PDS Biotechnology Corporation · NASDAQ:PDSB
PDS Biotechnology — Investor Presentation (May 2023)
38 slides from PDS Biotechnology's investor presentation, May 2023
Slide 1: Developing Transformational Immunotherapies for Cancer
Developing Transformational Immunotherapies for Cancer Precision Designed Science For Immunotherapy NASDAQ: PDSB May 2023 © 2023 PDS Biotechnology. All Rights Reserved. 1
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
Executive Summary: Positioned for Market Leadership Company Overview PDS0101 to enter Phase 3 registrational trial in 1 2023 to treat recurrent or metastatic, HPV-positive head and neck squamous cell cancer (HNSCC) Fast Track Designation 2 PDS0101 addresses large and growing market with significant
Slide 4: Experienced Management Team
Experienced Management Team Historical success in development and commercialization of leading pharmaceutical products Frank Bedu- Matthew Lauren V. Gregory Addo, PhD Hill Wood, MD Conn, PhD Chief Executive Officer Chief Financial Officer Chief Medical Officer Chief Scientific Officer • Senior execu
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 Versamune® immune system and activates a specific signaling pathway that promotes the production
Slide 6: Versamune Mechanism of Action
Versamune® Mechanism of Action • Comprised of cationic lipids Injection Site Lymph Node Tumor Site (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, mu
Slide 7: Versamune Based Oncology Pipeline
Versamune® Based Oncology Pipeline Partnerships with World Class Institutions in Immuno-Oncology Candidate/ Indication Combination PC P1 P2 P3 R Partner(s) Study Recurrent or metastatic HPV16- Clinical PDS0101 (HPV)/ positive head and neck cancer KEYTRUDA® (Lead) VERSATILE-002 • Arm 1: ICI naïve (st
Slide 8: HPV16-Positive Head and Neck Squamous Cell Cancer (HNSCC)
HPV16-Positive Head and Neck Squamous Cell Cancer (HNSCC) Disease Overview and Market Size 8
Slide 9: HNSCC is a Devastating Group of Cancers
HNSCC is a Devastating Group of Cancers Genotype of *HPV- Oral and Pharyngeal Positive Oral and Cancers Pharyngeal Cancer Paranasal sinuses 10% Other HPV Nasal Nasopharynx Cavity Oral Cavity HPV- HPV+ Oropharynx Tongue Salivary 30% 70% 90% HPV16 Pharynx glands Hypopharynx Larynx Reference: Noseyaba
Slide 10: Significant Unmet Needs Remain in Recurrent or Metastatic HNSCC
Despite the Availability of Treatments, Significant Unmet Needs Remain in Recurrent or Metastatic HNSCC Oncologist2 – Stated Unmet Standard of Care for Recurrent or Metastatic HNSCC – Published Results*1 Medical Needs in HNSCC KEYTRUDA® Plus Chemotherapy KEYTRUDA® Chemo + EGFR Inhibitor Objective Re
Slide 11: HPV16-positive HNSCC Presents a Significant Market Opportunity
HPV16-positive HNSCC Presents a Significant Market Opportunity Largely Attributed to the High Rate of Oral HPV Infections in Men Est. U.S. Oral and Initial commercial opportunity Pharyngeal Cancer ~54,400 for PDS0101 Est. U.S. HPV Positive Oral and Pharyngeal Cancer ~38,100 No available HPV specific
Slide 12: PDS0101 for HPV16-Positive HNSCC
PDS0101 for HPV16- Positive HNSCC 12
Slide 13: 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 PDS0101 with KEYTRUDA® demons
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 FDA Approved Key Entry Study Study Partner Standard of Criteria for ICI Endpoints Design Treatment Care Naïve Subjects KEYTRUDA® Op
Slide 15: Demographics of the ITT and mITT Populations
Demographics of the ITT (Safety) and mITT (Efficacy) Populations Demographics and Baseline Characteristics Summary of Exposure Demographic or Baseline ITT Population mITT Population Exposure ITT Characteristic (N=48) (N=34) Population (N=48) Age, Median (Min, Max) 62.5 (45, 83) 63.5 (46, 83) PDS0101
Slide 16: 70.6% of Patients Achieved Disease Stabilization or Tumor Shrinkage
To Date 70.6% of Patients have Achieved Disease Stabilization or Tumor Shrinkage 100 14/34 (41.2%) Confirmed and Unconfirmed Objective Response Complete Response 9/34 (26.5%) Confirmed Partial and Complete Response 80 15/34 (44.1%) Stable Disease Partial Response 9/34 (26.5%) Progressive Disease 60
Slide 17: Compelling Durability of the Anti-Tumor Response
Compelling Durability of the Anti-Tumor Response Demonstrated median PFS of 10.4 months; published results of 2-3 months for approved immune checkpoint inhibitors* Progressive Free Survival (PFS) per Investigator Assessment (mITT Population) 1.0 Censored 0.8 Survival Fraction 0.6 0.4 Median 95% CI N
Slide 18: Promising Survival Benefit
Promising Survival Benefit Demonstrated 12-month OS rate of 87.1%; published results of 35-50% for approved immune checkpoint inhibitors* Overall Survival (OS) (ITT Population) 1.0 Censored 0.8 Survival Fraction 0.6 0.4 12-month OS rate = 87.1% Median 95% CI N Events (Months) (Months) 0.2 48 4 NE (1
Slide 19: 67.6% of Patients Experienced Tumor Shrinkage
67.6% of Patients Experienced Tumor Shrinkage Demonstrated objective response rate of 41% (confirmed and unconfirmed) 150 Complete Response 125 PD A % Change from Baseline in Target Lesions Partial Response 100 Stable Disease Progressive Disease 75 PD A PD 50 PD PD PD A PD D PD PD A PD A 25 SD SDPD
Slide 20: Several Patients Approaching Two Years of Survival
Several Patients Approaching Two Years of Survival Days on Treatment and Survival Grouped by Best Overall Response mITT Population (n=34) with at least 1 scan G… EE C… A… Y W U S Q O M K I G E C A 0 100 200 300 400 500 600 700 STUDY Days Blue Dot: Timing of last scan demonstrating PD; Red Bars – PD,
Slide 21: 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 Progression Free Survival (Months) KEYTRUDA®+ Chemotherapy 5.0 months KEYTRUDA® 3.2 months PDS0101 + KEYTRUDA® 10.4 months 0 2 4 6 8 10 12 12-Month OS (%)* KEYTRUDA®+ Chem
Slide 22: Tumor Reduction, ORR and OS Remain Consistent
Tumor Reduction, ORR and OS Remain Consistent Comparison: ASCO 2022 & 2023 PDS0101 + KEYTRUDA® Clinical Results ASCO 2022 vs ASCO 2023 Data 87.1% Overall Survival (OS)* 87.2% 67.6% Patients with tumor reduction (%) 64.7% 26.5% Confirmed ORR (%) 29.4% 41.2% Confirmed & Unconfirmed ORR (%) 41.2% 0 20
Slide 23: Addition of PDS0101 to KEYTRUDA Does not Appear to Compound Toxicity
The Addition of PDS0101 to KEYTRUDA® Does not Appear to Compound Toxicity PDS0101+KEYTRUDA® Treatment Related Adverse Events (TRAE) >5% (ITT Population) Preferred Term n (%) • Only 4 subjects had Grade 3 Any PSD0101-KEYTRUDA® TRAE 37 (77.1) PDS0101-KEYTRUDA® TRAEs: Injection site pain Fatigue 24 (50
Slide 24: VERSATILE-003 Phase 3 Study Design
VERSATILE-003 Phase 3 Study Design Worldwide Randomized, Controlled Clinical Study Targeted For the treatment of recurrent or metastatic HPV16-positive HNSCC Indication Primary Progression free survival (PFS) and overall survival (OS) Endpoints Planned Interim Analysis: Planned Interim Analysis: Fin
Slide 25: 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 Trac
Slide 26: 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
Slide 27: Antibody-Conjugated IL-12 (PDS0301)
Antibody-Conjugated IL-12 (PDS0301) 27
Slide 28: Antibody-Conjugated IL-12 (PDS0301) Overview
PDS Biotech Antibody-Conjugated IL-12 (PDS0301) Overview Antibody-Conjugated IL-12 Opportunities • Overcomes tumor’s ability to suppress • Monotherapy attack by T cells. PDS0301 is a novel investigational tumor-targeting IL-12 that • Combinations: enhances the proliferation, potency and • Versamune®
Slide 29: 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
Slide 30: 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 Non-Immunogenic Immunogenic Injection Site Tumor Site (Cold Tumor) (Hot Tumor) Tumor Site 1 2 3 4 Increased tumor PDS0301 increases PDS0301 travels CD8 T cells kill inflammation from T c
Slide 31: Antibody-Conjugated IL-12 (PDS0301) Regimens
Antibody-Conjugated IL-12 (PDS0301) Regimens Candidate/ Indication Combination PC P1 P2 P3 R Partner(s) Study HPV-positive anal, cervical, head and PDS0301/ neck, penile, vaginal, vulvar cancers NCI-led Triple PDS0101 & ICI • Arm 1: ICI naive Combination • Arm 2: ICI refractory PDS0301 Advanced Kapo
Slide 32: 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 Partner FDA Approved None Standard of Care SITC, November 2022: • Greater than two-fold increase in HPV16-specific T cells in the
Slide 33: NCI-led Triple Combination: PDS0301 + PDS0101 + ICI
NCI-led Triple Combination: PDS0301 + PDS0101 + ICI Advanced HPV16-positive ICI Refractory Cancer Patients Phase 2 Results in Recurrent Metastatic ICI Refractory HPV-Positive Cancer (CPS>0; PD-L1 agnostic) Plot Includes Published Data in HSNCC Median OS (Months) ICI monotherapy Best published median
Slide 34: Infectimune Infectious Disease Platform
Infectimune™ Infectious Disease Platform 34
Slide 35: PDS0202: Universal Prevention of Influenza
PDS0202: Universal Prevention of Influenza Universal Influenza Vaccines PDS0202 Provided Full Protection Against Lethal Challenge with H1N1 Pandemic Strain in $7 Billion Universal Flu Market Preclinical Study Opportunity in 2021 120 100 % survival 80 License agreement with University of Georgia for
Slide 36: Projected Milestones Through 3Q24
Projected Milestones Through 3Q24 2Q23 3Q23 4Q23 1Q24 2Q24 3Q24 Anticipate updated data (VERSATILE-002) File amended IND with FDA for registrational trial for PDS0101 (VERSATILE-003) Completion of enrollment (VERSATILE-002) PDS0101 Initiate registrational trial for PDS0101 (VERSATILE-003) Anticipate
Slide 37: Executive Summary: Positioned for Market Leadership
Executive Summary: Positioned for Market Leadership Company Overview PDS0101 to enter Phase 3 registrational trial in 1 2023 to treat recurrent or metastatic, HPV-positive head and neck squamous cell cancer (HNSCC) Fast Track Designation 2 PDS0101 addresses large and growing market with significant
Slide 38: Thank you
Thank you 38