PDS Biotechnology Corporation · NASDAQ:PDSB
PDS Biotechnology — H.C. Wainwright 21st Annual Global Investment Conference 2019
25 slides from PDS Biotechnology's conference presentation, Sep 10, 2019
Slide 1: A new generation of multi-functional cancer immunotherapies
A new generation of multi-functional cancer immunotherapies H.C. Wainwright 21st Annual Global Investment Conference September 10, 2019 Frank Bedu-Addo Ph.D. President & CEO
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 preclinical and clinical drug development activit
Slide 3: Investment Highlights
Investment Highlights PDS • Clinical stage biotechnology company developing pipeline of novel cancer Biotechnology immunotherapies based on proprietary Versamune® platform • Versatile T-cell-activating platform developed to treat early- & late-stage cancers Versamune® • Early clinical data and precl
Slide 4: Current State of Immuno-Oncology (I-O)
Current State of Immuno-Oncology (I-O) • Durability of anti-tumor responses in some patients The Promise of I-O • Disease control for many years, resulting in improvements in duration of overall survival • Only minority of patients respond (15-25% on average) The Frustration of I-O • Additive toxici
Slide 5: Differentiated Versamune Platform Overcomes Key I-O Limitations
Differentiated Versamune® Platform Overcomes Key I-O Limitations Engineered to address the basics: Results in potent tumor-recognizing and attacking killer T-cells in vivo* 1 2 3 4 Trains killer T- Activates Makes tumors Induces memory cells to powerful T-cells more susceptible immune recognize & to
Slide 6: Efficient Activation of MOAs #1 & 2: Superior HPV-Specific T-Cells
Efficient Activation of MOAs #1 & 2: Promotes Superior Quantity & Quality of HPV-Specific Tumor-Attacking T-Cells In-Vivo Versamune® induces superior levels of CD8+ T-Cells versus competing approaches (analysis by interferon gamma ELISPOT) **P<0.05 # of HPV-Recognizing T-Cells 2,000 IFN-γ Spot Formi
Slide 7: PDS0101: Efficient Activation of MOAs #1-4: Eliminates HPV-Positive TC-1 Tumors
PDS0101: Efficient Activation of MOAs #1 - 4: Promotes Unique Ability to Eliminate HPV-Positive TC-1 Tumors with Sustained T-Cell Response In vivo induction of superior quantity & quality of tumor-specific CD4+ and CD8+ T-cells result in complete regression & effective T-cell memory after a single d
Slide 8: Unique Formulations Present Advantages in Potency, Manufacturing, and Administration
Unique Formulations Present Advantages in Potency, Manufacturing, and Administration Proprietary Antigen Versamune® Design Potential best-in-class simplicity, ease of administration and cost of goods 8
Slide 9: Power of PDS0101 Demonstrated in Humans: Phase 1/2a Study
Power of PDS0101 Demonstrated in Humans: Phase 1/2a Dose Escalating Study Showed Potent CD8+ T-Cell Induction Over 20-Fold Increase in HPV-Specific CD8+ T-Cell Responses Versus Pre-Treatment Levels at Recommended Clinical Doses 10mg Granzyme-b: Killer T-Cells (CD8+) 18x Clinical Study Design R-DOTAP
Slide 10: PDS0101 Monotherapy: Phase 2b Clinical Study in CIN2/3
PDS0101 Monotherapy: Phase 2b Clinical Study in CIN2/3 Treatment of HPV16-Positive Cervical Intraepithelial Neoplasia (CIN2/3) (Study Initiation in Q4 2019) Placebo Controlled, Double Blind Study PDS0101 PLACEBO TOTAL Study Sample Size N=100 N=50 150 Planned # of Study Sites Up to 35 Planned Interim
Slide 11: PDS0101 + Keytruda Clinical Study in HPV-Associated Head and Neck Cancer
PDS0101 + Keytruda® Clinical Study in HPV-Associated Head and Neck Cancer First Line Treatment of HPV16 Positive Recurrent/Metastatic Head and Neck Cancer (Study Initiation in Q4 2019) Open Label, Single Arm, Non-Randomized Study TOTAL Study Sample Size 96 Anticipated # of Study Sites ~20 Primary Ef
Slide 12: PDS0101 Clinical Combination Study in Advanced HPV-Associated Cancers
PDS0101 Clinical Combination Study in Advanced HPV-Associated Cancers Treatment of Advanced HPV-Associated Cancers (PDS-NCI Collaboration) (Study Initiation Anticipated in Q1 2020) Open Label, Single Arm, Non-Randomized Study TOTAL Study Sample Size 30 Anticipated # of Study Sites N=1 (NCI Bethesda,
Slide 13: Developing Broad Product Pipeline with Leaders in I-O
Developing Broad Product Pipeline with Leaders in I-O Product Indication Partner Combination Status Cervical pre-cancer CIN 2/3 Monotherapy Start Phase 2b 4Q 2019* Head & neck cancer First line treatment Keytruda® Start Phase 2 4Q 2019* Recurrent/metastatic PDS0101 Novel (HPV) Advanced HPV cancers I
Slide 14: PDS0104: Regression of B16 Melanoma Lung Metastasis Tumors (Preclinical)
PDS0104: Powerful In-Vivo Killer T-Cell Induction Results in Unique Ability to Regress B16 Melanoma Lung Metastasis Tumors (Preclinical) In vivo induction of superior quantity and quality of tumor-specific CD4+ and CD8+ T-cells results in regression of metastatic tumors in lungs after a single dose
Slide 15: Intellectual Property (Versamune-Related Products)
Intellectual Property (Versamune® -Related Products) IP strategy intended to provide multiple layers of technology & product protection • Versamune® and associated patents 100% owned by PDS • Five issued US patents valid from 2025 – 2034 • Five issued international patent families (including Europe
Slide 16: Projected Near-Term Milestones / Catalysts
Projected Near-Term Milestones / Catalysts ❑Q4 2019: Release available patient outcome data from Phase 1/2a clinical study ❑Q4 2019: Initiation of CIN2/3 monotherapy Phase 2b study ❑Q4 2019: Initiation of PDS-Merck Phase 2 combination study in head and neck cancer ❑Q1 2020: Initiation of PDS-NCI Pha
Slide 17: Financial Information
Financial Information Nasdaq: PDSB 1 Shares Outstanding 5.2M 1 Cash on Hand $21.7M 2 Recent Share Price $5.60 2 Market Cap $29.9M 1 Debt None 1 June 30, 2019 2 September 4, 2019 17
Slide 18: Wrap-Up
Wrap-Up 1 Powerful and safe T-cell-activating immunotherapy platform 2 Versatility - potential to transform treatment of early- & late-stage cancers Validation: Superior preclinical and clinical data 3 Clinical partnerships with both Big Pharma and NCI Upcoming Phase 2 clinical studies 4 Both in mon
Slide 19: Appendix
APPENDIX 19
Slide 20: Management Team
Management Team Frank Bedu-Addo, PhD Andrew Saik Lauren V. Wood, MD Gregory Conn, PhD Chief Executive Officer Chief Financial Officer Chief Medical Officer Chief Science Officer • Strategy & managed • >20 years of • >30 years of • Co-founder execution at both large experience in pharma translational
Slide 21: Versamune MOA #1: Antigen Processing and Internalization
Versamune® MOA #1: Unique Ability to Facilitate Antigen Processing and Internalization Promotes Effective Training/Priming of Killer T-Cells (CD8+) Confocal microscopy (Fluorescent DQ-Ovalbumin as model tumor antigen) DQ-OVA ONLY ± MPL DQ-OVA DQ-OVA + (Receptor-mediated ± Versamune® + R-DOTAP Ineffi
Slide 22: Versamune MOA #2: Localized & Specific Activation of Type I Interferons
Versamune® MOA #2: Localized & Specific Activation of Type I Interferons Promotes Superior Quantity & Quality of Tumor-Attacking T-Cells In-Vivo Versamune® induced superior levels of polyfunctional (multi-cytokine inducing) CD8+ T-Cells versus competing approaches* Versamune® IFA.Cyt** MontanideTM 4
Slide 23: Versamune MOA #2: Upregulation of Type I IFN Genes
Versamune® MOA #2: Upregulation of Type I IFN Genes Promotes Chemokine- Induced T-Cell Infiltration into Lymph Nodes Which Persists For Several Days Elevated T-cell levels persist in LNs for greater than 7 days after 1 subcutaneous injection* *J. Immunology, 2019 (202), 1215 23 ** IFA.Cyt (quadruple
Slide 24: Versamune MOA #3: Altering the Tumor Microenvironment
Versamune® MOA #3: Versamune® + Antigen Results in Altering of Tumor Microenvironment - Makes Tumors More Susceptible to T-Cell Attack Significant lowering of the immune suppressive T-reg to CD8+ T-cell ratio in tumors c e ll in f ilt r a t in g t o t u m o r 128 * P<0.01 T c e ll r a t io 64 32 PDS
Slide 25: A new generation of multi-functional cancer immunotherapies
A new generation of multi-functional cancer immunotherapies H.C. Wainwright 21st Annual Global Investment Conference September 10, 2019 Frank Bedu-Addo Ph.D. President & CEO
PDS Biotechnology — H.C. Wainwright 21st Annual Global Investment Conference 2019 on 6ix