EN Cell vows to provide multi-product, one-stop service at pre-IPO briefing

"EN Cell has a track record of multi-product cell and gene therapy (CGT) contract development manufacturing organization (CDMO) with world-class GMP capabilities. Our experience in multi-product manufacturing and history of winning regulatory-approved products is key to winning new CDMO projects, and we are an established CDMO company that has been in the CDMO business since its inception."

En Cell CEO Chang Jong-wook said so while stressing the company's differentiated strategy at a news conference before its initial public offering (IPO) at the Conrad Seoul Hotel in Yeouido on Tuesday. The company, which is set to be listed on the Kosdaq market revealed its growth strategy and vision at the event.

Founded in 2018 by CEO Chang, also a professor of convergence biomedical sciences at Samsung Institute of Convergence Biomedical Sciences of Sungkyunkwan University, EN Cell is a faculty startup company engaged in the CGT CDMO business, and the world's first new drug development business based on early lineage mesenchymal stem cell therapy (EN001).

It has established a collaborative system for the entire CGT cycle from drug development to patient administration with its strategic partner Samsung Medical Center. They have jointly won three national projects related to CGT drug development.

En Cell has built a GMP facility that can produce cell and viral vectors simultaneously, providing a “one-stop CDMO service.” The company has conducted 33 projects with 17 companies and has been designated a central cell processing center (CCPC) for CAR-T therapeutics by global pharmaceutical giants Novartis and Janssen. It also manufactures semi-finished products for commercial and conducting phase 3 clinical trials of B-cell lymphoma therapeutics.

EN Cell's cumulative CDMO sales totaled 24.2 billion won ($17.7 million), with a balance of stem cells, immune cells, adeno-associated virus (AAV), and exosomes. Last year, the company's sales totaled 10.5 billion won, up 43 percent from 2022.

In addition, EN Cell is developing EN001, a mesenchymal stem cell therapy. It features reducing the production cost through the mass acquisition technology of early-generation mesenchymal stem cells and reducing the culture time by about half to enhance the efficacy by inhibiting cell aging.

EN001 is being developed as a treatment for Charcot-Marie-Tooth disease (CMT), Duchenne muscular dystrophy (DMD), and sarcopenia, which lack a cure. It has received phase 1b, phase 1/2, and phase 1/2a approvals from the Ministry of Food and Drug Safety. For the Charcot-Marie-Tooth disease indication, the company aims to obtain conditional approval in 2026.

"We aim to be a model biotech company with a virtuous cycle of reinvesting CDMO business profits into new drug development,” CEO Chang said. “We will contribute to localizing therapeutic drugs and improving human health by innovating next-generation cell and gene therapy technologies based on GMP technology."

EN Cell plans to offer 1.56 million shares, with an offering price range of 13,600 won to 15,300 won. The offering size is expected to be between 21.3 billion and 24 billion won, resulting in an expected post-listing market capitalization of 127.2 billion won to 143.1 billion won.