Nicox Sa · EURONEXT:ALCOX
Nicox Sa — Investor Presentation (March 2022)
24 slides from Nicox Sa's investor presentation, Mar 7, 2022
Slide 1: Corporate Presentation
Corporate Presentation March 7, 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 to address unmet medical need 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 NO-Donating Product Candidates Targeting Glaucoma Top-line results: NCX 470 | novel NO-donating prostaglandin analog Mont Blanc and Denali trials - Mont Blanc Q1 2023 Partnered with Ocumension in the
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: 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 8: NCX 470 Targets the Two Key Outflow Pathways for Lowering IOP
NCX 470 Targets the Two Key Outflow Pathways for Lowering IOP Potential for Best-in-Class Efficacy with Novel Dual Mechanism of Action Two pathways for aqueous humor outflow 8
Slide 9: 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 10: NCX 470: 2 Phase 3 trials Support U.S. & China NDA Submissions
NCX 470: 2 Phase 3 trials Support U.S. & China NDA Submissions Top-line Results Currently Expected in Q1 2023 and by end 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 some sites in China.
Slide 11: 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 (netarsudil therapies bunod ophthalmic solution), and latanoprost ophthalmic NCX 470 potential Latanoprost: Latanoprost:>70% prescriptio
Slide 12: 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 13: NCX 1728: Lead Compound in a New Class of IOP Lowering Agents
NCX 1728: Lead Compound in a New Class of IOP Lowering Agents Molecules in this new class showed robust IOP lowering in a non-human primate model of ocular hypertension1 • Lead in a new class of compounds (non-PGA related) with NO-mediated IOP lowering effects enhanced and prolonged by concomitant P
Slide 14: NCX 1741, an Analog of NCX 1728, Lowers IOP in Ocular Hypertensive Non-human Primates
NCX 1741, an Analog of NCX 1728, Lowers IOP in Ocular Hypertensive Non-human Primates Potential as monotherapy, as adjunctive therapy or in fixed-dose combinations with PGAs for IOP lowering Intraocular pressure (IOP)-lowering v e h ic le (n = 7 ) 5 N C X 1 7 4 1 (1 .5 % , 0 .5 m o le /e y e , n =
Slide 15: NCX 4251: Novel Treatment to Address Unmet Medical Need in Dry Eye Disease
NCX 4251: Novel Treatment to Address Unmet Medical Need in Dry Eye Disease 15
Slide 16: Dry Eye Disease – Existing Market with Unmet Medical Need
Dry Eye Disease – Existing Market with Unmet Medical Need NCX 4251: 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 i
Slide 17: 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 18: 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 19: Corporate
Corporate • Key Partnerships • Financial Highlights • Anticipated Value-Creating Milestones 19
Slide 20: Key Commercial Partnerships
Key Commercial Partnerships VYZULTA ZERVIATE OCUMENSION PARTNERSHIP Partnered with Bausch + Lomb worldwide Partnered with Eyevance in the U.S. • First eye drop approved in 20 • First and only eye drop • Exclusive rights4 in China and years with a novel approach to formulation of cetirizine certain S
Slide 21: 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 22: Financial Highlights
Financial Highlights Estimated Financial Position as of December 31, 20211 Analyst Coverage Cash, Cash Equivalents €41.9 million Bryan Garnier Dylan Van Haaften Debt2 €18.3 million H.C. Wainwright Yi Chen Cash runway Q4 2023 Kepler Cheuvreux Damien Choplain Edison Investment Pooya Hemami Research Ou
Slide 23: Value-Creating Milestones
Value-Creating Milestones Building Our Late-Stage Ophthalmic Portfolio for Commercialization NCX 4251 Phase 2b NCX 4251 move into Mississippi trial DED following completed U.S. FDA meeting NCX 470 Phase 3 Mont NCX 470 Phase 3 Mont NCX 470 Glaucoma Blanc >70% enrollment Blanc >90% enrollment Phase 3
Slide 24: 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