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 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 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 announced an extension of the PACEO equity line of financing with Vester Finance, allowing for an additional maximum of 5,000,000 shares, representing 6.43% of the currently issued share capital [1][3] - The company estimates it is financed into Q3 2026 based on current cash and debt positions, excluding proceeds from the new financing [2] - The total gross proceeds from the additional shares could potentially reach €3.1 million at the current share price [3] Financing Details - The financing agreement allows Vester Finance to subscribe for up to 5,000,000 additional shares under the same terms as previously announced [3] - A shareholder holding 1.00% of Nicox's capital before the transaction would see their stake reduced to 0.94% if the full extension is utilized [3] - The agreement can be terminated by the company at any time without penalty [3] Corporate Governance - The transaction was authorized by the CEO based on a delegation from the Board of Directors [4] - No prospectus is required to be submitted to the Autorité des marchés financiers (AMF) for this transaction [4] Shareholder Information - Vester Finance holds approximately 4% of Nicox's share capital and may sell shares over varying timeframes [5] - The company will announce the number of shares issued under this transaction on its website [6] Company Overview - Nicox SA is focused on developing innovative ophthalmology solutions, with its lead program being NCX 470, aimed at lowering intraocular pressure in glaucoma patients [8] - The company also has a preclinical research program on NCX 1728 and generates revenue from products like VYZULTA® and ZERVIATE® [8] - Nicox is listed on Euronext Growth Paris and is part of the CAC Healthcare index [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].

Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for vision maintenance and ocular health [7] - The company's lead 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 [7] - Nicox's first product, VYZULTA®, is commercially available in the U.S. and over 15 other territories, licensed exclusively to Bausch + Lomb [7] - The company also generates revenue from ZERVIATE® for allergic conjunctivitis, licensed in multiple regions including the U.S. and China [7] Shareholders' Meeting - The Ordinary and Extraordinary General Meeting is scheduled for June 27, 2025, at 2:30 p.m. at the company's headquarters in Sophia Antipolis, France [1] - The agenda and draft resolutions for the meeting were published in the Official Bulletin of Mandatory Legal Announcements [2] - An ad hoc representative has been appointed to represent defaulting shareholders due to difficulties in reaching the required quorum [3] - The ad hoc representative will ensure that the quorum reaches 100% of shares with voting rights [4] Voting Process - Shareholders can vote by proxy, internet, or in person at the meeting [5] - A guide for voting, including internet voting instructions, is available on the company's website [5] - Voting requirements include half the votes in favor for ordinary resolutions and two-thirds in favor for extraordinary resolutions proposed by the Board of Directors [6]

Core Viewpoint - Nicox SA announced positive results from the Whistler Phase 3b exploratory trial for NCX 470, indicating its potential as a differentiated treatment for lowering intraocular pressure (IOP) in patients with glaucoma and ocular hypertension [1][2][3]. Group 1: Trial Results - The Whistler trial demonstrated that NCX 470 showed favorable outcomes in several aqueous humor dynamics parameters, attributed to its dual mechanism of action involving nitric oxide and prostaglandin analogs [2][3]. - Statistically significant results were observed for IOP lowering and uveoscleral outflow at all measured time points, with outflow facility showing significance at 3 pm (p=0.001) and diurnal outflow at p=0.004 [3][5]. - The trial involved 18 healthy volunteers with mean baseline IOPs of 16.6 mmHg for NCX 470 and 16.9 mmHg for placebo, indicating a normotensive population [4][5]. Group 2: Future Developments - The ongoing Phase 3 trial, Denali, is expected to provide further safety and efficacy results in Q3 2025, which will support New Drug Application submissions in the U.S. and China [2][7]. - The safety profile of NCX 470 in the Whistler trial was consistent with the earlier Mont Blanc trial, which has already demonstrated its efficacy [3][5]. Group 3: Company Overview - Nicox SA is focused on developing innovative ophthalmic solutions, with NCX 470 being its lead product candidate for lowering IOP in open-angle glaucoma and ocular hypertension [8]. - The company also has a preclinical program for NCX 1728 and generates revenue from its commercial product, VYZULTA®, and ZERVIATE® [8].

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].