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September 2013 Corporate Presentation
Citation preview
Revolutionizing Vaccines
Dr. J. Joseph Kim President & CEO
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, 2012, our Form 10-Q for the quarter ended June 30, 2013 and other regulatory filings from time to time.
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Overview
Inovio’s Technology
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Plasmids
Electroporation device
• DNA vaccines
• Electroporation delivery
• Best-in-class immune responses
• Favorable safety profile
• Over 400 patents
Products
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• Targeting cancers and infectious diseases
• Multi-billion dollar healthcare markets
• Lead program for
HPV-caused disease in phase II
• First efficacy data in mid-2014
• Multiple clinical trials in phase I
• Collaborating with a global leader in innovative cancer drugs • Develop and commercialize Inovio’s prostate cancer (INO-
5150) and hepatitis B (INO-1800) immunotherapies • $10 million up-front payment • $412.5 million milestone payments for certain development
and commercial events • Roche may pay other development milestone payments if it
pursues other indications with INO-5150 or INO-1800 • Roche to fund all ongoing development costs • Up to double-digit royalties on sales of a marketed product
Roche Partnership
Validation
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• Advancing partnering discussions with large pharma
• Gates-funded malaria program
• US gov’t $25M grant for HIV vaccine development
• NIH Director: “Transformational Research” grant • Almost $60 million in
non-dilutive grants in past few years
Strategy
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• Establish product proof-of-principle with phase I and II clinical trials
• Spread cost/risk & advance development & commercialization: o R&D grants
o “Sponsored”
clinical trials
o Partnerships
Why Revolutionize Vaccines?
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Stimulating the Immune System: A Powerful Legacy
• 1776: concept of “modern” vaccination
• Effective vaccines
against 20+ diseases cowpox anthrax
polio
measles Edward Jenner Louis Pasteur Maurice Hilleman
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#1 Medical Invention
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INFANT MORTALITY RATE
WORLDWIDE LIFE EXPECTANCY
• Reduced child mortality
• Increased life span
• Protected billions from sickness and death
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Extending the Legacy
• Concept of stimulating immune system as relevant today as ever
• Can we create 21st century technology to fight today’s cancers & challenging infectious diseases?
• Yes!
How do we Revolutionize Vaccines?
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Immune Stimulation in the 21st Century
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• Synthetic • Not a
weakened, killed, or part of a virus
• Therapeutic
• Not preventive only
• Universal
• Not protective against only a single, matched strain
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Inovio’s Synthetic DNA Vaccines
• Contain DNA code for target disease antigen(s)
• Body produces antigen
• Cannot replicate
• Closest to body’s natural
immune response
• Preventive antibodies • Therapeutic T-cells
• Formulated in water • Stable at room temp
Immune response to last century conventional vaccine
antibodies
Immune response to 21st century DNA vaccine
T-cells
antibodies
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Novel Consensus Design
• Use gene sequences from multiple strains or types of target disease antigen
• Create new antigen DNA
sequence to help the body recognize: • “Self” made cancer
cells
• Break tolerance
• Similar but unmatched strains
• Universal, cross-strain protection
• Novel DNA sequences
patentable
Differentiate cancer cells from “self”
Multi-strain protection within Pathogen families
New synthetic consensus sequence
Multiple unique strains
Break Tolerance Universal Protection
Efficient DNA Vaccine Manufacturing
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• DNA plasmid production
• Bacterial fermentation process
• Efficient, fast, cost effective, scalable
DNA Delivery: Electroporation
Electric fields applied Vaccine injection
• Overcome two decade hurdle of DNA delivery
• Millisecond electric pulses create pores in cells
• Increase vaccine
uptake 1000X
• Enables cells to produce target antigen
• Widest and deepest global patent estate
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Cellular vaccine uptake Cell produces coded antigen
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Raising the Bar: Best in Class Immune Responses
Functional T-Cell Responses
• Highest magnitude of T-cell responses
• 83% response rate in highest dose group
• 92% of responders showed 9 month durability
• 91% of responders showed killing effect against target cells
• HIV study: 89% response rate with robust T-cells
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Universal Immune Responses
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• Protective HAI titers in humans against 9 unmatched strains of H1N1 flu from last 100 years
• Strong HAI titers in humans against 6 unmatched strains of deadly H5N1 flu
• Protection against
newly emergent, pandemic-potential H7N9 influenza in mice challenge study
Conventional vaccine: single matched strain only
DNA vaccine: multiple unmatched strains
Broad Medical and Market Opportunities
Product Name
INTERNALLY FUNDED
Indication Preclinical Phase I Phase II
Cervical dysplasia Vgx-3100
Prostate cancer Ino-5150
Breast/lung cancers Ino-1400
EXTERNALLY FUNDED
hiv pennvax®
influenza Ino-3510
Hepatitis C Ino-8000
Hepatitis B ino-1800
malaria MaV-12
Milestones
Therapeutic
Therapeutic
Therapeutic
Therapeutic
Preventive
Preventive
Preventive/Therapeutic
Therapeutic
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1H 2014 Initiate phase I/IIa
Mid-2014 Phase II study data
2014 Initiate phase I/IIa
2013 Initiate PENNVAX – GP phase I study
2013 Phase I data reported
4Q 2013 Initiate phase I/IIa
2014 Prepare phase I/IIa
2014 Initiate phase I/IIa
VGX-3100 • Capitalizes on Inovio’s ability to generate T
cells • Immunotherapy for pre-cancers & cancers
caused by human papillomavirus (HPV) • Phase II on-going: high grade cervical pre-cancers (CIN 2/3 dysplasia) • Projected efficacy data: mid-2014
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Broad Medical and Market Opportunities
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Cervical Cancer 12,357 new cases 3,909 deaths
CIN 2/3 dysplasia 300-400K new cases
CIN 1 dysplasia 1.4M new cases
Head & neck cancer (HPV Related) 20,000 new cases 7,922 deaths (oropharyngeal only)
Anogenital cancers (HPV related ) - Excluding cervical
7,931 new cases 2,396 deaths
U.S. Market opportunity ~ 70% of high risk cervical pre-cancers & cancers caused by HPV Type 16 and 18
Therapeutic HPV
VGX-3100
Therapeutic HPV
• Diseases caused by HPV Type 16 and 18; Target antigens: E6 and E7
• 18 “healthy” patients with
prior CIN 2/3 dysplasia
• Robust immediate T-cell response, average across dose groups/78%
• Dose response
• 92% of responders showed 9 month durability
• 91% with killing effect
• Safe & well tolerated
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Phase I Trial
Results
Next steps
Therapeutic HPV
Top-line efficacy data expected mid-2014
• Study protocol: minimum 148 patients with CIN 2/3
• Enrollment completed • Randomized, double-blinded,
placebo controlled
• More than 25 sites in 7 countries • Primary endpoint: regression to
CIN 1
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Phase II Trial
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HPV Product
Franchise Planning:
• CIN 2/3 phase III
• Other HPV-related indications: initiate phase IIs • Orphan designation potential
Therapeutic HPV
power of our people
• Management • Board of Directors • Scientific Advisory Board
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Management
anthrax
polio
cowpox
Louis Pasteur
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
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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Board of Directors
anthrax
polio
cowpox
Louis Pasteur Simon X. Benito
• Former Senior Vice President, Merck Vaccine Division
Angel Cabrera, PhD • President, George Mason University
• Former President, Thunderbird School of Global Management
J.Joseph Kim, PhD • President & CEO, Inovio
Adel Mahmoud, PhD • Professor, Princeton University • Former President, Merck Vaccines • Responsible for Gardasil®, Zostavax®, Proquad® and Rotateq®
Avtar Dhillon, MD Chairman, BOD
• Former President & CEO, Inovio Biomedical
Morton Collins, PhD • General Partner, Battelle Ventures and Innovations Valley Partners
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Scientific Advisory Board
anthrax
polio
cowpox
Louis Pasteur 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®
Stanley A. Plotkin, MD • Developed rubella and rabies vaccines • Oversaw Sanofi flu vaccine • Emeritus Professor, Wistar Institute & University of Pennsylvania
David B. Weiner, PhD Chairman
•“Father of DNA vaccines” • Dept. of Pathology & Laboratory Medicine,
University of Pennsylvania
Philip Greenberg, MD • Expert in T-cell immunology • Head, Immunology Program, Fred Hutchinson Cancer Research Center
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Stock Price
Financial Information
Cash, cash equivalents & short-term investments1 $ 23.6 M
Debt1 0 M
Cash runway 3Q 2015
Issued & outstanding shares2 190.8 M
Recent price3 $2.33
Market cap3 $444.6 M
NYSE MKT: INO
1June 30, 2013 3 Sept. 19, 2013
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8/19/2013 9/19/2013
Additional cash raised2
$ 11.4 M
2Aug. 9, 2013
Roche up-front payment $ 10 M
Investor Highlights • Break-through 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
• Phase II efficacy data coming
• Validating partnership with Roche
The Opportunity
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Bernie Hertel Senior Director, Corporate Communications 858-410-3101 [email protected]
Investor Contact
investor contacts
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