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revolutionizing
vaccines
J. Joseph Kim, Ph.D.
President & CEO
January 6, 2011
NYSE Amex: INO
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, 2010, our Form 10-Q
for the quarter ended September 30, 2011, and other regulatory filings from
time to time.
Page 2
Who We Are
• Developing synthetic vaccines and immune therapies
• Coded to produce one or more target antigens in the body
• SynCon® antigen design focused on universal protection
• Optimized vaccine formulation + proprietary electroporation
delivery achieves broad antibody and T cell immune responses
• Targeting multi-billion dollar therapeutic markets with
unmet needs such as cancers, HIV, and hepatitis C virus
• Multiple ongoing clinical trials: internal development,
grant funding & partnerships
• Industry-leading potency & safety
• Best-in-class immune responses for cervical dysplasia & HIV
• Durable immune responses
• Dominant IP position: synthetic vaccines + EP delivery
Page 3
Inovio Optimized Synthetic Vaccines
• Achieve the powerful immune response benefits of live
virus vaccines in new diseases
• Superior immune responses
• All synthetic product
• No possibility of infection
• Improved safety profile
• Potential to prevent and treat
• Faster development
• Easier to manufacture and store
No vector induced responses –
repeat boosts; multiple/combination vaccines
Greater potency than viral vectors in primates and humans
Page 4
SynCon® Universal Vaccine Design
Immune responses more cross-reactive (universal)
than those induced by single-strain vaccines
Page 5
Superior Vaccine Delivery Using Electroporation
Page 6
Inovio Electroporation (EP) Technology & Devices
• Efficient & effective vaccine delivery
• 100X increase in immune responses
• Far stronger T-cell immune responses than viral vectors
• Safe and tolerable
• No unwanted immune response
• No residual carrier/vector causing toxicity
• Delivery into muscle or skin for differentiated immune
responses i.e. preventive and/or therapeutic
• Devices facilitate mass vaccination in the field
• Broad and deep patent position
Intramuscular
Intradermal
Page 7
Design + Delivery = Improved Immune Responses
T Cell Responses By ELISpot Assay
Optimization
5000
3000
2000
1000
EP
1 x 10-6 spleenocytes
4000
0
Display of GFP gene
expression after
electroporation delivery
into rabbit muscle
+EP
Immunized 3x with 15ug pNP
responses @2 wk post Imm
Page 8
Inovio’s Strategy
• Advance/validate SynCon® + EP delivery platform
• Best in-class immunogenicity established in human studies
• Increase platform value through product validation
• Develop proprietary products through proof-of-concept human
data
• Maximize non-dilutive third party funding
• Direct: R&D grants
• $35M received since 2008
• Indirect: clinical trials sponsored by outside agencies
• Seven ongoing studies
• Partner/out-license products for later-stage clinical
development and marketing
Page 9
Inovio Product Pipeline: Cancers
Cancers
Indication
Product (Antigen)
Cervical
Dysplasia/Cancer
Therapeutic
VGX-3100 (E6/E7
Type 16/18 HPV)
Leukemia
(Wilms’ tumor
gene 1)
Prostate
INO-5150
(PSA + PSMA)
Breast/Lung/
Prostate
V934
(hTERT)
Preclinical
Phase I
Phase II
Partner/Funding
Milestone
2H 2013
Report Phase II
study data
University of
Southampton
2H 2012 Report
interim Phase II
study data
3Q 2012 Initiate
Phase I study
Merck
Internally Funded
Partner Funded/Supported
Page 10
Inovio Product Pipeline: Infectious Diseases
Indication
Infectious Diseases
Preclinical
Partner/Funding
Milestone
(NS3/4A) + SOC
ChronTech
2H 2012 Report
Phase II interim data
(NS3/4A, NS4B,
NS5A)
VGX Inter/
PA CARE Grant
2H 2012
Launch Phase I study
PENNVAX-B
HIV Vaccine
Trials Network
Phase I final data
reported 3Q 2011
PENNVAX-G
USMHRP/NIAID
Phase I interim data
reported 3Q 2011
PENNVAX-GP
NIH/NIAID
2H 2012
Initiate Phase I study
HIV Therapeutic
PENNVAX-B
University of
Pennsylvania
1Q 2012 Report
interim Phase I data
Avian Influenza
VGX-3400X
(H5N1)
Universal Influenza
INO-3510
(H5N1 & H1N1)
Hepatitis C Virus
Therapy
HIV Preventive
Product (Antigen)
Phase I
Phase II
1Q 2012 Report add’l
Phase I data
NIH Director’s Office
Transformative
Research Award
2Q 2012 Report
Phase I interim data
Internally Funded
Partner Funded/Supported
Page 11
VGX-3100: Cervical Dysplasia/Cancer Therapy
• Cervical cancer
•
•
99% caused by human papillomavirus (HPV)
Second leading cancer killer in women worldwide
•
~500,000 new cases of cervical cancer annually
• Cervical dysplasias (CIN) preceding cancer (U.S. annually)
•
•
CIN 1: 1.4 M
CIN 2/3: 300,000
• Gardasil® & Cervarix®: preventive, not therapeutic
• INO candidate VGX-3100 targets E6 + E7 oncogenes
•
•
HPV Types 16 and18
Transform HPV-infected cells into precancerous & cancerous
cells
Page 12
VGX-3100 Phase I Study
• Design
• 18 patients
• 3 dose levels (0.3, 1.0 & 3.0
mg/each of 2 plasmids)
• 3 vaccinations (months 0, 1 & 3) via EP delivery
• Results
• Vaccine safe and well-tolerated
• Positive T-cell immune responses
• Most robust generated by a DNA vaccine in humans
• Stronger responses than other vaccines including viral
vector (MVA)
Page 13
VGX-3100: Phase I Study Data
T cell responses
by other vaccines
Low Dose
Mid Dose
High Dose All Groups
• 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
• After 4th vaccination, 7 of 8 (87%) displaying strong
T-cell responses up to 2 years
Page 14
VGX-3100: Phase II Study
• Randomized, blinded, placebo controlled
• Up to 25 sites in 5 countries
• 148 patients with CIN 2/3 + HPV 16/18
• Three vaccinations over 3 months, 6 months monitoring
• 1˚endpoint: CIN 2/3 lesion clearance at month 9
• Initiated Q1 2011; enrollment ongoing
• Efficacy data expected 2H 2013
Page 15
Leukemia Vaccine: CML & AML
• Chronic myeloid leukemia (CML)
• Acute myeloid leukemia (AML)
300,000+ new cases
222,000 deaths each year
• Vaccine coded for Wilms’ tumor gene 1 (WT1)
• Overexpressed in majority of acute leukemias
• WT1 without EP in humans for other cancers
modest CD8+ T-cells and measurable clinical responses
• WT1 without EP in humans for leukemia
strong CD8+ T-cell responses; killed human leukemia cells
expressing WT1
Page 16
Leukemia Vaccine: Phase II Study
• Study design
• Open label phase II clinical trial
• Active: 37 CML patients, 37 AML patients
• Control group: 100-110 AML/CML patients, non-vaccinated
• 1˚ endpoints
• CML: molecular response to disease marker (BCR-ABL)
• AML: time to disease progression
• Initiated Q1 2011; enrollment ongoing
• Interim data expected 2H 2012
Page 17
ChronVac-C® Therapeutic Vaccine
• Hepatitis C virus (HCV)
• Most common chronic blood-borne infection in the U.S.
• 3.5 million chronically infected in U.S.: ~300 million worldwide
• ~8,000 to 10,000 deaths annually from liver disease caused by HCV
• Positive phase I study outcomes (HCV Genotype 1)
• ChronVac-C via EP safe & well-tolerated
• Positive T-cell immune responses
• ChronVac-C + subsequent standard of care (SOC: interferon &
ribavirin)
• Rapid viral response (RVR): 5 of 7 patients (71%)
• Sustained viral response (SVR): 5 of 6 patients (83%)
Page 18
ChronVac-C® Phase IIb Study
• Open label, randomized phase IIb study in Sweden
• 32 treatment-naïve subjects w/chronic HCV (genotype-1)
• Active (n=20): 2 vaccinations ChronVac-C via EP + SOC
• Control (n=12): SOC only
• 1˚ endpoints
• RVR (4 weeks)
• Partial early viral response (pEVR) (12 weeks)
• Initiated Q2 2011; enrollment ongoing
• Interim data expected 2H 2012
Page 19
PENNVAX™ Global HIV Vaccine Program
• SynCon® PENNVAX DNA vaccines target HIV gag, pol, and
env proteins
PENNVAX-G/
• Env protein determines clades (subtypes)
PENNVAX-GP
Coverage:
Clades A, C, D
PENNVAX-B
Coverage:
Clade B
Page 20
PENNVAX-B: Phase I Study Completed
• Randomized, placebo-controlled Phase I clinical trial
(preventive) conducted 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 Responses
by intracellular cytokine staining (ICS) assay
Positive Reponses
Placebo Group
Vaccine + DNA IL-12 + EP
CD4
0% (0/8)
80.8% (21/26)
CD8
0% (0/8)
51.9% (14/27)
Total CD4 + CD8
0% (0/8)
88.9% (24/27)
• T-cell immune responses superior to all other previouslytested HIV vaccines
Page 21
SynCon® Universal Influenza Vaccines
• Targets critical sub-types
• 100% protection in mice and
ferrets against H5N1 & H1N1
challenge
• H5N1 phase I interim data:
Strong T-cells and antibodies in
72% and 96% of subjects w/
intramuscular delivery
• Intradermal boost achieved 4X
increase in HAI titers (1:20-1:80)
• Cross-protection against six
unmatched strains
• Interim data from 2nd ID boost:
1Q 2012
• H1N1 + H5N1 w/ intradermal
delivery Phase I data: 2Q 2012
Influenza A sub-types responsible for key
seasonal & pandemic outbreaks of last century,
plus lethal sub-type of potential concern (H5N1)
Potential to shift flu prevention
paradigm to broad cross-protection
Page 22
Experienced Management Team
J. Joseph Kim, Ph.D., President & CEO
• 19+ years biotechnology/pharma management; 9 years at Merck;
hepatitis A and B vaccines manufacturing; HIV vaccine (Ad5) R&D;
100+publications on DNA vaccines; co-founded VGX Pharmaceuticals
Niranjan Y. Sardesai, Ph.D., COO
• 12+ years biotechnology management; product development expert
• PI on HIV (NIAID) and malaria (MVI-PATH) vaccine development
contracts
• Ex-Fujirebio Diagnostics: led development of diagnostic tests for
mesothelioma, bladder cancer, and ovarian cancer
Mark L. Bagarazzi, M.D., Chief Medical Officer
• 13+ years in clinical research, 8+ years at Merck; led clinical/
regulatory development for shingles and rotavirus vaccines; expert in
DNA vaccines
Managed development and approval of several vaccines
Page 23
Premier Advisors
Scientific Advisory Board
David B. Weiner, Ph.D.
Dept. of Pathology & Laboratory Medicine, U of PA
• “Father of DNA vaccines”
Thomas S. Edgington, M.D. Emeritus Professor, Scripps Research Institute
• Founded multiple biotech companies; extensively published
Philip Greenberg, M.D.
• Expert in T-cell
immunology
Iacob Mathiesen, Ph.D.
Head, Immunology Program,
Fred Hutchinson Cancer Research Center
CEO, Otivio AS
• International electroporation technology expert
Stanley A. Plotkin, M.D.
Emeritus Professor, Wistar Institute & U of PA
• Developed rubella and rabies vaccines, oversaw Sanofi flu vaccine
Board of Directors
• Senior vaccine/pharma management experience
Page 24
Financial Information
Cash & short term investments1
$31.1 M
+ Net proceeds from financing2
~ $3.7 M
Debt1
0M
Burn rate
Cash runway
Listing
3Q 2013
NYSE Amex: INO
Issued & outstanding shares1
127.3 M
+ Financing shares2
7.7 M
Recent price3
$0.45
Market cap3
1
~$4.5 M/Q
Sept. 30, 2011
2
$61 M
Dec. 6, 2011 3 Jan. 4, 2012
Page 25
Investment Summary
• Strong management team with vast vaccine discovery &
development expertise
• Paradigm shifting synthetic vaccine platform displaying
best-in-class immunogenicity and other characteristics
significantly improving upon conventional and new
competitive vaccine technologies
• Healthy cash position, no debt
• Extensive third-party funding
• Important validating clinical milestones over next
quarters
Page 26
revolutionizing
vaccines
Investor Contact:
Bernie Hertel
Senior Director, Corporate Communications
858-410-3101 ● [email protected]
NYSE Amex: INO
www.inovio.com