Athersys, Inc. and HEALIOS K.K. jointly announced an expansion and deepening of their partnership to optimize and better align the collaboration structure to drive therapeutic reach and commercial success in Japan for the MultiStem® (invimestrocel) product following potential regulatory approval. The changes and new agreements reflect improved clarity regarding Japanese regulatory, manufacturing, and commercial requirements gained in recent years and better enable the optimal investments and efforts in manufacturing and commercialization. The agreements will facilitate the regulatory approval process for MultiStem in Japan, prepare the companies for commercial manufacturing and supply and expand the overall scope of collaboration between the companies.

Key elements of the improved collaboration include: Providing Healios access to Athersys's manufacturing technology to enable Healios to manufacture MultiStem products, using a qualified manufacturer, for a potential commercial launch in Japan and allow Athersys to focus resources on advanced commercial manufacturing development. Clarifying Athersys's role in providing support services necessary for regulatory approvals, manufacturing readiness, and commercial launch in Japan. Sharing investment in commercial preparation and product supply through planned investment by Healios in certain manufacturing preparation activities and additional production capacity for Japan and, through deferrals and certain adjustments to financial terms of the license agreement, including milestones and royalties, during the early commercial phase.

Expanding Healios' license in Japan to include two new additional indications under certain conditions to enable Healios to further leverage its investment in MultiStem while providing Athersys the opportunity for additional revenues from this market.