Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Edge Therapeutics — Merger or Acquisition (March 2019)
29 slides from Pds Biotechnology's merger presentation, Mar 4, 2019
Slide 1: PDS Biotechnology: Next Generation Immunotherapies
PDS Biotechnology ‘Next Generation Immunotherapies Anew generation of multi-functional cancer immunotherapies March 2019
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements about Edge Therapeutics, Inc. ("Edge") and PDS Biotechnology Corporation (“PDSB"), and their respective businesses, business prospects, strategies and plans, including but not limited to statements regarding anticipated
Slide 3: Other Important Information
Other Important Information In connection with a proposed strategic merger, Edge has filed relevant materials with the Securities and Exchange ‘Commission (SEC), including a registration statement on Form S-4 that contains a proxy statement and prospectus. Investors ‘may obtain the proxy statement/p
Slide 4: PDS Biotechnology Corporation (PDSB)
PDS Biotechnology Corporation (PDSB) + PDS Biotechnology Corporation (Princeton, NJ; Private) and Edge Therapeutics, Inc. (Berkeley Heights, NJ; Nasdaq: EDGE) have agreed upon a merger, subject to Edge stockholder approval and the satisfaction of certain other conditions precedent + The combined com
Slide 5: Investment Highlights
Investment Highlights + Clinical stage biotechnology company developing pipeline of novel cancer Eos immunotherapies based on proprietary Versamune® platform Biotechnology a Proprietary Pl + Versatile T-cell-activating platform developed to treat early- & late-stage cancers + Early clinical data and
Slide 6: Projected 2019 Key Milestones
010 2019: 4102019: 02a 2019: 04a 2019: 040 2019: 040 2019: Projected 2019 Key Milestones Completion of PDS Biotechnology — Edge Therapeutics merger Submission of publication on Versamune® mechanism of action Submission of publication on results of PDS0101 Phase 1 clinical study Initiation of CIN2/3
Slide 7: Post-Combination Management Team
Post-Combination Management Team Frank Bedu-Addo, Andrew Saik Lauren V. Wood, Gregory Conn, Brad Middlekauft ‘MD PhD Chief Financial Oficer Chief Medical Oc Chit Science Oficer Chief Legal Officer merck Pri mga Medrex endo = REGENERON Cooley + Strategy & managed || + >20 years of + 230 years of + Co
Slide 8: PDSB Board of Directors
PDSB Board of Directors Board of Directors Affiliation Robert Spiegel, MD, FACP vow! chara ® Schering Plough Former CMO Sir Richard Sykes, PhD [es Former CEO & Chairman De Lyle Bloomquist TATA CHEMICALS Former Global President Gregory Freitag @sxoGen.__ General Counsel, SVP BD, BoD James J. Loughlin
Slide 9: 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 Start Potential Registration CIN 23 Monetherapy ‘Study 402019" Head & neck cancer First line treatment merck —_—Keytruda Start Phase 2.40 2019" posoro1 ——Recurtentimetastatic (HPV)
Slide 10: Clinical Strategy: Establish PDS0101 Market Leadership
Clinical Strategy: Establish PDS0101 Market Leadership and Validate Versamune® Platform + Potential for market-leading potency, efficacy, and safety + Phase 1/2a study demonstrated in-vivo induction of HPV-specific killer T- cells (CD8+) - Potentially overcomes limitation of currently available immu
Slide 11: Projected Clinical Milestones
Projected Clinical Milestones 2019 2020 2021 Fi 2022 2023: Qs ai 2 Q3 Q4 ai Q@2 Qs asiai a2 3 a4 ai CIN 2/3 Registration - Monotherapy Precancer 150 Subjects First Line i Recurrent/Metastatic Phase 2 - Combination Head & Neck Cancer 85 Subjects Partner: Merck & Co.) eens: NCL Phase 2 - Combination a
Slide 12: Differentiated Versamune Platform Activates Key I-O Pathways
Differentiated Versamune® Platform Activates Key I-O Pathways Mechanism of Action Overcomes Critical Limitations of Current Immunotherapies To Induce Sufficient Levels of Active Tumor-Targeting Killer T-cells In Vivo Effectively Stimulates trains killer T- cells to attack cancer Makes. tumors more v
Slide 13: Versamune Potential: Best-in-Class In Vivo Induction
Versamune® Potential: Best-in-Class In Vivo Induction & Activation of Tumor-Targeting CD8+ T-Cells ¥ Destabilizes cell endosomes + Allows antigens to access MHC Class | Pathway + MHC Class 1 access necessary to activate CD8+ Killer T-cells Broad range of possible applications in oncology by activati
Slide 14: Lead Phase Clinical Product: PDS0101
Lead Phase 2 Clinical Product: PDS0101 + PDS0101 is comprised of two separate component vials, mixed at bedside: one of Versamune®, and another containing a proprietary mixture of six HPV proteins — Subcutaneous injection, using off-the-shelf product + Efficacy is expected to be independent of patie
Slide 15: Unique PDS0101 Formulation Presents Advantages
Unique PDS0101 Formulation Presents Advantages in Efficacy, Manufacturing, and Administration == Vial of HPV Peptides Vial of Versamune® Vials PDS0101 Formulation By Electron Microscopy Mixed Bedside > Proprietary HPV Versamune' Peptide Antigens
Slide 16: Superior PDS0101 Preclinical Activity Vs. Published I-O Data
Superior PDS0101 Preclinical Activity Vs. Published I-O Data in HPV Pre-cancers All Companies Have Reported Strong Human Clinical Data Genexine"** Inovio* Antigen Technology DNA Peptides DNA Method of administration | Electroporation | Subcutaneous | Electroporation Preclinical regression of Partial
Slide 17: Rationale for Development of PDS0101
Rationale for Development of PDS0101 Potent Ability to Eliminate HPV-Positive Tumors in Preclinical Studies as a Result of Excellent /n-Vivo Induction of CD8+ (Killer) & CD4+ (Helper) T-cells & Infiltration into Tumors + PDS0101 (Versamune® + HPV16) uniquely induces complete regression of HPV-positi
Slide 18: Rationale for Combination of Versamune with Checkpoint Inhibitors
Rationale for Combination of Versamune® with Checkpoint Inhibitors (aPD1/L1) Excellent /n-Vivo Induction of CD8+ (Killer) T-cells Leads to Strong Synergy with anti PD-1 ‘Antibody in Melanoma Preclinical Studies - Resulting in Significantly Prolonged Survival * PDS0104 (Versamune® + melanoma antigen)
Slide 19: PDS0101 Phase 1/2a Dose Escalating Study
PDS0101 Phase 1/2a Dose Escalating Study Over 20-Fold Increase in HPV-Specific CD8+ T-Cell Responses Versus Pre-Treatment Levels at Recommended Clinical Doses 10mg ‘iller T-Cells (CD8+) 18x Clinical Study Design + Open-label study + Cervical intraepithelial Neo- plasia (CIN) & high-risk HPV + 3 coho
Slide 20: Worldwide Burden of Cancer Attributable to HPV
Worldwide Burden of Cancer Attributable to HPV Based on Data Collected in 2012* Incidence in Vulvar! Thousands Anal Cervical _| Head & Neck | _ Peni Vaginal Asia 174 278.0 120 59 63 Europe 69 58.0 138 27 5A Latin America 29 69.0 13 20 25 N. America 45 14.0 89 14 33 World 35.0 530.0 37.5 13.0 20.0 +
Slide 21: HPV Market — United States
HPV Market — United States* HPV Experts Project Current HPV Preventive Vaccines to have Little Impact on HPV-related Cancer Incidences for Several Decades** Annual Incidence ‘Annual incidence Female Male ovectanr See vate Penis ~ Incidence 3412 3% hes ‘269 anwst | — ~43,000 HPV-associated cancers un
Slide 22: Key Takeaways From PDS0101 Phase 1/2a Clinical Study
Key Takeaways From PDS0101 Phase 1/2a Clinical Study + Strong correlation between preclinical animal data and human data 7 — Strong and measurable in-vivo induction of Proceed into HPV-specific killer T-cells 14-19 days after multiple PDS0101 treatment nase — Induction of a memory immune response me
Slide 23: PDSB Intellectual Property (Versamune-Related Products)
PDSB Intellectual Property (Versamune®-Related Products) PDSB IP Strategy Provides Multiple Layers of Technology and Product Protection + Versamune® and associated patents 100% owned by PDS + Four issued US patents, valid from 2025 — 2033 + Five issued international patents (including Europe & Japan
Slide 24: Post-Combination Operational/Financial Overview
Post-Combination Operational/Financial Overview + PDSB will continue operations in NJ with approximately 10 employees * Approximately $25M of net cash* projected as of expected merger closing + Cash on hand expected to be sufficient to fund operations into Q4 2020 + Additional funds required to purs
Slide 25: Summary: Differentiating Versamune Technology
Summary: Differentiating Versamune® Technology Presents Potential to Address Key I-O Limitations Checkpoint Cancer Inl lors CAR ells: Vaccines Versamut Induction of CD8+ x v x v (killer) T-cells Ex-vivo Limited In-vivo Overcome tumor immune suppressive v x x v mechanisms Induction of 7 rignory Pestl
Slide 26: What Makes Versamune The Next Generation Cancer Immunotherapy?
What Makes Versamune® The Next Generation Cancer Immunotherapy? + Potential best-in-class activation of tumor-targeted CD8+ T-cells — Stimulating a successful immunologic anti-tumor response requires the following * Ability to present variety of antigens via MHC Class | Pathway * Ability to prime th
Slide 27: Differentiated Platform & Data Strongly Support Progression of Phase 2 Programs
Differentiated Platform & Data Strongly Support Progression of PDS Phase 2 Clinical Programs Versamune® Platform Lead Clinical Program: PDS0101 Versatile T-cell-activating platform developed to treat early & late-stage cancers Early clinical data and preclinical studies suggest potential for best-in
Slide 28: PDSB Wrap-up
PDSB Wrap-up Powerful and safe T-cell-activating immunotherapy platform Potential to transform treatment of early- and late-stage HPV-cancers Validation: Superior preclinical and clinical data Clinical Partnerships with Big Pharma and National Cancer Institute @ 2) © Upcoming Phase 2 clinical trials
Slide 29: PDS Biotechnology: Next Generation Immunotherapies
PDS Biotechnology ‘Next Generation Immunotherapies Anew generation of multi-functional cancer immunotherapies March 2019
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