Candel Therapeutics Reports Third Quarter 2026 Financial Results and Recent Corporate Highlights
Key Highlights
- ➤BLA submission targeted for mid-2027, pending FDA dialogue and assay refinement
- ➤Cash and equivalents $203.1 million, funding operations into Q2 2028
- ➤PrTK03 showed 41% lower recurrence or prostate cancer-specific death risk
- ➤NSCLC phase 2a produced 24.5-month median overall survival
- ➤Linoserpaturev phase 1b showed 12.0-month median overall survival in rHGG
Expert Statements
Paul Peter Tak, President and CEO of Candel Therapeutics
“During the quarter we continued to execute well and make significant progress across the business, as we build the foundation to potentially become a commercial-stage biopharma company”
Paul Peter Tak, President and CEO of Candel Therapeutics
“On the clinical side, we were honored to have had three posters accepted for presentation at SITC, featuring data on aglatimagene in localized prostate cancer and non-small cell lung cancer, and linoserpaturev in recurrent high-grade glioma. Together, the new biomarker data provide mechanistic support for the systemic effect and long-term clinical outcomes observed in our phase 3 trial of aglatimagene in patients with intermediate- to high-risk localized prostate cancer.”
Paul Peter Tak, President and CEO of Candel Therapeutics
“On the corporate side, we continued to build commercial-stage company capabilities. We appointed Martine Zimmermann, a regulatory and quality leader with more than 30 years of experience, to our Board, and Maria Ostrovsky, who has supported multiple oncology launches and strategic partnerships, as Candel’s General Counsel. Both bring expertise that is highly relevant as we prepare for BLA submission and potential future launch. We believe we are well positioned to execute our operating plan into Q2 2028.”
* The Company is in ongoing dialogue with the FDA regarding the submission of a Biologics License Application (BLA) for aglatimagene in prostate cancer. Due to timelines associated with certain assay refinement, the Company currently plans to submit this BLA in the middle of 2027 pending the result of that dialogue. * Cash and cash equivalents of $203.1 million, as of September 30, 2026, are expected to be sufficient to fund the Company’s current operating plan into Q2 2028.
* Three accepted poster presentations, including a late-breaking presentation, at the Society for Immunotherapy of Cancer’s (SITC) 41st Annual Meeting, showcasing new data for aglatimagene besadenovec (aglatimagene) and linoserpaturev, in localized prostate cancer and non-small cell lung cancer (NSCLC), and recurrent high-grade glioma (rHGG), respectively. * Data presented at SITC from the PrTK05 clinical trial provided evidence of systemic activation of CD8 positive T cells after aglatimagene treatment, including an increase in proliferating cytotoxic T cells and expansion of both central memory and effector memory T cells. We also observed transient biodistribution and shedding after aglatimagene treatment.
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