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PDSB - Bull Thesis

BULL THESIS

  • PDSB overall corporate and summary

    • Immuno-oncology company with novel cancer vaccine technology

    • Initial efficacy results using HPV immunotherapy (PDS0101) on head & neck and other HPV cancers were impressive

    • Clinical partnerships with Merck, MD Anderson cancer Center and National Cancer Institute

    • Market cap of $170M (EV of $70M) is very attractive for a company with POC data in HPV cancers

    • Debt free and almost $70M (>2 yrs) in cash as of Q3 ‘21

  • PDS0101 (All Ph2 trials) (Versamune based immunotherapies)

    • Novel cancer immunotherapy vaccine technology targeting HPV cancers

    • Binary/Mover data to be presented throughout first half of 2022

    • Patents valid through mid 2030’s

    • Versamune based therapy has potential to generate the right type and quantity of CD8+ killer T cells, generate memory T cells and generate potency without systemic side effects

    • PDS0101 + M7824 and NHS-IL12

      • Stock jumped over 100% when presented at ASCO21 in June 2021

        • Tumor reduction in 83% of patients (advanced HPV16 positive CPI naive patients)

        • 58% tumor reduction in HPV16 checkpoint inhibitor refractory patients

        • The first ⅚ patients responded compared to historical 15-20% ORR

      • Updated data coming in mid 2022

    • PDS0101 + Keytruda (partnered with Merck) - VERSATILE-002

      • No dose limiting toxicities and OK safety (Sept 2021)

      • Preliminary ORR benchmarks were met (Feb 2022)

        • Will now progress to full enrollment

        • Achieved ORR in at least 4 of first 17 patients

          • In Keytruda monotherapy trials, ORR was 16% and complete response rate was 5% (33% of participants had HPV+ tumors and ORR irrespective of HPV status)

      • Prelim efficacy data expected H1 2022

    • PDS0101 + Chemo-radiation

      • Data expected in mid 2022

  • Additional pipeline candidates entering clinical trials by end of year

    • PDS0102, PDS0103, PDS0104, PDS0202

      • PDS0102 targets TARP protein

      • Expect to start PDS0102 trial with prostate cancer indication

    • PDS0203 2nd gen COVID vaccine, partnership extended to May 2022 with Farmacore

  • Infectimune (second proprietary technology)

    • Proprietary T-cell immune activating platform technology designed to train the immune system to better protect against disease.


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