Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (August 2025)
22 slides from Pds Biotechnology's investor presentation, August 2025
Slide 1: Precision Designed Science for Cancer Patients
Precision Designed Science for Cancer Patients NASDAQ: PDSB August 2025 1 Confidential © 2025 PDS Biotechnology. All Rights Reserved.
Slide 2: Forward-Looking Statements
Forward-Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E 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
Slide 3: Multiple Opportunities for Value Creation
Multiple Opportunities for Value Creation Potential first to market in rapidly growing multi-billion-dollar HPV16+ HNSCC Potential for Leadership in HPV16+ HNSCC First Pivotal Study in 1L R/M HPV16+ HNSCC • Positive results in Phase 2 Trial of PDS0101 in • PDS0101 is the only investigational therapy
Slide 4: HPV16-Positive Head and Neck Cancers Represent a Significant Unmet Need
HPV16-Positive Head and Neck Cancers Represent a Significant Unmet Need Large and growing opportunity with poor current treatment options Two (2) Types of Head and Neck Cancer Large subset of HNSCC cases1,2 Fast growing segment due to HPV positive HPV HPV16+ Poor uptake of HPV vaccine1 Virus-
Slide 5: Projected Rapid Increase in Incidence of HPV16-positive HNSCC
Projected Rapid Increase in Incidence of HPV16-positive HNSCC1 30,000 HPV16 HPV18 HPV 31/33/45/52/58 HPV 35/39/51/56/59/68 HPV-negative 25,000 Annual Number of OPC Cases 20,000 15,000 HPV16+ PDS Biotech focus 10,000 5,000 0 2010 2020 2030 2040 2050 2060 2070 2080 2090 2100 Year 5 OPC – Oropharyngeal
Slide 6: Significant Unmet Needs Remain in HPV16-Positive HNSCC
Significant Unmet Needs Remain in HPV16-Positive HNSCC HPV16-positivity reported to result in poor treatment outcomes and poor survival Limitations of Current Therapies: Published median overall survival with standard of care pembrolizumab or pembrolizumab + chemotherapy is about 12-18 months7) Two
Slide 7: VERSATILE-002: Phase 2 Study of PDS0101 and Pembrolizumab in HPV16+ 1L R/M HNSCC
VERSATILE-002: Phase 2 Study of PDS0101 and Pembrolizumab in HPV16+ First Line (1L) Recurrent/Metastatic (R/M) HNSCC Patient demographics incorporated historically low IO responders: 60% of patients were CPS <20, 81% had recurrent disease Key Entry Study Criteria for ICI Study Treatment Design Endpo
Slide 8: Positive PDS0101 Phase 2 Clinical Data (VERSATILE-002)
Positive PDS0101 Phase 2 Clinical Data (VERSATILE-002)8 Promising clinical responses and patient survival Median overall survival of 39.3 months* (pembrolizumab benchmark in 1L R/M HPV- positive and HPV-negative HNSCC is approx. 12-18 months) 21% complete or near complete (90-100%) tumor shrinka
Slide 9: Noteworthy Tumor Regression Independent of Patient CPS Score
Noteworthy Tumor Regression Independent of Patient CPS Score8 81% of patients had progressed after prior treatment and 60% had low CPS status 100 Best Percentage Change from Baseline Response in Target Lesions (mITT population) Confirmed Disease Complete Response (CR) 5/53 9.4% 75 Partial Response
Slide 10: Promising Median Overall Survival of 39.3 Months for CPS ≥1
Promising Median Overall Survival of 39.3 Months for CPS ≥ 1 11 patients with survival beyond 30 months Overall survival plotted by standard Kaplan-Meier methodology. At the time of the data cut, 23 subjects were alive and still being followed for survival, 9 subjects discontinued the study (7 withd
Slide 11: PDS0101 Plus Pembrolizumab Was Well-Tolerated
PDS0101 Plus Pembrolizumab Was Well-Tolerated 8/87 (9%) patients had a Grade 3 TRAE*; 1/87 (1%) had a Grade 4 TRAE** Treatment related adverse events (TRAEs) by Grade in ICI n (%) naïve and resistant patients Any Combination TRAE 76 (87.4) Grade 1 40 (46.0) Grade 2 26 (29.9) Grade 3 8 (9.2) Grade 4
Slide 12: VERSATILE-003: Pivotal Phase 3 in Progress
VERSATILE-003: Pivotal Phase 3 in Progress9 PDS0101 + pembrolizumab in HPV16+ 1L R/M HNSCC with HPV16 Companion diagnostic Interim Interim Final Study Start Analysis 2 Analysis Analysis 1 Versamune® HPV + Patient Recruitment Survival Follow-up Pembrolizumab Pembrolizumab Patient Recruitment Survival
Slide 13: PDS0101 Drives Powerful and Durable Anti-Tumor Responses
PDS0101 Drives Powerful and Durable Anti-Tumor Responses MOA provides potent and targeted HPV16-specific T cell response17 Lymph Node Tumor Dendritic Cell Versamune® + HPV16 E6 & E7 Immune HPVmix (PDS0101) Checkpoint Inhibitor MHC class I CD8+ killer T cell Targeted CD8+ T Cells Tracks to Tumor CD4+
Slide 14: Well Positioned in HPV16+ 1L R/M HNSCC in the US and Europe
Well Positioned in HPV16+ 1L R/M HNSCC in the US and Europe Merus Bicara BioNTech PDS Biotech Combinations with Pembrolizumab Median OS Not disclosed 21.3 months 22.6 months 39.3 months** 95% CI (23.9, NE) Population All comers HPV-negative HPV16-positive HPV16-positive Administration IV Q2W until P
Slide 15: Deep Pipeline in Large Cancer Markets
Deep Pipeline in Large Cancer Markets PDS focused on VERSATILE-003 15 Confidential
Slide 16: PDS0101: Potentially Differentiated Late Clinical-Stage Immunotherapy
PDS0101: Potentially Differentiated Late Clinical-Stage Immunotherapy Lead Indication in HPV16+ HNSCC with Potential for Opportunities Significant Commercial Potential Favorable Product • Differentiated profile for Profile HPV16+ HNSCC • Non-chemo approach • Potential use in earlier Late-Stage Clini
Slide 17: Upcoming Milestones
Upcoming Milestones Potential for near-term value creating clinical milestones expected PDS01ADC + HAIP** Stage 1 VERSATILE-003 enrollment Cholangiocarcinoma2 complete PDS01ADC + HAIP** PDS01ADC + HAIP** Recruitment PDS01ADC + Xtandi®*** PDS01ADC + HAIP** Stage 1 Stage 2 milestones Prostate cancer**
Slide 18: Market Research and Commercial Opportunities
Market Research and Commercial Opportunities First line (1L) Recurrent/Metastatic HPV16+ HNSCC19 US annual incidence* 13,600 Oncologist view of PDS0101 TPP Favorable Oncologist anticipated adoption rate 82% Favorable, consider checkpoint Payer feedback inhibitors as closest pricing analog US revenue
Slide 19: Multiple Opportunities for Value Creation
Multiple Opportunities for Value Creation Potential first to market in rapidly growing multi-billion-dollar HPV16+ HNSCC Potential for Leadership in HPV16+ HNSCC First Pivotal Study in 1L R/M HPV16+ HNSCC • Positive results in Phase 2 Trial of PDS0101 in • PDS0101 is the only investigational therapy
Slide 20: References
References 1. 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. 2. Tabatabaeian H et al, Navigating therape
Slide 21: References (continued)
References (continued) 14. Yoshida-Court K, Gjyshi O, Lin L, et al. IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy with chemotherapy and radiation for treatment of locally advanced cervical cancers (NCT04580771). Poster Presented at: SITC; November 8-12
Slide 22: Thank You
Thank You NASDAQ: PDSB August 2025 22 Confidential © 2025 PDS Biotechnology. All Rights Reserved.
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