Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (August 2023)
40 slides from Pds Biotechnology's investor presentation, Aug 18, 2023
Slide 1: Developing Transformational Immunotherapies for Cancer
Developing Transformational Immunotherapies for Cancer NASDAQ: PDSB August 2023
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: Executive Summary: Positioned for Market Leadership
PDS0101 to enter Phase 3 registrational trial in 2023 to treat recurrent or metastatic, HPV16-positive head and neck squamous cell cancer (HNSCC) Fast Track Designation PDS0101 addresses large and growing market with significant unmet need Transformational data generated with PDS0101 and PDS0301 in
Slide 4: Experienced Management Team
Experienced Management Team Historical success in development and commercialization of leading pharmaceutical products Frank Bedu-Addo, PhD Chief Executive Officer Senior executive experience with management of strategy and execution at both large pharma and biotechs Notable drug development: Abelce
Slide 5: PDS Biotech Versamune Overview
PDS Biotech Versamune® Overview Designed to address limitations of current immunotherapy PLATFORM: Induces powerful, long-lasting anti-tumor response by promoting uptake of tumor-specific proteins by the immune system and activates a specific signaling pathway that promotes the production of active
Slide 6: How Does the Versamune Subcutaneous Injection Work?
How Does the Versamune® Subcutaneous Injection Work? Comprised of positively charged lipid (R-DOTAP) co-administered with proprietary tumor antigens, delivered via subcutaneous injection Delivers antigen to CD4 and CD8 T cells. Activates the Type I Interferon pathway, leading to potent, multifunctio
Slide 7: IMMUNOCERV: PDS0101 Appears to Induce Clinically Beneficial Killer (CD8) T Cells
IMMUNOCERV: PDS0101 Appears to Induce Clinically Beneficial Killer (CD8) T Cells PDS0101 activates the immune system to generate active killer T cells (CD8 T) cells that induce a critical mediator of the T cell’s tumor-killing function called granzyme-B Multifunctional killer T cells target, infiltr
Slide 8: HPV16-Positive Head and Neck Squamous Cell Cancer: Disease Overview and Market Size
HPV16-Positive Head and Neck Squamous Cell Cancer (HNSCC) Disease Overview and Market Size
Slide 9: HNSCC is a Devastating Group of Cancers
HNSCC is a Devastating Group of Cancers Reference: Noseyaba et al. 2018. Cancer. Suicide Risk Among Cancer Survivors: Head and Neck Versus Other Cancers https://virologyj.biomedcentral.com/articles/10.1186/s12985-021-01688-9 https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.html *Human Pap
Slide 10: HPV16-Positive HNSCC Presents a Significant Market Opportunity
Est. HPV16Locally Advanced,Unresectable andMetastatic HPV16-positive HNSCC Presents a Significant Market Opportunity Largely Attributed to the High Rate of Oral HPV Infections in Men Data sources: 1 PD-L1 negative and PD-L1 positive populations (> 9000 incidence PD-L1 Positive) https://seer.cancer.g
Slide 11: Significant Unmet Needs Remain in Recurrent or Metastatic HNSCC
Targeted treatment option to address the growing population of HPV16-positive HNSCC and improve outcomes Novel MOA that is clinically effective in a broader patient population and provides more durable responses. Safer and more effective treatments that may be used with or in place of current standa
Slide 12: PDS0101 for HPV16-Positive HNSCC
PDS0101 for HPV16-Positive HNSCC
Slide 13: Key Opinion Leaders Involved with VERSATILE-002 Trial
Several Key Opinion Leaders Involved with PDS Biotech’s VERSATILE-002 Head and Neck Cancer Trial Katharine A. Price, MD Associate Professor, Oncology Mayo Clinical (Presented ASCO data) Jared Weiss, MD Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine UNC Lineberger Comprehensi
Slide 14: VERSATILE-002 Phase 2 Clinical Trial
VERSATILE-002 Phase 2 Clinical Trial Objective: To assess the combination of PDS0101 and KEYTRUDA® in ICI naïve subjects with recurrent or metastatic HPV-positive HNSCC KEYTRUDA® (pembrolizumab) FDA Approved Standard of Care Partner Study Design Open-label, non-randomized, adaptive design study N=54
Slide 15: 70.6% of Patients Achieved Disease Stabilization or Tumor Shrinkage
To Date 70.6% of Patients have Achieved Disease Stabilization or Tumor Shrinkage Confirmed best overall response was determined based on confirmed CR or confirmed PR per RECIST 1.1 per investigator assessment. One subject (NE) died prior to target lesion measurement and is included in the mITT popul
Slide 16: Addition of PDS0101 to KEYTRUDA Does not Appear to Compound Toxicity
The Addition of PDS0101 to KEYTRUDA® Does not Appear to Compound Toxicity Preferred Term n (%) Any PSD0101-KEYTRUDA® TRAE 37 (77.1) Injection site pain 24 (50.0) Fatigue 18 (37.5) Injection site swelling 13 (27.1) Injection site erythema 8 (16.7) Headache 7 (14.6) Injection site discoloration 7 (14.
Slide 17: Data Suggests Prolonged Responses and Patient Survival
Data Suggests Prolonged Responses (Durability) and Patient Survival PDS0101 + KEYTRUDA® Data – Median PFS and 12 Month OS *median OS for PDS0101 + KEYTRUDA® not yet reached KEYNOTE-048: Burtness B et al. Lancet 2019;394:1915-28, Published results for reference only 17 10.4 months 3.2 months 5.0 mont
Slide 18: Several Patients Approaching Two Years of Survival
Several Patients Approaching Two Years of Survival Overall response: CR=Complete Response; PR=Partial Response; SD=Stable Disease; PD=Progressive Disease; NE=Not Evaluable. Overall response was based on investigator assessment per RECIST v1.1. Survival status: A=Alive; D=Deceased. Alive subjects wer
Slide 19: VERSATILE-003 Timeline to Registrational Trial Initiation
VERSATILE-003 Timeline to Registrational Trial Initiation Worldwide Randomized, Controlled Clinical Study to Be Initiated Q4 2023 with an Overall Estimated 90–100 Sites PDS0101 + KEYTRUDA® in Recurrent or Metastatic HPV16-Positive HNSCC 2Q 2022 3Q 2022 1Q 2023 2Q 2023 3Q 2023 4Q 2023 FDA Fast Track
Slide 20: Expanding Evidence of Consistent and Durable PDS0101 Clinical Results
Expanding Evidence of Consistent and Durable PDS0101 Clinical Results Across Multiple Phase 2 Trial Indications PDS0101 is an HPV16-targeted immunotherapy PDS0101 is providing strong proof of concept data for the Versamune® technology platform Efficacy data in >90 patients to date Strong agreement b
Slide 21: Versamune Based Oncology Pipeline
Versamune® Based Oncology Pipeline Partnerships with World Class Institutions in Immuno-Oncology Reference: Data on file. PDS Biotech Funded Candidate/ Study Indication Combination PC P1 P2 P3 R Partner(s) Clinical (Lead) PDS0101 (HPV)/ VERSATILE-002 Recurrent or metastatic HPV16-positive head and n
Slide 22: Antibody-Conjugated IL-12 (PDS0301)
Antibody-Conjugated IL-12 (PDS0301)
Slide 23: PDS0301 Overview
PDS Biotech Antibody-Conjugated IL-12 (PDS0301) Overview Antibody-Conjugated IL-12 Opportunities Overcomes tumor’s ability to suppress attack by T cells. PDS0301 is a novel investigational tumor-targeting IL-12 that enhances the proliferation, potency and longevity of T cells in the tumor microenvir
Slide 24: PDS0301 Targets Tumors and Enhances T Cell Infiltration and Proliferation
Antibody-Conjugated IL-12: PDS0301 Targets Tumors and Enhances T Cell Infiltration and Proliferation in the Tumor Tumor Site Injection Site Non-Immunogenic (Cold Tumor) Immunogenic (Hot Tumor) Tumor Site PDS0301 travels direct to tumor Increased tumor inflammation from PDS0301 PDS0301 increases T ce
Slide 25: NCI-led Triple Combination: PDS0301 + PDS0101 + ICI
NCI-led Triple Combination: PDS0301 + PDS0101 + ICI Advanced HPV16-Positive Anal, Cervical, Head and Neck, Penile, Vaginal, Vulvar Cancer Patients Who Are ICI Refractory 173% grade 3 and higher adverse events reported in KEYNOTE-048 Burtness 2019 https://doi.org/10.1016/S0140-6736(19)32591-7 Goswami
Slide 26: Phase 2 Results in Recurrent Metastatic ICI Refractory HPV-Positive Cancer
Phase 2 Results in Recurrent Metastatic ICI Refractory HPV-Positive Cancer (CPS>0; PD-L1 agnostic) Plot Includes Published Data in HSNCC NCI-led Triple Combination: PDS0301 + PDS0101 + ICI Advanced HPV16-Positive ICI Refractory Cancer Patients 1Published results for ICI monotherapy <10%, Strauss J,
Slide 27: Antibody-Conjugated IL-12 (PDS0301) Regimens
Antibody-Conjugated IL-12 (PDS0301) Regimens Reference: Data on file. Candidate/ Study Indication Combination PC P1 P2 P3 R Partner(s) IIT Studies PDS0301/ NCI-led Triple Combination HPV-positive anal, cervical, head and neck, penile, vaginal, vulvar cancers Arm 1: ICI naive Arm 2: ICI refractory PD
Slide 28: Projected Milestones Through 3Q24
3Q23 4Q23 1Q24 2Q24 3Q24 PDS0101 Anticipate ICI naïve/refractory data – KOL Event (VERSATILE-002) Submit IND with FDA for registrational trial for PDS0101 (VERSATILE-003) Updated OS data from NCI-led triple combination Immune response data (VERSATILE-002) (ESMO 2023) Initiate registrational trial fo
Slide 29: Executive Summary: Positioned for Market Leadership
PDS0101 to enter Phase 3 registrational trial in 2023 to treat recurrent or metastatic, HPV16-positive head and neck squamous cell cancer (HNSCC) Fast Track Designation PDS0101 addresses large and growing market with significant unmet need Transformational data generated with PDS0101 and PDS0301 in
Slide 30: Infectimune Infectious Disease Platform
Infectimune® Infectious Disease Platform
Slide 31: PDS0202: Universal Prevention of Influenza
License agreement with University of Georgia for proprietary influenza antigens Top-line preclinical data announced; effective delivery of flu proteins activate the critical immune signals necessary to generate neutralizing antibody responses to all flu strains tested in animals Preclinical data pre
Slide 32: Thank you
Thank you
Slide 33: Appendix
Appendix
Slide 34: Demographics of the ITT (Safety) and mITT (Efficacy) Populations
Demographics of the ITT (Safety) and mITT (Efficacy) Populations Demographics and Baseline Characteristics Demographic or Baseline Characteristic ITT Population (N=48) mITT Population (N=34) Age, Median (Min, Max) 62.5 (45, 83) 63.5 (46, 83) Sex, n (%) Male Female 45 (93.8) 3 (6.3) 32 (94.1) 2 (5.9)
Slide 35: PDS0101: A Novel Investigational HPV-Targeted Immunotherapy
PDS0101: A Novel Investigational HPV-Targeted Immunotherapy PDS0101 is given by subcutaneous injection and stimulates a potent targeted T cell attack against HPV-positive cancers Interim VERSATILE-002 data suggests PDS0101 generates clinically effective immune responses The combination of PDS0101 wi
Slide 36: Compelling Durability of the Anti-Tumor Response
Compelling Durability of the Anti-Tumor Response Progressive Free Survival (PFS) per Investigator Assessment (mITT Population) Number of Subjects at Risk (Events) CPI Naïve 34 (0) 33 (1) 32 (2) 27 (6) 25 (7) 16 (11) 14 (12) 12 (12) 12 (12) 10 (12) 9 (13) 8 (14) 6 (15) 4 (15) 4 (15) 3 (16) 1 (18) 1 (
Slide 37: Promising Survival Benefit
Promising Survival Benefit Overall Survival (OS) (ITT Population) Number of Subjects at Risk (Events) CPI Naïve 47 (0) 41 (1) 36 (1) 31 (1) 29 (1) 26 (1) 23 (2) 19 (2) 17 (2) 16 (2) 13 (3) 13 (3) 13 (3) 13 (3) 12 (3) 11 (3) 6 (4) 5 (4) 4 (4) 3 (4) 2 (4) 0 (4) N Events Median (Months) 95% CI(Months)
Slide 38: Several Patients Approaching Two Years of Survival
Several Patients Approaching Two Years of Survival Blue Dot: Timing of last scan demonstrating PD; Red Bars – PD, Grey Bars – SD, Green Bars – PR, Black Bar – CR, Orange Bars – survival period through last known date alive Days on Treatment and Survival Grouped by Best Overall Response mITT Populati
Slide 39: Tumor Reduction, ORR and OS Remain Consistent
Tumor Reduction, ORR and OS Remain Consistent Comparison: ASCO 2022 & 2023 PDS0101 + KEYTRUDA® Clinical Results *9-Month OS in 2022; 12-Month OS in 2023 ASCO 2022 vs ASCO 2023 Data 87.1% 87.2% 67.6% 64.7% 26.5% 29.4% 41.2% 41.2%
Slide 40: Antibody-Conjugated IL-12 (PDS0301)
Antibody-Conjugated IL-12 (PDS0301) A novel investigational tumor-targeting Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment Together with Versamune® based immunotherapies PDS0301 works synergistically to promote a targeted T cell
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