Nicox Sa · EURONEXT:ALCOX
Nicox Sa — Investor Presentation (February 2024)
35 slides from Nicox Sa's investor presentation, Feb 29, 2024
Slide 1: Nicox Corporate Presentation
Nicox Corporate Presentation An international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health February 29, 2024 Euronext Growth Paris: ALCOX 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 and an Experienced Team
Driving Innovation in Ophthalmology, Led by NCX 470 and an Experienced Team Differentiated pipeline Experienced Leadership, Board and Advisors with Global partnerships and out- NICOX VISIBLE SCIENCE with positive NCX 470 pivotal Phase 3 clinical expertise to drive licensed commercial products trial
Slide 4: 2023 Highlights
2023 Highlights A year of progress in development and revenue NICOX VISIBLE SCIENCE NCX 470 ZERVIATE Revenue NCX 470 Phase 3 Denali trial Approval and launch of Net revenue from licensing 75% randomized and full one- ZERVIATE in China by Nicox’s income reached €4.2 million for year safety cohort enr
Slide 5: Broad Global Leadership Experience
Broad Global Leadership Experience NICOX VISIBLE SCIENCE Gavin Spencer Sandrine Gestin Doug Hubatsch Emmanuelle Pierry Chief Executive Officer VP, Finance EVP, Chief Scientific Officer General Counsel & Head, Legal Former member of the Paris Bar 5
Slide 6: Board Bringing Extensive Experience in Ophthalmology and Pharmaceuticals
Board Bringing Extensive Experience in Ophthalmology and Pharmaceuticals NICOX VISIBLE SCIENCE JEAN-FRANÇOIS LABBE MICHELE GARUFI LES KAPLAN Chairman of the Board Director Director 6
Slide 7: 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 8: 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 9: 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 10: 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 Mont Blanc Trial completed partnership for U.S. NCX 470 | novel NO-donating bimatoprost1 Denal
Slide 11: NCX 470
NCX 470 Leveraging the potent intraocular pressure-lowering effects of nitric oxide and prostaglandin analogs for potentially differentiated treatment in glaucoma
Slide 12: 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 12 1. Heijl
Slide 13: 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 14: 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 15: 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 16: 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 17: 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) NICOX VISIBLE SCIENCE Gender, n (%) Female 200 ( 61.0%) 188 ( 56.5%) Male 128 ( 39.0%) 145 ( 43.5%) Age, Years (SD
Slide 18: 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) 18
Slide 19: NCX 470 Achieved Non-inferiority and Greater IOP Lowering
NCX 470 0.1% achieved non-inferiority and demonstrated an IOP Lowering greater than Latanoprost 0.005% of up to 1.0mmHg NICOX VISIBLE SCIENCE To be non-inferior, the treatment difference between NCX 470 and latanoprost had to meet BOTH criteria: • For all 6 timepoints, the upper limit of all confide
Slide 20: 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 21: 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. Fechtner et al., 2023, AGS Abstract #232 NICOX VISIBLE SCIENCE 2. NCX 470, a nitric oxide (NO)-donating bimatopr
Slide 22: 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 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: NCX 1728
NCX 1728 Novel class of molecules for retinal conditions
Slide 25: Phase 3b Trials to Further Evaluate NCX 470
Phase 3b Trials to Further Evaluate NCX 470 Dual MOA in IOP lowering 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 to enhance outflow through the trabecular meshwork are being investigated
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 in Dry Eye Disease
Mississippi1: Phase 2b Post-Hoc Results Puts Dry Eye Disease in Sight Unique eyelid margin application designed to minimize Overall Summary – The trial evaluated NCX 4251 in NICOX VISIBLE SCIENCE corticosteroid-induced ocular patients with acute exacerbations of blepharitis. adverse events NCX 4251
Slide 30: Nicox Corporate
Nicox Corporate nicox ©
Slide 31: Path to U.S. NDA Submission for NCX 470
Path to U.S. NDA submission for NCX 470 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 worldwide, $2.9Bn U.S. market1 40% of
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 NDA in U.S. and China to be filed after Denali Phase 3 trial results in 2025 NCX 470 NICOX
Slide 33: Financial Highlights
Financial Highlights Cash balance expected to support current operations through November 2024 Estimated Financial Position and Ownership as of December 31, 20231 NICOX VISIBLE SCIENCE Cash, Cash Equivalents €14.9 million (including the upfront payment from Kowa) Long term debt2 €21.0 million Cash r
Slide 34: Value-Creating Milestones
Value-Creating Milestones Building a high-value ophthalmology pipeline NICOX VISIBLE SCIENCE December 2023 February 2024 2024 Q1 2025 Initiation Restructuring Approval and Whistler Phase 3b clinical Whistler Phase 3b debt agreement launch of ZERVIATE data on NCX 470 trial investigating Appointment i
Slide 35: Nicox contact details
Nicox S.A. Nicox Research Institute S.r.l. Nicox Ophthalmics, Inc. Sundesk Sophia Antipolis 4819 Emperor Blvd. Suite 400 Via Ariosto 21 Emerald Square Bâtiment C 20091 Bresso Durham, NC 27703, U.S. rue Evariste Galois, Milano, Italy T. +1 984 710 5354 06410 Biot, France T: +39 02 61 03 61 T: +33 (0)