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Sharing Your Vision™. Focus. Introducing Integrin Peptide Therapy for the treatment of vascular eye diseases. 2. Allegro’s Target Markets. Wet Age-Related Macular Degeneration 1 1.5M patients in the US 2x by 2020. Diabetic Macular Edema & Diabetic Retinopathy 2,3
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Focus Introducing Integrin Peptide Therapy for the treatment of vascular eye diseases 2
Allegro’s Target Markets • Wet Age-Related Macular Degeneration1 • 1.5M patients in the US • 2x by 2020 • Diabetic Macular Edema & Diabetic Retinopathy2,3 • 10.2M patients in the US over 40 with diabetes • 4.1M have some form of DR • 30% of adults with diabetes for 20 years have DME • Current Treatment Options • Lucentis-Avastin • Eylea • Sales Revenue • 2011: $3.5B globally (23% YoY growth) • 2017P: $6.5B globally • U.S. Center for Disease Control • American Diabetes Association • Ophthalmology. 1984;91:1464-1474 3
ALG-1001 Target Market in Wet AMD ALG-1001 primarily targets this 75% of patients that either progress or plateau despite anti-VEGF treatments Source: Lucentis/Avastin Data: Comparison of AMD Treatments Trials (CATT) Study. 4
Paving A Clear Path to Commercialization • Experienced Team • 100+ years of ophthalmic industry experience, supported by world class SAB & BoD • New Class of Treatment for Vascular Eye Diseases • Potent • Long-lasting • Unique patient benefits • Strong IP Position • Composition of matter patent applications pending in US and internationally • PCT written opinion that patent claims are novel • Clear Regulatory Path • FDA confirmed efforts will support a Phase 2 IND application later this year • Proving Safety & Efficacy through Clinical Trials • Phase 1a study evidenced safety and initial efficacy • Phase 1b/2a studies currently in progress • Phase 2 US study scheduled for 2H 12 5
Paving A Clear Path to Commercialization Hampar Karageozian Chief Executive Officer Marc Kirshbaum Chief Operating Officer Vicken Karageozian, MD Chief Technical Officer John Park, PhD VP, Product Development Tom Bender Independent Board Member Bob Byrnes Independent Board Member • Experienced Team • 100+ years of ophthalmic industry experience, supported by world class SAB & BoD • New Class of Treatment for Vascular Eye Diseases • Potent • Long-lasting • Unique patient benefits • Strong IP Position • Composition of matter patent applications pending in US and internationally • PCT written opinion states claims are novel • Clear Regulatory Path • FDA confirmed efforts will support a Phase 2 IND application later this year • Proving Safety & Efficacy through Clinical Trials • Phase 1a study evidenced safety and initial efficacy • Phase 1b/2a studies currently in progress • Phase 2 US study scheduled for 2H 12 Vitreo Retinal Technologies, Inc. 6
Scientific Advisory Board David S. Boyer, M.D. Peter Campochiaro, M.D. Founder Retina-Vitreous Associates Medical Group Professor, Dept. of Ophthalmology The Wilmer Eye Institute, Retina Division Johns Hopkins University Barry Kuppermann, M.D., Ph.D. Julia Kornfield, Ph.D. Professor & Chief of The Retina Service University of California, Irvine Professor Department of Chemical Engineering California Institute of Technology Visdex Hugo Quiroz-Mercado, M.D. Professor University of Colorado, Dept. of Ophthalmology Director of Ophthalmology Service Denver Health Medical Center 7
Treating DME and Wet AMD with ALG-1001 After ALG-1001 treatment Diabetic Macular Edema Clusters of aberrant blood vessels due to VEGF accumulation Wet Age-Related Macular Degeneration After ALG-1001 treatment 8
Approaches To Neovascular Diseases Current Standard of Care Works downstreamto bind and inhibit VEGF that causes bleeding and fluid leakage into the eye ALG-1001 Works upstream to block abnormal blood vessel growth in the eye and shut off VEGF production at its source 9
ALG-1001 Drug Development Progression Prior 18 Months: • In vitro • Animal safety • Animal efficacy • Human safety • Initial human efficacy 10
Proving Animal Efficacy: CNV Mouse Model Statistical significance (p=0.018) • Well established laser-induced mouse model for choroidal neovascularization • Showed strong efficacy of ALG-1001 with statistical significance • 43% reduction in the area of neovascularization N=10 N=10 N=9 N=10 Source: P. Campochiaro, Johns Hopkins University 11
Proving Animal Efficacy: ROP Mouse Model • Ischemic retinopathy treated mouse model for pre-retinal neovascularization • ALG-1001 caused significant inhibition of neovascularization • 3 doses exhibiting statistical significance Control 4 N=9 50µg/1µl Drug N=9 Source: P. Campochiaro, Johns Hopkins University 12
Phase I Human Study Trial Facts • February 2011 – September 2011 • Primary goals: determine safety and potential efficacy • Open label, single dose study, 3 monthly injections, subjects followed 3 months off-treatment • 15 subjects with advanced diabetic macular edema, many with proliferative diabetic retinopathy • Best corrected visual acuity of 20/100 or worse • End-stage patients; many failed to respond to current standard of care Subject #6 prior to ALG-1001 treatment, exhibiting advanced stage disease 13
Vision Improvement in Phase I Subjects 8 out of 15 subjects’ vision improved at least 3 lines on the eye chart after 90 days • Improvement held until end of trial – at least 90 days off-treatment • 7 out of 15 subjects did not respond, yet vision did not continue to get worse • Many subjects had not previously responded to current standard of care # of subjects responding to treatment after 90 days 14
Vision Improvement 20/200 Lines of Improvement in BCVA 20/50 Responders Non-Responders 30 Days Off Treatment 60 Days Off Treatment 90 Days Off Treatment 15
Mean OCT Central Macular Thickness Baseline: 608μ Central Macular Thickness Non-Responders Microns Responders Study Duration (days) Day 150: 128μ 30 Days Off Treatment 60 Days Off Treatment 90 Days Off Treatment 16
Projected Milestone Timeline Phase I Trial 15 DME Patients Feb – Oct 11 Multiple Animal Safety Studies Q1 11 – Q2 12 Multiple Animal Efficacy Studies Q2 11 – Q4 12 Phase Ib/2a Trial 30 DME Patients Q4 11 – Q3 12 Phase Ib/2a Trial 20 Wet AMD Patients Q1 12 – Q3 12 US Phase 2a/b Trial 75 Wet AMD Patients Q3 12 – Q3 13 Phase 3 Trial Wet AMD Q4 13 – Phase I Data First Presented (AAO) Pre-IND Meeting Helmsley Grant OCTANe Award IND Filing 17
Funding Approach & Strategy • Self-funding: $700K • Molecule discovery • In vitro testing at CalTech • Animal safety and efficacy testing • Human safety and initial efficacy (Phase I Study) • Patent applications • The Helmsley Trust Grant: $600K • Multiple animal studies at Johns Hopkins • Continued basic science research at CalTech • GMP drug manufacturing and testing • Series A Round: $3M • Phase Ib/2a DME Study • Phase Ib/2a Wet AMD Study • Phase 2 US Study • G&A expenses • Strategic Partner: $MM • Indication of interest prior to commencing Phase 2 US Study • Perceived value in studying delivery mechanisms, multiple indications, etc. Opportunity for additional grant funding 18
For More Information Allegro Ophthalmics, LLC 31473 Rancho Viejo Road, Suite 204 San Juan Capistrano, CA 92675 www.allegroeye.com Marc D. Kirshbaum Chief Operating Officer mkirshbaum@allegroeye.com (714) 553-2139 Vicken Karageozian, MD Chief Technical Officer vkarageozian@allegroeye.com (949) 295-2135 20