Pds Biotechnology Corporation · NASDAQ:PDSB

Pds Biotechnology — Investor Presentation (February 2025)

24 slides from Pds Biotechnology's investor presentation, Feb 5, 2025

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

    Transforming How the Immune System Targets and Fights Cancer to Promote Survival NASDAQ: PDSB February 2025 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 Potential for Market Leadership Position High-Value Lead Program With Strong KOL support Growing Unmet Need Phase 3 HNSCC Trial Rapidly growing HPV16-positive indication 50%+ of HNSCC in US/EU Unique cancer with atypical presentation and phy

  4. Slide 4: Upcoming Milestones 2025-2026

    Upcoming Milestones 2025-2026 (Phase 2 and Phase 3 Trials) Q1 2025 Q2 2025 Q3 2025 Q4 2025 Q1 2026 Q2 2026 Q3 2026 Regulatory clearance to start VERSATILE-003 File IND for Versamune® MUC1 Initiate VERSATILE-003 (V-003) Data readout from VERSATILE-002 (V-002) Data readout: Versamune® HPV and Versamun

  5. Slide 5: HPV-positive and HPV-negative HNSCC: Two Distinct Diseases

    HPV-positive and HPV-negative HNSCC: Two Distinct Diseases1-3 HPV-negative HNSCC Alcohol & tobacco Causes mutations in oncogenic river genes HPV-positive HNSCC High-risk HPVViral oncoproteins E6/E7 degrade tumor suppressor proteins Low expression of viral genes & limited T cell infiltration Treatabl

  6. Slide 6: 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 2030s4 Current estimated US annual incidence of HPV16-positive HNSCC ~ 21,000 (~40-50% of all HNSCC)5-8 Incidence of locally advanced, unresectable, metast

  7. Slide 7: Significant Unmet Needs Remain in Recurrent or Metastatic HNSCC

    Significant Unmet Needs Remain in Recurrent or Metastatic (R/M) HNSCC Pembrolizumab (KEYTRUDA®) Pembrolizumab Plus Chemo Chemotherapy + EGFR Inhibitor Objective Response Rate (ORR) 19% 36% 35% Progression Free Survival (PFS) 3.2 mos 5.0 mos 5.0 mos Median Overall Survival (OS) 12.3 mos 13.6 mos 10.3

  8. Slide 8: FDA Views Overall Survival as Primary Endpoint for Approval

    FDA Views Overall Survival (OS) as Primary Endpoint for Approval in R/M HNSCC KEYNOTE-04812 Pembrolizumab EGFR antibody (cetuximab) + chemotherapy LEAP-01014 Pembrolizumab Pembrolizumab + lenvatinib Combination Drug Candidates Have Not Resulted in Improved (OS) over Pembrolizumab ORR = Objective Res

  9. Slide 9: VERSATILE-002: Global Phase 2 Study Design

    VERSATILE-002: A Global Phase 2 Study of Versamune® HPV and Pembrolizumab in Subjects with HPV16-positive R/M 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 Naïve Subj

  10. Slide 10: VERSATILE-002: Most Patients Had Recurrent Disease and Prior Treatment

    VERSATILE-002: Most Patients Had Recurrent Disease and Prior Treatment Historical Responses Published data reports lower ORR, PFS and OS with pembrolizumab in patients with CPS 1-19 vs. CPS ≥ 2016 Published data reports lower responses in patients with recurrent disease No controlled or comparative

  11. Slide 11: Percent Change from Baseline in Target Lesions

    Percent Change from Baseline in Target Lesions -50 -25 25 50 75 100 0 -75 -100 -125 CPS Group 1-19 ≥20 CPS Group Response Complete Response (CR) 5/53 9.4% Partial Response (PR) 14/53 26.4% Stable Disease (SD) 22/53 41.5% Progressive Disease (PD) 9/53 17.0% Treatment Ongoing Confirmed Objective Respo

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

    Extended Disease Control in Majority of Patients15 Based on Investigator Assessment Per RECIST v1.1 Best Percentage Change from Baseline in Target Lesions Spider plot: Sustained CR, PR, and SD responses. Median Duration of Response is 21.8 months Percent Change from Baselinein Target Lesions Time of

  13. Slide 13: Median Overall Survival of 30 Months

    Survival Fraction 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 0.0 0.2 0.4 0.6 0.8 1.0 Censored ‒ Ongoing (N=27) Censored ‒ Discontinued (N=8) Discontinued: N=2 Lost to follow up; N=6 withdrawn consent; Ongoing: Patients ongoing and awaiting next clinical assessment Median Overall Survival of

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

    Versamune® HPV plus Pembrolizumab Appears to be well Tolerated17 Protocol stipulates 5 subcutaneous injections of Versamune® HPV: 4 injections over 2 months and a final injection after an additional 6 months *Grade 3 Combination-TRAE were: Fatigue (2), Rash, Alanine aminotransferase increased, Blood

  15. Slide 15: VERSATILE-002 Summary of Results

    VERSATILE-002 Summary of Results15 ESMO 2024* Published Results* VERSATILE-002 KEYNOTE-048 LEAP-010 CPS ≥ 1 CPS ≥ 20 CPS ≥ 1 CPS ≥ 20 CPS ≥ 1 Objective Response Rate (ORR) 36% 48% 19% 23% 25% Median Overall Survival (mOS) 30.0 months 30.0 months 12.3 months 14.9 months 17.9 months * Not a head-to-he

  16. Slide 16: Durable Anti-Tumor Immune Response Observed

    Durable Anti-Tumor Immune Response Observed Objective Response Rate (ORR) Patients with Tumor Shrinkage of 90-100% Patients with Complete Responses (CR) Disease Control Rate (DCR) Median Overall Survival May 2023 (N=34)15 26% 6% 3% 70% Not Estimable November 2023 (N=53)16 34% 21% 7.5% 77% 30 months

  17. Slide 17: Corroborating Biomarker/Clinical Support: IMMUNOCERV

    Corroborating Biomarker/Clinical Support for Versamune® HPV IMMUNOCERV Chemoradiotherapy + Versamune® HPV Published KEYNOTE-A18 Chemoradiotherapy + Pembrolizumab (KEYTRUDA®) 36-Month Survival Rate Number of Versamune® HPV doses 5 doses: 100% (N=8) ≥2 doses: 84.4% (N=17) 82.6% 36-Month Progression Fr

  18. Slide 18: Elimination of Micro-Metastatic Tumors by ctDNA Analysis

    Study in locally advanced cervical cancer patients treated with Versamune® HPV and chemoradiotherapy 91.7% clearance of ctDNA at Week 5 vs 53.1% clearance with CRT alone18 5/5 tested HPV16-positive patients had undetectable ctDNA at 3-4 months22 Undetectable ctDNA resulted in superior 2-year recurre

  19. Slide 19: Superior Survival and Response in HPV16-positive vs HPV16-negative Cancers

    Objective Response Rate (ORR) Progression Free Survival (PFS) N=8 N=8 N=6 N=6 Corroborating Biomarker/Clinical Support for Versamune® HPV Superior Survival and Response in HPV16-positive vs HPV16-negative R/M Cancers26 Study performed by National Cancer Institute

  20. Slide 20: VERSATILE-003 First Line R/M HNSCC Trial Design

    VERSATILE-003 First Line Recurrent/Metastatic HNSCC Trial Design Interim Analysis 1 Possible Early Approval Versamune® HPV + PDS01ADC + pembrolizumab Study Start Versamune® HPV + Pembrolizumab Pembrolizumab (KEYTRUDA®) Aligned with FDA on Study Design and Initiation in Q1 2025 Patient Recruitment Pa

  21. Slide 21: Late-Stage Head and Neck Cancer Program as Value Catalyst

    Late-Stage Head and Neck Cancer* Program as Value Catalyst Potential for Market Leadership Position High-Value Lead Program With Strong KOL support Growing Unmet Need Phase 3 HNSCC Trial Rapidly growing HPV16-positive indication 50%+ of HNSCC Unique cancer with atypical presentation and physiology N

  22. Slide 22: Thank You

    2 PDS Biotechnology Thank You ea NASDAQ: PDSB a [ite © 2025 PDS Biotechnology. All Rights Reserved

  23. Slide 23: References

    References Tabatabaeian H et al, Navigating therapeutic strategies: HPV classification in head and neck cancer, British Journal of Cancer. (2024) 131: 220-230 Wang H, et al (2019) The Double-Edged Sword—How Human Papillomaviruses Interact With Immunity in Head and Neck Cancer, (2019). Front. Immunol

  24. Slide 24: References (continued)

    References (continued) Weiss J et al. VERSATILE-002: Survival with First-Line Treatment with PDS0101 Therapeutic Vaccine and Pembrolizumab in HPV16-positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). Poster Presented: ESMO Congress 2024; September 13-17, 2024; Barcelona, Spa

PDS Biotechnology — Investor Presentation (February 2025) on 6ix