News

On January 29, 2026, we announced that we would raise funds through the issuance of new shares and the 27th series of stock acquisition rights via third-party allotment.

This issuance will secure approximately 6.3 billion yen in funding, substantially strengthening our cash position to over 10 billion yen. Our company has disclosed the late-stage development of invimestrocel for ARDS as our top-priority, and we are currently preparing to launch our global Phase 3 REVIVE-ARDS study and submit an application for conditional and time-limited approval in Japan. Together with Minaris, a contract manufacturing organization (CMO) specializing in stem cell and bioreactor-based manufacturing, we are advancing the establishment of a commercial manufacturing facility equipped with our proprietary 50L bioreactor-based invimestrocel manufacturing process for the purposes of obtaining marketing approval and producing commercial product. In parallel, and for future capacity expansion, we plan to utilize a substantial subsidy from the Ministry of Economy, Trade and Industry to establish in Kobe, Japan, a large-scale commercial production facility (CDMO) for cell-based medicines, including 500L bioreactor-based invimestrocel production.

On January 20, we submitted the clinical trial notification for the REVIVE-ARDS trial to the Pharmaceuticals and Medical Devices Agency (PMDA). Patient enrollment will commence in Japan first, and subsequently, we will expand the study to other geographies, with enrollment taking place primarily the United States. In order to actively advance our business initiatives, the funds raised will be allocated towards conducting the global Phase 3 clinical trials, preparing for application and approval domestically, strengthening the production system, as well as covering expenses related to company operations.

Additionally, if the 27th series of stock acquisition rights are exercised in full, approximately 3.8 billion yen in additional funds will be secured. As we make progress in our business operations, we plan to use the funds obtained through the exercise of these rights to deliver cures and hope to patients suffering from difficult-to-treat diseases worldwide.