[비즈한국] NatureCell007390 has unveiled a strategic card: seeking accelerated FDA approval for its degenerative arthritis treatment, Jointstem, and pursuing a direct NASDAQ listing through American Depositary Receipts (ADR). This is interpreted as a move to secure large-scale capital to build a global production hub in the U.S. and to overcome recent setbacks involving stem cell medical tourism in Japan by targeting the U.S. market directly.
During an IR session held at the KBIZ Hall of the Korea Federation of SMEs in Yeongdeungpo-gu, Seoul, on the 26th, Chairman Ra Jung-chan stated, "We will pursue a NASDAQ listing based on ADRs to expand accessibility to the U.S. capital market," adding, "Through the NASDAQ listing, we will leap forward as a global leader in the regenerative medicine business and maximize corporate value based on FDA clinical and regulatory momentum."
The ADR-based NASDAQ listing method gained prominence recently as it is being pursued by SK Hynix000660. On the 24th, SK Hynix submitted a registration statement (Form F-1) for a public offering to the U.S. Securities and Exchange Commission (SEC) for its ADR listing. ADRs are securities issued to allow foreign companies to trade their shares on U.S. stock exchanges to increase accessibility for global investors.
Chairman Ra's timeline for the NASDAQ listing involves collaborating with the U.S. investment firm Adelphi Ventures to hold IR roadshows in major U.S. cities this June and September, applying for the NASDAQ listing between September and November, and completing the listing in the first half of next year. Through these roadshows, Chairman Ra also disclosed goals to attract $50 million (75.5 billion KRW) in investment this year, followed by $150 million (226.4 billion KRW) in 2027 upon NASDAQ listing, and an additional $100 million (150.9 billion KRW) in 2028. The funds raised will be used to expand the GMP center currently under construction in Baltimore, Maryland. "I visited the headquarters of Raymond James Financial last October to discuss selecting lead underwriters," Chairman Ra said. "We are also in discussions with several other global investment banks."
Chairman Ra then outlined the commercialization plan for the degenerative osteoarthritis stem cell treatment Jointstem and the operation schedule for the U.S. GMP center. For Jointstem, the plan is to discuss accelerated approval and the commencement of phase 3 clinical trials with the FDA this May. The goal is to submit an Investigational New Drug (IND) application in the U.S. in June, apply for accelerated approval in September, and receive FDA product approval next year. If accelerated approval is obtained, Jointstem could be launched in the U.S. market based on early indicators like pain and joint function improvement before the phase 3 clinical trials are completed.
Chairman Ra explained that construction of the Baltimore GMP center, the core hub for NatureCell’s stem cell business in the U.S., is also proceeding smoothly. "Once completed in October, we will be able to supply 20,000 doses annually (enough stem cells to treat 20,000 patients), and by the first half of next year, we will reach a production capacity of 50,000 doses per year," he said. "By 2031, when full completion is reached, it will become a stem cell supply base camp with an annual production capacity of 1 million doses."
He continued, "With research cooperation with Johns Hopkins University and support from the Maryland state government, our goal is to achieve $10 billion (15.09 trillion KRW) in annual sales from stem cells by 2033," expressing high expectations. "We are in contact with the EU to commercialize Jointstem early, and we plan to launch it in advanced markets such as Europe after it hits the U.S. market." Professor Si-Jung Yoon of Johns Hopkins University, who attended the event, added, "In the U.S., stem cells are considered the next-generation commercialization technology. Johns Hopkins plans to collaborate with NatureCell on mechanism research across various fields."
Meanwhile, Chairman Ra emphasized that the recent death of a patient receiving stem cell treatment in Japan is unrelated to NatureCell’s Japanese business. Local reports indicated that a Korean woman in her 60s died while receiving intravenous stem cell therapy for chronic pain at the Neopolis Clinic Ginza in Tokyo mid-this month. It is known that this clinic uses stem cell products manufactured by the JASC Kyoto Stem Cell Culture Center and the R-Bio Stem Cell Culture Center.
Although NatureCell stated the cause of the patient's death was a fall, the Japanese Ministry of Health, Labour and Welfare ordered JASC to undergo safety management inspections and cease cell manufacturing, and requested the R-Bio Stem Cell Culture Center to halt cell shipments. Since both JASC and R-Bio are key affiliates of NatureCell, there are concerns that this incident might hinder NatureCell’s stem cell therapy business in Japan. Chairman Ra clarified, "We have provided explanations to both the South Korean Ministry of Food and Drug Safety and the Japanese Ministry of Health, Labour and Welfare, and I understand they have both tentatively concluded it was an accidental occurrence."
Despite NatureCell's IR session that day, some retail shareholders remained cold to the presentation. They have stated their intent to vote against all agenda items at the 55th Regular General Shareholders' Meeting on the 31st, except for the approval of financial statements, including the reappointment of inside director Byun Dae-joong and the granting of stock options to Chairman Ra Jung-chan, President Jung Sang-mok, and inside director Byun Dae-joong. They argue that it is premature to grant 1.2 million common stock options to three key executives at an exercise price of 80,000 KRW per share, given that the FDA approval for Jointstem has not been achieved and the company continues to post losses. As of today, 12.98% of shareholders have united on the online shareholder solidarity platform, 'Act'. Conversely, the stake held by specially related parties, including Chairman Ra, was 17.83% as of the end of last year.