Nicox to Receive €3M as NCX 470 Nears Phase 3 in Japan

Nicox SA has announced that its exclusive partner in Japan, Kowa, has received Clinical Trial Notification approval—Japan’s equivalent to a U.S. Investigational New Drug (IND) application—to initiate Phase 3 clinical trials of NCX 470 for the treatment of ocular hypertension.

Phase 3 Authorization Triggers First Milestone Payment

The approval of the Clinical Trial Notification marks a significant regulatory step and triggers a €1 million milestone payment to Nicox. According to the agreement between the companies, a second milestone payment of €2 million will be made upon the initiation of Phase 3 trials, which is anticipated in the second half of 2025.

Strategic Collaboration with Kowa

“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,” said Gavin Spencer, Chief Executive Officer of Nicox.

“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. 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.”

Financial Outlook and Licensing Agreement

Nicox has confirmed that, based on its current cash position, estimated revenues, and anticipated milestone payments—including those from Kowa—the company is financed through the end of 2025.

The company licensed the development and commercialization rights to NCX 470 in Japan to Kowa in February 2024. Under the agreement, Nicox is eligible to receive:

• An additional €7 million in development and regulatory milestones

• Up to €17.5 million in sales-based milestone payments

• Tiered royalties ranging from 7% to 12% on net sales in Japan

Kowa holds full responsibility for all development, regulatory, and commercialization costs related to NCX 470 in the Japanese market.