France - Nicox SA (Euronext Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided financial results for Nicox SA and its subsidiaries (the 'Nicox Group') for the first half of 2023 and for the third quarter of 2023 and provided an update on key future milestones.
'The NCX 470 Denali trial is on track to report data in 2025, with over 65% of the target number of patients randomized in the trial. NCX 470, a novel nitric oxide donating bimatoprost eyedrop, is our lead clinical asset and earlier this year we announced that potential annual global peak net sales of NCX 470, based on the profile from the first Phase 3 trial Mont Blanc, could exceed $300 million.' said Andreas Segerros, Chief Executive Officer of Nicox. 'In parallel with the progress of the Denali trial, and the upcoming commercial launch of ZERVIATE in China, we are particularly focused on our financial situation and are evaluating all avenues to find a sustainable solution for the Company.'
Key Future Milestones
Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: The trial is on track to generate topline results in 2025, based on current recruitment rates.
Initiation of Whistler Phase 3b clinical trial investigating NCX 470's dual mechanism of action (nitric oxide and prostaglandin analog) in intraocular pressure (IOP) lowering: The Whistler trial is expected to be initiated in Q4 2023 and to take approximately one year to complete.
Approval and launch of ZERVIATE in China by Nicox's partner, Ocumension Therapeutics: Expected in 2024.
About Nicox
Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox's lead program in clinical development is NCX 470, a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox generates revenue from VYZULTA in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.
Contact:
Tel: +33 (0)4 97 24 53 00
Email: communications@nicox.com
Forward-Looking Statements
The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.
Risks factors which are likely to have a material effect on Nicox's business are presented in section 2.7 of the 'Rapport Annuel 2022' and in section 4 of the 'Rapport semestriel financier et d'activite 2023' which are available on Nicox's website (www.nicox.com).
OCUMENSION THERAPEUTICS 
