SanBio Q2 2026 slides reveal increased R&D spending, FDA agreement on Phase 3 trial

Introduction & Market Context

SanBio Company Limited (TSE:4592) presented its financial results for the second quarter of fiscal year 2026 (ending January 31, 2026) on September 18, 2025. The regenerative medicine company, which focuses on developing treatments for central nervous system disorders, reported widening losses as it prepares for the commercialization of its flagship product AKUUGO®.

SanBio’s stock has shown significant volatility over the past year, with a 52-week range of 661 to 3,935 yen. The company’s shares recently traded at 3,335 yen, up 13.78% from the previous close of 2,931 yen, suggesting positive market sentiment despite the increased losses reported in the presentation.

Quarterly Performance Highlights

SanBio reported no revenue for Q2 FY2026, consistent with the same period last year, as the company continues to focus on research and development activities. Operating expenses increased to 1,888 million yen, up from 1,571 million yen in Q2 FY2025, primarily due to activities related to obtaining a partial change approval for AKUUGO®.

As shown in the following consolidated income statement, R&D expenses rose significantly to 1,346 million yen, compared to 1,024 million yen in the same period last year:

The company’s net loss widened to 1,997 million yen, compared to 1,309 million yen in Q2 FY2025, representing a 52.6% increase in losses. This expansion in net loss was influenced by both the increased operating expenses and changes in the yen/US dollar exchange rate, which shifted from 154.16 to 146.96.

SanBio’s balance sheet shows a slight decrease in cash and cash equivalents to 2,738 million yen as of July 31, 2025, down from 2,921 million yen at the end of January 2025. The company emphasized that it is maintaining a prudent level of cash to meet foreseeable short- to medium-term needs:

To strengthen its financial position, SanBio has secured committed credit line agreements with three major Japanese banks totaling 3 billion yen, which will support the commercialization of AKUUGO® and the establishment of manufacturing, distribution, and marketing infrastructure:

Product Development and Regulatory Progress

The presentation highlighted significant progress for AKUUGO® (Vandefitemcel), which SanBio describes as the "World’s First Therapeutic Agent for Regenerating Brain." The product received conditional and time-limited approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) on July 31, 2024, for the improvement of chronic motor paralysis associated with traumatic brain injury:

SanBio has completed filing a partial change application for AKUUGO® and expects approval in the second half of the fiscal year ending January 2026. The company reported that its third manufacturing run cleared all specification requirements and was deemed compliant, a critical milestone for commercial production.

The company is also advancing its pipeline for multiple central nervous system indications, positioning AKUUGO® as a platform for treating various conditions including Alzheimer’s disease, ischemic stroke, Parkinson’s disease, and retinitis pigmentosa:

Strategic Initiatives and Global Expansion

SanBio outlined its three-pillar growth strategy, focusing on establishing Japan as its "home base" for global expansion, restarting US clinical initiatives, and re-engaging in ischemic stroke treatment:

A significant development is the agreement reached with the US Food and Drug Administration (FDA) on the Phase 3 trial design for traumatic brain injury. This milestone builds on SanBio’s previous achievements in the US market, including the Regenerative Medicine Advanced Therapy (RMAT) Designation granted by the FDA in 2019:

The company presented a detailed roadmap for maximizing corporate value across both the Japanese and US markets, with specific timelines for regulatory milestones and commercial launches:

Financial Outlook and Revised Forecasts

SanBio has revised its consolidated earnings forecast for FY2026, increasing projected expenses and losses. The primary change is an increase in manufacturing-related expenses to secure inventory of AKUUGO® at an earlier stage. The revised forecast shows R&D expenses increasing from 2,405 million yen to 2,795 million yen, and the projected net loss widening from 3,554 million yen to 4,045 million yen:

Looking ahead, SanBio projects several key events through FY2027, including obtaining approval for the partial change application for AKUUGO® in the second half of FY2026, followed by NHI drug price listing and the beginning of product sales in the first half of FY2027. In the US market, the company plans to finalize the Phase 3 clinical trial design for traumatic brain injury by January 2026, with trial preparations beginning in the first half of FY2027:

SanBio remains focused on its vision of becoming a global leader in regenerative medicine, developing treatments that create benefits for patients and value for stakeholders, despite the near-term financial challenges associated with its pre-revenue status and ongoing R&D investments.

Full presentation:

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