Nicox Sa · EURONEXT:ALCOX
Nicox Sa — Investor Presentation (July 2023)
36 slides from Nicox Sa's investor presentation, Jul 19, 2023
Slide 1: Nicox Corporate Presentation
Nicox Corporate Presentation An international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health July 19, 2023 September 2022
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: Driving Innovation in Ophthalmology, Led by NCX 470 & an Experienced Team
Driving Innovation in Ophthalmology, Led by NCX 470 & an Experienced Team Differentiated pipeline Experienced Leadership, NICOX VISIBLE SCIENCE with positive NCX 470 Board and Advisors with Global partnerships and out- pivotal Phase 3 clinical expertise to drive licensed commercial products trial re
Slide 4: Broad Global Leadership Experience
Broad Global Leadership Experience NICOX VISIBLE SCIENCE Andreas Segerros Sandrine Gestin Doug Hubatsch Emmanuelle Pierry Gavin Spencer Chief Executive Officer VP, Finance EVP, Chief Scientific Officer General Counsel & Head, Legal EVP, Chief Business Officer & Head, Corporate Development Former mem
Slide 5: Board Bringing Extensive Experience in Ophthalmology and Pharmaceuticals
Board Bringing Extensive Experience in Ophthalmology and Pharmaceuticals JEAN-FRANÇOIS LABBE LES KAPLAN NICOX VISIBLE SCIENCE Chairman of the Board Director MICHELE GARUFI LAUREN SILVERNAIL Director Director ADRIENNE GRAVES LUZI VON BIDDER Director Director 5
Slide 6: U.S. Glaucoma Clinical Advisory Board with Leading Experts
U.S. Glaucoma Clinical Advisory Board with Leading Experts DR. ROBERT D. FECHTNER, MD, CHAIRMAN DR. STEVEN MANSBERGER, MD MPH Professor and Chair of the Department of Ophthalmology Vice-Chair, Senior Scientist, and Director of Glaucoma Services NICOX VISIBLE SCIENCE at SUNY Upstate Medical Universit
Slide 7: Unique Combination of Competencies
Unique Combination of Competencies Capable of driving NCX 470 development and delivering future pipeline growth NICOX VISIBLE SCIENCE International R&D Management with deep ophthalmology experience Corporate, Finance and Legal teams have completed multiple transactions, restructuring and financing B
Slide 8: NCX 470 Value Proposition
Novel molecule for intraocular pressure (IOP) lowering, the leading cause of glaucoma Positive pivotal Phase 3 topline results from the NICOX VISIBLE SCIENCE Mont Blanc trial1,2,3 Potential best-in- First non-combination product to demonstrate NCXin470 class profile statistical non-inferiority to a
Slide 9: NCX 470 Leads a Differentiated Ophthalmology Pipeline
NCX 470 Leads a Differentiated Ophthalmology Pipeline Stages of Development In-house Development Product Candidates Preclinical Phase 1 Phase 2 Phase 3 NDA Marketed Expected Milestones Exploring commercial partnerships Mont Blanc Trial completed for U.S. and Japan NCX 470 | novel NO-donating bimatop
Slide 10: NCX 470
NCX 470 Leveraging the potent intraocular pressure-lowering effects of nitric oxide and prostaglandin analogs for potentially differentiated treatment in glaucoma
Slide 11: Glaucoma Snapshot
Glaucoma Snapshot Elevated IOP contributes to irreversible optic nerve damage, leading to progressive vision loss NICOX VISIBLE SCIENCE As published in the landmark EMGT study “…each mmHg of decreased IOP was related to an approximately 10% lowering [of risk of vision loss progression]”1 11 1. Heijl
Slide 12: Unmet Medical Need for Glaucoma Treatment
Unmet Medical Need for Glaucoma Treatment NICOX VISIBLE SCIENCE Despite having well established first line therapies, including the 40% of patients do Many patients Tolerability issues standard of care, latanoprost, not achieve their require >1 with some patients do not react to target IOP on medica
Slide 13: NCX 470 Acts Through A Dual Mechanism for IOP Lowering
NCX 470 Acts Through A Dual Mechanism1 for IOP Lowering Nonclinical optic nerve/retinal damage models also demonstrate potentially beneficial retinal effects2 Two pathways for NICOX VISIBLE SCIENCE Primary or conventional aqueous humor outflow 1 outflow normally Stimulated by accounts for ~60% to ni
Slide 14: Positive NCX 470 Mont Blanc Topline Results
Positive NCX 470 Mont Blanc Topline Results1,2,3 Phase 3 clinical program intended to support planned U.S. & China NDA submissions Designed to demonstrate safety and efficacy of NCX 470 0.1% vs latanoprost 0.005%, defined by IOP reduction from time-matched baseline at pre-established time points NIC
Slide 15: Mont Blanc Phase 3 Efficacy Trial Design
Mont Blanc Phase 3 Efficacy Trial Design1 Designed to evaluate NCX 470 vs. established therapy, latanoprost Randomized, controlled, double-masked, parallel design trial. Patients with open angle glaucoma or ocular hypertension were randomized 1:1 to once-daily treatment with NCX 470 0.1% or latanopr
Slide 16: Baseline Characteristics, Demographics and Disposition
Baseline Characteristics, Demographics and Disposition1 NCX 470 0.1% Latanoprost 0.005% N = 328 N = 333 Mean Diurnal Baseline (8am+4pm) IOP, mmHg, Study Eye (SD) 26.9 (2.04) 26.8 (2.02) Gender, n (%) NICOX VISIBLE SCIENCE Female 200 ( 61.0%) 188 ( 56.5%) Male 128 ( 39.0%) 145 ( 43.5%) Age, Years (SD
Slide 17: Significant, sustained IOP-lowering effects
Significant, sustained IOP-lowering effects IOP-lowering from baseline was 8.0 to 9.7 mmHg for NCX 470 vs. 7.1 to 9.4 mmHg for latanoprost NICOX VISIBLE SCIENCE NCX 470 0.1%: N = 328 Latanoprost 0.005%: N = 333 * Denotes statistically significant differences vs latanoprost (p<0.049) 17
Slide 18: NCX 470 0.1% achieved non-inferiority to Latanoprost 0.005%
NCX 470 0.1% achieved non-inferiority and demonstrated an IOP Lowering greater than Latanoprost 0.005% of up to 1.0mmHg To be non-inferior, the NICOX VISIBLE SCIENCE treatment difference between NCX 470 and latanoprost had to meet BOTH criteria: • For all 6 timepoints, the upper limit of all confide
Slide 19: NCX 470 Topline Results Demonstrate Robust Efficacy and Safety
NCX 470 Topline Results Demonstrate Robust Efficacy and Safety1 All comparisons are based on NCX 470 0.1% and latanoprost 0.005% IOP-lowering effect from baseline was 8.0 to 9.7 mmHg for NCX 470 vs. 7.1 to 9.4 mmHg for latanoprost NICOX VISIBLE SCIENCE Statistical non-inferiority was met vs. latanop
Slide 20: NCX 470 – Ophthalmology Conference Presentations in 2023
NCX 470 – Ophthalmology Conference Presentations in 2023 1. NCX 470, a Nitric Oxide Donating Bimatoprost, Demonstrates Non-inferiority to Latanoprost in Phase 3 Mont Blanc Clinical Trial. Fichtner et al., 2023, AGS Abstract #232 NICOX VISIBLE SCIENCE 2. NCX 470, a nitric oxide (NO)-donating bimatopr
Slide 21: Retinal Benefits: A Potential Differentiator for NCX 470
Retinal Benefits: A Potential Differentiator for NCX 470 Elevated IOP is the main risk factor in glaucoma, however a variety of IOP-independent risk factors, including ischemia, contribute to damage of the optic nerve head and the retina, NICOX VISIBLE SCIENCE ultimately causing vision loss Explorat
Slide 22: Why Nitric Oxide Could Generate Retinal Benefits
Why Nitric Oxide Could Generate Retinal Benefits NICOX VISIBLE SCIENCE NO elicits NO inhibits NO & PGA vasorelaxation & inflammatory lower IOP improves ocular cytokines & blood flow oxidative stress Retinal benefits 22
Slide 23: NCX 470 Shows Retinal Cell Protection in a Nonclinical Model
NCX 470 Shows Retinal Cell Protection in a Nonclinical Model1,2 Improved ocular perfusion and retinal function in damaged eyes – head-to-head study vs. Lumigan® Ocular hemodynamics Retinal function (Echo-doppler - Ophthalmic artery) (Scotopic Electroretinogram - rod/cone responses) NICOX VISIBLE SCI
Slide 24: Planned Phase 3b Trials to Further Evaluate NCX 470
Planned Phase 3b Trials to Further Evaluate NCX 470 Episcleral Venous Pressure Trial (Whistler): Nitric oxide has been shown to induce NICOX VISIBLE SCIENCE vasodilation. NCX 470’s ability to lower episcleral venous pressure as well as enhance outflow through the trabecular meshwork will be evaluate
Slide 25: NCX 1728
NCX 1728 Novel class of molecules for retinal conditions
Slide 26: NCX 1728: Lead Compound in a New Class of NO-donating Molecules
NCX 1728: Lead Compound in a New Class of NO-donating Molecules NO-donating PDE5 inhibitor MOA for this novel class of molecules is based Combining entirely on NO-mediated activity NO-release NICOX VISIBLE SCIENCE with PDE5 NO-mediated effects are enhanced and prolonged by Inhibition concomitant pho
Slide 27: NCX 4251
NCX 4251 Novel treatment with unique mode of application in dry eye disease
Slide 28: NCX 4251: Novel Approach to Dry Eye Disease
NCX 4251: Novel Approach to Dry Eye Disease Novel, patented ophthalmic nanocrystal suspension of fluticasone propionate, a well-established Novel corticosteroid corticosteroid. Fluticasone has 10x affinity for the glucocorticoid receptor vs. dexamethasone, presentation leverages commonly used in oph
Slide 29: Mississippi: Phase 2b Post-Hoc Results Puts Dry Eye Disease in Sight
Mississippi1: Phase 2b Post-Hoc Results Puts Dry Eye Disease in Sight Overall Summary – The trial evaluated NCX 4251 in Unique eyelid margin patients with acute exacerbations of blepharitis. NCX application designed to NICOX VISIBLE SCIENCE 4251 was found to be safe and well tolerated over 14 minimi
Slide 30: Nicox Corporate
Nicox Corporate nicox ©
Slide 31: Mont Blanc Phase 3 Results May Bring NCX 470 Closer to U.S. Approval
Mont Blanc Phase 3 Results May Bring NCX 470 Closer to U.S. Approval Glaucoma: Approximately 3 million patients in the U.S. with open angle glaucoma2 An established First line, prostaglandin-based therapies represent a $1.3 billion opportunity in the U.S. alone1 NICOX VISIBLE SCIENCE $5.9Bn worldwid
Slide 32: Current and Future Potential Revenue Through Partnerships
Current and Future Potential Revenue Through Partnerships Potentially differentiated treatment for IOP lowering Annual global net sales could exceed $300 million within 8 years of launch in China and the U.S.1 NCX 470 Exploring NICOX VISIBLE SCIENCE commercial NDA in U.S. and China expected to be fi
Slide 33: VYZULTA - Prescription Growth
VYZULTA® - Prescription Growth 9000 NICOX VISIBLE SCIENCE 8000 7000 Prescriptions per week 6000 5000 4000 3000 2000 1000 0 Repeat prescriptions New prescriptions 33 Source: Bloomberg. to Q2 2023
Slide 34: Financial Highlights
Financial Highlights Cash balance expected to support current operations through June 2024 Estimated Financial Position and Ownership as of March 31, 20231 NICOX VISIBLE SCIENCE Cash, Cash Equivalents €19.0 million Long term debt2 €21.6 million Cash runway3 June 2024 Outstanding Shares4 50.1 million
Slide 35: Value-Creating Milestones
Value-Creating Milestones Building a high-value ophthalmology pipeline NICOX VISIBLE SCIENCE April 2023 Throughout 2023 2024 20251 ZERVIATE NDA in Communication of Mont Whistler Phase 3b Topline results China submitted Blanc results clinical data on NCX NCX 470 Denali Priority review 470 MOA* Phase
Slide 36: Nicox S.A. Nicox Research Institute S.r.l. Nicox Ophthalmics, Inc.
Nicox S.A. Nicox Research Institute S.r.l. Nicox Ophthalmics, Inc. Drakkar 2 – Bât. D 4819 Emperor Blvd. Suite 400 Via Ariosto 21 2405 Route des Dolines Durham, NC 27703, U.S 20091 Bresso 06560 Valbonne, France Milano, Italy T. +1 984 710 5354 T: +33 (0)4 97 24 53 00 T: +39 02 61 03 61 F: +33 (0)4 9