Nicox Sa · EURONEXT:ALCOX
Nicox Sa — H.C. Wainwright Life Sciences Conference 2019
28 slides from Nicox Sa's conference presentation, Apr 9, 2019
Slide 1: H.C.Wainwright Life Sciences Conference
H.C.Wainwright Life Sciences Conference London, April 8-9 , 2019 Innovative Solutions to Help Maintain Vision and Improve Ocular Health Euronext Paris: COX © 2019 Nicox. All rights reserved
Slide 2: Disclaimer
Disclaimer 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, and no reliance sh
Slide 3: Unique Company from Research to Market
Unique Company from Research to Market DEVELOPMENT MARKET RESEARCH VYZULTA® - Commercialized in U.S. NCX 470 - Glaucoma NO-donating PDE5 inhibitors by partner Bausch + Lomb NCX 4251 - Blepharitis since December 2017 NO-donating sGC stimulators ZERVIATETM - Commercial launch NCX 4280 - Morning ocular
Slide 4: A Look into Our Future
A Look into Our Future VYZULTA® and ZERVIATETM will generate significant and increasing worldwide revenues to support and boost our growth Our goal is to become a specialty NCX 470 and NCX 4251 will be the first drugs to be Ophthalmology marketed in U.S. directly by a Nicox commercial Company driven
Slide 5: Broad Pipeline of Ophthalmic Therapeutics
Broad Pipeline of Ophthalmic Therapeutics Stages of Development Products and product candidates / Indications Rights Research Preclinical Phase 1 Phase 2 Phase 3 NDA Marketed NO-Donating Product Candidates Targeting Glaucoma and Other Indications NCX 470 Second generation NO-donating PGA Glaucoma 1
Slide 6: Nitric Oxide (NO)-Donating Product Candidate & Research Projects in Glaucoma
Nitric Oxide (NO)-Donating Product Candidate & Research Projects in Glaucoma NCX 470 Future generation NO-donors 6
Slide 7: The Central Role of Nitric Oxide in IOP Homeostasis
The Central Role of Nitric Oxide in IOP Homeostasis Nobel Prize 1998 RF Furchgott O LJ Ignarro N F Murad Primary or Conventional Outflow Endogenous cell- Stimulated by Nitric Oxide signaling molecule Secondary or Uveoscleral Outflow Stimulated by PGAs NO in ophthalmology Present in ocular tissues, N
Slide 8: Leading Glaucoma R&D Pipeline
Leading Glaucoma R&D Pipeline First generation Latanoprostene bunod (active ingredient in VYZULTA®) NO-donating prostaglandin analog HO O O ONO2 (first line therapy) HO OH Second generation NCX 470 O N NO-donating prostaglandin analog HO (first line therapy) HO O ONO2 O NO-donating PDE5 inhibitors F
Slide 9: NCX 470 – Second Product in Development from our Research Platform
NCX 470 – Second Product in Development from our Research Platform Novel second generation NO-donating prostaglandin analog Single molecule with the same dual • In development in the U.S. for the lowering mechanism of action (MOA) as VYZULTA of IOP in patients with open-angle generated from our prop
Slide 10: NCX 470 Demonstrated Robust IOP Lowering Effect in Vivo
NCX 470 Demonstrated Robust IOP Lowering Effect in Vivo Up to 8.4 mmHg IOP Lowering Due to NO Alone Up to 3.5 mmHg Greater IOP Lowering in a Model Poorly Responsive to Bimatoprost vs. High Strength Bimatoprost (0.03%) Transient hypertonic (5%) saline-induced ocular hypertensive rabbits1 Laser-induce
Slide 11: NCX 470 - Phase 2 Clinical Study Initiated August 1st, 2018
NCX 470 - Phase 2 Clinical Study Initiated August 1st, 2018 Well-Powered Study for Selection of the Dose for Phase 3 studies • Phase 2, multi-center, double-masked, 28-day, parallel group, dose-response study • Evaluating the efficacy and safety of NCX 470 compared to latanoprost 0.005% for IOP lowe
Slide 12: NCX 470 - Phase 2 Study Design
NCX 470 - Phase 2 Study Design All Doses Administered Topically as Eye Drops in a 1:1:1:1 Ratio NCX 470 0.065% (equimolar 0.05% bimatoprost) Exit Visit NCX 470 0.042% (equimolar 0.03% bimatoprost) Exit Visit Wash-out Period* NCX 470 0.021% (equimolar 0.015% bimatoprost) Exit Visit Latanoprost 0.005%
Slide 13: Increasing Treatment Effect by 1.0 mmHg Reduces Risk in Progression of Glaucoma
Increasing Treatment Effect by 1.0 mmHg Reduces Risk in Progression of Glaucoma More than 120,000 people in the U.S. are blind from glaucoma, accounting for 9-12% of all cases of blindness in the world1 . Results from the Early Manifest Glaucoma Results from the United Kingdom Glaucoma Trial (EMGT)2
Slide 14: Future Generation NO-Donors: Potential Adjunctive Treatments in Glaucoma
Future Generation NO-Donors Potential Adjunctive Treatments in Glaucoma Glaucoma Treatment Cascade Approximately 40%1 of patients High IOP diagnosed have been reported as requiring two or more Treatment initiated with first line therapy – usually medications in order to achieve prostaglandin analogs
Slide 15: Future Generation NO-Donors
Future Generation NO-Donors NO-signaling pathway Enhanced with soluble guanylate cyclase (sGC) stimulators Prolonged in the presence of phosphodiesterase-5 (PDE5) inhibitors Nitric Oxide PDE5 inhibition Guanylate cyclase activation NO-donating NO-donating PDE5 inhibitors PDE5 sGC sGC stimulators 5’-
Slide 16: Future Generation NO-Donors as New Therapeutic Classes
Future Generation NO-Donors as New Therapeutic Classes Focus on New Agents Active on the Trabecular Meshwork Outflow Pathway NO-donating sGC stimulators NO-donating PDE5 inhibitors Research collaboration Nicox has rights to negotiate for Ongoing internal research developing any identified product pr
Slide 17: Novel Formulation Targeting Blepharitis
Novel Formulation Targeting Blepharitis NCX 4251 17
Slide 18: Blepharitis - An Unmet Medical Need
Blepharitis - An Unmet Medical Need NCX 4251 - Ophthalmic Suspension of Fluticasone Propionate Nanocrystals • No U.S. FDA-approved product solely indicated for blepharitis • Blepharitis encountered by 37% and 47% of all patients seen by ophthalmologists/optometrists in the U.S.1 who consider anti- i
Slide 19: NCX 4251 - Phase 2 Clinical Study Initiated March 18th, 2019
NCX 4251 - Phase 2 Clinical Study Initiated March 18th, 2019 Designed to select the dose(s) of NCX 4251 for next stage of development • Phase 2, multi-center, randomized, double-masked, 14-day, placebo-controlled, dose-escalation study • Evaluating the safety and tolerability of NCX 4251 compared to
Slide 20: Cohort 1 and Cohort 2 Design
NCX-4251-01: Study Design All Doses Administered via Daily Eyelid Application in Two Consecutive Cohorts (Cohort 1 QD and Cohort 2 BID Dosing) Exit Visit Cohort 1 and Cohort 2 Design NCX 4251 0.01% 2 Week Follow-up Screening Visit Placebo 2 Week Follow-up Baseline Day 4 Day 8 Day 11 Day 14 Day 1 Vis
Slide 21: Key Commercial & Development Partnerships
Key Commercial & Development Partnerships VYZULTA® ZERVIATE™ NCX 470 21
Slide 22: VYZULTA - Commercialized in the U.S. by Partner Bausch + Lomb
VYZULTA® - Commercialized in the U.S. by Partner Bausch + Lomb • First eye drop approved in 20 years with a novel approach to IOP lowering • A novel IOP lowering agent with a dual mechanism of action • Proven IOP lowering up to 7-9 mmHg • Approved in Canada as of January 2019 Exclusive worldwide lic
Slide 23: VYZULTA - Prescription Growth
VYZULTA® - Prescription Growth • Patients who start on VYZULTA® are 34% more likely to stay on it than other branded 2500 agents1 Prescriptions per week 2000 1500 • ~ 30% of prescriptions are newly diagnosed 1000 glaucoma patients; of the remaining 70% 500 prescriptions, ~ 50% are switches from gene
Slide 24: ZERVIATE - U.S. Commercial Launch by Partner Eyevance Planned in Summer 2019
ZERVIATETM - U.S. Commercial Launch by Partner Eyevance Planned in Summer 2019 The first and only topical ocular formulation of cetirizine, indicated for the treatment of ocular itching associated with allergic conjunctivitis • Same active ingredient as ZYRTEC®1 with established systemic efficacy an
Slide 25: Strategic collaborations in China with Ocumension Therapeutics
Strategic collaborations in China with Ocumension Therapeutics NCX 470 for glaucoma • One-time upfront payment of €3 million Validated • Further €2.5 million at the initiation of a Phase 3 study by Nicox with NCX 470 Partnerships Milestones outside the agreed territory. Additional milestones payment
Slide 26: Financial Highlights
Financial Highlights Key Capitalization Overview Additional Key Statistics • Lean organization with 34 employees in Cash & Cash Equivalents1 € 22.0 million France (Headquarters), Italy (Research Center) and U.S. (Development Center) • Debt facility for up to €20 million from Outstanding shares2 ~29.
Slide 27: Upcoming Main Milestones / Investment Highlights
Upcoming Main Milestones NCX 470: Top-line results from Phase 2 study expected in Q4 2019 NCX 4251: Top-line results from Phase 2 study expected in Q4 2019 ZERVIATETM: Commercial launch in the U.S.by partner Eyevance expected in summer 2019. New local out-licensing agreements in 2019 Presentations a
Slide 28: Innovative Solutions to Help Maintain Vision and Improve Ocular Health
Nicox S.A. Innovative Solutions to Help Maintain Drakkar 2 – Bât. D 2405 Route des Dolines Vision and Improve Ocular Health CS 10313 Sophia Antipolis 06560 Valbonne, France T: +33 (0)4 97 24 53 00 F: +33 (0)4 97 24 53 99 [email protected] HQ Nicox Ophthalmics, Inc. Sophia-Antipolis, Nice, FRA
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