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Biotech General Discussion

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PDSB - Bull Thesis

(Updated 4/6/2022)

BULL THESIS SUMMARY

  • 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 ~$110M) is very attractive for a company with POC data in HPV cancers

  • Debt free and almost $70M (>2 yrs) in cash as of Q4 ‘21


FS/MV 4/6/22


(See below for full bull/bear analysis)





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 ~$110M) is very attractive for a company with POC data in HPV cancers

  • Debt free and almost $70M (>2 yrs) in cash as of Q4 ‘21


  • PDS0101 (Versamune based immunotherapies)

  • Novel cancer immunotherapy vaccine technology targeting HPV cancers

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

  • Patents protection thru 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 (Phase 2)

  • 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 at conference in 2022

  • PDS0101 + Keytruda (partnered with Merck) - VERSATILE-002 (Phase 2)

  • 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 at conference in 2022

  • Initiated additional investigator led trial in Feb 2022 and expect preliminary data in mid 2022

  • PDS0101 + Chemo-radiation (Phase 2)

  • Data expected in Q2 or early Q3 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.


FS/MV 2/4/22 (updated 4/6/22)


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#PDSB #PDS0101

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