Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (October 2022)
25 slides from Pds Biotechnology's investor presentation, Oct 27, 2022
Slide 1: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | October 2022
Slide 2: Forward-looking statements
2 Certain information in this presentation may include 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: Company Overview
1 2 4 5 6 Company Overview Clinical-stage Company developing targeted immunotherapies to treat cancer and infectious disease Versamune® and Infectimune™ platforms leverage the body’s own defense systems to induce disease-specific killer T cells and antibodies to combat cancer and infectious disease
Slide 4: Versamune Oncology Platform
Versamune® Oncology Platform
Slide 5: Interim efficacy data from oncology trials suggest potential long-term efficacy
Interim efficacy data from 3 oncology trials and 56 patients suggest potential long-term efficacy Promising top line PDS0101 phase 2 clinical data 119% response rate with Keytruda monotherapy reported in KEYNOTE-048 study (CPS >1) 5 2 Objective response rates in CPI refractory cancer reported to be
Slide 6: Versamune is designed to promote the 3 R's of T cell activation
Generate memory T cells, to enhance long-lasting response Generate potency without serious systemic side effects Generate the right type, right potency and right quantity of effective CD8+ killer T cells 12-30% Success in checkpoint inhibitor treatments due to low CD8+ T cell response 2 Versamune® i
Slide 7: Versamune Platform Designed to Recruit, Train and Arm T cells in the Body
References: Gandhapudi SK, et al. 2019. Antigen priming with enantiospecific cationic lipid nanoparticles induces potent antitumor CTL responses through novel induction of a Type I IFN response. J Immunol. 202 (12): 3524-3536. Smalley R umfield C et al. 2020. Immunomodulation to enhance the efficacy
Slide 8: Versamune based oncology pipeline developed in partnership with immuno-oncology leaders
Combination PDS Biotech Funded Partner Co-Funded Versamune® Platform Versamune® based oncology pipeline is being developed in partnership with the leaders in immuno oncology PDS0104 (TRP2) TBD Arm 1: CPI naïve 1st line treatment Arm 2: CPI refractory 2nd or 3rd line treatment PDS0101 (HPV16) VERSATI
Slide 9: PDS0101: Lead Asset Designed to treat HPV16-associated cancers
More than 46,0002 patients were estimated to have been diagnosed last year with HPV-associated cancers in the US1,2 HPV vaccination is not expected to impact the rate of HPV-related cancer incidence for decades3 Existing immunotherapies cost $150,000+ annually per patient1 US HPV-associated cancer i
Slide 10: Phase 2: PDS0101 in Combination with KEYTRUDA
Phase 2: PDS0101 in Combination with KEYTRUDA® Company-sponsored trial for the potential treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002) Status Fast Track designation Q2 2022 – End-of-Phase 2 meeting with FDA –allows for registrational trial Efficacy and safety
Slide 11: Phase 2: PDS0101 + KEYTRUDA results
Phase 2: PDS0101 + KEYTRUDA® Company-sponsored trial for the potential treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002) 11 Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) N=17 Subjects w/Imaging Data OR (2 CR + 5PR) 7 (41
Slide 12: Phase 2: PDS0101 + Bintrafusp alfa + M9241 (Triple Combination)
Phase 2: PDS0101 + Bintrafusp alfa + M9241 (Triple Combination) NCI-led trial for the potential treatment of HPV16-positive anal, cervical, head and neck, penile, vaginal, vulvar cancers Status Expanded efficacy data released October 2022 Updated efficacy and safety data released at ASCO Q2 2022 Pre
Slide 13: Phase 2: Extended Interim Data – Efficacy and Safety
Phase 2: Extended Interim Data – Efficacy and Safety Extended interim data continue to appear to show clinical signs of efficacy, durability and safety 13 Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positiv
Slide 14: PDS0102: TARP Antigen
CFA + TARP (1-20) X PDS0102: TARP Antigen Versamune® induced CD8+ killer T cells may result in the ability to treat TARP positive AML and prostate cancers Pre-Clinical Optimization Studies1: TARP-Specific T cell Induction after 2 injections of PDS0102 1 Reference: Wood LV et al, Oncoimmunology, 2016
Slide 15: PDS0103: MUC1 Antigen
Induced a >10-fold number of polyfunctional (highly potent) MUC1 specific CD8+ T cells PDS0103: MUC1 Antigen Greater quantity and quality of Versamune® induced CD8+ killer T cells may result in the ability to treat breast, ovarian, lung, and colon cancers *References: Surveillance Research Program,
Slide 16: Phase 2: PDS0101 + Chemoradiotherapy
Phase 2: PDS0101 + Chemoradiotherapy Investigator-led trial evaluating the combination in patients with locally advanced cervical cancer (IMMUNOCERV) Timing Abstract accepted for presentation at the 37th Annual Meeting for the Society for Immunotherapy of Cancer (SITC 2022) November 8- 12th Indicati
Slide 17: Phase 2: PDS0101 Monotherapy and in Combination with KEYTRUDA
KEYTRUDA®: Cisplatin and radiation therapy PDS0101: Versamune® based immunotherapy generating HPV-specific CD8+ and CD4+ T cells 3 Phase 2: PDS0101 Monotherapy and in Comb. with KEYTRUDA® Investigator-led trial evaluating potential treatments in patients with HPV-associated oropharyngeal cancer with
Slide 18: Projected Milestones Through 1Q 2023
Projected Milestones Through 1Q 2023* *Based on current enrollment and forecast modeling as of June 2022. Subject to change. 18 1Q22 2Q22 3Q22 4Q22 1Q23 2Q23 PDS0101 Completed enrollment of HPV- associated cancer trial CPI refractory arm (NCI) Preliminary data from VERSATILE- 002 (KEYTRUDA® combo) (
Slide 19: Infectimune Infectious Disease Platform
Infectimune™ Infectious Disease Platform
Slide 20: PDS Biotech's Infectimune Pipeline
PDS Biotech’s Infectimune™ Pipeline Developed in partnership with leaders in infectious disease Prevention of tuberculosis PDS0201 (M-tuberculosis) Candidate Indication PC P1 P2 P3 R Partner(s) Universal prevention of influenza PDS Biotech Funded Partner Co-Funded PDS0202 (influenza) PDS0203 (SARS-C
Slide 21: Infectimune Pipeline Highlights
20 Infectimune™ Pipeline Highlights 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 te
Slide 22: PDS0202: Universal Prevention of Influenza
Reference: Ross T. and Woodward J. et al. evaluation of the PDS0202 (Infectimune™+ COBRA) Universal flu formulation. PDS0202: Universal Prevention of Influenza Appeared to Provide Protection in Preclinical Study in Keeping Animals Alive and Healthy Against Challenge with Flu Virus Control High-Dose
Slide 23: PDS Biotech Management
PDS Biotech Management Historical success in the development and commercialization of leading pharmaceutical products Timing Safety data confirmed and released Q4 2021 Preliminary efficacy data anticipated Q1 2022 Frank Bedu-Addo, PHD Chief Executive Officer Senior executive experience with manageme
Slide 24: Company Overview
1 2 4 5 6 Company Overview Clinical-stage Company developing targeted immunotherapies to treat cancer and infectious disease Versamune® and Infectimune™ platforms leverage the body’s own defense systems to induce disease-specific killer T cells and antibodies to combat cancer and infectious disease
Slide 25: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | October 2022
PDS Biotechnology — Investor Presentation (October 2022) on 6ix