PDS Biotechnology Corporation · NASDAQ:PDSB
PDS Biotechnology — Investor Presentation (March 2024)
17 slides from PDS Biotechnology's investor presentation, March 2024
Slide 1: Transforming How the Immune System Targets and Fights Cancer
Transforming How the Immune System Targets and Fights Cancer Precision Designed Science For Immunotherapy NASDAQ: PDSB March 2024 © 2024 PDS Biotechnology. All Rights Reserved. 1
Slide 2: Forward-Looking Statement
Forward-Looking Statement This communication contains forward-looking statements (including within the meaning of Section 27E of the United States Securities Exchange Act of 7934, as amended, and Section 27A of the United States Securities Act of 7933, as amended) concerning PDS Biotechnology Corpor
Slide 3: Late-Stage Head and Neck Cancer Program as Value Catalyst
Late-Stage Head and Neck Cancer Program as Value Catalyst • Pivotal trial planned for PDS01ADC + Versamune® HPV (PDS0101) High-Value Lead Program + KEYTRUDA® in head and neck cancer • PDS01ADC + Versamune® disrupts tumor’s inside defenses, and Novel Investigational “Inside- generates potent, targete
Slide 4: Strategy Addresses Why Immunotherapies Fail in Solid Tumors
Strategy Addresses Why Immunotherapies Fail in Solid Tumors Two Critical Limitations Remain TME Prevents Immunogenicity 1. Inadequate T Cell Response Immune-Desert Tumors: Lack T cells Inability to generate the right type and because T cells don’t get activated or quantity of effective tumor-inf
Slide 5: Combination Platform Enables Inside-Outside Attack to Address Limits
Combination Platform Enables Inside-Outside Attack to Address Limits Immuno-cytokine IL-12 Fused Antibody Drug Conjugate NHS76 (Tumor Necrosis Targeting Ab – Binds to exposed DNA) Inside PDS01ADC De-immunized Junction Infiltrates TME to Suppress the First immuno- Tumor’s Defenses & Promotes T cytoki
Slide 6: PDS01ADC + Versamune + ICI: Unique Combined Mechanism
PDS01ADC + Versamune® + ICI: Unique Combined Mechanism Mechanism Attacks the Tumor from Both the Inside (TME) and Outside of the Tumor Versamune® Activated HPV+ Targeting CD8+ Killer T-Cell 2 Inside Outside 3 1 2 PDS01ADC 1 Versamune® Infiltrates TME; Oxygenated Induces Right Necrotic Core Weakens T
Slide 7: PDS01ADC and Versamune Have Broad Therapeutic Potential
PDS01ADC and Versamune® Have Broad Therapeutic Potential Synergistic Effect With SoC Modalities Across a Spectrum of Tumors PDS01ADC Versamune® Designed to deliver and sustain IL-12 in tumor Designed to train T cells to recognize the cancer Conjugate limits systemic toxicity of IL-12 Activates the r
Slide 8: Patients Had Sustained Tumor Shrinkage, Objective Response Rate
Patients Had Sustained Tumor Shrinkage, Objective Response Rate % of Patients with Sustained Tumor Shrinkage of ≥30% ICI Naïve Cancer ICI Resistant Cancer 75%* Optimal Dose PDS01ADC 63% 36% 19% 17% 10% KEYTRUDA® KEYTRUDA® + PDS01ADC + PDL1-tgf beta Cetuximab PDS01ADC + Chemo Versamune® HPV + Versamu
Slide 9: Triple Combination Has Shown Compelling Survival Data
Triple Combination Has Shown Compelling Survival Data Proof-of-Concept in ICI-resistant Cancer Validates MOA and Preclinical Results One-Year Survival Median Overall Survival 72% 20.0 Months 8.4 30% Months 17% 3.4 Months No Salvage EFGR Inhibitor +/- PDS01ADC + ICI EFGR Inhibitor +/- PDS01ADC + Chem
Slide 10: Compelling Long-Term Survival of ICI Naïve Advanced HNSCC Cancer
Compelling Long-Term Survival of ICI Naïve Advanced HNSCC Cancer Patients (Double & Triple Combinations) PDS01ADC and Versamune® HPV May Significantly Promote Patient Survival 12, 24 & 36 Month Survival Rates 100 100 90 90 80 (Anal, cervical, HNSCC, Vaginal, Vulvar Patients) 80 Survival Rates (%) PD
Slide 11: Proof-of-Concept Results Indicate Favorable Tolerability
Proof-of-Concept Results Indicate Favorable Tolerability 48% Had Grade 3 TRAEs, 4% Grade 4 Grade 3/4 Adverse Events (AE) Grade 3/4 Adverse Events (cont.) Preferred Term n (%) Preferred Term n (%) Myocarditis 1 (2) Leukopenia 1 (2) Anemia 15 (30) Neutropenia 1 (2)** HLH* 1 (2) Hematuria 5 (10) Flu-li
Slide 12: Program Is Supported and Validated by Robust Clinical Data
Program Is Supported and Validated by Robust Clinical Data Experience in More Than 430 Patients PDS01ADC + Versamune® HPV + Bintrafusp alfa (triple) and HNSCC Patient Exposure Versamune® HPV + KEYTRUDA® (double) administered to 110+ Across Product Portfolio head & neck cancer patients to date PDS01A
Slide 13: HNSCC: Devastating Cancers with High Prevalence and Mortality
HNSCC: Devastating Cancers with High Prevalence and Mortality Increasing Incidence Driven Largely by HPV16+ Genotype of *HPV- Oral and Pharyngeal Positive Oral and Cancers (~40% of HNSCC) Pharyngeal Cancer Paranasal sinuses 15% Other HPV Nasal Nasopharynx Cavity Oral Cavity HPV- HPV+ Oropharynx Tong
Slide 14: HPV16-positive HNSCC Presents Significant Initial Market Opportunity
HPV16-positive HNSCC Presents Significant Initial Market Opportunity Epidemiology-Based Estimate of Addressable Population: HNSCC Est. U.S. HNSCC ~53,305 Est. U.S. HPV Positive HNSCC ~22,000 No approved HPV-specific Est. HPV16 Genotype ~18,200 cancer therapy Significant unmet need ~13,600 Est. HPV16
Slide 15: Pipeline Continues to Validate Platforms, Drive Future Opportunities
Pipeline Continues to Validate Platforms, Drive Future Opportunities Candidate/ Study Indication PC P1 P2 P3 Partner PDS01ADC + Versamune® HPV + ICI Recurrent or metastatic HPV16-positive HNSCC PDS01ADC + Versamune® PDS01ADC + Versamune® MUC1 + ICI Recurrent or metastatic colorectal cancer (Phase 1/
Slide 16: Veteran New Leadership to Execute Strategy
Veteran New Leadership to Execute Strategy Record of Execution in Development, Commercialization of Leading Pharmaceutical Products Frank Bedu-Addo, Gregory Lars Boesgaard Kirk Shepard, M.D. PhD Conn, PhD Chief Financial Officer Chief Medical Officer Chief Executive Officer Chief Scientific Officer
Slide 17: Thank You
Thank You ally NASDAQ: PDSB
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