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Inovio may13presentation
- 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, and other regulatory filings from time to time. 2
- 3. Revolutionizing Vaccines measles anthrax polio cowpox • Prevent and treat diseases • Build on legacy of vaccines: tackle conditions that traditional vaccines have not touched • Provide “universal” protection from known and unknown strains of infectious diseases Edward Jenner Louis Pasteur Jonas Salk Maurice Hilleman3
- 4. Products • Best in class immune responses 4
- 5. Products • Best in class immune responses • Products target multi-billion dollar healthcare markets • Multiple clinical trials in Phase I & II • Favorable safety profile • Best gene therapy delivery system (electroporation) • Dominant global IP position 5
- 6. Validation • Bill Gates funding our malaria program • US Gov’t granted $25 million to speed HIV vaccine development • NIH Director: “transformational research” • Major media attention • Overall, almost $50 million in non- dilutive grants in past few years 6
- 7. Strategy • Build on proof-of- concept studies with phase I and II clinical trials • Spread cost/risk with: o Non-dilutive partner funding o R&D grants o “Sponsored” clinical trials • May partner out licensed products for final development and commercialization 7
- 9. • If you’re over 45 you probably would not be here today • Drastically lowered infant mortality rate • #1 human invention Impact of Vaccines: Pros 9
- 10. Traditional vaccinetechnology • 60 years old (some vaccines still grown in eggs) • Has safety concerns • Reached limits Impact of Vaccines: Cons 10
- 11. Inovio’s DNA Vaccine Platform • Vaccine Design • Vaccine Delivery • Vaccine Manufacturing 11
- 12. DNA Vaccine Design • No killed or weakened virus • Begin with strip of DNA called plasmid • Use existing genetic sequences to target disease or infection • Create “synthetic consensus” DNA- sequenced vaccine • Made in pure water 12
- 13. DNA Vaccine Delivery electroporation pulse • Successfully jumped the hurdle of DNA vaccine delivery • The “no adjuvants” DNA delivery method: millisecond electric pulse (electroporation) • Can increase uptake by 1000-fold 13
- 14. DNA Vaccine Manufacturing • Dedicated manufacturing facility • Speed: faster than traditional methods • Scalability • Thermal stability 14
- 15. 15
- 16. Inovio’s clinical trials • Three programs in phase II • Best-in-class antibody and T-cell results • Important trial results in 2013 16
- 17. Disease Vaccine Name Disease Impact Trial Results Clinical Trials Cancer VGX-3100 Cervical cancer 500,000 new cases and 250,000 deaths annually Phase I (completed) • Most robust immediate T-cell response/78% • Most durable (9 months) T-cell response/92% • Safe & well tolerated 17
- 18. Disease Vaccine Name Disease Impact Trial Results Next steps Clinical Trials Cancer VGX-3100 Cervical cancer 500,000 new cases and 250,000 deaths annually Phase II (on-going) Efficacy data expected 1Q 2014 • Randomized, double-blinded, placebo controlled • More than 25 sites in 7 countries • Advanced cervical dysplasia clearance within 9 months 18
- 19. Disease Vaccine name Disease Impact Trial Results Preventative therapeutic Next steps Clinical Trials HIV DNA HIV vaccine PENNVAX-B® 30 million infected worldwide • First vaccine designed to prevent and treat HIV infection Phase I interim: Data accepted for publication • 89% T-cell response Best in class results • 75% antigen-specific T-cell response 19
- 20. Disease Vaccine name Disease Impact Clinical Trials Influenza Universal influenza vaccine 500,000 deaths each year 20
- 21. Disease Vaccine name Disease Impact Trial Results Clinical Trials Influenza Universal influenza vaccine 500,000 deaths each year Phase I : VGX-3400X • T-cell and antibody responses • Protection against all “unmatched” strains tested • Greater than 1:20 HAI titers INO-3510 • DNA vaccine w/annual vaccine doubled protection in elderly • Protection against all “unmatched” strains tested • Greater than 1:40 HAI titers 21
- 22. Disease Vaccine name Partner Disease Impact Trial Results Next steps Clinical Trials Hepatitis C (Genotype 1) ChronVac-C (NS3/4A DNA) delivered with INO’s MedPulser device ChronTech Pharma 5 million infected in U.S; 200 million worldwide Phase I: (4 vaccinations + IFN-α + ribavirin) Phase II: (2 vaccinations + IFN- α + ribavirin) Interim results at week 12 of treatment: • 75% (6 of 8) subjects showed viral clearance • Safe & well tolerated • Vaccine + drug group: 65% (11 of 17) HCV clearance • Drug only group: 58% (7 of 12) HCV clearance 22
- 23. Disease Vaccine name Trial Results Next steps Clinical Trials Hepatitis C (genotype 1) INO-8000: Inovio’s proprietary DNA HCV vaccine • Multi-antigen: NS3/4A, NS4B, and NS5A • Most advanced CELLECTRA® device Preclinical results: Initiate phase I/IIa clinical trial by year-end 2013 • Generated robust T-cell responses in the liver • Toxicity testing 23
- 24. Disease Vaccine name Partner Disease Impact Trial Results Clinical Trials Leukemia DNA leukemia vaccine University of Southampton (UK) CML- 300,000 new cases annually AML- 200,000 deaths annually Phase II Interim: • Antibodies and “killer” T-cells detected in CML patients 24
- 25. power of our people • Management • Board of Directors • Scientific Advisory Board 25
- 26. 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 26
- 27. 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 27
- 28. 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 28
- 29. 12/1/12 1/1/13 2/1/13 3/1/13 4/1/13 5/1/13 financial information $0.80 $0.60 $0.40 $0.20 2013 C u r r e n c y i n u s d 29
- 30. Financial Information Cash, cash equivalents & short-term investments1 $ 30.9 M Debt1 0 M Cash runway 4Q 2014 issued& outstandingshares2 179.9 M Recent price2 $ 0.60 Market cap2 $ 107.9 M listing Nysemkt: INO 1February2013cash,cash equivalents& short-Term investmentsof $16.9M, plusnet proceedsof $14.0M from march2013financing 2 Asof May1, 2013 4/1/13 5/1/13 $0.60 $0.40 $0.20 $0.80 30
- 31. investment rationale • The future of vaccines: DNA vaccines • Best-in-class immune responses • Near-term clinical milestones • Non-dilutive funding • Partnership discussions with Big Pharma 31
- 32. Bernie Hertel Senior Director, Corporate Communications 858-410-3101 bhertel@inovio.com Investor Contact investor contacts 32