Earnings

Candel Reports Wider Q3 2026 Loss, Delays Prostate Cancer BLA to Mid-2027

The Tip Desk · November 13, 2026 · 4 min read

Third-quarter 2026 net loss widened to $21.9 million from $11.3 million a year earlier. Cash of $203.1 million as of September 30, 2026 is expected to fund operations into Q2 2028, a quarter later than the company previously said.

Candel Therapeutics, Inc. (CADL), a clinical-stage biopharmaceutical company developing multimodal immunotherapies, reported a net loss of $21.9 million for the third quarter ended September 30, 2026, compared with $11.3 million a year earlier. Research and development expenses rose to $15.6 million from $8.5 million. The company said it currently plans to submit a Biologics License Application for aglatimagene besadenovec in localized prostate cancer in the middle of 2027, after timelines associated with certain assay refinement and ongoing dialogue with the FDA.

That date is later than the fourth-quarter 2026 BLA filing the company had planned when it reported second-quarter results. President and CEO Paul Peter Tak said the company continued to execute and build the foundation to potentially become a commercial-stage biopharma company.

Cash and cash equivalents were $203.1 million as of September 30, 2026, versus $201.6 million as of June 30, 2026. The company said that cash is expected to be sufficient to fund its current operating plan into Q2 2028, rather than into Q1 2028 as previously stated. Cash had been $119.7 million as of December 31, 2025.

Research and development expenses were $15.6 million for the third quarter of 2026, compared with $8.5 million a year earlier. The company attributed the increase primarily to higher clinical trial and manufacturing costs in support of aglatimagene programs and an increase in employee-related expenses. R&D included $1.0 million of non-cash stock compensation, versus $0.5 million a year earlier.

General and administrative expenses were $7.4 million, compared with $4.7 million a year earlier, due primarily to higher employee-related expenses and commercial readiness costs. G&A included $1.7 million of non-cash stock compensation, versus $0.6 million a year earlier.

Net loss was $21.9 million, or $0.28 a share, compared with a net loss of $11.3 million, or $0.21 a share, a year earlier. Net other income was $1.1 million, versus $1.9 million, which the company said was primarily related to an increase in interest expense, partially offset by higher interest income. Weighted-average shares outstanding were 77.4 million, versus 54.9 million a year earlier.

On the prostate program, the company said it continues to advance BLA readiness work, including CMC and clinical modules. A process validation campaign for drug substance and drug product has been executed at its contract development and manufacturing organization; validation batches are undergoing testing and are intended for commercial use, pending BLA approval. Clinical material has been produced using the new process. Biodistribution and shedding data from the ongoing PrTK05 phase 2 trial in intermediate-risk localized prostate cancer remain on track.

At the Society for Immunotherapy of Cancer’s 41st Annual Meeting, the company presented a late-breaking poster from PrTK05 showing increases in CD8+ cytotoxic T cells, central memory T cells, and effector memory T cells after the first aglatimagene treatment, with no such increases after standard of care alone. Additional shedding data showed transient detection of aglatimagene vector DNA in peripheral blood and clearance in urine at weeks 16–18.

The company also presented digital-pathology biomarker data from the completed phase 3 prostate trial. Among digital-pathology evaluable biopsies, aglatimagene plus EBRT significantly increased overall lymphocytic fraction versus control (p=0.048). In paired biopsies from patients with residual tumor, aglatimagene significantly increased intratumoral lymphocyte fraction, lymphocyte-tumor enrichment, and lymphocyte-tumor mixing. Previously reported two-year biopsy results showed 80% of evaluable aglatimagene patients with negative prostate biopsies versus 63% of control patients. Extended PrTK03 follow-up through March 15, 2026 showed a 41% reduction in the risk of prostate cancer recurrence or prostate cancer-specific death among patients with intermediate-risk disease treated with aglatimagene plus EBRT versus placebo plus EBRT.

In non-small cell lung cancer, the company initiated the first clinical trial site of the global pivotal phase 3 AURORA trial, which is expected to enroll patients with metastatic stage IV non-squamous NSCLC across approximately 150 sites worldwide. The trial randomizes 1:1 to two courses of aglatimagene plus valacyclovir with continued pembrolizumab or standard-of-care docetaxel, with overall survival as the primary endpoint. Phase 2a results published in the Journal for ImmunoTherapy of Cancer showed a median overall survival of 24.5 months in the evaluable population.

Updated phase 1b linoserpaturev data in recurrent high-grade glioma showed median overall survival of 12.0 months in Arms A+B (n=50) and 14.3 months in Arm C (n=12). In Arms A+B, 22% of patients were alive at 18 months. Arm C survival data remain immature.

In September 2026 the company appointed Martine Zimmermann to its board, and in October it appointed Maria Ostrovsky as General Counsel, effective November 3, 2026.

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