Nature Cell Advances Accelerated Approval and Phase 3 Clinical Trial Strategy for JointStem, Outlines Nasdaq Listing Roadmap

LOS ANGELES, CA / ACCESS Newswire / March 26, 2026 /Nature Cell Co., Ltd. (Chairman: Dr. Jeong-Chan Ra), a biopharmaceutical company specializing in adult stem cell therapeutics, has formalized its U.S. regulatory strategy for JointStem, simultaneously presenting a roadmap for FDA Accelerated Approval and NASDAQ listing.

Building on its Breakthrough Therapy designation, the company is preparing for an FDA meeting in May 2026 to concretize its accelerated approval strategy and finalize Phase 3 clinical trial design. In parallel, Nature Cell is pursuing a U.S. IR roadshow and NASDAQ listing to attract global investment, with the dual objective of entering the U.S. market and enhancing corporate value.

Nature Cell announced the details of its U.S. regulatory strategy at an Investor Relations (IR) presentation held on March 26, addressing FDA approval pathways, development timelines, and global capital market entry plans - topics of greatest interest to the market and shareholders.

The company confirmed that JointStem has already received Breakthrough Therapy (BT) designation from the U.S. Food and Drug Administration (FDA), granting access to an expedited development support program. The company completed its BT meeting request on March 18, 2026, with the FDA meeting scheduled for May 2026. This meeting is regarded as a critical milestone in determining the U.S. regulatory pathway for JointStem, with discussions expected to focus on accelerated approval eligibility, Phase 3 clinical trial design, key endpoints, and the overall development strategy.

In preparation for the FDA meeting, Nature Cell noted that it is receiving strategic counsel from Dr. Lee Simon, a leading U.S. regulatory expert who previously oversaw approvals in the relevant therapeutic area. This advisory engagement is intended to ensure both regulatory compliance and scientific validity of the accelerated approval strategy, maximizing the likelihood of approval by proactively incorporating FDA requirements. The company expects to secure a higher level of strategic completeness through these preparations during the FDA consultation process.

Following RMAT and End-of-Phase 2 (EOP2) meetings with the FDA last year, the company reached an agreement to advance development through a single pivotal trial, reducing costs, shortening the development timeline, and further improving the probability of approval.

Nature Cell 's U.S. development strategy operates on two tracks: accelerated approval and standard Phase 3. Under the accelerated approval pathway, initial approval would be based on improvements in pain and joint function, followed by confirmatory trials to demonstrate long-term outcomes such as avoidance of total knee replacement (TKR) surgery. This approach enables early market entry based on symptom improvement while simultaneously establishing the therapeutic value of disease progression inhibition. Under the standard Phase 3 pathway, approval would be sought through a Phase 3 trial with pain and joint function improvement at the 6-month timepoint as the primary endpoints, in accordance with the framework agreed upon at the FDA EOP2 meeting. The U.S. Phase 3 IND filing is planned for June 2026. Should the accelerated approval pathway be confirmed, the company targets a regulatory submission in August-September 2026, with a U.S. market launch targeted for the first half of 2027. The two strategies differ in clinical design and regulatory approach, and on this basis, Nature Cell is currently prioritizing the accelerated approval option as it prepares for the May FDA Breakthrough Therapy (BT) meeting.

The Phase 3 IND filing, originally scheduled for February 2026, has been adjusted to follow the FDA meeting. The company explained that clinical trial design may differ depending on whether accelerated approval is pursued, making prior consultation essential. The timeline adjustment, therefore, represents a strategic optimization to enhance the probability of clinical success, not a simple delay. Nature Cell plans to finalize the most approvable clinical design through thorough advance consultation with the FDA before submitting the IND.

In parallel with U.S. development of JointStem, Nature Cell is pursuing a NASDAQ listing via American Depositary Receipts (ADRs). Discussions with investment banks are currently underway, and the company has appointed Dr. Tae-Heum Jeong, an experienced investment professional, as Financial Advisor to systematically advance listing preparations. Through this appointment, the company aims to formalize its global capital market entry strategy and drive institutional investor engagement in earnest.

Nature Cell plans to file its NASDAQ listing application between September and November 2026, with a target of completing the listing in the first half of 2027. This timeline was established in consideration of JointStem 's clinical progress and the overall global fundraising strategy.

For global investor outreach, the company will execute a phased IR strategy. In June 2026, Nature Cell will conduct a roadshow across four major U.S. cities and participate in BIO International Convention (BIO US), the world 's largest biotech event. At this event, the company will pursue partnering discussions with global pharmaceutical companies while conducting IR sessions targeting approximately 100 investment firms to expand its global investor base. Following Phase 3 IND approval, a second global IR roadshow is planned for September 2026 to accelerate investment commitments.

Through this IR presentation, Nature Cell addressed market concerns regarding its development strategy and timeline, delivering the following key messages: the clinical timeline change is a strategic adjustment, not a development delay; the Breakthrough Therapy designation has strengthened the level of FDA engagement; accelerated approval, if granted, would enable an earlier market entry; and the company is actively pursuing corporate value enhancement through its NASDAQ listing and global IR activities. Nature Cell stated that it has entered the execution phase of its journey toward becoming a global stem cell leader.

Dr. Jeong-Chan Ra, Chairman of Nature Cell, stated: "JointStem has secured the foundation for close collaboration with the FDA through its Breakthrough Therapy designation. Based on counsel from the foremost FDA expert in this space, we are committed to establishing the viability of our accelerated approval strategy at the May meeting. " He added: "Nature Cell will advance toward becoming a global stem cell leader, driven by a competitively differentiated stem cell therapy in the global market. "

The upcoming milestones are as follows. The FDA BT meeting request was completed on March 18, 2026, with the FDA meeting scheduled for May 2026, to be followed by the Phase 3 IND filing. In June 2026, the company will conduct a U.S. IR roadshow and participate in BIO International Convention. A second global IR roadshow and investment engagement are planned for September 2026. The NASDAQ listing application is targeted for September through November 2026, with listing completion and U.S. market launch both targeted for the first half of 2027.

Nature Cell stated it will continue to disclose major development milestones and strategic updates as it advances toward becoming a global stem cell leader with a competitively differentiated stem cell therapy. Additionally, starting May 2026, the company plans to launch YouTube and Twitter channels to strengthen communication with shareholders, investors, and global stakeholders.

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SOURCE:Nature Cell

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