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 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].

Press Release Nicox Announces Shareholder Q&A Webpage AvailableAugust 26, 2025 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that a new webpage “Q&A” is available on the company’s website, www.nicox.com, including information on the most frequently asked questions for shareholders in the form of a Q&A about Nicox and its business. The Q&A page can be reached here: Q&A Any investor questions can ...

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]

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].