Presentaiton inovio 314


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Presentaiton inovio 314

  1. 1. Revolutionizing Vaccines Dr. J. Joseph Kim President & CEO NYSE MKT: INO
  2. 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, 2013, and other regulatory filings from time to time. 2
  3. 3. 3 2013: Dynamic Year • Best T cell responses in published clinical studies • Validating license deal with Roche in 2013 2014: Transformative Year • Phase II efficacy and immunogenicity data from lead drug mid-year • More cancer trials starting (cervical, head & neck, prostate, breast, lung, pancreatic cancers) • Additional pharma discussions on-going Inovio: Global Leader in Active Immune Therapy
  4. 4. • 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 • Roche funding all ongoing development costs as well as funded research for new prostate cancer antigens • $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 • Up to double-digit royalties on sales of a marketed product Validating Partnership with Roche (September 2013) 4
  5. 5. Broad Medical and Market Opportunities Product Name INTERNALLYFUNDED Indication Preclinical Phase I Phase II Vgx-3100 Ino-5150 Ino-1400 EXTERNALLYFUNDED pennvax® Ino-3510 Ino-8000 ino-1800 malariaMaV-12 Phase III Preventive 5 INO-3112 INO-3112 Preventive HepatitisC Therapeutic HepatitisB Therapeutic influenza Preventive hiv Preventive/ Therapeutic Breast/lung/ Pancreaticcancers Therapeutic Prostatecancer Therapeutic Head&NeckCancer Therapeutic CervicalCancer Therapeutic Cervicaldysplasia Therapeutic
  6. 6. • Are safe and tolerable • Requires a directive to attack T cells: Inovio Commands the Body’s SWAT Team T cell Cytotoxic T lymphocyte Target cell Provided by Dr. Philip Greenberg Hutchinson Cancer Research Center 6
  7. 7. • T cells are vital to clearing cancerous or infected cells • Active immuno- therapies: harnessing the power of T cells • Inovio’s DNA immunotherapies displaying best-in-class T cells • Functional killing effect • Safe and well tolerated • >400 patents globally T cells: Inovio Commands the Body’s SWAT Team Antigen- specific T cell Cytotoxic T lymphocyte CD8+ T cells Target cell and antigen(s) 7
  8. 8. 8 Checkpoint Inhibitors Alone are Good but Not Good Enough • Inovio cancer vaccines greatly increase T cells • Overwhelm cancer cells as monotherapy • Potential to combine with checkpoint inhibitors to increase efficacy • Potential to improve safety and tolerability • Unprecedented efficacy • Melanoma • Lung cancer • Validate potential of T cell active immunotherapies • Evidence suggests that non- responders do not have sufficient pre-existing T cell levels • Concerns re: safety/tolerability • Projected $24 billion market Source: Citi
  9. 9. Strain 1 Strain X Strain 2 Antigen Y Antigen Y Antigen Y T Cells by Design: Antigen-Specific, Optimized, Best-in-Class 9 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 – PATENTABLE
  10. 10. Insert SynCon® gene sequence for selected antigen into DNA plasmid. SYNCON® DNA Antigen consensus sequence DNA Plasmid Designed to Break Tolerance or Provide Universal Protection 10 SynCon DNA plasmid ready to manufacture.
  11. 11. Electroporation Delivery Plays a Vital Role 11
  12. 12. Optimized DNA Plasmid + EP: Better Antigen Expression Ref: Sardesai & Weiner Curr. Opin. Immunol. 2011 1000x enhancement in cellular uptake and antigen expression Intramuscular Intradermal 12 EP = electroporation
  13. 13. Inovio DNA/EP Beats Previous Gold Standard (Merck Ad5 Viral Vector) for T Cell Generation (Non-Human Primates) SIV Model: UPenn/Merck/Inovio Assay: Data Co-Published T Cell ELISpot Assay T Cell Proliferation Assay DNA + EP Ad5 DNA + EP Ad5 Ref: Hirao et al. Molecular Therapy, August 2010 Flow Cytometry Assay 13
  14. 14. PENNVAX®: Highest CD8+ T Cell Responses for HIV Vaccine Ref: Kalams et al JID 201314 A: 3X vaccination without EP B: 4X vaccination without EP C: 2x vaccination with EP (month 2) D: 3x vaccination with EP (month 4) E: Memory response (month 9) A B C D E • Best CD8+ T cell response in HIV clinical studies • Durable T cell memory responses • Safe and well tolerated
  15. 15. 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) • Targeting E6/E7 oncogenes • Phase II on-going: high grade cervical pre-cancers (CIN 2/3 dysplasia) • Efficacy and immunogenicity data: mid-2014 15
  16. 16. Inovio’s Lead Product Targets All HPV-caused Diseases 16 Source: CDC Incidence rates in the U.S.
  17. 17. Combined CohortsIndividual Dose Cohorts VGX-3100 Induces Robust and Durable T Cell Responses Bagarazzi, Yan, Morrow et al. Sci Transl Med 4, 155ra138 (2012) • 14/18 (78%) subjects responded to at least one antigen • 13/18 (72%) responded to at least two antigens • 9/18 (50%) responded to all four antigens 17 ELISpot Assay
  18. 18. Bagarazzi, Yan, Morrow et al, Science Trans. Med. (2012) HPV16-, HPV18-Specific IFN-γ Production Multi-parameter flow cytometry: CD4, CD8 activation phenotype
  19. 19. HPV16-, HPV18-Specific CD107a, Granzyme B, Perforin Bagarazzi, Yan, Morrow et al, Science Trans. Med. (2012) CD8 cytolytic phenotype 19
  20. 20. VGX-3100 Flow Cytometry – Functional Killing Assays Inovio ConfidentialBagarazzi, Yan, Morrow et al. Sci Transl Med 4, 155ra138 (2012) Quantitative Assay Qualitative Assay • Patient pre-VGX3100 PBMC are targets, post-VGX3100 PBMC are effectors • Quantitative - PBMC added irrespective of Ag-specific CD8 frequency • Qualitative - PBMC normalized to account for Ag-specific CD8 frequency • Measure granzyme B delivery to targets 20
  21. 21. 21 VGX-3100 Phase II Study Design
  22. 22. Phase II Data Impact on Medical and Market Opportunities • Efficacy data • Path forward to phase III for CIN 2/3 • Expansion of product use to other HPV-related indications (cervical cancer, head/neck cancer, and anogenital cancer) • Seek orphan designation potential • T cell and safety data • Broader platform validation for all Inovio immunotherapy products in the pipeline 22
  23. 23. INO-1400: Potential Universal Cancer Therapy Yan J et al., Cancer Immunol Res. (2013)23 Dharmapuri et al., Mol Ther. (2009)
  24. 24. 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 24 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
  25. 25. 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 25 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
  26. 26. 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 26 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
  27. 27. Financial Information Cash, cash equivalents & short-term investments3 $ 52.6 M Debt3 0 M Cash runway 4Q 2017 Shares outstanding2 239.6 M Recent price1 $3.42 Market cap1 $ 819.4 M NYSE MKT: INO 1Mar 17, 2014 3 Dec 31, 2013 27 Additional cash after year end4 $ 69.3 M 2Mar 7, 2014 4 Mar 14, 2014
  28. 28. INTERNALLYFUNDED EXTERNALLYFUNDED Ino-5150 1H 2014 Initiate phase IProstatecancer Vgx-3100 Mid-2014 Phase II study dataCervicaldysplasia INO-3112 1H 2014 Initiate phase I/IIaHead&NeckCancer 28 Upcoming Value Drivers INO-3112 1H 2014 Initiate phase I/IIaCervicalCancer Ino-1400 2H 2014 Initiate phase I/IIa Breast/lung/ PancreaticCancer PennVAX® 2H 2014 Initiate PENNVAX-GP phase IHIV Ino-8000 2015 Report phase I data Hepatitis C Ino-1800 Early 2015 Initiate phase I/IIaHepatitis B c
  29. 29. Investor Highlights • Break-through active 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 with more deals in the works The Opportunity 29