revolutionizing against cancers and infectious...
TRANSCRIPT
Revolutionizing the Fight Against Cancers and Infectious Diseases
Capital Introduction Meeting by
www.narucapital.com
Capital Introduction Meetings ● Investor Roadshows
Inovio Pharmaceuticals, Inc. NYSE MKT: INO
Forward Looking Statement
This presentation 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, 2013, our Form 10-Q for the quarter ended June 30, 2014, and other regulatory filings from time to time.
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Inovio is setting a new standard! • Game-changing milestone July 2014 - Lead product for HPV-related cervical
pre-cancer achieved : • Positive phase II efficacy data, a first in the active immunotherapy field • Advancing to phase III
• Best-in-class killer T cell responses published in peer reviewed journals,
Science-Translational Medicine and Journal of Infectious Diseases, for DNA immunotherapies targeting HPV (human papillomavirus) and HIV
• Multi-product potential for cancers and infectious diseases
• Focus on cancer: cervical, head & neck, breast, lung, pancreatic, prostate in current/near-term human studies
• Partnership with Roche (2013) for prostate cancer and hepatitis B therapies; $412M in milestones, plus development costs and royalties
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Global Leader in Active Immunotherapies
Guided by an Eminent Team of Experts
• Management • CEO and CMO: ex-Merck • CFO: ex-Ernst and Young • Extensive development, clinical
and growth company experience
• Board of Directors • Past president, Merck Vaccines • Venture capital and financial
management expertise
• Scientific Advisory Board • “Father” of the field of DNA-based
immunotherapies • Decades of experience and
accomplishment in vaccines and immunotherapies
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• Cancers and chronic infections: significant unmet medical needs
• Immunotherapies build on powerful concept proven by numerous successful vaccines: activate the immune system
• New immunotherapy technology opens door to powerful treatments
• Market forecasted to double in size
Immunotherapies: Large, Rapidly Growing Opportunity
Projected immunotherapy market 2018: $111.4B
Cancers
InfectiousDiseases
$43.5B
$67.9B
Immunotherapies will potentially become the backbone treatment in up to 60% of cancers over next 10 years − from less than 3% today (Citi Research)
Human Papillomavirus
Low Grade Cervical
Precancer
(CIN 1)
High Grade Cervical
Precancer
(CIN 2/3)
VGX-3100 Clinical Efficacy: Technology Breakthrough
• VGX-3100: designed to treat HPV (human papillomavirus)-associated precancers and cancers
• Phase II study achieved efficacy endpoints: high grade cervical precancer regression and clearance of HPV
• Unmet need: non-surgical alternative; ability to eliminate residual HPV in untreated tissue
• Advance phase III for cervical precancer (CIN 2/3) in 2016; final step to FDA approval
• De-risks product and business development strategy
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Disease Progression
Cervical Cancer
Inovio Technology: All About Activating T Cells
Disease/antigen- specific killer T cell
Target cell and disease-specific antigen(s)
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• Inovio immunotherapies activate disease/antigen-specific killer T cells to eliminate diseased cells
• Long-lasting immune memory
• Safe and well tolerated
Strain 1
Strain X
Strain 2
Antigen Y
Antigen Y Antigen Y
Inovio Products: Disease-Specific T Cells by Design
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Identify DNA code to target specific cancer or chronic infection
Synthetically create unique DNA sequence for target disease – PATENTABLE
SynCon® DNA immunotherapy ready to manufacture
VGX-3100: Multiple Multi-Billion Dollar Product Opportunities
9 Sources: CDC, www.hpvcentre.net; WHO IARC
Annual New Cases: U.S. + EU5
Project Highlights: VGX-3100
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VGX-3100, HPV Immunotherapy, Phase III Clinical Study
• High-grade cervical precancer
• Publish complete phase II study data in peer-reviewed journal in 2015
• End-of-study meeting with US Food & Drug Administration (FDA) to review phase II data and proposed phase III trial design: 2015
• Manufacture VGX-3100 immunotherapy and CELLECTRA® delivery devices: 2015
• Launch phase III study in 2016
• Potential regulatory approval and commercialization: 2019
• Potential $100M clinical trial cost
Project Highlights: INO-3112
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INO-3112, HPV Immunotherapy, Human Studies for Other Cancers
• VGX-3100 + immune activator
• Complete phase I/IIa cervical and head & neck cancer exploratory studies
• Design and launch phase II studies for INO-3112 for cervical and head & neck cancers
• Initiate other human studies for HPV-related precancers and cancers of the cervix, head & neck, and anogenital areas
• Potential regulatory approval and commercialization: 2019
• Potential $40M clinical trial cost in Phase II
INO-3112
Anogenital
Head + Neck
Cervical
Possible Project: MERS (Middle East Respiratory Syndrome)
• 838 cases, 293 deaths, primarily in Saudi Arabia, since Sept. 2012; Fatality rate: 35% (WHO, August 11 2014)
• Inovio’s MERS immunotherapy induced strong immune responses in animal study
• Opportunity, with government funding/support, to advance preclinical and clinical studies for potential MERS immune therapy
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INTERNALLY FUNDED EXTERNALLY FUNDED
Ino-5150 2015 Initiate phase Ia/Ib Prostate cancer
Vgx-3100
2016 Initiate phase III Cervical dysplasia
INO-3112
2Q 2014 Initiated phase I/IIa
Head & Neck Cancer
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Strong Clinical Pipeline & Value Drivers
INO-3112
2Q 2014 Initiated phase I/IIa
Cervical Cancer
Ino-1400
2H 2014 Initiate phase I/IIa
Breast/lung/
Pancreatic Cancer
PennVAX®
4Q 2014 Initiate PENNVAX -GP phase I HIV
Ino-8000 2015 Report phase I data
Hepatitis C
Ino-1800 2015 Initiate phase I/IIa
Hepatitis B
Leading Global Patent Portfolio
SynCon® DNA-based immunotherapy DNA antigen sequences targeting specific cancers and infectious diseases
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Protected by over 500 global patents issued and pending:
CELLECTRA® electroporation delivery methods and devices
DNA immunotherapy
Electroporation device
Financial Information
Cash, cash equivalents & short-term investments2 $ 109.0 M
Debt2 0 M
Cash runway 4Q 2017
Shares outstanding2 60.3 M
Recent share price1 $10.75
Market cap1 $ 648.2 M
NYSE MKT: INO
1Aug 25, 2014 2Jun 30, 2014
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Recent insider buying $2.75M
• US-based publicly traded company: NYSE MKT: INO • Located in Plymouth Meeting, Pennsylvania, and San Diego, California • Staff: 85 people • Proposed investment structure: straight common equity investment into
corporate treasury • Investment size: flexible up to $100M; payable upfront • US tax and legal structure • Use of proceeds: research and clinical development for outlined projects • Investment returns and cash flow: guidance cannot be provided • Break-even cash flow due to product sales or royalties cannot be realized until
after approval and commercial launch of a first product in 2019 or later • Additional non-equity cash inflows may be realized through partner development
fees and milestone payments or other third party grants/contracts • Exit: publicly traded shares offer liquidity and exit as preferred by the investor,
without restriction
Other Financial & Corporate Details
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• Biotechnology: strategic industry providing globe-changing health and economic impacts
• Investment diversification: biotech not correlated with underlying economic drivers common to most industries
• Capital appreciation: potentially multiples of original investment over long term (i.e. five years)
• Potential to facilitate in-country clinical studies for therapies targeting devastating cancers and infectious diseases
• Low historical company market valuation relative to intrinsic asset value, based on recent accomplishments
• Equity investment into Inovio corporate treasury:
• Aligned with management and key shareholders
• Diversifies capital appreciation and risk across multiple products and technologies
Inovio Investment Merits
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