Biotech company MEDIPOST said on the 16th that it signed a funding agreement worth a total of 205 billion won.
The company plans to use the funds to finance the phase 3 U.S. clinical trial of the stem cell therapy "Cartistem."
The funding was raised through the issuance of convertible bonds (CB). This method issues bonds with rights that allow conversion into shares to raise capital. Investors receive interest income as bonds for a certain period and can convert them into shares depending on the conversion price and period.
The investment included Skylake Equity Partners, known as MEDIPOST's largest existing shareholder and long-term partner, Crescendo Equity Partners, and new domestic investors.
MEDIPOST plans to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) to proceed with a phase 3 U.S. clinical trial of the umbilical cord blood-derived mesenchymal stem cell therapy Cartistem (CARTISTEM®) for knee osteoarthritis. It aims to dose the first patient in the first half of next year.
The company also said it will accelerate commercialization efforts in the Japanese market. The phase 3 trial in Japan was completed in Nov. It plans to announce the clinical results in the first half of next year and apply for approval to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in the second half of the same year.
A MEDIPOST official said, "By signing this funding agreement, we have secured stable resources for the upcoming U.S. phase 3 clinical trial and commercialization," and added, "With Cartistem entering the U.S. phase 3 trial, full-fledged entry into the global market will begin."
Meanwhile, Cartistem is the world's first allogeneic umbilical cord blood-derived stem cell therapy developed by MEDIPOST. In 2012, it received marketing approval from the Ministery of Food and Drug Safety as a treatment for knee cartilage damage and was launched in Korea.