Latanoprostene Bunod

Press Release Nicox Announces NCX 470 NDA in China Accepted for Review Acceptance of the NCX 470 dossier initiates the review processRegulatory decision expected within 12-18 months from the August submissionQ&A on Ocumension available on Nicox’s website September 11, 2026 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that its exclusive licensee in China, Ocumension Therapeutics, has received confirmation from China’s National Medical Products Administration (NMPA) that the NCX 470 (also referred to as OT-301 by Ocumension) New Drug Application (NDA) in China has been accepted for review. This acceptance initiates the review of the NDA by the NMPA. Nicox had previously announced the submission of the NCX 470 NDA in China as a treatment to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. “The acceptance for review of the NCX 470 NDA in China initiates the examination process and is another key step towards its commercialisation in this territory. We look forward to continuing to work with the Ocumension team as they prepare for a future launch.” said Gavin Spencer, Chief Executive Officer of Nicox. Ocumension’s Press release is here.Ocumension has paid Nicox license fees of €18 million for the rights to develop and commercialise NCX 470 in the Chinese, Korean and Southeast Asian markets, contributed 50% of the Denali clinical trial costs and is one of Nicox’s principal shareholders. Nicox will receive tiered royalties on sales of NCX 470 made by Ocumension ranging from 6% to 12%. Ocumension already has an ophthalmology sales force in place throughout China and is therefore well-positioned for a rapid launch of NCX 470.There is no fixed period for approval of a pharmaceutical product in China, however the review process typically takes 12 to 18 months following submission. The decision on NCX 470 in China is expected after the decision by the U.S. FDA, who have assigned the PDUFA date1 for 30 April 2027. Key Upcoming NCX 470 Milestones Japan Phase 3 clinical trials results: trials ongoing NDA approval in the U.S.: PDUFA date 30 April 2027U.S. Launch: expected in H2 2027, subject to NDA approvalNDA decision in China: Submission made in August 2026, accepted for review on 10 September 2026 About NCX 470NCX 470 is a novel nitric oxide (NO)-donating bimatoprost eye drop that leverages the potent intraocular pressure (IOP)-lowering effects of NO and prostaglandin analogs (PGAs). NCX 470 incorporates Nicox’s proprietary NO-donating research platform and bimatoprost in a single molecule. NCX 470 is designed to release bimatoprost and NO into the eye to lower IOP by two different pathways in patients with open-angle glaucoma or ocular hypertension. NO is a well-known small, naturally occurring signalling molecule that plays a key role in the regulation of IOP through activation of soluble guanylate cyclase (sGC). NO brings additional IOP-lowering efficacy by enhancing aqueous humor drainage from the eye via a different mechanism of action to that of PGAs.NCX 470 has completed two Phase 3 clinical trials designed to fulfil the regulatory requirements for safety and efficacy to support NDA submissions in the U.S. and China, Mont Blanc and Denali. Both trials were positive and met the efficacy endpoints necessary for submission of a New Drug Application in the United States and China. NDAs for NCX 470 have been submitted in the U.S. and China. NCX 470 is an investigational product and has not yet been approved by the FDA. About NicoxNicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead late-stage development program is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa in the rest of the world. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX). For more information www.nicox.com Analyst coverageH.C. Wainwright & Co Yi Chen New York, U.S. The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports. Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@nicox.com DisclaimerThe information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.Risks factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2025” which are available on Nicox’s website (www.nicox.com).Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 1 A PDUFA date is the target date by which the U.S. Food and Drug Administration (FDA) aims to complete its review and issue a decision on a New Drug Application (NDA) under the Prescription Drug User Fee Act (PDUFA). Attachment EN_NCX470ChinaNDAAcceptanceSeptempber2026_PR_FINAL

Press Release Nicox Announces Extension of Cash Runway Cash position, of €8.4 million1 as of 31 August 2026, sufficient to fund existing operations beyond Q1 2028NCX 470 U.S. NDA approval milestone would fund operations into 2029, while subsequent royalties could extend the cash runway substantially further Discussions on future strategic opportunities continuing September 2, 2026 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced an extension of its cash runway and provided a corporate and financial update. The PDUFA date2 for NCX 470 in the United States was announced on 27 August. “Our current level of cash provides visibility for over 18 months, and our exclusive U.S. partner, Kowa, anticipates a commercial launch of NCX 470, subject to approval, in H2 2027. The expected NDA approval milestone supports us into 2029, with subsequent royalty revenue extending financial visibility well beyond that. With NCX 470 moving through the regulatory review period in two major markets, we are in a financially solid position to support our partners’ regulatory and pre-commercialisation activities whilst increasingly focussing our experienced team on evaluating future growth opportunities.” said Gavin Spencer, Chief Executive Officer of Nicox. Cash RunwayAs of 31 August 2026, Nicox had estimated cash and cash equivalents of €8.4 million1, compared to €4.1 million as of 31 December 2025. The Company has significantly reduced its fixed costs and, based on its current structure and operations, estimates that its cash position is sufficient to fund existing operations beyond Q1 2028. The receipt of the milestone payable upon approval of the NCX 470 in the U.S. (PDUFA date2 30 April 2027) would fund existing operations into 2029, while subsequent royalties expected following U.S. launch in H2 2027 could extend the cash runway substantially further. Additional financing options remain available under the Vester Finance shareholder loan announced in June 2026. The Company remains committed to cost control and optimizing resource allocation to support our strategic objectives. If any of the assumptions around estimated income, debt or costs change, this may impact the estimated cash runway. In parallel, the Company is pursuing business development discussions and continuing to evaluate several strategic growth opportunities, including potential collaborations or business combinations. Management UpdateDoug Hubatsch, Nicox’s EVP, Head of Research and Development and Chief Scientific Officer since December 2021, has assumed the new position of Chief Scientific Advisor, transitioning away from operational management. In this role, he will continue to support NCX 470 through the NDA review period, as well as advise the Company on growth opportunities and scientific strategy. Siobhan Garbutt, VP and Head of Clinical Development, will assume leadership of the development team and will continue to support Nicox’s partners during the NDAs review process while also contributing to the evaluation of future development opportunities for the Company. Siobhan has been with Nicox since July 2022 and has led the NCX 470 clinical activities, as well as playing a major role in writing the NDA. She has close to 20 years of clinical development experience, the majority of it in ophthalmology, and has worked in large pharma, biotech and CRO settings.We thank Doug for his leadership in driving NCX 470 to NDA submission and we congratulate Siobhan on taking on this expanded role in the Company.“I would like to take the opportunity to thank Doug Hubatsch, who has led the Development team so strongly through the later stages of the NCX 470 clinical program, and has played a key role in building lasting partnerships with Kowa and Ocumension. Doug has now assumed the role of Chief Scientific Advisor and we are pleased that he will continue to contribute his expertise to Nicox, supporting through the NCX 470 NDA review period and advising on scientific strategy and future growth opportunities. Siobhan Garbutt, VP Clinical Development, who has worked closely with Doug since joining Nicox in 2022, will assume leadership of the development function and will be working closely with the rest of the Nicox team on defining the future,” added Gavin Spencer, Chief Executive Officer of Nicox.About NicoxNicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead late-stage development program is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa in the rest of the world. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX). For more information www.nicox.com Analyst coverageH.C. Wainwright & Co Yi Chen New York, U.S. The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports. Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@nicox.comMediaSophie BaumontRose Piquante ConsultingT +33 6 27 74 74 49sophie.baumont@rosepiquante-consulting.comDisclaimerThe information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.Risks factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2025” which are available on Nicox’s website (www.nicox.com).Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 1 Unaudited estimate prepared by management based on information available as of the date of this press release. The Company’s next reporting will be the first half 2026 accounts in October 2026. 2 A PDUFA date is the target date by which the U.S. Food and Drug Administration (FDA) aims to complete its review and issue a decision on a New Drug Application (NDA) under the Prescription Drug User Fee Act (PDUFA). Attachment EN_CorporateUpdateSeptember2026_PR_FINAL