NatureCell Q1 2026: FDA Breakthrough Therapy Designation for JointStem Continues, Domestic Approval Rejected and Lawsuit Ongoing, Net Loss Narrows
Consolidated Q1 sales: KRW 4.06 billion, operating loss KRW 1.32 billion (narrowed YoY). Separate net loss: KRW 0.71 billion.
JointStem (osteoarthritis therapy): FDA Breakthrough Therapy designation (Mar 2025), RMAT designation (2024), Expanded Access Program approval. Domestic approval rejected (Aug 2025); administrative lawsuit ongoing.
Subsidiary Nature Cell America Inc. received FDA approval for Phase 1/2 clinical trial for autism spectrum disorder (AstroStem-AU) in April 2026. Plans to acquire and expand Baltimore global stem cell campus.
Short-term borrowings surged to KRW 17 billion (from KRW 5 billion at year-end 2025). Cash equivalents: KRW 28.3 billion (from KRW 16.8 billion). Debt-to-equity ratio: 37.5%.
Related party sales to (ju)AlBio accounted for 39.6% of total revenue. Long-term prepayment of KRW 3.75 billion exists for JointStem domestic rights.
R&D expenses: KRW 36.8 million (0.9% of sales), decreased compared to prior year period.
KOSDAQ Filing Information
Filing: Quarterly Report (2026.03)
Company: NATURECELL (007390)
Submission: NATURECELL CO.,LTD.
Receipt: 05-15-2026