Candel adds director, plans Q4 2026 BLA filing
Candel Therapeutics adds an independent director with deep regulatory expertise as it prepares a planned BLA submission for aglatimagene besadenovec in late 2026.
Rhea-AI Filing Summary
Candel Therapeutics, Inc. (CADL) expanded its Board of Directors from ten to eleven members and appointed Martine Zimmermann, Pharm.D. as a Class III independent director, effective September 8, 2026, with a term expiring at the 2027 annual stockholders’ meeting. Her compensation includes an option to purchase 64,000 shares of common stock, vesting monthly over three years, and a $40,000 annual cash retainer, paid quarterly and pro rated for service. Candel highlights Dr. Zimmermann’s more than 30 years of global regulatory and quality experience as it prepares for a planned Biologics License Application (BLA) submission for aglatimagene besadenovec in the fourth quarter of 2026 and potential commercial readiness. The company also reiterates that more than 1,000 patients have received aglatimagene in clinical trials and summarizes multiple FDA designations, including Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy, for its lead programs.
Positive
- None.
Negative
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Filing Explained
The filing states that aglatimagene remains unapproved by the FDA and other regulators, so the planned fourth-quarter 2026 BLA submission is a future regulatory step rather than an approval.
8-K Event Classification
Key Figures
Key Terms
Biologics License Application (BLA) regulatory
Regenerative Medicine Advanced Therapy Designation regulatory
Orphan Drug Designation regulatory
Special Protocol Assessment regulatory
multimodal biological immunotherapy medical
intratumoral administration medical
FAQ
What board change did CADL announce in this 8-K?
How will the new CADL director Martine Zimmermann be compensated?
What is the regulatory milestone CADL is preparing for with aglatimagene besadenovec?
What experience does Martine Zimmermann bring to Candel Therapeutics (CADL)?
What clinical experience does CADL report for aglatimagene besadenovec?
What regulatory designations has CADL’s aglatimagene received from the FDA?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On September 6, 2026, the Board of Directors (the “Board”) of Candel Therapeutics, Inc. (the “Company”) increased the size of the Board from ten (10) to eleven (11) directors and unanimously appointed Martine Zimmermann, Pharm.D, to fill the newly created vacancy on the Board, effective September 8, 2026. Upon her appointment, Dr. Zimmermann became a member of the slate of Class III directors with terms expiring at the 2027 Annual Meeting of Stockholders of the Company. The Board has determined that Dr. Zimmermann qualifies as an independent director and is qualified to serve under the applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) and the listing rules of the Nasdaq Stock Market LLC. For her service on the Board, Dr. Zimmermann will receive an option to purchase 64,000 shares of the Company’s common stock, vesting in equal monthly installments over three years. Dr. Zimmermann will also receive a $40,000 annual retainer for her service on the Board to be paid quarterly in arrears, pro-rated based on the number of actual days served by the director during such calendar quarter. Dr. Zimmermann has also entered into the Company’s standard form of indemnification agreement.
There are no arrangements or understandings between Dr. Zimmermann and any other persons pursuant to which she was elected as a director of the Company. There are no family relationships between Dr. Zimmermann and any director or executive officer of the Company, and she has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K. Dr. Zimmermann is qualified to serve on the Board based on her technical expertise and leadership experience at various biopharmaceutical companies.
Dr. Zimmermann has served as the Executive Vice President of Regulatory Affairs and Quality Assurance of Inventiva S.A. since August 2025. Prior to that, she served as the Senior Vice President and Head of Regulatory Affairs of Ipsen Biopharmaceuticals, a global biopharmaceuticals company, between January 2023 and August 2025, as Senior Vice President, Head of Global Regulatory & Quality Affairs of Alexion Pharma International from June 2016 until January 2023, and in various roles of increasing responsibility at Alexion Pharma International since 2009. Throughout her career, she has acquired extensive expertise as Regulatory Affairs Executive in both small and large pharmaceutical groups, holding senior roles in the United States, Europe and Asia-Pacific. Dr. Zimmermann has worked across all phases of drug development within several therapeutic areas, interacting with relevant regulatory authorities in key markets, including the FDA, the EMA and the Japanese Pharmaceuticals and Medical Devices Agency. Dr. Zimmermann has also served as director of Ligand Pharmaceuticals, a Nasdaq-listed biopharmaceutical company, since October 2023 and previously served as director of Caelum Biosciences between February 2018 and October 2021 and of Inventiva S.A. between April 2021 and August 2025. Dr. Zimmermann holds a Doctor of Pharmacy degree from the University of Strasbourg.
Item 7.01 Regulation FD Disclosure.
On September 10, 2026, the Company issued a press release titled “Candel Therapeutics Appoints Martine Zimmermann, PharmD, to its Board of Directors.” A copy of the press release is furnished hereto as Exhibit 99.1 and incorporated herein by reference.
The information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K are furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report on Form 8-K, regardless of any general incorporation language in any such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Press release dated September 10, 2026 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Candel Therapeutics, Inc. |
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September 10, 2026 |
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/s/ Paul Peter Tak |
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Paul Peter Tak, M.D., Ph.D., FMedSci |
Exhibit 99.1
Candel Therapeutics Appoints Martine Zimmermann, PharmD, to its Board of Directors
NEEDHAM, Mass., Sept. 10, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, today announced the appointment of Martine Zimmermann, PharmD, to the Company’s Board of Directors (Board) effective September 8, 2026.
“Martine joins Candel at an important stage in our evolution, as we prepare for the planned submission of the BLA for aglatimagene besadenovec in the fourth quarter of 2026 and continue building the capabilities required of a potential commercial-stage company,” said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. “Her extensive global experience across regulatory affairs, quality and drug development, and her track record supporting successful product approvals, will bring highly relevant expertise to our Board. We look forward to benefiting from her strategic perspective as we work to deliver potentially transformative medicines to patients with cancer.”
Dr. Zimmermann brings more than 30 years of global regulatory affairs and quality expertise across all phases of drug development. She currently serves as Executive Vice President, Head of Regulatory Affairs, Quality and Alliance Management at Inventiva S.A. Previously, she held the position of Senior Vice President, Head of Global Regulatory Affairs and R&D Quality at Ipsen Biopharmaceuticals, and she spent more than 13 years at Alexion Pharma International in senior regulatory leadership roles. Dr. Zimmermann earned her Doctor of Pharmacy degree from the University of Strasbourg.
“I am pleased to join Candel’s Board at this pivotal moment,” said Dr. Zimmermann. “The clinical data for aglatimagene is compelling, and I am impressed by the thoughtful approach to regulatory strategy and commercialization. I look forward to contributing
my expertise as Candel advances toward a planned BLA submission and potential commercial launch.”
Paul B. Manning, Chairman of Candel’s Board, added, “Dr. Zimmermann’s regulatory and quality leadership brings valuable experience as we navigate the path to potential approval and commercial readiness. Her insights will strengthen our Board at a key inflection point in Candel’s trajectory.”
About aglatimagene besadenovec
Aglatimagene besadenovec (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 proteins promote 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 use with standard of care, when indicated. Aglatimagene is currently not approved by the FDA or any other regulatory authority for any use.
About Candel Therapeutics
Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. Aglatimagene besadenovec (aglatimagene) is the lead product candidate from the adenovirus platform. The Company completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the U.S. Food and Drug Administration (FDA) and published in The Lancet Oncology. The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the
treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC.
Linoserpaturev is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma, evaluating the effects of repeat linoserpaturev injections. Initial results were published in Nature and Science Translational Medicine and linoserpaturev received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.
For more information about Candel, visit www.candeltx.com
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, including expectations regarding planned BLA submission and potential commercial readiness; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat, solid tumors; and expectations regarding the potential benefits conferred by regulatory designations. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; the impact of the Company’s existing and any future indebtedness on its ability to operate its business; the Company’s ability to access any future tranches under its debt facility and to comply with all of its obligations thereunder; and other risks identified in the Company’s filings with the U.S. Securities and Exchange
Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
Investor Contact
Theodore Jenkins
Vice President, Investor Relations, and Business Development
Candel Therapeutics, Inc.
tjenkins@candeltx.com
Media Contact
Ben Shannon
ICR Healthcare
CandelPR@icrhealthcare.com