Nicox to Receive Milestone Payments from Kowa as NCX 470 Prepares to Enter Phase 3 Clinical Trials in Japan

Nicox SA announced that its exclusive Japanese partner for NCX 470, Kowa, has received Clinical Trial Notification (equivalent of a US Investigational New Drug, IND) approval to initiate phase 3 clinical trials on NCX 470 for the treatment of ocular hypertension in Japan. The notification triggers a €1 million milestone payment to Nicox. The clinical trials are expected to be initiated in H2 2025, which would trigger a second milestone payment of €2 million.

“This important achievement, which enables the initiation of phase 3 clinical development of NCX 470 for Japanese patients, demonstrates the effective collaboration established between the Kowa and Nicox teams and represents a significant advance by Kowa in the delivery of theiraccelerated development plan. As a result, we expect to receive a total of €3 million in development milestones from Kowa in 2025, extending our cash runway until at least the end of 2025,” Gavin Spencer, Chief Executive Officer of Nicox, said in a company news release. “We congratulate our Japanese partner on the swift progress and look forward to continuing to work with them to bring NCX 470 to the Japanese market.”   

Based on the current cash position, estimated revenue and anticipated milestone payments (including the Kowa milestones mentioned above) Nicox now estimates that it is financed until the end of 2025. Nicox licensed the rights to develop and commercialize NCX 470 in Japan to Kowa in February 2024. Nicox may receive a further €7 million in development and regulatory milestones, up to €17.5 million in sales milestones and tiered royalties from 7% to 12% on net sales of NCX 470 in Japan. Kowa is responsible for all development, regulatory and commercialization costs for NCX 470 in Japan.

Key Future Milestones 

• Denali phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: Topline results are expected in the third quarter of 2025   
• NCX 470 phase 3 clinical trial in Japan: Initiation expected in H2 2025