Candel Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Research and development expenses were $15.6 million for the third quarter of 2026, up from $8.5 million in the same period of 2025, driven by higher clinical trial and manufacturing costs and increased employee-related expenses.
• General and administrative expenses were $7.4 million for the third quarter of 2026, compared to $4.7 million in the third quarter of 2025, primarily due to increased employee-related expenses and higher commercial readiness costs.
• Net loss for the third quarter of 2026 was $21.9 million, compared to a net loss of $11.3 million in the third quarter of 2025.
• Net loss per share (basic and diluted) was $0.28 for the three months ended September 30, 2026, compared to $0.21 in the prior year period.
• Cash and cash equivalents totaled $203.1 million as of September 30, 2026, an increase from $119.7 million as of December 31, 2025.
• Total operating expenses for the nine months ended September 30, 2026, were $66.0 million, compared to $32.5 million in the same period of 2025.
• Net loss for the nine months ended September 30, 2026, was $69.6 million, compared to a net loss of $8.7 million in the same period of 2025.

Guidance and Future Outlook:

• The Company plans to submit a Biologics License Application (BLA) for aglatimagene in prostate cancer in the middle of 2027, pending dialogue with the FDA regarding assay refinement timelines.
• Cash and cash equivalents of $203.1 million are expected to fund the Company's current operating plan into the second quarter of 2028.
• The Company intends to build commercial-stage capabilities in preparation for BLA submission and potential future product launch.

Business Segments and Product Lines:

• Aglatimagene besadenovec (Prostate Cancer):
  • Process validation campaigns for drug substance and product have been executed at a contract development and manufacturing organization, with validation batches undergoing testing for potential commercial use pending BLA approval.
  • Clinical material has been produced using the new process.
  • Phase 2 PrTK05 trial data presented at SITC 2026 showed systemic activation of CD8+ T cells, including increased proliferating cytotoxic T cells and expansion of central and effector memory T cells.
  • Digital pathology analysis of the phase 3 trial demonstrated that aglatimagene plus EBRT significantly increased intratumoral lymphocyte infiltration and remodeled the tumor microenvironment compared to placebo.
  • Two years post-treatment in the phase 3 trial, 80% of evaluable aglatimagene patients had negative prostate biopsies versus 63% of control patients.
  • PrTK03 trial data with median follow-up of 58.0 months showed a 41% reduction in the risk of prostate cancer recurrence or prostate cancer-specific death for patients treated with aglatimagene plus EBRT versus placebo.
• Aglatimagene besadenovec (NSCLC):
  • Phase 2a trial results published in the Journal for ImmunoTherapy of Cancer showed a median overall survival (mOS) of 24.5 months in patients with stage III/IV NSCLC progressing after immunotherapy.
  • The global pivotal phase 3 AURORA trial (NCT07660094) has initiated its first clinical site, evaluating aglatimagene plus valacyclovir with continued pembrolizumab in metastatic non-squamous NSCLC.
  • The AURORA trial is expected to enroll patients across approximately 150 sites worldwide with a primary endpoint of overall survival.
• Linoserpaturev (rHGG):
  • Updated phase 1b data presented at SITC 2026 showed a median overall survival (mOS) of 12.0 months for 50 patients in single-administration arms (Arms A+B), with 22% of patients alive at 18 months and 4% alive at 48 months.
  • Arm C data for repeated administrations showed an mOS of 14.3 months for 12 patients, though survival data remains immature.
  • Data suggests linoserpaturev could be combined with vascular endothelial growth factor blockade to overcome hypoxia-associated immune suppression.

Market and Competitive Landscape:

• Aglatimagene has received Fast Track Designation and Regenerative Medicine Advanced Therapy Designation from the FDA for localized prostate cancer, and Fast Track Designation for NSCLC.
• Linoserpaturev has received Fast Track Designation and Orphan Drug Designation from the FDA for recurrent high-grade glioma.
• The Company has dosed more than 1,000 patients with aglatimagene in clinical trials to date.

Risks and Challenges:

• The BLA submission timeline for aglatimagene in prostate cancer is dependent on the outcome of ongoing dialogue with the FDA regarding assay refinement.
• Clinical trial data, including interim data from ongoing studies, may differ materially from final results.
• The Company faces risks related to obtaining and maintaining regulatory approval, maintaining intellectual property, and the ability to access future debt tranches.
• Actual results may differ from forward-looking statements regarding development programs, therapeutic benefits, and cash runway due to various uncertainties and factors.

Management Commentary and Tone:

• CEO Paul Peter Tak, M.D., Ph.D., stated the Company continued to execute well and build the foundation to potentially become a commercial-stage biopharma company.
• Management highlighted the acceptance of three poster presentations at SITC 2026 as evidence of mechanistic support for systemic effects and long-term clinical outcomes.
• Dr. Tak noted the Company is well-positioned to execute its operating plan into Q2 2028.

Other Key Points:

• Martine Zimmermann, PharmD, was appointed to the Board of Directors in September 2026, bringing over 30 years of regulatory and quality expertise.
• Maria Ostrovsky, JD, was appointed General Counsel in October 2026, adding 20 years of legal experience in the life sciences industry.
• The Company reported non-cash stock compensation expenses of $1.0 million for R&D and $1.7 million for G&A in the third quarter of 2026, compared to $0.5 million and $0.6 million, respectively, in the prior year period.
• Interest expense increased to $1.6 million in the third quarter of 2026 from $0.2 million in the same period of 2025.
• Working capital increased to $179.965 million as of September 30, 2026, from $112.392 million as of December 31, 2025.