1. What Happened?

NatureCell’s JointStem has received RMAT (Regenerative Medicine Advanced Therapy), BTD (Breakthrough Therapy Designation), and EAP (Expanded Access Program) designations from the US FDA. This is incredibly positive for US market entry. However, domestic approval has been denied, halting progress in the Korean market. Concurrently, the 2025 semi-annual report reveals declining sales and increasing operating losses.

2. Why These Outcomes?

The FDA approvals recognize the innovative potential of JointStem. The domestic setback suggests unmet regulatory requirements in Korea. The financial downturn is attributed to declining cosmetics sales within the stem cell business and struggles in the food business.

3. What’s the Outlook?

Short-term volatility is expected due to the domestic approval setback. However, the long-term trajectory hinges on US market success. A successful US launch could significantly boost NatureCell’s valuation.

4. What Should Investors Do?

  • Closely monitor FDA approval follow-up procedures and clinical trial results.
  • Observe potential improvements and strategic shifts in the domestic business.
  • Consider long-term investment and consult with experts before making decisions.