Pds Biotechnology Corporation · NASDAQ:PDSB

Pds Biotechnology — Investor Presentation (September 2024)

27 slides from Pds Biotechnology's investor presentation, September 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 Precision Designed Science For Immunotherapy NASDAQ: PDSB September 2024 1 © 2024 PDS Biotechnology. All Rights Reserved.

  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 High-Value Lead Program • Targeted immunotherapy in HPV16-positive Recurrent and/or Metastatic with strong KOL support Head & Neck Squamous Cell Carcinoma (R/M HNSCC) • 30 months median Overall Survival (mOS) Promising Phase 2 Data • 77% Dise

  4. Slide 4: Significant and Growing Market Potential in HPV16-positive HNSCC

    Significant and Growing Market Potential in HPV16-positive HNSCC HPV16 to Drive Increased HNSCC Incidence Rates & Exceed 50% of all HNSCC by mid 2030s1 • Current US annual incidence of HPV16-positive HNSCC = 18,000 (~35-40% of all HNSCC)2-4 • Incidence of locally advanced, unresectable, metastatic H

  5. Slide 5: Approx. 13,600 US Patients Annually with Advanced HPV16-positive HNSCC

    Approx. 13,600 US Patients Annually with Advanced HPV16-positive HNSCC Epidemiology-Based Estimate of Addressable Population: HNSCC8 Oropharyngeal Cancer (OPC) Other HNSCC (non-OPC) Growing Market – Key Opportunity Focus of bi-specific EGFR Inhibitors ~32,500 ~20,805 U.S. Oropharyngeal Cancer in 202

  6. Slide 6: Significant Unmet Needs Remain in Recurrent/Metastatic HPV16 HNSCC

    Significant Unmet Needs Remain in Recurrent/Metastatic HPV16 HNSCC Oncologists10 – Stated Unmet Standard of Care for Recurrent or Metastatic HNSCC – Published Results*9 Medical Needs in HPV16 HNSCC • HPV16-Specificity: Need Targeted treatment option to address the KEYTRUDA® Plus Chemotherapy KEYTRUD

  7. Slide 7: Versamune HPV may Address a Significant Unmet Need in R/M HNSCC

    Versamune® HPV may Address a Significant Unmet Need in R/M HNSCC Improved ORR and PFS Have Not Resulted in FDA-Required Improved Patient Survival KEYNOTE-0489 40% 35% 6.0 5.1 15.0 12.3 10.4 Pembrolizumab 30% 4.0 3.2 10.0 Months Months 19% EGFR antibody 20% (cetuximab) + 2.0 5.0 chemotherapy 10% 0% 0

  8. Slide 8: 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-positive Recurrent/Metastatic HNSCC Study Evaluating Effects of Versamune® HPV Attributes on Clinical Responses Study Key Entry Study Partner Criteria for ICI Endpoints Treatment Design Naïve Subjects Ve

  9. Slide 9: VERSATILE-002: Most Patients Had Recurrent Disease and CPS Score 1-19

    VERSATILE-002: Most Patients Had Recurrent Disease and CPS Score 1-19 Key Demographics and Treatment Exposure12 Demographic/Baseline Characteristic Efficacy Population (N=53) Age, Median (Min, Max) 64.0 (46, 83) Historical Responses9 Sex, n (%) Male 49 (92.5) Female 4 (7.5) • Published data reports

  10. Slide 10: Versamune HPV + ICI Promoted Deep Tumor Regression in Several Patients

    Versamune® HPV + ICI Promoted Deep Tumor Regression in Several Patients Independent of CPS Score; Confirmed Disease Control Rate of 77.4%12 100 Best Percentage Change from Baseline Response in Target Lesions (mITT population) Complete Response (CR) 5/53 9.4% 75 Partial Response (PR) 14/53 26.4% Perc

  11. Slide 11: Extended Disease Control Observed in Majority of Patients

    Extended Disease Control Observed in Majority of Patients Promising Long-Lasting Immune Response with CR, PR and SD Maintained Long-Term12 Best Percentage Change from Baseline in Target Lesions 225 Response 200 Complete Response 175 Partial Response 150 Stable Disease Percent Change from Baseline 12

  12. Slide 12: Survival Exceeds Historical Median Survival in Majority of Patients

    Survival Exceeds Historical Median Survival in Majority of Patients Swimmer Plot of Overall Survival and Progression Free Survival12 Complete Response Subjects Partial Response Stable Disease Progressive Disease Not Evaluable Survival Follow-up Death Withdrew Consent Lost to Follow-up 0 2 4 6 8 10 1

  13. Slide 13: Multiple Patients Approaching 3 Years of Survival

    Median Overall Survival of 30 Months12 Multiple Patients Approaching 3 Years of Survival 1.0 Censored ‒ Discontinued (N=8) Censored ‒ Ongoing (N=27) 0.8 Survival Fraction 0.6 0.4 0.2 Median OS, months (95% CI) = 30.0 (19.7, NE) Median follow up (months) = 16 0.0 0 2 4 6 8 10 12 14 16 18 20 22 24 26

  14. Slide 14: Versamune HPV Plus Pembrolizumab Appears to be Well Tolerated

    Versamune® HPV Plus Pembrolizumab Appears to be Well Tolerated 8/87 (9%) Patients had a Grade 3 TRAE*; 1/87 (1%) had a Grade 4 TRAE** TRAEs by Grade n (%) Non-Injection Site TRAEs ≥ 5% n (%) Any Combination TRAE 76 (87.4) Fatigue 30 (34.5) Grade 1 40 (46.0) Headache 13 (14.9) Grade 2 26 (29.9) Diarr

  15. Slide 15: VERSATILE-002 Summary of Results

    VERSATILE-002 Summary of Results • Study has met primary ORR endpoint by RECIST v1.1 in ICI naïve patients • ORR by Investigator Assessment: 36% (CPS ≥1) and 48% (CPS ≥20) • 21% of patients had 90-100% shrinkage of their tumors • Versamune® HPV + KEYTRUDA® may significantly impact DCR and OS in firs

  16. Slide 16: VERSATILE-003 First Line Recurrent/Metastatic HNSCC Study Design

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

  17. Slide 17: VERSATILE-003 Trial Implementation Enabling Q4 2024 Patient Enrollment

    VERSATILE-003 Trial Implementation 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 • 18 months estimated time to

  18. Slide 18: Versamune HPV Biomarker Studies (CD8+ T Cells)

    Versamune® HPV Biomarker Studies (CD8+ T Cells) Long-Term Tumor Infiltration and Accumulation of Multi-functional CD8+ T Cells Clinical: CD8 T Cell Accumulation in Tumor Correlated with Elimination of Circulating Cancer Cells (ctDNA)13,14 Representative Plot from a Single Patient Quantity of HPV+ tu

  19. Slide 19: Preclinical Versamune HPV Biomarker Studies (Memory T Cells)

    Preclinical Versamune® HPV Biomarker Studies (Memory T Cells) Memory T cells Promoted Immune Surveillance and Prevented Re-establishment of Cancer CD8 T Cells Attacked the Cancer Leading to Tumor Eradication & Memory T Cells Prevented Re-establishment15 Versamune® HPV Secondary Tumor Primary Tumor T

  20. Slide 20: Triple Combination Trial Inclusion of HPV16-Negative Patients in ICI Naive Cohort

    Triple Combination Trial Inclusion of HPV16-Negative Patients in ICI Naïve Cohort Provided Internal Study Control & Demonstrated Versamune® HPV Specificity Versamune® HPV May be Effective HPV16-targeted Immunotherapy Objective Response Rate (ORR) Progression Free Survival (PFS) 80 N=8 20 N=8 70 18 7

  21. Slide 21: Versamune HPV + PDS01ADC: Novel Anti-Tumor Mechanism

    Versamune® HPV + PDS01ADC: Novel Anti-Tumor Mechanism PDS01ADC + Versamune® HPV + ICI Combination May Overcome Tumor Immune Suppression Inside PDS01ADC IL-12 fused antibody drug conjugate Versamune® Activated PDS01ADC Targeting CD8+ Killer T- Infiltrates TME; Weakens Tumor’s Tumor Necrosis Targeting

  22. Slide 22: Addition of PDS01ADC to Versamune HPV and an ICI Presents Potential for Deeper Responses

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

  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 File IND for Versamune® MUC1 in MUC1+ Cancers Preliminary data readout: Neoadjuvant Study in

  24. Slide 24: Pipeline Continues to Validate Platforms, Drive Future Opportunities

    Pipeline Continues to Validate Platforms, Drive Future Opportunities Candidate/ Study Indication PC P1 P2 P3 Partner Recurrent or metastatic HPV16-positive Versamune® HPV + pembrolizumab Fast Track HNSCC Versamune® HPV + chemo 1st-line treatment of locally advanced Versamune® (IMMUNOCERV)* (IB3-IVA)

  25. Slide 25: PDS01ADC Being Extensively Studied in Multiple Indications

    PDS01ADC Being Extensively Studied in Multiple Indications Candidate/ Study Indication PC P1 P2 P3 Partner PDS01ADC Monotherapy Advanced/Recurrent Kaposi Sarcoma PDS01ADC + Hepatic Artery Infusion Colon Cancer/Intrahepatic Pump (HAIP) Cholangiocarcinoma Castration sensitive and castration resistant

  26. Slide 26: Thank You

    Thank You NASDAQ: PDSB 26 © 2024 PDS Biotechnology. All Rights Reserved.

  27. Slide 27: References

    References 1. Damgacioglu H., et al. The Lancet Regional Health – Americas. 2022;8:100143 2. https://www.cdc.gov/cancer/hpv/oropharyngeal-cancer.html. Accessed August 26, 2024 3. Lechner M. et al. Nature Reviews Clinical Oncl. 2022, 19, 306-327 4. CDC.gov accessed January 2022; 5. Saraiya, Mona et a

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