Corestem ChemOn Awaits Regulatory Decision, Pursues Precision medicine Strategy for Neuronata-R
Corestem ChemOn is currently awaiting a decision from the Ministry of Food and Drug safety (MFDS) regarding a requested change to the product license for its Neuronata-R treatment for Amyotrophic Lateral Sclerosis (ALS). The company submitted the submission in April, seeking to narrow the target patient population to a specific subgroup identified through biomarker analysis. This shift represents a “precision targeting” strategy following the initial global phase 3 clinical trial (ALSUMMIT), which did not demonstrate statistically critically important efficacy across the entire patient group.
Post-trial analysis revealed positive signals – improvements in function (ALSFRS-R), breathing (SVC), and reduced levels of NfL – within a “Slow Progressor” subgroup defined by NfL levels below 52 pg/mL. Corestem ChemOn is now focusing on this subgroup, believing a targeted approach offers a more effective path forward.Supporting this application is nearly a decade of real-world evidence (RWE) gathered from over 400 patients as the treatment’s conditional approval in 2015, intended to demonstrate long-term safety.
The MFDS began reviewing the application in April and requested supplementary data in July, extending the initial submission deadline from September 1st to October 31st. corestem ChemOn has confirmed it met the extended deadline and states the MFDS is currently conducting a detailed review.
the company disclosed the status of the MFDS review coinciding with a subscription period for existing shareholders (November 3-4), a move interpreted as an investor relations effort to encourage participation in a KRW 26.1 billion paid-in capital increase. Corestem chemon has stated the funds are primarily intended to support commercialization of the precision targeting strategy, now that most clinical risks have been addressed.
Of the KRW 26.1 billion raised, KRW 19.1 billion will be allocated to debt repayment, specifically for the 3rd and 4th exchangeable bonds (EB). The remaining KRW 6.2 billion will be used for operating expenses, including a KRW 5.5 billion FDA product approval application fee,completion of payments for equipment at the Osong ATMP Center,and outstanding CRO analysis costs (KRW 700 million).
Corestem ChemOn also recently addressed circulating rumors regarding the potential sale of its CRO division and abandonment of FDA approval plans, clarifying that these were listed as conservative risk factors in a securities report and do not reflect current business strategy. The company affirmed its commitment to strengthening both Neuronata-R’s commercialization and its non-clinical/CRO infrastructure to accelerate global market entry and enhance future business value.
