Pds Biotechnology Corporation · NASDAQ:PDSB

Pds Biotechnology — Investor Presentation (June 2024)

28 slides from Pds Biotechnology's investor presentation, Jun 12, 2024

  1. Slide 1: Transforming How the Immune System Targets and Fights Cancer

    Transforming How the Immune System Targets and Fights Cancer to Promote Survival NASDAQ: PDSB June 2024 Precision Designed Science For Immunotherapy

  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 1934, as amended, and Section 27A of the United States Securities Act of 1933, 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 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). PDSB Platforms Designed to Overcome Limitations of Immuno-oncology Immune-Desert Tumors: Lack T cells because T cells don’t get activated or re

  5. Slide 5: Lead Program Supported by Robust Clinical Data

    More Than 430 Patients Treated with PDS01ADC and/or Versamune® HPV Lead Program Supported 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 + pembrolizumab (double) ad

  6. Slide 6: Overcoming Tumor Immune Suppression and Increasing the Potential of Cancer Vaccines

    Overcoming Tumor Immune Suppression and Increasing the Potential of Cancer Vaccines 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

  7. Slide 7: VERSATILE-003 Plus Design – First Line Recurrent/Metastatic HNSCC

    VERSATILE-003 Plus Design – First Line Recurrent/Metastatic HNSCC Key Eligibility Criteria CPS ≥1 HPV16-positive HNSCC ≥18 years of age ECOG 0-1 Interim Analysis Versamune® HPV + PDS01ADC + pembrolizumab Q4 2024 Versamune® HPV + pembrolizumab Pembrolizumab FDA-aligned VERSATILE-003 protocol design A

  8. Slide 8: Planned Pivotal Trial Based on Two Phase 2 Clinical Trials

    Study to Evaluate Treatment in First Line Recurrent/Metastatic HPV16-positive HNSCC PDS Biotech Data on File. National Cancer Institute. (2023). Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set], 2024 Planned Pivotal Trial Based on Two Phase 2 Clinical Trial

  9. Slide 9: Triple Combination Demonstrates Strong Results

    Triple Combination Demonstrates Strong Results Published Studies KEYNOTE-048 LEAP-010 PDS Triple Combination Treatment Pembrolizumab Pembrolizumab Pembrolizumab Versamune® HPV, PDS01ADC, ICI Population Advanced, anal, cervical, vulvar R/M HNSCC R/M HNSCC Advanced anal, cervical, HNSCC, vaginal/vulva

  10. Slide 10: Mechanism Attacks the Tumor from Both the 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: New Combined Mechanism Necrotic Core PDS01ADC binds to necrotic DNA Versamune® Activated Targeting CD8+ Killer T-Cell Oxygenated Are

  11. Slide 11: Triple Combination Investigator-Initiated 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 IIT Partner StudyDesign

  12. Slide 12: 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

  13. Slide 13: Triple Combination Results Indicate Favorable Tolerability

    Phase 2 Triple Combination Results Indicate Favorable Tolerability 48% Grade 3 Treatment Related Adverse Events (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) Neu

  14. Slide 14: Survival of Patients with Recurrent/Metastatic Cancers Associated with HPV

    First Line Recurrent/Metastatic HPV16-positive HNSCC *Pembrolizumab reported median overall survival range in anal, cervical & vulvar cancers = 6-12 Months **Includes anal, cervical, HNSCC, vulvar cancers No controlled head-to-head trials have been performed between pembrolizumab and the Versamune®

  15. Slide 15: Strong Objective Responses with Versamune HPV and PDS01ADC

    34% (18/53) 75%** (6/8) No controlled head-to-head trials have been performed between KEYTRUDA® and the Versamune® HPV combinations Best Objective Response (BOR) 11-25%* *Pembrolizumab reported ORR range in anal, cervical, HNSCC & vulvar cancers = 11-25% **Includes anal, cervical, HNSCC, vulvar canc

  16. Slide 16: Oncologists Strongly Support Use of Triple Combination in First Line HNSCC

    In Interviews, Oncologists Strongly Support 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 on

  17. Slide 17: Triple Combination Conclusions

    Triple Combination Conclusions Triple Combination successfully met primary endpoint of at least a 60% confirmed objective response rate in first line R/M HPV16+ patients by RECIST v1.1 BOR = 63% (RECIST v1.1) BOR = 75% (iRECIST) Versamune® HPV + PDS01ADC + ICI may significantly impact survival in fi

  18. Slide 18: Planned Pivotal Trial Based on Two Phase 2 Clinical Trials

    Study to Evaluate Treatment in First Line Recurrent/Metastatic HPV16-positive HNSCC PDS Biotech Data on File. National Cancer Institute. (2023). Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set], 2024 Planned Pivotal Trial Based on Two Phase 2 Clinical Trial

  19. Slide 19: VERSATILE-002 Study Met Primary Endpoint

    VERSATILE-002 Study Met Primary Endpoint Overall Survival Doubles with Versamune® HPV Combination with pembrolizumab in First Line Recurrent/Metastatic HNSCC VERSATILE-002 (Versamune® HPV + pembrolizumab) KEYNOTE-048 (pembrolizumab) CPS≥1 CPS≥20 CPS≥1 CPS≥20 Confirmed ORR (%) 34 48 19 23 Median PFS

  20. Slide 20: VERSATILE-002 Phase 2 Clinical Trial Design

    VERSATILE-002 Phase 2 Clinical Trial Design (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-randomize

  21. Slide 21: VERSATILE-002 Key Demographics and Treatment Exposure

    VERSATILE-002 First Line R/M HNSCC Demographic mITT Population (N=53) Age, Median (Min, Max) 64.0 (46, 83) Sex, n (%) Male Female 49 (92.5) 4 (7.5) Race, n (%) American Indian or Alaska Native Asian Black or African American Pacific Islander White Other 0 1 (1.9) 1 (1.9) 0 50 (94.3) 1 (1.9) ECOG, n

  22. Slide 22: Kaplan-Meier Analysis: Multiple Patients Approaching 3-Years of Survival

    Data on File: Represents a May 17 data cut; full data from May 17 data cut expected to be announced July 2024 Median Overall Survival of 30 Months *N=2 Lost to follow up; N=6 withdrawn consent; **Patients ongoing and awaiting next clinical assessment (N=8)* (N=27)** Kaplan-Meier Analysis: Multiple P

  23. Slide 23: Durable Responses Reported in Patients with CPS ≥1

    Durable Responses Reported with 75.5% of Patients with CPS ≥1 Having CR, PR or SD Data on File: Data represents a 15Feb2024 extraction of all cleaned and Q/C’d data through 30Nov2023 SD = Stable disease for at least 6 months Complete Response (CR) Partial Response (PR) Stable Disease (SD) ≥ 6 months

  24. Slide 24: Disease Stabilization or Tumor Reduction Reported in 87% of 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*) * Modified Intent-to-Treat: All ITT subjects who had at least 1 imaging assessment Data on File: Data represent

  25. Slide 25: Versamune HPV and KEYTRUDA Combination Well Tolerated

    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

  26. Slide 26: VERSATILE-002 Conclusions

    VERSATILE-002 Conclusions VERSATILE-002 successfully met primary endpoint of 14 or more confirmed objective responses by RECIST v1.1 in ICI naïve patients with CPS ≥1 ORR by Investigator Assessment: 34% (CPS ≥1) and 48% (CPS ≥20) Versamune® HPV may significantly impact survival in first line treatme

  27. Slide 27: 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®) Recu

  28. Slide 28: Thank You

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

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