On March 12, 2026 Circle Pharma, Inc., a clinical-stage biopharmaceutical company pioneering next-generation targeted macrocycle therapeutics for cancer, reported publication of research in the Journal of Medicinal Chemistry titled, "Orally Bioavailable Cyclin A/B RxL Inhibitors: Optimization of a Novel Class of Macrocyclic Peptides That Target E2F-High and G1-S-Checkpoint-Compromised Cancers." The paper is included in the journal’s special issue on Peptide Therapeutics.

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The publication builds on the company’s August 2025 Journal of Medicinal Chemistry paper titled, "Discovery of Cell-Permeable Macrocyclic Cyclin A/B RxL Inhibitors that Demonstrate Antitumor Activity," which described the first cell-permeable macrocyclic cyclin A/B RxL inhibitors and provided initial in vivo proof-of-concept efficacy.

"This publication demonstrates the capability of our MXMO macrocycle platform to bring forward orally bioavailable macrocycles against therapeutic targets that have been refractory to small molecule chemistry," said James Aggen, Ph.D., vice president of medicinal chemistry at Circle Pharma. "Our earlier work established that the cyclin A/B hydrophobic patch was druggable with macrocycles. This new research demonstrates these molecules can be delivered orally with compelling in vivo activity."

Cyclins A and B regulate cell cycle progression by recruiting substrates through an RxL-mediated interaction. In cancers characterized by RB1 loss or elevated E2F activity – including nearly all small-cell lung cancers – this pathway becomes dysregulated, driving uncontrolled tumor growth. Rather than inhibiting CDK catalytic activity, Circle Pharma’s approach disrupts the protein-protein interactions between cyclins A and B and their RxL-containing substrates, selectively killing E2F-high tumor cells.

CID-078, Circle Pharma’s oral cyclin A/B RxL inhibitor is currently being evaluated in a multi-center Phase 1 clinical trial in patients with advanced solid tumors (NCT06577987).

(Press release, Circle Pharma, MAR 12, 2026, View Source [SID1234663493])

On March 12, 2026 Champions Oncology, Inc. (Nasdaq: CSBR), a leading translational oncology research organization, reported its financial results for its third quarter of fiscal 2026, ended January 31, 2026.

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Third Quarter and Recent Highlights:

•Record study service revenue of $16.6 million, up approximately 32% year over year
•Total revenue of $16.6 million, compared to $17.0 million in the prior-year period
•Adjusted EBITDA of $574,000; GAAP loss from operations of approximately $276,000

The Company’s third quarter reflected record service revenue driven by strong study execution and the conversion of previously booked work. As is typical in the Company’s business, quarterly revenue can fluctuate depending on study timing and completion milestones. The strong third quarter reflects, in part, the conversion of backlog that had been delayed earlier in the year and may normalize somewhat in the near term before continuing to grow as bookings expand.

Robert Brainin, CEO of Champions, commented, "We delivered strong operational performance in the third quarter, including another quarter of record study services revenue and our third consecutive quarter of positive adjusted EBITDA. While quarterly results can fluctuate in our business, we remain on track for annual growth and full-year positive adjusted EBIDTA while continuing to invest in our data platform and discovery therapeutics initiatives. We are also encouraged by the early momentum we are beginning to see in our data business and remain confident that our differentiated tumor bank, expanding capabilities, and growing customer engagement position Champions well for long-term growth."

David Miller, CFO of Champions, added, "Study service revenue grew 32% year over year, benefiting in part from the conversion of previously booked work during the quarter. Total revenue declined modestly compared to the prior-year period due to the absence of the $4.5 million data license transaction recognized in the third quarter of last year."

"Cost of sales during the quarter included more than $2 million of outsourced radiolabeling work. As this work transitions in-house over time, we expect these costs to decline and margins to improve. We also continue to invest in both our commercial organization and our data platform capabilities to expand our pipeline of opportunities and support future growth."

Third Fiscal Quarter Financial Results

Total oncology revenue for the third quarter of fiscal 2026 was $16.6 million compared to $17.0 million for the same period last year, a decrease of 2.8%. The decline was primarily attributable to the absence of the $4.5 million data license revenue recognized in the third quarter of fiscal 2025. Excluding data, revenue increased 32% reflecting strong study execution and the conversion of bookings from earlier quarters into revenue during the third quarter.

Total costs and operating expenses for the third quarter of fiscal 2026 were $16.8 million compared to $12.5 million for the third quarter of fiscal 2025, an increase of $4.3 million or 34.3%.

For the third quarter of fiscal 2026, Champions reported a net loss of $279,000, including $423,000 in stock-based compensation, $341,000 in depreciation and amortization expenses, and a loss on equipment sale and disposal of $89,000 . This compares to net income of $4.5 million in the third quarter of fiscal 2025, which included $256,000 in stock-based compensation and $398,000 in depreciation and amortization expenses. Adjusted EBITDA, which is defined as net income excluding stock-based compensation, depreciation and amortization expenses, and a loss on the sale and / or disposal of lab equipment was $574,000 for the third quarter of fiscal 2026 compared to adjusted EBITDA of $5.1 million in the third quarter of fiscal 2025.

Cost of oncology revenue was $8.8 million, for the three months ended January 31, 2026, an increase of $2.2 million, or 33.5%, compared to $6.6 million in the same quarter of fiscal 2025. The increase was primarily driven by higher outsourced lab service costs. As the Company transitions more of this work in-house, management expects margins to improve. Oncology services margin for the quarter was 47%, compared to 61% for three months ended January 31, 2025. The margin decline reflects outsourced radiolabeling work as well as the contribution of high-margin data revenue recognized in the prior-year period. Oncology services margin and profit are defined below in our Non-GAAP financial information discussion.

Research and development expense for the three months ended January 31, 2026 was $2.3 million, an increase of $552,000 or 32.1%, compared to $1.7 million for the three months ended January 31, 2025. The increase reflected greater investment in sequencing and related activities to advance the Company’s data licensing platform. Sales and marketing expense for the quarter was $2.7 million, an increase of $860,000, or 47.6%, compared to $1.8 million in the prior year period, driven primarily by higher compensation expense to support the growth of both the data and commercial businesses. General and administrative expense for the three months ended January 31, 2026 was $3.0 million, an increase of $0.6 million, or 24.1%, compared to $2.4 million for the three months ended January 31, 2025. The increase was primarily due to higher compensation expense, including stock-based compensation, and increased IT-related costs.Net cash used in operating activities was approximately $1.4 million for the three months ended January 31, 2026, primarily driven by an increase in accounts receivable and a decline in deferred revenue partially offset by an increase in accounts payable. Net cash used in financing and investing activities totaled approximately $30,000, reflecting purchases of lab and computer equipment, repayment of financing leases, and a stock options exercise.

The Company ended the quarter with cash on hand of approximately $7.1 million and no debt.

Year-to-date Financial Results

Total revenue for the nine months ending January 31, 2026 was $45.6 million, compared to $44.6 million for the same period last year, an increase of 2.2%. Total costs and operating expenses for the nine months ending January 31, 2026 were $46.2 million, compared to $38.0 million for the nine months ending January 31, 2025, an increase of $8.2 million, or 21.5%.

For the nine months ending January 31, 2026, Champions reported a net loss of $508,000, including $880,000 in stock-based compensation, $1.1 million in depreciation and amortization expenses, and a loss on the sales and disposal of equipment of $110,000. This compares to net income of $6.6 million in the nine months ending January 31, 2025, which included $523,000 in stock-based compensation and $1.2 million in depreciation and amortization expenses. Excluding stock-based compensation, depreciation and amortization, and an equipment disposal and sale losses, adjusted EBITDA was $1.5 million for the nine months ending January 31, 2026, compared to $8.3 million in the nine months ending January 31, 2025.

Cost of oncology services was $24.1 million for the nine months ended January 31, 2026, an increase of $3.0 million, or 14.1%, compared to $21.1 million for the same period in 2025. The increase was primarily driven from higher mice costs and outsourced lab services. Oncology services margin for current year period was 47% compared to 52.6% for the prior year period.

Research and development expense for the nine months ended January 31, 2026 was $7.0 million, an increase of $2.1 million, or 43.3%, compared to $4.9 million for the same period in 2025. The increase was primarily driven by greater investment in sequencing and related costs to support the development of our data platform, as well as an increase in investment in Corellia. Sales and marketing expense for the nine months ended January 31, 2026 was $6.5 million, an increase of $1.3 million, or 24.5%, compared to the prior-year period. General and administrative expense was $8.5 million, an increase of $1.7 million, or 25.0%, compared to $6.8 million for the nine months ended January 31, 2025.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its third quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 957548, or provide the verbal reference "Champions Oncology".
Full details of the Company’s financial results will be available on or before March 16, 2026 in the Company’s Form 10-Q at www.championsoncology.com.

(Press release, Champions Oncology, MAR 12, 2026, View Source [SID1234663492])

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.
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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

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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.
•
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.
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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 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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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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"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.
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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])