Helios Technologies (HLIO) investor relations material

Strategic positioning and global development

• Leveraging Japanese biotech advantages and global operations to build a leading allogeneic cell therapy company.

• Focused on critical care, especially ARDS, with a robust clinical and commercial pipeline.

• Combining Japanese regulatory pathways and government support with international clinical expansion.

• Building commercial manufacturing capacity in Japan with 50L and 500L bioreactors, supported by government grants.

• Preparing for imminent commercialization in Japan and scaling for global markets.

Clinical pipeline and trial progress

• Lead product invimestrocel targets ARDS, with conditional approval and launch preparations underway in Japan.

• REVIVE-ARDS, a global phase III pivotal trial, is set to enroll up to 550 patients, starting in Japan and expanding internationally.

• Trauma study (MATRICS-1) in Texas, funded by the U.S. Department of Defense, focuses on acute kidney injury as a primary endpoint.

• Gene-modified iPS cell-derived NK cell program for solid tumors expected to enter clinical trials next year in Japan.

• Stroke and other pipeline programs remain in earlier stages of development.

Manufacturing and commercial readiness

• Advanced 3D manufacturing in bioreactors enables large-scale, low-cost production with minimal donor variability.

• First commercial product runs underway at Minaris in Yokohama; 500L suite in Kobe to be operational by 2028.

• Commercial team expansion ongoing, with significant hiring in manufacturing, sales, and clinical operations.

• Japanese government grant (JPY 45 million) supports scaling up manufacturing infrastructure.

• Product is off-the-shelf, IV-administered, and logistically simple, aiding adoption.