inovio apr13presentation
TRANSCRIPT
Revolutionizing Vaccines
Dr. J. Joseph Kim President & CEO
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.
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
Products
• Best in class immune responses
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
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
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
vaccines historic impact
• If you’re over 45 you probably would not be here today
• Drastically lowered infant mortality rate
• #1 human invention
Impact of Vaccines: Pros
Traditional vaccine technology • 60 years old (some vaccines still grown in eggs)
• Has safety concerns
• Reached limits
Impact of Vaccines: Cons
Inovio’s DNA Vaccine Platform • Vaccine Design • Vaccine Delivery • Vaccine Manufacturing
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
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
DNA Vaccine Manufacturing
• Dedicated manufacturing facility
• Speed: faster than traditional methods
• Scalability
• Thermal stability
Inovio’s clinical trials
• Three programs in phase II • Best-in-class antibody
and T-cell results • Important trial results in 2013
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
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
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
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
Clinical Trials
• 4 vaccinations Vs. 2 vaccinations • Older generation DNA and EP • Single antigen target Vs. multi-antigen
targets
Important Considerations:
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
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
Disease
Vaccine name
Disease Impact
Clinical Trials
Influenza Universal influenza vaccine 500,000 deaths each year
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
power of our people
• Management • Board of Directors • Scientific Advisory Board
Management
anthrax
polio
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
Board of Directors
anthrax
polio
cowpox
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
Scientific Advisory Board
anthrax
polio
cowpox
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
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
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
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
Bernie Hertel Senior Director, Corporate Communications 858-410-3101 [email protected]
Investor Contact
investor contacts