On March 12, 2026 Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), a biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies for autoimmune diseases, including type 1 diabetes, and cancer, reported financial results for the full year ended December 31, 2025, and recent business highlights.

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"Century entered 2026 with strong momentum, fueled by the successful completion of our $135 million private placement and continued focus on advancing our prioritized programs closer to patients living with significant unmet medical need," said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. "We are moving fast and executing with precision on CNTY-813, our top priority and a program we believe has the potential to functionally cure type 1 diabetes. Recent achievements, including compelling preclinical results combined with constructive interactions with the FDA, strengthen our confidence in the clinical path ahead. We plan to submit an IND as early as the fourth quarter of this year and anticipate initial clinical data in the second half of 2027. We are energized by the progress across our pipeline, confident in the road ahead, and focused on advancing our most promising programs into the clinic."

Fourth Quarter 2025 and Recent Highlights

Pipeline

· CNTY-813, priority program for type 1 diabetes, advancing through IND-enabling activities and tracking toward planned IND submission in 2026: Century continues to advance IND-enabling studies for its lead pipeline program, CNTY-813, a beta islet replacement therapy with Allo-Evasion 5.0 as a potential functional cure for type 1 diabetes. To date, Century has generated compelling preclinical data for CNTY-813, demonstrating high potency and long duration for functional glucose control and protection against immune rejection via Allo-Evasion 5.0 engineering to potentially minimize or eliminate the need for chronic immunosuppression. This data package, which includes the maintenance of normoglycemia in animal models for more than 6 months, completion of the manufacturing of a GMP Master Cell Bank for CNTY-813, along with recent engagement with the U.S. Food and Drug Administration (FDA), has reinforced the company’s belief in an efficient pathway to IND submission for CNTY-813. Century expects to submit an IND for the program in the fourth quarter of 2026 and anticipates initial clinical data in the second half of 2027.

· CNTY-308 advancing in IND-enabling studies for projected clinical entry in 2026: Century continues to make progress in IND-enabling studies with CNTY-308, a CD19-targeted CD4+/CD8+ ab CAR-iT cell therapy with Allo-Evasion 5.0 as a potential treatment for B-cell-mediated diseases. In previously presented preclinical studies, CNTY-308 demonstrated functional comparability to primary CAR-T cells, including target-mediated proliferation, cytokine secretion, and long-term persistence. These data, coupled with the growing academic and industry experience with CAR-T treatment supporting its potential to deliver deep and durable responses in patients, reinforce Century’s belief in CNTY-308 to deliver autologous, CAR-T-like clinical benefits in an allogeneic, patient-centric format for enhanced treatment accessibility. Subject to completion of IND-enabling studies and regulatory clearance, Century expects CNTY-308 to enter the clinic in 2026.

· Additional insights from ongoing CARAMEL IST expected in 2026: The company anticipates updated preliminary clinical data this year from the ongoing CARAMEL study, a Phase 1/2 investigator-sponsored trial (IST) led by Professors Georg Schett and Andreas Mackensen and sponsored by the Friedrich-Alexander University Erlangen-Nürnberg. Previously disclosed clinical data from the trial have demonstrated that CNTY-101 was generally well tolerated and exhibits a predictable biologic profile with early signs of clinical response in autoimmune diseases.

Corporate

· Completed oversubscribed $135 million private placement financing: In January 2026, Century entered into a securities purchase agreement led by new investor TCGX with participation from additional new and existing investors, including RA Capital Management, Commodore Capital, Deep Track Capital, RTW Investments, Venrock Healthcare Capital Partners, and the T1D Fund. The gross proceeds were approximately $135 million before placement agent fees and offering expenses.

· Appointed two new members to the Board of Directors: In December 2025, Han Lee, Ph.D., M.B.A., and Martin Murphy, Ph.D., were appointed to Century’s Board of Directors. As part of their appointments, Dr. Lee serves as a member of the Audit and the Compensation Committees and Dr. Murphy serves as Chair of the Compensation and a member of the Nominating and Corporate Governance Committees.

Full Year 2025 Financial Results

· Cash Position: Cash, cash equivalents, and marketable securities were $117.1 million as of December 31, 2025, as compared to $220.1 million as of December 31, 2024. Net cash used in operations was $103.9 million for the year ended December 31, 2025, compared to net cash used in operations of $110.1 million for the year ended December 31, 2024. The company estimates its cash, cash equivalents, and investments as of December 31, 2025, together with the net proceeds raised after year end, will support operations into the first quarter of 2029.

· Collaboration Revenue: Collaboration revenue generated through the company’s collaboration, option, and license agreement with Bristol-Myers Squibb was $109.2 million for the year ended December 31, 2025, compared to $6.6 million for the same period in 2024.

· Research and Development (R&D) Expenses: R&D expenses were $95.7 million for the year ended December 31, 2025, compared to $107.2 million for the same period in 2024. The decrease in R&D expenses was primarily due to a reduction of personnel and manufacturing costs, offset by an increase in research and laboratory costs to progress clinical trials and preclinical programs.

· General and Administrative (G&A) Expenses: G&A expenses were $24.0 million for the year ended December 31, 2025, compared to $33.2 million for the same period in 2024. The decrease was primarily the result of a decrease in legal fees associated with the Clade acquisition in 2024, a gain on lease modification, a gain on reduction of contingent consideration liability, and a decrease in stock-based compensation.

· Net Loss: Net loss was $9.6 million for the year ended December 31, 2025, compared to net loss of $126.6 million for the same period in 2024.

(Press release, Century Therapeutics, MAR 12, 2026, View Source [SID1234663491])

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

•
Aglatimagene besadenovec (CAN-2409) – Prostate Cancer
•
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.
•
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.
•
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.
•
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.
•
Aglatimagene besadenovec (CAN-2409) – Non-Small Cell Lung Cancer (NSCLC)
•
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.

•
The FDA previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC.
•
Aglatimagene besadenovec (CAN-2409) – Pancreatic Cancer
•
The Company previously generated encouraging data based on a randomized controlled phase 2a clinical trial of aglatimagene in borderline resectable pancreatic cancer (PDAC).
•
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.
•
With Candel’s top priorities focused on prostate cancer and NSCLC, the Company has paused the PDAC program.
•
Linoserpaturev (CAN-3110) – Recurrent High-Grade Glioma (rHGG)
•
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.
•
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.
•
The FDA previously granted Fast Track Designation and Orphan Drug Designation to linoserpaturev in rHGG.
•
Recent Corporate Events
•
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.
•
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.
•
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

•
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.
•
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.
•
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.
•
Biomarker data related to the effects of aglatimagene in patients with localized prostate cancer is expected in Q3 2026.
•
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.
•
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 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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

•
Aglatimagene besadenovec (CAN-2409) – Prostate Cancer
•
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.
•
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.
•
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.
•
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.
•
Aglatimagene besadenovec (CAN-2409) – Non-Small Cell Lung Cancer (NSCLC)
•
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.

•
The FDA previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC.
•
Aglatimagene besadenovec (CAN-2409) – Pancreatic Cancer
•
The Company previously generated encouraging data based on a randomized controlled phase 2a clinical trial of aglatimagene in borderline resectable pancreatic cancer (PDAC).
•
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.
•
With Candel’s top priorities focused on prostate cancer and NSCLC, the Company has paused the PDAC program.
•
Linoserpaturev (CAN-3110) – Recurrent High-Grade Glioma (rHGG)
•
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.
•
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.
•
The FDA previously granted Fast Track Designation and Orphan Drug Designation to linoserpaturev in rHGG.
•
Recent Corporate Events
•
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.
•
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.
•
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

•
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.
•
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.
•
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.
•
Biomarker data related to the effects of aglatimagene in patients with localized prostate cancer is expected in Q3 2026.
•
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.
•
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.

Schedule your 30 min Free 1stOncology Demo!
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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])