CorestemChemon Advances Toward ALS Stem Cell Commercialization with Regulatory Progress in Korea and NSF-Backed U.S. Expansion

SEOUL, South Korea, Dec. 17, 2025 /PRNewswire/ -- CorestemChemon (KOSDAQ: 166480) is entering a critical late-stage phase in the commercialization of its ALS stem cell therapy, Neuronata-R. The company attributes this momentum to advanced domestic regulatory review in Korea, entry into an NSF-supported regenerative medicine ecosystem in the United States, secured commercialization capital, and a sizable open-market share purchase by the CEO.

Key Strategic Updates

• Progressing through an advanced MFDS review of a precision-targeted ALS subgroup strategy in Korea
• Selected to participate in the NSF-supported U.S. regenerative medicine innovation engine
• KRW 26.1 billion in commercialization capital secured, supporting manufacturing readiness and global regulatory preparation
• Approximately KRW 1.7 billion open-market share purchase by the CEO, reinforcing management conviction and shareholder alignment

Regulatory Progress and Commercial Readiness in Korea

In Korea, Neuronata-R is undergoing a product license modification review by the Ministry of Food and Drug Safety (MFDS). Following mixed efficacy results in the overall patient population in the Phase 3 ALSUMMIT trial, CorestemChemon refined its regulatory strategy to focus on a clinically defined "slow progressor" subgroup.

Post-hoc analyses in this subgroup showed clinically meaningful and internally consistent signals, including maintenance of ALS Functional Rating Scale-Revised (ALSFRS-R) scores, stabilization of slow vital capacity (SVC), and favorable trends in neurofilament light chain (NfL) biomarkers. The company believes these findings have supported a more structured and focused regulatory dialogue with the MFDS.

The company expects this precision-targeted approach to further clarify the domestic regulatory pathway, while preserving the option for initial commercialization upon potential approval. A favorable MFDS decision would enable domestic market entry and generation of real-world evidence (RWE), which could support future global regulatory strategies. The company expects a final regulatory decision in Korea before the first quarter of 2026.

Entry into NSF-Supported U.S. Regenerative Medicine Ecosystem

CorestemChemon has been selected to join the Piedmont Triad Regenerative Medicine Innovation Engine, a U.S. regional innovation cluster supported by the National Science Foundation (NSF). The company stated that it is the first Korean biotechnology firm to be included in an NSF-backed regenerative medicine ecosystem.

The selection was initiated by the Wake Forest Institute for Regenerative Medicine (WFIRM), which cited the scientific robustness of Neuronata-R's Phase 3 clinical dataset and the consistency observed in long-term real-world follow-up data. Participation in the NSF Engine is expected to provide access to translational research capabilities, manufacturing resources, and a broader regulatory network.

To align more closely with this ecosystem, CorestemChemon plans to relocate its U.S. subsidiary to North Carolina. The company intends to leverage the cluster as a platform for regulatory engagement with the U.S. Food and Drug Administration (FDA), targeting submission of a Biologics License Application (BLA) in the third quarter of 2026.

Commercialization Funding and Financial Position

To support commercialization readiness following potential domestic approval, CorestemChemon recently completed a rights offering, raising KRW 26.1 billion in operating capital (approximately USD 17.8 million, based on recent exchange rates). The proceeds are allocated to upgrading production facilities, establishing commercial-scale manufacturing systems, and preparing for both domestic and global regulatory processes.

The company expects the capital raise to strengthen its financial position and reduce execution risk associated with manufacturing scale-up and regulatory preparation, while addressing near-term funding concerns.

CEO Share Purchase Reinforces Management Conviction

In a move widely interpreted as reinforcing market confidence, CEO Yang Gil-ahn recently executed a large-scale open-market share purchase. Over a two-week period, he acquired more than one million shares, representing an investment of approximately KRW 1.7 billion (approximately USD 1.2 million, based on recent exchange rates).

The purchase coincided with the submission of supplementary regulatory materials to the MFDS and is viewed as a signal of management's conviction at a key regulatory inflection point. Following the transaction, the combined ownership stake of the controlling shareholder group increased to 10.32%, further strengthening alignment between management and shareholders.

Outlook

With continued domestic regulatory progress, secured commercialization capital, and a defined U.S. regulatory pathway supported by NSF-backed infrastructure, CorestemChemon is positioning Neuronata-R to transition from late-stage development toward initial market entry and real-world evidence generation. The company expects these milestones to support broader global expansion and long-term value creation.

SOURCE CorestemChemon Inc.