Nicox Sa · EURONEXT:ALCOX
Nicox Sa — Investor Presentation (November 2022)
36 slides from Nicox Sa's investor presentation, Nov 28, 2022
Slide 1: Nicox Corporate Presentation
Nicox Corporate Presentation An international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health November 28, 2022 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 with recent, positive NCX Board and Advisors with global partnerships and out- 470 pivotal Phase 3 expertise to drive NICOX VISIBLE SCIENCE 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 VP, Finance EVP, Chief Scientific Officer General Counsel & Head, EVP, Chief Business Officer & Officer Legal 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 Chairman of the Board Director NICOX VISIBLE SCIENCE MICHELE GARUFI LAUREN SILVERNAIL Director Director ADRIENNE GRAVES LUZI VON BIDDER Director Director 5
Slide 6: Unique Combination of Competencies
Unique Combination of Competencies Capable of bringing NCX 470 to approval and driving future growth Corporate, Finance and Legal team have NICOX VISIBLE SCIENCE completed multiple transactions, restructuring and financing International R&D Management with deep ophthalmology experience World-recogni
Slide 7: NCX 470 Value Proposition
Novel molecule for intraocular pressure lowering, the leading cause of glaucoma Positive pivotal Phase 3 topline results from the Mont Blanc trial announced October 31, 2022 NICOX VISIBLE SCIENCE Potential best-in- Large and established market1: NCXin470 class profile $5.9 billion worldwide Value Pr
Slide 8: 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 Company pursuing out- NCX 470 | novel NO-donating bimatoprost1 Mont Blanc Trial completed licensing U.S. and Japan
Slide 9: NCX 470
NCX 470 Leveraging the potent intraocular pressure-lowering effects of nitric oxide and prostaglandin analogs for potentially differentiated treatment in glaucoma
Slide 10: 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 11: Unmet Medical Need for Glaucoma Treatment
Unmet Medical Need for Glaucoma Treatment Despite having well established NICOX VISIBLE SCIENCE 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 12: NCX 470 Targets the Two Key Outflow Pathways for IOP Lowering
NCX 470 Targets the Two Key Outflow Pathways for IOP Lowering Proven dual mechanism of action1 Two pathways for Primary or conventional aqueous humor outflow 1 outflow normally Stimulated by accounts for ~60% to nitric oxide (NO) NICOX VISIBLE SCIENCE 80% of outflow 2 Secondary or uveoscleral outflo
Slide 13: Positive Topline NCX 470 Mont Blanc Results Released October 31, 2022
Positive Topline NCX 470 Mont Blanc Results Released October 31, 2022 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 pr
Slide 14: 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 15: 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 (%) Female 200 ( 61.0%) 188 ( 56.5%) NICOX VISIBLE SCIENCE Male 128 ( 39.0%) 145 ( 43.5%) Age, Years (SD
Slide 16: NCX 470 0.1% IOP Lowering Compared to Latanoprost 0.005%
NCX 470 0.1% IOP Lowering Compared to Latanoprost 0.005% Significant, sustained IOP-lowering effects NICOX VISIBLE SCIENCE * Denotes statistically significant differences vs latanoprost (p<0.049) IOP-lowering effect from baseline was 8.0 to 9.7 mmHg for NCX 470 0.1% vs. 7.1 to 9.4 mmHg for latanopro
Slide 17: NCX 470 0.1% IOP Lowering Compared to Latanoprost 0.005%
NCX 470 0.1% IOP Lowering Compared to Latanoprost 0.005% NCX 470 0.1% achieved non-inferiority vs. latanoprost 0.005% NICOX VISIBLE SCIENCE * * * * Non-inferiority criteria: The upper limit of all 6 95.1% confidence intervals were required to be ≤1.5 mmHg and at least 4 of 6 were required to be ≤1.0
Slide 18: 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 Measured by a change from baseline in time-matched IOP at 8 AM and 4
Slide 19: Positive NCX 470 Phase 3 Results a Milestone for Nicox
Positive NCX 470 Phase 3 Results a Milestone for Nicox Novel dual action NCX 470 reduced IOP by 8.0 Mont Blanc Phase 3 results compound designed to to 9.7 mmHg in the 691- may bring NCX 470 closer to leverage PGA and NO for a patient Mont Blanc Phase 3 U.S. approval NICOX VISIBLE SCIENCE differentia
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, ultimately causing vision loss NICOX VISIBLE SCIENCE Initial
Slide 21: Why Nitric Oxide Could Generate Retinal Benefits
Why Nitric Oxide Could Generate Retinal Benefits NO elicits NO inhibits NICOX VISIBLE SCIENCE 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 Potential therapeutic properties beyond IOP lowering Ocular hemodynamics Retinal function (Echo-doppler - Ophthalmic artery) (Scotopic Electroretinogram - rod/cone responses)
Slide 23: Planned NCX 470 Phase 3b Clinical Trials to Evaluate Potential Retinal Benefit
Planned NCX 470 Phase 3b Clinical Trials to Evaluate Potential Retinal Benefit Nitric oxide has been shown to induce vasodilation. NCX 470’s ability to lower episcleral venous pressure as well as enhance outflow through the trabecular meshwork will be NICOX VISIBLE SCIENCE evaluated in a clinical tr
Slide 24: Commercial Landscape of the United States Glaucoma Market
Commercial Landscape of the United States Glaucoma Market NCX 470 Profile1 A space in the market Potential growth levers NICOX VISIBLE SCIENCE Mont Blanc Phase 3 results • 8-9.7 mmHg IOP reduction ~$200 million - estimated potential peak net • Non-inferior to latanoprost sales in the U.S. for a prod
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 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 Inhibition (PDE5) inhibition within the s
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: Post-Hoc Results Puts Dry Eye Disease in Sight
Mississippi: Post-Hoc Results Puts Dry Eye Disease in Sight Phase 2b Mississippi2 Trial Summary Unique eyelid margin The trial evaluated NCX 4251 in patients with acute application designed to exacerbations of blepharitis. Topline results of the trial minimize corticosteroid-induced did not meet pri
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 $5.9Bn worldwide, 40% of patients on
Slide 32: 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 at SUNY Upstate Medical University, Syracuse, NY and Op
Slide 33: Partnering Deals Include Potential Future Payments & Royalties
Partnering Deals Include Potential Future Payments & Royalties Potentially differentiated treatment for IOP lowering NCX 470 6% to 12% royalties on future net sales1 in China and Southeast Asia Ocumension pays 50% of the Denali Phase 3 clinical trial costs NICOX VISIBLE SCIENCE First eye drop for gl
Slide 34: Financial Highlights
Financial Highlights Cash balance expected to support current operations through mid-May 2024 Estimated Financial Position and Ownership as of September 30, 20221 (updated with financing announced Nov. 22, 2022) Cash, Cash Equivalents €31.0 million (includes proceeds after closing of financing annou
Slide 35: Value-Creating Milestones
Value-Creating Milestones Building a high-value ophthalmology pipeline 2025 NICOX VISIBLE SCIENCE 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 20
Slide 36: Nicox S.A. contact details
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