Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (June 2025)
23 slides from Pds Biotechnology's investor presentation, Jun 25, 2025
Slide 1: Addressing the Growing Incidence of HPV16-Related Cancers
Addressing the Growing Incidence of HPV16-Related Cancers NASDAQ: PDSB June 2025 Precision Designed Science For Immunotherapy
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 Potential for Market Leadership Position Addressing Critical Unmet Need Rapidly Growing Market Pivotal Trial in HPV16+ HNSCC HPV16-positive HNSCC* projected to be dominant type of HNSCC by 20302 with $4-6B market potential in US+EU Ph
Slide 4: Types of Head and Neck Cancer
Types of Head and Neck Cancer HPV16-positive >50% of all HNSCC in US according to HNSCC oncologist survey3 p16 positive p16-negative (HPV-negative) HPV16-positive tumors HNSCC (head and neck cancer) Non-HPV16 tumors HPV16-positive HNSCC Presents Unique and Growing Medical Problem
Slide 5: Incidence of HPV16-positive HNSCC Experiencing Rapid Growth
Incidence of HPV16-positive HNSCC Experiencing Rapid Growth2 HPV16 HPV18 HPV 31/33/45/52/58 HPV 35/39/51/56/59/68 HPV-negative Oropharyngeal Cancer
Slide 6: HPV-positive and HPV-negative HNSCC: Two Distinct Diseases
HPV-negative HPV-positive (p16 gene positive) non-HPV16 HPV16 Underlying causes & associations with HNSCC4 Alcohol and/or tobacco Sexually transmitted Disease onset/progression4 Alterations in tumor suppressor genes e.g. TP53 Integration of HPV into the host genome Integration of HPV16 into the host
Slide 7: Mechanism of Action: HPV16 Targeted T Cell Stimulating Immunotherapy
Versamune® HPV Addressing HPV16-positive 1L R/M HNSCC Phase 3 Development Other Phase 3 Trials In Progress PDS Biotech (Versamune® HPV) Therapeutic Approach Blocking antibodies targeting EGFR and a second receptor HPV16 targeted T cell immunotherapy Treated Population Predominantly HPV-negative (No
Slide 8: Versamune HPV: HPV16-Targeted Immunotherapy
Versamune® HPV: HPV16-Targeted Immunotherapy Versamune® (Proprietary) Immunologically active R-enantiomer of 1,2-dioleoyl-trimethyl-ammonium (R-DOTAP) R-DOTAP, a positively charged lipid spontaneously forms virus-like nanoparticles R-DOTAP upregulates Type I Interferon signaling Upregulates critical
Slide 9: Right Type & Quantity of HPV16-Specific Killer and Memory T Cells
Right Type & Quantity of Powerful HPV16-Specific Killer and “Memory” T Cells6-9 Successful Specific Activation of the “Right” Immunological Pathway Lymph Node Tumor CD4+helper T cell CD8+killer T cell HPV16 E6 & E7 Versamune®Activated CD8+Killer T Cell ImmuneCheckpointInhibitor Versamune® +HPVmix Ta
Slide 10: Significant Unmet Needs Remain in 1L R/M HNSCC
Significant Unmet Needs Remain in 1L 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 mos Treatment Related
Slide 11: VERSATILE-002: 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 Partner StudyDesign Single-arm study 31 sites in US and EU 2 Cohorts: ICI Naïve ICI Resistant Enrollment complete Key Entry Criteria for ICI Naïve Subjects R/M HNSCC ≥18 years of age H
Slide 12: VERSATILE-002: Most Patients Historical Low Responders to Pembrolizumab
VERSATILE-002: Most Patients Historical Low Responders to Pembrolizumab Historical Responses Published data reports lower ORR, PFS and OS with pembrolizumab in patients with CPS 1-19 vs. CPS ≥ 201 Published data reports lower responses in patients with recurrent disease Key Demographics & Treatment
Slide 13: Phase 2 Response and Survival Data
Confirmed Objective Response Rate (ORR) Based on Investigator Assessment Per RECIST v1.1 Overall survival plotted by standard Kaplan-Meier methodology. At the time of the data cut, 22 subjects were alive and still being followed for survival, 10 subjects discontinued the study (7 withdrew consent, 2
Slide 14: VERSATILE-002 Summary of Results Stratified by CPS Status
Median OS is 30 Months; Best Reported with Pembrolizumab is 17.9 Months11 VERSATILE-002 Summary of Results Stratified by CPS Status10 No controlled or comparative studies have been conducted between checkpoint inhibitors and Versamune® HPV. Versamune® HPV (PDS0101) + Pembrolizumab (VERSATILE-002) CP
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%) Grade 3 Combination TRAEs were: Fatigue (2), Colitis (2), Rash, Diarrhea, Alanine aminotransferase increased, Blood alkaline phosphatase increased, Lymphocyte count de
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 KEYNOTE-0481 Pembrolizumab EGFR antibody (cetuximab) + chemotherapy LEAP-0109 Pembrolizumab Pembrolizumab + lenvatinib FDA Views OS as Necessary Primary Endpoint for Approval in R/M HNSCC ORR = Objective Response Rate; PFS = Progression Free
Slide 17: VERSATILE-003 Pivotal Trial in Progress
VERSATILE-003 Pivotal Trial in Progress Interim Analysis 1 Trial Start Patient Recruitment Survival Follow-up Interim Analysis 2 Secondary Endpoints Objective Response Rate (ORR) Disease Control Rate (DCR) Duration of Response (DoR) Progression Free Survival (PFS) Assessed by RECIST v1.1 and BICR Pr
Slide 18: Broad and Extensive PDS Biotech Owned Patent Portfolio
Broad and Extensive PDS Biotech Owned Patent Portfolio Selected Pertinent Intellectual Property Versamune® Platform (PCT/US2018/064060) Method of Activating Type I IFN Signaling Expires not before Dec. 2038 Confidential Versamune® HPV (PCT/US2017/055119) Composition patent – HPV16+ Cancers Expires n
Slide 19: Broad Applicability in HPV16-positive Cancers with $8-10B Potential
Broad Applicability in HPV16-positive Cancers with $8-10B Potential Versamune® HPV Commercialization Approach 1L R/M HNSCC Versamune® + Pembrolizumab Confidential No controlled or comparative studies have been conducted between checkpoint inhibitors and Versamune® HPV. Locally Advanced Cervical Canc
Slide 20: Pipeline
Pipeline Versamune® HPV + pembrolizumab vs. pembrolizumab Versamune® HPV + pembrolizumab Versamune® Versamune® HPV + chemo, (IMMUNOCERV) Versamune® HPV +/- pembrolizumab Versamune® HPV + PDSOTADC + 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 Potential for Market Leadership Position Addressing Critical Unmet Need Rapidly Growing Market Pivotal Trial in HPV16+ HNSCC HPV16-positive HNSCC* projected to be dominant type of HNSCC by 20302 with $4-6B market potential in US+EU Ph
Slide 22: PDS Biotechnology
2 PDS Biotechnology References © 2025 PDS Biotechnology. All Rights Reserved
Slide 23: References
References 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. Damgacioglu H,
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