Nicox - Denali trial remains on track for 2025 readout
Nicox has provided a preliminary Q223 update, with net revenue (primarily consisting of net royalties attributable to net sales of Vyzulta by global licensee Bausch + Lomb, or B+L) of €0.9m, up from €0.7m in Q222. Total US Vyzulta prescriptions grew 26% in Q223 (vs 23% in Q122 and 25% in Q422). Importantly, the company reiterated its guidance that it expects to complete the Denali study in 2025. Denali is the company’s second Phase III study assessing lead candidate NCX-470, a nitric oxide (NO) donating bimatoprost, in the treatment of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension (OHTN). Denali enrolment and randomisation is around 55% complete, which provides us with confidence that the company will complete the trial within the currently anticipated timeline. We continue to anticipate that NCX-470 could reach commercial launch in 2027. Nicox reported €19.0m in gross cash at 30 June (vs €27.7m at 31 December 2022), and expects its cash runway should fund its operations into June 2024, based on the development of NCX-470 alone.Nicox is engaged in the ophthalmic market. Co. markets several ophthalmic products in the United States and Europe with a portfolio of therapies and diagnostic tools that can help people to enhance their sight. Co. has developed naproxcinod, the first member of the Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents, for the treatment of the signs and symptoms of osteoarthritis. Beyond naproxcinod, Co. has a pipeline containing multiple nitric oxide-donating NCEs, which are in clinical development with partners for the treatment of diseases, such as hypertension, glaucoma and Chronic Obstructive Pulmonary Disease (COPD).
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