On March 12, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to help patients fight cancer, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update.

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"During the quarter we made meaningful progress across our clinical pipeline and pre-commercial readiness, entering 2026 with strong momentum and a robust set of potential value-driving catalysts," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. "For aglatimagene in localized, intermediate-to high-risk prostate cancer, we continue to work toward a planned BLA submission in Q4 2026. We continue to follow the patients in our phase 3 study for prostate cancer-specific outcomes and expect to share

results after extended follow-up in Q2 2026. We also expect to share additional biomarker data from our prostate program in Q3 2026. We plan to initiate a pivotal phase 3 clinical trial of aglatimagene in NSCLC despite ICI treatment in Q2 2026. In a phase 1b clinical trial of linoserpaturev in patients with rHGG, we reported encouraging survival data, supported by sophisticated serial brain biopsy analyses, and we expect to announce mature overall survival data for Arm C in Q4 2026. We submitted an IND for linoserpaturev in Q4 2025 to advance the development of this asset in rHGG and received clearance from the U.S. Food and Drug Administration in Q1 2026.

Dr. Tak continued, "We were pleased to strengthen the Company’s financial position with the additional strategic funding from the term loan facility with Trinity Capital, the institutionally focused follow-on equity offering in February 2026, and our royalty financing agreement with funds managed by RTW Investments, LP. This further strengthens our balance sheet, brings new institutional investors into the Company, and positions us to advance our key priorities, including the initiation of a pivotal phase 3 clinical trial of aglatimagene in NSCLC and preparation for a potential commercial launch of aglatimagene in localized prostate cancer."

Fourth Quarter 2025 & Recent Highlights

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Aglatimagene besadenovec (CAN-2409) – Prostate Cancer
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The Company continues to advance its pre-BLA readiness initiative, including its Chemistry, Manufacturing, and Controls (CMC) activities, and preparation of clinical study reports and BLA modules.
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The Company will present follow-up clinical data from its phase 3 trial of aglatimagene in prostate cancer in Q2 2026 and novel biomarker data in Q3 2026.
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The Company’s control manufacturer plans to conduct process validation in Q2 2026 to potentially enable filing of a BLA in Q4 2026. The Company’s control manufacturer has manufactured four large-scale batches to date. Clinical material from the new process has been manufactured and filled. Candel intends to use this material in the pivotal phase 3 clinical trial in NSCLC.
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The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of localized prostate cancer. The phase 3 clinical trial of aglatimagene in localized prostate cancer was conducted under a Special Protocol Assessment with respect to the study design, agreed with the FDA.
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Aglatimagene besadenovec (CAN-2409) – Non-Small Cell Lung Cancer (NSCLC)
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Following a positive end-of-phase 2 meeting with the FDA in July 2025, the Company is preparing to initiate a pivotal phase 3 clinical trial of aglatimagene in NSCLC in Q2 2026.

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The FDA previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC.
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Aglatimagene besadenovec (CAN-2409) – Pancreatic Cancer
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The Company previously generated encouraging data based on a randomized controlled phase 2a clinical trial of aglatimagene in borderline resectable pancreatic cancer (PDAC).
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The FDA previously granted Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC, and the European Medicines Agency granted Orphan Designation for aglatimagene for the treatment of pancreatic cancer in July 2025.
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With Candel’s top priorities focused on prostate cancer and NSCLC, the Company has paused the PDAC program.
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Linoserpaturev (CAN-3110) – Recurrent High-Grade Glioma (rHGG)
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In February 2026, at the 7th Annual Glioblastoma Drug Development Summit, the Company shared insights from its herpes simplex virus (HSV)-based platform and its linoserpaturev program through workshop presentations and panel discussions focused on advancing biomarker-driven clinical development in glioblastoma.
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The Company submitted an IND for linoserpaturev to advance the development of this asset in rHGG in Q4 2025 and received clearance from the FDA in Q1 2026.
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The FDA previously granted Fast Track Designation and Orphan Drug Designation to linoserpaturev in rHGG.
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Recent Corporate Events
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On February 23, 2026, Candel issued and sold 18,348,624 shares of common stock at a price to the public of $5.45 per share for aggregate gross proceeds of approximately $100 million, which will be used to complete critical launch readiness, medical affairs, pre-commercialization, and commercial activities for aglatimagene in early, localized prostate cancer, ongoing development costs related to the phase 3 trial of aglatimagene in NSCLC, and for general corporate purposes.
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On February 19, 2026, Candel announced a $100 million royalty funding agreement with funds managed by RTW Investments, LP (RTW), subject to FDA approval of aglatimagene in localized, intermediate-to high-risk, prostate cancer. Under the terms of the agreement, RTW will receive a tiered single digit percentage of annual net sales of aglatimagene in the U.S., subject to a cap. Funds will strengthen the Company’s balance sheet for potential U.S. commercial launch of aglatimagene in intermediate- to high-risk localized prostate cancer.
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On December 5, 2025, Candel hosted a virtual Research and Development (R&D) Event, which included presentations and panel discussions from its executive leadership, clinical investigators, scientific advisors, and key collaborators. The event provided an extensive overview of Candel’s viral immunotherapy approach and oncology focused pipeline. Click here to view the event.
Anticipated Milestones

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Updated mOS data and potential long tail of survival from the phase 2a open-label clinical trial of aglatimagene in patients with stage III/IV NSCLC who had progressed despite ICI treatment (NCT04495153) is expected in Q1 2026.
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Updated extended follow-up data on prostate cancer-specific disease-free survival, time to salvage anti-cancer therapy, and time to metastasis from the positive phase 3 clinical trial of aglatimagene in patients with localized, intermediate- to high-risk prostate cancer is expected in Q2 2026.
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The Company plans to initiate a pivotal phase 3 clinical trial of aglatimagene in patients with metastatic, non-squamous, NSCLC and progressive disease despite ICI treatment in Q2 2026.
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Biomarker data related to the effects of aglatimagene in patients with localized prostate cancer is expected in Q3 2026.
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The Company expects to present mature mOS data and an update on long-term survivors from arm C of its phase 1b clinical trial of linoserpaturev in patients with rHGG in Q4 2026.
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Submission of BLA for aglatimagene in prostate cancer is planned for Q4 2026.

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2025

Research and Development Expenses: Research and development expenses were $11.0 million for the fourth quarter of 2025 compared to $4.8 million for the fourth quarter of 2024, and $30.5 million for the full year 2025 compared to $19.3 million for the full year 2024. The increase was primarily due to higher manufacturing, clinical trial and regulatory costs, in support of the Company’s aglatimagene programs, and an increase in employee-related expenses. Research and development expenses included a non-cash stock compensation expense of $0.7 million and $1.5 million for the fourth quarter and full year of 2025, respectively, as compared to a non-cash stock compensation expense of $0.8 million and $3.3 million for the fourth quarter and full year of 2024, respectively.

General and Administrative Expenses: General and administrative expenses were $4.7 million for the fourth quarter of 2025, compared to $3.3 million for the fourth quarter of 2024, and $17.8 million for the full year 2025 compared to $14.1 million for the full year 2024. The increase was primarily due to an increase in commercial readiness costs and employee-related expenses, as well as higher professional and consulting fees. General and administrative expenses included non-cash stock compensation expense of $0.6 million and $2.3 million for the fourth quarter and full year of 2025, respectively, as compared to a non-cash stock compensation expense of $0.4 million and $2.0 million for the fourth quarter and full year of 2024, respectively.

Net Loss: Net loss for the fourth quarter of 2025 was $29.5 million compared to a net loss of $14.1 million for the fourth quarter of 2024 and included net other expense of $13.7 million and net other expense of $5.9 million, respectively. Net loss for the full year 2025 was $38.2 million compared to a net loss of $55.2 million for the full year 2024 and included net other income of $10.1 million and net other expense of $21.8 million, respectively. The change from net other expense in 2024, to net other income in 2025, is primarily related to the change in the fair value of the Company’s warrant liabilities.

Cash Position: Cash and cash equivalents, as of December 31, 2025, were $119.7 million compared to $102.7 million as of December 31, 2024. Based on current operating plans, the Company expects that its existing cash and cash equivalents, as of December 31, 2025, together with proceeds from the follow-on equity offering in February 2026, will be sufficient to fund operations into Q1 2028.

About aglatimagene besadenovec (CAN-2409)

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid protein promotes inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated.

About linoserpaturev (CAN-3110)

Linoserpaturev is a first-in-class, replication-competent, next-generation oncolytic herpes simplex virus-1 (HSV-1) immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where linoserpaturev was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single linoserpaturev injection in this therapy-resistant condition.1 The Company and academic collaborators are currently supported by the Break Through Cancer foundation to evaluate the effects of repeated linoserpaturev injections in patients with recurrent glioblastoma in an expansion cohort from the phase 1b clinical trial. In October 2025, Science Translational Medicine presented findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of linoserpaturev in arm C. Linoserpaturev previously received Fast Track Designation and Orphan Drug Designation for the treatment of rHGG from the U.S. Food and Drug Administration (FDA).

About the enLIGHTEN Discovery Platform

The enLIGHTEN Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors. The enLIGHTEN Discovery Platform has been designed to deconvolute the characteristics of the tumor microenvironment related to clinical outcomes. These characteristics are rapidly translated into optimized multi-gene payloads of tumor modulators that can be delivered to the tumor microenvironment for specific indications, disease stages, and rationally designed therapeutic combinations.

(Press release, Candel Therapeutics, MAR 12, 2026, View Source [SID1234663490])

On March 12, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported on its proprietary manufacturing process for CLD-401, the Company’s first lead candidate from its RedTail platform, at the BioProcessing Summit in Barcelona.

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RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumor cells, remodel the tumor microenvironment (TME), and enable high-level expression of therapeutic genetics at the tumor. CLD-401 is designed to reach metastatic sites, replicate only in tumor cells, and express high levels of IL-15 superagonist (IL-15 SA), a known T-cell and Natural Killer cell activator, in the TME.

At the meeting, Calidi outlined key aspects of its manufacturing system designed to support scalable and high-yield manufacturing of CLD-401. This process, developed in-house, maintains the integrity of the CD55 over-expressing envelope unique to the Company’s RedTail virus that allows for systemic delivery by preventing immune recognition.

Calidi has interacted with the FDA around the Company’s manufacturing and analytical approaches through its Type D meeting request process. The feedback it has received from the agency supports the use of this process for the clinical development of CLD-401.

"The process discussed today highlights key scalability properties of the manufacturing system we have developed for the RedTail platform and CLD-401" said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "Based on our interactions with the FDA, we believe this process can be used to support CLD-401 through clinical development with the ultimate goal of commercialization."

"The RedTail platform represents an exciting new approach for the systemic and targeted delivery of genetic payloads to distal sites of disease," said Eric Poma, PhD, Chief Executive Officer of Calidi. "Early engagement with the FDA on our manufacturing strategy has been an important step in building a scalable and robust manufacturing program, and the feedback we have received supports our approach as we advance CLD‑401 through clinical development"

Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The Company anticipates submitting an Investigational New Drug (IND) application for CLD-401 by the end of 2026. The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, MAR 12, 2026, https://www.calidibio.com/calidi-biotherapeutics-presents-its-innovative-and-scalable-manufacturing-process-for-cld-401-at-the-9th-annual-bioprocessing-summit-fda-feedback-support-companys-approach-to-manufacturing/ [SID1234663489])

On March 12, 2026 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the fourth quarter and full-year ended December 31, 2025, and provided a business update.

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"BDC‑4182 is the first of our next‑generation Boltbody ISACs to enter the clinic, and we saw a clear difference versus our first-gen ISACs in terms of immune response from the very first patient treated," said Willie Quinn, President and Chief Executive Officer. "The ISAC mechanism is radically different from ADCs and T cell engagers, and we believe that demonstrating anti-tumor activity with BDC-4182 will unlock an entirely new approach to treating cancer. We continue to enroll patients with gastric and gastroesophageal cancers in the Phase 1 dose‑escalation trial and remain on track to report initial data in the third quarter of 2026."

Recent Highlights and Anticipated Milestones

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Initial clinical data from BDC-4182 Phase 1 study for patients with gastric and gastroesophageal cancer expected in the third quarter of 2026. BDC-4182 is a next-generation BoltbodyTM ISAC targeting claudin 18.2, a clinically validated target with expression in gastric cancer, gastroesophageal junction cancer, pancreatic cancer, and other tumor types. In preclinical models, including cancer models with low claudin 18.2 expression, BDC-4182 demonstrated significant anti-tumor activity, induced immunological memory, and outperformed cytotoxic claudin 18.2 ADCs. Following a strong immune response that was observed at the initial dose levels, Bolt modified the clinical trial protocol to allow for step-up dosing, which has been successfully used commercially for T-cell engagers. The clinical trial in gastric and gastroesophageal cancers is ongoing, and the Company expects to present initial clinical data in the third quarter of 2026.
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Next-generation Boltbody ISACs targeting CEA and PD-L1. Bolt has two ISAC programs in preclinical development. Both programs are on hold pending partnering or funding and have the potential to be in the clinic within 18 months once activities resume.
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Bolt’s CEA-targeted ISAC comprises a novel, fully human antibody with high affinity and selectivity to CEACAM5 (CEA), and not to other members of the CEACAM family, conjugated to a proprietary next-generation TLR7/8 agonist via a non-cleavable linker. Bolt’s CEA ISAC induced complete and durable anti-tumor responses in preclinical models and was more effective than a Topo1-based ADC at lower doses and in a lower antigen density tumor model. This CEA ISAC was well tolerated in a non-GLP toxicology study.

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Bolt’s PD-L1 ISAC utilizes a novel human anti-PD-L1 antibody conjugated to a TLR7/8 agonist via a non-cleavable linker. This ISAC leverages a unique mechanism of action due to its ability to target both tumor and immune cells that express PD-L1. Preclinical results demonstrated that PD-L1 ISACs represent a compelling new approach to treat cancer, leveraging mechanisms that are distinct from and potentially complementary to conventional PD-1/PD-L1 blockade with the potential for enhanced immune activation and antitumor activity.
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Cash, cash equivalents, and marketable securities were $31.8 million as of December 31, 2025. Cash on hand is expected to fund multiple milestones and operations into 2027.

Fourth Quarter and Full Year 2025 Financial Results

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Collaboration Revenue – Total collaboration revenue was $2.5 million and $7.7 million for the fourth quarter and full year ended December 31, 2025, respectively, compared to zero and $7.7 million for the same quarter and year in 2024, respectively. Revenue in the fourth quarter and full year ended 2025 was due to continued progress in our collaborations as we fulfill our performance obligations to our collaboration partners. We reported no collaboration revenue in the fourth quarter of 2024 as a result of the reassessment of our expected future performance obligations.

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Research and Development (R&D) Expenses – R&D expenses were $5.0 million for the fourth quarter and $28.5 million for the full year ended December 31, 2025, respectively, compared to $11.7 million and $57.5 million for the same quarter and year in 2024, respectively. The decrease between the comparable periods was mainly due to a continued decrease in salary and related expenses primarily as a result of our restructuring plans, reduced clinical trial expenses and lower research and development expenses.

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General and Administrative (G&A) Expenses – G&A expenses were $3.1 million for the fourth quarter and $13.8 million for the full year ended December 31, 2025, respectively, compared to $3.9 million and $18.5 million for the same quarter and year in 2024, respectively. The decrease between the comparable periods was mainly due to a continued decrease in salary and related expenses primarily as a result of our restructuring plans.

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Loss from Operations – Loss from operations was $7.1 million for the fourth quarter and $36.1 million for the full year ended December 31, 2025, respectively, compared to $16.9 million and $73.0 million for the same quarter and year in 2024, respectively.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.

(Press release, Bolt Biotherapeutics, MAR 12, 2026, View Source [SID1234663487])

On March 12, 2026 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the Complete Response Letter (CRL) to the Biologics License Application (BLA) for tabelecleucel (tab-cel) held by our partner Pierre Fabre Pharmaceuticals.

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Pierre Fabre Pharmaceuticals, with Atara’s support, will meet with the agency to collaboratively address the points from the CRL and enable a resubmission with the additional efficacy data that has been collected since the original BLA submission.

"We are pleased that the FDA has granted a Type A Meeting to our partner, Pierre Fabre, and hope to gain clarity on a path forward for re-submission of the tab-cel BLA," said Cokey Nguyen, President and Chief Executive Officer of Atara. "We anticipate providing a regulatory update in the second quarter."

(Press release, Atara Biotherapeutics, MAR 12, 2026, View Source [SID1234663486])

On March 12, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported corporate updates and announced financial results for the quarter and full year ended December 31, 2025.

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"Allogene is approaching a pivotal inflection point, with the first interim data of cema-cel’s ALPHA3 trial just weeks away," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "We designed ALPHA3 to answer a bold question: can early, MRD-guided allogeneic CAR T prevent relapse in LBCL? We believe that this trial will answer that question and has the potential to mark one of the most significant advances in the field in decades. Importantly, through ALPHA3 we are working to demonstrate that allogeneic CAR T can move beyond academic settings and be delivered at biologic-like scale. Beyond oncology, ALLO-329 demonstrates how our Dagger technology may redefine the delivery of CAR T in autoimmune disease. Supported by a cash runway into 2028, we are focused on disciplined execution and delivering transformative data across our portfolio."

Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL
Allogene’s lead program, cemacabtagene ansegedleucel (cema-cel), is being evaluated in the pivotal, randomized Phase 2 ALPHA3 trial, the first study designed to test whether early, MRD-guided consolidation with cema-cel can prevent recurrence of large B-cell lymphoma (LBCL).

ALPHA3 seamlessly integrates cema-cel as a "7th cycle" of first-line therapy, without altering existing first-line treatment workflows, enabling early, MRD-guided treatment intervention for patients at high risk of relapse. The trial is enrolling patients across more than 60 activated clinical trial sites, including sites outside the United States, spanning both academic and community cancer centers. This broad site footprint is designed to enhance patient access, particularly as the majority of LBCL patients in the U.S. are treated in community settings.

The interim futility analysis in April 2026 will compare MRD clearance rates between cema-cel after standard fludarabine and cyclophosphamide (FC) lymphodepletion versus observation (12 patients in each cohort). The update will also include a summary of safety outcomes and additional information about screening and treatment patterns across the trial site footprint. Clearance of MRD in 25–30% more patients assigned to the cema-cel arm compared to those in the observation arm may indicate a proof of concept that early treatment of MRD+ disease could improve long term outcomes.

ALLO-329: Purpose-Built Allogeneic CAR T for Autoimmune Disease with Built-In Lymphodepletion
ALLO-329 is a next-generation, dual-targeted CD19/CD70 AlloCAR T therapy that incorporates Allogene’s proprietary Dagger technology. Dagger is designed to provide built-in, targeted lymphodepletion by selectively eliminating activated CD70-positive T cells responsible for rejecting AlloCAR T products. This approach is intended to enable robust expansion and persistence of allogeneic CAR T cells, while potentially reducing or eliminating the need for conventional cytotoxic lymphodepletion.

The Phase 1 RESOLUTION trial is a 3+3 dose-escalation study enrolling patients across multiple autoimmune indications, including systemic lupus erythematosus, lupus nephritis, scleroderma, and inflammatory myositis. The trial is evaluating up to four dose levels, beginning at 20 million CAR T cells, in two parallel cohorts: one receiving reduced lymphodepletion consisting of cyclophosphamide only and one receiving no lymphodepletion. For context, competitive CAR T programs are evaluating dose levels ranging from approximately 150 million cells (autologous) to nearly 1 billion cells (allogeneic).

Initial data from the patients treated in the first dosing cohort are expected in June 2026. The planned data update is expected to include translational data, including disease-related biomarkers, CAR T expansion, immune reconstitution, and early clinical outcomes.

If successful, ALLO-329 could open one of the largest new markets in cell therapy, where scalable manufacturing, tolerability profile, and accessibility to rheumatologists become critical competitive differentiators.

ALLO-316: TRAVERSE Trial in RCC
ALLO-316 remains the only allogeneic CAR T therapy to show clinically significant response rates and meaningful durability of response in a metastatic solid tumor. The TRAVERSE trial in renal cell carcinoma has completed enrollment in its Phase 1b cohort and the Company is currently exploring partnering opportunities to advance the asset.

2025 Fourth Quarter and Year End Financial Results

Research and development expenses were $28.6 million for the fourth quarter of 2025, which includes $2.5 million of non-cash stock-based compensation expense. For the full year of 2025, research and development expenses were $150.2 million, which includes $12.9 million of non-cash stock-based compensation expense.
General and administrative expenses were $13.8 million for the fourth quarter of 2025, which includes $5.6 million of non-cash stock-based compensation expense. For the full year of 2025, general and administrative expenses were $56.8 million, which includes $24.7 million of non-cash stock-based compensation expense.
Net loss for the fourth quarter of 2025 was $38.8 million, or $0.17 per share, including non-cash stock-based compensation expense of $8.1 million. For the full year of 2025, net loss was $190.9 million, or $0.87 per share, including non-cash stock-based compensation expense of $37.6 million and non-cash impairment of long-lived asset expense of $2.4 million.
The Company had $258.3 million in cash, cash equivalents, and investments as of December 31, 2025.

Based on its cash, cash equivalents, and investments as of December 31, 2025, the Company has extended its cash runway into the first quarter of 2028. This extension reflects disciplined expense management, focused investment in advancing the ALPHA3 and RESOLUTION programs, the return of $23.7 million in escrow funds in February 2026 related to the favorable outcome in Servier’s arbitration with Cellectis, and the prudent, opportunistic use of the Company’s at-the-market (ATM) facility.

Guidance for operating cash expense in 2026 is expected to be approximately $150 million. GAAP Operating Expenses are expected to be approximately $210 million, including estimated non-cash stock-based compensation expense of approximately $35 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT / 5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

(Press release, Allogene, MAR 12, 2026, View Source [SID1234663485])