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- 1. Revolutionizing Vaccines Dr. J. JosephKim President & CEO
- 2. Forward Looking Statement Ourcommentary 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 March 31, 2013 and other regulatory filings from time to time. 2
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- 4. Inovio’s Technology 4 Plasmids Electroporation device •DNA vaccines • Electroporation delivery • Best-in-class immune responses • Favorable safety profile • Over 400 patents
- 5. Products 5 • Targeting cancers andinfectious diseases • Multi-billion dollar healthcare markets • Lead program for HPV-caused disease in phase II • First efficacy data in Q1 2014 • Multiple clinical trials in phase I
- 6. Validation 6 • Advancing partnering discussions with largepharma • Gates-funded malaria program • US gov’t $25M grant for HIV vaccine development • NIH Director: “Transformational Research” grant • Almost $50 million in non-dilutive grants in past few years
- 7. Strategy 7 • Establish product proof-of-principle withphase I and II clinical trials • Spread cost/risk & advance development & commercialization: o R&D grants o “Sponsored” clinical trials o Partnerships
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- 9. Stimulating the ImmuneSystem: A Powerful Legacy • 1776: concept of “modern” vaccination • Effective vaccines against 20+ diseases cowpox anthrax polio measles Edward Jenner Louis Pasteur Maurice Hilleman 9
- 10. #1 Medical Invention 10 INFANTMORTALITY RATE WORLDWIDELIFE EXPECTANCY • Reduced child mortality • Increased life span • Protected billions from sickness and death
- 11. 11 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!
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- 13. Immune Stimulation inthe 21st Century 13 • Synthetic • Not a weakened, killed, or part of a virus • Therapeutic • Not preventive only • Universal • Not protective against only a single, matched strain
- 14. 14 Inovio’s Synthetic DNAVaccines • 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
- 15. 15 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 BreakTolerance Universal Protection
- 16. Efficient DNA VaccineManufacturing 16 • DNA plasmid production • Bacterial fermentation process • Efficient, fast, cost effective, scalable
- 17. DNA Delivery: Electroporation Electricfields appliedVaccine 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 17 Cellular vaccine uptakeCell produces coded antigen
- 18. 18 Raising the Bar: Bestin Class Immune Responses
- 19. 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 19
- 20. Universal Immune Responses 20 •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
- 21. Preclinical Phase IPhase II Product Pipeline indication milestone INOVIO STUDIES INTERNALLY FUNDED EXTERNALLYFUNDED Cervical dysplasia THERAPEUTIC HIV PREVENTIVE/THERAPEUTIC influenza PREVENTIVE Hepatitis C THERAPEUTIC Malaria PREVENTIVE 1Q 2014 Phase II study data 2013 Initiate PENNVAX-GP Phase I study 2013 Phase I data reported 4Q 2013 Initiate Phase I/IIa 2014 Initiate Phase I/IIa
- 22. Inovio’s Lead Program • VGX-3100:therapeutic vaccine • HPV-caused pre-cancers & cancers • Phase II • First efficacy data: 1Q 2014 22
- 23. 23 Cervical Cancer 12,357new cases 3,909 deaths CIN 2/3 dysplasia 300-400K new cases CIN 1 dysplasia 1.4M new cases Head & neck cancer (HPV Related) 8,380 new cases 7,922 deaths (oropharyngeal only) Anogenital cancers (HPV related ) - Excludingcervical 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
- 24. VGX-3100 Therapeutic HPV • Diseasescaused by HPV Type 16 and 18; Target antigens: E6 and E7 • 18 “healthy” patients with prior CIN 2/3 dyplasia • 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 24 Phase I Trial Results
- 25. Next steps Therapeutic HPV Efficacydata expected 1Q 2014 • 148 patients with CIN 2/3 • Randomized, double-blinded, placebo controlled • More than 25 sites in 7 countries • Primary endpoint: lesion clearance within 9 months 25 Phase IITrial
- 26. 26 HPV Product Franchise Planning: • CIN2/3 phase III • Other HPV-related indications: initiate phase IIs • Orphan designation potential Therapeutic HPV
- 27. power of our people •Management • Board of Directors • Scientific Advisory Board 27
- 28. Management anthrax polio cowpox Louis Pasteur J.Joseph Kim,PhD President & CEO • Decades of biotechnology/pharma management • Ex-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 • Ex-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 28
- 29. Board of Directors anthrax polio cowpox LouisPasteur 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 29
- 30. Scientific Advisory Board anthrax polio cowpox LouisPasteur 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 30
- 31. 1/1/13 2/1/13 3/1/134/1/13 5/1/13 6/1/13 7/1/13 financial information $1.47 31
- 32. Financial Information Cash, cashequivalents & short-term investments1 $ 28.2M Debt1 0 M Cash runway 4Q 2014 issued& outstandingshares2 179.9 M Recent price2 $ 1.47 Market cap2 $ 264.5M listing Nysemkt: INO 1March 31,2013 2 July10,2013 6/10/13 7/10/13 $1.47 32
- 33. 33 Investment highlights • Novelvaccine technology platform with best-in-class immune responses • Partnering discussions with Big Pharma • Phase II efficacy data 1Q 2014 • Large opportunity – cancers and infectious diseases with unmet needs; broad pipeline • Substantial non-dilutive funding
- 34. Bernie Hertel Senior Director,Corporate Communications 858-410-3101 bhertel@inovio.com Investor Contact investor contacts 34