inovio - corporate presentation - july 2014
DESCRIPTION
Corporate Presentation - July 2014TRANSCRIPT
Revolutionizing the Fight Against Cancers and Infectious Diseases
Dr. Joseph Kim President & CEO NYSE MKT: INO
Forward Looking Statement
Our commentary and responses to your questions may contain forward-looking statements, including comments concerning clinical trials and product development programs, evaluation of potential opportunities, the level of corporate expenditures, the assessment of Inovio’s technology by potential corporate partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors that could cause actual results to differ materially from those set forth in our Annual Report on Form 10-K for the year ended December 31, 2013, our Form 10-Q for the quarter ended March 31, 2014, and other regulatory filings from time to time.
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2013: Dynamic Year • Best T cell responses in published clinical studies • Validating license deal with Roche in 2013
2014: Transformative Year
• Phase II meets efficacy endpoints: breakthrough for active immunotherapy field
• More cancer trials starting (cervical, head & neck, prostate, breast, lung, pancreatic cancers)
• Working toward additional pharma partnerships
Inovio: Global Leader in Active Immune Therapy
Phase II Data: Meets Efficacy Endpoints With Robust T Cells
• Efficacy data meets primary and secondary efficacy endpoints
• Induces regression of a cervical intraepithelial neoplastic process • Eliminates HPV • Robust HPV-specific T cell responses in majority of treated
subjects, as in phase I study • Treatment well-tolerated; administration site redness • Detailed data will be submitted for publication in
peer-reviewed journal 4
VGX-3100 Placebo P Value
CIN 2/3 Regression to CIN 1 or No Disease
49.5% 53 of 107
30.6% 11 of 36 <0.025
HPV Clearance AND CIN 2/3 Regression to CIN 1 or No Disease
40.2% 43 of 107
14.3% 5 of 35 <0.025
Phase II Data: Clinical and Technology Validation
• Significant step toward providing women and physicians a non-surgical treatment for pre-cancerous lesions
• Advance VGX-3100 for precancerous dysplasias and HPV-associated cervical, head and neck, and anogenital cancers
• SynCon® immunotherapy technology can activate immune system to fight chronic infections, pre-cancers — and ultimately cancers
• De-risk product and business development strategy for VGX-3100 and broad pipeline of SynCon® active immune therapy products
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Broad Medical and Market Opportunities
Product Name
INTERNALLY FUNDED
Indication Preclinical Phase I Phase II
Vgx-3100
Ino-5150
Ino-1400
EXTERNALLY FUNDED
pennvax®
Ino-3510
Ino-8000
ino-1800
malaria MaV-12
Phase III
Preventive
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INO-3112
INO-3112
Preventive
Hepatitis C Therapeutic
Hepatitis B Therapeutic
influenza
Preventive
hiv
Preventive/Therapeutic
Breast/lung / Pancreatic cancers
Therapeutic
Prostate cancer Therapeutic
Head & Neck Cancer Therapeutic
Cervical Cancer Therapeutic
Cervical dysplasia
Therapeutic
T cells: Inovio Commands the Body’s SWAT Team
T cell Cytotoxic T lymphocyte
Target cell
Provided by Dr. Philip Greenberg Hutchinson Cancer Research Center
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• T cells are vital to clearing cancerous or infected cells
• Active immuno-therapies: harnessing the power of T cells
• Inovio’s DNA immunotherapies displaying best-in-class T cells
• Functional killing effect • Safe and well tolerated • >400 patents globally
T cells: Inovio Commands the Body’s SWAT Team
Antigen-specific T cell Cytotoxic T lymphocyte CD8+ T cells
Target cell and antigen(s)
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Strain 1
Strain X
Strain 2
Antigen Y
Antigen Y Antigen Y
T Cells by Design: Antigen-Specific, Optimized, Best-in-Class
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Identify gene sequence of selected antigen(s) from chosen strains/variants of the virus/cancer
Synthetically create optimal consensus gene sequence for the selected antigen – PATENTABLE
Insert SynCon® gene sequence for selected antigen into DNA plasmid.
SYNCON® DNA
Antigen consensus
sequence
DNA Plasmid
Designed to Break Tolerance or Provide Universal Protection
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SynCon DNA plasmid ready to manufacture.
Electroporation Delivery Plays a Vital Role
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SynCon®+ Electroporation: Significant Antigen Expression
Ref: Sardesai & Weiner Curr. Opin. Immunol. 2011
1000x increase in cellular uptake and antigen production/ expression
Intramuscular Intradermal
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Inovio DNA/EP Beats Previous Gold Standard (Merck Ad5 Viral Vector) for T Cell Generation (Non-Human Primates)
SIV Model: UPenn/Merck/Inovio Assay: Data Co-Published T Cell ELISpot Assay T Cell Proliferation Assay
DNA + EP Ad5 DNA + EP Ad5
Ref: Hirao et al. Molecular Therapy, August 2010
Flow Cytometry Assay
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Ad5 DNA + EP Ad5 DNA + EP
PENNVAX®: Highest CD8+ T Cell Responses for HIV Vaccine
Ref: Kalams et al JID 2013 14
A: 3X vaccination without EP B: 4X vaccination without EP C: 2x vaccination with EP (month 2) D: 3x vaccination with EP (month 4) E: Memory response (month 9)
A B C D E
• Best CD8+ T cell response in HIV clinical studies
• Durable T cell memory responses
• Safe and well tolerated
0 1 2 3 4 5 6 7 8 9 Dosing Schedule (Months)
Combined Cohorts Individual Dose Cohorts
VGX-3100 Induces Robust and Durable T Cell Responses
Bagarazzi, Yan, Morrow et al. Sci Transl Med 4, 155ra138 (2012)
• 14/18 (78%) subjects responded to at least one antigen • 13/18 (72%) responded to at least two antigens • 9/18 (50%) responded to all four antigens
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ELISpot Assay
0 1 2 3 4 5 6 7 8 9 Dosing Schedule (Months)
Bagarazzi, Yan, Morrow et al, Science Trans. Med. (2012)
HPV16-, HPV18-Specific IFN-γ Production
Multi-parameter flow cytometry: CD4, CD8 activation phenotype
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HPV16-, HPV18-Specific CD107a, Granzyme B, Perforin
Bagarazzi, Yan, Morrow et al, Science Trans. Med. (2012)
CD8 cytolytic phenotype
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VGX-3100 Flow Cytometry – Functional Killing Assays
Inovio Confidential Bagarazzi, Yan, Morrow et al. Sci Transl Med 4, 155ra138 (2012)
Quantitative Assay
Qualitative Assay
• Patient pre-VGX-3100 PBMC are targets, post-VGX-3100 PBMC are effectors • Quantitative - PBMC added irrespective of Ag-specific CD8 frequency • Qualitative - PBMC normalized to account for Ag-specific CD8 frequency • Measure granzyme B delivery to targets
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Checkpoint Inhibitors: T Cell Validation; Combination Potential
• Inovio cancer vaccines greatly increase T cells
• Potential to overwhelm cancer cells as monotherapy
• Potential to combine with checkpoint inhibitors to increase efficacy
• Unprecedented efficacy • Melanoma, lung cancer
• Validate potential to enhance T
cell capabilities
• Evidence suggests non-responders do not have sufficient pre-existing T cells
• Projected $24 billion market (Citi)
Inovio’s Lead Program
VGX-3100: • Capitalizes on Inovio’s ability to generate T cells • Immunotherapy for pre-cancers and cancers caused by
human papillomavirus (HPV) • Targeting E6/E7 oncogenes
• Phase II completed: high grade cervical pre-cancers (CIN 2/3 dysplasia)
• Top-line efficacy data reported • In-depth data to be submitted to peer-reviewed journal
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Inovio’s Lead Product Targets All HPV-caused Diseases
21 Sources: CDC, www.hpvcentre.net; WHO IARC
Incidence rates in the U.S. + EU5
VGX-3100 Phase II Study
• Placebo-controlled, randomized, doubled blind • 148+ subjects: females 18-55 • Histologically confirmed HPV16 or 18-associated CIN 2/3 or 3 • 3:1 VGX-3100/electroporation vs. placebo/electroporation • Two plasmids: Type 16 and Type 18, each encoded for E6/E7
antigens; 3 mg/ml per plasmid; treatment at months 0, 1, 3 • Primary endpoint month 9
• Regression of CIN 2/3 to CIN 1 or no disease • Secondary endpoints
• Clearance of HPV 16 or 18 AND CIN 2/3 regression • Immunogenicity • Safety
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INO-1400: Potential Universal Cancer Therapy Targeting hTERT (overexpressed in 85% of cancers)
Yan J et al., Cancer Immunol Res. (2013) 23
Dharmapuri et al., Mol Ther. (2009)
T-cell generation: older generation DNA vaccine and electroporation device
SynCon® T-cell generation with CELLECTRA® electroporation device
anthrax Louis Pasteur
Peter Kies CFO • Ernst & Young • Experience with growth companies
Mark L. Bagarazzi, MD CMO • Clinical research experience incl. Merck • Led clinical/regulatory for shingles and rotavirus vaccines; DNA vaccine expert
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J.Joseph Kim, PhD President & CEO
• Decades of biotechnology/pharma management
• Merck: hepatitis A and B vaccines manufacturing; HIV vaccine (Ad5) R&D
Niranjan Y. Sardesai, PhD COO
• Extensive biotech management and product development experience
• Led development of diagnostics for mesothelioma, bladder cancer, and ovarian
cancer for Fujirebio Diagnostics
Management
anthrax Louis Pasteur
J.Joseph Kim, PhD • President & CEO, Inovio
Adel Mahmoud, PhD • Professor, Princeton University • Former President, Merck Vaccines • Responsible for Gardasil®, Zostavax®, Proquad® and Rotateq®
Morton Collins, PhD • General Partner, Battelle Ventures and Innovations Valley Partners
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Simon X. Benito • Former Senior Vice President,
Merck Vaccine Division
Angel Cabrera, PhD • President, George Mason University
• Former President, Thunderbird School of Global Management
Avtar Dhillon, MD Chairman, BOD
• Former President & CEO, Inovio Biomedical
Board of Directors
anthrax Louis Pasteur
Stanley A. Plotkin, MD • Developed rubella and rabies vaccines • Oversaw Sanofi flu vaccine • Emeritus Professor, Wistar Institute & University of Pennsylvania
Philip Greenberg, MD • Expert in T cell immunology • Head, Immunology Program, Fred Hutchinson Cancer Research Center
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Thomas S. Edgington, MD • Founded multiple biotech companies;
extensively published • Emeritus Professor, Scripps
Research Institute
Anthony W. Ford-Hutchinson, PhD • Former SVP, Vaccines R&D, Merck
• Oversaw development: Singulair®, Januvia®, Gardasil®, Zostavax®, Proquad® and Rotateq®
David B. Weiner, PhD Chairman
•“Father of DNA vaccines” • Dept. of Pathology & Laboratory Medicine,
University of Pennsylvania
Scientific Advisory Board
Financial Information
Cash, cash equivalents & short-term investments2 $ 116.8 M
Debt2 0 M
Cash runway 4Q 2017
Shares outstanding3 60.0 M
Recent price1 $11.14
Market cap1 $ 668.4 M
NYSE MKT: INO
1July 22, 2014
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2Mar 31, 2014 3March 31 (reflecting June 6th 1:4 reverse split)
INTERNALLY FUNDED EXTERNALLY FUNDED
Ino-5150 3Q 2014 Initiate phase I Prostate cancer
Vgx-3100 Phase II meets efficacy endpoints Cervical dysplasia
INO-3112 2Q 2014 Initiated phase I/IIa
Head & Neck Cancer
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Upcoming Value Drivers
INO-3112 2Q 2014 Initiated phase I/IIa
Cervical Cancer
Ino-1400 2H 2014 Initiate phase I/IIa
Breast/lung/ Pancreatic Cancer
PennVAX®
4Q 2014 Initiate PENNVAX -GP phase I HIV
Ino-8000 2015 Report phase I data
Hepatitis C
Ino-1800 Early 2015 Initiate phase I/IIa Hepatitis B
• Phase II data meets efficacy endpoints
• Break-through active immune therapy with the power to save lives and maximize shareholder value
• Targeting broad range of diseases and billion dollar markets • Best-in-class T cells to prevent, treat & cure cancers and infectious diseases • Validating partnership with Roche with more deals in the works
Investor Highlights
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Revolutionizing the Fight Against Cancers and Infectious Diseases