Press Release Nicox Provides First Half 2025 Financial Results New Drug Application (NDA) submissions for NCX 470 expected in 2026 in the U.S. and ChinaCompany believes that it can finance its existing operations for at least 12 months and expects to fully repay existing financial debts in 2026 October 23, 2025 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided the financial results for Nicox SA (the ...

Core Viewpoint - Nicox SA anticipates fully repaying its financial debts by 2026, bolstered by the global licensing of NCX 470 and positive results from its Phase 3 clinical trial, Denali [1][2]. Financial Update - The company expects milestone payments from NCX 470 in 2026 and 2027, with royalties on net sales anticipated from 2027 [5]. - Nicox is financed into Q3 2026, with a commitment to cost control and resource optimization [5]. Product Development - NCX 470 has been licensed globally to Kowa and Ocumension Therapeutics, with NDA submissions planned for the U.S. in H1 2026 and subsequently in China [6][10]. - The Phase 3 clinical program for NCX 470 in Japan has been initiated, managed by Kowa [9][10]. Strategic Options - The company is considering future strategic options, including collaborations or business combinations [4][2]. - Glaukos has extended its research agreement for NCX 1728, which is being evaluated for glaucoma and retinal diseases [7]. Market Presence - Nicox's ZERVIATE is commercially available in the U.S. and China through exclusive licensing agreements [8]. - The company has a diverse portfolio, including VYZULTA, which is licensed worldwide to Bausch + Lomb [11].

Core Viewpoint - Nicox SA reported its financial results for the full year of 2024, highlighting a revenue increase and significant exceptional income from the sale of VYZULTA royalties, while also outlining future clinical milestones for its lead product, NCX 470 [1][4][6]. Financial Performance - Revenue for 2024 was €7.9 million, an increase from €6.9 million in 2023, including €3.0 million from VYZULTA royalties prior to their sale [4][6]. - Exceptional income in 2024 amounted to €13.7 million, primarily from the transfer of VYZULTA's future revenue stream to Soleus Capital, compared to €0.1 million in 2023 [6][8]. - Operating expenses decreased to €18.7 million in 2024 from €24.2 million in 2023 [5]. - The net loss for 2024 was €22.4 million, slightly higher than the €20.9 million loss in 2023, influenced by a non-cash impairment of €27.1 million related to intercompany receivables [9]. Cash Position and Financing - As of December 31, 2024, cash and cash equivalents were €10.5 million, down from €11.3 million in 2023, with funding expected to last into the fourth quarter of 2025 [10]. - Financial debt stood at €15.1 million, primarily from a bond financing agreement and a credit agreement related to COVID-19 support [11]. Future Milestones - Topline results from the Denali Phase 3 clinical trial for NCX 470 are expected in the third quarter of 2025, with additional results from the Whistler Phase 3b trial anticipated in May 2025 [6][7]. - The company is actively pursuing business development discussions for NCX 470, including potential partnerships in the U.S. [6][12]. Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for ocular health, with NCX 470 as its lead program aimed at lowering intraocular pressure in glaucoma patients [13].