HS-001’s Conditional and Time-Limited Approval and Early Commercialization

「In the domestic Phase I/II clinical trial conducted in combination with coronary artery bypass surgery, the LAPiS trial, analysis of all 10 cases, including data compilation and interpretation by a third-party organization, has been completed. The results showed no safety concerns, the primary endpoint, that would affect our policy toward filing an application for marketing approval. In terms of efficacy, the secondary endpoint, favorable results were obtained across multiple measures relating to cardiac pump function and the reduction in the size of the enlarged heart, supporting our policy of filing an approval application. Going forward, we will focus on discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) toward filing a marketing approval application for HS-001 and on patient enrollment in the EMERALD trial for HS-005.」

「For HS-001, a treatment program involving open-chest administration of allogeneic iPS cell-derived myocardial spheres for patients with heart failure associated with ischemic heart disease, we intend first to complete the ongoing LAPiS trial and then establish a structure that generates sales revenue following the pursuit of conditional and time-limited approval in Japan.」

「In the ongoing Phase I/II clinical trial conducted in combination with coronary artery bypass surgery, the LAPiS trial, enrollment of the planned 10 patients, consisting of 5 in the low-dose group and 5 in the high-dose group, was completed with administration to the final patient during the first quarter accounting period.」

「First, we aim to complete the ongoing LAPiS trial and establish a structure for HS-001 that generates sales revenue following conditional and time-limited approval in Japan.」