Inovio apr13presentation

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Revolutionizing Vaccines Dr. J. Joseph Kim President & CEO

Transcript of Inovio apr13presentation

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Revolutionizing Vaccines

Dr. J. Joseph Kim President & CEO

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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, 2012, and other regulatory filings from time to time.

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Revolutionizing Vaccines

measles

anthrax

polio

cowpox

• Prevent and treat diseases

• Build on legacy of vaccines: tackle conditions that traditional vaccines have not touched

• Provide “universal” protection from known and unknown strains of infectious diseases

Edward Jenner Louis Pasteur

Jonas Salk Maurice Hilleman

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Products

• Best in class immune responses

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Products

• Best in class immune responses

• Products target

multi-billion dollar healthcare markets

• Multiple clinical trials in Phase I & II

• Favorable safety profile

• Best gene therapy delivery system (electroporation)

• Dominant global IP position

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Validation

• Bill Gates funding our malaria program

• US Gov’t granted $25 million to speed HIV vaccine development

• NIH Director: “transformational research”

• Major media

attention

• Overall, almost $50 million in non-dilutive grants in past few years

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Strategy

• Build on proof-of-concept studies with phase I and II clinical trials

• Spread cost/risk with: o Non-dilutive

partner funding o R&D grants

o “Sponsored”

clinical trials • May partner out

licensed products for final development and commercialization

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vaccines historic impact

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• If you’re over 45 you probably would not be here today

• Drastically lowered infant mortality rate

• #1 human invention

Impact of Vaccines: Pros

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Traditional vaccine technology • 60 years old (some vaccines still grown in eggs)

• Has safety concerns

• Reached limits

Impact of Vaccines: Cons

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Inovio’s DNA Vaccine Platform • Vaccine Design • Vaccine Delivery • Vaccine Manufacturing

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DNA Vaccine Design

• No killed or weakened virus

• Begin with strip of DNA called plasmid

• Use existing genetic sequences to target disease or infection

• Create “synthetic consensus” DNA-sequenced vaccine

• Made in pure water

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DNA Vaccine Delivery

electroporation

pulse

• Successfully jumped the hurdle of DNA vaccine delivery

• The “no adjuvants” DNA delivery method: millisecond

electric pulse (electroporation)

• Can increase uptake

by 1000-fold

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DNA Vaccine Manufacturing

• Dedicated manufacturing facility

• Speed: faster than traditional methods

• Scalability

• Thermal stability

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Inovio’s clinical trials

• Three programs in phase II • Best-in-class antibody

and T-cell results • Important trial results in 2013

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Disease

Vaccine Name

Disease Impact

Trial Results

Clinical Trials

Cancer VGX-3100 Cervical cancer 500,000 new cases and 250,000 deaths annually Phase I (completed) • Most robust immediate

T-cell response/78%

• Most durable (9 months) T-cell response/92%

• Safe & well tolerated

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Disease

Vaccine Name

Disease Impact

Trial Results

Next steps

Clinical Trials

Cancer VGX-3100 Cervical cancer 500,000 new cases and 250,000 deaths annually Phase II (on-going) Efficacy data expected 1Q 2014

• Randomized, double-blinded, placebo controlled

• More than 25 sites in 7 countries

• Advanced cervical dysplasia clearance within 9 months

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Disease

Vaccine name

Partner

Disease Impact

Trial Results

Clinical Trials

Leukemia DNA leukemia vaccine University of Southampton (UK) CML- 300,000 new cases annually AML- 200,000 deaths annually Phase II Interim: • Antibodies and “killer”

T-cells detected in CML patients

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Disease

Vaccine name

Partner

Disease Impact

Trial Results

Next steps

Clinical Trials

Hepatitis C (Genotype 1) ChronVac-C (NS3/4A DNA) delivered with INO’s MedPulser device ChronTech Pharma 5 million infected in U.S; 200 million worldwide Phase I: (4 vaccinations + IFN-α + ribavirin) Phase II: (2 vaccinations + IFN- α + ribavirin) Interim results at week 12 of treatment:

• 75% (6 of 8) subjects showed viral clearance • Safe & well tolerated

• Vaccine + drug group: 65% (11 of 17) HCV clearance • Drug only group: 58% (7 of 12) HCV clearance

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Clinical Trials

• 4 vaccinations Vs. 2 vaccinations • Older generation DNA and EP • Single antigen target Vs. multi-antigen

targets

Important Considerations:

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Disease

Vaccine name

Trial Results

Next steps

Clinical Trials

Hepatitis C (genotype 1) INO-8000: Inovio’s proprietary DNA HCV vaccine • Multi-antigen: NS3/4A, NS4B, and NS5A • Most advanced CELLECTRA® device

Preclinical results: Initiate phase I/IIa clinical trial by year-end 2013

• Generated robust T-cell responses in the liver

• Toxicity testing

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Disease

Vaccine name

Disease Impact

Trial Results Preventative

therapeutic

Next steps

Clinical Trials

HIV DNA HIV vaccine PENNVAX-B® 30 million infected worldwide • First vaccine designed to

prevent and treat HIV infection Phase I interim: Data accepted for publication

• 89% T-cell response Best in class results

• 75% antigen-specific T-cell response

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Disease

Vaccine name

Disease Impact

Clinical Trials

Influenza Universal influenza vaccine 500,000 deaths each year

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Disease

Vaccine name

Disease Impact

Trial Results

Clinical Trials

Influenza Universal influenza vaccine 500,000 deaths each year Phase I : VGX-3400X • T-cell and antibody responses

• Protection against all “unmatched” strains tested • Greater than 1:20 HAI titers

INO-3510 • DNA vaccine w/annual vaccine doubled protection

in elderly • Protection against all “unmatched” strains tested • Greater than 1:40 HAI titers

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power of our people

• Management • Board of Directors • Scientific Advisory Board

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Management

anthrax

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cowpox

Louis Pasteur

J.Joseph Kim, PhD President & CEO

• Decades of biotechnology/pharma management

• Ex-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

Peter Kies CFO • Ex-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

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Board of Directors

anthrax

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Louis Pasteur Simon X. Benito

• Former Senior Vice President, Merck Vaccine Division

Angel Cabrera, PhD • President, George Mason University

• Former President, Thunderbird School of Global Management

J.Joseph Kim, PhD • President & CEO, Inovio

Adel Mahmoud, PhD • Professor, Princeton University • Former President, Merck Vaccines • Responsible for Gardasil®, Zostavax®, Proquad® and Rotateq®

Avtar Dhillon, MD Chairman, BOD

• Former President & CEO, Inovio Biomedical

Morton Collins, PhD • General Partner, Battelle Ventures and Innovations Valley Partners

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Scientific Advisory Board

anthrax

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Louis Pasteur 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®

Stanley A. Plotkin, MD • Developed rubella and rabies vaccines • Oversaw Sanofi flu vaccine • Emeritus Professor, Wistar Institute & University of Pennsylvania

David B. Weiner, PhD Chairman

•“Father of DNA vaccines” • Dept. of Pathology & Laboratory Medicine,

University of Pennsylvania

Philip Greenberg, MD • Expert in T-cell immunology • Head, Immunology Program, Fred Hutchinson Cancer Research Center

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1 1 / 1 / 1 2 1 2 / 1 / 1 2 1 / 1 / 1 3 2 / 1 / 1 3 3 / 1 / 1 3

financial information $0.80

$0.60

$0.40

$0.20 2013

C u r r e n c y i n u s d

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Financial Information

Cash, cash equivalents & short-term investments1 $ 30.9 M

Debt1 0 M

Cash runway 4Q 2014

issued & outstanding shares2 179.9 M

Recent price2 $ 0.60

Market cap2 $ 107.9 M

listing Nyse mkt: INO

1February 2013 cash, cash equivalents & short-Term investments of $16.9M, plus net proceeds of $14.0 M from march 2013 financing

2 As of march 28, 2013

2/28/13 3/28/13

$0.60

$0.40

$0.20

$0.80

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investment rationale • The future of vaccines: DNA vaccines • Best-in-class immune responses

• Near-term clinical milestones

• Non-dilutive funding

• Partnership discussions with Big Pharma

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Bernie Hertel Senior Director, Corporate Communications 858-410-3101 [email protected]

Investor Contact

investor contacts