Press Release
Nicox Updates on Corporate, Pipeline and Financing Perspectives and Will Hold a Webcast on March 18, 2024
March 13, 2024 – release at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided an update on its corporate and development strategy, in the context of its debt restructuring and the appointment of Gavin Spencer as Chief Executive Officer and announced it will be holding a Webcast (in French) on March 18, 2024 at 6:00 pm CET. Further details on the webcast will be sent shortly.
“Nicox is focusing its resources on the Denali Phase 3 pivotal trial of its lead asset NCX 470 in glaucoma. This trial, which we are conducting with our long-term Chinese partner Ocumension Therapeutics, is on track with 80% of the target number of patients already randomized. We expect topline results in H2 2025 and expect that these will be supportive of future regulatory approval and partnering in the U.S. and other territories. We are reducing costs, including the size of the organization, and are exploring advancing NCX 1728, through collaborations. Our licensed, marketed products, VYZULTA and ZERVIATE, are generating royalty revenues for Nicox. With an experienced team delivering on the Denali trial, we are also focused on putting financing in place to complete the debt restructuring and to deliver on the promise of our innovative treatment NCX 470,” said Gavin Spencer, Chief Executive Officer of Nicox. “We maintain constructive relationships with potential licensing and strategic partners for NCX 470 in the U.S and other territories outside of those already partnered and continue to update them on the status.”
Update on Development Pipeline
The Whistler Phase 3b trial investigating the dual mechanism of action of NCX 470 in IOP lowering is underway and results are expected in Q1 2025. The Phase 3b optical coherence tomography (OCT) trial to investigate the potential benefits of NCX 470 on the retina is not included in the current plan, however this development will be revisited when finances allow. Neither of the two Phase 3b trials are required for an NDA submission in either the U.S. or China. The potential of NCX 470 has been validated by our established partnerships with Ocumension and more recently with Kowa, for China and Japan respectively. With the completion of the Denali trial, Nicox expects to be in a position to partner NCX 470 for commercialization in the U.S. and potentially other territories. Mont Blanc and Denali trials have been designed to fulfill the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China, where NCX 470 is exclusively licensed to Ocumension.
Update on Revenue Generating Products
Update on Cash Runway
The Company is financed to at least November 2024, based on focusing exclusively on the development of NCX 470. The Company is pursuing business development discussions, including the sale or license of certain assets, and exploring multiple strategic options which could further extend the cash runway. The Company is evaluating all options for financing and will use the most appropriate at the time.
As of February 28, 2024, Nicox had a total amount of debt2 of €18.2 million consisting of €16.9 million debt outstanding from Kreos Capital VI (UK) Limited (an affiliate of BlackRock) and a €1.3 million of non-dilutive loan facility credit agreement guaranteed by the French state related to the COVID-19 pandemic.
About Nicox
Nicox SA 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 bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.
Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index.
For more information www.nicox.com.
Analyst coverage
Bryan, Garnier & Co Eric Yoo Paris, France
H.C. Wainwright & Co Yi Chen New York, U.S.
The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.
Contacts
Nicox Gavin Spencer Chief Executive Officer T +33 (0)4 97 24 53 00 communications@nicox.com | Media / Investors Sophie Baumont Cohesion Bureau +33 6 27 74 74 49 sophie.baumont@cohesionbureau.com |
Forward-Looking Statements
The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.
Risks factors which are likely to have a material effect on Nicox’s business are presented in section 2.7 of the “Rapport Annuel 2022” and in section 4 of the “Rapport semestriel financier et d’activité 2023” which are available on Nicox’s website (www.nicox.com).
Nicox S.A.
Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, France
T +33 (0)4 97 24 53 00
1 See Press Release of 10 July 2023
2 This figure is the contractual amount of the debt which is different from that reported under accounting standards. It does not include the premium of €2.4 million due to BlackRock upon repayment of the non-amortizing, non-convertible bond, which would be paid on January1st, 2026 at the earliest. Nor does it include the Armistice put option granted in the November 2022 equity financing, payable in the case of a merger by acquisition (fusion par absorption), merger (fusion par création d’une nouvelle société), division (scission), or a change of control within the meaning assigned in article L.233-3 I of the French commercial code (Code de commerce) where the consideration for such transaction is Nicox shares at a value of less than €1.70, the exercise price of the warrants, Armistice can request that Nicox purchases the warrants granted to Armistice at their Black Scholes value (using pre-defined terms). This figure will no longer be reported following the Company’s decision to change from Consolidated Financial Statements under IFRS to statutory financial statements under French Gaap.
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