MEDIPOST disclosed on the 19th that, on a consolidation basis, last year's operating loss came to 67.9 billion won, up 40.0% from a year earlier. Revenue for the same period rose 4.2% to 73.6 billion won.
The company cited increased expense from progressing global clinical trials as the reason for the wider operating loss. With clinical expense for entry into the U.S. and Japan markets reflected, recurring research and development expense rose 30.5% from a year earlier. The completion of phase 3 in Japan and preparations to start phase 3 in the U.S. were the main factors.
In particular, advance investment related to the U.S. phase 3 accounted for a large portion. North American local contract manufacturing organization (CMO) expense took up the largest share, and funds were also put into patient enrollment through building infrastructure to operate clinical trial sites, training researchers, and preparing protocols.
In February, the degenerative knee cartilage stem cell therapy "CARTISTEM®" received approval for an investigational new drug (IND) application for a U.S. phase 3 clinical trial, and the company plans to conduct the trial with the goal of registering the first patient in the first half of this year.
In Japan, with phase 3 nearing completion, preparation of the final clinical study report (CSR) for a product approval application to the Pharmaceuticals and Medical Devices Agency (PMDA) is underway. The company is aiming to announce clinical results in the second quarter of 2026 and file for product approval in the second half.
It also built a foundation for commercialization. MEDIPOST signed an exclusive distribution agreement in December last year with Teikoku Pharma in Japan for CARTISTEM sales in Japan.
A MEDIPOST official said, "We have entered key stages of global expansion, including the start of a U.S. phase 3 and the wrap-up of a Japan phase 3," adding, "We will focus on securing mid- to long-term growth drivers."