inovio pharmaceuticals, inc. corporate presentation december 2013
TRANSCRIPT
Revolutionizing Vaccines
Dr. J. 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, 2012, our Form 10-Q for the quarter ended September 30, 2013 and other regulatory filings from time to time.
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Roche Partnership
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• 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 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
• Are safe and tolerable
• Requires a directive to attack
T cells: Inovio Commands the Body’s SWAT Team
T cell Cytotoxic T lymphocyte
Infected cell
Provided by Dr. Philip Greenberg Hutchinson Cancer Research Center
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Inovio’s Technology
Plasmids
Electroporation device
• Synthetic DNA vaccines
• Electroporation delivery
• Best-in-class immune responses
• Favorable safety profile • Over 400 patents
Inovio’s Technology
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Choose important strains/variants of target virus/cancer
Select important common antigen(s), which body recognizes as foreign and relates to a cancer or infected cell
The Basis For How We Stimulate T-cells
Strain 1
Strain 2
Strain X
Antigen Y
Antigen Y
Antigen Y
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Strain 1
Strain X
Strain 2
Antigen Y
Antigen Y Antigen Y
The Basis For How We Stimulate T-cells
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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
Insert SynCon® gene sequence for selected antigen into DNA plasmid
SYNCON® DNA
Antigen consensus
sequence
DNA Plasmid
The Basis For How We Stimulate T-cells
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SynCon DNA plasmid ready to manufacture
DNA vaccine delivered into muscle or skin
Electroporation: millisecond electrical fields applied
Temporary pores in cell membrane; significant cellular uptake of vaccine
Antigen-presenting cells engulf the antigens and carry them to lymph nodes
Antibodies or killer T-cells that can eliminate cancerous or infected cells are produced
Cell membrane reseals. Cellular machinery uses the DNA code to produce one or more of the targeted disease antigens
The Basis For How We Stimulate T-cells
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Better Delivery = Enhanced Gene Expression
Ref: Sardesai & Weiner Curr. Opin. Immunol. 2011
1000x enhancement in cellular uptake > 10-100x enhancement in immunogenicity
Intramuscular Intradermal
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#1 in Accelerating and Driving T Cell Responses
“Immunotherapy against HPV 16/18 generates potent TH1 and cytotoxic cellular immune responses” October 10, 2012
“Safety and comparative immunogenicity of an HIV-1 DNA vaccine in combination with plasmid Interleukin 12 and impact of intramuscular electroporation for delivery” July 8, 2013
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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
Phase III
Therapeutic
Therapeutic
Therapeutic
Therapeutic
Preventive
Preventive
Preventive/Therapeutic
Therapeutic
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Therapeutic
Therapeutic
Cervical Cancer
Head & Neck Cancer
INO-3112
INO-3112
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) • Phase II on-going: high grade cervical pre-
cancers (CIN 2/3 dysplasia) • Projected efficacy data: mid-2014
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Inovio’s Lead Program
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VGX-3100: Phase I Study Data
• Strong T-cell response in 14 of 18 (78%) vaccinated subjects at month 4
• 83% response rate in highest dose group
*Immunotherapy against HPV16/18 generates potent TH1 and cytotoxic cellular immune responses. Sci Transl Med. 2012 Oct; 4:155ra13. dOI:10.1126/scitranslmed.3004414
Inovio’s Lead Program
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Phase I trial results for vgx-3100
• 9 month durability of robust T cell response in 12/14 responders
• Safe & well tolerated
Inovio’s Lead Program
Source: Science Translational Medicine Oct. 2012 16
• 10/11 responders showed killing effect against target cells
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Inovio’s Lead Program
Broad Medical and Market Opportunities
HPV product franchise planning • CIN 2/3 Phase III • Other HPV-related indications: initiate Phase IIs • Orphan designation potential
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Strategy
• Build on proof-of-concept studies with phase I/II clinical trials
• Spread cost/risk with: o Non-dilutive
partner funding o R&D grants
o “Sponsored”
clinical trials • May partner or license
out products for further development and commercialization
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Broad Base of Support for Inovio
• Universities • Government • Foundations • Corporate partnerships
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Almost $60M in funding since 2009
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Broad Base of Support for Inovio
power of our people
• Management • Board of Directors • Scientific Advisory Board
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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
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Stock Price $3.00
$0.50
Financial Information
Cash, cash equivalents & short-term investments1 $ 46.3 M
Debt1 0 M
Cash runway 1Q 2016
Issued & outstanding shares2 208.4 M
Recent price3 $1.98
Market cap3 $412.6 M
NYSE MKT: INO
1Sep. 30, 2013 3 Dec. 9, 2013
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11/9/2013 12/9/2013
Additional cash raised2
$ 11.1 M
2Nov. 12, 2013
$1.98
Upcoming Value Drivers
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INTERNALLY FUNDED EXTERNALLY FUNDED
Ino-5150 1H 2014 Initiate phase I/IIa Prostate cancer
Vgx-3100 Mid-2014 Phase II study data Cervical dysplasia
INO-3112 1H 2014 Initiate phase I/IIa
Head & Neck Cancer
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Upcoming Value Drivers
INO-3112 1H 2014 Initiate phase I/IIa
Cervical Cancer
Ino-1400 2014 Initiate phase I/IIa
Breast/lung Cancer
INTERNALLY FUNDED EXTERNALLY FUNDED
PennVAX® 1H 2014 Initiate PENNVAX -GP phase I study HIV
Ino-8000 2015 Report phase I data Hepatitis C
MAV-12 2014 Initiate phase I/IIa
Malaria
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Upcoming Value Drivers
Ino-1800 2014 Prepare phase I/IIa Hepatitis B
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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