Positive topline results from Dolomites Phase 2 clinical trial of NCX 470 in glaucoma
VYZULTA prescriptions exceeded 3,000 per week for the first time1
Q3 2019 net revenue of €0.5 million
Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today provided a Q3 2019 business update and financial highlights, revenue and cash position for Nicox and its subsidiaries (the “Nicox Group”), as well as key upcoming milestones.
Michele Garufi, Chairman and Chief Executive Officer of Nicox, said, “The encouraging topline results from the Dolomites Phase 2 clinical trial of NCX 470 confirm the potential of both this product candidate and of our research platform, and set the stage for the next phase of Nicox’s development. Together with the NCX 4251 blepharitis trial, results of which we expect later in the fourth quarter, Nicox would have two advanced clinical programs in 2020.”
Key Upcoming Milestone
- NCX 4251 Phase 2 results: Clinical trial in patients with acute exacerbations of blepharitis continuing on track for topline data in Q4 of this year.
- NCX 470 Phase 3: End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) expected in early 2020.
Third Quarter 2019 Business update
- Nicox announced positive topline results of the Dolomites trial, its multicenter, U.S. Phase 2 safety and efficacy clinical study evaluating NCX 470, a novel second generation nitric oxide (NO)-donating bimatoprost analog, in patients with open-angle glaucoma or ocular hypertension. The 0.065% dose of NCX 470 demonstrated non-inferiority and statistical superiority to latanoprost 0.005%, the U.S. market leader in prostaglandin analog prescriptions.
- The total number of prescriptions1 for VYZULTA in the U.S. exceeded 3,000 per week for the first time, with scripts in the third quarter of 2019 increasing by 10% compared to second quarter 2019 and by 127% compared to third quarter 2018.
- Nicox amended its bond financing agreement with Kreos Capital and drew down €4 million in additional debt. Under the amended agreement, Nicox may draw down a further €3 million or €8 million on December 31, 2019 subject to notice to Kreos prior to December 16, 2019. Apart from the amended notice dates, payment dates and amounts mentioned here, all other contractual terms remain unchanged.
- Nicox entered into an exclusive license agreement with Ocumension Therapeutics for the development and commercialization of NCX 4251, a novel, patented ophthalmic suspension of fluticasone propionate nanocrystals, in the Chinese market and received a €2.0 million upfront payment in July 2019.
- In July 2019 we received a $3.0 million milestone payment from U.S. partner Eyevance Pharmaceuticals linked to completion by Nicox of regulatory and manufacturing responsibilities concerning ZERVIATE (cetirizine ophthalmic solution), 0.24% in the U.S. From now on, all manufacturing and regulatory responsibilities, together with decisions on launch timing, lie with Eyevance. Eyevance has informed Nicox that the commercial launch of ZERVIATE in the U.S. is currently projected in the first half of 2020.
- We strengthened our Management in CMC Development by appointing Dr. Ramesh Krishnamoorthy, Ph.D., to the newly-created position of Senior Director and Head, Late Stage CMC and Quality Control, effective September 1, 2019. Dr. Krishnamoorthy brings to Nicox over 24 years of experience in CMC, pharmaceutical development, and quality control aspects of sterile ophthalmic products. Dr. Krishnamoorthy holds an M.S. degree in pharmaceutics and Ph.D. in industrial and physical pharmacy.
Third Quarter 2019 Financial Highlights
As of September 30, 2019, the Nicox Group had cash and cash equivalents of €17.4 million, as compared with €17.3 million at June 30, 2019 and €22.1 million at end December 31, 2018. Including the cash from the recent bond financing and the research tax credit payments related to years 2017 and 2018 received in October, the cash available is €22.6 million. Net revenue2 for the third quarter of 2019 was €0.5 million versus €0.4 million in the third quarter of 2018.
As of September 30, 2019, the Nicox Group had financial debt of €7.4 million in the form of a bond financing agreement with Kreos Capital signed in January 2019.
Only figures at 31 December 2018 are audited. All figures of this press release are non-audited.
1. Bloomberg data, comparing the period of the weeks ending 5 July 2019 to 27 September 2019 with the periods of the weeks ending 5 April 2019 to 28 June 2019 and 6 July 2018 to 28 September 2018
2. Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit in the consolidated statements of profit or loss