Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (August 2025)
22 slides from Pds Biotechnology's investor presentation, Aug 25, 2025
Slide 1: Precision Designed Science for Cancer Patients
Precision Designed Science for Cancer Patients NASDAQ: PDSB August 2025
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 for Leadership in HPV16+ HNSCC Positive results in Phase 2 Trial of PDS0101 in HPV16+ 1L R/M HNSCC Median overall survival (OS) 39.3 months* Robust activity in multiple HPV16+ indications First Pivotal Study in 1L R/M HPV16+ HNSCC PDS0101 is the on
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 HPV positive Two (2) Types of Head and Neck Cancer Large subset of HNSCC cases1,2 Fast growing segment due to Poor uptake of HPV vaccine1 Changing sexual behavior
Slide 5: Projected Rapid Increase in Incidence of HPV16-positive HNSCC
Projected Rapid Increase in Incidence of HPV16-positive HNSCC1 HPV16 HPV18 HPV 31/33/45/52/58 HPV 35/39/51/56/59/68 HPV-negative OPC – Oropharyngeal cancer
Slide 6: Significant Unmet Needs Remain in HPV16-Positive HNSCC
Significant Unmet Needs Remain in HPV16-Positive HNSCC Limitations of Current Therapies: Published median overall survival with standard of care pembrolizumab or pembrolizumab + chemotherapy is about 12-18 months7) No controlled or comparative studies have been conducted between checkpoint inhibitor
Slide 7: VERSATILE-002: Phase 2 Study of PDS0101 and Pembrolizumab
VERSATILE-002: Phase 2 Study of PDS0101 and Pembrolizumab in HPV16+ First Line (1L) Recurrent/Metastatic (R/M) HNSCC StudyDesign Single-arm study 31 sites in US and EU 2 Cohorts: ICI Naïve ICI Resistant Study complete Key Entry Criteria for ICI Naïve Subjects R/M HNSCC HPV16-positive tumor ≥18 years
Slide 8: Promising clinical responses and patient survival
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 shrinkage with durable responses for a median of 22 months Significa
Slide 9: Percent Change from Baseline in Target Lesions
Percent Change from Baseline in Target Lesions -50 -25 25 50 75 100 0 -75 -100 -125 Response Complete Response (CR) 5/53 9.4% Partial Response (PR) 14/53 26.4% Stable Disease (SD) 22/53 41.5% Progressive Disease (PD) 9/53 17.0% Treatment Ongoing Confirmed Objective Response Rate (ORR) Based on Inves
Slide 10: Promising Median Overall Survival of 39.3 Months
Promising Median Overall Survival of 39.3 Months for CPS ≥ 1 11 patients with survival beyond 30 months Per standard KM methodology, subjects who discontinued the study are censored at the last visit date. A sensitivity analysis including survival status of discontinued subjects where attainable was
Slide 11: PDS0101 Plus Pembrolizumab Was Well-Tolerated
PDS0101 Plus Pembrolizumab Was Well-Tolerated *Grade 3 Combination-TRAE were: Fatigue (2), Rash, Alanine aminotransferase increased, Blood alkaline phosphatase increased, Lymphocyte count decreased, Autoimmune colitis, Colitis, Headache, Acute kidney injury, Hyponatremia, Hyperglycemia, **Grade 4 Co
Slide 12: VERSATILE-003: Pivotal Phase 3 in Progress
VERSATILE-003: Pivotal Phase 3 in Progress9 Interim Analysis 1 Study Start Versamune® HPV + Pembrolizumab Pembrolizumab (KEYTRUDA®) Patient Recruitment Patient Recruitment Survival Follow-up Survival Follow-up Key Eligibility Criteria HPV16-positive HNSCC CPS ≥1 ≥18 years of age ECOG 0-1 Secondary E
Slide 13: PDS0101 Drives Powerful and Durable Anti-Tumor Responses
PDS0101 Drives Powerful and Durable Anti-Tumor Responses Lymph Node Tumor CD4+helper T cell CD8+killer T cell HPV16 E6 & E7 Versamune®Activated CD8+Killer T Cell ImmuneCheckpointInhibitor Versamune® +HPVmix (PDS0101) Targeted CD8+ T CellsTracks to Tumor Dendritic Cell MHC class I MHC class II Subcut
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 Convenience IV
Slide 15: Deep Pipeline in Large Cancer Markets
Deep Pipeline in Large Cancer Markets PDS focused on VERSATILE-003
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 Strong IP Coverage 12 Patent families Composition and method claims cover platform and products PDS0101 LOE expected 2042/2043 Late-Stage Clinical Program Positive P
Slide 17: Potential for near-term value creating clinical milestones expected
Potential for near-term value creating clinical milestones expected Upcoming Milestones 1H 2026 VERSATILE-003 enrollment complete PDS01ADC + HAIP** Complete stage 2 Cholangiocarcinoma PDS01ADC + HAIP** Stage 2 Colorectal cancer PDS01ADC + HAIP** Stage 1 Cholangiocarcinoma2 PDS01ADC + HAIP** Colorect
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% Payer feedback Favorable, consider checkpoint inhibitors as closest pricing analog US revenue
Slide 19: Multiple Opportunities for Value Creation
Multiple Opportunities for Value Creation Potential for Leadership in HPV16+ HNSCC Positive results in Phase 2 Trial of PDS0101 in HPV16+ 1L R/M HNSCC Median overall survival (OS) 39.3 months* Robust activity in multiple HPV16+ indications First Pivotal Study in 1L R/M HPV16+ HNSCC PDS0101 is the on
Slide 20: References
References 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. Tabatabaeian H et al, Navigating therapeutic s
Slide 21: References (continued)
References (continued) 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, 20
Slide 22: Thank You
Thank You NASDAQ: PDSB August 2025
PDS Biotechnology — Investor Presentation (August 2025) on 6ix