Nicox SA announced that the first patient has been screened in China in the ongoing Denali Phase 3 clinical trial, opening the way for New Drug Application (NDA) submissions in both the United States (U.S.) and China for NCX 470, Nicoxs lead clinical product candidate in glaucoma. Denali, which also includes a long-term safety extension, has been recruiting patients in the U.S. since November 2020. Approximately 670 patients are expected to be randomized at approximately 60 clinical sites in the U.S. and China, with approximately 80% of the patients to be recruited in the U.S. and the remaining ~20% of the patients to be recruited in China. This is the first patient to be enrolled in the Chinese part of the trial. Results from Denali are expected by the end of 2023. The Denali Phase 3 trial evaluates the intraocular pressure (IOP) lowering efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005% in patients with open-angle glaucoma or ocular hypertension. Denali is a multiregional (U.S. and China) clinical trial financed equally by Nicox and Ocumension, Nicoxs exclusive licensee for China, Korea and Southeast Asia. The inclusion of Chinese patients in the Denali trial is essential to satisfy the requirements of Chinese regulatory authority, the National Medical Products Administration. The Denali trial was designed to fulfill the regulatory requirements to support NDA submissions of NCX 470 in the U.S. and China.