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Inovio Pharmaceuticals
- 1. Revolutionizing the Fight AgainstCancers and Infectious Diseases Dr. J. Joseph Kim PRESIDENT & CEO NASDAQ: INO It’s All About the T-Cells
- 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, 2014, our Form 10-Q for the quarter ended June 30, 2015, and other regulatory filings from time to time. 2
- 3. 3 Licensing agreement andR&D collaboration • MedImmune acquired the rights to INO-3112 • Inovio retains the rights to VGX-3100 • INO-3112 will be evaluated in combination with immune-oncology molecules • Joint research on two additional DNA-based cancer vaccine products not in Inovio’s pipeline Financial Terms: • Upfront payment of $27.5 million • Development and commercial milestone payments amounting to $700 million • Up to double-digit tiered royalties on INO-3112 product sales • MedImmune will pay all developments costs Further validation of the potential of Inovio’s DNA immunotherapies to fight cancer Validating Partnership with MedImmune
- 4. Vital Weapon forFighting Cancer and Infections: T Cells Cytotoxic T lymphocyte T cell Target cell 4 • Targeted destroyer of unhealthy cells • Great strides in new immuno-oncology therapy technologies enabling T cells to perform their function • Still unmet needs • Just scratching the surface
- 5. 5 An “Ideal” TCell-Generating Immunotherapy? Attributes • Activate targeted, antigen-specific T cells • Functional, with “killing tools” granzyme and perforin • Robust in magnitude • Persistent and durable over time • In vivo (in the body) rather than ex vivo production • No unwanted immune response against a vector • No toxic inflammatory response • Capable of breaking immune system tolerance to a cancer
- 6. Inovio DNA Immunotherapies:T Cells by Design IT’S ALL ABOUT THE T CELLS Identify pertinent disease-specific antigen(s) Encode one or more DNA plasmids with genetic code for individual antigens Deliver plasmids into cells, enabling them to produce antigen(s) T cells eliminate cells displaying disease- specific antigen Immune system responds to antigens; activates antigen-specific T cells Effective, efficient, safe in vivo T cell activation Cellular machinery uses DNA code to produce encoded disease antigens ANTIGENIC PROTEINS 5
- 7. 7 • Activate disease-specificCD8+ killer T cells and antibodies Antigen targeting immunotherapies & vaccines • Enhance immune response activation • Impact durability of immune responses • Drive immune responses to sites of infection Immune activators • Simplified design, product stability, better manufacturing, dosing, and cost effectiveness • Rapidly activates robust antibody responses • Target infections or cancers (checkpoint inhibitors) DNA-Based Monoclonal Antibodies (dMAbs) DNA Immunotherapy Platform: Multiple Applications
- 8. 8 Immuno-Oncology Development Strategy 1 2 3 Monotherapy •Single agent T cell activating immunotherapies: potential in specific scenarios (e.g. early stage or slowly progressing cancers) Combination Therapies With Partners • Checkpoint inhibitors achieving 20-40% response rates; missing link is robust T cell presence • Inovio immunotherapy: best-in-class T cells • MedImmune partners with Inovio; pursue combos Combination Therapies In-House Using dMAbs • Inovio’s dMAb application encodes for checkpoint inhibitors to overcome cancer detection avoidance • Brings all IP under one roof; strategic power/flexibility
- 9. Inovio Immuno-Oncology Pipeline ProductName Indication Preclinical Phase I Phase II Vgx-3100 Ino-5150 Ino-1400 Phase III 9 INO-3112 INO-3112 Breast/lung/Pancreatic cancers Prostatecancer Head&NeckCancer CervicalCancer Cervicaldysplasia AerodigestiveCancerINO-3106
- 10. 10 Cervical Dysplasia: Schiffmanet al. Arch Pathol Lab Med (2003), Public Health England Cervical Cancer Screening Programme, Stoler et al. Anatomic Path (2011), Castle et al. JNCI (2005), Mayrand et al. NEJM (2007) Cancers: CDC, www.hpvcentre.net, WHO IARC HIGHGRADE CERVICAL DYSPLASIA (CIN2/3) US: 220,000 – 270,000 EU5: 260,000 HighGrade Vulvar Neoplasia (VIN) US: 4,400 - 27,000 EU5: 6,500 Highgrade Anal Neoplasia (AIN) US: 13,400 EU5: 13,400 ORO- PHARYNGEAL CANCER US: 14,410 EU5: 33,330 CERVICAL CANCER Annual incidences: US and EU5 HPV-Caused Pre-Cancers & Cancers US: 12,900 EU5: 43,670 HPV driven cancers
- 11. Phase II: StudyDesign • 148 subjects: 18-55 year old females with high-grade cervical dysplasia (CIN2/3) • HPV 16 and/or 18 positive • 6 mg VGX-3100 or placebo(IM followed by EP) at weeks 0, 4, and 12 Placebo-Controlled, Randomized, Double Blind • Regression of CIN2/3 to CIN1 or normal at six months post third dose (Week 36)Primary Endpoint • Regression of CIN2/3 to CIN1 or normal and • Clearance of HPV 16 and/or 18 genotype detected during screen Secondary Endpoint 11
- 12. 0 10 20 30 40 50 60 Phase II: Regressionof Cervical Lesions to CIN 1 or Normal Pre-Specified 1° Endpoint: Histopathologic Regression of CIN2/3 to CIN1 or Normal 30.6% (11/36) Statistically significant difference (p=0.017; strata-adjusted) Post-Hoc Analysis: Regression of CIN2/3 to Normal 0 10 20 30 40 50 60 40.2% (43/107) 16.7% (6/36) Percent VGX-3100 Placebo VGX-3100 Placebo Statistically significant difference (p=0.006; strata-adjusted) Overall Histopathologic Regression Incidence Per-Protocol Population (N=143) 12 49.5% (53/107) Percent
- 13. Phase II: ClinicallySignificant Efficacy; Achieves Endpoints 49.5% (53/107) 30.6% (11/36) Histopathologic Regression to CIN1 or Normal AND Virological Clearance (HPV16 or 18) (n=143) 0 10 20 30 40 50 60 40.2% (43/107) 14.3% (5/35) Percent VGX-3100 Placebo Statistically significant difference (p=0.001; strata-adjusted) 13
- 14. VGX-3100 Generates HPV-16and HPV-18 T Cell Responses 14 N=140
- 15. Regression of CIN3to Normal and HPV Clearance Observed in VGX-3100 Treated Patient (via IHC)Week0:CIN3pathology IHC Staining: HPV Week36:Nosignificant pathology IHC Staining: CD815
- 16. Powerful Impact ofVGX-3100 Phase II T Cell & Efficacy Data • Simple 3 monthly injections generated antigen-specific CD8 killer T cells • Measured in blood • Observed in cervical tissue (tissue infiltrating T cells) • Direct correlation found between CD8 T cells and efficacy • Demonstrated phase II efficacy and safety • Regressed disease to normal • Cleared virus which caused the disease • Non-surgical option for the treatment of CIN2/3 • Proof of principle regarding all HPV-related antigens and diseases • Advance other anti-cancer therapies (lung, breast, pancreas, prostate) • Virus (HPV) clearance supports other anti-viral therapies (HBV, HCV, HIV) 16 Phase II results facilitate strategic cancer vaccine collaboration and license with MedImmune and support advancement into phase III HPV precancer trial
- 17. VGX-3100: Next Steps EXPANSIONOF HPV PROGRAM TO RELATED CANCERS AND PRE-CANCERS • HPV cancers licensed to MedImmune for use in combination therapies • Inovio to pursue HPV pre-cancers SCIENTIFIC PAPER IN PEER REVIEWED JOURNAL • Completed immunological analysis to characterize T cell subsets. Phase II data adds to phase I data, which was extensively characterized (Bagarazzi, et al. Sci Transl Med 2012) • Manuscript accepted in top-tier journal PHASE III PLANNING FOR EARLY 2016 LAUNCH • Clinical and regulatory • Scale up immunotherapy production • Market research • Supply chain strategy • EP device production • Pricing & reimbursement 17
- 18. • 20 men/women •Safety, tolerability, immunogenicity • Anti-tumor effects & progression free survival • Arm #1: treat before/after tumor resection • Arm #2: treat after chemoradiation HPV-Associated Head & Neck Cancer Studies: INO-3112 Phase I/IIa clinical trial INO-3112 (VGX-3100 + IL-12 DNA immune activator) HPV 16/ 18 related disease 18 Head & Neck Squamous Cell Carcinoma Being advanced as part of MedImmune’s license and combination strategy development plan with Inovio
- 19. • 126 womenwith cervical carcinoma • Safety & progression free survival at 18 months • INO-3112 administered during standard chemo-radiotherapy (CRT) or during and after standard CRT as an adjuvant • Funded by the EORTC • 20 women with cervical carcinoma • Safety, tolerability, immunogenicity • Cervical histology • Treat after chemoradiation HPV-Associated Cervical Cancer Studies: INO-3112 Two clinical trials for cervical cancer: INO-3112 (VGX-3100 + IL-12 DNA immune activator) HPV 16/ 18 related disease 19 Phase I/II Cervical Cancer Phase II Cervical Cancer Being advanced as part of MedImmune’s license and combination strategy development plan with Inovio
- 20. Phase I: INO-1400 +/-IL-12 DNA immune activator Human telomerase reverse transcriptase (hTERT), associated with cancer cell survival hTERT-Associated Cancers Study: INO-1400 • hTERT overexpressed in 85% of cancers - potential “universal” cancer therapy • 54 patients • Safety, tolerability, immunogenicity • Anti-tumor effects and progression free survival • Trial launched: 4Q 2014 20 Breast, Lung, or Pancreatic Cancers
- 21. • Men withbiochemically relapsed prostate cancer • Safety, tolerability, and immunogenicity of INO-5150 alone or in combination with DNA-based IL-12 immune activator • Evaluating changes in PSA levels • Study initiated 3Q 2015 Prostate Cancer Study: INO-5150 Phase I clinical trial INO-5150 or INO-5150 + IL-12 Targeting PSA & PSMA Prostate cancer 21 Prostate Cancer
- 22. 22 Ino-3510 ino-1800 HepatitisB Therapeutic influenza EbolaINO-4212 Preventive Pennvax®-Bhiv Pennvax®-GP hiv Preventive/ Therapeutic Preventive/ Therapeutic Ino-8000 HepatitisC Therapeutic Product Name Indication Preclinical Phase I Phase II Phase III Broad Medical/Market Opportunities: Infectious Diseases Preventive/ Therapeutic
- 23. • 126 patients •Safety, tolerability, immunogenicity • Trial started: 2Q 2015 • Roche paying all development costs plus milestones • 240M+ global market opportunity 23 Hepatitis B Study: INO-1800 Phase I: INO-1800 +/- IL-12 DNA immune activator Multi-antigen: HBV pan-clade surface antigens & core antigens Chronic Hepatitis B Virus
- 24. 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 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 diagnostics development for mesothelioma, bladder cancer, and ovarian cancer for Fujirebio Diagnostics Management 24
- 25. 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 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 25 Nancy Wysenski , MBA • Former COO of Endo Pharmaceuticals and Vertex Pharmaceuticals
- 26. 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 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. Financial Information Cash &short-term investments2 $ 154.6 M Debt2 0 M Cash runway 4Q 2018 Shares outstanding2 71.8 M Recent share price1 $8.19 Market cap1 $ 588.0 M NASDAQ: INO 27 1Aug 10, 2015 2June 30, 2015 3 Payable in Q3, 2015 Upfront payment: MedImmune 3 $ 27.5 M
- 28. INTERNALLYFUNDED EXTERNALLYFUNDED Ino-1400 2016 Reportinterim data Breast,Lung,And PancreaticCancer Vgx-3100 2015 Publish data in med journal Early 2016 Initiate phase IIICervicaldysplasia 28 Value Drivers INO-3112 Phase I/II studies progressingHead&Neck and Cervical Cancer Ino-8000 2015 Report interim phase I data Hepatitis C Ino-1800 2Q 2015 Initiated phase I Hepatitis B Ebola 2Q 2015 Initiated phase I INO-4212 Ino-5150 3Q 2015 Initiated phase I Prostatecancer PennVAX® 3Q 2015 Initiate PENNVAX-GP phase I HIV INO-3112 2016 Initiate phase II with EORTCCervical Cancer
- 29. Best-in-class immune responses to fight cancers andinfectious diseases Targeting broad range of billion dollar disease markets Breakthrough in vivo T cell generating technology Validating partnerships with MedImmune & Roche Lead product achieved phase II efficacy endpoints Investor Highlights 29