inovio dec12corppesentation
TRANSCRIPT
Page 1
Dr. J. Joseph KimPresident & CEO
Page 2
Forward Looking StatementForward 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, 2011, our Form 10-Q
for the quarter ended September 30, 2012, and other regulatory filings from
time to time.
Page 3
• 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
Inovio: Revolutionizing VaccinesInovio: Revolutionizing Vaccines
Page 4
Conventional VaccinesConventional Vaccines
• Saved millions from sickness/death• Added decades to 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
Increased life expectancy
Page 5
Synthetic DNA Vaccine Platform 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 6
SynCon® Universal Vaccine DesignSynCon® Universal Vaccine Design
Immune responses more cross-reactive (universal) than those induced by single-strain vaccines
Page 7
Superior Vaccine Delivery Using ElectroporationSuperior Vaccine Delivery Using Electroporation
> 10-100x enhancement in immune responses
Page 8
Best‐in‐Class Immune Responses in HumansBest‐in‐Class Immune Responses in Humans
InovioClinical Study
Clinical Results
Competition
FLU-001/002H5N1Pandemic Flu
Broad protective antibodytiters against 6 different H5N1 strains
Stockpiledinactivated vaccines
FLU-101Universal Flu –H1N1
Broad protective antibodytiters against 9 different H1N1 strains
Trivalent inactivated virus vaccines (TIV)Live-attenuatedvaccines
Inovio Clinical Study
Clinical Results
Competition
HPV-001 Cervical Cancer/ Dysplasia
Best in class T cell responses (magnitude and durability); killing effect(Science TM 2012)
Adenovirus vectorsMVA vectorsDNA vaccinesPeptides/proteins
HVTN-080 Preventive HIV Vaccine
Best in class T cell responses (magnitude and durability)
Adenovirus vectorsMVA vectorsDNA vaccinesPeptides/proteinsCombinations
Therapeutic (T Cell) Immune Responses
Preventive (Antibody) Immune Responses
Page 9
Inovio’s StrategyInovio’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 10
Inovio Product PipelineInovio Product Pipeline
Indication Preclinical Phase I Phase II Milestone
Canc
ers
Cervical DysplasiaTherapeutic
4Q 2013 Phase II study data
LeukemiaTherapeutic
2013Additional Phase II data
Hepatitis CTherapeutic
1Q 2013Phase II interim data
HIVPreventive/Therapeutic
1H 2013Publication of phase I data
InfluenzaPreventive
1H 2013Phase I additional data
Internally Funded
Partner Funded/Supported
Infe
ctio
us D
isea
ses
Page 11
VGX‐3100: Cervical Dysplasia/Cancer TherapyVGX‐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 a DNA vaccine in humans
• Stronger responses than other 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
Low Mid High AllDose Level
T cell responses by othervaccines
Page 12
VGX‐3100: Phase II StudyVGX‐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 13
• Chronic myeloid leukemia (CML) • Acute myeloid leukemia (AML)
• 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
300,000+ new cases,222,000 deaths yearly
Leukemia Vaccine: Phase IILeukemia Vaccine: Phase II
Page 14
ChronVac‐C® Therapeutic VaccineChronVac‐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 15
PENNVAX‐B: Phase I StudiesPENNVAX‐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
____________________________________________________________________________________________________________________________________
• 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
T-cell Responsesby intracellular cytokine staining (ICS) assay
Positive Reponses Placebo Group Vaccine + DNA IL-12 + EP
Total CD4 + CD8 0% (0/8) 88.9% (24/27)
Page 16
SynCon® Universal Influenza VaccinesSynCon® Universal Influenza Vaccines
Potential to shift flu vaccination from “one bug, one drug” approach to pre-emptive, universal prevention across strains, subtypes and years
• 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
Page 17
ManagementManagement
J. Joseph Kim, PhD, President & CEO
• Decades of biotechnology/pharmamanagement
• Ex-Merck: hepatitis A and B vaccines manufacturing; HIV vaccine (Ad5) R&D
Peter Kies, CFO
• Ex-Ernst & Young • Experience with growth companies
Niranjan Y. Sardesai, PhD, COO
• Extensive biotech managementand product developmentexperience
• Led development of diagnostics for mesothelioma, bladder cancer, and ovarian cancer for Fujirebio Diagnostics
Mark L. Bagarazzi, MD, CMO
• Clinical research experience incl. Merck
• Led clinical/regulatory for shingles and rotavirus vaccines; DNA vaccine expert
Managed development and approval of several vaccines
Page 18
Board of DirectorsBoard of Directors
Avtar Dhillon, MD, Chairman, BOD• Former President & CEO, Inovio
Biomedical
Morton Collins, PhD• General Partner, Battelle Ventures
and Innovations Valley Partners
Simon X. Benito • Former Senior Vice President, Merck
Vaccine Division
J. Joseph Kim, PhD• President & CEO, Inovio
Angel Cabrera, PhD• President, George Mason University• Former President, Thunderbird School
of Global Management
Adel Mahmoud, PhD• Professor, Princeton University • Former President, Merck Vaccines• Responsible for Gardasil®, Zostavax®,
Proquad® and Rotateq®
Page 19
Scientific Advisory BoardScientific Advisory Board
David B. Weiner, PhD, Chairman• “Father of DNA vaccines”• Dept. of Pathology & Laboratory
Medicine, U of PA
Thomas S. Edgington, MD • Founded multiple biotech companies;
extensively published• Emeritus Professor, Scripps Research
Institute
Philip Greenberg, MD• Expert in T-cell immunology• Head, Immunology Program, Fred
Hutchinson Cancer Research Center
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 &
U of Penn
Page 20
Financial InformationFinancial Information
Cash & short term investments1 $15.2 M
Debt1 0 M
Cash runway 3Q 2013
Listing NYSE MKT: INO
Issued & outstanding shares1 137.1 M
Recent price2 $0.48
Market cap2 $66.89M
1 September 30, 2012 2 December 10, 2012
Page 21
Investment SummaryInvestment 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
r e v o l u t i o n i z i n g v a c c i n e s
Investor Contact: Bernie Hertel
Senior Director, Corporate Communications858-410-3101 ● [email protected]
NYSE MKT: INO www.inovio.com