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- 1. Revolutionizing Vaccines Dr. J. Joseph Kim President & CEO
- 2. 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. 2
- 3. 3 Overview
- 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 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
- 6. • 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
- 7. Validation 7 • 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
- 8. Strategy 7 • 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
- 10. 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 10
- 11. #1 Medical Invention 11 INFANT MORTALITY RATE WORLDWIDELIFE EXPECTANCY • Reduced child mortality • Increased life span • Protected billions from sickness and death
- 12. 12 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!
- 14. Immune Stimulation in the 21st Century 14 • Synthetic • Not a weakened, killed, or part of a virus • Therapeutic • Not preventive only • Universal • Not protective against only a single, matched strain
- 15. 15 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
- 16. 16 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
- 17. Efficient DNA Vaccine Manufacturing 17 • DNA plasmid production • Bacterial fermentation process • Efficient, fast, cost effective, scalable
- 18. DNA Delivery: Electroporation Electric fields 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 18 Cellular vaccine uptakeCell produces coded antigen
- 19. 19 Raising the Bar: Best in Class Immune Responses
- 20. 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 20
- 21. Universal Immune Responses 21 • 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
- 22. Broad Medical and Market Opportunities Product Name INTERNALLY FUNDED Indication Preclinical Phase I Phase II Cervical dysplasiaVgx-3100 Prostate cancerIno-5150 Breast/lung cancersIno-1400 EXTERNALLY FUNDED hivpennvax® influenzaIno-3510 Hepatitis CIno-8000 Hepatitis Bino-1800 malariaMaV-12 Milestones Therapeutic Therapeutic Therapeutic Therapeutic Preventive Preventive Preventive/Therapeutic Therapeutic 22 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
- 23. 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 23 Broad Medical and Market Opportunities
- 24. 24 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 ) - 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
- 25. 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 25 Phase I Trial Results
- 26. 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 26 Phase IITrial
- 27. 27 HPV Product Franchise Planning: • CIN 2/3 phase III • Other HPV-related indications: initiate phase IIs • Orphan designation potential Therapeutic HPV
- 28. power of our people • Management • Board of Directors • Scientific Advisory Board 28
- 29. 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 29
- 30. 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 30
- 31. 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 31
- 32. 32 1/1/13 2/1/13 3/1/13 4/1/13 5/1/13 6/1/13 7/1/13 8/1/13 9/1/13 Stock Price
- 33. 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 $2.55 Market cap3 $486.5 M NYSE MKT: INO 1June 30, 2013 3 Sept. 10, 2013 33 8/10/2013 9/10/2013 Additional cash raised2 $ 11.4 M 2Aug. 9, 2013 Roche up-front payment $ 10 M
- 34. 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 34
- 35. Bernie Hertel Senior Director, Corporate Communications 858-410-3101 bhertel@inovio.com Investor Contact investor contacts 35