Published DATE: May 24th, 2022
NEXEL, a company specializing in human induced pluripotent stem cells (hiPSC), has officially embarked on the technical evaluation process in the second half of the year to prepare for its special technology exception listing on KOSDAQ. Despite the recently heightened entry barrier in a market listing for bio companies, there are high hopes for a positive outcome for NEXEL. This is mainly due to indicators such as its stable growth in sales, and its well-deserved recognition for its differentiated technological prowess, certified by the Korea Evaluation Institute of Industrial Technology (KEIT), as a company specializing in materials, parts, and equipment (MPE).
According to the industry reports on the 24th, NEXEL has recently been certified as a company specializing in MPE by KEIT. Overseen by KEIT under the Ministry of Trade, Industry and Energy, the MPE certification system was implemented in 2020 to ensure faster growth of companies in applicable fields.
A company affiliate stated, “NEXEL has a platform that can create and commercialize various somatic cells including myocardial cells through its hiPSC technology” and continued, “NEXEL has been certified as a company specializing in materials based on this technology, which is quite unorthodox for a bio company.”
NEXEL has also recently obtained certification (ISO/IEC 17025) from Korea Laboratory Accreditation Scheme (KOLAS) for its heart safety evaluation method using hiPSC-based myocardial cells. ISO/IEC 17025 is an official institutional certification system under the Framework Act on National Standards established by International Standard Organization (ISO). This certification is solid proof that NEXEL’s heart safety evaluation method is equipped with a quality management system and technological capability that meet international standards.
NEXEL is planning to undergo the technical evaluation process for the special technology exception listing on KOSDAQ in the second half of this year with its technological capability well-recognized in Korea, as well as overseas. While many bio companies have continuously failed to be listed on the market concerning the recently heightened technical evaluation criteria, NEXEL is expected to pass the technical evaluation with ease with its second-to-none technological capability. The IPO underwriter for NEXEL is NH Investment & Securities.
350% Increase in Sales This Year with KRW 2.7 Billion... Sales of JV Expected to Spike in the US
NEXEL’s annual sales are expected to amount to KRW 2.7 billion, which is a 350% YoY increase from last year. The company’s sales for the first quarter have already grown by 168% YTD. This is mainly due to the surge in sales of myocardial cells for testing toxicity in new drugs after founding Celogics, a joint venture (JV) with the US biotech company Curi Bio last year. Celogics is currently supplying myocardial cells to pharmaceutical companies, research labs, etc. in the US.
An increase in sales is also expected for NEXEL’s major business lineup, the cardiac safety evaluation service (NeXST). This is because the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) under the US Food and Drug Administration (FDA) is reviewing the inclusion of hiPSC-based myocardial cell utilization in its cardiac drug safety evaluation guideline (S7B/E14). NEXEL is currently the only company in Korea to participate in the revision of the cardiac drug safety evaluation guideline of ICH. NeXST is a method of electrophysiologically analyzing the effect of new drug candidates using hiPSC-based myocardial cells during new drug development, which are the most similar to actual cardiac cells. This method boasts its high accuracy compared to the traditional animal testing method.
A company affiliate stated, “Currently, 90% of the company sales are generated from the sale of myocardial cells, but we expect to witness a significant increase in NeXST sales after the guideline revision” and added, “In preparation, Celogics has built an 1858㎡ bio manufacturing facility in the suburbs of Seattle, US, and is planning to manufacture hiPSC-based myocardial cells from this facility.” He also added, “it has already been decided in Europe that, starting from August, myocardial cells will be utilized in cardiac drug safety evaluations” and continued, “After the guideline revision, the market will gradually shift towards the exclusive use of myocardial cells after a brief period of concomitant use of myocardial cells and animal testing.”
NEXEL is also developing two types of new bio drug pipelines from the secretion of hiPSS-based liver cells. The new protein drug NP-011 aims to treat non-alcoholic steatohepatitis (NASH), ST-segment elevation myocardial infarction-schemia/reperfusion injury (STEMI-IRI), and inflammatory bowel disease (IBD). STEMI-IRI indicant is currently undergoing phase I of a clinical trial in Australia and it is scheduled to undergo phase II of a global clinical trial in the first half of next year. NASH indicant is scheduled to begin its phase I of the clinical trial in Korea in the third quarter of this year. The new peptide drug NPT-0025 is currently undergoing non-clinical trials for idiopathic pulmonary fibrosis (IPF), and it is also undergoing proof of concept (PoC) for glaucoma.
Choongseong Han, CEO of NEXEL, stated, “NEXEL is currently executing its mid/long-term roadmap to secure a new growth engine based on its well-established existing businesses” and continued, “We will achieve our target sales this year and develop new stable drugs to firmly plant ourselves as the world’s leading bio company in the hiPSC technology.”