Pds Biotechnology Corporation · NASDAQ:PDSB

Pds Biotechnology — Investor Presentation (May 2024)

31 slides from Pds Biotechnology's investor presentation, May 8, 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 © 2024 PDS Biotechnology. All Rights Reserved. NASDAQ: PDSB May 2024 Precision Designed Science For Immunotherapy

  2. 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

  3. Slide 3: Late-Stage Head and Neck Cancer Program as Value Catalyst

    Late-Stage Head and Neck Cancer Program as Value Catalyst 1. Company’s 10-K for year ended 12/31/2023 includes going concern opinion. Cash runway estimate based on currently available cash resources and cash flow projections and assumes no initiation of pivotal trial and Company debt not being calle

  4. Slide 4: Two Critical Limitations Remain

    Two Critical Limitations Remain References: Darvin et al. Experimental & Molecular Medicine (2018) 50:165. Chen, D. S. & Mellman, I. Nature 541, 321 (2017). Why Immunotherapies Fail in Solid Tumors Immune-Desert Tumors: Lack T cells because T cells don’t get activated or recognize the cancer Immune-

  5. Slide 5: Potential to Overcome Suppression of the T Cell Response by the Tumor

    Potential to Overcome Suppression of the T Cell Response by the Tumor TME = Tumor Microenvironment Proprietary Dual Platform Enables Inside-Outside Attack on Tumor NHS76 (Tumor Necrosis Targeting Ab – Binds to exposed DNA) De-immunized Junction IL-12 (p40 clipping-resistant) IL-12 (p40 clipping-resi

  6. Slide 6: VERSATILE-002 Phase 2 Clinical 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 KEYTRUDA®(pembrolizumab) FDA-Approved Standard of Care Partner StudyDesign Open-label, non-randomized, adap

  7. Slide 7: VERSATILE-002 Key Demographics and Treatment Exposure

    VERSATILE-002 First Line R/M HNSCCKey Demographics and Treatment Exposure Demographic ITT Population (N=55) Age, Median (Min, Max) 64.0 (46, 83) Sex, n (%) Male Female 51 (92.7) 4 (7.3) Race, n (%) American Indian or Alaska Native Asian Black or African American Pacific Islander White Other 0 1 (1.8

  8. Slide 8: Summary of VERSATILE-002 Results

    Summary of VERSATILE-002 Results First Line Recurrent/Metastatic HNSCC VERSATILE-002 (Versamune® HPV + KEYTRUDA®) KEYNOTE-048 (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 (months)* (Future Pivotal Trial Endpoint) 30.

  9. Slide 9: Median Overall Survival 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 Data on File. 02/15/24 Data Cut Patients without a progression event or lost to follow up (N=2) at data cut off date – censor date is last date of tumor assessment

  10. Slide 10: Versamune HPV and KEYTRUDA Combination Demonstrates Promising Survival

    Versamune® HPV and KEYTRUDA® Combination Demonstrates Promising Survival In First Line R/M HNSCC * No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101Data on File. 02/15/24 Data CutBurtness B et al., Lancet. 2019; 394:1915-1928 OS Rate (%) VERSATILE-002

  11. Slide 11: Durable Responses Reported in Patients with CPS ≥1

    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 Data on File. 02/15/24 Data Cut

  12. Slide 12: Disease Stabilization or Tumor Reduction Reported in 87%

    Disease Stabilization or Tumor Reduction Reported in 87% (46/53) of First Line Recurrent/Metastatic HNSCC Patients * Modified Intent-to-Treat: All ITT subjects who had at least 1 imaging assessment Best Percentage Change from Baseline in Target Lesions (mITT population*) Data on File. 02/15/24 Data

  13. Slide 13: 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 (%) Injection site pain 37 (59.7) Injection site swelling 19 (30.6) Injection site erythema 13 (21.0) Injection site warmth 11 (17.7) Injection site discoloration 9 (14.5) I

  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 first lin

  15. Slide 15: Synergistic Effect With SoC Modalities Across Solid Tumors

    Synergistic Effect With SoC Modalities Across a Spectrum of Solid Tumors PDS01ADC and Versamune® Have Broad Therapeutic Potential PDS01ADC VERSAMUNE® Designed to deliver and sustain IL-12 in tumor Fused conjugate limits systemic presence and toxicity of IL-12 and also prevents free IL-12 Activates/e

  16. Slide 16: Mechanism Attacks the Tumor from Both Inside and Outside

    Mechanism Attacks the Tumor from Both the Inside (TME) and Outside Potential first tumor-targeting immuno-cytokine antibody drug conjugate PDS01ADC + Versamune® + ICI: Unique Combined Mechanism Necrotic Core PDS01ADC binds to necrotic DNA Versamune® Activated Targeting CD8+ Killer T-Cell Oxygenated

  17. Slide 17: Triple Combination Investigator-Initiated Phase 1/2 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 IIT Partner StudyDesign

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

    Triple Combination Key Demographics and Treatment Exposure National Cancer Institute. (2023). Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set] Demographic ITT Population (N=50) Age, Median (Min, Max) 56.0 (28, 80) Sex, n (%) Male Female 26 (52%) 24 (48%) Tu

  19. Slide 19: First Line R/M HPV16+ HNSCC: Strong Survival Benefit

    First Line Recurrent/Metastatic HPV16+ HNSCC: Versamune® HPV and PDS01ADC Promoted Strong Survival Benefit References: Burtness B. et al. Lancet. 2019;394:1915-28. Licitra L. et al. 2024 Multidisciplinary Head and Neck Cancers Symposium. February 29-March 2, 2024. PDS Biotech Data on File. National

  20. Slide 20: First Line R/M HPV16+ Cancer: Objective Responses

    First Line Recurrent/Metastatic HPV16+ Cancer: Versamune® HPV and PDS01ADC Promoted Objective Responses References: PDS Biotech Data on File. National Cancer Institute. (2023). Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set], KEYNOTE-158, Efficacy and safe

  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 Preferred Term n (%) Myocarditis 1 (2) Anemia 15 (30) HLH* 1 (2) Flu-like Symptoms 1 (2) Lymphopenia 3 (6) CPK Elevation 1 (2) Preferred Term n (%) Leukopenia 1 (2) Neutropenia 1 (2)** Hematuria 5 (1

  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 second line t

  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 VERSATILE-002 (NCT04260126) HPV16+ HNSCC Versamune® HPV + pembrolizumab N=53 mOS = 30 months NCI Triple Study* (NCT04287868) Advanced HPV16+ Cance

  24. Slide 24: Patients Treated with PDS01ADC and/or Versamune HPV

    More Than 430 Patients Treated with PDS01ADC and/or Versamune® HPV Lead Program Supported and Validated by Robust Clinical Data PDS01ADC 300+ Patients Treated to Date HNSCC Patient Exposure Across Product Portfolio PDS01ADC + Versamune® HPV + Bintrafusp alfa (triple) and Versamune® HPV + pembrolizum

  25. Slide 25: Oncologists Preferred Triple Combination in First Line R/M HNSCC

    In Interviews, Oncologists Preferred use of Triple Combination in First Line Recurrent/ Metastatic HNSCC ICI: Immune Checkpoint Inhibitor Source: Triangle Insights Group Interviews with N=20 medical oncologists, conducted March 2024 On a scale of 1-7, the triple combination was rated 6.3 by oncologi

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

    Study Design – First Line Recurrent/Metastatic (VERSATILE-003 Plus) Dose Optimization 1:1 randomization Evaluate activity, safety, tolerability Randomized controlled trial 1:1:1 randomization OS primary endpoint Interim Analysis Versamune® HPV + PDS01ADC + pembrolizumab ~40 subjects ~350 subjects PD

  27. Slide 27: Increasing Incidence Driven Largely by HPV16+

    Increasing Incidence Driven Largely by HPV16+ References: https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.htm. Accessed January 30, 2024. Lechner M. et al. Nature. 2022 HNSCC: Devastating Cancers with High Prevalence and Mortality Oral and PharyngealCancers (~40% of HNSCC) Paranasalsinus

  28. Slide 28: Epidemiology-Based Estimate of Addressable Population: HNSCC

    Epidemiology-Based Estimate of Addressable Population: HNSCC Company market research HPV16-positive HNSCC Presents Significant Initial Market Opportunity No approved HPV-specific cancer therapy Significant unmet need Est. HPV16Locally Advanced,Unresectable andMetastatic HNSCC ~13,600 ~18,200 ~22,000

  29. Slide 29: Pipeline Continues to Validate Platforms, Drive Future Opportunities

    Candidate/ Study Indication PC P1 P2 P3 Partner PDS01ADC + Versamune® PDS01ADC + Versamune® HPV + ICI Recurrent or metastatic HPV16-positive HNSCC PDS01ADC + Versamune® MUC1 + ICI (Phase 1/2 anticipated 2024) Recurrent or metastatic colorectal cancer Versamune® Versamune® HPV + ICI (KEYTRUDA®) Recur

  30. Slide 30: Record of Execution in Development and Commercialization

    Record of Execution in Development, Commercialization of Leading Pharmaceutical Products Veteran New Leadership to Execute Strategy Senior executive experience with management of strategy and execution at large pharma and biotechs Notable drug development: Abelcet® (Liposome Company/ Elan) PEG-Intro

  31. Slide 31: PDS Biotechnology

    2 PDS Biotechnology Thank You aa NASDAQ: PDSB a [ite © 2024 PDS Biotechnology. All Rights Reserved.

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