Nicox Sa · EURONEXT:ALCOX
Nicox Sa — Investor Presentation (March 2020)
28 slides from Nicox Sa's investor presentation, Mar 17, 2020
Slide 1: Corporate Presentation March 17, 2020
Corporate Presentation March 17, 2020 Innovative Solutions to Help Maintain Vision and Improve Ocular Health Euronext Paris: COX © 2020 Nicox. All rights reserved
Slide 2: Nicox Forward-Looking Statements
Nicox 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
Slide 3: Investment Highlights
Investment Highlights Two Phase 2 NCX 470 - Successful Phase 2 leading to two Phase 3 trials starting clinical proof-of- in 2020 in U.S. in open angle glaucoma patients concept trials successfully NCX 4251 - Exploratory Phase 2 completed, showing potential in completed acute exacerbations of blephar
Slide 4: Pipeline
Pipeline Stages of Development Products and product candidates/ Indications Research Preclinical Phase 1 Phase 2 Phase 3 NDA Marketed Main partners Markets NO-Donating Product Candidates Targeting Glaucoma NCX 470 second generation NO-donating bimatoprost analog Chinese market Glaucoma NO-donating P
Slide 5: NO-Donating Programs in Glaucoma
NO-Donating Programs in Glaucoma NCX 470 NO-donating PDE5 inhibitors 5
Slide 6: U.S. Glaucoma Market Worth ~$3 Billion
U.S. Glaucoma Market Worth ~$3 Billion1 Largest Eye Drop Market Worldwide Branded PGA products still account for nearly 90% of PGA sales revenues1 More than 50% of prescriptions for glaucoma are PGAs2 NCX 470 Targets $1.4 Billion First-line Therapy NO-PDE5 Inhibitors Target $1.5 Billion Adjunct Mark
Slide 7: The Central Role of Nitric Oxide in Intraocular Pressure Homeostasis
The Central Role of Nitric Oxide in Intraocular Pressure Homeostasis Primary or Conventional Outflow Stimulated by Nitric Oxide Secondary or Uveoscleral Outflow Stimulated by PGAs NO decreases intraocular pressure (IOP) by increasing the outflow of fluid through the primary outflow pathway 7
Slide 8: NCX 470 – Novel Second Generation NO-Donating Bimatoprost Analog
NCX 470 – Novel Second Generation NO-Donating Bimatoprost Analog Potential for NCX 470 to become the best single compound for IOP lowering therapy • Targeting the IOP lowering in patients with glaucoma or ocular hypertension • Single molecule with potential molecular advantages over LUMIGAN (bimatop
Slide 9: NCX 470 - Dolomites Phase 2 Trial Design
NCX 470 - Dolomites Phase 2 Trial Design Patients with open angle glaucoma or ocular hypertension N=433 subjects randomized at 25 U.S. Sites in 1:1:1:1 Ratio, All QD (PM) Primary efficacy endpoint: Reduction from baseline in mean diurnal IOP at Day 28 NCX 470 0.065%; n=107 Exit Visit NCX 470 0.042%;
Slide 10: NCX 470 0.065% Consistently Superior to Latanoprost 0.005%
NCX 470 0.065% Consistently Superior to Latanoprost 0.005% • Up to 1.4 mmHg superior IOP lowering vs latanoprost • Superiority demonstrated at all time points at Day 28,*p<0.05 • Also demonstrated non-inferiority (CI) and superiority1 vs. latanoprost at all study visits • Well tolerated at all doses
Slide 11: NCX 470 Demonstrated a Dose Response with Mid and Top Doses
NCX 470 Demonstrated a Dose Response with Mid and Top Doses with Statistical Superiority vs. Latanoprost in Mean Diurnal IOP Dose response of NCX 470 showed improved IOP lowering with each incremental concentration of NCX 470 tested, thus creating potential for additional IOP lowering with higher do
Slide 12: Safety and Tolerability of NCX 470
Safety and Tolerability of NCX 470 • There were no drug-related serious adverse events • There was no evidence of treatment-related systemic effects • Only 3 out of 433 patients discontinued due to an adverse event • The most frequent adverse event was conjunctival hyperemia in 16.8% of NCX 470 0.06
Slide 13: NCX 470 Shows a Favorable Therapeutic Index
NCX 470 Shows a Favorable Therapeutic Index Allowing for Higher Dose of NCX 470 to Be Evaluated in Phase 3 • NCX 470 dose response showed improved IOP with each incremental concentration of NCX 470 (*p<0.05, **p=0.0009) • Conjunctival hyperemia dose response plateaued at the middle dose of NCX 470 (
Slide 14: NCX 470 vs Current First-line Glaucoma therapies
NCX 470 vs Current First-line Glaucoma therapies Phase 2 trial with NCX 470 0.065% QD: 7.6 to 9.8 mmHg IOP reduction, 16.8% hyperemia XALATAN1 LUMIGAN1 TRAVATAN Z1 VYZULTA2 ROCKLATAN1 (latanoprost (bimatoprost 0.01%) (travoprost 0.004%) (latanoprostene (latanoprost 0.005% 0.005%) bunod 0.024%) and n
Slide 15: NCX 470 Market Survey with Prescribers and Payers
NCX 470 Market Survey with 40 Prescribers and Payers Potential U.S. Statistical superiority to latanoprost 0.005% (displayed in Potential U.S. peak net sales peak share of U.S. FDA-approved label) based on head-to-head Phase 3 (assuming industry-standard branded PGA trials discounting for the catego
Slide 16: NCX 470 - Executive Summary and Next Steps
NCX 470 - Executive Summary and Next Steps Executive Summary • Non-inferiority and superiority vs. latanoprost 0.005% were met in pre-defined analyses • IOP lowering effect of NCX 470 0.065% was 7.6 to 9.8 mmHg – the largest IOP lowering ever demonstrated in an eye drop glaucoma clinical trial • NCX
Slide 17: Targeting the Other Half of $3B Market: NO-Donating PDE5 Inhibitors
Targeting the Other Half of $3B Market: NO-Donating PDE5 Inhibitors Statistically significant IOP lowering in non-human primate model of ocular hypertension • NO-donating PDE5 inhibitors: a new horizon in glaucoma NCX 1741 in Glaucoma development with novel non-PGA chemistry and non-PGA pharmacology
Slide 18: U.S. Glaucoma Clinical Advisory Board with Leading Experts
U.S. Glaucoma Clinical Advisory Board with Leading Experts Professor and Chair of the Department of Ophthalmology at SUNY Upstate Medical Dr. Robert D. Fechtner, MD Chairman University, Syracuse, NY Kittner Family Distinguished Professor and Chairman, Department of Ophthalmology, UNC Dr. Donald Bude
Slide 19: Novel Route of Delivery and Formulation Targeting Blepharitis
Novel Route of Delivery and Formulation Targeting Blepharitis NCX 4251 19
Slide 20: NCX 4251 in Blepharitis - An Unmet Medical Need
NCX 4251 in Blepharitis - An Unmet Medical Need Ophthalmic Suspension of Fluticasone Propionate Nanocrystals • Targeting the treatment of acute exacerbations of blepharitis • No U.S. FDA-approved product solely indicated for blepharitis • 37% and 47% of all patients seen by ophthalmologists/ optomet
Slide 21: NCX 4251 – Danube Phase 2 Trial Design
NCX 4251 – Danube Phase 2 Trial Design U.S. multi-center, randomized, double-masked, placebo-controlled, dose escalating Patients with acute exacerbations of blepharitis, n=36 Evaluating safety and tolerability. Primary objective: selection of the dose(s) for larger Phase 2b NCX 4251 once daily; n=1
Slide 22: Danube Phase 2 Trial Positive Proof of Concept Results
Danube Phase 2 Trial Positive Proof of Concept Results NCX 4251 0.1% once daily treatment selected to advance into a larger Phase 2b trial • All patients across all cohorts successfully completed the trial • No serious adverse events, no treatment related systemic adverse events, and no adverse even
Slide 23: Key Development & Commercial Partnerships
Key Development & Commercial Partnerships Ocumension Therapeutics Bausch + Lomb Eyevance Pharmaceuticals 23
Slide 24: Validating Chinese Partnership
Validating Chinese Partnership Ocumension is an emerging Chinese ophthalmology company whose investors include 6 Dimensions Capital. Development personnel and infrastructure in place and operational, with highly qualified management and development teams with significant international experience gai
Slide 25: Key Commercial Partnerships
Key Commercial Partnerships Bausch + Lomb Partnered Program VYZULTA® (Glaucoma) (Allergic Conjunctivitis) Deal Exclusive worldwide license Exclusive U.S. license Positioning First new MoA in IOP reduction First and only topical ophthalmic formulation of cetirizine, active ingredient in Zyrtec, over
Slide 26: Financial Highlights
Financial Highlights Cash Position Shares Cash & Cash Equivalents ~ €47 million Outstanding shares2 ~33.5 million Debt4 ~ €18.5 million Fully diluted shares3 ~35 million Free float ~98% HBM 7.2% Key Investors Orbimed 5.7% 1. Unaudited figure. Estimation at end of February 2020, plus €15 million rece
Slide 27: Key Milestones
Key Milestones NCX 470 NCX 470 Initiation of the first Initiation of the NCX 470 Phase 3 clinical trial second Phase 3 Top-line results Mont (‘Mont Blanc’) clinical trial (‘Denali’) Blanc clinical trial Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2020 2021 NCX 4251 ZERVIATE FDA Meeting to Initiation of Phase 3 discuss
Slide 28: Innovative Solutions to Help Maintain Vision and Improve Ocular Health
Innovative Solutions to Help Maintain Vision and Improve Ocular Health Nicox S.A. Nicox Research Institute S.r.l. Nicox Ophthalmics, Inc. Drakkar 2 – Bât. D Via Ariosto 21 4721 Emperor Blvd. Suite 260 2405 Route des Dolines 20091 Bresso Durham, NC 27703, U.S. CS 10313 Sophia Antipolis Milano, Italy