Nicox Sa · EURONEXT:ALCOX
Nicox Sa — Investor Presentation (May 2022)
27 slides from Nicox Sa's investor presentation, May 3, 2022
Slide 1: Corporate Presentation
Corporate Presentation May 3, 2022 © 2022 Nicox. All rights reserved
Slide 2: Forward-Looking Statements
Forward-Looking Statements This document has been prepared by Nicox SA and may not be reproduced or distributed, in whole or in part. The information contained in this document has not been independently verified and no representation, warranty or undertaking, expressed or implied, is made as to, an
Slide 3: Nicox at a Glance
Nicox at a Glance Lead asset NCX 470, Phase 3, a potential best-in-class glaucoma treatment NCX 4251, Phase 2, novel treatment with unique mode of application in dry eye disease Financial strength underpinned by global partnerships and revenue generated from out-licensed commercial products 3
Slide 4: Pipeline
Pipeline Stages of Development Expected Preclinical Phase 1 Phase 2 Phase 3 NDA Marketed milestones Product Candidates NCX 470 | novel NO-donating prostaglandin analog Mont Blanc and Denali trials Mont Blanc top-line Glaucoma & Ocular Hypertension results Q1 2023 Partnered with Ocumension in the Chi
Slide 5: NCX 470: Novel Late-Stage Product Candidate in Glaucoma
NCX 470: Novel Late-Stage Product Candidate in Glaucoma Based on Nicox’s NO-Donating Research Platform 5
Slide 6: Glaucoma Results in Progressive and Irreversible Vision Loss
Glaucoma Results in Progressive and Irreversible Vision Loss Normal Reduced aqueous aqueous humor humor outflow outflow Healthy eye Intraocular Pressure (IOP) builds up Typical effect of glaucoma on vision ~3 million patients in the U.S. with open angle glaucoma1 Unmet medical need: 40% of patients
Slide 7: Every mmHg of IOP Lowering Reduces Risk of Glaucoma Progression
Every mmHg of IOP Lowering Reduces Risk of Glaucoma Progression Results from the Early Manifest Glaucoma Results from the United Kingdom Glaucoma Trial (EMGT)1 Treatment Study (UKGTS)2,3 “[…] the risk reduction could be about “In these analyses, each mmHg of 19% per mmHg, confirming results decrease
Slide 8: NCX 470 Targets ~$1.4 Billion U.S. Glaucoma PGA Market
NCX 470 Targets ~$1.4 Billion U.S. Glaucoma PGA Market1 U.S. Glaucoma Pharmaceuticals Market is ~50% of the Global Market1 PGA Prescription Volume2 PGA Prescription Value3 TRAVATAN Z VYZULTA LUMIGAN (bimatoprost) (travoprost) (latanoprostene 12% 9% bunod) TRAVATAN Z (travoprost) 4% 3% ROCKLATAN (net
Slide 9: NCX 470 Targets the Two Key Outflow Pathways for IOP Lowering
NCX 470 Targets the Two Key Outflow Pathways for IOP Lowering Potential for Best-in-Class Efficacy with Novel Dual Mechanism of Action Two pathways for aqueous humor outflow 9
Slide 10: NCX 470: Statistical Superiority to Market Leader in IOP Lowering
NCX 470: Statistical Superiority to Market Leader in IOP Lowering Linear Dose Response Suggests Potential Higher Efficacy for Phase 3 Dose Efficacy vs Side Effect Profile Summary Phase 2 Dolomites Trial Results Observed in Phase 2 Trial • Large Phase 2 trial achieved statistical superiority to marke
Slide 11: NCX 470: 2 Phase 3 trials Support U.S. & China NDA Submissions
NCX 470: 2 Phase 3 trials Support U.S. & China NDA Submissions Mont Blanc Top-line Results Currently Expected in Q1 2023 Randomized, double-masked in patients with open angle glaucoma or ocular hypertension Mont Blanc trial N=~670, across ~50 clinical sites in the U.S. and one site in China. NCX 470
Slide 12: NCX 470 Potential Peak Sales in U.S. First-Line Glaucoma Market
NCX 470 Potential Peak Sales in U.S. First-Line Glaucoma Market EXISTING MARKET: ~$1.4 billion1 NCX 470 Current Traditional2 PGAs VYZULTA (latanoprostene ROCKLATAN (fixed dose therapies bunod ophthalmic solution), combination of netarsudil Two market research Latanoprost: Latanoprost:>70% of PGA >70
Slide 13: NCX 470 Shows Retinal Cell Protection in a Non-Clinical Model
NCX 470 Shows Retinal Cell Protection in a Non-Clinical Model1 Improved ocular perfusion and retinal function in damaged eyes Potential therapeutic properties beyond IOP lowering • Ophthalmic OcularArtery Retinal function1 Resistive Index changes ischemia/reperfusion hemodynamics (Echo-doppler - Oph
Slide 14: NCX 4251: Novel Treatment in Dry Eye Disease
NCX 4251: Novel Treatment With Unique Mode of Application in Dry Eye Disease 14
Slide 15: NCX 4251 and Dry Eye Disease
NCX 4251 and Dry Eye Disease An Innovative Potential Therapy for Treatment of Dry Eye Disease Product Prevalence Market Over $5bn sales worldwide2 Unique eyelid margin application 34 million designed to minimize corticosteroid- Americans estimated to have dry induced ocular adverse events eye diseas
Slide 16: NCX 4251: Mississippi Phase 2b Clinical Trial and Next Steps
NCX 4251: Mississippi Phase 2b Clinical Trial and Next Steps Targeting Future Development in Dry Eye Disease Design Mississippi was a U.S. Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension, 0.1% QD for the
Slide 17: NCX 4251: Efficacy in Reducing Signs & Symptoms of Dry Eye Disease
NCX 4251: Efficacy in Reducing Signs & Symptoms of Dry Eye Disease1 Reduction from baseline in eye dryness score2 Post hoc subset analysis in patients with inferior corneal fluorescein staining score of >=2 • 123 of the overall 224 patients had inferior corneal fluorescein staining scores ≥2 on a sc
Slide 18: NCX 1728: NO-Donating PDE5 Inhibitor in Glaucoma and Retinal Diseases
NCX 1728: NO-Donating PDE5 Inhibitor in Glaucoma & IOP-Lowering and Certain Retinal Diseases Based on Nicox’s NO-Donating Research Platform 18
Slide 19: NCX 1728: NO-donating PDE5 inhibitor
NCX 1728: NO-donating PDE5 inhibitor • Lead in a new class of compounds (non-PGA related) with NO-mediated IOP lowering effects enhanced and prolonged by concomitant PDE5 inhibition within the same molecule • Class of molecules is being evaluated for development in glaucoma & IOP lowering and in cer
Slide 20: NCX 1728 Mechanism of action
NCX 1728 Mechanism of action Enhancing and prolonging the activity of NO NCX 1728 - + PDE5 sGC 5’-GMP cGMP GTP - [Ca2+]i Improved ocular perfusion and reduced intraocular pressure 20
Slide 21: Corporate
Corporate • Key Partnerships • Financial Highlights • Anticipated Value-Creating Milestones 21
Slide 22: Key Partnerships
Key Partnerships • Exclusive rights1 in China and certain Southeast Asian markets on three key assets • NCX 470: received €18 million; 6% to 12% net royalties on sales; funding 50% of Phase 3 OCUMENSION Denali clinical trial NCX 470, ZERVIATE, NCX 4251 • ZERVIATE: Up to $17.2 million in sales milest
Slide 23: Partnership with Fera on Naproxcinod in Sickle Cell Disease
Partnership with Fera on Naproxcinod in Sickle Cell Disease Developing Naproxcinod for an Inherited Orphan Disease Disease Prevalence Status • Naproxcinod is a COX-Inhibiting Nitric Oxide Donor (CINOD) • Orphan Drug Designation granted by the U.S. FDA for sickle cell disease • Fera has an exclusive
Slide 24: Financial Highlights
Financial Highlights Estimated Financial Position as of March 31, 20221 Analyst Coverage Cash, Cash Equivalents €35.1 million Bryan Garnier Dylan Van Haaften Debt2 €20.5 million H.C. Wainwright Yi Chen Cash runway Q4 2023 Kepler Cheuvreux Arsene Guekam Edison Investment Pooya Hemami Research Outstan
Slide 25: Value-Creating Milestones
Value-Creating Milestones Building Our Late-Stage Ophthalmic Portfolio for Commercialization Accomplished Expected Last patient enrolled in NCX 470 Phase 3 NCX 4251 Phase 2b NCX 4251 move into Mont Blanc Mississippi trial DED following completed U.S. FDA meeting NCX 470 Phase 3 Mont NCX 470 Phase 3
Slide 26: Nicox at a Glance
Nicox at a Glance Lead asset NCX 470, Phase 3, a potential best-in-class glaucoma treatment NCX 4251, Phase 2, novel treatment with unique mode of application in dry eye disease Financial strength underpinned by global partnerships and revenue generated from out-licensed commercial products 26
Slide 27: Innovative Solutions to Help Maintain Vision and Improve Ocular Health
Innovative Solutions to Help Maintain Vision and Improve Ocular Health Nicox S.A. Nicox Ophthalmics, Inc. Nicox Research Institute S.r.l. Drakkar 2 – Bât. D 4721 Emperor Blvd. Suite 260 Via Ariosto 21 2405 Route des Dolines Durham, NC 27703, U.S. 20091 Bresso CS 10313 Sophia Antipolis Milano, Italy