Nicox Ordinary and Extraordinary General Meetings of April 14, 2021
March 26, 2021
Today I am writing to you to request your continued support for Nicox by voting in our upcoming Ordinary and Extraordinary General Meetings convened on April 14, 2021.
2020 has been a year of great progress in our development programs. Despite the challenging circumstances due to the global COVID-19 pandemic, we initiated four late-stage clinical trials in 2020, including the ZERVIATE trial launched by our Chinese partner Ocumension Therapeutics, demonstrating the strength of our development teams, supported by very capable corporate and financial functions. Both of the pivotal Phase 3 efficacy trials for NCX 470 in glaucoma patients, Mont Blanc and Denali, are now underway, allowing for the potential submission for marketing approval in both the United States and China. Given the positive results of the Dolomites Phase 2 trial, and the fact that we selected the higher dose of NCX 470 in the initial adaptive design of the Mont Blanc trial, we eagerly await, as a first step, the Mont Blanc top-line results currently expected in the first half of next year.
As to NCX 4251, based on the encouraging data from the Danube Phase 2 trial in blepharitis patients, we also now have a larger Phase 2b trial, Mississippi, up and running, with top-line results currently expected before the end of this year. Depending on those results, it may be that we only need one further pivotal trial to be able to submit NCX 4251 for approval in the United States.
Alongside the launch of ZERVIATE in the United States by our partner Eyevance Pharmaceuticals, recently acquired by the Japanese company, Santen, we have continued to expand our portfolio of licensees for this product in the rest of the world. Our partner Bausch + Lomb has also widened the availability of VYZULTA in the U.S. market by increasing its insurance coverage; and as a consequence VYZULTA prescriptions have increased despite the restrictions caused by the COVID-19 pandemic. Beyond the U.S and Canada, VYZULTA has been launched in Mexico, Argentina and Hong Kong and is approved or under regulatory review in many other countries.
We were grateful for the strong support from investors in our December equity financing and in the restructuring of our bond financing agreement with Kreos Capital, which ensure Nicox remains financed beyond the key upcoming Mississippi and Mont Blanc results.
This means we can retain our focus on execution of the ongoing clinical trials throughout 2021, aiming to keep them on track to deliver results according to our expected timelines. In addition, we expect to continued growth in our licensing revenues as prescriptions increase for VYZULTA and ZERVIATE. In short, we believe the right team and assets are in place to position the company for growth as a leading player in ophthalmology.
Your support and your vote in the upcoming Ordinary and Extraordinary General Meetings are very important to us being able to build on our past successes and continue to achieve our objectives.
For this purpose, a proxy form, the resolutions, a guide explaining how to vote, and several other documents pertaining to the General Meetings are enclosed. All the documents pertaining to the General Meetings are available on Nicox’s website www.nicox.com (‘Shareholder Meetings’ button on the home page).
Should you have any question on the voting process, please contact our Investor Relations team either by e-mail at email@example.com or by phone at 04 97 24 53 28.
With my best regards,
Chairman & Chief Executive Officer