What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-13 compared with 2025-11-06 · 103 added, 146 removed, 227 unchanged (52% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q (Quarterly Report) and the audited financial statements and notes thereto as of and for the year ended December 31, 2024 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the year ended December 31, 2024 (Annual Report), which was filed with the Securities and Exchange Commission (SEC) on March 13, 2025.

You should read the following discussion of our financial condition and results of operations in conjunction with our unaudited condensed financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q (Quarterly Report) and the audited financial statements and notes thereto as of and for the year ended December 31, 2025 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the year ended December 31, 2025 (Annual Report), which was filed with the Securities and Exchange Commission (SEC) on March 12, 2026.

Unless the context requires otherwise, references in this Quarterly Report to the “Company”, “Allogene,” “we,” “us” and “our” refer to Allogene Therapeutics, Inc., and references to “Servier” collectively refer to Les Laboratoires Servier SAS and Institut de Recherches Internationales Servier SAS.

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We have a deep pipeline of allogeneic chimeric antigen receptor (CAR) T cell product candidates targeting multiple promising antigens in a host of hematological malignancies, solid tumors and autoimmune diseases.

Last year we announced our 2024 Platform Vision under which we are now focusing on three core programs:

We are focusing our resources on three core programs:

ALPHA3, RESOLUTION and TRAVERSE clinical trials.

In June 2024, we initiated a pivotal Phase 2 clinical trial (ALPHA3) evaluating cemacabtagene ansegedleucel (cema-cel, previously ALLO-501A) as part of a first-line (1L) consolidation treatment for patients newly diagnosed with large B-cell lymphoma (LBCL) who, despite initial treatment success, remain at high risk for relapse.

A trial-in-progress poster highlighting ALPHA3 was presented at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO, June 1, 2025).

We now have over 50 activated trial sites in the United States and Canada.

Additional sites in Australia and South Korea are progressing toward activation and are expected to open in early 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 we are now completing operational feasibility assessments for both the EU and United Kingdom (UK).

The ALPHA3 trial design expands on findings from our Phase 1 ALPHA2 study and incorporates an investigational diagnostic developed by Foresight Diagnostics, Inc.

This diagnostic test identifies patients who, despite achieving remission according to standard evaluations, remain at risk due to minimal residual disease (MRD) following 1L chemoimmunotherapy.

The study is currently enrolling across more than 60 sites in North America and is now expanding globally, with site activation and patient screening underway in South Korea and Australia, which global expansion is expected to bring the trial to more than 80 sites worldwide.

The ALPHA3 trial design expands on findings from our Phase 1 ALPHA2 study and incorporates an investigational diagnostic developed by Foresight Diagnostics, Inc., which was acquired by Natera, Inc.

(Natera) in December 2025 and continues to operate as a standalone subsidiary.

This diagnostic test identifies patients who, despite achieving remission according to standard evaluations, remain at risk of relapse due to minimal residual disease (MRD) following 1L chemoimmunotherapy.

Patients eligible for enrollment include those who achieve either a complete response or a near-complete partial response to initial treatment and would otherwise be monitored through observation as the current standard of care.

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On August 1, 2025, we announced that we selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen.

This lymphodepletion regimen selection was made in

conjunction with the ALPHA3 Data and Safety Monitoring Board (DSMB) and Steering Committee and following consultation with the U.S.

This lymphodepletion regimen selection was made in conjunction with the ALPHA3 Data and Safety Monitoring Board (DSMB) and Steering Committee and following consultation with the U.S.

Food and Drug Administration (FDA).

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Instead, we will advance our next-generation AlloCAR T product candidates using the proprietary Dagger® Platform Technology, which is designed to minimize or potentially eliminate the need for standard lymphodepletion.

The amended ALPHA3 trial now proceeds as a randomized study with two arms, comparing cema-cel after standard FC lymphodepletion to observation, the current standard of care.

The amended ALPHA3 trial is proceeding as a randomized study with two arms, comparing cema-cel after standard FC lymphodepletion to observation, the current standard of care, and is expected to enroll approximately 220 patients.

Statistical design of the trial and the prespecified study conduct remain the same.

The next milestone will be the futility analysis comparing minimal residual disease (MRD) conversion and is expected to occur in the first half of 2026.

The Company expects to provide the rates of MRD conversion between the two arms at the time of this announcement.

As we seek to better understand the effectiveness of our updated enrollment strategies, we are currently not providing guidance regarding the timing of additional milestones beyond the futility analysis, but expect to do so following such milestone.

We have completed enrollment of 20 treated patients in an expansion cohort in a Phase 1b clinical trial (TRAVERSE) of ALLO-316, an allogeneic CAR T cell product candidate targeting CD70, in adult patients with advanced or metastatic clear cell renal cell carcinoma (RCC).

On April 13, 2026, we announced results from the planned interim futility analysis of the first 24 randomized patients to the two ongoing arms in ALPHA3.

At the protocol-defined data cutoff, which was triggered when the 24th patient completed Day 45 MRD assessment, MRD negativity was observed in 58.3% (7/12) of patients in the cema-cel arm compared with 16.7% (2/12) of patients in the observation arm, and ctDNA levels decreased from baseline by a median of 97.7% in the cema-cel arm compared with a median increase of 26.6% in the observation arm.

The primary endpoint of EFS and key secondary endpoints, including progression-free survival and overall survival, remain blinded.

In the cema-cel arm, no treatment-related serious adverse events, cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, graft-versus-host disease or treatment-related hospitalizations were reported, and ten of the twelve treated patients were managed in the outpatient setting post-infusion.

At the time of the interim analysis, approximately one-third of screening activity and cema-cel infusions occurred at community cancer centers, including sites with limited prior CAR T experience.

We believe this early experience supports the potential for cema-cel to be administered in a broader range of treatment settings than autologous CAR T therapies, although these data remain limited and may not be predictive of future outpatient or community-based administration.

We anticipate completing enrollment by the end of 2027, conducting an interim EFS analysis in mid-2027, and conducting the primary EFS analysis in mid-2028.

We are also advancing ALLO-316, and we have completed enrollment of 20 treated patients in an expansion cohort in a Phase 1b clinical trial (TRAVERSE) of ALLO-316, an allogeneic CAR T cell product candidate targeting CD70, in adult patients with advanced or metastatic clear cell renal cell carcinoma (RCC).

The Phase 1b expansion cohort evaluated ALLO-316 administered as a single dose of 80 million CAR T cells following a standard lymphodepletion regimen (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for three days).

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

We have implemented a diagnostic and treatment algorithm designed to mitigate treatment-associated immune effector cell-associated hyperinflammatory syndrome (IEC-HS) while preserving CAR T efficacy.

We have implemented a diagnostic and treatment algorithm designed to mitigate treatment-associated immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) while preserving CAR T efficacy.

We continue to believe this approach has proven effective by enabling early intervention and effective management, resulting in a safety profile consistent with standard lymphodepletion and active CAR T treatment.

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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 AID.

In January 2025, we announced that the FDA had cleared our investigational new drug (IND) application for a Phase 1 rheumatology basket study of ALLO-329 (RESOLUTION trial), which we initiated in the second quarter of 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 (IIM), and systemic sclerosis (SSc).

We anticipate having proof-of-concept data by the first half of 2026, which we anticipate will include both biomarker and clinical data.

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.

ALLO-329 is manufactured using CRISPR gene-editing technology.

In 2025, we initiated a Phase 1 rheumatology basket study of ALLO-329 (RESOLUTION trial).

The ongoing RESOLUTION trial is a 3+3 dose-escalation study evaluating ALLO-329 across multiple autoimmune diseases, including systemic lupus erythematosus (SLE), including lupus nephritis, idiopathic inflammatory myopathies (IIM), and systemic sclerosis (SSc).

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

The RESOLUTION trial is evaluating ALLO-329 under multiple treatment approaches, including administration following cyclophosphamide-based

lymphodepletion, with the option of adding fludarabine permitted under the protocol, and administration in a separate arm without lymphodepletion.

As of May 2026, nine patients have been treated, including six patients across Dose Level 1 (20 million cells) and Dose Level 2 (40 million cells) following lymphodepletion with cyclophosphamide and three patients at Dose Level 1 with no lymphodepletion.

Initial observations at these early dose levels have shown signs of clinical activity and favorable tolerability.

Dose escalation and lymphodepletion optimization are ongoing, and we expect to provide an additional clinical and translational data update in late 2026.

In April 2026, Nature Communications published preclinical data supporting the design of ALLO-329 and our CD70 Dagger® technology.

The publication described an optimized CD70 CAR designed to prevent rejection of allogeneic CAR T cells by targeting activated alloreactive lymphocytes.

In the reported preclinical studies, co-expression of the CD70 CAR with a CD19 CAR resulted in sustained CAR T-cell persistence in the presence of alloreactive lymphocytes and prolonged antitumor activity in a CD19 antigen escape model.

In humanized mouse models, CD19/CD70 dual CAR T cells eliminated B cells and CD70+ T cells derived from patients with systemic lupus erythematosus and reduced immunoglobulin production.

These preclinical data support the rationale for evaluating ALLO-329 as an allogeneic CD19/CD70 dual CAR T product candidate designed to target CD19+ B cells and CD70+ activated T cells while potentially reducing or eliminating the need for standard lymphodepletion.

While we have additional programs in our pipeline, our clinical development priorities are focused on cema-cel (1L Consolidation), ALLO-316 and ALLO-329.

The development of our other product candidates is currently focused on pre-clinical studies, including studies of BCMA and DLL3 CARs with and without our CD70 Dagger® protein technology, and various manufacturing improvements that may be applicable to such product candidates.

We continue to explore opportunities to partner with collaborators on product candidates across our pipeline.

The development of our other product candidates is currently focused on preclinical studies, including studies of BCMA and DLL3 CARs with and without our CD70 Dagger® protein technology, and various manufacturing improvements that may be applicable to such product candidates.

In April 2026, preclinical data presented at the American Association for Cancer Research Annual Meeting described an allogeneic BCMA/CD70 dual CAR T construct designed to target BCMA and CD70 in a relevant experimental model while incorporating CD70-directed rejection avoidance.

In the reported preclinical studies, BCMA/CD70 dual CAR T cells demonstrated specific cytotoxic activity, resistance to allorejection, expansion in mixed lymphocyte reaction assays, activity in a xenograft model and activity against BCMA target cells that had downregulated BCMA.

In May 2024, we entered into an Amendment and Settlement Agreement (the Servier Amendment) under which we expanded the geographic territory for our CD19 license to include the EU and the UK.

The Servier Amendment also grants us an option to further expand the licensed territory to include China and Japan upon the objective showing of sufficient resources to develop licensed products in those countries, which could be met through the Company entering into a strategic partnership covering those countries.

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 in the EU, UK, Canada and Australia in support of our clinical development of cema-cel.

Additionally, in February 2025, we entered into an Amended and Restated Strategic Collaboration Agreement with Foresight Diagnostics (which was acquired by Natera in December 2025 and continues to operate as a standalone subsidiary), which expands our collaboration to enable the development of Foresight Diagnostics’ MRD assay in the EU, UK, Canada and Australia in support of our clinical development of cema-cel.

In May 2025, we initiated a workforce reduction of approximately 28% of our employees (Workforce Reduction) in connection with a reduction in manufacturing operations and a reprioritization of resources to focus on our ongoing clinical programs.

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Since inception, we have had significant operating losses.

Our net loss was $41.4 million and $152.1 million for the three and nine months ended September 30, 2025, respectively.

As of September 30, 2025, we had an accumulated deficit of $2.0 billion.

As of September 30, 2025, we had $277.1 million in cash and cash equivalents and investments and we expect our cash runway to fund operations into the second half of 2027.

Our net loss was $42.6 million for the three months ended March 31, 2026.

As of March 31, 2026, we had an accumulated deficit of $2.1 billion.

As of March 31, 2026, we had $266.9 million in cash and cash equivalents and investments, before giving effect to $187.9 million in net proceeds from our April 2026 Public Offering.

We expect our cash runway, including such net proceeds, to fund operations into the first quarter of 2029.

We expect to continue to incur net losses for the foreseeable future, and we expect our research and development expenses and general and administrative expenses will continue to increase.

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Below is a summary of the key terms for certain of our licenses and collaboration agreements.

For a more detailed description of these agreements, see Note 6 to our consolidated financial statements included in our Annual Report.

For a more detailed description of these agreements, refer to Note 6 to our consolidated financial statements included in our Annual Report.

Asset Contribution Agreement with Pfizer

In April 2018, we entered into an Asset Contribution Agreement (the Pfizer Agreement) with Pfizer pursuant to which we acquired certain assets and assumed certain liabilities from Pfizer, including agreements with Cellectis S.A.

(Cellectis) and Servier as described below, and other intellectual property for the development and administration of CAR T cells for the treatment of cancer.

(Cellectis) and

Servier as described below, and other intellectual property for the development and administration of CAR T cells for the treatment of cancer.

Research Collaboration and License Agreement with Cellectis

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In May 2024, we entered into an Amendment and Settlement Agreement (the Servier Amendment) with Servier under which we:

(1) expanded our territory under the Original Servier Agreement to include the European Union and the United Kingdom, and provided for an option to further expand our territory to include China and Japan, (2) waived certain of our rights to elect to convert certain of our license rights to a worldwide license, (3) revised our future milestone payments to coincide with Servier’s milestone payments to Cellectis under the Servier-Cellectis Agreement, (4) agreed to pre-pay a future €20

million milestone payment into an escrow account, and (5) increased the United States tiered royalty rates to a range from the low tens to the mid teen percentages, and agreed to an ex-U.S.

royalty rate of 10%.

For more information, see “Risk Factors— Servier’s discontinuation of its involvement in the development of CD19 Products and Servier's disputes with Cellectis, or future disputes with us, may have adverse consequences.

Collaboration and License Agreement with Notch

On December 15, 2025, Cellectis publicly reported that an arbitral tribunal issued a decision providing for a partial termination of the Servier-Cellectis Agreement with respect to UCART19V1, which is the same as ALLO-501, a product candidate which we previously abandoned in favor of cema-cel (formerly known as ALLO-501A), and affirmed continued licensing rights relating to cema-cel.

As a result of that decision, our Servier license covering UCART19V1/ALLO-501 was automatically terminated.

The arbitration decision requires Cellectis, at our request, to engage in good-faith discussions regarding the granting of a direct license to UCART19V1/ALLO-501.

Collaboration and License Agreement with Roche (formerly Notch)

On November 1, 2019, we entered into a Collaboration and License Agreement (the Notch Agreement) with Notch Therapeutics Inc.

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Under the License Amendment, we continue to grant Allogene Overland PRC an exclusive license to develop, manufacture, and commercialize the Overland Licensed Products in the Territory, with us retaining exclusive rights to the Overland Licensed Products outside the JV Territory, and the royalty obligations to us were amended to a flat mid single-digit royalty on net sales in the JV Territory that are no longer subject to reductions as previously provided.

The License Amendment also provides us with additional rights to terminate the License Agreement in its entirety or with respect to the

relevant Overland Licensed Product(s) if Allogene Overland PRC fails to initiate manufacturing technology transfer with respect to an Overland Licensed Product as agreed in the License Amendment, or if HBP commits a funding default or a material breach of its representations, warranties, or covenants under the Share Exchange Agreement.

The License Amendment also provides us with additional rights to terminate the License Agreement in its entirety or with respect to the relevant Overland Licensed Product(s) if Allogene Overland PRC fails to initiate manufacturing technology transfer with respect to an Overland Licensed Product as agreed in the License Amendment, or if HBP commits a funding default or a material breach of its representations, warranties, or covenants under the Share Exchange Agreement.

The License Amendment also provides that the License Agreement will terminate automatically if our ownership in Allogene Overland falls below 7.5% (other than due to our sale of the shares of Allogene Overland), unless at that time we and Allogene Overland PRC have mutually agreed on the manufacturing technology transfer plan for the Overland Licensed Product(s) and Allogene Overland PRC elects to continue the license for such Overland Licensed Product(s) with increased milestones and royalties.

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(Overland Therapeutics).

Subsequent to March 31, 2026, on May 12, 2026, we entered into a termination agreement with Overland Therapeutics (SH) Co.

and Overland Therapeutics Inc., pursuant to which the License Agreement was terminated in its entirety.

The parties also provided mutual releases of claims, and no termination payments were made in connection with the termination.

In connection with the termination and related transactions, we surrendered a portion of our equity interests in Overland Therapeutics, resulting in a reduction of our ownership interest to approximately 3% on an as-converted and fully diluted basis.

Collaboration and License Agreement with Antion

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(Foresight Diagnostics).

Pursuant to the Foresight Agreement, the parties have agreed to collaborate on a non-exclusive basis in the development of Foresight Diagnostics’ MRD assay as an in vitro diagnostic to identify the MRD+ patient population to be enrolled in our ALPHA3 trial of cemacabtagene ansegedleucel, or cema-cel (previously known as ALLO-501A) for treatment of LBCL.

In December 2025, Foresight Diagnostics was acquired by Natera and continues to operate as a standalone subsidiary.

Pursuant to the Foresight Agreement, the parties have agreed to collaborate on a non-exclusive basis in the development of Foresight Diagnostics’ CLARITY TM MRD assay as an in vitro diagnostic to identify the MRD+ patient population to be enrolled in our ALPHA3 trial of cemacabtagene ansegedleucel, or cema-cel (previously known as ALLO-501A) for treatment of LBCL.

Under the Foresight Agreement, we have agreed to use commercially reasonable efforts to obtain regulatory approval of cema-cel, and Foresight Diagnostics has agreed to use commercially reasonable efforts to obtain regulatory approval of an MRD assay for use as an in vitro diagnostic with cema-cel.

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Components of Results of Operations

As of September 30, 2025, our revenue has been exclusively generated from the License Agreement with Overland Therapeutics.

See Note 6 to our consolidated financial statements appearing in our Annual Report for more information related to our recognition of revenue and the License Agreement.

From inception to March 31, 2026, our revenue has been exclusively generated from the License Agreement with Overland Therapeutics.

Refer to Note 6 to our consolidated financial statements appearing in our Annual Report for more information related to the License Agreement.

In the future, we may generate revenue from a combination of product sales, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or a combination of these approaches.

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To date, our research and development expenses have related primarily to discovery efforts, preclinical and clinical development, and manufacturing of our product candidates.

Research and development expenses for the three and nine months ended September 30, 2025 included costs associated with our clinical and preclinical stage pipeline candidates and research into newer technologies.

Research and development expenses for the three months ended March 31, 2026 included costs associated with our clinical and preclinical stage pipeline candidates and research into newer technologies.

The most significant research and development expenses for the year to date relate to costs incurred for the development of our most advanced product candidates and include:

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General and administrative costs are expensed as incurred, and we accrue for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from our service providers, and adjusting our accruals as actual costs become known.

Other Income (Expense), Net:

Other Income (Expenses), Net:

Interest and Other Income, Net

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Results of Operations

Comparison of the Three Months Ended September 30, 2025 and 2024

The following sets forth our results of operations for the three months ended September 30, 2025 and 2024 (in thousands, except percentage amounts):

Three Months Ended September 30, Change

Comparison of the Three Months Ended March 31, 2026 and 2025

The following sets forth our results of operations for the three months ended March 31, 2026 and 2025 (in thousands, except percentage amounts):

Three Months Ended March 31, Change

2026 2025 $ %

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General and administrative 14,089 14,991 (902) (6) %

Impairment of long-lived assets — 10,728 (10,728) (100) %

Total operating expenses 46,092 65,191 (19,099) (29) %

Loss from operations (46,092) (65,191) 19,099 (29) %

Other income (expense), net:

Interest and other income, net 3,926 6,705 (2,779) (41) %

Interest expense (344) (100) (244) 244 %

Other income (expenses), net:

Total other income (expense), net 3,501 5,481 (1,980) (36) %

Net loss $ (41,400) $ (66,293) $ 24,893 (38) %

Research and Development Expenses

The following table shows the primary components of our research and development expenses for the periods presented:

Three Months Ended September 30,

2025 2024 Change

Personnel $ 12,928 $ 19,699 $ (6,771)

Development costs 7,932 12,469 (4,537)

Facilities and depreciation 8,922 10,381 (1,459)

Other 1,382 2,164 (782)

Total research and development expenses $ 31,164 $ 44,713 $ (13,549)

Our research and development expenses included $15.6 million of internal expenses and $15.6 million of external expenses for the three months ended September 30, 2025.

Of the $15.6 million of external expenses for the three months ended September 30, 2025, $6.1 million was related to our cema-cel program.

Our research and development expenses included $22.5 million of internal expenses and $22.2 million of external expenses for the three months ended September 30, 2024.

Research and development expenses were $31.2 million and $44.7 million for the three months ended September 30, 2025 and 2024, respectively.

The decrease of $13.5 million was driven primarily by a decrease in personnel related costs of $6.8 million, including a decrease in stock-based compensation expense of $2.8 million, a decrease in development costs of $4.5 million related to the advancement of our product candidates due to the timing of development activities and manufacturing runs, and facilities and depreciation costs of $1.5 million.

General and Administrative Expenses

General and administrative expenses were $13.7 million and $16.3 million for the three months ended September 30, 2025 and 2024, respectively.

The decrease of $2.6 million was primarily due to a decrease in personnel related costs of $2.4 million, including $1.9 million related to a decrease in stock-based compensation expense, and a decrease in other expenses of $0.2 million.

Impairment of long-lived asset

In September 2024, we identified additional impairments as the carrying values of to-be-sublet property asset groups were not recoverable due to current market conditions.

We revised the valuations of the assets within these groups based on terms with a subtenant for a portion of one of the buildings within one of the asset groups and based on new market data for both asset groups.

For the three months ended September 30, 2024, we recorded long-lived asset impairment charge of $10.7 million.

No such expense was recorded for the three months ended September 30, 2025.

Interest and other income, net 3,573 5,516 (1,943) (35) %

Interest and other income, net was $3.9 million and $6.7 million for the three months ended September 30, 2025 and 2024, respectively.

The decrease of $2.8 million was due to lower interest earned on our cash, cash equivalents and investments and net gain on foreign exchange translation, partially offset by sublease income.

Interest expense (300) (150) (150) 100 %

Interest expense was related to the CIRM award proceeds received for the three months ended September 30, 2025 and 2024.

Other income (expenses), net 212 92 120 130 %

For the three months ended September 30, 2025 and 2024, we recorded other expenses of less than $0.1 million and other expense of $1.1 million, respectively.

Other income during the three months ended September 30, 2024 consisted of the share of net losses in our equity method investments.

Comparison of the Nine Months Ended September 30, 2025 and 2024

The following sets forth our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands, except percentage amounts):

Nine Months Ended

September 30, Change

2025 2024 $ %

Collaboration revenue - related party $ — $ 22 $ (22) (100) %

Operating expenses:

Research and development 121,520 147,327 (25,807) (18) %

General and administrative 43,009 49,687 (6,678) (13) %

Impairment of long-lived assets 2,382 15,717 (13,335) (85) %

Total operating expenses 166,911 212,731 (45,820) (22) %

Loss from operations (166,911) (212,709) 45,798 (22) %

Other income (expense), net:

Interest and other income, net 15,629 17,126 (1,497) (9) %

Interest expense (762) (100) (662) 662 %

Other income (expenses), net (32) (1,968) 1,936 (98) %

Total other income (expense), net 14,835 15,058 (223) (1) %

Total other income (expenses), net 3,485 5,458 (1,973) (36) %

Net loss $ (42,607) $ (59,733) $ 17,126 (29) %

Collaboration revenue - related party

Revenue recognized for the nine months ended September 30, 2024 was mainly due to participation in the joint steering committee performance obligation related to the License Agreement entered into with Overland Therapeutics on December 14, 2020.

Research and Development Expenses

The following table shows the primary components of our research and development expenses for the periods presented:

Nine Months Ended September 30,

Three Months Ended March 31,

2026 2025 Change

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Total research and development expenses $ 32,003 $ 50,200 $ (18,197)

Our research and development expenses included $60.1 million of internal expenses and $61.4 million of external expenses for the nine months ended September 30, 2025.

Of the $61.4 million of external expenses for the nine months ended September 30, 2025, $19.2 million was related to our cema-cel program.

Our research and development expenses included $70.1 million of internal expenses and $77.3 million of external expenses for the nine months ended September 30, 2024.

Research and development expenses were $121.5 million and $147.3 million for the nine months ended September 30, 2025 and 2024, respectively.

The decrease of $25.8 million was driven primarily by a decrease in development costs of $11.6 million relating to the advancement of our product candidates due to the timing of development activities and manufacturing runs, a decrease in personnel related costs of $9.5 million, including decreases in salaries and benefits of $8.2 million and stock-based compensation expense of $4.4 million, partially offset by an increase in severance expense of $3.1 million related to the Workforce Reduction, and facilities and depreciation costs of $3.0 million attributable to the completion of useful life for certain machinery and equipment.

Our research and development expenses included $16.4 million of internal expenses and $15.6 million of external expenses for the three months ended March 31, 2026.

Of the $15.6 million of external expenses for the three months ended March 31, 2026, $7.7 million was related to our cema-cel program.

Our research and development expenses included $24.1 million of internal expenses and $26.1 million of external expenses for the three months ended March 31, 2025.

Of the $26.1 million of external expenses for the three months ended March 31, 2025, $6.2 million was related to our cema-cel program.

Research and development expenses were $32.0 million and $50.2 million for the three months ended March 31, 2026 and 2025, respectively.

The decrease of $18.2 million was driven primarily by a decrease in development costs of $8.1 million related to the advancement of our product candidates due to the timing of development activities and manufacturing runs, a decrease in personnel related costs of $7.5 million, including a decrease in stock-based compensation expense of $2.3 million, and facilities and depreciation costs of $1.9 million.

General and Administrative Expenses

General and administrative expenses were $43.0 million and $49.7 million for the nine months ended September 30, 2025 and 2024, respectively.

The decrease of $6.7 million was primarily due to a decrease in personnel related costs of $6.1 million, including $4.9 million related to a decrease in stock-based compensation expense, and other expenses of $0.6 million.

Impairment of long-lived asset

During the nine months ended September 30, 2025, we recorded an additional long-lived asset impairment charge of $1.0 million related to one of our subleased buildings.

In addition, during the nine months ended September 30, 2025, we recorded equipment impairment of $1.3 million in conjunction with the Workforce Reduction.

In June 2024, we recorded long-lived asset impairment charges of $5.0 million.

In September 2024, we identified additional impairments as the carrying value of this to-be-sublet property asset group was not recoverable due to current market conditions.

We revised the valuation of this asset group based on new market data.

In September 30, 2024, we recorded an additional long-lived asset impairment charge of $1.2 million.

Previously, in December 2023, we made a decision to sublease one of our other leased buildings in South San Francisco.

In September 2024, we identified additional impairments as the carrying value of to-be-sublet property asset group was not recoverable due to the then-current market conditions.

We revised the valuations of this asset group based on a non-binding letter of intent with a potential subtenant for a portion of the building included in this asset group and based on new market data.

In the three months ended September 30, 2024, we recorded long-lived asset impairment charges of $9.5 million.

During the nine months ended September 30, 2024, we recognized total impairment charges of $15.7 million.

General and administrative expenses were $14.1 million and $15.0 million for the three months ended March 31, 2026 and 2025, respectively.

The decrease of $0.9 million was primarily due to a decrease in personnel related costs of $1.7 million, including $1.6 million related to a decrease in stock-based compensation expense, partially offset by an increase in other expenses of $0.8 million, attributable to corporate communications.

Interest and Other Income, Net

Interest and other income, net was $15.6 million and $17.1 million for the nine months ended September 30, 2025 and 2024, respectively.

The decrease of $1.5 million was due to lower interest earned on our cash, cash equivalents and investments, partially offset by gain on foreign exchange translation and sublease income.

Interest and other income, net was $3.6 million and $5.5 million for the three months ended March 31, 2026 and 2025, respectively.

The decrease of $1.9 million was due to lower interest earned on our cash, cash equivalents and investments and net gain on foreign exchange translation, partially offset by sublease income.

Interest Expense

Interest expense was related to the CIRM award proceeds received for the nine months ended September 30, 2025 and 2024.

Interest expense was related to the CIRM award proceeds received for the three months ended March 31, 2026 and 2025.

Other Income (Expenses), Net

For the nine months ended September 30, 2025 and 2024, we recorded other expense of less than $0.1 million and $2.0 million, respectively.

Other income during the nine months ended September 30, 2024 consisted of the share of net losses in our equity method investments, partially offset by a gain from the Organizational Restructuring of Overland Therapeutics.

For the three months ended March 31, 2026 and 2025, we recorded other income of $0.2 million and $0.1 million, respectively.

Liquidity and Capital Resources

To date, we have incurred significant net losses and negative cash flows from operations.

As of September 30, 2025, we had $277.1 million in cash, cash equivalents and investments.

We believe that the aggregate of our current cash, cash equivalents and investments available for operations will be sufficient to fund our operations for at least the next 12 months from the date this Quarterly Report is filed with the SEC.

Our operations have been financed primarily by net proceeds from the sale and issuance of our convertible preferred stock, the issuance of convertible promissory notes, net proceeds from our IPO, our at-the-market (ATM) offerings, our June 2020 underwritten public offering, upfront cash payment of $40.0 million received in December 2020 pursuant to our License Agreement with Overland Therapeutics, and our May 2024 registered offering.

In May 2024, we completed a registered offering pursuant to which we issued and sold 37,931,035 shares of our common stock.

We received net proceeds of $105.2 million, after deducting underwriting discounts and commissions and offering expenses payable by us.

In November 2019, we entered into a sales agreement with TD Securities (U.S.A.) LLC (f/k/a Cowen and Company, LLC) (TD Cowen), as amended on November 2, 2022 and November 2, 2023, under which we may from time to time issue and sell shares of our common stock through TD Cowen in ATM offerings.

During the nine months ended September 30, 2025, we sold an aggregate of 7,477,047 shares in ATM offerings resulting in net proceeds of $14.5 million.

As of March 31, 2026, before giving effect to our April 2026 Public Offering, we had $266.9 million in cash, cash equivalents and investments.

In April 2026, we received net proceeds of approximately $187.9 million from the underwritten public offering described below.

We believe that the aggregate of our current cash, cash equivalents and investments available for operations, together with such net proceeds, will be sufficient to fund our operations for at least the next 12 months from the date this Quarterly Report is filed with the SEC.

Our operations have been financed primarily through equity financings and license arrangements.

During the three months ended March 31, 2026, we sold an aggregate of 12,476,533 shares of common stock in ATM offerings resulting in net proceeds of $20.7 million.

The specified dollar limit on the amount of common stock that may be sold under the sales agreement was removed pursuant to the November 2, 2023 amendment to the sales agreement.

In connection with our April 2026 Public Offering (described below), we suspended our ATM offerings until a new prospectus or prospectus supplement is filed with the SEC.

In April 2026, we closed an underwritten public offering (April 2026 Public Offering) in which we sold 100,200,000 shares of our common stock at a public offering price of $2.00 per share, including 12,700,000 additional shares sold pursuant to the underwriters’ partial exercise of their option to purchase additional shares.

We received aggregate net proceeds of approximately $187.9 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

We expect to use the net proceeds from the April 2026 Public Offering for general corporate purposes, which may include clinical trial expenses, research and development expenses, general and administrative expenses, and capital expenditures.

The following table summarizes our cash flows for the periods indicated:

Nine Months Ended September 30,

Three Months Ended March 31,

(In thousands)

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Operating Activities

During the nine months ended September 30, 2025, cash used in operating activities of $121.6 million was attributable to a net loss of $152.1 million, a decrease of $10.7 million in our net operating assets and liabilities, partially offset by non-cash charges of $41.1 million.

The non-cash charges consisted primarily of stock-based compensation expense of $29.5 million, depreciation of $9.3 million, non-cash rent expense of $3.3 million, and impairment of long-lived assets of $2.4 million, partially offset by net amortization and accretion on investment securities of $3.4 million.

The change in operating assets and liabilities was primarily due to a decrease in operating lease liabilities of $5.6 million, an increase in deposit in escrow of $2.7 million, a decrease in accrued and other current liabilities of $2.4 million, a decrease in accounts payable of $1.8 million, an increase in other long-term assets of $1.2 million, partially offset by a decrease in prepaid expense and other current assets of $2.3 million and an increase in other long term liabilities of $0.8 million.

During the nine months ended September 30, 2024, cash used in operating activities of $163.6 million was attributable to a net loss of $197.7 million and a decrease of $30.1 million in our net operating assets and liabilities, partially offset by non-cash charges of $64.1 million.

The non-cash charges consisted primarily of stock-based compensation expense of $38.9 million, impairment of long-lived assets of 15.7 million, depreciation of $10.4 million, non-cash rent expense of $4.1 million, and our

share of equity investments’ net losses for the period of $1.7 million, partially offset by net amortization and accretion on investment securities of $6.7 million.

The change in operating assets and liabilities was primarily due to a deposit placed in escrow related to the Servier Amendment of $22.3 million, a decrease in operating lease liabilities of $4.5 million, a decrease in accrued and other current liabilities of $4.1 million, an increase in prepaid expenses and other current assets of $2.3 million, and a decrease in accounts payable of $0.5 million, partially offset by a decrease in other long-term assets of $3.6 million.

During the three months ended March 31, 2026, cash used in operating activities of $12.9 million was attributable to a net loss of $42.6 million, partially offset by an increase of $18.4 million in our net operating assets and liabilities and non-cash charges of $11.3 million.

The change in operating assets and liabilities was primarily due to a decrease in deposit in escrow of $23.5 million, a decrease in prepaid expense and other current assets of $1.1 million, an increase in accounts payable of $0.7 million and an increase in other long-term liabilities of $0.3 million, partially offset by a decrease in accrued and other current liabilities of $5.1 million and a decrease in operating lease liabilities of $2.2 million.

The non-cash charges consisted primarily

of stock-based compensation expense of $8.3 million, depreciation of $2.9 million and non-cash rent expense of $1.1 million, partially offset by net amortization and accretion on investment securities of $0.9 million.

During the three months ended March 31, 2025, cash used in operating activities of $52.9 million was attributable to a net loss of $59.7 million and a decrease of $8.3 million in our net operating assets and liabilities, partially offset by non-cash charges of $15.1 million.

The non-cash charges consisted primarily of stock-based compensation expense of $12.2 million, depreciation of $3.1 million, and non-cash rent expense of $1.1 million, partially offset by net amortization and accretion on investment securities of $1.3 million.

The change in operating assets and liabilities was primarily due to decrease in accrued and other current liabilities of $5.2 million, decrease in operating lease liabilities of $1.8 million, increase in deposit in escrow of $0.9 million and increase in prepaid expense and other current assets of $0.6 million, partially offset by decrease in other long-term assets of $0.4 million.

Investing Activities

During the nine months ended September 30, 2025, net cash provided by investing activities of $61.9 million was related to cash provided by investment maturities of $172.2 million, partially offset by cash used in the purchase of investments of $109.9 million.

During the nine months ended September 30, 2024, net cash provided by investing activities of $20.8 million was related to cash provided by investment maturities of $330.3 million and cash provided by investment sales of $5.4 million, partially offset by cash used in the purchase of investments of $314.5 million.

During the three months ended March 31, 2026, net cash used in investing activities of $29.6 million was related to cash used in the purchase of investments of $101.7 million, partially offset by cash provided by investment maturities of $72.1 million.

During the three months ended March 31, 2025, net cash provided by investing activities of $6.2 million was related to cash provided by investment maturities of $56.5 million, partially offset by cash used in the purchase of investments of $50.2 million.

Financing Activities

During the nine months ended September 30, 2025, cash provided by financing activities of $22.3 million was related to cash provided by net proceeds from the issuance of common stock through ATM transactions of $14.5 million, proceeds from the CIRM award of $6.9 million and the sale of common stock through our employee stock purchase plan of $0.9 million.

During the nine months ended September 30, 2024, cash provided by financing activities of $110.9 million was related to $105.3 million in net proceeds from the issuance of common stock through our May 2024 registered offering, $2.3 million of cash provided from the CIRM award, $1.5 million of cash provided by the sale of common stock through our employee stock purchase plan, $1.0 million of net proceeds from the issuance of common stock through ATM transactions, and $0.8 million of cash provided by the issuance of common stock upon exercise of stock options.

During the three months ended March 31, 2026, cash provided by financing activities of $21.1 million was related to cash provided by net proceeds from the issuance of common stock through ATM transactions of $20.7 million and the sale of common stock through our employee stock purchase plan of $0.5 million.

During the three months ended March 31, 2025, cash provided by financing activities of $14.0 million was related to cash provided by net proceeds from the issuance of common stock through ATM transactions of $10.0 million, proceeds from the CIRM award of $3.4 million and the sale of common stock through our employee stock purchase plan of $0.6 million.

Material Cash Commitments and Requirements

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The payment obligations under the license agreements are contingent upon future events such as our achievement of specified development, regulatory and/or commercial milestones and we will be required to make development milestone payments and royalty payments in connection with the sale of products developed under these agreements.

As of September 30, 2025, we were unable to estimate the timing or likelihood of achieving the milestones or making future product sales.

As of March 31, 2026, we were unable to estimate the timing or likelihood of achieving the milestones or making future product sales.

For additional information regarding our agreements, see Note 6 to our consolidated financial statements included in our Annual Report.

Our operating lease obligations primarily consist of lease payments on our research, lab and office facilities in South San Francisco, California, as well as lease payments on our cell manufacturing facility in Newark, California (CF1).

For additional information regarding our lease obligations, see Note 7 to our condensed consolidated financial statements included elsewhere in this Quarterly Report.

additional information regarding our lease obligations, see Note 7 to our condensed financial statements included elsewhere in this Quarterly Report.

On October 6, 2020, we announced we entered into a strategic five-year collaboration agreement with MD Anderson for the preclinical and clinical investigation of allogeneic CAR T cell product candidates.

In August 2025 we extended the term

of the agreement for an additional year.

In August 2025 we extended the term of the agreement for an additional year.

We and MD Anderson are collaborating on the design and conduct of preclinical and clinical studies with oversight from a joint steering committee.

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Critical Accounting Policies and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles.

The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported expenses incurred during the reporting periods.

Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed financial statements, which have been prepared in accordance with United States generally accepted accounting principles.

The preparation of these condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed financial statements, as well as the reported expenses incurred during the reporting periods.

Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.

Actual results may differ from these estimates under different assumptions or conditions.

We believe that the assumptions and estimates associated with accrued research and development expenditures, stock-based compensation and leases have the most significant impact on our condensed consolidated financial statements.

Therefore, we consider these to be our critical accounting policies and estimates.

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Recent Accounting Pronouncements

There have been no new accounting pronouncements issued or effective that are expected to have a material impact on our unaudited condensed consolidated financial statements.

There have been no new accounting pronouncements issued or effective that are expected to have a material impact on our unaudited condensed financial statements.

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-Q

Item 2. Management’s Discussion and Analysis