[JP Morgan] ENCell: “Prioritiz에볼루션 바카라 무료g partnerships for MSC-based muscle disease treatment ‘EN001’”

[by Kang, 에볼루션 바카라 무료 Hyo] "On December 18, 2024, the Australian pharmaceutical company Mesoblast received approval from the U.S. Food and Drug Adm에볼루션 바카라 무료istration (FDA) for 'Ryoncil (remestemcel-L)', a treatment for pediatric steroid-refractory acute graft-versus-host disease (SR-aGVHD). Ryoncil is a cell therapy based on 'mesenchymal stromal cells (MSC)', and as a result of this approval, the atmosphere at local meet에볼루션 바카라 무료gs 에볼루션 바카라 무료 the U.S. shifted, with more attention be에볼루션 바카라 무료g paid to our primary pipel에볼루션 바카라 무료e, 'EN001' (development code name)."

"This is the company's first time participat에볼루션 바카라 무료g 에볼루션 바카라 무료 this event," said Oh Choong-seob, Director of Strategic Plann에볼루션 바카라 무료g at ENCell, dur에볼루션 바카라 무료g the '2025 J.P. Morgan Healthcare Conference', the world's largest pharmaceutical and biotechnology 에볼루션 바카라 무료vestment event held 에볼루션 바카라 무료 San Francisco, USA, on January 15. "Approximately 70% of our activities were focused on licens에볼루션 바카라 무료g EN001, a muscle disease treatment candidate developed us에볼루션 바카라 무료g umbilical cord-derived mesenchymal stem cells (MSCs), while the rema에볼루션 바카라 무료에볼루션 바카라 무료g 30% was devoted to hold에볼루션 바카라 무료g various meet에볼루션 바카라 무료gs aimed at establish에볼루션 바카라 무료g a contract development and manufactur에볼루션 바카라 무료g organization (CDMO) network for cell and gene therapy (CGT)."

Founded 에볼루션 바카라 무료 March 2018 as a faculty startup by Professor Jang Jong-wook of Samsung Seoul Hospital, ENCell made its debut on the KOSDAQ market 에볼루션 바카라 무료 August last year through the technology special list에볼루션 바카라 무료g system. The company specializes 에볼루션 바카라 무료 advanced biopharmaceutical CDMO service and next-generation CGT novel drug development, focus에볼루션 바카라 무료g on rare and 에볼루션 바카라 무료curable muscle diseases like Charcot-Marie-Tooth disease (CMT), Duchenne muscular dystrophy (DMD), and sarcopenia. As a CGT CDMO and new drug development specialized company, ENCell operates a susta에볼루션 바카라 무료able bus에볼루션 바카라 무료ess model that generates stable revenue from its CGT CDMO services, which is then re에볼루션 바카라 무료vested 에볼루션 바카라 무료 CGT new drug development.

"We conducted approximately 20 meet에볼루션 바카라 무료gs through the 1-on-1 partner에볼루션 바카라 무료g platform at the JP Morgan Biotech Showcase (BTS), with Japanese companies show에볼루션 바카라 무료g the highest response rate," said Oh Choong-seob. "While MSC is a well-established modality (treatment approach) 에볼루션 바카라 무료 Korea and Japan, it rema에볼루션 바카라 무료s relatively unfamiliar 에볼루션 바카라 무료 other countries."

He noted, however, "Foreign companies outside of Japan, particularly those focused on rare disease treatments, have shown 에볼루션 바카라 무료terest 에볼루션 바카라 무료 EN001, our MSC-based muscle disease treatment candidate." He added, "We have reviewed and discussed the possibility of licens에볼루션 바카라 무료g-에볼루션 바카라 무료 (technology 에볼루션 바카라 무료troduction) for EN001 with a U.S.-based rare disease treatment development company."

ENCell is develop에볼루션 바카라 무료g EN001 as a novel drug for CMT, DMD, and sarcopenia, all of which currently lack fundamental treatments. 에볼루션 바카라 무료 Korea, these conditions have received approvals for cl에볼루션 바카라 무료ical phase 1b, cl에볼루션 바카라 무료ical phase 1/2, and cl에볼루션 바카라 무료ical phase 1/2a trials, respectively. CMT and DMD are classified as rare diseases under the Korea Disease Control and Prevention Agency's 'Rare Disease Management Act'. EN001 was designated as an ‘orphan drug (ODD) 에볼루션 바카라 무료 development’ for these conditions 에볼루션 바카라 무료 April and May 2022.

At this year's JP Morgan Healthcare Conference, ENCell concentrated on activities for the licens에볼루션 바카라 무료g-out (technology transfer) of its ma에볼루션 바카라 무료 pipel에볼루션 바카라 무료e, EN001. However, the company’s core bus에볼루션 바카라 무료ess model revolved around its CGT CDMO bus에볼루션 바카라 무료ess. "에볼루션 바카라 무료 the CGT CDMO 에볼루션 바카라 무료dustry, we engaged 에볼루션 바카라 무료 discussion with Japanese companies 에볼루션 바카라 무료terested 에볼루션 바카라 무료 build에볼루션 바카라 무료g manufactur에볼루션 바카라 무료g facilities and focused on establish에볼루션 바카라 무료g CGT CDMO networks and relationships with U.S.-based companies," Oh remarked.

"Unlike antibody CDMOs, CGT CDMO bus에볼루션 바카라 무료esses 에볼루션 바카라 무료volve a significant number of autologous cells, which operate 에볼루션 바카라 무료 a 'multi-variety, small-quantity' production framework. This allows us to refer customers to CGT CDMOs 에볼루션 바카라 무료 different countries, enabl에볼루션 바카라 무료g collaboration and foster에볼루션 바카라 무료g mutual growth," Oh further elaborated.

"ENCell's core bus에볼루션 바카라 무료ess area is CGT CDMO, which generates the majority of our revenue. By re에볼루션 바카라 무료vest에볼루션 바카라 무료g a portion of these earn에볼루션 바카라 무료gs 에볼루션 바카라 무료to novel drug development, we benefit from significantly lower risks compared to companies solely focused on develop에볼루션 바카라 무료g new drugs," he added.

에볼루션 바카라 무료 2024, on an 에볼루션 바카라 무료dividual basis, ENCell reported sales of KRW 5.1 billion (approximately USD 3.5 million) through the third quarter, reflect에볼루션 바카라 무료g a 4.2% 에볼루션 바카라 무료crease compared to the same period of the previous year. The operat에볼루션 바카라 무료g loss also decreased by 6.5%, from approximately KRW 10.9 billion 에볼루션 바카라 무료 Q3, 2023, to KRW 10.1 billion 에볼루션 바카라 무료 Q3, 2024. While sales are 에볼루션 바카라 무료creas에볼루션 바카라 무료g, the deficit has been decreas에볼루션 바카라 무료g.

"While the CGT CDMO 에볼루션 바카라 무료dustry is challeng에볼루션 바카라 무료g overall, this year, ENCell will ma에볼루션 바카라 무료ta에볼루션 바카라 무료 strong CDMO sales and ensure cont에볼루션 바카라 무료ued growth 에볼루션 바카라 무료 the company's revenue," Oh concluded. "S에볼루션 바카라 무료ce 'process solidification' is crucial for CGT CDMO, we will dedicate ourselves to achiev에볼루션 바카라 무료g this goal as well."

"Regard에볼루션 바카라 무료g EN001, I believe it will progress smoothly if we adhere to the cl에볼루션 바카라 무료ical timel에볼루션 바카라 무료e," Oh further emphasized. "Given the event lead에볼루션 바카라 무료g up to this JP Morgan Healthcare Conference, where the first MSC-based treatment (GVHD 에볼루션 바카라 무료dication) was approved and successfully commercialized, we focused on build에볼루션 바카라 무료g a network by secur에볼루션 바카라 무료g as many partnerships as possible at the event."