PDS Biotechnology Corporation · NASDAQ:PDSB

PDS Biotechnology — Investor Presentation (May 2024)

31 slides from PDS Biotechnology's investor presentation, May 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 May 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 7934, as amended, and Section 27A of the United States Securities Act of 7933, 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 Pivotal trial planned for PDS01ADC + Versamune® HPV (PDS0101) + pembrolizumab in first line recurrent/metastatic head and neck cancer in 2024 PDS01ADC + Versamune® disrupts tumor’s inside defenses, and generates potent

  4. Slide 4: Why Immunotherapies Fail in Solid Tumors

    Why Immunotherapies Fail in Solid Tumors Two Critical Limitations Remain Immune-Desert Tumors: TME Prevents Lack T cells because T cells don’t get activated or recognize the cancer Immunogenicity Immune-Excluded Tumors: Contain immune suppressive cytokines and inhibitory factors that prevent T cell

  5. Slide 5: Proprietary Dual Platform Enables Inside-Outside Attack on Tumor

    Proprietary Dual Platform Enables Inside-Outside Attack on Tumor Potential to Overcome Suppression of the T Cell Response by the Tumor NHS76 (Tumor Necrosis Targeting Ab – Binds to exposed DNA) PDS01ADC Inside De-immunized Infiltrates TME to Suppress the Tumor’s Most clinically advanced Junction Def

  6. Slide 6: VERSATILE-002 Phase 2 Clinical Trial (Multi-Site US/EU Trial)

    VERSATILE-002 Phase 2 Clinical Trial (Multi-Site US/EU Trial) Objective: To Assess the Combination of Versamune® HPV and KEYTRUDA® in Subjects with Recurrent or Metastatic HPV16-positive HNSCC FDA-Approved Study Key Entry Study Partner Criteria for ICI Endpoints Standard of Care Treatment Design Naï

  7. Slide 7: VERSATILE-002 First Line R/M HNSCC Key Demographics and Treatment Exposure

    VERSATILE-002 First Line R/M HNSCC Key Demographics and Treatment Exposure Demographic ITT Population (N=55) Treatment Exposure (ITT Population) Age, Median (Min, Max) 64.0 (46, 83) Sex, n (%) • Median number of PDS0101 Male 51 (92.7) doses: 4 (range 1–5) Female 4 (7.3) • 76.4% received ≥4 doses Rac

  8. Slide 8: Summary of VERSATILE-002 Results

    Summary of VERSATILE-002 Results First Line Recurrent/Metastatic HNSCC VERSATILE-002 KEYNOTE-048 (Versamune® HPV + KEYTRUDA®) (KEYTRUDA®) CPS≥1 CPS≥20 CPS≥1 CPS≥20 Confirmed BOR (%) 34 48 19 23 Median PFS (months) 6.3 14.1 3.2 3.4 Median Overall Survival 30.0 30.0 12.3 14.9 (months)* (Future Pivotal

  9. Slide 9: Median Overall Survival of 30 Months in mITT and ITT Populations

    Median Overall Survival of 30 Months in mITT and ITT Populations Kaplan-Meier Estimates of OS in Recurrent/Metastatic HNSCC 1.0 0.9 Censored, Discontinued(N=8)* Censored, Ongoing (N=29)** 0.8 0.7 Survival Fraction 0.6 0.5 0.4 0.3 0.2 0.1 N Events Median(Months) 95% CI(Months) 53 16 30.0 (18.4, NE) 0

  10. Slide 10: Versamune HPV and KEYTRUDA Combination Demonstrates Promising Survival In First Line R/M HNSCC

    Versamune® HPV and KEYTRUDA® Combination Demonstrates Promising Survival In First Line R/M HNSCC Keytruda® Chemotherapy + Keytruda® Versamune® HPV + Keytruda® 12-month OS Rate Median Overall Survival (mOS) VERSATILE-002 KEYNOTE-048 VERSATILE-002 OS Rate (%) (CPS≥1) 80% 30 Months KEYNOTE-048 55% (CPS

  11. Slide 11: Durable Responses Reported with 75.5% of Patients with CPS ≥1 Having CR, PR or SD

    Durable Responses Reported with 75.5% of Patients with CPS ≥1 Having CR, PR or SD According to RECIST 1.1 Spider Plot Showing Disease State with Time in Recurrent/Metastatic HNSCC 11 Data on File: Data represents a 15Feb2024 extraction of all cleaned and Q/C’d data through 30Nov2023

  12. Slide 12: Disease Stabilization or Tumor Reduction Reported in 87% of First Line R/M HNSCC Patients

    Disease Stabilization or Tumor Reduction Reported in 87% (46/53) of First Line Recurrent/Metastatic HNSCC Patients Best Percentage Change from Baseline in Target Lesions (mITT population*) 100 90 80 70 60 50 Change from Baseline (%) 40 30 20 10 0 -10 -20 -30 -40 -50 -60 -70 -80 -90 -100 * Modified I

  13. Slide 13: Versamune HPV and KEYTRUDA Combination Well Tolerated in First Line R/M

    Versamune® HPV and KEYTRUDA® Combination Well Tolerated in First Line R/M with No Grade 5 TRAE* Injection Site Related TRAEs n (%) All Other TRAEs n (%) Injection site pain 37 (59.7) Fatigue 23 (37.1) Headache 12 (19.4) Injection site swelling 19 (30.6) Pruritis 9 (14.5) Injection site erythema 13 (

  14. Slide 14: VERSATILE-002 Conclusions

    VERSATILE-002 Conclusions • VERSATILE-002 has successfully met its primary end point of 14 or more confirmed objective responses by RECIST v1.1 in ICI naïve patients with CPS ≥1 • BOR by Investigator Assessment: 34% (CPS ≥1) and 48% (CPS ≥20) • Versamune® HPV may significantly impact survival in fir

  15. Slide 15: PDS01ADC and Versamune Have Broad Therapeutic Potential

    PDS01ADC and Versamune® Have Broad Therapeutic Potential Synergistic Effect With SoC Modalities Across a Spectrum of Solid Tumors PDS01ADC VERSAMUNE® Designed to deliver and sustain IL-12 in tumor Designed to train T cells to recognize the cancer Fused conjugate limits systemic presence and Activate

  16. Slide 16: PDS01ADC + Versamune + ICI: Unique Combined Mechanism

    PDS01ADC + Versamune® + ICI: Unique Combined Mechanism Mechanism Attacks the Tumor from Both the Inside (TME) and Outside Versamune® Activated Targeting CD8+ Killer T-Cell Inside PDS01ADC Infiltrates TME; Weakens Tumor’s Protection from Immune System Stimulates T Cells in TME to Promote Expansion +

  17. Slide 17: Triple Combination Investigator-Initiated Trial: Phase 2 Clinical Trial

    Triple Combination Investigator-Initiated Trial: Phase 2 Clinical Trial Objective: To Assess the Triple Combination of Versamune® HPV plus PDS01ADC plus the Bi-functional Immune Checkpoint Inhibitor Bintrafusp alfa in Subjects with Recurrent or Metastatic HPV-positive Cancer Study Key Entry Study II

  18. Slide 18: Triple Combination Key Demographics and Treatment Exposure

    Triple Combination Key Demographics and Treatment Exposure Demographic ITT Population (N=50) Age, Median (Min, Max) 56.0 (28, 80) Sex, n (%) Male 26 (52%) Female 24 (48%) Tumor Type, n (%) Anal 10 (20%) Cervical 14 (28%) Head and Neck 23 (46%) Vaginal/Vulvar 3 (6%) Prior Treatments, n (%) Chemothera

  19. Slide 19: First Line R/M HPV16+ HNSCC: Versamune HPV and PDS01ADC Promoted Strong Survival Benefit

    First Line Recurrent/Metastatic HPV16+ HNSCC: Versamune® HPV and PDS01ADC Promoted Strong Survival Benefit Survival of Patients with Recurrent/Metastatic HPV16+ Cancers 45 42.3** 40 35 30.0 30 HNSCC Months 25 20 17.9* 15 12.3* HNSCC 10 HNSCC 5 0 KEYNOTE-048 (pembrolizumub) LEAP-010 (pembrolizumab) V

  20. Slide 20: First Line R/M HPV16+ Cancer: Versamune HPV and PDS01ADC Promoted Objective Responses

    First Line Recurrent/Metastatic HPV16+ Cancer: Versamune® HPV and PDS01ADC Promoted Objective Responses Best Objective Response (BOR) 75%** 80 (6/8) 70 60 50 34% 40 (18/53) 30 11-25%* HNSCC 20 10 0 Pembrolizumab Versamune® HPV+pembrolizumab Versamune® HPV+PDS01ADC+ICI *Pembrolizumab reported ORR ran

  21. Slide 21: Phase 2 Triple Combination Results Indicate Favorable Tolerability

    Phase 2 Triple Combination 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 (

  22. Slide 22: Triple Combination Conclusions

    Triple Combination Conclusions • Triple Combination has successfully met its primary endpoint of at least a 60% confirmed objective response rate by RECIST v1.1 • BOR = 63% (RECIST v1.1) • BOR = 75% (iRECIST) • Versamune® HPV + PDS01ADC + ICI may significantly impact survival in first line and secon

  23. Slide 23: Compelling Survival Data Supports Triple Combination Pivotal Study

    Compelling Survival Data Supports Triple Combination Pivotal Study Supported by strong results in difficult-to-treat resistant patients with Triple Study FIRST LINE R/M SECOND LINE R/M VERSATILE-002 NCI Triple Study* NCI Triple Study** (NCT04260126) (NCT04287868) (NCT04287868) HPV16+ HNSCC Advanced

  24. Slide 24: Lead Program Supported and Validated by Robust Clinical Data

    Lead Program Supported and Validated by Robust Clinical Data More Than 430 Patients Treated with PDS01ADC and/or Versamune® HPV HNSCC PDS01ADC + Versamune® HPV + Bintrafusp alfa (triple) and Versamune® HPV Patient Exposure Across Product Portfolio + pembrolizumab (double) administered to 110+ head &

  25. Slide 25: In Interviews, Oncologists Preferred use of Triple Combination in First Line R/M HNSCC

    In Interviews, Oncologists Preferred use of Triple Combination in First Line Recurrent/ Metastatic HNSCC On a scale of 1-7, the triple combination was rated 6.3 by oncologists for use in first line R/M HNSCC Not at All 6.3 Very Favorable 1 2 3 4 5 6 7 Favorable Perceived Concerns Perceived Benefits

  26. Slide 26: Study Design – First Line Recurrent/Metastatic (VERSATILE-003 Plus)

    Study Design – First Line Recurrent/Metastatic (VERSATILE-003 Plus) Median Overall Survival (OS) endpoint and Study Size Designed for Potential Success in both Treatment Arms* PDS01ADC dose Interim selection Analysis Versamune® HPV + 16.8 mcg/kg PDS01ADC + Added triple combo arm to pembrolizumab 12

  27. Slide 27: HNSCC: Devastating Cancers with High Prevalence and Mortality

    HNSCC: Devastating Cancers with High Prevalence and Mortality Increasing Incidence Driven Largely by HPV16+ Oral and Pharyngeal Genotype of HPV-Positive Oral and Cancers (~40% of HNSCC) Pharyngeal Cancer Paranasal sinuses 15% Other HPV Nasal Nasopharynx Cavity Oral Cavity Oropharynx HPV- HPV+ Tongue

  28. Slide 28: 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 Est. HPV16 Genotype ~18,200 No approved HPV-specific cancer therapy ~$2-3B Market ~13,600 Significant unmet n

  29. Slide 29: 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 PDS01ADC + Versamune® HPV + ICI HNSCC PDS01ADC + Versamune® PDS01ADC + Versamune® MUC1 + ICI Recurrent or metastatic colorectal cancer (Phase 1/

  30. Slide 30: 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, PhD Lars Boesgaard Kirk Shepard, M.D. Gregory Conn, PhD Stephan Toutain Chief Executive Officer Chief Financial Officer Chief Medical Officer Chief Sci

  31. Slide 31: Thank You

    Thank You NASDAQ: PDSB 31 © 2024 PDS Biotechnology. All Rights Reserved.

PDS Biotechnology — Investor Presentation (May 2024) on 6ix