Nicox Sa · EURONEXT:ALCOX
Nicox Sa — Investor Presentation (March 2023)
35 slides from Nicox Sa's investor presentation, Mar 20, 2023
Slide 1: Nicox Corporate Presentation
Nicox Corporate Presentation An international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health March 20, 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, Cash position enhanced by NICOX VISIBLE SCIENCE with recent, positive NCX Board and Advisors with global partnerships and out- 470 pivotal Phase 3 expertise to drive licensed com
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 bringing NCX 470 to approval and driving future growth NICOX VISIBLE SCIENCE International R&D Management with deep ophthalmology experience Corporate, Finance and Legal team have completed multiple transactions, restructuring and financing Board members
Slide 8: NCX 470 Value Proposition
Novel molecule for intraocular pressure lowering, the leading cause of glaucoma Positive pivotal Phase 3 topline results from the NICOX VISIBLE SCIENCE Mont Blanc trial1 Potential best-in- Large and established market2: NCXin470 class profile $5.9 billion worldwide Value Proposition intraocular $1.3
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 Mont Blanc Trial completed Company exploring commercial partnerships for U.S. and Japan NCX 470 | novel NO-donating
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 intraocular pressure (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 pro
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 Topline NCX 470 Mont Blanc Results
Positive Topline NCX 470 Mont Blanc Results1 Phase 3 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 intraocular pressure reduction from time-matched baseline at pre-established time points
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 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 17 * Denotes statistically significant differences vs latanoprost (p<0.049)
Slide 18: NCX 470 0.1% Achieved Non-Inferiority to Latanoprost
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 NCX470 and latanoprost had to meet BOTH criteria: • For all 6 timepoints, the upper limit of all confiden
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: 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 Initial
Slide 21: 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 21
Slide 22: NCX 470 Shows Retinal Cell Protection in a Nonclinical Model
NCX 470 Shows Retinal Cell Protection in a Nonclinical Model1 Improved ocular perfusion and retinal function in damaged eyes Ocular hemodynamics Retinal function NICOX VISIBLE SCIENCE (Echo-doppler - Ophthalmic artery) (Scotopic Electroretinogram - rod/cone responses) Detrimental effect of ET-1 on o
Slide 23: Phase 3b Trials to Further Evaluate NCX 470 Planned for H1 2023
Phase 3b Trials to Further Evaluate NCX 470 Planned for H1 2023 Episcleral Pressure Study: Nitric oxide has been shown to induce vasodilation. NCX NICOX VISIBLE SCIENCE 470’s ability to lower episcleral venous pressure as well as enhance outflow through the trabecular meshwork will be evaluated in a
Slide 24: NCX 1728
NCX 1728 Novel class of molecules for retinal conditions
Slide 25: NCX 1728: Lead Compound in a New Class of NO-donating Molecules
NCX 1728: Lead Compound in a New Class of NO-donating Molecules Combining NO- MOA* for this novel class of molecules is based entirely on NO-mediated activity release with PDE5 NO-mediated effects are enhanced and prolonged by concomitant phosphodiesterase-5 NICOX VISIBLE SCIENCE Inhibition (PDE5) i
Slide 26: Nitric oxide (NO)-donating phosphodiesterase type 5 (PDE-5) inhibitors
Nitric oxide (NO)-donating phosphodiesterase type 5 (PDE-5) inhibitors Cellular/molecular mechanism NO-donating PDE5 inhibitor NICOX VISIBLE SCIENCE • Vasorelaxation Muscle cell relaxation • Enhancement of ocular blood flow • Ocular tissues oxygenation • Sparing of ONH & retinal damage GTP = guanosi
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 United States 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
Slide 32: Partnering Deals Include Potential Future Payments & Royalties
Partnering Deals Include Potential Future Payments & Royalties Potentially differentiated treatment for IOP lowering 6% to 12% royalties on future net sales1 in China and Southeast Asia NCX 470 NICOX VISIBLE SCIENCE Ocumension pays 50% of the Denali Phase 3 clinical trial costs Company is exploring
Slide 33: Financial Highlights
Financial Highlights Cash balance expected to support current operations through Q2 2024 Estimated Financial Position and Ownership as of December 31, 20221 NICOX VISIBLE SCIENCE Cash, Cash Equivalents €27.7 million Long term debt2 €24.7 million Cash runway3 Q2 2024 Outstanding Shares4 50.1 million
Slide 34: Value-Creating Milestones
Value-Creating Milestones Building a high-value ophthalmology pipeline NICOX VISIBLE SCIENCE 20251 Throughout 2023 October 2022 NCX 470 Denali Communication of Mont Phase 3 (enrolling); NCX 470 Mont Blanc Blanc results at key topline results Phase 3 topline results ophthalmology congresses H1 2023 2
Slide 35: 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