Pds Biotechnology Corporation · NASDAQ:PDSB

Pds Biotechnology — Investor Presentation (August 2024)

26 slides from Pds Biotechnology's investor presentation, Aug 1, 2024

  1. Slide 1: Transforming How the Immune System Targets and Fights Cancer to Promote Survival

    Transforming How the Immune System Targets and Fights Cancer to Promote Survival NASDAQ: PDSB August 2024 Precision Designed Science For Immunotherapy

  2. Slide 2: Forward-Looking Statements

    Forward-Looking Statements This communication contains forward-looking statements (including within the meaning of Section 27E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corpo

  3. Slide 3: Late-Stage Head and Neck Cancer Program as Value Catalyst

    Late-Stage Head and Neck Cancer Program as Value Catalyst Potent Long-Lasting “Memory” T Cells High-Value Lead Program with strong KOL support Promising Patient Survival Oncology Pipeline Consistent and compelling Phase 2 data demonstrate potential for safe and effective therapy that promotes patien

  4. Slide 4: Market Potential in HPV16-Positive HNSCC

    Market Potential in HPV16-Positive HNSCC HPV16 will Continue to Drive Increased HNSCC Incidence Rates for Decades1 Current US annual incidence of HPV16+ HNSCC = 18,000 (40% of all HNSCC)4 Incidence of locally advanced, unresectable, metastatic HPV16+ HNSCC = 15,3004-7 Versamune® HPV US Market Potent

  5. Slide 5: A Significant Unmet Need Remains in R/M HNSCC

    A Significant Unmet Need Remains in R/M HNSCC KEYNOTE-0488 Pembrolizumab EGFR antibody (cetuximab) + chemotherapy LEAP-0109 Pembrolizumab Pembrolizumab + lenvatinib In Trials Improved ORR and PFS Have Not Resulted in Improved Overall Survival (OS) ORR = Objective Response Rate; PFS = Progression Fre

  6. Slide 6: Versamune Platform Enables Potent Long-Lasting T Cell Induction

    Promotes Right Type and Quantity of Effective CD8 Killer T Cells and “Memory” T Cells10,11 Versamune® Platform Enables Potent Long-Lasting T Cell Induction Water-insoluble fatty acids/ hydrocarbon chains Water-soluble, positively charged head-group coats particle surface Immunologically active R-ena

  7. Slide 7: Preclinical: Single Versamune HPV Injection Eradicated Established HPV+ Cancer

    Preclinical: Single Versamune® HPV Injection Eradicated Established HPV+ Cancer Day 0: HPV16+ TC1 tumor cells were injected into mice Day 12: Resulting tumors had a size of ~250mm3 (volume) Day 12 : A group of the mice received a single injection of Versamune® HPV Day 25: All treated mice had comple

  8. Slide 8: Clinical Proof-of-Concept: Versamune HPV Promoted Tumor Shrinkage

    Clinical Proof-of-Concept: Versamune® HPV Promoted Tumor Shrinkage Stage III and IV locally advanced cervical cancer patients were treated with Versamune® HPV and chemoradiotherapy (CRT) Versamune® HPV induced active CD8+ killer T cells that targeted and accumulated in the patients’ tumors (activate

  9. Slide 9: VERSATILE-002: A Global Phase 2 Study of Versamune HPV and Pembrolizumab

    VERSATILE-002: A Global Phase 2 Study of Versamune® HPV and Pembrolizumab in Subjects with HPV16+ Recurrent/Metastatic HNSCC Partner StudyDesign Open-label, non-randomized, adaptive design study 31 sites in US and EU 2 Cohorts: ICI Naïve ICI Resistant Enrollment complete Key Entry Criteria for ICI N

  10. Slide 10: VERSATILE-002: Most Patients Had CPS Score 1-19

    VERSATILE-002: Most Patients Had CPS Score 1-19 Demographic mITT Population (N=53) Age, Median (Min, Max) 64.0 (46, 83) Sex, n (%) Male Female 49 (92.5) 4 (7.5) Race, n (%) American Indian or Alaska Native Asian Black or African American Pacific Islander White Other 0 1 (1.9) 1 (1.9) 0 50 (94.3) 1 (

  11. Slide 11: Versamune HPV + ICI Promoted Deep Tumor Regression Independent of CPS Score

    Versamune® HPV + ICI Promoted Deep Tumor Regression in Several Patients Independent of CPS Score; Confirmed Disease Control Rate of 77.4% Confirmed Objective Response Rate (ORR) Based on Investigator Assessment Per RECIST v1.1 Data on File: Data represents a 30Nov2023 data cut Results According to R

  12. Slide 12: Extended Disease Control Observed in Majority of Patients

    Extended Disease Control Observed in Majority of Patients Confirmed Objective Response Rate (ORR) Based on Investigator Assessment Per RECIST v1.1 Data on File: Data represents a 30Nov2023 data cut Best Percentage Change from Baseline in Target Lesions Promising Long-Lasting Immune Response with CR,

  13. Slide 13: Promising Survival in First Line HPV16-Positive R/M HNSCC

    Promising Survival in First Line HPV16-Positive R/M HNSCC (CPS Score ≥1) VERSATILE-002 (Versamune® HPV + pembrolizumab) KEYNOTE-0488 (pembrolizumab) CPS≥1 CPS≥20 CPS≥1 CPS≥20 Confirmed ORR (%) 34 48 19 23 Median PFS (months) 6.3 14.1 3.2 3.4 Median Overall Survival (months)* 30.0 30.0 12.3 14.9 Conf

  14. Slide 14: Median Overall Survival of 30 Months

    Data on File: Represents a 17May2024 data cut Discontinued: N=2 Lost to follow up; N=6 withdrawn consent; Ongoing: Patients ongoing and awaiting next clinical assessment Median Overall Survival of 30 Months Multiple Patients Approaching 3 Years of Survival Kaplan-Meier Analysis: Median Follow-up of

  15. Slide 15: Versamune HPV Plus Pembrolizumab Was Well Tolerated

    Versamune® HPV Plus Pembrolizumab Was Well Tolerated Non-Injection Site TRAEs ≥ 5% n (%) Fatigue 30 (34.5) Headache 13 (14.9) Diarrhea 10 (11.5) Pruritis 9 (10.3) Rash 7 (8.0) Malaise 6 (6.9) Pyrexia 6 (6.9) Pain 5 (5.7) Cough 5 (5.7) TRAEs by Grade n (%) Any Combination TRAE 76 (87.4) Grade 1 40 (4

  16. Slide 16: VERSATILE-002 Conclusions

    VERSATILE-002 Conclusions VERSATILE-002 successfully met primary endpoint of 14 or more confirmed objective responses by RECIST v1.1 in ICI naïve patients with CPS ≥1 ORR by Investigator Assessment: 34% (CPS ≥1) and 48% (CPS ≥20) 21% of patients had >90% shrinkage of their tumors Versamune® HPV may

  17. Slide 17: VERSATILE-003 First Line Recurrent/Metastatic HNSCC Study Design

    VERSATILE-003 First Line Recurrent/Metastatic HNSCC Study Design Interim Analysis Possible Early Approval Versamune® HPV + PDS01ADC + pembrolizumab Q4 2024 Versamune® HPV + Pembrolizumab Pembrolizumab Aligned with FDA on Study Design and Initiation Patient Recruitment Patient Recruitment Survival Fo

  18. Slide 18: Enabling Q4-2024 Patient Enrollment

    Enabling Q4-2024 Patient Enrollment CRO engaged in site selection and preparation, investigator agreements, etc. Approx. 130 sites Site locations: US, Canada, UK, EU, Latin America 18-24 months estimated time to full enrollment Interim analysis for OS following event trigger 18 months estimated time

  19. Slide 19: PDS01ADC + Versamune HPV + ICI Combination May Overcome Tumor Immune Suppression

    PDS01ADC + Versamune® HPV + ICI Combination May Overcome Tumor Immune Suppression TME: Tumor microenvironment Versamune® HPV + PDS01ADC: Novel Anti-Tumor Mechanism Necrotic Core PDS01ADC binds to necrotic DNA Versamune® Activated Targeting CD8+ Killer T-Cell Inside PDS01ADC Infiltrates TME; Weakens

  20. Slide 20: Addition of PDS01ADC to Versamune HPV and a Checkpoint Inhibitor

    Addition of PDS01ADC to Versamune® HPV and a Checkpoint Inhibitor Presents Potential for Deeper Anti-Tumor Responses and Prolonged Survival Versamune® HPV + PDS01ADC + ICI (First Line) Versamune® HPV + PDS01ADC + ICI (Second Line) Number of patients 8 29 HPV Status HPV16-Positive HPV16-Positive ICI

  21. Slide 21: Inclusion of HPV16-Negative Patients Provided an Internal Study Control

    Inclusion of HPV16-Negative Patients Provided an Internal Study Control that Suggests Clinical Efficacy of Versamune® HPV in Advanced HPV16-Positive Cancers * 1 subject with response by iRECIST National Cancer Institute. (2023). Triple Combination Immunotherapy in Subjects With Advanced HPV Associat

  22. Slide 22: Pipeline Continues to Validate Platforms, Drive Future Opportunities

    Candidate/ Study Indication PC P1 P2 P3 Partner Versamune® Versamune® HPV + pembrolizumab Recurrent or metastatic HPV16-positive HNSCC Versamune® HPV + chemo (IMMUNOCERV)* 1st-line treatment of locally advanced(IB3-IVA) cervical cancer Versamune® HPV +/- pembrolizumab* Neo-adjuvant treatment of loca

  23. Slide 23: Upcoming Milestones 2024-2025

    Upcoming Milestones 2024-2025 Q3 2024 Q4 2024 1H 2025 2H 2025 Regulatory Confirmation of VERSATILE-003 Study Design Initiate VERSATILE-003 Pivotal Study in HNSCC IMMUNOCERV Trial Update in Cervical Cancer Preliminary data readout: Neoadjuvant Study in Oral Cancer File IND for Versamune® MUC1 in MUC1

  24. Slide 24: PDS01ADC Being Extensively Studied in Multiple Indications

    Candidate/ Study Indication PC P1 P2 P3 Partner PDS01ADC PDS01ADC Monotherapy Advanced/Recurrent Kaposi Sarcoma PDS01ADC + Hepatic Artery Infusion Pump (HAIP) Colon Cancer/Intrahepatic Cholangiocarcinoma PDS01ADC + Docetaxel Castration sensitive and castration resistant prostate cancer PDS01ADC + En

  25. Slide 25: References

    References Damgacioglu H., et al. The Lancet Regional Health – Americas. 2022;8:100143 https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.htm. Accessed January 30, 2024 Lechner M. et al. Nature Reviews Clinical Oncl. 2022, 19, 306-327 CDC.gov accessed January 2022; Saraiya, Mona et al. “US

  26. Slide 26: Thank You

    2 PDS Biotechnology Thank You ea NASDAQ: PDSB a [ite © 2024 PDS Biotechnology. All Rights Reserved.

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