SanBio Company (4592) investor relations material

Executive summary

• Focused on advancing regenerative medicine, particularly with AKUUGO® for brain regeneration and SB623 for traumatic brain injury and stroke, achieving conditional approval for AKUUGO® in Japan and progressing toward commercialization.

• Three major achievements: regulatory progress in Japan, agreement with FDA on US phase III trial, and securing new bank credit lines.

• Strategic growth pillars include Japan as a base, restarting US clinical initiatives, and expanding into ischemic stroke treatment.

• R&D expenses reached ¥1,346 million, mainly for AKUUGO® approval-related activities.

Financial highlights

• Operating expenses increased to ¥1,888 million in Q2 FY2026.1, mainly due to AKUUGO® approval activities.

• Net loss widened to ¥1,997 million in Q2 FY2026.1, an increase of ¥688 million year-over-year.

• Cash and cash equivalents at period-end were ¥2,372 million, down ¥480 million from prior year-end.

• Operating expenses revised upward for the full year to ¥3,920 million due to increased manufacturing costs.

• No dividends declared or forecasted for the fiscal year.

Outlook and guidance

• Full-year forecast revised: operating loss expected at ¥3,920 million, ordinary loss at ¥4,530 million, and net loss at ¥4,045 million.

• Anticipates partial change approval for AKUUGO® in Japan between August and January, with drug price listing and product sales expected in the first half of next year.

• US phase III TBI trial design agreed with FDA; preparations for trial to begin in the next fiscal year.

• Plans to expand AKUUGO® indications to stroke, spinal cord injury, retinal disease, Parkinson's, and Alzheimer's.

• Four-year vision includes US product launch and substantial progress in stroke program.