Candel Therapeutics (CADL) investor relations material

Pipeline and clinical progress

• Two investigational viral immunotherapies are in clinical development, targeting difficult-to-treat solid tumors.

• Aglatimagene has positive phase III data in localized prostate cancer, with BLA submission targeted for year-end.

• Positive data also reported in metastatic non-small cell lung cancer and pancreatic cancer, with a global phase III trial underway for lung cancer.

• Linoserpaturev, a next-generation oncolytic virus, shows encouraging results in recurrent glioblastoma, with a randomized control trial in preparation.

• New immunological biomarker data for aglatimagene in prostate cancer expected in Q3, with further disclosures planned soon.

Market positioning and investment outlook

• Market cap has grown from under $50 million to $1 billion in three years, with institutional ownership nearing 80%.

• Aglatimagene represents a new therapeutic modality and a novel regulatory pathway in prostate cancer.

• Probability of regulatory approval for aglatimagene estimated at 90%, based on robust phase III data and regulatory designations.

• Positioned as a preferred option alongside radical prostatectomy for intermediate/high-risk patients, potentially replacing radiotherapy alone.

Regulatory and clinical milestones

• Biodistribution and shedding study (PrTK05) required by FDA is on track for BLA submission.

• Immunological biomarker research ongoing, with data collection and analysis in progress.

• Digital pathology and AI are being used to assess immune-tumor interactions in clinical samples.

• Key upcoming milestones include biomarker data release, BLA submission, and survival data in glioblastoma.