ico Therapeutics Andrew Rae, President & CEO / TSX-V: ICO

Transcription

1 ico Therapeutics Andrew Rae, President & CEO / TSX-V: ICO

2 Forward Looking Statements Certain of the statements contained in this presentation are forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. 2

3 About ico Therapeutics Targeting ocular diseases Lead program: Pipeline: Partnerships: Ph 2 for Diabetic Macular Edema (DME) - Human Monoclonal Antibody Targeting eotaxin-1 - Oral Amphotericin B Delivery System JDRF, ISIS, AstraZeneca MedImmune & Immune Pharmaceuticals Efficient use of capital Experienced management & board 3

4 Validated Therapeutic Arena 104.5% return * Pfizer Santen Novartis Lpath (wamd) >$500 M Macusight $50 M upfront + undisclosed milestones ( wamd & DME) Genentech (wamd & DME) Undisclosed Bayer Regeneron (wamd & DME) >$320 M Sanofi-Aventis Fovea 370 M (DME & Other Ophthalmic Therapies) Alcon ThromboGenics 375 (VMA & Other Ophthalmic Therapies) Alcon Novartis Allergan ESBATech $589 M Alcon $12.9 B Molecular Partners $1.4 B (Ophthalmic Platform) (Ocular Drug and Device Pipeline) (wamd) DME = diabetic macular edema wamd = wet age-related macular degeneration * Last 12 Months, October 2012, BMO Capital Markets 4

5 ico 007 Novel 2 nd generation antisense candidate for the treatment of Diabetic Macular Edema Partner: Isis Pharmaceuticals

6 Diabetic Macular Edema (DME) Leading cause of blindness in working age adults Abnormal Retina Normal Retina Proliferation of new, permeable blood vessels allows blood to leak into retinal area, causing swelling and deformation Current treatments: Steroids Laser Anti-VEGF 6

7 ico-007: MOA - VEGF Plus Growth factors Modulate signal ico-007 inhibits the production of c-raf, thereby preventing the signaling of growth factors, which in turn prevents the production of new and permeable blood vessels Retina 7

8 ico-007 & C-Raf Kinase Recent results have shown that the pathways activated by Ras/Raf play a crucial role in diabetes-associated complications including retinopathy. 8

9 6 months Baseline Phase 1: Patient Examples Single Injection 110ug dose (sample patient) 350ug dose (sample patient) 700ug dose (sample patient) 1000ug dose (sample patient) 528 micron s 391 microns 867 microns 423 microns 379 microns 228 microns 124 microns 187 microns Delta: 149 microns Delta: 163 microns Delta: 743 microns Delta: 236 microns The number of patients in study is low, statistical significance cannot be inferred 9

10 ideal Physician-sponsored US Phase 2 Randomized, multi-center study Up to 208 patients 4 Study Groups Monotherapy dose 1 (350 ug) Monotherapy dose 2 (700 ug) Combination with Ranibizumab Combination Laser Photocoagulation 12 month follow up Initiated in Q Primary endpoint Change in visual Acuity Secondary endpoints Visual acuity & reduction of retinal thickness Duration of effect Safety of repeated injections Pharmacokinetic assessments (PK) 10

11 Competitive Landscape Category Product Device Anti-VEGF Steroids Laser Avastin Macugen Eylea Lucentis (approved) Iluvien, Ozurdex Triamcinolone, etc. Key Product Profile Issues Treatment burden Side effects Cost Biological targets 11

12 ico-007 Product Differentiation Novel c-raf kinase-targeted antisense specific for DME Targets more than just VEGF: Existing competitors target VEGF only, while DME is caused by multiple growth factors Longer half life = fewer injections: Competitors require monthly injections costly, time consuming and a logistical burden on both patients and physicians Easy to manufacture No known side effects comparable to select competitors 12

13 Market Opportunity U.S. Diabetes Patients 21 million 40 million 10 % Penetration % of diabetes patients report visual impairment (5.3 million Diabetic Retinopathy patients today) (1.6 million DME patients today) $ 500 $10,000 per annual treatment (only clinically significant cases) *Lucentis = $24,000 annually M 13

14 ico-007 Next Steps Received Health Canada Clearance for Phase 2 Completed fill finish manufacturing to produce clinical supply US FDA Clearance for Phase 2 US Phase 2 trial initiated August 2011 Interim results year end Ongoing regional partnership discussions 14

15 ico 008 Human monoclonal antibody treating both the back and front of the eye Partners: AstraZeneca/MedImmune & Immune Pharmaceuticals

16 ico-008 Human monoclonal antibody targeting eotaxin-1 Binds with high affinity to CCR3 Good safety & significant clinical history Ph 1 & 2 (n=126) Ocular: Vernal & Atopic Keratoconjunctivitis, Wet Age Related Macular Degeneration Systemic: Inflammatory Bowel Disease, Severe Asthma (License granted to Immune Pharmaceuticals) 16

17 ico 008 Licensing: MedImmune & Immune In-licensing $400,000 up front payment $7,000,000 milestone payments Exclusive rights to entire body Out-licensing $500,000 upfront received $32,000,000 incoming milestones 600,000 Immune shares 200,000 Immune warrants 6.14% ownership with dilution provisions Royalties on net sales Retained WW rights to all ocular applications 17

18 Oral Amphotericin B Delivery System Partner: The University of British Columbia

19 Amphotericin B & IV Delivery IT WORKS Gold standard AmBisome >$400M in sales Premium pricing for safety BUT NOT PRACTICAL IN MANY SITUATIONS Variety of Developed World fungal infections Lack of resources in Developing World Inconvenient unmet need: oral formulation 19

20 Proprietary Oral Delivery Platform Lipid capsule Candy Wrapper Proprietary platform Used for insoluble products including vaccines and proteins Expanding the Amp B market: Safety and convenience, HIV Oral treatment for : Goal of WHO & Gates Foundation, Governments & several other global health organizations Non-dilutive funding to date: CPDD/Gates and CIHR, NRC 20

21 Oral Amphotericin B Delivery System Studies HIV/AIDS currently managed using a combination of drugs (HAART) HIV often remains hidden in tissue reservoirs Amphotericin B may be efficient at flushing out latent HIV in reservoirs $1.1 million in non-dilutive grant funding from Canadian government/gates Foundation Next steps: feasibility testing, further pre-clinical studies and clinical trials 21

22 Financials & Corporate Review

23 ico Pipeline 23

24 Biotech Value Inflection: ico & Peers (as of Nov 1, 2012) Medicago $114.1 M Thrombogenics Lpath $68.5 M MethylGene $57.3 M ico $39.5 M $1,731.1 M Just received approval for Symptomatic Vitreomacular Adhesion (VMA) Other Biotech Value Drivers Partnerships SPA Other ico Value Drivers Ph 2 Interim data Partnerships Immune holdings IND Ph 1 data Ph 2 data Ph 3 final data NDA Approval 24

25 Upcoming Milestones Milestone Timing Completed ico 007: Complete fill finish manufacturing for clinical supply ico 007: US FDA Clearance for Phase 2 ico 007: US Phase 2 trial initiated ico 008: Licensed systemic rights to Immune Pharma $32+ Million Amp B: Non-dilutive grant funding ico 007: Interim results H ico 007: Regional partnership discussions ico 008: Pursuing non-dilutive funding of ocular programs 2012 YE Ongoing Ongoing Amp B: Phase 1 trial

26 Management and Directors Management Andrew Rae, MBA Co-founder, Director, President & CEO Peter Hnik, MD, MHSc. Chief Medical Officer John Meekison, BA, CIM, P. Log. Co-founder & Chief Financial Officer Non-Executive Directors William Jarosz, JD Chairman of the Board, ico Cartesian Capital Group, LLC Richard Barker, PhD Former Director General of the Association of the British Pharmaceutical Industry, Celgene director Noel Hall Co-founder of Aspreva Douglas Janzen Former President & CEO, Cardiome Strategic Advisory Board Donald Buell, MD ico-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point Consultants, LLC, Former VP Corp Development, Allergan Extensive public company and life science experience Solid operational and product development expertise Ophthalmic specific expertise 26

27 Financials (as of June 30, 2012) Invested Capital to Date $22.5 million Largest Shareholders Cash Cash Runway Special Situations Funds (11%) Isis Pharmaceuticals (9.7%) Management (8.7%) $2.8 million *not including $1.1M grant Through Q (past interim data) Share Capital 52.7M (SO) 65.8M (FD) Head Office Vancouver BC, Canada Filings available at 27

28 ico Therapeutics TSX-V: ICO