NCX 470 Mont Blanc Phase 3 clinical trial in glaucoma at over 98% recruitment
Development pathway for NCX 4251 in dry eye disease confirmed following meeting with the U.S. FDA
First quarter 2022 U.S. prescriptions for VYZULTA® increased by 43% over first quarter 2021
Cash position of €42.0 million as of December 31, 2021 and €35.1 million as of March 31, 2022, confirming the Company is financed to Q4 2023
April 28, 2022 – release at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the financial and operating results for Nicox and its subsidiaries (the “Nicox Group”) for the year ended December 31, 2021, as approved by the Board of Directors on April 27, 2022, along with a business update and financial highlights for the first quarter 2022, and provided an update on key upcoming milestones.
“We are very pleased by the rapid progress of the NCX 470 Mont Blanc phase 3 trial and are eagerly expecting its completion which will mark a major inflexion point for our Company and a turning point in the development of drugs for the treatment of patients with open-angle glaucoma and ocular hypertension.” said Michele Garufi, Chief Executive Officer of Nicox.
Key Upcoming Milestone
First Quarter 2022 and Recent Events and Pipeline Updates
NCX 470 is a novel nitric oxide (NO)-donating prostaglandin analog currently in a Phase 3 clinical program for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Owing to a better than expected enrollment rate in recent months, over 98% of the patients required to complete the NCX 470 Mont Blanc Phase 3 clinical trial have been enrolled.
Patient enrollment is continuing in both the United States (U.S.) and China in the ongoing Denali Phase 3 clinical trial on NCX 470 in patients with open-angle glaucoma or ocular hypertension. 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. The topline results will not be available by the end of 2023 as previously communicated due to several hurdles (including the COVID-19 pandemic situation in the U.S. and China). The Company will announce a new date for availability of the results when we have more visibility on the overall timelines of the trial.
The Chinese National Intellectual Property Administration has granted Nicox a formulation patent for NCX 470 in China to 2039. With the equivalent U.S. and European patents already granted, the formulation is now covered in most major global territories. NCX 470 is also covered by granted composition of matter patents.
NCX 4251 is a novel, patented, ophthalmic suspension of fluticasone propionate nanocrystals in clinical development stage for dry eye disease.
Following the encouraging post hoc results from the Mississippi Phase 2b clinical trial and a subsequent meeting with the U.S. Food and Drug Administration (FDA), the future development of NCX 4251 will be focused on dry eye disease. The Mississippi post hoc results, reported on November 30, 2021, suggest that once-daily dosed NCX 4251, fluticasone propionate ophthalmic suspension 0.1%, is effective in reducing dry eye symptoms in patients who score more highly for a key sign of dry eye disease. The Company is currently exploring how to best advance the development of NCX 4251 in dry eye disease and will communicate its strategy at a future date.
The Japanese Patent Office has granted a new patent expiring in 2040 for NCX 4251. Patent JP.7021301 covers ophthalmic suspensions comprising a specific form of fluticasone propionate nanocrystals and the method for manufacturing the ophthalmic suspensions. It complements the recent granting of a patent from the same family in Europe. Corresponding patent applications are under examination in the U.S., China and other territories.
Commercial Out-licensed Products
VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% U.S. prescriptions1 increased by 43% in the first quarter of 2022 compared to first quarter 2021, however revenue remained unchanged due to an increased level of rebates. As of December 31, 2021, VYZULTA, exclusively licensed worldwide to Bausch + Lomb, was commercialized in 7 territories: United States (2017), Canada (2019), Argentina (2020), Mexico (2020), Hong Kong (2020), Taiwan (2021) and Ukraine (2021). VYZULTA is also approved in 9 other countries, namely Brazil, Colombia, Jordan, Qatar, Singapore, South Korea, Thailand, Turkey and United Arab Emirates. VYZULTA is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Our partnership with Samil Pharmaceutical concerning ZERVIATE in South Korea has been expanded to include Vietnam.
Our Chinese partner Ocumension Therapeutics successfully completed a Phase 3 clinical trial of ZERVIATE (cetirizine ophthalmic solution), 0.24% in Chinese patients with allergic conjunctivitis in which ZERVIATE was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine marketed under the brand name EMADINE®. ZERVIATE was found to be non-inferior to emedastine difumarate in the primary efficacy endpoint of change from baseline in the itching score in the 24 hours prior to the Day 14 visit. ZERVIATE was safe and well-tolerated with no difference in the proportion of patients with adverse events compared to emedastine difumarate. This Phase 3 clinical trial was required for Ocumension to be able to submit a New Drug Application (NDA) for approval to commercialize ZERVIATE in China.
The U.S. FDA has granted Orphan Drug Designation for naproxcinod for the treatment of sickle cell disease, which affects an estimated 100,000 Americans. Naproxcinod is a nitric oxide (NO)-donating naproxen combining the cyclooxygenase (COX) inhibitory activity of naproxen with that of nitric oxide developed by Nicox and exclusively licensed to Fera in the U.S. Nicox has tested naproxcinod in over 2,700 patients in osteoarthritis, generating a significant package of clinical safety data which is available to support Fera’s development of naproxcinod, and ultimately an NDA submission for sickle cell disease.
Management and Advisors
In December 2021, we announced the appointment of Doug Hubatsch as Chief Scientific Officer to lead all of the Company’s non-clinical and clinical development activities. Based in Nicox’s U.S. subsidiary Nicox Ophthalmics Inc., he is responsible for setting the research and development strategy of the Group and is a member of the Nicox Executive Committee.
In July 2021, we announced that two internationally recognized experts in glaucoma, Robert N. Weinreb, M.D., Distinguished Professor and Chair, Ophthalmology and Director, Shiley Eye Institute, University of California San Diego, and Sanjay G. Asrani, M.D., Professor of Ophthalmology, Duke University, joined the Nicox Glaucoma Clinical Advisory Board.
2021 Financial Summary
Net revenue2 for the full year 2021 was €7.2 million (€2.4 million in net royalties, €4.8 million in license payments), compared to €12.9 million (€2.4 million in net royalties, €10.5 million in license payments) for the full year 2020. The principal difference in revenue is due to an IFRS treatment of a licensing payment received from our partner Ocumension Therapeutics in 2020.
Operating expenses for the year 2021 increased to €25.1 million from €19.5 million for the previous year among which €5.2 million comes from non-clinical and development expenses due to the advancement and progress of the Phase 3 trials on NCX 470.
Net loss of the Nicox Group for the full year 2021 was €43.8 million against €18.1 million for the full year 2020. However, the 2021 net loss includes €27.8 million of non-recurring, non-cash items due to a reduction in the estimated fair value of ZERVIATE (of €12.7 million) and of NCX 4251 (of €15.1 million) reflecting, respectively, the changes in the allergic conjunctivitis market in the U.S. and the changes in the development plan and timeline for NCX 4251.
As of December 31, 2021, the Nicox Group had cash and cash equivalents of €42.0 million, as compared with €47.2 million at December 31, 2020, and as previously announced, the Company is financed until Q4 2023, assuming the development of NCX 470 alone.
As of December 31, 2021, the Nicox Group had financial debt of €20.5 million, consisting of €18.5 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and a €2 million credit agreement guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic.
First Quarter 2022 Financial Highlights
As of March 31, 2022, the Nicox Group had cash and cash equivalents of €35.1 million as compared with €42.0 million at December 31, 2021. Net revenue2 for the first quarter of 2022 was €0.7 million (entirely composed of net royalty payments). Net revenue2 for the first quarter of 2021 was €1.7 million (including €0.7 million of net royalty payments).
As of March 31, 2022, the Nicox Group had financial debt of €20.5 million consisting of €18.5 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and a €2 million credit agreement guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic.
Only the figures related to the cash position, revenue and debt of the Nicox Group as of December 31, 2021 and December 31, 2020 are audited; all other figures of this press release are non-audited.
Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470, a novel nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The Company is also developing NCX 4251, a proprietary formulation of fluticasone, for dry eye disease. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.
Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment C: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes.
For more information on Nicox, its products or pipeline, please visit: www.nicox.com.