Inovio Pharmaceuticals, Inc. · NASDAQ:INO
Inovio Pharmaceuticals — Investor Presentation (January 2006)
27 slides from Inovio Pharmaceuticals's investor presentation, Jan 25, 2006
Slide 1: Late Stage Development Company: Oncology & Gene Delivery
• AMEX: INO • Late Stage Development Company • Oncology & Gene Delivery Q1-2006 Avtar Dhillon, M.D. President and CEO January 25, 2006
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 tumor ablation eliminates the needs for surgical removal of tumors & margins • Two pivotal Phase III clinical trials in recurrent H&N cancer - Fast track designation, SPA • European newly diagnosed and recurrent H&N cancer pre-sales stu
Slide 4: Therapeutic Platform Based on Electroporation
Therapeutic Platform Based on Electroporation Electroporation DC Cell membrane Cell membrane Cell membrane before pulsing during pulsing after pulsing (Cell returns to original state) Electroporation applies brief electrical pulses, inducing pores to open in the cell membrane and dramatically increa
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 treatment applicators
Slide 6: Selective Electrochemical Tumor Ablation (SECTA)
Cancer Therapy Procedure Utilizing Selective Electrochemical Tumor Ablation (SECTA) 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 mi
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: Electrochemical Tumor Ablation Therapy: Pre-clinical & Clinical Experience
Electrochemical Tumor Ablation 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
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 Two weeks post- - SCC on floor of mouth treatment - 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: 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 13: 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 14: US Commercialization Strategy: H&N cancers
US Commercialization Strategy SECTA treatment for H&N cancers • Phase III pivotal trials for recurrent and new primary H&N cancers • 124,000 annual incidences (Europe and USA); nearly 500,000 new cases worldwide • SPA-reviewed • Fast track designation • Over 100 patients enrolled
Slide 15: US Commercialization Strategy: Pancreas cancer
US Commercialization Strategy SECTA treatment of pancreas cancer • Over 32,000 cases will be diagnosed this year (U.S.) • Most patients are not candidates for surgery • Standard chemo-radiation outcomes are poor • Median survival 6-10 months • Phase I study in patients with non-resectable cancer • 1
Slide 16: US Commercialization Strategy: Breast cancer
US Commercialization Strategy SECTA treatment for breast cancer • 184,000 cases will be diagnosed this year (U.S.) • Most frequently diagnosed cancer in U.S. women • Second leading cause of death in U.S. women • In 10-20% of patients receiving a partial mastectomy, the cancer recurs along the area o
Slide 17: Breast Cancer Skin Metastases Post-Mastectomy
Breast Cancer Skin Metastases Post- Mastectomy • Initially treated with chemotherapy followed by mastectomy and radiotherapy Before • Subsquently developed skin metastases that were treated with SECTA • Lesions disappeared completely After • Only pigmentation and fibrosis in biopsy
Slide 18: European Commercialization Strategy
European Commercialization Strategy •CE certified market-ready device (H&N and cutaneous) •Two pre-marketing studies • Head and neck cancer • Skin cancers •Efficacy and pharmacoeconomic studies → reimbursement and partnership •Additional indications could be rapidly developed by partner •Therapy ben
Slide 19: 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 20: 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 than one second of electroporation pulsing
Slide 21: DNA Vaccination
DNA Vaccination • The promise: rapid vaccination (including cost effective, mass immunization) • The challenge: achieving therapeutic immune responses • Potential solution: electroporation (EP) to enable DNA-based immunization • Pre-clinical studies demonstrate that EP induces rapid, strong, durable
Slide 22: Collaborations
Collaborations • Multiple first-in-man clinical trials - Electroporation-mediated gene delivery - Enables strong immunological responses to DNA vaccines • All clinical programs funded by partners
Slide 23: 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 60 US and 140 corresponding foreign patents, plus numerous pending patents in the
Slide 24: Inovio's Product Pipeline – Clinical Trials
Inovio’s Product Pipeline – 10 Clinical Trials Oncology Pipeline – United States Complete In d Progress Oncology Pipeline – Europe Complete In d Progress DNA Vaccine / Gene Delivery Pipeline Complete In d Progress
Slide 25: Financial Information
Financial Information (as of January 25, 2005) Shares Issued & Outstanding: 29,452,195 Shares Outstanding Fully Diluted: 41,554,036 Cash Position (September 30, 2005): $4.97M *$15.8M financing completed December 30, 2005 Average Daily Volume (last 3 months): 38.1K 52 Week Range: $1.99 - $5.06
Slide 26: Near-Term Milestones
Near-Term Milestones Cancer Therapy • Phase III recurrent H&N cancer trials (fast track, SPA) - Increase enrollment (over 100 patient enrolled) • European newly diagnosed and recurrent H&N cancer pre-sales study - Pharmacoeconomic comparison to surgery • European newly diagnosed and recurrent skin c
Slide 27: Inovio
NOVIO
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