assurance, labeling, packaging and shipping of medical devices.

A medical device manufacturer’s manufacturing processes and those of its suppliers are required to comply with the applicable portions of the QSR, which cover the methods and documentation of the

design, testing, production, processes, controls, quality assurance, labeling, packaging and shipping of medical devices.

Domestic facility records and manufacturing processes are subject to periodic unscheduled inspections by the FDA.

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As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S.

For example, pharmaceutical and other healthcare companies have

been, and continue to be, investigated or prosecuted under these laws for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product and for causing false claims to be submitted because of the companies’ marketing of the product for unapproved, and thus non-reimbursable, uses.

For example, pharmaceutical and other healthcare companies have been, and continue to be, investigated or prosecuted under these laws for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product and for causing false claims to be submitted because of the companies’ marketing of the product for unapproved, and thus non-reimbursable, uses.

HIPAA created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

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We may be subject to data privacy and security regulations by both the federal government and the states in which we conduct our business.

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and their implementing regulations, imposes requirements on certain types of individuals and entities relating to the privacy, security and transmission of individually identifiable health information.

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act

(HITECH) and their implementing regulations, imposes requirements on certain types of individuals and entities relating to the privacy, security and transmission of individually identifiable health information.

Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to business associates that are independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity as well as their covered subcontractors.

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In the United States and markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend, in part, on the extent to which third-party payors provide coverage, and establish adequate reimbursement levels for such products.

In the United States, third-party payors include federal and state

healthcare programs, private managed care providers, health insurers and other organizations.

In the United States, third-party payors include federal and state healthcare programs, private managed care providers, health insurers and other organizations.

The process for determining whether a third-party payor will provide coverage for a product may be separate from the process for setting the price of a product or for establishing the reimbursement rate that such a payor will pay for the product.

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Coverage policies and third-party reimbursement rates may change at any time.

For example, HHS imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis.

In addition, HHS has been empowered to negotiate the price of certain single-source biologics that have been on the market for at least eleven (11) years covered under Medicare as part of the Medicare Drug Price Negotiation Program.

Each year up to twenty (20) products will be selected by HHS for the Medicare Drug Price Negotiation Program.

Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis.

Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

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There have been legal and political challenges and amendments to certain aspects of the Affordable Care Act.

For example, on August 16, 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in Affordable Care Act marketplaces through plan year 2025.

The IRA also eliminates the "donut hole" under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program.

For example, on July 4, 2025, the One Big Beautiful Bill Act (the OBBBA) was signed into law, which narrowed access to Affordable Care Act marketplace exchange enrollment and declined to extend the Affordable Care Act enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance.

The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program.

Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired Affordable Care Act subsidies.

It is possible that the Affordable Care Act will be subject to judicial or Congressional challenges in the future.

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Other legislative changes have been proposed and adopted since the Affordable Care Act was enacted.

For example, in August 2011, the Budget Control Act of 2011 was signed into law, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals in spending reductions.

The Joint Select Committee on Deficit Reduction did not achieve a targeted deficit reduction of at least $1.2 trillion for fiscal years 2012 through 2021, triggering the legislation’s automatic reduction to several government programs.

This includes aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect beginning on April 1, 2013 and will stay in effect until 2032 unless additional Congressional action is taken.

For example, in August 2011, the Budget Control Act of 2011 was signed into law, which, among other things, included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which began in 2013 and will stay in effect until 2032 unless additional Congressional action is taken.

Additionally, on March 11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminated the statutory Medicaid drug rebate cap, previously set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, effective January 1, 2024.

Additionally, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices.

Specifically, there have been several recent U.S.

Congressional inquiries and federal and state legislative activity designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

For example, the IRA, among other things (i) directs HHS to negotiate the price of certain high-expenditure, single-source biologics that have been on the market for at least 11 years covered under Medicare (the “Medicare Price Negotiation Program”) and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.

These provisions began to take effect progressively in fiscal year 2023.

On August 15, 2024, HHS announced the agreed-upon price of the first ten drugs that were subject to price negotiations, although the Medicare drug price negotiation program is currently subject to legal challenges.

On January 17, 2025, HHS selected fifteen additional products covered under Part D for price negotiation in 2025.

Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program.

On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights.

While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework.

The current administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, the Centers for Medicare & Medicaid Services (“CMS”) and related agencies.

These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business.

These actions may, for example, include directives to reduce agency workforce, rescinding a previous executive order tasking the Center for Medicare and Medicaid Innovation (“CMMI”) to consider new payment and healthcare models to limit drug spending and eliminating a previous executive order that directed HHS to establishing an AI task force and developing a strategic plan.

Additionally, in its June 2024 decision in Loper Bright Enterprises v.

Raimondo (“Loper Bright”), the U.S.

Supreme Court overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes.

The Loper Bright decision could result in additional legal challenges to current regulations and guidance issued by federal agencies applicable to our operations, including those issued by the FDA.

Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program created under the IRA.

For example, the current administration has announced agreements with pharmaceutical companies that require the drug manufacturers to offer, through a direct-to-consumer platform (TrumpRx), U.S.

patients and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues.

Other recent actions may, for example, include (1) directing agencies to reduce agency workforce;

(2) directing HHS and other agencies to lower prescription

drug costs through a variety of initiatives;

(3) imposing tariffs on imported pharmaceutical products;

and (4) as part of the Make America Healthy Again Commission’s Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising.

Additionally, the current administration recently called on Congress to enact “The Great Healthcare Plan,” to codify and expand Most-Favored Nation pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions on pharmacy benefit manager payment methodologies, among other things.

In June 2024, in Loper Bright Enterprises v.

Raimondo, the U.S.

Supreme Court greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations.

Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

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Additional Regulation

In addition to the foregoing, state and federal laws regarding environmental protection and hazardous substances, including the Occupational Safety and Health Act, the Resource Conservancy and Recovery Act and the Toxic Substances Control Act, affect our business.

In addition to the foregoing, state and federal laws regarding environmental protection and hazardous substances, including the Occupational Safety and Health Act, the Resource Conservation and Recovery Act and the Toxic Substances Control Act, affect our business.

These and other laws govern our use, handling and disposal of various biological, chemical and radioactive substances used in, and wastes generated by, our operations.

If our operations result in contamination of the environment or expose individuals to hazardous substances, we could be liable for damages and governmental fines.

believe that we are in material compliance with applicable environmental laws and that continued compliance therewith will not have a material adverse effect on our business.

We believe that we are in material compliance with applicable environmental laws and that continued compliance therewith will not have a material adverse effect on our business.

We cannot predict, however, how changes in these laws may affect our future operations.

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Because biologically sourced raw materials are subject to unique contamination risks, their use may be restricted in some countries.

The EU Clinical Trials Regulation is now fully applicable, including for trials previously authorized under the prior Clinical Trials Directive framework.

As of the end of the transition period in January 2025, clinical trial applications and oversight in the EU are conducted through the Clinical Trials Information System (CTIS).

The requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country.

In all cases, the clinical trials must be conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.

To obtain regulatory approval of an investigational drug or biological product under EU regulatory systems, we must submit an MAA.

To obtain regulatory approval of an investigational drug or biological product under EU regulatory systems, we must submit a marketing authorization application (MAA).

The application used to file the BLA in the United States is similar to that required in the EU, with the exception of, among other things, country-specific document requirements.

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Many other US states have passed similar comprehensive privacy laws, and more are likely to do so in the future.

See the section titled “Risk Factors – Risks Related to Our Business and Industry” and “Risk Factors – Risks Related to Government Regulation” for additional information about the laws and regulations to which we may become subject and about the risks to our business associated with such laws and regulations.

Refer to the section titled “Risk Factors – Risks Related to Our Business and Industry” and “Risk Factors – Risks Related to Government Regulation” for additional information about the laws and regulations to which we may become subject and about the risks to our business associated with such laws and regulations.

Human Capital

As of March 1, 2025, we had 229 total employees, of which 226 are full-time.

As of March 2, 2026, the Company had 152 total employees, of which 150 are full-time.

Of our full-time employees, 34 hold Ph.D.

degrees, 3 hold Pharm.D.

degrees, and 59 are engaged in research, development and technical operations.

Most of our employees are located in South San Francisco and Newark, California.

Our employees are not represented by labor unions or covered by collective bargaining agreements.

We believe that our employee morale is healthy and consider our relationship with our employees to be good.

In May 2025 the Company implemented a workforce reduction in manufacturing and related functions that affected 61 employees.

The Company continues to prioritize retention of critical clinical, manufacturing, and development personnel and has instituted targeted hiring programs to preserve operational continuity for its ongoing clinical programs.

Most employees remain located in South San Francisco and Newark, California.

The Company’s employees are not represented by labor unions or covered by collective bargaining agreements.

We believe our workforce is key to Allogene’s success and we actively focus on the following core elements of human capital:

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We also train relevant members of our team on important environmental health and safety topics to help ensure we protect our people and our environment as we operate our business.

We encourage our employees to participate

and take advantage of a variety of learning and development resources, including online business skills courses, professional development events, and external training programs based on individual needs.

We encourage our employees to participate and take advantage of a variety of learning and development resources, including online business skills courses, professional development events, and external training programs based on individual needs.

We also actively review employee performance and business needs every six months that lead to promotional opportunities for employees across departments and levels.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business