Nicox Sa · EURONEXT:ALCOX
Nicox Sa — Investor Presentation (March 2024)
23 slides from Nicox Sa's investor presentation, Mar 19, 2024
Slide 1: Nicox Corporate Presentation
Nicox Corporate Presentation An international ophthal mol ogy company devel oping innovative sol utions to hel p maintain vision and improve ocul ar heal th March 19, 20 24 Euronext Growth Paris: ALCOX September 2022
Slide 2: Forward-looking statements
Forward- l ooking 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,
Slide 3: Focused on value inflection points expected for 2024-2025
Nicox is focused on the val ue infl ection points expected for 20 24- 20 25 1 ✔ Appointment of Gavin Spencer as Chief Executive Officer Recent Highl ights ✔ A new val idation of NCX 470 though Kowa partnership NICOX visible science ✔ Restructuring of debt agreements with Bl ackRock 2 ✔ Streaml ining
Slide 4: Consistently delivering innovations in ophthalmology
Consistentl y del ivering innovations in ophthal mol ogy … … with NCX 470 the next derisked asset advancing toward NDA fil ing in the U.S. and China Commercial val ue of l ead Gl obal partnerships with asset NCX 470 in l ate- Deep ophthal mol ogy Tier 1 ophthal mol ogy NICOX visible science stage Ph
Slide 5: Highlights
Highl ights Important achievements in 20 23 position the company for several positive mil estones in 20 24 NCX 470 ZERVIATE Corpora te NICOX visible science ✔ Phase 3 Denali trial on track (80% ✔ Transfer of U.S. rights to Harrow ✔ Net revenue from licensing income randomized and full one- year safe
Slide 6: An innovative portfolio led by NCX 470, a derisked product candidate
An innovative portfol io l ed by NCX 470 , a derisked product candidate with gl obal potential St ages of Devel opment 3 Product Candidates Precl inical Phase 1 Phase 2 Phase 3 NDA Marketed Expected Mil estones Denal i topl ine resul ts in H2 20 25 NCX 470 | NO- donating bimatoprost eye drops Whistl
Slide 7: Glaucoma snapshot
Gl aucoma snapshot El evated IOP contributes to irreversibl e optic nerve damage, l eading to progressive vision l oss NICOX visible science As publ ished in the l andmark EMGT study “…each mmHg of decreased IOP was rel ated to an approximatel y 10 % l owering [of risk of vision l oss progression]”
Slide 8: Unmet medical needs for glaucoma treatment
Unmet medical needs for Gl aucoma treatment ✔ 40 % of patients ✔ Many patients ✔ Tol erabil ity do not achieve require >1 issues with some NICOX visible science Despite having wel l establ ished first- l ine therapies, incl uding the their target IOP medication which medications l ead standard- of-
Slide 9: NCX 470 acts through a dual mechanism for IOP lowering
NCX 470 acts through a dual mechanism1 for IOP l owering Non-clinical optic nerve/retinal damage models also demonstrate potentially beneficial retinal effects2 Two pathways for Primary or conventional aqueous humor outfl ow 1 outfl ow normal l y Stimul ated by NICOX visible science accounts for ~60
Slide 10: Positive NCX 470 Mont Blanc topline results
Positive NCX 470 Mont Bl anc topl ine resul ts1,2,3 Phase 3 cl inical program intended to support pl anned U.S. & China NDA submissions Designed to demonstrate safety and efficacy of NCX 470 0 .1% vs. l atanoprost 0 .0 0 5%, defined by IOP reduction from time- matched basel ine at pre- establ ished
Slide 11: Mont Blanc Phase 3 efficacy trial design
Mont Bl anc Phase 3 efficacy trial design 1 Designed to eval uate NCX 470 vs. establ ished therapy, l atanoprost Randomized, control l ed, doubl e- mask ed, paral l el design trial . Patients with open angl e gl aucoma or ocul ar hypertension were randomized 1:1 to once- dail y treatment with NCX 47
Slide 12: Baseline characteristics, demographics and disposition
Basel ine characteristics, demographics and disposition 1 NCX 470 0 .1% Latanoprost 0 .0 0 5% N = 328 N = 333 Mean Diurnal Basel ine (8am+4pm) IOP, mmHg, Study Eye (SD) 26.9 (2.0 4) 26.8 (2.0 2) Gender, n (%) Femal e 20 0 ( 61.0 %) 188 ( 56.5%) NICOX visible science Mal e 128 ( 39.0 %) 145 ( 43.5%)
Slide 13: Significant, sustained IOP-lowering effects
Significant, sustained IOP- l owering effects IOP-lowering from baseline was 8.0 to 9.7 mmHg for NCX 470 vs. 7.1 to 9.4 mmHg for latanoprost NCX 470 0.1%: N = 328 Latanoprost 0.005%: N = 333 NICOX visible science • Denotes statistically significant differences vs latanoprost (p<0.049) 13 • Fechtner
Slide 14: NCX 470 0.1% achieved non-inferiority vs latanoprost
NCX 470 0 .1% achieved non- inferiority and demonstrated an IOP- l owering greater than Latanoprost 0 .0 0 5% of up to 1.0 mmHg To be non- inferior, the treatment difference between NCX 470 and l atanoprost had NICOX visible science to meet BOTH criteria: • For al l 6 timepoints, the upper l imit of
Slide 15: NCX 470 topline results demonstrate robust efficacy and safety
NCX 470 topl ine resul ts demonstrate robust efficacy and safety 1 Al l comparisons are based on NCX 470 0 .1% and l atanoprost 0 .0 0 5% Topl ine resul ts from this pivotal trial : • IOP- l owering effect from basel ine was 8 .0 to 9.7 mmHg for NCX 470 vs. 7.1 to 9.4 mmHg for l atanoprost • Statist
Slide 16: NCX 470 presentations at key ophthalmology conferences
NCX 470 – Presentations at key ophthal mol ogy conferences • Poster 1: Intraocular Pressure Reduction with NCX 470 versus Latanoprost Across the Spectrum of Baseline Intraocular Pressures • Poster 2: Intraocular Pressure Reduction with NCX 470 versus Latanoprost In Previously Treated Versus Treatmen
Slide 17: U.S. glaucoma clinical advisory board with leading experts
U.S. gl aucoma cl inical advisory board with l eading experts DR. ROBERT D. FECHTNER, MD, CHAIRMAN DR. STEVEN MANSBERGER, MD MPH Professor and Chair of the Department of Vice- Chair, Senior Scientist, and Director of Gl aucoma Services Ophthal mol ogy at SUNY Upstate Medical University, and Ophthal
Slide 18: Value proposition of NCX 470
Val ue proposition of ✔ N o vel mo l ecu l e wit h compet it ive posit ive impact on l owerin g in traocu l ar pressu re (IOP), t he l eading NCX 470 cau se of gl au coma ✔ Po si t i ve p i vo t al Ph ase 3 t o p l i n e r esu l t s from t h e Mon t Bl an c t rial 1,2,3 ✔ First n on - combination pr
Slide 19: Consistent business development track record across markets
Nicox has a consistent business development track record across markets NCX 470 ✔ Nicox to receive from Ocumension 6% to 12% royal ties on future net sal es1 in China and Southeast Asia. Ocumension pays 50 % of the Denal i Phase 3 trial costs ✔ Upfront payment of €3 mil l ion received from Kowa for
Slide 20: A refocused global leadership team
A refocused gl obal l eadership team NICOX visible science Gavin Spencer Sandrine Gest in Doug Hubat sch Emmanuel l e Pierry Chief Execut ive Officer VP, Finance EVP, Chief Scient ific Officer General Counsel & Head, Legal Former member of the Paris Bar Jean- François Labbe Michel e GarufiI Les Kapl
Slide 21: Financial highlights
Financial highl ights Cash bal ance expected to support current operations through November 20 24 Estimated Financial Position and Ownership €14.9 mil l ion (incl uding the upfront payment from Kowa in Cash, Cash Equival ents as at 31 December 20 23 NICOX visible science February) Long term debt 2 a
Slide 22: Investment highlights
Investment highl ights A proven track record in cl inical devel opment and business devel opment • Two product approval s in the U.S., one pending in China • Business devel opment deal s in the U.S., Japan, China, and gl obal l y with Tier 1 companies NICOX visible science NCX 470 , a derisk ed,
Slide 23: Nicox contact details
Nicox S.A. Nicox Research Institute S.r.l . Nicox Ophthal mics, Inc. Sundesk Sophia Antipolis Via Ariosto 21 4819 Emperor Blvd. Suite 400 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 (