Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (October 2019)
20 slides from Pds Biotechnology's investor presentation, Oct 1, 2019
Slide 1: Corporate Presentation September 2019
Corporate PresentationSeptember 2019Frank Bedu-Addo Ph.D.President & CEO
Slide 2: Forward-Looking Statements
Forward-Looking Statements 2 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 activ
Slide 3: Investment Highlights
Investment Highlights 3 Versamune® Platform Versatile T-cell-activating platform developed to treat early- & late-stage cancersEarly clinical data and preclinical studies suggest potential for best-in-class combination of potency and safetyStrong induction of CD8+ and CD4+ T-cells demonstrated in Ph
Slide 4: Current State of Immuno-Oncology (I-O)
Current State of Immuno-Oncology (I-O) 4 The Promise of I-O Durability of anti-tumor responses in some patientsDisease control for many years, resulting in improvements in duration of overall survival Only minority of patients respond (15-25% on average) Additive toxicities of different I-O agents i
Slide 5: Multi-Functional Versamune Platform Overcomes Key I-O Limitations
Multi-Functional Versamune® Platform Overcomes Key I-O Limitations 5 Engineered to promote in-vivo induction of tumor-recognizing and attacking killer (CD8+) T-cells* Trains killer T-cells to recognize & attack cancer Activates powerful T-cells to attack cancer cells Makes tumors more susceptible to
Slide 6: Versamune Mechanisms of Action: Superior HPV-Specific Killer T-Cells In-Vivo
6 500 1,000 1,500 2,000 PDS0101* GM-CSF/E7* DNA-Vaccine# Live Vector Vaccine## # of HPV-Recognizing T-CellsIFN-γ Spot Forming Cells/1X106 Spleen cells Versamune® Mechanisms of Action: Promote Superior Quantity & Quality of HPV-Specific Tumor-Attacking Killer T-Cells In-Vivo Versamune® induces superi
Slide 7: PDS0101 Eliminates HPV-Positive TC-1 Tumors & Generates Sustained T-Cell Response
PDS0101: Multi-Functional Mechanism Promotes Superior Ability to Eliminate HPV-Positive TC-1 Tumors & Generates Sustained T-Cell Response 7 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
Slide 8: Unique Formulations Present Advantages in Potency, Manufacturing, and Administration
Unique Formulations Present Advantages in Potency, Manufacturing, and Administration 8 Versamune® Proprietary AntigenDesign Potential best-in-class simplicity, ease of administration and cost of goods
Slide 9: PDS0101 Phase 1 Dose Escalating Study Showed Potent CD8+ T-Cell Induction
PDS0101 Mechanism Leads to Potent in-vivo Killer T-cell Response in Humans: Phase 1 Dose Escalating Study Showed Potent CD8+ T-Cell Induction 14x 24x IFN-γ: Total T-Cells 26x >20-Fold Increase in HPV-Specific CD8+ T-Cell ResponsesVs. Pre-Treatment Levels at Recommended Clinical Doses 9 Order of Magn
Slide 10: PDS0101 Phase 1 Follow-up: Clearance of CIN Lesions in 60% of Evaluable Patients
PDS0101 Phase 1 Follow-up Data Supports Observed Strong Killer T-Cell Induction:Demonstrated Clearance of CIN Lesions in 60% of Evaluable Patients 10 PDS0101 was immunologically active at all three doses resulting in 5 to 73-fold increase in circulating HPV disease-attacking T-cells in 10/12 subject
Slide 11: PDS0101 + KEYTRUDA Clinical Study in HPV-Associated Head and Neck Cancer
PDS0101 + KEYTRUDA® Clinical Study in HPV-Associated Head and Neck Cancer 11 Primary Efficacy EndpointObjective Response Rate (ORR) at 9 months following the initial dose of combination treatment.NoteMerck received FDA approval for KEYTRUDA® (checkpoint inhibitor) alone or with chemotherapy on 06/10
Slide 12: PDS0101 Clinical Combination Study in Advanced HPV-Associated Cancers
PDS0101 Clinical Combination Study in Advanced HPV-Associated Cancers 12 Combination with two novel & clinically tested (large pharma owned) immunotherapiesPrimary Efficacy EndpointPercentage of subjects that achieve an objective confirmed complete or partial response using RECIST 1.1.Regulatory Str
Slide 13: Developing Broad Product Pipeline with Leaders in I-O
Developing Broad Product Pipeline with Leaders in I-O 13 Product Indication Partner Combination Status PDS0101(HPV-Cancer) Head & neck cancer First line treatment Recurrent/metastatic KEYTRUDA® Initiate Phase 2 1Q 2020* Advanced HPV cancers NovelImmunotherapies Initiate Phase 2 1Q 2020* Cervical can
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) 14 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 do
Slide 15: Intellectual Property (Versamune-Related Products)
Intellectual Property (Versamune® -Related Products) 15 Versamune® and associated patents 100% owned by PDSFive issued US patents valid from 2025 – 2034Five issued international patent families (including Europe & Japan)10 total patent families – provides possible protection of products through 2038
Slide 16: Projected Near-Term Milestones / Catalysts
16 3Q 2019: Release available patient outcome data from Phase 1 clinical study1Q 2020: Initiation of PDS-Merck Phase 2 combination study in head and neck cancer 1Q 2020: Initiation of PDS-NCI Phase 2 combination study in advanced HPV-cancers 2Q 2020: Publication of PDS0101 Phase 1 clinical study res
Slide 17: Financial Information
Financial Information 17 1 June 30, 2019 2 September 30, 2019 Nasdaq: PDSB Shares Outstanding1 5.2M Cash1 $21.7M Share Price2 $3.33 Market Cap2 $17.3M Debt1 ---
Slide 18: Wrap-Up
Wrap-Up 18 Powerful and safe T-cell-activating immunotherapy platform Versatility: Potential to transform treatment of early- & late-stage cancers Validation: Superior preclinical and clinical data Clinical partnerships with both Big Pharma and NCI Upcoming Phase 2 clinical studies 1 2 3 4
Slide 19: Management Team
Management Team 19 Frank Bedu-Addo, PhDChief Executive Officer Gregory Conn, PhDChief Science Officer Lauren V. Wood, MDChief Medical Officer Andrew SaikChief Financial Officer Strategy & managed execution at both large pharma & biotechsNotable drug development:Abelcet® (Liposome Company/ Elan)PEG-I
Slide 20: Corporate Presentation October 2019
Corporate PresentationOctober 2019Frank Bedu-Addo Ph.D.President & CEO
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