PDS Biotechnology
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PDS Biotechnology (PDSB) investor relations material

PDS Biotechnology KOL event summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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KOL event summary15 Oct, 2026

Introduction and agenda

  • Agenda covered PDS0301, metastatic colorectal cancer treatment, Dr. Hernandez’s Phase II study in second- and third-line disease with liver metastases, then Q&A.

  • PDS0301 is an antibody-fused IL-12 designed to bind DNA-histone complexes at damaged tumor sites and retain IL-12 in tumors; administration is subcutaneous.

KOL background and credentials

  • Jonathan Hernandez is Chief of Surgical Oncology at the NCI; his lab studies hepatic metastasis, and he has authored over 175 peer-reviewed publications.

  • Hernandez said he was not paid to endorse a company and presented the data to advance the field.

Market insights and analysis

  • CRC ranked third in incidence and second in cancer mortality worldwide in 2022, with 1.9M new cases and 900,000 deaths; pMMR/MSS represents ~95% of CRC and generally does not respond to immunotherapy.

  • Trial benchmarks cited ORR of 53%-65% in first line, 11%-20% in second line and 1%-6% in third line; late-line controlled-trial experimental arms averaged ~2.5% ORR and 7.9-month median OS. Cross-trial comparisons are descriptive.

  • Liver metastases occur in ~50% of metastatic CRC cases and are a major driver of morbidity and mortality; treatment options after oxaliplatin and irinotecan were characterized as limited.

  • Hepatic artery infusion pump therapy delivers floxuridine directly to liver tumors; a randomized second-line ECOG study targets 400 patients and had slightly over 100 randomized at the time of the event.

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Frequently asked questions

PDS Biotechnology Corporation, a clinical-stage biopharmaceutical company, focuses on developing multifunctional cancer immunotherapies. Its product pipeline includes thermo-sensitive PDS0101 (Amiket), which is in Phase 3 clinical trials for the treatment of patients with human papillomavirus associated disease; Discovery Program, a research and discovery program with a focus on tumor neo-antigens and synthetic vaccines; and Thermo-Oxidative Stress Induced Antigen(TOSIA) Program that combines chemical engineering, molecular biology, and immunology to discover tumor associated antigens.