What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-13 compared with 2025-05-13 · 155 added, 95 removed, 216 unchanged (54% of the section changed)

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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 LBCL who, despite initial treatment success, remain at high risk for relapse.

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

We now have nearly 50 activated trial sites.

The ALPHA3 trial design builds on Phase 1 results from our ALPHA2 study and leverages an investigational diagnostic developed by Foresight Diagnostics, Inc.

This diagnostic test aims to identify patients who, although in remission according to standard assessments, remain at risk due to minimal residual disease (MRD) following first-line chemoimmunotherapy.

Approximately 240 MRD-positive patients achieving either complete response, or a near-complete partial response for which the current standard of care would be observation, to initial therapy will be randomized to receive cema-cel following one of two different lymphodepletion regimens (standard fludarabine and cyclophosphamide (FC) or standard fludarabine and cyclophosphamide plus ALLO-647 (FCA)) or standard-of-care observation.

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, and are actively evaluating expansion of the trial to other regions around the world.

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.

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.

The trial’s primary endpoint is event-free survival (EFS).

To date, over 250 patients have consented for MRD screening, nearly half in the last three months, with many awaiting completion of 1L treatment.

Following a planned interim analysis designed to test futility and identify the optimal lymphodepletion regimen, one regimen will be discontinued.

While we believe that early learnings and growing operational momentum have positioned us to accelerate enrollment, our initial trial milestone of futility analysis and lymphodepletion regimen selection is now anticipated to occur in the first half of 2026.

At this futility analysis, we forecast at least 12 patients in each arm of the trial will have been

enrolled and followed for MRD measurement.

This adjustment in timing reflects challenges associated with the unforeseen delays due to site resource issues and the adoption of new trial workflows related to identifying and enrolling patients who were expected to complete the initial therapy for LBCL at the completion of R-CHOP or equivalent therapy.

In addition, based on interest from potential international trial sites, to facilitate the pace of enrollment and support a U.S.

BLA, we plan to expand the trial to international sites including Canada where we anticipate activation in the second quarter of 2025.

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 lymphodepletion regimen selection and futility analysis, but will do so following such milestone.

We have completed enrollment 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).

Initially, the trial was designed to randomize approximately 240 MRD-positive patients into one of three arms:

(1) cema-cel therapy following lymphodepletion with standard fludarabine and cyclophosphamide (FC arm), (2) cema-cel therapy following lymphodepletion with fludarabine, cyclophosphamide, and ALLO-647 (an anti-CD52 monoclonal antibody) (FCA arm), or (3) standard-of-care observation (control arm).

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.

Food and Drug Administration (FDA).

The FCA arm is now closed to further enrollment.

This decision, made ahead of the scheduled futility analysis, was prompted by a Grade 5 adverse event in the FCA arm that has been attributed to the use of ALLO-647.

The event occurred on Day 54 post-infusion from hepatic failure, believed to have resulted from disseminated adenovirus infection in the setting of immune suppression.

This event was deemed unrelated to cema-cel.

Severe viral infections have been rare across our clinical trials.

However, when present, they have been attributed to immunosuppression due in part to ALLO-647.

There have been no cases of adenoviral infection or hepatic failure in any participant treated with only FC lymphodepletion across our trials.

Following the adoption of standard FC in the ALPHA3 trial, none of our trials open to enrollment or pipeline programs include ALLO-647.

Instead, we will advance its 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.

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).

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).

On October 29, 2024, we announced that we had received Regenerative Medicine Advanced Therapy (RMAT) designation for ALLO-316 for adult patients with advanced or metastatic RCC.

We have implemented a protocol amendment that incorporates a diagnostic and treatment algorithm into the study design.

The algorithm is designed to mitigate the treatment-associated hyperinflammatory response without compromising the CAR T function needed to eradicate solid tumors.

In November 2024, we provided a data update from patients with CD70 positive RCC, and highlighted that the newly implemented diagnostic and management algorithm appears effective in abating IEC-HS while preserving CAR T efficacy.

Additional data from dose escalation cohorts, as well as a Phase 1b expansion cohort, was presented at the 2024 International Kidney Cancer Symposium (IKCS, November 8, 2024) and the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting (November 9, 2024).

As of the October 14, 2024, data cutoff, 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.

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

Data from dose escalation cohorts and ongoing Phase 1b expansion cohort are included in the presentations.

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 three days) lymphodepletion regimen.

The Phase 1b expansion cohort has now completed enrollment with 20 patients enrolled.

Updated data from the Phase 1b expansion cohort will be presented in an oral presentation at the ASCO 2025 Annual Meeting on June 1, 2025.

In data presented on June 1, 2025, at the ASCO 2025 Annual Meeting, ALLO-316 demonstrated a confirmed overall response rate (ORR) of 31% in patients with high CD70 expression (TPS ≥50%), with 44% achieving at least a 30% reduction in tumor burden.

Four out of five confirmed responders continue to maintain their responses, including one patient in sustained remission exceeding 12 months.

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 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.

In July 2025, we held an RMAT meeting with the FDA regarding next steps for the ALLO-316 development program, and we believe we have reached alignment with the FDA on the design of a registration trial for adult patients with advanced or metastatic RCC.

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

We are developing ALLO-329, a next-generation allogeneic CAR T cell product candidate targeting both CD19 and CD70 for the treatment of certain autoimmune diseases (AID).

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 has cleared our investigational new drug (IND) application for a Phase 1 rheumatology basket study of ALLO-329 (RESOLUTION trial).

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) and we have now initiated the trial.

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 expect to initiate the Phase 1 trial with ALLO-329 in mid-2025 and anticipate having proof-of-concept by the first half of 2026 to enable inclusion of both biomarker and clinical data.

On April 27, 2025, we announced that ALLO-329 had received three Fast Track Designations (FTD) from the U.S.

Food and Drug Administration (FDA) for the treatment of adult patients with SLE, IIM, and SSC.

We are developing an anti-CD52 monoclonal antibody, ALLO-647, which is a proprietary component of our oncology lymphodepletion regimen.

ALLO-647 may be able to reduce the likelihood of a patient’s immune system rejecting the engineered allogeneic T cells for a sufficient period of time to enable a window of persistence during which our engineered allogeneic T cells can actively target and destroy cancer cells.

During Part A of our pivotal ALPHA3 trial, we will be assessing ALLO-647’s contribution to the overall benefit to risk ratio of the lymphodepletion regimen for cema-cel.

Patients will be randomized to receive cema-cel and a lymphodepletion regimen with fludarabine and cyclophosphamide either with or without ALLO-647.

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

The selection of the final regimen with which we will complete enrollment in the study (Part B) is now anticipated in the first half of 2026.

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.

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

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

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 European Union and the United Kingdom.

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.

In the coming months, we plan to seek scientific advice from European and UK regulatory authorities 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 in the EU, UK, Canada and Australia in support of Allogene’s clinical development of cema-cel.

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

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.

In the coming months, we plan to seek scientific advice from EU and UK regulatory authorities to assist us with finalizing our regulatory strategy for the EU and the UK.

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.

We believe we currently hold sufficient inventory of cema-cel, ALLO-329, and ALLO-316 to meet our near-term clinical needs, including completing our current ALPHA3, RESOLUTION and TRAVERSE trials.

We estimate that we will incur approximately $3.3 million in cash-based expenses related to employee severance payments, benefits and related costs in connection with the Workforce Reduction.

We expect that the majority of the Workforce Reduction charges will be incurred in the second quarter of 2025 and that the Workforce Reduction will be substantially completed by the end of the second quarter of 2025.

The Workforce Reduction was substantially completed in the second quarter of 2025, and we estimate that we incurred approximately $3.3 million in cash-based expenses related to employee severance payments, benefits and related costs in connection with the Workforce Reduction.

We may also incur other charges, including cash expenditures, not currently contemplated due to events that may occur as a result of, or are associated with, the Workforce Reduction.

Since inception, we have had significant operating losses.

Our net loss was $59.7 million for the three months ended March 31, 2025.

As of March 31, 2025, we had an accumulated deficit of $1.9 billion.

As of March 31, 2025, we had $335.5 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 $50.9 million and $110.7 million for the three and six months ended June 30, 2025, respectively.

As of June 30, 2025, we had an accumulated deficit of $1.9 billion.

As of June 30, 2025, we had $302.6 million in cash and cash equivalents and investments and we expect our cash runway to fund operations into the second half of 2027.

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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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 provides 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.

(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.

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

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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.

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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(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 large B cell lymphoma (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 March 31, 2025, our revenue has been exclusively generated from the License Agreement with Overland Therapeutics.

As of June 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.

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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 months ended March 31, 2025 included costs associated with our clinical and preclinical stage pipeline candidates and research into newer technologies.

Research and development expenses for the three and six months ended June 30, 2025 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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Interest and Other Income, Net

Interest and other income, net primarily consists of interest earned on our cash and cash equivalents and investments, as well as investment gains and losses recognized during the period.

Interest and other income, net primarily consists of interest earned on our cash and cash equivalents and investments, investment gains and losses recognized and sublease income earned from our subtenants during the period.

Interest Expense

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Other Income (Expenses), net

Other income (expenses), net, consist of non-operating income and expenses, including primarily our share of net losses for the period from, and impairment of, our equity method investments and impairment of our equity investments.

Other income (expenses), net, consist of non-operating income and expenses, including primarily our share of net losses for the period from, and impairment of, our equity investments.

Results of Operations

Comparison of the Three Months Ended March 31, 2025 and 2024

The following sets forth our results of operations for the three months ended March 31, 2025 and 2024 (dollars in thousands):

Three Months Ended March 31, Change

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

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

Three Months Ended June 30, Change

2025 2024 $ %

Operating expenses:

Research and development 40,156 50,355 (10,199) (20) %

General and administrative 14,281 16,087 (1,806) (11) %

Impairment of long-lived assets 2,382 4,989 (2,607) (52) %

Total operating expenses 56,819 71,431 (14,612) (20) %

Loss from operations (56,819) (71,431) 14,612 (20) %

Other income (expense), net:

Interest and other income, net 6,187 4,988 1,199 24 %

Interest expense (268) — (268) (100) %

Other income (expenses), net (43) 85 (128) (151) %

Total other income (expense), net 5,876 5,073 803 16 %

Net loss $ (50,943) $ (66,358) $ 15,415 (23) %

Research and Development Expenses

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

Three Months Ended June 30,

2025 2024 Change

Personnel $ 17,621 $ 19,139 $ (1,518)

Development costs 11,019 18,377 (7,358)

Facilities and depreciation 9,598 10,281 (683)

Other 1,918 2,558 (640)

Total research and development expenses $ 40,156 $ 50,355 $ (10,199)

Our research and development expenses included $20.4 million of internal expenses and $19.7 million of external expenses for the three months ended June 30, 2025.

Of the $19.7 million of external expenses for the three months ended June 30, 2025, $6.9 million was related to our cema-cel program.

Our research and development expenses included $22.1 million of internal expenses and $28.3 million of external expenses for the three months ended June 30, 2024.

Research and development expenses were $40.2 million and $50.4 million for the three months ended June 30, 2025 and 2024, respectively.

The decrease of $10.2 million was driven primarily by a decrease in development costs of $7.4 million related to the advancement of our product candidates and the timing of development activities and manufacturing runs, a decrease in personnel related costs of $1.5 million, including decreases in stock-based compensation expense of $3.0 million and salaries and benefits of $1.6 million partially offset by an increase of $3.1 million in severance expense related to the Workforce Reduction, and depreciation costs of $0.7 million attributable to the completion of useful life for certain machinery and equipment.

General and Administrative Expenses

General and administrative expenses were $14.3 million and $16.1 million for the three months ended June 30, 2025 and 2024, respectively.

The decrease of $1.8 million was primarily due to a decrease in personnel related costs of $2.4 million, including $1.0 million related to a decrease in stock-based compensation expense, partially offset by an increase in other expenses of $0.6 million.

Impairment of long-lived asset

In June 2024, we made a decision to sublease one of our leased buildings in South San Francisco.

We vacated and ceased occupancy of this building in June 2024 and actively marketed the leased building for sublease.

We recorded long-lived asset impairment charge of $5.0 million for the three months ended June 30, 2024 based on the performed impairment analysis.

During the three months ended June 30, 2025, we recorded an additional long-lived asset impairment charge of $1.0 million related to this subleased building.

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

Interest and Other Income, Net

Interest and other income, net was $6.2 million and $5.0 million for the three months ended June 30, 2025 and 2024, respectively.

The increase of $1.2 million was due to net gain of foreign exchange and sublease income, partially offset by lower interest earned on our cash, cash equivalents and investments.

Interest Expense

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

No such interest expense was recorded for the three months ended June 30, 2024.

Other Income (Expenses), Net

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

Other income during the three months ended June 30, 2024 consisted of a gain from the

Organizational Restructuring of Overland Therapeutics, partially offset by the share of net losses in our equity method investments.

Comparison of the Six Months Ended June 30, 2025 and 2024

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

Six Months Ended

June 30, Change

2025 2024 $ %

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

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General and administrative 29,272 33,354 (4,082) (12) %

Impairment of long-lived assets 2,382 4,989 (2,607) (52) %

Total operating expenses 122,010 140,957 (18,947) (13) %

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Collaboration revenue - related party

Revenue recognized for the three months ended March 31, 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.

Revenue recognized for the six months ended June 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:

Three Months Ended March 31,

Six Months Ended June 30,

2025 2024 Change

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Total research and development expenses $ 90,356 $ 102,614 $ (12,258)

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.

Our research and development expenses included $25.5 million of internal expenses and $26.8 million of external expenses for the three months ended March 31, 2024.

Research and development expenses were $50.2 million and $52.3 million for the three months ended March 31, 2025 and 2024, respectively.

The decrease of $2.1 million was driven primarily by a decrease in personnel related costs of $1.2 million and facilities and depreciation costs of $0.8 million attributable to the completion of useful life for certain machinery and equipment.

Our research and development expenses included $44.6 million of internal expenses and $45.8 million of external expenses for the six months ended June 30, 2025.

Of the $45.8 million of external expenses for the six months ended June 30, 2025, $13.1 million was related to our cema-cel program.

Our research and development expenses included $47.5 million of internal expenses and $55.1 million of external expenses for the six months ended June 30, 2024.

Research and development expenses were $90.4 million and $102.6 million for the six months ended June 30, 2025 and 2024, respectively.

The decrease of $12.3 million was driven primarily by a decrease in external costs of $7.1 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 $2.7 million, including decreases in salaries and benefits of $4.2 million and stock-based compensation expense of $1.6 million, partially offset by an increase in severance expense of $3.1 million related to the

Workforce Reduction, and facilities and depreciation costs of $1.5 million attributable to the completion of useful life for certain machinery and equipment.

General and Administrative Expenses

General and administrative expenses were $15.0 million and $17.3 million for the three months ended March 31, 2025 and 2024, respectively.

General and administrative expenses were $29.3 million and $33.4 million for the six months ended June 30, 2025 and 2024, respectively.

The decrease of $4.1 million was primarily due to a decrease in personnel related costs of $3.8 million, including $3.0 million related to a decrease in stock-based compensation expense, and other expenses of $0.3 million, attributable to decreases in legal and consulting expenses.

Impairment of long-lived asset

In June 2024, we made a decision to sublease one of our leased buildings in South San Francisco.

We vacated and ceased occupancy of this building in June 2024 and actively marketed the leased building for sublease.

We recorded long-lived asset impairment charge of $5.0 million for the six months ended June 30, 2024 based on the performed impairment analysis.

During the six months ended June 30, 2025, we recorded an additional long-lived asset impairment charge of $1.0 million related to this subleased building.

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

Interest and Other Income, Net

Interest and other income, net was $5.5 million and $5.4 million for the three months ended March 31, 2025 and 2024, respectively.

The increase of $0.1 million was due to net gain of foreign exchange and additional sublease income, partially offset by a lower interest earned on our cash, cash equivalents and investments.

Interest and other income, net was $11.7 million and $10.4 million for the six months ended June 30, 2025 and 2024, respectively.

The increase of $1.3 million was due to net gain of foreign exchange and sublease income, partially offset by lower interest earned on our cash, cash equivalents and investments.

Interest Expense

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

No such interest expense was recorded for the three months ended March 31, 2024.

Interest expense was related to the CIRM award proceeds received for the six months ended June 30, 2025.

No such interest expense was recorded for the six months ended June 30, 2024.

Other Income (Expenses), Net

For the three months ended March 31, 2025 and 2024, we recorded other income of $0.1 million and other income (expenses), net of $0.9 million, respectively.

The increase in other income (expenses), net, of $1.0 million was primarily due to a decrease in the share of net losses in our equity method investments.

For the six months ended June 30, 2025 and 2024, we recorded other income of less than $0.1 million and other expense of $0.8 million, respectively.

The increase in other income (expenses), net of $0.9 million was primarily due to a decrease in the share of net losses in our equity method investments, partially offset by a gain from the Organizational Restructuring of Overland Therapeutics.

Liquidity and Capital Resources

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

As of March 31, 2025, we had $335.5 million in cash, cash equivalents and investments.

As of June 30, 2025, we had $302.6 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 an underwritten offering pursuant to which we issued and sold 37,931,035 shares of our common stock.

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 three months ended March 31, 2025, we sold an aggregate of 3,842,282 in ATM offerings resulting in net proceeds of $10.0 million.

During the six months ended June 30, 2025, we sold an aggregate of 4,979,153 in ATM offerings resulting in net proceeds of $11.5 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.

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

Three Months Ended March 31,

Six Months Ended June 30,

(In thousands)

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Operating Activities

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, 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.

During the three months ended March 31, 2024, cash used in operating activities of $55.9 million was attributable to a net loss of $65.0 million, a decrease of $5.7 million in our net operating assets and liabilities, partially offset by non-cash charges of $14.8 million.

The non-cash charges consisted primarily of stock-based compensation expense of $11.9 million, depreciation of $3.6 million, non-cash rent expense of $1.2 million, and our share of equity investments’ net losses for the period of $0.9 million, partially offset by net amortization and accretion on investment securities of $2.8 million.

The change in operating assets and liabilities was primarily due to a decrease in accrued and other current liabilities of $5.7 million and operating lease liabilities of $1.2 million, partially offset by a $1.4 million decrease in other long-term assets.

During the six months ended June 30, 2025, cash used in operating activities of $92.0 million was attributable to a net loss of $110.7 million, a decrease of $10.5 million in our net operating assets and liabilities, partially offset by non-cash charges of $29.2 million.

The non-cash charges consisted primarily of stock-based compensation expense of $20.9 million, depreciation of $6.2 million, impairment of long-lived assets of $2.4 million and non-cash rent expense of $2.3 million, partially offset by net amortization and accretion on investment securities of $2.5 million.

The change in operating assets and liabilities was primarily due to a decrease in operating lease liabilities of $3.8 million, a decrease in accrued and other current liabilities of $3.5 million, an increase in deposit in escrow of $2.7 million and an increase in other long-term assets of $1.5 million, partially offset by a decrease in prepaid expense and other current assets of $1.2 million.

During the six months ended June 30, 2024, cash used in operating activities of $119.5 million was attributable to a net loss of $131.4 million and a decrease of $24.0 million in our net operating assets and liabilities, partially offset by non-cash charges of $35.9 million.

The non-cash charges consisted primarily of stock-based compensation expense of $25.5 million, depreciation of $7.2 million, impairment of long-lived assets of $5.0 million, non-cash rent expense of $2.7 million and our share of equity investments’ net losses for the period of $0.6 million, partially offset by net amortization and accretion on investment securities of $5.0 million.

The change in operating assets and liabilities was primarily due to a $21.4 million deposit placed in escrow related to the Servier Amendment, decrease in accrued and other current liabilities of $6.7 million, decrease in operating lease liabilities of $2.8 million and increase in prepaid expenses and other current assets of $2.0 million, partially offset by an increase in accounts payable of $6.7 million and decrease in other long-term assets of $2.1 million.

Investing Activities

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.

During the three months ended March 31, 2024, net cash provided by investing activities of $22.1 million was related to cash provided by investment maturities of $103.3 million, partially offset by cash used in the purchase of investments of $81.1 million.

During the six months ended June 30, 2025, net cash provided by investing activities of $50.0 million was related to cash provided by investment maturities of $110.3 million, partially offset by cash used in the purchase of investments of $60.1 million.

During the six months ended June 30, 2024, net cash provided by investing activities of $96.7 million was related to cash provided by investment maturities of $220.5 million, partially offset by cash used in the purchase of investments of $123.7 million.

Financing Activities

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.

During the three months ended March 31, 2024, cash provided by financing activities of $1.7 million was related to $0.9 million of cash provided by the sale of common stock through our employee stock purchase plan and $0.8 million of cash provided by the issuance of common stock upon exercise of stock options.

During the six months ended June 30, 2025, cash provided by financing activities of $19.1 million was related to cash provided by net proceeds from the issuance of common stock through ATM transactions of $11.5 million, proceeds from the CIRM award of $6.9 million and the sale of common stock through our employee stock purchase plan of $0.6 million.

During the six months ended June 30, 2024, cash provided by financing activities of $110.3 million was related to $105.3 million in net proceeds from the issuance of common stock through our May 2024 registered offering, $1.0 million of net proceeds from the issuance of common stock through ATM transactions, $2.3 million of cash provided from the CIRM award, $0.9 million of cash provided by the sale of common stock through our employee stock purchase plan, and $0.8 million of cash provided by the issuance of common stock upon exercise of stock options.

Material Cash Commitments and Requirements

Our primary use of cash is for operating expenses, which consist primarily of clinical manufacturing and research and development expenditures related to our lead product candidates, other research efforts, and to a lesser extent, general and administrative expenditures.

administrative expenditures.

Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses and other current liabilities.

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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 March 31, 2025, we were unable to estimate the timing or likelihood of achieving the milestones or making future product sales.

As of June 30, 2025, 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.

For additional

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

For additional information regarding our lease obligations, see Note 7 to our condensed consolidated 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.

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Payment of this funding is contingent on mutual agreement to study orders in order for any study to be included under the alliance.

We made an upfront payment of $3.0 million to MD Anderson in the year ended December 31, 2020 and made an additional upfront payment of $3.0 million to MD Anderson in October 2023.

We made an upfront payment of $3.0 million to MD Anderson in the year ended December 31, 2020 and made additional upfront payments of $3.0 million to MD Anderson in October 2023 and June 2025.

We are committed to make further payments to MD Anderson each year upon the anniversary of the agreement effective date through the duration of the agreement term, however, if MD Anderson has sufficient funds to continue the agreed-upon research projects, we may defer the additional payment to a later date.

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Where any legal or regulatory authorization is finally withdrawn or terminated, the relevant study will also terminate automatically.

In July 2020, we entered into a Solar Power Purchase and Energy Services Agreement for the installation and operation of a solar photovoltaic generating system and battery energy storage system at our manufacturing facility in Newark, California.

The agreement has a term of 20 years and commenced in September 2022.

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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 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.

are not readily apparent from other sources.

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

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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-Q

Item 2. Management’s Discussion and Analysis