Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (August 2022)
28 slides from Pds Biotechnology's investor presentation, Aug 10, 2022
Slide 1: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | August 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: Versamune designed to promote CD8+ killer T-cell responses in vivo
Generate memory T cells, to enhance durability of response Generate potency without serious systemic side effects Generate the right type and quantity of effective CD8+ killer T cells 12-30% Success in checkpoint inhibitor treatments due to low CD8+ T-cell response 2 Versamune® is designed to promot
Slide 6: 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 7: Versamune based oncology pipeline
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 8: 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 9: Phase 2: PDS0101 in Combination with KEYTRUDA
Phase 2: PDS0101 in Combination with KEYTRUDA® Company-sponsored trial for the treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002) Status Fast Track designation Q2 2022 Efficacy and safety data presented on first 19 patients at ASCO Q2 2022 Data safety monitoring co
Slide 10: Phase 2: PDS0101 + KEYTRUDA
Phase 2: PDS0101 + KEYTRUDA® Company-sponsored trial for the treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002) 10 Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) N=17 Subjects w/Imaging Data OR (2 CR + 5PR) 7 (41.2%) SD (r
Slide 11: Phase 2: PDS0101 + KEYTRUDA safety and survival
Phase 2: PDS0101 + KEYTRUDA® Company-sponsored trial for the treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002) 11 Treatment Emergent Adverse Events (TEAEs) Safety Population (N=19) CPI Naïve Subjects (N=19) N (%) : Events Subjects with any TEAEs Grade 1 Grade 2 Gr
Slide 12: Phase 2: PDS0101 + Bintrafusp alfa + M9241 (Triple Combination)
Phase 2: PDS0101 + Bintrafusp alfa + M9241 (Triple Combination) NCI-led trial for the treatment of HPV16-positive anal, cervical, head and neck, penile, vaginal, vulvar cancers Status Updated efficacy and safety data released at ASCO Q2 2022 Preliminary efficacy and safety data released at ASCO Q2 2
Slide 13: PDS0101 Designed to Promote Efficacy in HPV16 Cancers
PDS0101 Designed to Promote Efficacy in HPV16 Cancers Studies show key contributions of PDS0101, M9241 & Bintrafusp alfa* to clinical response to date 13 *Bintrafusp alfa monotherapy showed 30% ORR in CPI naïve and 10% ORR in CPI refractory HPV-positive cancers (Strauss et al, 2020, Dec 8(2) **All H
Slide 14: Best Overall Response Active Against Diverse HPV16 Cancers
Best Overall Response Active Against Diverse HPV16 Cancers PDS0101: Triple Combination Active Against HPV16 Cancer Responses to date across tumor types and higher NHS-IL12 dose show the potential to result in greater clinical efficacy 14 *HNSCC – head and neck squamous cell carcinomas Higher M9241 D
Slide 15: Phase 2: Triple Combination May Extend Patient Survival
Phase 2: Triple Combination May Extend Patient Survival High dose M9241 may provide improved synergy with PDS0101 15 CPI Naïve Subjects CPI Refractory Subjects Objective Response Rate (ORR) > 30% tumor shrinkage High Dose M9241 - 83% Low Dose M9241 (2/2) - 100% Overall - 88% High Dose M9241 - 63% Lo
Slide 16: Versamune + M9241 May Overcome CPI-Independent Tumor T Cell Evading Mechanisms
Versamune® + M9241 May Overcome CPI-Independent Tumor T Cell Evading Mechanisms Potential to advance cancer immunotherapy 16 Tumors blocking T cell attack using immune checkpoints Tumors blocking T cell attack using alternative immune suppressive mechanisms KEYTRUDA® unlocks checkpoint-dependent imm
Slide 17: Phase 2: PDS0101 + Chemoradiotherapy (IMMUNOCERV)
Phase 2: PDS0101 + Chemoradiotherapy Investigator-led trial evaluating the combination in patients with locally advanced cervical cancer (IMMUNOCERV) Timing Preliminary data anticipated in Q4 2022 Indication Treatment of patients with locally advanced cervical cancer–Stages IB3-IVA Clinical Agents C
Slide 18: 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 treatments in patients with HPV-associated oropharyngeal cancer with high risk
Slide 19: 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 20: 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 21: Projected Milestones Through 1Q 2023
Projected Milestones Through 1Q 2023* *Based on current enrollment and forecast modeling as of June 2022. Subject to change. 21 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 22: Infectimune Infectious Disease Platform
Infectimune™ Infectious Disease Platform
Slide 23: 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 24: 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 25: 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 Subjects Alive and Healthy Against Challenge with Flu Virus Control High-Dose
Slide 26: 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 27: 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 28: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | August 2022
PDS Biotechnology — Investor Presentation (August 2022) on 6ix