Core Insights - Nicox SA presented positive Phase 3 data for NCX 470 at the 2026 American Glaucoma Society Annual Meeting, highlighting its potential as a new treatment for glaucoma [1][3] - NCX 470 demonstrated a best-in-class intraocular pressure (IOP) lowering efficacy of up to 10mmHg from baseline, meeting the efficacy requirements for New Drug Applications in the U.S. and China [2][3] Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for vision maintenance and ocular health [8] - The lead product, NCX 470, is a nitric oxide-donating bimatoprost eye drop aimed at lowering IOP in patients with open-angle glaucoma or ocular hypertension [8] Clinical Trial Results - The DENALI Trial showed that NCX 470 0.1% was non-inferior to latanoprost 0.005% at all time points, with NCX 470 achieving statistically superior IOP reductions at 3 out of 6 evaluated time points [4][7] - NCX 470 was found to be safe and well tolerated, with low discontinuation rates and no serious adverse events reported [5][7] Mechanism of Action - NCX 470 operates through a dual mechanism of action, enhancing both trabecular meshwork and uveoscleral outflow to lower IOP [3][6] - Preclinical data suggest potential benefits in retinal protection, further differentiating NCX 470 from existing treatments [3] Market Potential - Approximately 40% of glaucoma patients do not reach their target IOP with current monotherapies, indicating a significant need for new treatment options [3] - Nicox's strategic partnerships for NCX 470 include licensing agreements with Ocumension Therapeutics and Kowa for various markets [8]

Core Viewpoint - Nicox SA has received positive feedback from the U.S. FDA regarding the pre-NDA meeting for NCX 470, indicating that the data package and proposed NDA content are generally acceptable for submission, with the NDA submission expected in summer 2026 [1][2]. Group 1: FDA Meeting and NDA Submission - The FDA meeting was productive and collaborative, supporting the finalization of the registration dossier, which includes positive results from two Phase 3 studies [2]. - The FDA has requested additional pharmacokinetic data from an ongoing study in Japan, which will not affect the NDA submission timeline [1]. - The NDA submission is on track for summer 2026, with Nicox set to receive a milestone payment from Kowa upon submission [5][6]. Group 2: Product Information - NCX 470 is a novel nitric oxide-donating bimatoprost eye drop designed to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension [1][7]. - The product is licensed globally to Kowa, except in China, South Korea, and Southeast Asia, where it is licensed to Ocumension Therapeutics [3]. Group 3: Future Milestones - The NDA submission in the U.S. is expected in summer 2026, with a subsequent submission in China anticipated shortly after [6]. - The Phase 3 clinical program for NCX 470 in Japan was initiated in summer 2025 [6].

Core Insights - Nicox SA received positive feedback from the FDA following a pre-NDA meeting regarding NCX 470, indicating that the current data package and proposed NDA format are generally acceptable for submission [1][2] - The NDA submission is scheduled for summer 2026, with additional pharmacokinetic data required from an ongoing study in Japan, which will not affect the timeline [1][4] Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for vision maintenance and eye health [4] - The primary advanced development program is NCX 470, an innovative nitric oxide donor eye drop aimed at reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension [1][4] Licensing and Financial Aspects - NCX 470 is globally licensed to Kowa, except for China, South Korea, and Southeast Asia, where the license is granted to Ocumension Therapeutics [3][6] - Nicox will receive regulatory milestone payments and sales-related milestone payments, as well as royalties on global sales, while Kowa and Ocumension will cover all regulatory and marketing costs [3][6] Clinical Development - The NDA submission for NCX 470 in China is expected shortly after the submission in the United States [5] - A Phase 3 clinical program for NCX 470 in Japan was initiated in summer 2025 [5]

Core Insights - Nicox SA will present phase 3 clinical study results for NCX 470 at the American Glaucoma Society (AGS) Annual Meeting 2026, highlighting the product's medical effectiveness [1][2] - The presentations will include two podium sessions focusing on the efficacy, safety, and mechanism of action of NCX 470, which is a nitric oxide-donating bimatoprost eye drop [2][3] Company Overview - Nicox is an international ophthalmology company focused on innovative solutions for ocular health, with NCX 470 as its lead late-stage development program [5] - The company has licensing agreements for NCX 470 with Kowa for global markets and Ocumension Therapeutics for China, Korea, and Southeast Asia [5] - Nicox also has a preclinical program for NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, and generates revenue from its product ZERVIATE® for allergic conjunctivitis [5] Presentation Details - The AGS 2026 Annual Meeting will take place from February 19 to February 22, 2026, in Rancho Mirage, CA, U.S. [3] - Key presentations include: - "A Randomized Trial Comparing NCX 470 0.1% and Latanoprost 0.005% for Open-Angle Glaucoma" by Dr. S. Asrani on February 20, 2026 [3] - "Aqueous Humor Dynamics of NCX 470" by Dr. A. Sit on February 20, 2026 [3] - "Outcomes in the United States Subgroup of the Denali Trial" [3]

Core Viewpoint - Nicox SA, an international ophthalmology company, announced its participation in several key conferences in the first half of 2026, including significant scientific data presentations at the American Glaucoma Society Annual Meeting [1][2]. Conference Attendance - Nicox will attend multiple conferences, including the Allinvest securities Biomed Forum on January 29, 2026, in Paris, the MidCap Event on February 5, 2026, in Frankfurt, and the Association for Research in Vision and Ophthalmology Annual Meeting from May 3-7, 2026, in Denver [7]. Scientific Data Presentations - At the American Glaucoma Society Annual Meeting, Nicox will present data from the NCX 470 studies, specifically the Denali and Whistler studies [2]. Company Overview - Nicox is focused on developing innovative solutions for ocular health, with its lead product being NCX 470, a nitric oxide-donating eye drop aimed at lowering intraocular pressure in glaucoma patients [5]. - The company has licensed NCX 470 to Ocumension Therapeutics for specific Asian markets and to Kowa for the rest of the world [5]. - Nicox's first product, VYZULTA®, is commercially available in the U.S. and over 15 other territories, and the company also generates revenue from ZERVIATE® for allergic conjunctivitis [5].

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 successfully completed the generation and analysis of all key data required for New Drug Applications (NDAs) in the U.S. and China, including clinical trial and long-term stability data for the NCX 470 drug material and finished product [1][5][6] - The company is preparing for a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) and plans to submit the NDA in the first half of 2026, with the Chinese submission expected shortly thereafter [5][6] Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for vision maintenance and ocular health, with its lead product being NCX 470, a nitric oxide-donating eye drop for lowering intraocular pressure in glaucoma patients [4][7] - The company has licensing agreements for NCX 470 with Ocumension Therapeutics for the Chinese, Korean, and Southeast Asian markets, and with Kowa for the rest of the world [4][6] Future Milestones - The NDA submission for NCX 470 in the U.S. is on track for H1 2026, with the submission in China expected to follow shortly after [5][6] - A Phase 3 clinical program for NCX 470 has been initiated in Japan, managed and financed by Kowa [6]

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 Points - Nicox SA has launched a new "Q&A" webpage on its website to address frequently asked questions from shareholders [1] - The company is focused on developing innovative ophthalmology solutions to maintain vision and improve ocular health [2] Company Overview - Nicox SA is an international ophthalmology company headquartered in Sophia Antipolis, France, and is listed on Euronext Growth Paris under the ticker symbol ALCOX [3] - The company's lead clinical program is NCX 470, a nitric oxide-donating bimatoprost eye drop aimed at lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension [2] - Nicox has licensed NCX 470 to Ocumension Therapeutics for the Chinese, Korean, and Southeast Asian markets, and to Kowa for the rest of the world [2] - The company also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, in collaboration with Glaukos [2] - Nicox's first product, VYZULTA®, is commercially available in the U.S. and over 15 other territories, licensed exclusively worldwide to Bausch + Lomb [2] - The company generates revenue from ZERVIATE® for allergic conjunctivitis, licensed in multiple geographies [2]

Core Insights - Nicox SA announced positive results from the Phase 3 Denali trial for NCX 470, demonstrating non-inferiority in lowering intraocular pressure (IOP) compared to latanoprost [1][4][5] - The trial involved 696 patients and showed IOP reductions of 7.9 to 10.0 mmHg for NCX 470 versus 7.1 to 9.8 mmHg for latanoprost [1][5] - NCX 470 is expected to be submitted for New Drug Applications (NDAs) in the U.S. and China in H1 2026 [4][7] Company Overview - Nicox is an international ophthalmology company focused on innovative solutions for ocular health, with NCX 470 as its lead product candidate [16] - The company has established partnerships with Kowa and Ocumension Therapeutics to facilitate NDA preparations and potential future strategies [7][16] - Nicox's revenue streams include royalties from various products, including ZERVIATE® and VYZULTA® [16] Clinical Trial Details - The Denali trial was a randomized, multi-regional, double-masked study comparing NCX 470 0.1% to latanoprost 0.005% [10][11] - The primary efficacy evaluation was based on IOP reduction at multiple time points, confirming the efficacy profile required for regulatory submissions [11][14] - The trial also included a long-term safety extension, with NCX 470 showing a favorable safety profile [6][11] Financial Implications - Nicox will receive a €5 million milestone payment from Kowa based on the trial results, with potential royalties starting at 8% on net sales in the U.S. [12] - Total potential milestones under the agreement with Kowa are valued at €127 million [12] - Royalties of 6% to 12% on net sales are expected from the Chinese, Korean, and Southeast Asian markets due to the partnership with Ocumension [13]