Nicox cuts net loss to €2.4m as NCX 470 NDA filing nears
Nicox SA has reported a sharply improved set of full-year 2025 financials, cutting its net loss to €2.4 million from €22.4 million in 2024 and more than doubling revenue to €16.8 million as milestone payments from licensing partner Kowa flowed in ahead of a pivotal US regulatory filing.
The Sophia Antipolis-based company, listed on Euronext Growth Paris, said the improvement was driven primarily by milestone receipts under the Kowa licence covering NCX 470 outside China and South-East Asia, and by substantially lower operating expenses following the completion of the Phase 3 Denali trial for NCX 470 in mid-2025. Operating costs fell to €14.3 million from €18.7 million in 2024.
NCX 470 pipeline and regulatory path
NCX 470, described as a nitric oxide-donating formulation of the established prostaglandin analogue bimatoprost, is Nicox's lead late-stage programme. The company is targeting patients with open-angle glaucoma or ocular hypertension, conditions that collectively represent a large and well-served global market — though one where newer mechanisms and improved tolerability profiles can still command premium positioning.
Chief executive Gavin Spencer said the NDA submission in the United States remains on track for summer 2026, with a parallel filing in China expected shortly thereafter. A Phase 3 clinical programme in Japan was initiated in the summer of 2025, extending the geographic ambition of the asset. The company anticipates that regulatory milestone payments triggered by these submissions will extend its cash runway beyond 2027 — a notable projection given that Nicox held only €4.1 million in cash and equivalents at 31 December 2025, down from €10.5 million a year earlier.
Spencer described 2025 as "a pivotal turning point", pointing to the elimination of secured debt and a reduction in long-term financial obligations alongside the improved loss figures. The company also disclosed that €1.0 million in ordinary bonds from a January 2026 financing have been converted into convertible bonds, approved by the board on 29 April 2026.
Market context and competitive positioning
The intraocular pressure-lowering market is mature, with prostaglandin analogues — including bimatoprost-based products — long established as first-line agents. Nicox's nitric oxide-donating approach, which the company argues addresses both conventional and trabecular outflow pathways, aims to differentiate NCX 470 from existing branded and generic alternatives. Bausch + Lomb's VYZULTA, itself a nitric oxide-donating bimatoprost developed originally by Nicox and licensed exclusively to Bausch + Lomb, provides some market proof-of-concept for the mechanism, though Nicox sold its VYZULTA royalty stream to Soleus Capital in mid-2024.
A successful FDA NDA submission would mark a meaningful inflection for a company that has been largely dependent on out-licensing economics. The standard 12-month review clock that Nicox assumes in its runway projections means a potential US approval decision could arrive in late 2027, broadly coinciding with the end of the current funding horizon — leaving limited margin for slippage. Investors will focus on whether additional business development deals or warrant proceeds materialise to underpin the balance sheet if the regulatory timeline extends.
Nicox said it continues to explore strategic opportunities, including potential collaborations or business combinations, without providing further detail.