Core Viewpoint - Nicox has fully repaid its secured debt to Kreos Capital and has secured additional financing, extending its cash runway beyond 2027, which positions the company for future strategic growth opportunities [1][2][5]. Debt Repayment - Nicox has repaid all outstanding debt of €20 million to Kreos Capital, releasing all security interests over its assets and terminating Kreos Capital's right to appoint an Observer to the Board of Directors [2][9]. - As of December 31, 2025, Nicox's remaining debt was €0.3 million, which is a COVID loan expected to be repaid by the end of August 2026 [10]. New Financing - The company has secured up to €4 million in additional unsecured financing through the issuance of €3 million in convertible bonds and €1 million in ordinary bonds, which will extend its cash runway beyond 2027 [2][5][11]. - The convertible bonds were issued at 92% of their nominal value, while the ordinary bonds were subscribed at 100% of their nominal value [12][13]. Strategic Positioning - The repayment of Kreos Capital debt and the new financing enhance Nicox's financial flexibility, allowing for better resource management and strategic discussions [2][5]. - Nicox is evaluating future strategic growth opportunities, including potential collaborations or business combinations [3]. Future Milestones - The company plans to submit an NCX 470 New Drug Application in the U.S. in summer 2026, with submissions in China expected shortly thereafter [6]. - The NCX 470 Phase 3 clinical program in Japan was initiated in summer 2025, managed and financed by Kowa [6]. Cash Runway - The financing and debt repayment allow Nicox to finance its current activities beyond the end of 2027, with a commitment to cost control and resource optimization [7]. - Potential proceeds from existing warrants and the additional bond financing are not included in the cash runway calculation [8].

Core Insights - Nicox SA has completed additional pre-planned analyses of the NCX 470 Denali Phase 3 clinical trial, confirming sustained efficacy in reducing intraocular pressure (IOP) over 12 months with no new safety observations [1][6][8] - The company is preparing New Drug Applications (NDAs) for NCX 470 in the U.S. and China, with submissions expected in H1 2026 for the U.S. and shortly thereafter for China [2][7] - Nicox plans to present further data at upcoming ophthalmology conferences [3] Clinical Trial Details - The Denali trial is a randomized, multi-regional, double-masked, parallel group study involving 696 patients across 90 sites in the U.S. and China, comparing NCX 470 to latanoprost [5] - NCX 470 demonstrated robust IOP reduction at 6, 9, and 12 months, aligning with trends observed in the Mont Blanc trial [6] Future Plans - The Phase 3 clinical program for NCX 470 in Japan was initiated in summer 2025, managed and financed by Kowa [7] - Nicox's lead product, NCX 470, is a nitric oxide-donating bimatoprost eye drop aimed at treating open-angle glaucoma or ocular hypertension [9]

Core Viewpoint - Nicox SA's exclusive Japanese partner, Kowa, has initiated a Phase 3 safety clinical trial for NCX 470 in Japan, which will trigger a €2 million milestone payment to Nicox. This trial is part of the process to seek marketing approval for NCX 470 in Japan, requiring only one additional confirmatory Phase 3 trial [1][6]. Group 1: Clinical Trials and Development - Kowa is responsible for financing and managing the Phase 3 trials under a license agreement with Nicox, and the first patient has been enrolled in the safety trial [2][6]. - The confirmatory trial, involving 500 patients, is expected to start shortly and is necessary for the marketing approval submission [3]. - NCX 470 is currently in Phase 3 clinical development programs in the U.S., China, and Japan, aimed at lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension [4]. Group 2: Product Information - NCX 470 is a novel NO-donating bimatoprost eye drop, and its Phase 3 trials are designed to meet regulatory requirements for safety and efficacy to support NDA submissions in the U.S. and China [4]. - The results of the first Phase 3 clinical trial, Mont Blanc, have been published, and topline results from the second trial, Denali, are expected between mid-August and mid-September 2025 [4]. Group 3: Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for ocular health, with NCX 470 being its lead clinical product candidate [5]. - The company has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, in collaboration with Glaukos [5]. - Nicox's first product, VYZULTA®, is commercially available in the U.S. and over 15 other territories, and the company generates revenue from ZERVIATE® in allergic conjunctivitis [5].