Inovio - Corporate Presentation - July 2014


Published on

Corporate Presentation - July 2014

Published in: Investor Relations
  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

Inovio - Corporate Presentation - July 2014

  1. 1. Revolutionizing the Fight Against Cancers and Infectious Diseases Dr. 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, our Form 10-Q for the quarter ended March 31, 2014, 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 meets efficacy endpoints: breakthrough for active immunotherapy field • More cancer trials starting (cervical, head & neck, prostate, breast, lung, pancreatic cancers) • Working toward additional pharma partnerships Inovio: Global Leader in Active Immune Therapy
  4. 4. Phase II Data: Meets Efficacy Endpoints With Robust T Cells • Efficacy data meets primary and secondary efficacy endpoints • Induces regression of a cervical intraepithelial neoplastic process • Eliminates HPV • Robust HPV-specific T cell responses in majority of treated subjects, as in phase I study • Treatment well-tolerated; administration site redness • Detailed data will be submitted for publication in peer-reviewed journal4 VGX-3100 Placebo P Value CIN 2/3 Regression to CIN 1 or No Disease 49.5% 53 of 107 30.6% 11 of 36 <0.025 HPV Clearance AND CIN 2/3 Regression to CIN 1 or No Disease 40.2% 43 of 107 14.3% 5 of 35 <0.025
  5. 5. Phase II Data: Clinical and Technology Validation • Significant step toward providing women and physicians a non- surgical treatment for pre-cancerous lesions • Advance VGX-3100 for precancerous dysplasias and HPV- associated cervical, head and neck, and anogenital cancers • SynCon® immunotherapy technology can activate immune system to fight chronic infections, pre-cancers — and ultimately cancers • De-risk product and business development strategy for VGX-3100 and broad pipeline of SynCon® active immune therapy products 5
  6. 6. 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 6 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
  7. 7. 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 7
  8. 8. • 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) 8
  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. SynCon®+ Electroporation: Significant Antigen Expression Ref: Sardesai & Weiner Curr. Opin. Immunol. 2011 1000x increase in cellular uptake and antigen production/ expression Intramuscular Intradermal 12
  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 Ad5 DNA + EP Ad5 DNA + EP
  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 0 1 2 3 4 5 6 7 8 9Dosing Schedule (Months)
  15. 15. 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 15 ELISpot Assay 0 1 2 3 4 5 6 7 8 9Dosing Schedule (Months)
  16. 16. Bagarazzi, Yan, Morrow et al, Science Trans. Med. (2012) HPV16-, HPV18-Specific IFN-γ Production Multi-parameter flow cytometry: CD4, CD8 activation phenotype 16
  17. 17. HPV16-, HPV18-Specific CD107a, Granzyme B, Perforin Bagarazzi, Yan, Morrow et al, Science Trans. Med. (2012) CD8 cytolytic phenotype 17
  18. 18. 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-VGX-3100 PBMC are targets, post-VGX-3100 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 18
  19. 19. 19 Checkpoint Inhibitors: T Cell Validation; Combination Potential • Inovio cancer vaccines greatly increase T cells • Potential to overwhelm cancer cells as monotherapy • Potential to combine with checkpoint inhibitors to increase efficacy • Unprecedented efficacy • Melanoma, lung cancer • Validate potential to enhance T cell capabilities • Evidence suggests non-responders do not have sufficient pre-existing T cells • Projected $24 billion market (Citi)
  20. 20. 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 completed: high grade cervical pre-cancers (CIN 2/3 dysplasia) • Top-line efficacy data reported • In-depth data to be submitted to peer-reviewed journal 20
  21. 21. Inovio’s Lead Product Targets All HPV-caused Diseases 21 Sources: CDC,; WHO IARC Incidence rates in the U.S. + EU5
  22. 22. VGX-3100 Phase II Study • Placebo-controlled, randomized, doubled blind • 148+ subjects: females 18-55 • Histologically confirmed HPV16 or 18-associated CIN 2/3 or 3 • 3:1 VGX-3100/electroporation vs. placebo/electroporation • Two plasmids: Type 16 and Type 18, each encoded for E6/E7 antigens; 3 mg/ml per plasmid; treatment at months 0, 1, 3 • Primary endpoint month 9 • Regression of CIN 2/3 to CIN 1 or no disease • Secondary endpoints • Clearance of HPV 16 or 18 AND CIN 2/3 regression • Immunogenicity • Safety 22
  23. 23. INO-1400: Potential Universal Cancer Therapy Targeting hTERT (overexpressed in 85% of cancers) Yan J et al., Cancer Immunol Res. (2013)23 Dharmapuri et al., Mol Ther. (2009) T-cell generation: older generation DNA vaccine and electroporation device SynCon® T-cell generation with CELLECTRA® electroporation device
  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 investments2 $ 116.8 M Debt2 0 M Cash runway 4Q 2017 Shares outstanding3 60.0 M Recent price1 $11.14 Market cap1 $ 668.4 M NYSE MKT: INO 1July 22, 2014 27 2Mar 31, 2014 3March 31 (reflecting June 6th 1:4 reverse split)
  28. 28. INTERNALLYFUNDED EXTERNALLYFUNDED Ino-5150 3Q 2014 Initiate phase IProstatecancer Vgx-3100 Phase II meets efficacy endpointsCervicaldysplasia INO-3112 2Q 2014 Initiated phase I/IIaHead&NeckCancer 28 Upcoming Value Drivers INO-3112 2Q 2014 Initiated phase I/IIaCervicalCancer Ino-1400 2H 2014 Initiate phase I/IIa Breast/lung/ PancreaticCancer PennVAX® 4Q 2014 Initiate PENNVAX-GP phase IHIV Ino-8000 2015 Report phase I data Hepatitis C Ino-1800 Early 2015 Initiate phase I/IIa Hepatitis B
  29. 29. • Phase II data meets efficacy endpoints • 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 • Validating partnership with Roche with more deals in the works Investor Highlights 29
  30. 30. 30 Revolutionizing the Fight Against Cancers and Infectious Diseases