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 reported its financial results for the first half of 2025, highlighting a significant decrease in revenue compared to the same period in 2024, primarily due to the sale of the VYZULTA royalty stream [5][9] - The company has secured over 12 months of operational runway and plans to fully repay its financial debts by 2026, aided by recent licensing payments [2][6] Financial Performance - Revenue for the first half of 2025 was €1.5 million, down from €6.1 million in the first half of 2024, reflecting a decrease in license payments and royalties [5] - Operating expenses decreased to €6.8 million from €10.1 million in the same period last year, mainly due to reduced payroll expenses [8] - The net loss for the first half of 2025 was €8.9 million, compared to a net loss of €4.3 million in the first half of 2024, which included a significant foreign exchange loss [9][10] Key Future Milestones - The company anticipates submitting New Drug Applications (NDA) for NCX 470 in the U.S. and China in 2026, with the Phase 3 clinical program in Japan already initiated [6][7] - Nicox's partners will handle the marketing authorization preparation and commercialization of NCX 470 in the global glaucoma market, valued at over $7 billion [2][4] Subsequent Events - In August and September 2025, Nicox received license payments totaling €12.5 million related to NCX 470 and clinical trial results, which will help reduce its financial debt of €7.4 million as of September 30, 2025 [4][11]

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 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 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]

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].

Core Viewpoint - Nicox has signed a significant agreement with Kowa Company, granting exclusive rights for the development and commercialization of NCX 470, a glaucoma treatment, in the U.S. and other unlicensed territories, potentially worth up to €191.5 million [1][2][3] Agreement Details - The agreement includes an upfront payment of €7.5 million, with additional milestone payments based on the results of the Denali clinical trial and the submission of a New Drug Application (NDA) to the FDA, which is expected in H2 2026 [2][6] - Total potential milestone payments could reach either €127 million or €191.5 million, depending on the Denali trial outcomes, along with tiered royalties of up to 20% in the U.S. [5][7] Financial Implications - 70% of the upfront payment will be used to partially repay Nicox's debt, reducing it to €9.6 million, with an estimated cash position of €5.9 million as of June 30, 2025, allowing for over 12 months of cash runway [10] Market Context - The glaucoma pharmaceutical market is valued at over $7 billion, with the U.S. market accounting for approximately 40% and expected to grow at a CAGR of 3% to 5% [11] Product Overview - NCX 470 is a novel nitric oxide-donating bimatoprost eye drop currently in Phase 3 clinical development for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension [12][13]

Core Insights - Nicox SA has announced the completion of the last patient visit in the Denali Phase 3 clinical trial for NCX 470, a treatment for open-angle glaucoma and ocular hypertension [1][3] - The trial enrolled a total of 696 patients, with topline results expected between mid-August and mid-September 2025 [2][6] - NCX 470 is a novel NO-donating bimatoprost eye drop aimed at lowering intraocular pressure, and the trial compares its efficacy to latanoprost [3][6] Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for ocular health [5][7] - The company is headquartered in Sophia Antipolis, France, and is listed on Euronext Growth Paris [8] Future Milestones - Topline results from the Denali trial are anticipated in mid-August to mid-September 2025 [6] - A New Drug Application (NDA) submission for NCX 470 in the U.S. is targeted for the first half of 2026, contingent on securing a U.S. partner or necessary funding [5][6] - Initiation of NCX 470 Phase 3 clinical trials in Japan is expected in the second half of 2025 [6]

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]