Nicox First Quarter 2020 Business Update and Financial Highlights

Press Release

Nicox First Quarter 2020 Business Update and Financial Highlights

Expanded collaboration with Ocumension Therapeutics in China allows NCX 470 to enter two Phase 3 glaucoma clinical trials ZERVIATETM launched in the U.S. by partner Eyevance Pharmaceuticals Q1 2020 net revenue of €1.7 million and cash of €45.2 million as of March 31, 2020 VYZULTA prescriptions in Q1 2020 increased by 60% over Q1 2019

April 17, 2020 – release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today provided Q1 2020 operational highlights, revenue and cash position for Nicox SA and its subsidiaries (the “Nicox Group”), as well as updating key expected milestones in 2020.

Key Expected Upcoming Milestones

• NCX 470 Mont Blanc Phase 3 clinical trial: The first Phase 3 clinical trial of NCX 470 for lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension is currently expected to start by the end of Q2 2020, with top-line results expected in Q3 2021.  The Mont Blanc trial will be conducted principally in clinical sites in the U.S. and will include a small number of Chinese clinical sites.  The trial will be initiated with 0.065% and 0.1% doses of NCX 470 vs. latanoprost 0.005%, with only one dose of NCX 470 being selected through an adaptive design to complete the trial.
• NCX 470 Denali Phase 3 clinical trial: The second Phase 3 glaucoma clinical trial, jointly managed and equally funded by Nicox and Ocumension, is currently expected to start in H2 2020.  It will include clinical sites in both the U.S. and China, with the majority of the patients being in the U.S. to support the U.S. New Drug Application (NDA) filing.  A sufficient number of patients from China will be included in the Denali trial to support an NDA filing in China.

• NCX 4251 Phase 2b clinical trial: This Phase 2b trial will include both blepharitis and dry eye endpoints with the option of declaring either acute exacerbations of blepharitis endpoint or dry eye endpoints as the primary outcome of the trial.  Timing and further trial design details will be announced in due course.
• ZERVIATE China: A Phase 3 clinical trial for approval in China, to be conducted and financed by Ocumension, is currently expected to start by Q4 2020.

Nicox continues to closely watch the spread of COVID-19 and its impact around the world.  We do not currently anticipate delays to our clinical timelines but we are monitoring the situation and will provide updates in due course if there is an impact on our development projects and timelines.