Pds Biotechnology Corporation · NASDAQ:PDSB

Pds Biotechnology — Corporate Update (November 2024)

27 slides from Pds Biotechnology's corporate update, Nov 14, 2024

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

    1 © 2024 PDS Biotechnology. All Rights Reserved. Transforming How the Immune System Targets and Fights Cancer to Promote Survival Precision Designed Science For Immunotherapy NASDAQ: PDSB November 2024

  2. Slide 2: Forward-Looking Statements

    Forward-Looking Statements 2 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 Cor

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

    Late-Stage Head and Neck Cancer Program as Value Catalyst Potent Long-Lasting “Memory” T Cells High-Value Lead Program with strong KOL support Promising Multi-Country Phase 2 Data Phase 3 Study 30 months Overall Survival (mOS) 77% Disease Control Rate (DCR) Well Tolerated: 9% Grade 3, 1% Grade 4 Tre

  4. Slide 4: Significant and Growing Market Potential in HPV16-positive HNSCC

    Significant and Growing Market Potential in HPV16-positive HNSCC HPV16 to Drive Increased HNSCC Incidence Rates & Exceed 50% of all HNSCC by mid 2030s1 Current US annual incidence of HPV16+ HNSCC = 18,200 (~35-40% of all HNSCC)2-3 Incidence of locally advanced, unresectable, metastatic HPV16+ HNSCC

  5. Slide 5: Approx. 13,600 US Patients Annually with Advanced HPV16+ HNSCC

    Approx. 13,600 US Patients Annually with Advanced HPV16+ HNSCC Epidemiology-Based Estimate of Addressable Population: HNSCC*7 U.S. Other Head and Neck Cancers U.S. HPV Positive ~5,900 (82%) HPV16 Genotype ~3,300 (56%) Locally Advanced, Unresectable and Metastatic ~7,200 (22%) ~32,500 U.S. Oropharyng

  6. Slide 6: HPV16-Positive HNSCC

    HPV16-Positive HNSCC Virally driven HNSCC increasingly seen as a distinct and rapidly growing type of cancer 2 HPV16 virus integrated into the human genome HPV-positive HNSCC has different presentation and tumor physiology8 Recurrent patients have distant metastases at multiple sites and poor clinic

  7. Slide 7: Significant Unmet Needs Remain in Recurrent or Metastatic HNSCC

    Significant Unmet Needs Remain in Recurrent or Metastatic HNSCC KEYTRUDA® KEYTRUDA® 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 Gra

  8. Slide 8: Treatment Outcomes Similar Between HPV+ and HPV- Patients

    Controlled Clinical Study Treatment Outcomes in Recurrent and/or Metastatic HNSCC Similar Between HPV+ and HPV- Patients KEYNOTE-048: Similar OS hazard ratio reported in HPV+ & HPV- patients10 2

  9. Slide 9: Versamune HPV may Address Significant Unmet Need in R/M HNSCC

    9 Versamune® HPV may Address Significant Unmet Need in R/M HNSCC 19% 35% 0% 20% 10% 30% 40% ORR PFS OS 3.2 5.1 6.0 5.0 4.0 3.0 2.0 1.0 0.0 Months 12.3 10.4 0.0 5.0 10.0 15.0 Months KEYNOTE-0489 Pembrolizumab EGFR antibody (cetuximab) + chemotherapy 25% 46% 8.0 50% 40% 30% 20% 10% 0% ORR 2.8 7.0 0.0

  10. Slide 10: VERSATILE-002: Global Phase 2 Study Design

    10 VERSATILE-002: A Global Phase 2 Study of Versamune® HPV and Pembrolizumab in Subjects with HPV16+ Recurrent/Metastatic HNSCC Partner Study Design Open-label, non- randomized, adaptive design study 31 sites in US and EU 2 Cohorts: ICI Naïve ICI Resistant Enrollment complete Key Entry Criteria for

  11. Slide 11: VERSATILE-002: Patient Demographics and Historical Responses

    11 VERSATILE-002: Most Patients Had Recurrent Disease and CPS Score 1-19 Historical Responses Published data reports lower ORR, PFS and OS with pembrolizumab in patients with CPS 1-19 vs. CPS ≥ 2013 Published data reports lower responses in patients with recurrent disease Lower pembrolizumab respons

  12. Slide 12: Percent Change from Baseline in Target Lesions

    12 Percent Change from Baseline in Target Lesions 25 0 -25 -50 -75 50 75 100 -100 CPS Group 1-19 ≥20 -125 CPS Group 9.4% 26.4% 41.5% 17.0% Response Complete Response (CR) 5/53 Partial Response (PR) 14/53 Stable Disease (SD) 22/53 Progressive Disease (PD) 9/53 Treatment Ongoing Confirmed Objective Re

  13. Slide 13: Extended Disease Control Observed in Majority of Patients

    13 Extended Disease Control Observed in Majority of Patients12 Based on Investigator Assessment Per RECIST v1.1 Best Percentage Change from Baseline in Target Lesions Promising Long-Lasting Immune Response with CR, PR and SD Maintained Long-Term Percent Change from Baseline in Target Lesions 0 2 4 6

  14. Slide 14: Median Overall Survival of 30 Months

    14 Survival Fraction 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 0.4 0.6 0.8 1.0 Censored ‒ Discontinued (N=8) Censored ‒ Ongoing (N=27) 0.2 Median OS, months (95% CI) = 30.0 (19.7, NE) Median follow up (months) = 16 0.0 Discontinued: N=2 Lost to follow up; N=6 withdrawn consent; Ongoing: Pa

  15. Slide 15: Versamune HPV plus pembrolizumab Appears to be Well Tolerated

    15 Versamune® HPV plus pembrolizumab Appears to be well Tolerated14 Protocol stipulates 5 subcutaneous injections of Versamune® HPV: 4 injections over 2 months and a final injection after an additional 6 months *Grade 3 Combination-TRAE were: Fatigue (2), Rash, Alanine aminotransferase increased, Bl

  16. Slide 16: VERSATILE-002 Summary of Results

    VERSATILE-002 Summary of Results12 16 Study has met primary ORR endpoint by RECIST v1.1 in ICI naïve patients ORR by Investigator Assessment: 36% (CPS ≥1) and 48% (CPS ≥20) 21% of patients had 90-100% shrinkage of their tumors Versamune® HPV + KEYTRUDA® may significantly impact DCR and OS in first l

  17. Slide 17: VERSATILE-003 First Line R/M HNSCC Study Design

    VERSATILE-003 First Line Recurrent/Metastatic HNSCC Study Design Interim Analysis 1 Possible Early Approval Study Start Versamune® HPV + Pembrolizumab Pembrolizumab Aligned with FDA on Study Design and Initiation Patient Recruitment Patient Recruitment Survival Follo w-up Survival Follo w-up Key Eli

  18. Slide 18: VERSATILE-003 Trial Implementation

    CRO engaged in site selection and preparation, investigator agreements, etc. Approximately 100 sites Site locations: US, UK, EU, Latin America 18 months estimated time to full enrollment 2 interim analyses for OS following event triggers 16 VERSATILE-003 Trial Implementation

  19. Slide 19: VERSATILE-002: Durable Anti-Tumor Immune Response Observed

    VERSATILE-002: Durable Anti-Tumor Immune Response Observed Improving Responses with Time and Sustained Survival Objective Response Rate (ORR) Patients with Tumor Shrinkage of 90- 100% Patients with Complete Responses (CR) Disease Control Rate (DCR) Median Overall Survival May 2023 (N=34)15 26% 6% 3%

  20. Slide 20: Versamune HPV Biomarker Studies (CD8+ T Cells)

    20 Versamune® HPV Biomarker Studies (CD8+ T Cells) Long-Term Tumor Infiltration and Accumulation of Multi-functional CD8+ T Cells Stage III and IV locally advanced cervical cancer patients treated with Versamune® HPV and chemoradiotherapy Increase in CD8 T cells in the tumor observed Day 0 to Week 2

  21. Slide 21: KEYTRUDA & Versamune HPV in Locally Advanced Cervical Cancer

    21 KEYTRUDA® & Versamune® HPV Were Both Independently Studied in Locally Advanced Cervical Cancer in Combination with CRT Versamune® HPV: Compelling Evidence of Survival Benefit *No head-to-head studies have been done between Keytruda and Versamune® HPV 3 C (P KEYTRUDA® Published KEYNOTE-A1819 Versa

  22. Slide 22: Versamune HPV Biomarker Preclinical Studies (Memory T Cells)

    Versamune® HPV Treated Secondary Tumor Primary Tumor 22 njected Time (Days) Day 0: HPV16+ TC1 tumor cells were injected into mice Day 12: Resulting tumors had a size of ~250mm3 (volume) Day 12 : A group of the mice received a single injection of Versamune® HPV Day 25: All treated mice had complete r

  23. Slide 23: NCI-Led Triple Combination Trial: HPV16-Negative Internal Control

    NCI-Led Triple Combination Trial: Inclusion of HPV16-Negative Patients Provided Internal Study Control & Demonstrated Versamune HPV Specificity22 Objective Response Rate (ORR) Progression Free Survival (PFS) Versamune® HPV May be Effective HPV16-targeted Immunotherapy 80 70 60 50 40 30 20 10 0 HPV16

  24. Slide 24: Upcoming Milestones 2024-2025

    Upcoming Milestones 2024-2025 22 Q3 2024 Q4 2024 1H 2025 2H 2025 Regulatory Confirmation of VERSATILE-003 Study Design Initiate VERSATILE-003 Phase 3 Trial in HNSCC IMMUNOCERV Trial Update in Cervical Cancer Preliminary data readout: Neoadjuvant Study in Oral Cancer File IND for Versamune® MUC1 in M

  25. Slide 25: Thank You

    25 © 2024 PDS Biotechnology. All Rights Reserved. Thank You NASDAQ: PDSB

  26. Slide 26: References

    References 26 1. 2. 3. 4. 5. 6. 7. 8. 9. Damgacioglu H, Sonawane K, Chhatwal J, et al. Long-term impact of HPV vaccination and COVID-19 pandemic on oropharyngeal cancer incidence and burden among men in the USA: A modeling Study. The Lancet Regional Health – Americas. 2022;8:100143. CDC. HPV and Oro

  27. Slide 27: References (continued)

    References (continued) 26 Weiss J, Kaczmar JM, Harrington K, et al. VERSATILE-002: Survival with First-Line Treatment with PDS0101 Therapeutic Vaccine and Pembrolizumab in HPV16-positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). Poster Presented at: ESMO Congress 2024; Sept

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