Nicox Announces First Patient Screened in the Whistler Phase 3b Trial of NCX 470 in Glaucoma

“The model we are using to investigate the effects on aqueous humor outflow is well established and we are pleased to be working with one of the experts in this field, Dr Arthur Sit at the Mayo Clinic. The data from this trial is expected to provide further evidence of the dual mechanism of action of NCX 470 as we should be able to tease out parameters related to how the nitric oxide and the prostaglandin analog components of NCX 470 function.” said Doug Hubatsch, EVP, Chief Scientific Officer of Nicox.

The Whistler Phase 3b trial will enroll ~20 healthy volunteers with ocular hypertension in a double-masked, placebo-controlled study which will investigate the action of NCX 470 on aqueous humor parameters including trabecular meshwork outflow and episcleral venous pressure. Each subject will participate in the trial for ~8 days and will provide insight into the mechanism of action of NCX 470. The trial is expected to take approximately 1 year to complete.

Nicox Corporate Status Update

The Company is currently funded until the end of June 2024, exclusively on the basis of the development of NCX 470. The Company is pursuing licensing discussions which could extend the cash runway. In parallel, the Company is exploring multiple strategic options and is also discussing with its creditors to restructure its debt.

About NCX 470
NCX 470, a novel NO-donating bimatoprost eye drop, is currently in Phase 3 clinical development for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the two Phase 3 clinical trials, were announced in October 2022. The second Phase 3 clinical trial, Denali, is currently ongoing, and the results are expected in 2025 based on current recruitment rates. Mont Blanc and Denali have been designed to fulfill the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China, where NCX 470 is exclusively licensed to Ocumension Therapeutics.

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.

Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index.

For more information on Nicox, its products or pipeline, please visit: www.nicox.com.

Bryan, Garnier & Co Eric Yoo Paris, France
Edison Investment Research Pooya Hemami London, UK
H.C. Wainwright & Co Yi Chen New York, U.S.

Nicox
Gavin Spencer
Executive Vice President, Chief Business Officer
& Head of Corporate Development
T +33 (0)4 97 24 53 00
communications@nicox.com

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’activité 2023” which are available on Nicox’s website (www.nicox.com).