PDS Biotechnology Corporation · NASDAQ:PDSB
PDS Biotechnology — Investor Presentation (January 2021)
24 slides from PDS Biotechnology's investor presentation, January 2021
Slide 1: Corporate Overview January 2021
CORPORATE OVERVIEW JANUARY 2021 Frank Bedu-Addo Ph.D. President & CEO Nasdaq: PDSB Developing powerful, safe, versatile immunotherapies
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements about PDS Biotechnology Corporation (“PDSB”), and its businesses, business prospects, strategies and plans, including but not limited to statements regarding anticipated pre-clinical and clinical drug development activi
Slide 3: PDS Biotech is a clinical stage biotechnology company developing immunotherapies
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on the proprietary Versamune® platform CORPORATE OVERVIEW VERSAMUNE® PLATFORM PIPELINE • Biopharma developing novel • Versatile, potent T-cell-activating treatments for cancer and T-cell platform dem
Slide 4: Versamune-based pipeline developed in partnership with leaders in immuno-oncology
PDS Biotech’s robust Versamune®-based pipeline being developed in partnership with the leaders in immuno-oncology Nasdaq: PDSB Reference: Data on file. 4
Slide 5: Executive team has demonstrated success in drug development and commercialization
PDS Biotech executive team has demonstrated success in the development and commercialization of leading pharmaceutical products • Senior executive experience with management of strategy and execution at both large pharma and biotechs Frank Bedu-Addo, PhD • Notable drug development: Chief Executive O
Slide 6: Introduction to the Versamune Platform
Introduction to the ® Versamune Platform
Slide 7: Versamune designed to induce robust, targeted anti-tumor response in vivo
Versamune® is designed to induce a robust and targeted anti-tumor response in vivo when administered with a tumor-associated antigen Versamune® + Tumor- associated proteins (antigens) Promotes uptake of vaccine Promotes antigen processing Activates Type I Interferon or immunotherapy and and presenta
Slide 8: Versamune-induced killer T-cells may eradicate HPV-positive tumors after a single dose
Greater quantity and quality of Versamune®-induced killer T-cells may result in unique ability to eradicate HPV-positive tumors after a single dose Induced a >10-fold number of highly potent T-cells and eradication of HPV-positive tumors after a single dose 500 # of Antigen-Recognizing T-Cells IFN-γ
Slide 9: Phase 1: CD8+ T-cell response results in regression of CIN cervical lesions
Phase 1 clinical trial: Powerful in-vivo CD8+ T-cell response results in regression of CIN cervical lesions – supports preclinical studies Overcomes key limitation of immuno-oncology: > 20-fold increase in circulating dual INF-γ & Granzyme-b inducing killer T-cells vs. pre-treatment at day 14 led to
Slide 10: PDS0101 trains tumor-specific T-cells effective in infiltrating and killing tumors
PDS0101 enhanced treatment by training tumor-specific T-cells (fewer T- cell clones) effective in infiltrating and killing tumors Red – CD8+ (killer) T-cells T-cell clones per 25% of Saline Green – CD4 + (helper) T-cells TCR repertoire (Average) Tumor Regression: 0/16 (0%) T-cell Clones: 18 M7824 (b
Slide 11: Versamune possesses key characteristics of safe and effective immunotherapeutic
Versamune® possesses the key characteristics of a safe and effective immunotherapeutic treatment Versamune®-based Checkpoint Traditional Cancer CAR-T Chemotherapy Immunotherapies* Inhibitors Vaccines Induction of high levels of active CD8+ (killer) T-cells ✓ ✓ Induction of high levels of CD4+ (helpe
Slide 12: Development of PDS0203 second generation COVID-19 vaccine
Development of PDS0203 - A second generation COVID-19 vaccine that promotes powerful T-cell responses and neutralizing antibodies Mt. Sinai data shows Versamune® promotes PDS generated data shows induction of induction of neutralizing antibodies with SARS-CoV-2 specific CD8+ T-cells with lowest dose
Slide 13: Versamune demonstrated compatibility with wide array of tumor and pathogenic antigens
Versamune® has demonstrated immunological compatibility with a wide array of tumor and pathogenic antigens • Today, 4 tumor antigens are being utilized with the Versamune® platform, more than 75 tumor antigens have been identified • We are currently progressing two Versamune®-based infectious diseas
Slide 14: PDS0101 Phase 2 Clinical Development
PDS0101 Phase 2 Clinical Development
Slide 15: PDS0101 designed to treat cancers caused by HPV
PDS0101 is designed to treat cancers caused by human papillomavirus (HPV) US annual HPV-associated cancer incidence1 • Approximately 43,000 patients are diagnosed with HPV-associated cancers Females (24,391) Males (18,280) annually in the US • Incidence rate is growing despite increased use of HPV p
Slide 16: Clinical strategy: combine PDS0101 with established therapies
Clinical strategy to evaluate improved therapy: Combine PDS0101 with established therapies for rapid proof-of-concept and risk mitigation Combinations of PDS0101 with FDA-approved Novel combinations of PDS0101 with promising standard of care immunotherapeutic agents − First line treatment of recurre
Slide 17: Phase 2 trial of PDS0101, M7824 and NHS-IL12 in advanced HPV-associated cancer
Phase 2 investigator-initiated clinical trial evaluating the combination of PDS0101, M7824 and NHS-IL12 in advanced HPV-associated cancer Indication Patients with advanced HPV-associated cancer who have failed prior treatment M7824: Bifunctional fusion protein - checkpoint inhibitor + TGF-b “TRAP” (
Slide 18: Phase 2 trial of PDS0101 and KEYTRUDA in head and neck cancer
PDS Biotech-sponsored phase 2 trial evaluating the combination of PDS0101 and KEYTRUDA for first-line treatment of HPV-associated metastatic/recurrent head and neck cancer Indication First line treatment of patients with HPV-associated head and neck cancer whose cancer has spread or returned KEYTRUD
Slide 19: Phase 2 trial of PDS0101 with chemoradiation in advanced cervical cancer
A Phase 2, investigator-initiated clinical trial evaluating PDS0101 in combination with chemoradiation therapy in patients with advanced cervical cancer Indication Treatment of patients with locally advanced cervical cancer – Stages IB3-IVA Chemoradiotherapy (CRT – Standard of Care): Cisplatin & rad
Slide 20: Studies designed to demonstrate efficacy and broad applicability of PDS0101 and Versamune
Studies are designed to demonstrate efficacy and broad applicability of PDS0101 and the Versamune® T-cell activating platform Potential to treat all types of HPV-cancer: PDS0101 Phase 2 clinical studies address all types of HPV-associated cancers. Enhance anti-cancer efficacy of various cancer treat
Slide 21: Looking Forward
Looking Forward
Slide 22: Financial position to support PDS0101 milestones through mid-2022
Financial position to support PDS0101 projected milestones through mid-2022* Nasdaq: PDSB *Based on current enrollment and forecast modeling as of November 2020. Subject to change. 22
Slide 23: Positioned for accelerated development: key advantages and differentiators
Positioned for accelerated development Key Advantages and Differentiators PIPELINE • Enhanced anti-cancer efficacy: Early clinical data and preclinical data suggest potentially superior efficacy, safety and versatility of the platform • Near-term milestone: PDS0101 preliminary data Q1-Q2 2021 • Vali
Slide 24: Nasdaq: PDSB
Nasdaq: PDSB Developing powerful, safe, versatile immunotherapies
PDS Biotechnology — Investor Presentation (January 2021) on 6ix