Nikox: Full 2021 financial results, first quarter 2022 financial overview, key program updates and next steps

  • P98 or more% from Patience Recruitment of Montblanc Phase 3 clinical trial of NCX470 in glaucoma
  • Confirmation of ddevelopment of Series NCX4251Eye care after a meeting with the US FDA
  • Increase in VYZULTA prescriptions® In the United States 43To% First quarter of 2022 is connected with First quarter of 2021
  • Cash as of December 31, 2021 European42.0 One millions And as of March 31, 2022, 35.1 million euros, Confirmation It society Funded Until the fourth quarter of 2023

April 28, 2022 – Broadcast at 7:30 am
Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX, PEA-PME eligible), an international company specializing in ophthalmology today finances Nikox and its subsidiaries (“Nikox Group”) for the fiscal year ended December 31, 2021. And announced the business results. The Board of Directors, April 27, 2022, will provide up-to-date information on activities in the first quarter of 2022 and key steps ahead.

“”We are very pleased with the rapid progress ofclinical trial of pBase 3 Mont Blanc NCX470.. Swe completion Score Inflection Important to us not only, Step In the development ofs Treatment For treatment Open-angle glaucoma and Increased intraocular pressure” Said Michele Galfi, Nikox Chairman and Chief Executive Officer..

Next step key

  • NCX 470 – Phase 3 clinical trial Mont Blanc With glaucoma : Recruitment progressed faster than expected, so check the schedule announced for the first results.

Main event First quarter of 2022, Recent news And PGreased wallet Of the product

Drug candidates

NCX470

  • NCX470 Is a novel nitric oxide (NO) -donating prostaglandin analog currently in Phase 3 clinical development to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • Over 98% of patients enrolled in Montblanc Phase 3 clinical trials NCX470Hired earlier than expected in the last few months.
  • Continued patient recruitment in the US and China for ongoing Denali Phase 3 clinical trials NCX470 Patients with open-angle glaucoma or ocular hypertension.. Recruitment of patients in the United States for Denali trials, including long-term safety trials, began in November 2020. Approximately 670 patients are randomized in approximately 60 clinical facilities in the United States and China, with approximately 80% of patients in the United States and the remaining 20% ​​in China. The first results of the Denali study will not be available until the end of 2023, as previously reported, for several reasons, including the COVID-19 pandemic situation in the United States and China. We will announce a new date for the transmission of results as the survey schedule becomes clearer.
  • The China National Intellectual Property Office To Nicox NCX470 In China until 2039. Equivalent patents have already been granted in the United States and Europe, and NCX470 formulations are currently protected in most major world territories. NCX 470 is also protected by a patent covering the composition of the substance.

NCX4251

  • NCX4251An innovative patented ophthalmic suspension of fluticasone propionate nanocrystals from Nicox is in clinical development for dry eye disease.
  • The following results after Promising results in NCX 4251 Mississippi Phase 2b clinical trials, Food and Drug Administration (FDA), future development NCX4251 Focus on dry eye.result after From a Mississippi study published November 30, 2021, fluticasone propionate for 0.1% ophthalmology given once daily to reduce dry eye symptoms in patients with high scores for important signs of dry eye. The effectiveness of NCX4251 as a suspension has been suggested. We are currently considering the best options for further development of NCX 4251 in dry eye disease and will announce its strategy at a later date.
  • The Japan Patent Office NCX4251 Patent JP.7021301 covers ophthalmic suspensions containing specific forms of fluticasone propionate nanocrystals and methods for producing ophthalmic suspensions. This patent is in addition to the recently granted European patent of the same family. Patent applications from this same family are pending in the United States, China, and other regions.

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  • Total number of prescriptions1 of VYZULTA® (Ratanoprostem benod ophthalmic solution), 0.024% in the United States, increased by 43% in the first quarter of 2022 compared to the first quarter of 2021. However, revenue was flat due to the increase in discount rates. As of December 31, 2021, VYZULTA, which is exclusively licensed to Bausch + Lomb worldwide, is 7 of the United States (2017), Canada (2019), Argentina (2020), Mexico (2020), and Hong Kong (2020). Sold in two regions. Taiwan (2021) and Ukraine (2021). VYZULTA is also approved in nine countries: Brazil, Colombia, Jordan, Qatar, Singapore, South Korea, Thailand, Turkey and the United Arab Emirates. VYZULTA is indicated in the United States for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
  • Partnership with Samil Pharmaceutical ZERVIATE In South Korea, it is expanding to Vietnam.
  • Nicox’s Chinese partner, Ocumension Therapeutics, has successfully completed a Phase 3 clinical trial of ZERVIATE.® (Cetirizine ophthalmic solution), 0.24% in Chinese patients with allergic conjunctivitis. In this study, ZERVIATE was compared with Emedastin diphmalate ophthalmic solution 0.05%. This is an antihistamine sold under the trade name EMADINE.®.. ZERVIATE was found to be non-inferior to emedastine difumarate at the primary efficacy endpoint in changes from baseline in itch scores within 24 hours prior to visit on day 14. Emedastin difumarate. This Phase 3 clinical trial is required for Ocumension to submit a marketing authorization application for the commercialization of ZERVIATE in China.

Other partnerships

  • The US FDA permits the designation of orphan drugs (Designation of orphan drugs) To Naproxcinod It affects about 100,000 Americans in the treatment of sickle cell disease. Naproxcinod is a nitric oxide (NO) -donating naproxen that combines the cyclooxygenase (COX) inhibitory activity of naproxen with the nitric oxide inhibitory activity developed by Nicox and exclusively licensed to Fera in the United States. .. Nikox has tested naproxcinod in more than 2,700 patients with osteoarthritis and the importance of clinical safety data available to support the development of naproxcinod in the sickle cell market and subsequent marketing approval applications. Brought a nice body.

Management and cconsultant

In December 2021, Nicox announced the adoption of Doug Hubatsch as follows: Chief Scientific Officer To direct all of our clinical and non-clinical development activities. Doug Hubatsch, a member of the Executive Committee, based at Nicox Ophthalmics Inc., a US subsidiary of Nicox, is responsible for implementing the Group’s R & D strategies.

In July 2021, Nicox was two internationally renowned glaucoma specialists based in the United States, Dr. Robert N. Waynelev, Professor Emeritus, Chairman of Ophthalmology, and Shirley Ophthalmology at the University of California, San Diego. Announced that he is the director of the institute. Dr. Sanjay G. Asrani, a professor of ophthalmology at Duke University, has been appointed to the Nicox Glaucoma Clinical Advisory Board.

Financial overview 2021

Net sales2 In 2021, it was € 7.2 million (net royalties € 2.4 million, milestone payments within the framework of the partnership € 4.8 million), compared to € 12.9 million in 2020 (net royalties € 2.4 million, It was 10.5 euros). Million partnership milestone payments). Revenue changes are primarily due to IFRS processing of license fees received from partner Ocumension Therapeutics in 2020.

Operating expenses in 2021 will be € 25.1 million, including € 5.2 million from nonclinical and development costs due to the progress of Phase 3 research on the NCX470, compared to € 19.5 million in 2020.

The Nikox Group’s full-year 2021 net loss was € 43.8 million, compared to € 18.1 million for the full year 2020, and this net loss in 2021 was € 27.8 million in non-cash and non-recurring items. Is specified to be included. 4251 due to reduced estimated fair value of ZERVIATE (12.7 million euros) and NCX 4251 (15.1 million euros), respectively, reflecting changes in the US allergic conjunctivitis market and changes in NCX development plans and schedules, respectively.

As of December 31, 2021, the Nikox Group’s cash and cash equivalents were € 42 million, compared to € 47.2 million as of December 31, 2020, and as mentioned above, we are based on development in 2023. We are raising funds until the fourth quarter. Only for NCX470.

As of December 31, 2021, the Nikox Group had a financial debt of € 20.5 million. This includes a € 18.5 million bond loan signed with Creos Capital in January 2019 and a € 2 million state-guaranteed loan granted in August 2020. COVID-19 Pandemic.

Financial Overview for the First Quarter of 2022

As of March 31, 2022, the Nikox Group’s cash and cash equivalents were € 35.1 million, compared to € 42.0 million as of December 31, 2021.Net sales2 The amount for the first quarter of 2022 was € 700,000 (composed entirely of net royalties).Net sales2 The amount for the first quarter of 2021 is 1.7 million euros (including 700,000 euros for net royalties).

As of March 31, 2022, the Nikox Group’s financial debt was € 20.5 million, including a € 18.5 million bond loan signed with Creos Capital in January 2019 and a grant in August 2020. Includes a national guarantee loan totaling € 2.1 million. COVID-19 In the context of a pandemic.

1 persons thes shapes Relatives To cash positionSales and liabilities As of December 31st of the Nikox Group2021 As of December 31, 2020 that is AuditedsAll other figures in this press release have not been audited..