Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (October 2023)
45 slides from Pds Biotechnology's investor presentation, Oct 3, 2023
Slide 1: Developing Transformational Immunotherapies for Cancer
Developing Transformational Immunotherapies for Cancer NASDAQ: PDSB October 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: Versamune Induces the Right Type, Potency and Quantity of T Cells
Versamune® Induces the Right Type, Potency and Quantity of Multifunctional Killer and Helper T Cells Comprised of positively charged lipid (R-DOTAP) co-administered with proprietary tumor-specific proteins, delivered via subcutaneous injection Presents antigen to CD4 and CD8 T cells. Activates the T
Slide 7: IMMUNOCERV: PDS0101 Induces Clinically Beneficial Killer 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 HNSCC Disease Overview and Market Size
HPV16-Positive Head and Neck Squamous Cell Cancer (HNSCC) Disease Overview and Market Size
Slide 9: 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 10: 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 11: PDS0101 for HPV16-Positive HNSCC
PDS0101 for HPV16-Positive HNSCC
Slide 12: VERSATILE-002 Phase 2 Clinical Trial Results
VERSATILE-002 Phase 2 Clinical Trial – Results Support Initiation of Phase 3 Clinical Trial in ICI Naïve R/M HNSCC 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 Ca
Slide 13: Disease Stabilization or Tumor Reduction in 81% of Patients
Disease Stabilization or Tumor Reduction in 81% of Patients Tumor Shrinkage in 60% (31/52) with Confirmed Objective Response in 27%1 (14/52) to Date Assessments based on Investigator assessment per RECIST 1.1 Data on File. 08/02/23 Data Cut. Burtness B et al., Lancet. 2019; 394:1915-1928. Best Perce
Slide 14: PDS0101 and KEYTRUDA Demonstrates Promising Patient Survival
PDS0101 and KEYTRUDA® Combination in ICI Naïve HNSCC Demonstrates Promising Patient Survival to Date Median OS Not Yet Estimable Data on File. 08/02/23 Data Cut. Kaplan-Meier Estimates of Overall Survival (OS) (Intent-to-Treat Population) No. of Subjects at Risk (Events) 55 (0) 53 (2) 50 (3) 42 (5)
Slide 15: Overall Survival is Primary Endpoint in Planned Phase 3 Study
PDS0101 and KEYTRUDA® Combination in ICI NaïveHNSCC Demonstrates Promising Patient Survival to Date Overall Survival is Primary Endpoint in Planned Phase 3 Study VERSATILE-003 * No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101Data on File. 08/02/23 D
Slide 16: Promising Survival with PDS0101 + KEYTRUDA
Promising Survival with PDS0101 + KEYTRUDA® 81% of subjects remain alive and continue to be followed for survival Data on File. 08/02/23 Data Cut Assessments were based on Investigator assessment per RECIST 1.1 OS and PFS (mITT Population) Time to PFS OS Alive
Slide 17: Addition of PDS0101 to KEYTRUDA Does not Appear to Compound Toxicity
The Addition of PDS0101 to KEYTRUDA® Does not Appear to Compound Toxicity * No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101Data on File. 08/02/23 Data CutBurtness B et al., Lancet. 2019; 394:1915-1928 Ferris RL, et al. NEJM. 2016;375:1856-67. Only 8
Slide 18: PDS0101 with KEYTRUDA Well Tolerated with Few Serious Toxicities
PDS0101 with KEYTRUDA® Well Tolerated in VERSATILE-002 to Date with Few Serious Toxicities Serious (Grade 3–5) Treatment Related Adverse Events *No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101 Data on File. 08/02/23 Data Cut Burtness B et al. Lancet
Slide 19: Data Continues to Hold Up as More Patients are Enrolled
Data Continues to Hold Up as More Patients are Enrolled and Follow up Time is Extended Data Summary Table Shows Consistency in Results PDS0101 KEYNOTE-048 Comments ASCO 2023 (06/05/23) KOL event (09/27/23) Cut-off Date January 13, 2023 August 02, 2023 Patients with CPS 1-19 50% 60% 48% Aug 02 cut of
Slide 20: Combination Continues to Show Promising Safety and Survival Outcomes
Combination of PDS0101 & KEYTRUDA® Continues to Show Promising Safety and Survival Outcomes VERSATILE-002 Study Shows Potential Of PDS0101 to Safely Modify the Tumor Microenvironment to Promote Patient Survival The 24-month OS rate in the ICI naïve cohort is 74%; Published results of 29% in KEYNOTE-
Slide 21: Timeline to Registrational Trial Initiation
Timeline to Registrational Trial Initiation Worldwide Randomized, Controlled Clinical Study to Be Initiated Q4 2023 PDS0101 + KEYTRUDA® in Recurrent or Metastatic HPV16-Positive HNSCC 2Q 2022 3Q 2022 1Q 2023 2Q 2023 3Q 2023 4Q 2023 FDA Fast Track designation for PDS0101 + KEYTRUDA® Successful EOP2 m
Slide 22: Assessing the Role of PDS0101 in Extending Survival
Assessing the Role of PDS0101 in Extending Survival in the Absence of a VERSATILE-002 KEYTRUDA® Control Arm Strauss J, et al. Journal for ImmunoTherapy of Cancer. 2020;8:e001395. Evaluation of the combination of PDS0101 and KEYTRUDA in patients who have failed KEYTRUDA therapy provides an “internal
Slide 23: 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 24: VERSATILE-003 Phase 3 Study Design
VERSATILE-003 Phase 3 Study Design Global Randomized, Controlled Clinical Study with Estimated 90–100 Sites Overall survival (OS) Primary Endpoint For the treatment of recurrent or metastatic HPV16-positive HNSCC Targeted Indication Randomization 2:1 PDS0101 +KEYTRUDA® PDS0101 + KEYTRUDA® KEYTRUDA®
Slide 25: Survival Rates Demonstrate Potential Contribution of PDS0101
Survival Rates Demonstrate Potential Contribution of PDS0101 to Survival in Advanced Head and Neck Cancer PDS0101 + KEYTRUDA Shows Promising Survival Benefit even in ICI Refractory Patients * No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101 Data on F
Slide 26: Antibody-Drug Conjugate (ADC) IL-12 (PDS0301)
Antibody-Drug Conjugate (ADC) IL-12 (PDS0301)
Slide 27: Antibody-Drug Conjugate IL-12 (PDS0301) Overview
PDS Biotech Antibody-Drug Conjugate IL-12 (PDS0301) Overview Antibody-Conjugated IL-12 Opportunities PDS0301 is a novel investigational tumor-targeting IL-12 that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment Proprietary combination of PDS0301 with Versam
Slide 28: 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 172% grade 3 and higher adverse events reported in KEYNOTE-048 Burtness 2019 https://doi.org/10.1016/S0140-6736(19)32591-7 Goswami
Slide 29: Phase 2 Results in 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 30: Antibody-Drug Conjugate (PDS0301) Pipeline
Antibody-Drug Conjugate (PDS0301) Pipeline 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 PDS0
Slide 31: Projected Milestones Through 3Q24
3Q23 4Q23 1Q24 2Q24 3Q24 PDS0101 Submit IND with FDA for registrational trial (VERSATILE-003) Anticipate ICI naïve/refractory data – KOL Event (VERSATILE-002) Updated OS data from PDS0101-PDS0301 based triple combination Immune response data (VERSATILE-002) (ESMO 2023) Initiate registrational trial
Slide 32: Infectimune Infectious Disease Platform
Infectimune® Infectious Disease Platform
Slide 33: PDS0202: Universal Influenza Vaccine
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 34: PDS0202 Induces Antibodies that Neutralize Broad Range of Influenza Strains
PDS0202 Promotes Induction of Antibodies that Neutralize a Broad Range of Influenza Viral Strains in Preclinical Studies Proprietary Computationally Designed Influenza Protein Studies in Ferrets – Model Viewed as Gold Standard in Influenza Research
Slide 35: PDS0202 Induces Antibodies and T Cells that Prevent Viral Replication
PDS0202 Promotes Induction of Antibodies and T Cells that Prevent Viral Replication in Lungs in Preclinical Studies Proprietary Computationally Designed Influenza Protein Studies in Ferrets – Model Viewed as Gold Standard in Influenza Research
Slide 36: 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 37: Thank you
Thank you
Slide 38: Appendix
Appendix
Slide 39: FDA Requires OS as Primary Endpoint
FDA Requires OS as Primary Endpoint PFS and ORR will not support a BLA approval From FDA’s Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics White Paper1: “In the 1970’s, the FDA usually approved cancer drugs based on objective response rate (ORR), determined by tumor assessmen
Slide 40: VERSATILE-002 ICI Naïve Key Demographics and Treatment Exposure
VERSATILE-002 ICI Naïve Key Demographics and Treatment Exposure Majority of Patients Are CPS 1-19 Demographic ITT Population (N=55) mITT Population (N=52) Age, Median (Min, Max) 64.0 (46, 83) 64.0 (46, 83) Sex, n (%) Male Female 51 (92.7) 4 (7.3) 48 (92.3) 4 (7.7) Race, n (%) American Indian or Alas
Slide 41: 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 42: 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 43: PDS0301 Targets Tumors and Enhances T Cell Infiltration
Antibody Drug Conjugate 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
Slide 44: 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 45: Antibody Drug Conjugate IL-12 (PDS0301)
Antibody Drug Conjugate 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
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