Nature Cell Bets KRW 9.6642 Billion on U.S. Stem Cell Campus as FDA Approval Comes Into View

Nature Cell will make an equity investment of KRW 9.6642 billion in its U.S. subsidiary, Nature Cell America Inc. Following a board resolution on the 26th, the company decided to participate in Nature Cell America’s paid-in capital increase and acquire 700,000 new shares. The scheduled acquisition date is the 8th of next month. The investment is intended to fund construction of the 100,000-square-foot (approximately 2,800 pyeong) Nature Cell Biostar U.S. Stem Cell Campus in Baltimore, Maryland, with business expansion and increased stem cell therapy manufacturing capacity as its primary objectives.

The acquisition amount is the converted value based on the Seoul Money Brokerage Services exchange rate published on the 25th, the day before the board resolution date, of KRW 1,380.60 per U.S. dollar, and may change depending on the exchange rate on the actual payment date. Through its participation in the capital increase, Nature Cell’s holdings in Nature Cell America will rise from 1.5 million shares to 2.2 million shares, while its ownership stake will remain at 100%. The acquisition amount represents 15.33% of equity capital of KRW 63.02988 billion as of the end of the previous fiscal year.

■ Participation in capital increases for 3 consecutive years expands cumulative investment

Nature Cell has consistently participated in Nature Cell America’s paid-in capital increases over the past 3 years. It acquired 1.1 million shares worth $11 million in 2024 and 100,000 shares worth $1 million in 2025, respectively, meaning investment in the U.S. entity has continued each year through the latest transaction. Nature Cell America’s performance, however, remains at an early stage. As of the end of 2025, it reported total assets of KRW 18.013 billion, total liabilities of KRW 891 million and total equity of KRW 17.123 billion. Revenue for the same year was only KRW 60 million, while net loss for the period was KRW 930 million.

Repeated capital injections into a loss-making entity over several years are a risk factor in themselves. There are, however, grounds that could justify the investment. The Baltimore campus is scheduled for completion in 2 phases by 2031 and is planned to have annual production capacity of up to 1 million doses of Jointstem. The state of Maryland and the city of Baltimore have also provided conditional loans totaling $4.4 million (approximately KRW 6 billion) for the project. The project has secured a degree of local confidence, as local governments have committed funding directly.

■ FDA recognizes that BLA application can be filed using only Korean clinical data

Behind the investment is the growing visibility of U.S. regulatory approval for Nature Cell’s lead pipeline, Jointstem. Jointstem is an autologous stem cell therapy for severe degenerative knee osteoarthritis. After receiving Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA in 2024, it was also designated a breakthrough therapy (BT) in 2025. In May 2026, the FDA stated that a biologics license application (BLA) could be filed using only phase 3 clinical data generated in Korea. Accordingly, Nature Cell is accelerating its U.S. expansion by formally requesting a pre-BLA meeting with the FDA at the end of August 2026.

Notably, Jointstem’s marketing authorization application was rejected by South Korea’s Ministry of Food and Drug Safety, and administrative litigation is currently underway, with Nature Cell prevailing at the first-instance trial and the MFDS appealing. It is unusual for a product that has not cleared the threshold of South Korea’s regulatory authorities to have the validity of its Korean clinical data recognized by the FDA, the world’s most stringent regulatory agency. The development is being closely watched by South Korea’s biotechnology industry.

■ U.S. launch and Nasdaq listing to be pursued simultaneously in 2027

According to market research firm Dataintelo, the global stem cell therapy market for osteoarthritis was worth approximately $1.8 billion (approximately KRW 2.5 trillion) in 2025 and is projected to grow at an annual average rate of 11.2% to reach $4.7 billion (approximately KRW 6.5 trillion) by 2034. North America is the largest market, accounting for 38% to 42% of the global market. Nature Cell’s concentrated investment in building the Baltimore campus reflects its assessment that it should gain an early foothold in this market.

Industry experts view the FDA’s dual RMAT and breakthrough therapy designations as factors that could increase the likelihood of accelerated approval. However, uncertainty remains between the pre-BLA request and actual approval, and the possibility that the FDA may request additional data during its interpretation of the clinical results cannot be ruled out. Following its pre-BLA meeting with the FDA, Nature Cell is targeting the official U.S. launch of Jointstem in the first half of 2027. It is also pursuing a Nasdaq (NASDAQ) listing through an American depositary receipt (ADR) structure in the second half of 2026 to establish a foothold in the U.S. market and secure global funding. Nature Cell America also plans to expand its pipeline through research and clinical trials of stem cell therapies for Alzheimer disease, in addition to its knee osteoarthritis treatment.