Inovio Pharmaceuticals, Inc. · NASDAQ:INO
Inovio Pharmaceuticals — Investor Presentation (August 2005)
25 slides from Inovio Pharmaceuticals's investor presentation, Aug 25, 2005
Slide 1: Late Stage Development Company: Oncology & Gene Delivery
• AMEX: INO • Late Stage Development Company • Oncology & Gene Delivery Q3-2005 Avtar Dhillon, M.D. President and CEO August 25, 2005
Slide 2: Forward Looking Statement
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 tech
Slide 3: Inovio Overview
Inovio Overview Cancer Therapy (Solid Tumors) • Electrochemical ablation eliminates the need for surgical removal of tumors • Two pivotal Phase III clinical trials recurrent H&N cancer (fast track designation) - Non-survival endpoint obtained through a Special Protocol Assessment (SPA) • European ne
Slide 4: Therapeutic Platform Based on Electroporation
Therapeutic Platform Based on Electroporation Electroporation DC Cell Membrane Cell Membrane Cell Membrane Before Pulse During Pulse After Pulse (Cell returns to original state) Electroporation applies brief electrical pulses, inducing pores to open in the cell membrane and dramatically increasing u
Slide 5: Inovio's Proprietary Medpulser System
Inovio’s Proprietary Medpulser® System Generator: • Capable of several thousand treatments • Generates square wave DC current Applicator: • One per patient • Usage restricted by smart-chip • Sizeable gross margin Revenue model: sale of disposable, single use applicators
Slide 6: Cancer Therapy Procedure Utilizing Electrochemical Ablation
Cancer Therapy Procedure Utilizing Electrochemical Ablation Injection of Bleomycin Pulsing the Electroporation enables cellular tumor with uptake applicator Drug surrounds Cell poration; Cells reseal tumor cells drug enters cells and die Simple two-step procedure requiring minimal training
Slide 7: Electrochemical Ablation of Basal Cell Cancer
Electrochemical Ablation of Basal Cell Cancer BCC of the Earlobe 30 days Pre- post- treatment treatment Tumor cells turn black as they die 90 days 120 days post- Post- treatment treatment Wound No further healing evidence itself of tumor Surgery would have required cutting out a portion of the ear
Slide 8: Cutaneous Cancer Therapy Clinical Data
Cutaneous Cancer Therapy Clinical Data (H.Lee Moffitt Cancer Center - USF) Type # of Patients Objective Complete Response* Response Basal Cell 56 of 56 51 of 56 18 Carcinoma (100%) (91.1%) 84 of 85 75 of 85 Melanoma 10 (98.8%) (88.2%) Squamous Cell 1 of 1 0 of 1 1 Carcinoma (100%) (0%) Kaposi’s 4 of
Slide 9: Electroporation Therapy Pre-clinical & Clinical Experience
Electroporation Therapy Pre-clinical & Clinical Experience Tumor Type In vitro In vivo Human ovarian endometrial prostate hepaticellular carcinoma Lewis lung carcinoma non-small cell lung fibrosarcoma glioma basal cell carcinoma melanoma Kaposi’s sarcoma adenocarcinoma squamous cell carcinoma oral,
Slide 10: Head & Neck Cancer Clinical Data
Head & Neck Cancer Clinical Data Phase II, recurrent late stage H&N tumors: N.A. and Europe Bleo Only Bleo & Electroporation Tumors Patients CR% PR% Tumors Patients CR% PR% OR% N. America I 37 25 0 3 20 17 30 25 55 N. America II 31 25 19 39 58 Europe 18 12 28 28 56 Total 69 54 26% 32% 57% Market see
Slide 11: Electrochemical Ablation of SCC in Oral Cavity
Electrochemical Ablation of SCC in Oral Cavity Day of treatment 2 weeks post-treatment - SCC on floor of mouth - cancer cells are dying Post-treatment - no evidence of cancer - no structural damage Destruction of healthy tissue is avoided with use of electrochemical ablation
Slide 12: Newly Diagnosed H&N Cancer (Europe)
Newly Diagnosed H&N Cancer (Europe) Patient 002: lateral tongue cancer Electrochemical ablation Electro- Tumor is poration injected is with applied bleomycin with the applicator 4 weeks post-electrochemical ablation 1 day post-electrochemical ablation No Cancer cell removal destruction of while heal
Slide 13: Electrochemical Ablation vs Surgery To Treat Solid Tumors
Electrochemical Ablation vs Surgery To Treat Solid Tumors • Equivalent local tumor control • Better tissue preservation • Better function preservation • Less cost
Slide 14: Two Pivotal Phase III Trials for SCCHN
Two Pivotal Phase III Trials for SCCHN Two open label, randomized trials comparing electrochemical ablation to surgery in patients with resectable tumors Tumors anterior to the tonsillar pillar (200 patients) SCCHN: 2 pivotal studies Tumors posterior to the tonsillar pillar (200 patients) 1o Endpoin
Slide 15: US Commercialization Strategy
US Commercialization Strategy • Seek marketing approval for recurrent and new primary H&N cancers • SPA-reviewed • Fast track designation • Expect to complete enrollment in Q1 2007 • Pancreas cancer • Phase I study • 1o Endpoint safety • 2o Endpoint pain control & weight maintenance • Breast cancer
Slide 16: European Commercialization Strategy
European Commercialization Strategy •CE certified market-ready device (H&N and cutaneous) •Thought leader endorsement through seeding •Seeking 30+ centers for initial introduction and pre-marketing studies Marketing •Acceptance → adoption partner •Pharmacoeconomic studies → reimbursement •Therapy be
Slide 17: Initial Market Opportunity
Initial Market Opportunity • Head & neck cancer: Europe and USA – 124,000 annual incidences • Disfiguring skin cancer: Europe and USA – 1,790,000 annual incidences, estimated 20% are disfiguring The market opportunity for the two initial indications is over $750 million, expanding to over a billion
Slide 18: Present Technologies for DNA Delivery
Present Technologies for DNA Delivery Vector Issues Efficacy Economics Mutations Viral Immune response +++++ $$$$$ Infection symptoms Lipids Toxicity ++ $$ Naked DNA No vector + $ (EP enhanced) No vector ++++ $ Electroporation enhanced gene expression is effective, low cost and avoids the side effec
Slide 19: Expression of SEAP in Pig Muscle
Expression of SEAP in Pig Muscle Serum levels of SEAP following expression in pig muscle N/6/200 V/cm/60ms No pulse L M Expression is enhanced nearly 100 times by a less then 1 second electroporation pulse
Slide 20: Electroporation with Clinically Relevant Genes
Electroporation with Clinically Relevant Genes (Gene Delivery & DNA Vaccines) Gene Delivery • Factor IX (FIX); hemophilia B • Thymidine kinase; oncology, CV* • Erythropoietin (Epo); anemia • Bcl–2 antisense; oncology, CV • Human growth hormone (hGH) * cardiovascular DNA Vaccines • Infectious disease
Slide 21: Collaborations
Collaborations Technology validated by industry partners
Slide 22: Intellectual Property Overview
Intellectual Property Overview Cancer Therapy Gene Transdermal Therapy Therapy Patent Families Primary patents Patents supporting EP apparatuses and methods Vascular Cosmetics Therapy Applications Ex vivo Applications 57 US and 125 corresponding foreign patents, plus numerous pending patents in the
Slide 23: Financial Information (as of June 30, 2005)
Financial Information (as of June 30, 2005) Shares Issued & Outstanding: 20,256,059 Shares Outstanding Fully Diluted: 31,440,925 Cash Position: $6.9M Average Daily Volume (last 3 months): 26K 52 Week Range: $2.37 - $5.06
Slide 24: Milestones (next 18 months)
Milestones (next 18 months) Cancer Therapy • Open label, Phase III clinical trials recurrent H&N cancer (fast track, SPA) -Complete enrollment • European newly diagnosed and recurrent H&N cancer pre-sales study - adoption by centers of excellence • European newly diagnosed and recurrent skin cancer
Slide 25: Inovio
NOVIO
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