Duyuru • May 20
Nicox S.A., Annual General Meeting, Jun 24, 2026 Nicox S.A., Annual General Meeting, Jun 24, 2026. Location: rue evariste galois, emerald square batiment c, biot France Duyuru • Feb 24
Nicox SA Highlights Positive NCX 470 Phase 3 Data Confirming Therapeutic Profile at the 2026 American Glaucoma Society Annual Meeting Nicox SA announced that positive data from the NCX 470 Phase 3 studies were highlighted in 2 podium presentations and a poster at the 2026 American Glaucoma Society (AGS) Annual Meeting (February 19 to February 22), one of the key scientific events in vision research. Data presented at AGS show that NCX 470, a novel, fast acting molecule, demonstrated best-in-class intraocular pressure (IOP) lowering efficacy of up to 10mmHg from baseline which has met the efficacy requirements for a New Drug Application in the U.S. and China. Duyuru • Jan 06
Nicox S.A. announced that it expects to receive €4.000031 million in funding from Vester Finance Nicox S.A announced a private placement to issue unsecured convertible bonds for aggregate proceeds of €3,000,028 and Ordinary bonds for aggregate proceeds of €1,000,003.2, total gross proceeds of €4,000,031.2 on January 5, 2025. The convertible bonds s bear no interest and are unsecured. The bonds are convertible at any time, at a conversion price determined based on the stock market price3 at the time, in accordance with pricing rules and the ceiling set by the shareholders’ meeting. The Ordinary bonds do not bear any interest nor guarantees and have the same term as the convertible bonds. Their subscription price will be made as one payment, at the moment when certain conditions have been met, at the latest at the start of September 2026. At a term of 24 months following the issuance, the bonds will be redeemed at maturity at 100% of their nominal value if they have not been converted at that date. The transaction will include participation from Vester Finance.
On the same day, the company issued the convertible bonds for aggregate proceeds of €3,000,028 in its first tranche. Duyuru • Sep 04
Nicox S.A. Provides Portfolio Update Nicox S.A. provided portfolio update. NCX 470, Nicox’s lead product candidate, is licensed globally to two top-tier pharma partners, Kowa and Ocumension Therapeutics. The first two Phase 3 trials, Mont Blanc and Denali, have met the requirements for submission of NDAs in the U.S. and China. U.S. – based on Nicox’s projections, an NDA with the U.S. Food and Drug Administration (FDA) is expected to be submitted in H1 2026. Kowa is responsible for the costs of the NDA submission.China – an NDA is expected to be filed with the Chinese regulatory authorities by its partner, Ocumension, after the U.S. submission. The costs of filing the NDA are the responsibility of Ocumension.Japan – a Phase 3 confirmatory efficacy and a Phase 3 safety trial have been initiated in Japanese patients. Kowa is responsible for managing the trials, at their cost, and expect to be able to file for a marketing authorisation in Japan based on these trials.Europe – the regulatory strategy is being evaluated. NCX 1728, an NO-donating PDE-5 inhibitor, is being evaluated in a pre-clinical research program exploring indications for the treatment of glaucoma, including neuroprotection, and in the treatment of retinal diseases, under an exclusive research and option to license agreement with Glaukos. Glaukos has paid an extension fee to prolong the period of evaluation of NCX 1728 for the treatment of glaucoma. Evaluation for retinal conditions is also continuing, and is subject to different option conditions. ZERVIATE (cetirizine ophthalmic solution), 0.24%, is currently commercialized through exclusive licensing agreements in the U.S. by Harrow Inc. and in China by Ocumension Therapeutics for ocular itching associated with allergic conjunctivitis. VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, is exclusively licensed worldwide to Bausch + Lomb. Nicoxsold the royalty revenue from VYZULTA to Soleus Capital in October 2024. NCX 4251: Changes in the U.S. dry eye market suggest that the investment in development may not be justified. NCX 4251 remains available for licensing outside the Chinese market. Duyuru • Aug 05
Nicox Sa's Partner Kowa Initiates Ncx 470 Phase 3 Clinical Trial in Japan Nicox SA announced that its exclusive Japanese partner, Kowa, has initiated a Phase 3 safety clinical trial of NCX 470 (also known as K-911) in Japan for the treatment of ocular hypertension, trigger a EUR2 million milestone payment to Nicox. Only one Phase 3 confirmatory clinical trial in Japanese patients, which will start shortly, plus this safety trial, is required for submission for marketing approval of NCX 470 in Japan. Kowa is responsible for financing and managing the trials under the February 2024 license agreement with Nicox. Duyuru • Jun 30
Nicox SA Announces Last Patient Completes the NCX 470 Denali Phase 3 Clinical Trial Nicox SA announced that the last patient has completed the Denali Phase 3 trial, evaluating the efficacy and safety of NCX 470, its lead compound, in patients with open-angle glaucoma or ocular hypertension. With this milestone reached, all patients have now completed their treatment and follow-up visits. A total of 696 patients were enrolled in the trial and topline results are expected mid-August to mid-September 2025. NCX 470, Nicox's lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development for the lowering of intraocular pressure (IOP) in patients with open-angle Glaucoma or ocular pulmonary hypertension. The Denali trial is evaluating the IOP lowering efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% compared to latanoprostophthalmic solution 0.005% in patients with open-angleglaucoma or ocular diabetes. It is a multi-country (U.S. and China) clinical trial financed equally by Nicox and Ocumension, Nicox's exclusive licensee for China, Korea and Southeast Asia. The Denali trial, together with the already completed Mont Blanc trial, was designed to fulfil the clinical regulatory requirements to support New Drug Application (NDA) submissions of NCX 470 in the U.S. and China. All remaining NDA-enabling pharmacokinetic and non-clinical studies necessary to support the U.S. NDA filing are on track. Subject to securing a U.S. partner, or obtaining the necessary funding, the Company estimates that a NDA for this country NCX 470 could potentially be submitted in first quarter of 2026. Denali Phase 3 clinical trial evaluating NCX 470 in patients with open- angle glaucoma or ophthalmic hypertension: Topline results are expected mid- August to mid-September 2025; NCX 470 Phase 3 clinical efficacy and long-term safety trials in Japan: Initiation expected in second quarter of 2025; NCX 470 NDA filing in the United States: expected in first quarter of 2026, subject to securing a U.S., or obtaining the necessary funding. Duyuru • May 22
Nicox S.A., Annual General Meeting, Jun 27, 2025 Nicox S.A., Annual General Meeting, Jun 27, 2025. Location: sundesk sophia antipolis, rue evariste galois, emerald square batiment c, biot France Duyuru • May 14
Nicox SA Announces Results of the Exploratory Whistler Phase 3B Glaucoma Trial Nicox SA announced the results of the Whistler Phase 3b exploratory clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in intraocular pressure (IOP) lowering in healthy volunteers and ocular hypertension. The company believe that the outcomes in favor of NCX 470 in several trabecular meshwork aqueous humor dynamics parameters are due to nitric oxide. These positive exploratory results suggest that further investigation may be warranted into the dual mechanism effect of NCX 470 on intraocular pressure. The therapeutic characteristics of NCX 470 demonstrated in the Phase 3 program so far shows that the company have an approvable and differentiated asset with a promising clinical profile. The company believe this change is due to the effect of nitric oxide on the trabecular meshwork1. IOP lowering and uveoscleral outflow were statistically significant at all timepoints measured, whilst episcleral venous pressure did not show a notable trend. These findings support the dual mechanism of action for IOP lowering of NCX 470 through both the conventional (nitric oxide-stimulated) and the uveoscleral (prostaglandin-stimulated) pathways. The safety profile observed was consistent with that of the first Phase 3 trial, Mont Blanc. The Whistler trial was an exploratory trial and is not a requirement for the submission of New Drug Applications for NCX 470 and therefore does not impact the development timeline. The patient population in the Whistler trial was primarily normotensive healthy volunteers with mean baseline IOPs of 16.6 mmHg and 16.9 mmHg for NCX 470 and placebo treated patients, respectively. This is not the same patient profile as in the Phase 3 glaucoma program. Safety and efficacy have already been demonstrated in the first Phase 3 clinical trial, Mont Blanc. Duyuru • Mar 19
Nicox SA Announces Last Patient Completes Final Visit in NCX 470 Phase 3b Whistler Glaucoma Trial Nicox SA announced that the last patient completed their final visit in the Whistler Phase 3b clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in intraocular pressure (IOP) lowering. The Whistler Phase 3b trial enrolled 18 healthy volunteers with ocular hypertension in a double-masked, placebo-controlled study investigating the action of NCX 470 on aqueous humor parameters including trabecular meshwork outflow and episcleral venous pressure. Each subject participated in the trial for approximately 8 days. NCX 470, Nicox's lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the two Phase 3 clinical trials, have been extensively published and are available on website. The second Phase 3 clinical trial, Denali, is currently ongoing. The last American patient in Denali has completed their final visit, with Chinese patients completing theirs, and the results are expected in third quarter 2025. Mont Blanc and Denali have been designed to fulfill the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China, where NCX 470 is exclusively licensed to Ocumension Therapeutics. NCX 470 is also licensed exclusively to Kowa for Japan. Duyuru • Jul 25
Nicox SA Announces Recruitment of Last Patient in U.S. in Denali Phase 3 Trial of NCX 470 Nicox SA announced the recruitment and randomization of the last patient in the U.S. in its Denali Phase 3 trial of NCX 470. The Denali trial is evaluating NCX 470 safety and efficacy in patients with open-angle glaucoma or ocular hypertension and topline results continue to be expected in second half of 2025, based on this completion of recruitment of patients in the U.S. and continuing good progress of the trial in China, where recruitment of patients is still ongoing. More than 95% of the total target number of patients have been randomized in this trial so far. The Denali trial is evaluating the intraocular pressure (IOP) lowering efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005% in patients with open-angle glaucoma or ocular hypertension. It is a multi-country (U.S. and China) clinical trial financed equally by Nicox and Ocumension, Nicox’s exclusive licensee for China, Korea and Southeast Asia. The Denali trial, together with the Mont Blanc trial, was designed to fulfill the regulatory requirements to support New Drug Application (NDA) submissions of NCX 470 in the U.S. and China. The U.S. NDA for NCX 470 is expected to be submitted in first half 2026. Topline results from the first Phase 3 trial, Mont Blanc, showed the IOP-lowering effect from baseline was 8.0 to 9.7 mmHg for NCX 470 vs. 7.1 to 9.4 mmHg for latanoprost. Statistical non-inferiority was met vs. latanoprost in the primary efficacy analysis and 4 out of 6 timepoints additionally demonstrated superiority; the trial therefore met the efficacy requirements for approval in the U.S. NCX 470 was well tolerated and discontinuation rates were low. The results of the Mont Blanc trial have been published in the prestigious American Journal of Ophthalmology, and numerous post hoc analyses have been presented. Duyuru • Jul 16
Nicox S.A. Announces Board Changes Nicox S.A. announced the appointment of the highly experienced healthcare executive, non-executive Director/Chair and advisor Damian Marron as Chair of the Board of Directors. Marc Le Bozec, an experienced life sciences entrepreneur, is also appointed as a new Director of Nicox. Both Damian Marron and Marc Le Bozec are independent Directors in accordance with the criteria set out by the recommendation 3 of the Middlenext Governance Code. Jean-François Labbe is retiring as Chair and member of the Board, at the completion of his term. Les Kaplan has also decided to step down from the Board. Both Jean-Francois Labbé and Les Kaplan have contributed many years of service as Directors of Nicox. Damian Marron is a seasoned executive, 4-time CEO, Chair, non-executive Board Member and company advisor with a proven track record in value creation through public funding, venture capital, portfolio planning, mergers and acquisitions, and license agreements, as well as R&D collaborations. He has extensive experience in both executive and independent administrator roles, with a specialization in immuno-oncology, cellular therapy, and orphan diseases. He is currently Chair of the Board of Directors for Circio Holding ASA, Imophoron Ltd, and Indegra Therapeutics Ltd. Marc Le Bozec is a life sciences entrepreneur with a strong background in finance, organization and strategic consulting. As CFO of Cellectis, he led its IPO in Paris in 2007 and raised €120 million from 2006 to 2013. He then redirected the company Cytoo towards human muscle research, leading to FDA validation and becoming a key shareholder of the company. After nine years as a professional investor, notably as fund manager at Financière Arbevel, he resumed consulting and also founded Neurodyx in January 2024 to advance neuro-inflammation research. Nicox's Board of Directors is composed as follows: Damian Marron, Chair of the Board and Independent Director, Gavin Spencer, Chief Executive Officer and Director, Michele Garufi, Co-Founder and Director, Marc le Bozec, Independent Director. Duyuru • May 26
Nicox S.A., Annual General Meeting, Jun 28, 2024 Nicox S.A., Annual General Meeting, Jun 28, 2024. Location: buroclub drakkar 2 batiment d, 2405 route des dolines, valbonne sophia antipolis France Duyuru • Jan 31
Nicox SA Receives Confirmation of 5-Year Patent Term Extension of U.S. Patent for Latanoprostene Bunod, Commercialized as VYZULTA Nicox SA announced that the United States Patent and Trademark Office (USPTO) has determined that U.S. Patent No. 7,629,345, which covers latanoprostene bunod, commercialized by Bausch + Lomb under the trademark VYZULTA, is eligible for patent term extension of five years. Nicox has also applied for patent term extension of two other patents covering latanoprostene bunod, U.S. patent Nos. 7,273,946 and 8,058,467. Nicox, in collaboration with Bausch + Lomb, must now elect which patent will be the subject of the patent term extension, and, depending on the choice of the patent, this may lead to an extension to either 2029 or 2030. Duyuru • Dec 14
Nicox's Announces Publication of New Nonclinical Data Demonstrating More Effective Intraocular Pressure Lowering of NCX 470 Compared to Lumigan Nicox SA announced that new nonclinical data on NCX 470 (0.1%) demonstrating greater intraocular pressure (IOP) lowering than Lumigan® (bimatoprost ophthalmic solution, 0.01%) upon both single and repeated (5-day) dosing in an in vivo nonclinical model has been published in the peer-reviewed Journal of Ocular Pharmacology and Therapeutics. The publication also includes outflow data on NCX 470 in a different in vivo non clinical model and on NCX 470 compared to equimolar bimatoprost in in vitro human trabecular meshwork/Schlemm’s canal constructs suggesting that NCX 470-mediated increase in outflow facility and uveoscleral outflow accounts for the robust IOP reduction exerted by this compound. NCX 470, a novel nitric oxide (NO)-donating bimatoprost eyedrop, is in Phase 3 clinical development for the lowering of IOP in patients with open angle glaucoma or ocular hypertension. NCX 470 is designed to release both bimatoprost and NO into the eye to lower IOP by two pathways. Lumigan, marketed by Allergan Inc., is the leading branded product by sales in the class of prostaglandin analogs, the most widely used class of drugs for IOP-lowering in patients with open-angle glaucoma or ocular hypertension. IOP lowering was measured in ocular normotensive beagle dogs following either single or repeat once-daily morning dosing over 5 consecutive days, in an open-label crossover design, of either NCX 470 (0.1%), Lumigan® (bimatoprost ophthalmic solution, 0.01%) or vehicle. After single-dosing, NCX 470 demonstrated greater IOP reduction than Lumigan at most timepoints tested up to 24 hours post-dosing, with the greatest difference seen at 5 hours. In the repeat dosing study, the effects of both NCX 470 and Lumigan were generally stable throughout the period of the study, with NCX 470 showing consistently greater IOP reduction than Lumigan® at all timepoints tested. Aqueous humor dynamics were studied in ocular normotensive non-human primates treated in a crossover design with either NCX 470 or vehicle over 4 days. Measurements were taken on the fourth day and demonstrated that NCX 470 increased both outflow facility and uveoscleral outflow compared to vehicle. Aqueous humor outflow was also investigated in human trabecular meshwork/Schlemm’s canal constructs treated with equimolar NCX 470 or bimatoprost, or vehicle. Outflow facility was increased by both NCX 470 and bimatoprost compared to vehicle, with NCX 470 having a greater effect than bimatoprost. Duyuru • Jul 22
Nicox S.A. to Report Q2, 2023 Results on Jul 19, 2023 Nicox S.A. announced that they will report Q2, 2023 results on Jul 19, 2023 Duyuru • Feb 14
Nicox S.A., Annual General Meeting, Feb 28, 2023 Nicox S.A., Annual General Meeting, Feb 28, 2023, at 14:00 Central European Standard Time. Location: BuroClub - Drakkar 2 - Bâtiment D - 2405 route des Dolines - 06560 Valbonne Sophia Antipolis France Duyuru • Jan 09
Nicox S.A., Annual General Meeting, Feb 14, 2023 Nicox S.A., Annual General Meeting, Feb 14, 2023, at 14:00 Central European Standard Time. Location: BuroClub - Drakkar 2 - Bâtiment D - 2405 route des Dolines - 06560 Valbonne France Agenda: To propose Intention to transfer listing from the Euronext Paris regulated market to Euronext Growth Paris. 
