Inovio 2012 Presentation

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Page 1 Dr. J. Joseph Kim President & CEO

Transcript of Inovio 2012 Presentation

Page 1: Inovio 2012 Presentation

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Dr. J. Joseph KimPresident & CEO

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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.

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• 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:

• $35M+ 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

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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

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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

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SynCon® Universal Vaccine DesignSynCon® Universal Vaccine Design

Immune responses more cross-reactive (universal) than those induced by single-strain vaccines

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Superior Vaccine Delivery Using ElectroporationSuperior Vaccine Delivery Using Electroporation

> 10-100x enhancement in immune responses

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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

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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 2008

• Indirect: clinical trials sponsored by outside agencies

• Partner/out-license products for preclinical/clinical development and marketing

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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

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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

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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

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• 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

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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

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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)

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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

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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

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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®

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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

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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

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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

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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