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REG-Nicox Reports First Half 2026 Financial Results

Globe Newswire•30/10/2026•02:30 ET
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Key Highlights

  • ➤Revenue €3.5 million in H1 2026, up from €1.5 million
  • ➤Net loss narrowed to €0.5 million from €8.9 million
  • ➤Cash €8.4 million at August 31, funding operations beyond Q1 2028
  • ➤NCX 470 U.S. NDA decision scheduled for April 30, 2027
  • ➤NCX 470 China submission made in August 2026, review ongoing

Expert Statements

Gavin Spencer, Chief Executive Officer of Nicox

“With €8.4 million in cash at the end of August and limited further investment required by Nicox to support NCX 470, we expect our existing operations to be funded beyond the first quarter of 2028, significantly strengthening our financial position and visibility. NCX 470 has now entered an important new phase, moving towards commercialization in the United States and China, subject to regulatory approval, with financial support from our partners and the continued expertise of our team. The completion of late-stage clinical trials together with our partners assuming responsibility for regulatory and commercial activities and their funding has significantly reduced the risk profile of Nicox, which is now well positioned to benefit from the potential future success of NCX 470 while focusing resources on the Company’s next chapter. Subject to approval, successful launches would provide the long-term revenue to support future value creation. At the same time, our experienced development and corporate team provides a strong foundation from which to identify and pursue future growth opportunities in ophthalmology.”

Press Release Nicox Reports First Half 2026 Financial Results * Revenue increased to €3.5 million compared to €1.5 million in H1 2025 * Net loss decreased to €0.5 million from €8.9 million in H1 2025 * Cash and cash equivalents of €6.0 million as of June 30, 2026, subsequently updatedto €8.4 million as of 31 August 2026, providing over 18 months cash runway * A Financial Q&Ais available on our website October 30, 2026 – release at 7:30 am Sophia Antipolis, France Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today reported its financial results for the first half of 2026, as approved by the Board of Directors on October 29, 2026, and provided an update on its ongoing activities and key future milestones. “With €8.4 million in cash at the end of August and limited further investment required by Nicox to support NCX 470, we expect our existing operations to be funded beyond the first quarter of 2028, significantly strengthening our financial position and visibility. NCX 470 has now entered an important new phase, moving towards commercialization in the United States and China, subject to regulatory approval, with financial support from our partners and the continued expertise of our team. The completion of late-stage clinical trials together with our partners assuming responsibility for regulatory and commercial activities and their funding has significantly reduced the risk profile of Nicox, which is now well positioned to benefit from the potential future success of NCX 470 while focusing resources on the Company’s next chapter. Subject to approval, successful launches would provide the long-term revenue to support future value creation. At the same time, our experienced development and corporate team provides a strong foundation from which to identify and pursue future growth opportunities in ophthalmology.” said Gavin Spencer, Chief Executive Officer of Nicox. Ongoing Activities and Future Strategy Nicox continues to support Kowa and Ocumension during the regulatory review processes for NCX 470, including preparing responses to any requests for additional information from the health authorities. Phase 3 clinical development of NCX 470 is ongoing in Japan, managed and financed in full by Kowa. In parallel, the Company continues to evaluate strategic opportunities to support long-term value creation, including potential partnerships, acquisitions and business combinations. The objective is to access innovative ophthalmology assets and build a focused new pipeline that leverages the Company’s experienced team. Opportunities are assessed based on the science, resources and financing requirements, and potential future value, while maintaining financial discipline. The estimated cash runway announced of September 2, does not include any potential strategic transaction, which may require additional financing. First Half 2026 Financial Results (1) Revenue for the first half of 2026 was €3.5 million compared to €1.5 million for the first half of 2025, with both periods consisting principally of license revenue. Operating expenses for the first half of 2026 were €4.5 million compared to €6.8 million for the first half of 2025. The reduction principally reflects the completion of the Denali trial and subsequent headcount reductions. Net loss for the six months ending June 30, 2026, was €0.5 million, compared to a net loss of €8.9 million for the same period in 2025. The improvement mainly reflects the €3.0 million milestone payment from Kowa recognised in the first half of 2026 and the reduction in operating expenses, notably following the completion of the Denali trial. As of June 30, 2026, Nicox SA had cash and cash equivalents of €6.0 million compared with €4.1 million as of December 31, 2025. The €3.0 million milestone payment from Kowa, recognised as revenue in the first half of 2026, was received after June 30, 2026, and is therefore not included in the cash position. Taking this receipt and the Company’s current cost structure into account, the Company believes its existing operations are funded for more than 12 months, based solely on the cash and cash equivalents available. The Company has provideda subsequent update on its cash runway as of August 31, 2026. As of June 30, 2026, Nicox SA had unsecured financial debt of €2.9 million, consisting principally of €2.8 million of outstanding convertible bonds subscribed by institutional investors, including Vester Finance, which the Company assumes will be repaid through conversion into shares. The Company had no significant financial debt as of December 31, 2025. The Company remains committed to cost control and optimizing resource allocation to support its strategic objectives. Changes in assumptions regarding estimated income, debt or costs may affect the estimated cash runway. Subsequent events Nicox has regained the rights to NCX 1728, a novel nitric oxide donating phosphodiesterase-5 inhibitor, following the decision by Glaukos not to exercise their exclusive option to a license following the completion of a research program. Nicox is evaluating other opportunities for the future development of NCX 1728. Key Upcoming NCX 470 Milestones * Japan Phase 3 clinical trials results: trials ongoing * NDA decision in the U.S.: PDUFA date 30 April 2027 * U.S. Launch: expected in H2 2027, subject to NDA approval * NDA decision in China: Submission made in August 2026, regulatory review ongoing About Nicox Nicox 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’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.

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