release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today provided operational highlights and upcoming milestones, as well as revenues and cash position for Nicox and its subsidiaries (the “Nicox Group”) as of June 30, 2018.

Michele Garufi, Chairman and Chief Executive Officer of Nicox, stated, “VYZULTA sales by our global partner Bausch + Lomb grew substantially in the second quarter, reflected by an increase of over 180% in net royalty received by Nicox compared to the first quarter of 2018. Looking ahead to the remainder of 2018, we expect to add a second revenue stream for the future through the planned launch in the fall of ZERVIATE™ in the United States by our U.S. partner Eyevance, and advancing towards the initiation of Phase 2 clinical studies for NCX 470 and NCX 4251.”

Key Upcoming Milestones

  • Q3 2018: Planned start of Phase 2 clinical study for NCX 470 for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • Fall 2018: Expected commercial launch of ZERVIATETM (cetirizine ophthalmic solution), 0.24% in the United States by partner Eyevance Pharmaceuticals, LLC.
  • Q1 2019: Planned U.S. Investigational New Drug (IND) submission to the U.S. FDA for NCX 4251 to enable a Phase 2 clinical study in patients with acute exacerbations of blepharitis, following the successful, latest pre-IND meeting with the U.S. FDA in June 2018 (discussed below).

Second Quarter 2018 and Recent Operational Highlights

  • Research Collaboration with Ironwood Pharmaceuticals, Inc. In June 2018, we announced that we have entered into a research collaboration with Ironwood, focused on combining Ironwood’s expertise in soluble guanylate cyclase (sGC) and our proprietary nitric oxide (NO)-donating research platform to generate novel compounds in order to identify potential new therapeutics for the treatment of certain ophthalmic conditions.
  • Further pre-IND meeting held for NCX 4251. In June 2018, an additional pre-IND meeting was held with the U.S. FDA, which addressed specific questions on development, including the potential primary endpoints for the Phase 2 clinical study. Based on the FDA comments from this and previous meetings, we are finalizing the design of the first in human Phase 2 clinical trial evaluating the safety and efficacy of NCX 4251 versus a vehicle comparator in subjects with acute exacerbations of blepharitis. We plan to submit an IND in Q1 2019 to enable this Phase 2 clinical study.
  • Presentation of scientific data at the Association for Research in Vision and Ophthalmology (ARVO) 2018 Annual Meeting. In May 2018, we presented preclinical data on NCX 667, a lead molecule among our future generation stand-alone NO-donors, demonstrating the lowering of IOP in a robust, dose-dependent manner in various normotensive and hypertensive ocular models.
  • Opening of new U.S. development office in Research Triangle Park, North Carolina. In April 2018, we announced our decision to relocate from our prior development office in Fort Worth, Texas, and to expand our presence in the United States to focus on the planned advancement of NCX 470 and NCX 4251 into Phase 2 clinical studies.

Second Quarter 2018 Financial Highlights

As of June 30, 2018, the Nicox Group had cash and cash equivalents of €32.6 million as compared with €36.3 million at March 31, 2018 and €41.4 million at December 31, 2017. Net revenue1 for the second quarter of 2018 was €0.226 million, comprised exclusively of royalties on Q2 2018 sales of VYZULTATM by global partner Bausch + Lomb, after deduction of royalty payments due by Nicox. The Group recorded no revenues for the second quarter of 2017.

Only the figure related to the cash position of the Group as of December 31, 2017 is audited; all other figures of this press release are non-audited.

References

1. Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit in the consolidated statements of profit or loss