Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (June 2025)
23 slides from Pds Biotechnology's investor presentation, June 2025
Slide 1: Addressing the Growing Incidence of HPV16-Related Cancers
Addressing the Growing Incidence of HPV16-Related Cancers Precision Designed Science For Immunotherapy NASDAQ: PDSB June 2025 1 © 2025 PDS Biotechnology. All Rights Reserved.
Slide 2: Forward-Looking Statements
Forward-Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E 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
Slide 3: Targeting HPV16-positive Head and Neck Cancer with Versamune HPV
Targeting HPV16-positive Head and Neck Cancer with Versamune® HPV Addressing Growing Market with Compelling Clinical Results Addressing Critical • Phase 2 results indicating 30 months survival in 1L recurrent/metastatic Unmet Need (R/M) HNSCC. Approx. 12 months published for current standard of care
Slide 4: Types of Head and Neck Cancer
Types of Head and Neck Cancer HPV16-positive HNSCC Presents Unique and Growing Medical Problem HNSCC (head and neck cancer) Non-HPV16 tumors p16 positive HPV16-positive p16-negative >50% of all HNSCC in (HPV-negative) US according to HNSCC HPV16-positive oncologist survey3 tumors 4
Slide 5: Incidence of HPV16-positive HNSCC Experiencing Rapid Growth
Incidence of HPV16-positive HNSCC Experiencing Rapid Growth2 30,000 HPV16 HPV18 HPV 31/33/45/52/58 HPV 35/39/51/56/59/68 HPV-negative 25,000 Annual Number of OPS Cases 20,000 15,000 HPV16 PDS Biotech focus 10,000 5,000 0 2010 2020 2030 2040 2050 2060 2070 2080 2090 2100 Year 5 Oropharyngeal Cancer
Slide 6: HPV-positive and HPV-negative HNSCC: Two Distinct Diseases
HPV-positive and HPV-negative HNSCC: Two Distinct Diseases HPV-positive (p16 gene positive) HPV-negative non-HPV16 HPV16 Underlying causes & associations with HNSCC4 Alcohol and/or tobacco Sexually transmitted Disease onset/progression4 Alterations in tumor suppressor Integration of HPV into the Int
Slide 7: Versamune HPV Addressing HPV16-positive 1L R/M HNSCC
Versamune® HPV Addressing HPV16-positive 1L R/M HNSCC Mechanism of Action: HPV16 Targeted T Cell Stimulating Immunotherapy Phase 3 Other Phase 3 Trials PDS Biotech Development In Progress (Versamune® HPV) Therapeutic Approach Blocking antibodies targeting EGFR and a HPV16 targeted T cell immunothera
Slide 8: Versamune HPV: HPV16-Targeted Immunotherapy
Versamune® HPV: HPV16-Targeted Immunotherapy Novel Investigational Approach to Generating Powerful and Targeted Anti-Tumor Immune Responses6 Versamune® (Proprietary) • Immunologically active R-enantiomer of 1,2-dioleoyl-trimethyl-ammonium (R-DOTAP) • R-DOTAP, a positively charged lipid spontaneously
Slide 9: Successful Specific Activation of the Right Immunological Pathway
Successful Specific Activation of the “Right” Immunological Pathway Right Type & Quantity of Powerful HPV16-Specific Killer and “Memory” T Cells6-9 Lymph Node Tumor Dendritic Cell Versamune® + HPV16 E6 & E7 Immune HPVmix Checkpoint Inhibitor MHC class I CD8+ killer T cell Targeted CD8+ T Cells Track
Slide 10: Significant Unmet Needs Remain in 1L R/M HNSCC
Significant Unmet Needs Remain in 1L R/M HNSCC Limitations of Current Therapies: Approx. 12 months Survival (Published1) Pembrolizumab Pembrolizumab Plus Chemotherapy (Keytruda®) Chemo + EGFR Inhibitor Objective Response 19% 36% 35% Rate (ORR) Progression Free 3.2 mos 5.0 mos 5.0 mos Survival (PFS)
Slide 11: 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 R/M HNSCC Study Evaluating Effects of Versamune® HPV Attributes on Clinical Responses Key Entry Study Criteria for ICI Study Endpoints Partner Treatment Design Naïve Subjects Versamune® HPV R/M
Slide 12: VERSATILE-002: Most Patients Historical Low Responders to Pembrolizumab
VERSATILE-002: Most Patients Historical Low Responders to Pembrolizumab Key Demographics & Treatment Exposure: 60% with CPS < 20, 81% with Prior Treatment10 Demographic/Baseline Characteristic Efficacy Population (N=53) Historical Responses Age, Median (Min, Max) 64.0 (46, 83) Sex, n (%) Male 49 (92
Slide 13: Phase 2 Response and Survival Data
Phase 2 Response and Survival Data Median Overall Survival 30 months; Confirmed Disease Control Rate 77.4%10 Percent Change from Baseline in Target Lesions 100 Best Percentage Change from Baseline in Target Lesions (mITT population) Kaplan-Meier Estimates of Overall Survival Censored 75 1.0 50 0.8 S
Slide 14: VERSATILE-002 Summary of Results Stratified by CPS Status
VERSATILE-002 Summary of Results Stratified by CPS Status10 Median OS is 30 Months; Best Reported with Pembrolizumab is 17.9 Months11 Versamune® HPV (PDS0101) + Pembrolizumab (VERSATILE-002) CPS ≥ 1 CPS ≥ 20 CPS 1-19 N=53 (100%) N=21/53 (40%) N=32/53 (60%) 30.0 months Median Overall Survival 39.3 mo
Slide 15: Versamune HPV plus Pembrolizumab was well Tolerated
Versamune® HPV plus Pembrolizumab was well Tolerated10 Versamune® HPV or Pembrolizumab Treatment-Related Adverse Events (TRAE) (≥5%) Safety Population Safety Population Preferred Term Preferred Term (N=62) (N=62) Any PDS0101 or Pembrolizumab TRAE, n Any Injection Site Reaction 46 (74.2) 55 (88.7) (%
Slide 16: ORR and PFS in R/M HNSCC have not Resulted in Improved OS
ORR and PFS in R/M HNSCC have not Resulted in Improved OS FDA Views OS as Necessary Primary Endpoint for Approval in R/M HNSCC KEYNOTE-0481 40% 35% 6.0 5.1 15.0 12.3 5.0 10.4 Pembrolizumab 30% Months 4.0 3.2 10.0 Months 19% EGFR antibody 20% 3.0 (cetuximab) + 2.0 5.0 chemotherapy 10% 1.0 0% 0.0 0.0
Slide 17: VERSATILE-003 Pivotal Trial in Progress
VERSATILE-003 Pivotal Trial in Progress Key Inclusion Criteria Stratification Pembrolizumab 200mg IV Q3W Confirmed R/M HNSCC PD-L1 CPS 1-19 Measurable disease vs ≥20 + Progressive Disease HPV16-positive Randomization PDS0101 1ml SC, Cycles 1-4, 12 or Completion of Long-Term Survival ECOG 0
Slide 18: Selected Pertinent Intellectual Property
Selected Pertinent Intellectual Property Broad and Extensive PDS Biotech Owned Patent Portfolio Versamune® Platform (PCT/US2018/064060) Versamune® TARP (PCT/US2023/035325) Method of Activating Type I IFN Signaling Composition patent – Breast, Prostate Cancers Expires not before Dec. 2038 Expires not
Slide 19: Versamune HPV Commercialization Approach
Versamune® HPV Commercialization Approach Broad Applicability in HPV16-positive Cancers with $8-10B Potential Phase 2 Trials with Promising Prioritized Phase 3 Trial to FDA Potential Follow-on Phase 3 Survival Results Across Approval Trials Multiple Indications (In Progress) ~30,000 new cases per ye
Slide 20: Pipeline
Pipeline Versamune® HPV + pembrolizumab vs. pembrolizumab Versamune® HPV + pembrolizumab Versamune® Versamune® HPV + chemo (IMMUNOCERV) Versamune® HPV +/- pembrolizumab Versamune® HPV + PDSO1ADC + immune checkpoint inhibitor (ICI) Versamune® MUC1 + PDSO1ADC + ICI (IND filed Q1-2025) Versamune® + PDS
Slide 21: Targeting HPV16-positive Head and Neck Cancer with Versamune HPV
Targeting HPV16-positive Head and Neck Cancer with Versamune® HPV Addressing Growing Market with Compelling Clinical Results Addressing Critical • Phase 2 results indicating 30 months survival in 1L recurrent/metastatic Unmet Need (R/M) HNSCC. Approx. 12 months published for current standard of care
Slide 22: References
References 22 © 2025 PDS Biotechnology. All Rights Reserved.
Slide 23: References
References 1. Burtness B, Harrington KJ, Greil R, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomized, open-label, phase 3 study. Lancet. 2019;394:1915-28. 2. Damgaciog
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