According to the company on the 8th, GI Innovation, which is pursuing a special listing for growth potential, is planning to submit a request for a KOSDAQ preliminary examination, which is a later procedure, to the Korean Exchange, and start IPO (public disclosure) in earnest.
Bio companies promoting the special listing of growth potential are evaluated by one or two technology evaluation agencies. Prior to the IPO, GI Innovation received technology evaluation from three technology evaluation agencies in order to convince investors about its technology. In the case of listing on special technology cases, two specialized evaluation agencies must obtain A grade and BBB grade or higher. The company explained that GI Innovation obtained a grade that exceeded the qualification requirements for listing on special technology by obtaining’A’ from all three specialized evaluation agencies.
GI Innovation is challenging to enter the KOSDAQ through a special listing of growth potential in the first half of this year. In the event of a special listing for growth potential, the organizer is responsible for the share price after the IPO and is obligated to take a put-back option (repurchase right). If the stock price flows after listing, the listing organizer is responsible for purchasing stocks at 90% of the offering price. It is a structure that actively protects the interests of general shareholders by taking responsibility for the stock price of IPO companies.
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Myung-ho Jang, CEO of GI Innovation, said, “Through this technical evaluation, we have been recognized for our high technology and growth potential. “We will spur research and development.”
GI Innovation’s main pipeline is GI-101, an immuno-cancer drug, and GI-301, an allergy treatment, produced using its own platform, GI-SMART technology. In 2019, GI-101 delivered 900 billion won to Shimshier, one of the top ten innovative pharmaceutical companies in China, and GI-301 transferred technology to Yuhan Corporation at 1.4 trillion won in 2020. In the case of GI-101, it achieved a feat of being selected as ‘2020 National R&D Excellence Achievements’ with the signing of an agreement with the global pharmaceutical company MSD to provide free immunotherapy kitruda for joint clinical trials.
GI Innovation completed a clinical trial plan (IND) submission to the Ministry of Food and Drug Safety and the US Food and Drug Administration (FDA) in January for a phase 1/2, global clinical trial for GI-101. The phase 1/2 clinical trial was given the KEYNOTE-B59 number from MSD, and various partnerships with MSD, such as jointly designing a clinical trial, are expected, the company explained.
Although the clinical trial of GI-101 is in its infancy, it will be conducted on a large scale with 400 patients with 12 solid cancers. Unlike the usual phase 1 clinical trial that only confirms the safety of the drug, it was designed as a seamless, basket-type phase 1/2 clinical trial to confirm anticancer activity in various cancer types. It consisted of four parts: single administration of GI-101, combined administration with MSD Kitruda (including a cohort of 7 carcinomas), combined administration of Lenbima, a multiple kinase inhibitor including VEGFR, and combination administration with radiotherapy.
Nam Soo-yeon, CEO of GI Innovation, said, “Recently, the development strategy of immune anti-cancer drugs has evolved. “It is absolutely necessary for rapid and strategic clinical development to strengthen the global competitiveness of GI-101, and MSD is conducting a joint clinical trial that provides free support of Kitruda for approximately 200 patients in 7 solid cancer cohorts. I said.