SanBio reports Q2 2026 results, advances AKUUGO® and SB623 pipeline

SanBio Company Limited announced its financial results for the second quarter of the fiscal year ending January 31, 2026, reporting operating expenses of 1,888 million yen, primarily due to activities for a partial change approval for AKUUGO®. This resulted in an operating loss of 1,888 million yen and a net loss of 1,997 million yen. Cash and cash equivalents stood at 2,738 million yen as of July 31, 2025.

Significant progress was made with AKUUGO® (Vandefitemcel), which obtained conditional and time-limited approval from the MHLW on July 31, 2024, as the world's first therapeutic agent for regenerating the brain. The company completed a partial change application for marketing approval on June 12, 2025, following a successful third manufacturing run, with approval expected in the second half of the fiscal year ending January 2026.

Additionally, SanBio reached an agreement with the FDA on the Phase 3 trial design for SB623 in Traumatic Brain Injury (TBI) in the United States, indicating further development in its pipeline. The company also secured commitment lines totaling 3.0 billion yen from multiple banks, including MUFG Bank, Mizuho Bank, and Resona Bank, to support commercialization and infrastructure development for AKUUGO® and future endeavors.