Inovio Pharmaceuticals, Inc. Corporate Presentation December 2013
Inovio - Revolutionizing the Fight Against Cancers and Infectious Diseases
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Transcript of Inovio - Revolutionizing the Fight Against Cancers and Infectious Diseases
Revolutionizing the Fight Against Cancers and Infectious Diseases
Dr. J. Joseph Kim PRESIDENT & CEO NASDAQ: INO
It’s All About the T-Cells
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, 2014 and other regulatory filings from time to time.
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A Highly Compelling Weapon: T Cells
Cytotoxic T lymphocyte
T cell
Target cell
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• T cells: vital to fighting disease
But… • Can we help T cells
recognize evasive cancers or mutating infectious diseases?
• Can we enhance their targeting, speed and magnitude?
• Great strides in new immunotherapy technology
• Just scratching the surface
Is There an “Ideal” T Cell-Generating Immunotherapy?
Effective, efficient, safe…
Attributes • Well-targeted, antigen-specific • Not dependent upon being patient specific • Functional, with “killing tools” granzyme and perforin • Robust in magnitude • Persistent and durable over time • No unwanted immune response against a vector • No toxic inflammatory response • Capable of breaking tolerance
The ideal T cell generator would be an active immunotherapy. Does not bypass the immune system’s inherent capabilities and controls.
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Inovio Active DNA Immunotherapies: It’s All About the T Cells
IT’S ALL ABOUT THE T CELLS
Identify pertinent disease-specific antigen(s)
Encode DNA plasmid with genetic code for antigen
Deliver plasmids into cells in the body (in vivo), enabling them to produce antigen
T cells eliminate cells displaying disease-specific antigen
Immune system activates antigen-specific T cells
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Effective, efficient, safe in vivo T cell activation
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• Activate disease-specific CD8+ killer T cells and antibodies
Antigen targeting immunotherapies &
vaccines
• Enhance immune response activation • Impact durability of immune responses • Drive immune responses to sites of infection
Immune activators
• Simplified design, product stability, better manufacturing, dosing, and cost effectiveness
• Rapidly activates sufficient quantities of specific antibodies
Monoclonal antibodies
(DNA-based)
DNA Immunotherapy Platform: Multiple Applications
Broad Medical and Market Opportunities
Product Name
INTERNALLY FUNDED OTHER Cancer Programs
Indication Preclinical Phase I Phase II
Vgx-3100
Ino-5150
Ino-1400
EXTERNALLY FUNDED Infectious Disease Programs
Ino-3510
ino-1800
Phase III
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INO-3112
INO-3112
Hepatitis B Therapeutic
influenza
Breast/lung / Pancreatic cancers
Therapeutic
Prostate cancer Therapeutic
Head & Neck Cancer Therapeutic
Cervical Cancer Therapeutic
Cervical dysplasia
Therapeutic
Preventive/ Therapeutic
Ebola
Aerodigestive Cancer Therapeutic
INO-3106
INO-4212
Preventive
INTERNALLY FUNDED HPV programs
Pennvax®- B hiv
Pennvax®-GP hiv
Preventive/ Therapeutic Preventive/ Therapeutic
Ino-8000 Hepatitis C Therapeutic
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Cervical Dysplasia: Schiffman et al. Arch Pathol Lab Med (2003), Public Health England Cervical Cancer Screening Programme, Stoler et al. Anatomic Path (2011), Castle et al. JNCI (2005), Mayrand et al. NEJM (2007) Cancers: CDC, www.hpvcentre.net, WHO IARC
LOW GRADE
CERVICAL DYSPLASIA
(CIN1)
US: 1,400,000
EU5: 1,300,000
HIGH GRADE
CERVICAL DYSPLASIA
(CIN2/3)
US: 270,800
EU5: 267,400
CERVICAL CANCER
US: 11,818
EU5: 14,043
ORO-PHARYNGEAL
CANCER
US: 11,726
EU5: 13,932
Anogenital cancer
Annual incidences: US and EU5
HPV-Caused Pre-Cancers & Cancers
US: 9,530
EU5: 15,288
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Normal Cervical Intraepithelial Neoplasia
(CIN3) Invasive Cancer
If untreated, moderate/severe cervical dysplasia (CIN2/3) may progress to invasive cancer
Preventing Cervical Cancers: New Market Opportunity
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Non-Surgical Treatment of Cervical Dysplasia Desired
IARC Monograph 2003: Edited by J.W. Sellors and R. Sankaranarayanan
• LEEP (Loop Electrosurgical Excision Procedure) uses high-voltage electrical arc at 100oC to vaporize a plane through the cervix • Invasive; associated with pre-term births; does not clear HPV in untreated tissue
• Market research: patient and physician desire for non-surgical first-line alternative • Non-invasive; eliminate HPV in untreated tissue; avoid potential risks to birthing
Phase II: Study Design
• 148 subjects: 19-55 year old females with high-grade cervical dysplasia (CIN2/3)
• HPV 16 and/or 18 positive • 6 mg VGX-3100 or placebo(IM followed by EP)
at weeks 0, 4, and 12
Placebo-Controlled, Randomized, Double
Blind
• Regression of CIN2/3 to CIN1 or normal at six months post third dose (Week 36) Primary Endpoint
• Regression of CIN2/3 to CIN1 or normal and • Clearance of HPV 16 and/or 18 genotype
detected during screen Secondary Endpoint
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0
10
20
30
40
50
60
Phase II: Regression of Cervical Lesions to CIN 1 or Normal
Pre-Specified 1° Endpoint: Histopathologic Regression to CIN1 or Normal
30.6% (11/36)
Statistically significant difference (p=0.017; strata-adjusted)
Post-Hoc Analysis: Regression to Normal
0
10
20
30
40
50
60
40.2% (43/107)
16.7% (6/36)
Perc
ent
VGX-3100 Placebo VGX-3100 Placebo Statistically significant difference
(p=0.006; strata-adjusted)
Overall Histopathologic Regression Incidence Per-Protocol Population (N=143)
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49.5% (53/107)
Perc
ent
Phase II: Clinically Significant Efficacy; Achieves Endpoints
49.5% (53/107)
30.6% (11/36)
Histopathologic Regression to CIN1 or Normal AND Virological Clearance (HPV16 or 18) (n=143)
0
10
20
30
40
50
60
40.2% (43/107)
14.3% (5/35)
Perc
ent
VGX-3100 Placebo
Statistically significant difference (p=0.001; strata-adjusted)
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Regression of CIN3 to Normal and HPV Clearance Observed in VGX-3100 Treated Patient (via IHC) Over 36 Weeks
Wee
k 0:
CIN
3 pa
thol
ogy
IHC Staining: HPV
Wee
k 36
: No
sign
ifica
nt
path
olog
y
IHC Staining: CD8 16
Powerful Impact of VGX-3100 Phase II Efficacy Data
• Non-surgical option for the treatment of CIN2/3
• Simple 3 monthly injections generated CD8 killer T cells
• Measured in blood
• Observed in cervical tissue (tissue infiltrating T cells)
• Direct correlation found between CD8 T cells and efficacy
• Demonstrated phase II efficacy and safety
• Regressed disease to normal
• Cleared virus which caused the disease
• Disease regression: expand into other HPV-caused diseases
• Advance other anti-cancer therapies (lung, breast, pancreas, prostate)
• Virus (HPV) clearance supports other antiviral therapies (HBV, HCV, HIV)
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VGX-3100: Next Steps
EXPANSION OF HPV PROGRAM TO RELATED CANCERS AND PRE-CANCERS • Cervical cancer (Ph I/IIa initiated) • Head & neck (Ph I/IIa initiated)
• Anogenital cancers • VIN, PIN
PREPARED SCIENTIFIC PAPER FOR PEER REVIEW • Completed immunological analysis to characterize T cell subsets.
Phase II data adds to phase I data, which was extensively characterized (Bagarazzi, et al. Sci Transl Med 2012)
• Manuscript prepared for submission
PHASE III PLANNING FOR EARLY 2016 LAUNCH • Clinical and regulatory • Scale up immunotherapy production • Market research
• Supply chain strategy • EP device production • Pricing & reimbursement
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HPV-Associated Cancer Studies Enrolling: INO-3112
Phase I/IIa’s: INO-3112 (VGX-3100 + IL-12 DNA immune activator); HPV 16/ 18 related disease
Cervical Cancer • 20 women with cervical carcinoma • Safety, tolerability, immunogenicity • Cervical histology • Treat after chemoradiation
Head & Neck Squamous Cell Carcinoma • 20 men/women • Safety, tolerability, immunogenicity • Anti-tumor effects & progression free
survival • Arm #1: treat before/after tumor resection • Arm #2: treat after chemoradiation
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hTERT-Associated Cancers: INO-1400
• Antigen: human telomerase reverse transcriptase (hTERT), associated with cancer cell survival; overexpressed in 85% of cancers - potential “universal” cancer therapy
• +/- IL-12 DNA immune activator
• Phase I: 54 patients with breast, lung, or pancreatic cancers
• Safety, tolerability, immunogenicity
• Anti-tumor effects and progression free survival
• Trial launched: 4Q 2014
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• Multi-antigen: HBV clades A & C surface antigens & HBV core antigens
• +/- IL-12 DNA immune activator • Phase I: patients with chronic HBV
infection • Safety, tolerability, immunogenicity • Trial initiation: 1H 2015 • Roche paying all development costs plus
milestones
• 350M+ global market opportunity
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Hepatitis B: INO-1800
anthrax Louis Pasteur
Peter Kies CFO • 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
J.Joseph Kim, PhD President & CEO
• Decades of biotechnology/ pharma management
• 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 diagnostics development for mesothelioma, bladder
cancer, and ovarian cancer for Fujirebio Diagnostics
Management
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anthrax J.Joseph Kim, PhD • President & CEO, Inovio
Adel Mahmoud, PhD • Professor, Princeton University
• Former President, Merck Vaccines
• Responsible for Gardasil®, Zostavax®, Proquad® and Rotateq®
Morton Collins, PhD • General Partner, Battelle Ventures and Innovations Valley Partners
Simon X. Benito • Former Senior Vice President,
Merck Vaccine Division
Angel Cabrera, PhD • President, George Mason
University
• Former President, Thunderbird School of Global Management
Avtar Dhillon, MD Chairman, BOD
• Former President & CEO, Inovio Biomedical
Board of Directors
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Nancy Wysenski , MBA • Founder & Board Member,
Research Triangle Park Chapter of the Healthcare Businesswomen's
Association
anthrax Louis Pasteur
Stanley A. Plotkin, MD • Developed rubella and rabies vaccines
• Oversaw Sanofi flu vaccine
• Emeritus Professor, Wistar Institute & University of Pennsylvania
Philip Greenberg, MD • Expert in T cell immunology
• Head, Immunology Program, Fred Hutchinson Cancer Research Center
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Anthony W. Ford-Hutchinson, PhD
• Former SVP, Vaccines R&D, Merck
• Oversaw development: Singulair®, Januvia®, Gardasil®, Zostavax®,
Proquad® and Rotateq®
David B. Weiner, PhD Chairman
•“Father of DNA vaccines”
• Dept. of Pathology & Laboratory Medicine, University of Pennsylvania
Scientific Advisory Board
Financial Information
Cash, cash equivalents & short-term investments2 $ 93.6 M
Debt2 0 M
Cash runway 4Q 2017
Shares outstanding2 60.7 M
Recent share price1 $8.42
Market cap1 $ 511.1 M
NASDAQ: INO
1Mar 16, 2015 2Dec 31, 2014 3 From Q3 20142
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Insider buying3 > $2.75M
INTERNALLY FUNDED EXTERNALLY FUNDED
Ino-1400 4Q 2014 Initiated phase I
Breast, Lung, And Pancreatic Cancer
Vgx-3100 2016 Initiate phase III Cervical dysplasia
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Value Drivers
INO-3112 2H 2015 Report interim data
Head & Neck and Cervical Cancer
Ino-8000 2015 Report interim phase I data
Hepatitis C
Ino-1800 1H 2015 Initiate phase I
Hepatitis B
Ebola 1H 2015 Initiate phase I INO-4212
Ino-5150 1H 2015 Initiate phase I
Prostate cancer
PennVAX®
1H 2015 Initiate PENNVAX-GP phase I HIV
Best-in-class immune
responses to fight cancers
and infectious diseases
Targeting broad range of billion dollar disease
markets
Breakthrough in vivo T cell generating technology
Validating partnership with Roche
Lead product achieved phase
II efficacy endpoints
Investor Highlights
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