Inovio dec12corppesentation


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Inovio dec12corppesentation

  1. 1. Dr. J. Joseph KimPresident & CEO Page 1
  2. 2. Forward Looking StatementOur commentary and responses to your questions may contain forward-lookingstatements, including comments concerning clinical trials and productdevelopment programs, evaluation of potential opportunities, the level ofcorporate expenditures, the assessment of Inovio’s technology by potentialcorporate partners, capital market conditions, timing of events, cashconsumption and other subjects. Information concerning factors that couldcause actual results to differ materially from those set forth in our AnnualReport on Form 10-K for the year ended December 31, 2011, our Form 10-Qfor the quarter ended September 30, 2012, and other regulatory filings fromtime to time. Page 2
  3. 3. Inovio: Revolutionizing Vaccines• Inovio’s synthetic vaccine technology designed to: • Treat some of today’s most challenging diseases • Provide universal protection against changing infectious disease strains • Break the body’s tolerance of cancerous cells• Targeting unmet needs with multi-billion dollar potential: cancers, universal flu, HIV, hepatitis B/C virus• Multiple ongoing clinical trials: phase II and phase I• Industry-leading potency & safety • Best-in-class immune responses• Dominant global IP position (424 patents issued/pending)• Validation: • $42M+ in non-dilutive grant funding over last few years • Advancing discussions for vaccine product development partnerships and further grant funding Page 3
  4. 4. Conventional Vaccines• Saved millions from sickness/death• Added decades to life expectancy Increased life expectancy• Deliver a virus or part of a virus to expose a unique antigen (foreign protein)• Generate antibodies that prevent targeted diseases from infecting cells• Low hanging fruit picked – old technology has reached its limitations• Safety concerns: can cause the disease or other bad side effects• Rely on technology that is often more than 50 years old; some vaccines are still grown in chicken eggs Page 4
  5. 5. Synthetic DNA Vaccine Platform  Revolutionizing vaccines through:• Strong safety profile• SynCon® “designer vaccines” give the body the DNA instructions to produce only the targeted antigen - nothing more• Generate powerful T-cells to kill infected cells or tumors (therapeutic vaccines)• Manufacturing advantages: rapid, scalable, thermal-stable Page 5
  6. 6. SynCon® Universal Vaccine DesignImmune responses more cross-reactive (universal)than those induced by single-strain vaccines Page 6
  7. 7. Superior Vaccine Delivery Using Electroporation > 10-100x enhancement in immune responses Page 7
  8. 8. Best‐in‐Class Immune Responses in Humans Therapeutic (T Cell) Preventive (Antibody) Immune Responses Immune Responses Inovio Clinical Competition Inovio Clinical CompetitionClinical Study Results Clinical Study ResultsHPV-001 Best in class T Adenovirus vectors FLU-001/002 Broad StockpiledCervical cell responses MVA vectors H5N1 protective inactivatedCancer/ (magnitude and DNA vaccines Pandemic Flu antibody vaccinesDysplasia durability); killing Peptides/proteins titers against effect 6 different (Science TM 2012) H5N1 strainsHVTN-080 Best in class T Adenovirus vectors FLU-101 Broad TrivalentPreventive cell responses MVA vectors Universal Flu – protective inactivatedHIV Vaccine (magnitude and DNA vaccines H1N1 antibody virus vaccines durability) Peptides/proteins titers against (TIV) Combinations 9 different Live-attenuated H1N1 strains vaccines Page 8
  9. 9. Inovio’s Strategy• Advance/validate SynCon® + electroporation delivery platform • Best in-class immunogenicity established in human studies• Develop proprietary products through proof-of-concept human data (phase I or phase II) and partner them• Maximize resources/opportunities; spread cost/risk • Non-dilutive third party funding • Direct: R&D grants – $42M received since 2009 • Indirect: clinical trials sponsored by outside agencies • Partner/out-license products for preclinical/clinical development and marketing Page 9
  10. 10. Inovio Product Pipeline Indication Preclinical Phase I Phase II Milestone Cervical Dysplasia 4Q 2013 Therapeutic Phase II study data Cancers Leukemia 2013 Therapeutic Additional Phase II data Hepatitis C 1Q 2013 Therapeutic Phase II interim dataInfectious Diseases HIV 1H 2013 Preventive/Therapeutic Publication of phase I data Influenza 1H 2013 Preventive Phase I additional data Internally Funded Partner Funded/Supported Page 10
  11. 11. VGX‐3100: Cervical Dysplasia/Cancer Therapy• Cervical cancer: ~500,000 cases, 250,000 deaths yearly• Cervical dysplasias (CIN) preceding cancer (U.S. annually) • CIN 1: 1.4 M ; CIN 2/3: 300,000• VGX-3100 phase I • 18 patients, 3 dose levels • Vaccine safe and well-tolerated • Most robust T-cells generated by T cell a DNA vaccine in humans responses by other • Stronger responses than other Low Mid High All vaccines Dose Level vaccines, including viral vectors • Strong T-cell response in 14 of 18 (78%) vaccinated subjects at month 4 • Durable responses: 12 of 13 responders (92%) displayed persistent, strong T-cell responses at month 9 • Strong killing effect against target cells Page 11
  12. 12. VGX‐3100: Phase II Study• Randomized, blinded, placebo controlled• > 25 sites in multiple countries• 148 patients with CIN 2/3• Three vaccinations over 3 months, 6 months monitoring• Primary endpoint: CIN 2/3 lesion clearance at month 9• Initiated in 2011; enrollment ongoing• Efficacy data expected 4Q 2013 Page 12
  13. 13. Leukemia Vaccine: Phase II• Chronic myeloid leukemia (CML) 300,000+ new cases,• Acute myeloid leukemia (AML) 222,000 deaths yearly• Vaccine coded for Wilms’ tumor gene 1 (WT1) • Overexpressed in majority of acute leukemias• Open label phase II clinical trial • Active: 37 CML patients, 37 AML patients • Control group: 100-110 AML/CML patients, non-vaccinated • Primary endpoints • CML: molecular response to disease marker (BCR-ABL) • AML: time to disease progression• Initiated in 2011; enrollment ongoing; interim data presented 4Q 2012 Page 13
  14. 14. ChronVac‐C® Therapeutic Vaccine• Hepatitis C virus (HCV) • 3.5 million chronically infected in US; >170 million worldwide • Causes liver disease/cancer• Positive phase I study (HCV genotype 1): ChronVac-C + standard of care (SOC: interferon & ribavirin) • Safe & well-tolerated • Positive T-cell immune responses • Sustained viral response (SVR): 5 of 6 patients (83%)• Open label, randomized phase II study (32 patients) • Vaccinated (20): 2 vaccinations; Control (12): SOC only • Primary endpoints • Rapid viral response (4 weeks) • Partial early viral response (pEVR) (12 weeks) • Initiated in 2011; enrollment completed • Interim data expected 1Q 2013 Page 14
  15. 15. PENNVAX‐B: Phase I Studies• Preventive study, randomized, placebo-controlled: run by HVTN• Three vaccinations over 3 months; 48 vaccinated subjects, 3 arms: • 1 mg PENNVAX-B (n=10) • 1 mg PENNVAX-B + DNA IL-12 delivered via EP (n=30) • Placebo (n=8) • T-cell immune responses superior to all other previously-tested HIV vaccines • Submitted for publication T-cell Responses by intracellular cytokine staining (ICS) assay Positive Reponses Placebo Group Vaccine + DNA IL-12 + EP Total CD4 + CD8 0% (0/8) 88.9% (24/27)____________________________________________________________________________________________________________________________________• Therapeutic study, open label, 12 vaccinated subjects, run by UPenn• Significant antigen-specific CD8+ T-cell responses: • against at least 1 of 3 antigens (gag, pol, or env) in 75% of subjects Page 15
  16. 16. SynCon® Universal Influenza Vaccines• H5N1 phase I data: • Strong T-cell/antibody responses • => 1:20 HAI titers – 71% positive responders to at least 1 H5N1 virus • Protection against all six unmatched H5N1 strains tested• H1N1 phase I data: • Significant # of responders exceeding 1:40 HAI titers against different strains • Protection against all nine unmatched H1N1 strains tested • Prime-boost with seasonal vaccine doubled protection rate in elderly Potential to shift flu vaccination from “one bug, one drug” approach to pre-emptive, universal prevention across strains, subtypes and years Page 16
  17. 17. ManagementJ. Joseph Kim, PhD, President & Peter Kies, CFOCEO• Decades of biotechnology/pharma • Ex-Ernst & Young management • Experience with growth companies• Ex-Merck: hepatitis A and B vaccines manufacturing; HIV vaccine (Ad5) R&DNiranjan Y. Sardesai, PhD, COO Mark L. Bagarazzi, MD, CMO• Extensive biotech management • Clinical research experience incl. and product development Merck experience • Led clinical/regulatory for shingles• Led development of diagnostics and rotavirus vaccines; DNA vaccine for mesothelioma, bladder expert cancer, and ovarian cancer for Fujirebio DiagnosticsManaged development and approval of several vaccines Page 17
  18. 18. Board of DirectorsAvtar Dhillon, MD, Chairman, BOD Morton Collins, PhD• Former President & CEO, Inovio • General Partner, Battelle Ventures Biomedical and Innovations Valley PartnersSimon X. Benito J. Joseph Kim, PhD• Former Senior Vice President, Merck • President & CEO, Inovio Vaccine DivisionAngel Cabrera, PhD Adel Mahmoud, PhD• President, George Mason University • Professor, Princeton University• Former President, Thunderbird School • Former President, Merck Vaccines of Global Management • Responsible for Gardasil®, Zostavax®, Proquad® and Rotateq® Page 18
  19. 19. Scientific Advisory BoardDavid B. Weiner, PhD, Chairman• “Father of DNA vaccines”• Dept. of Pathology & Laboratory Medicine, U of PAThomas S. Edgington, MD Philip Greenberg, MD• Founded multiple biotech companies; • Expert in T-cell immunology extensively published • Head, Immunology Program, Fred• Emeritus Professor, Scripps Research Hutchinson Cancer Research Center InstituteAnthony W. Ford-Hutchinson, PhD Stanley A. Plotkin, MD• Former SVP, Vaccines R&D, Merck • Developed rubella and rabies vaccines• Oversaw development: Singulair®, • Oversaw Sanofi flu vaccine Januvia®, Gardasil®, Zostavax®, • Emeritus Professor, Wistar Institute & Proquad® and Rotateq® U of Penn Page 19
  20. 20. Financial Information Cash & short term investments1 $15.2 M Debt1 0M Cash runway 3Q 2013 Listing NYSE MKT: INO Issued & outstanding shares1 137.1 M Recent price2 $0.48 Market cap2 $66.89M1 September 30, 2012 2 December 10, 2012 Page 20
  21. 21. Investment Summary• Paradigm shifting synthetic vaccine platform • Best-in-class immunogenicity • Characteristics significantly improving upon conventional and new competitive vaccine technologies• Strong management: vast vaccine discovery & development expertise• Extensive third-party grant funding• Important validating clinical milestones over next quarters• Advancing partnership discussions with large pharmaceutical companies Page 21
  22. 22. revolutionizing vaccines Investor Contact: Bernie Hertel Senior Director, Corporate Communications 858-410-3101 ● bhertel@inovio.comNYSE MKT: INO