[Kim Saemi, Edaily Reporter] South Korean biotech stocks saw sharp divergence on September 18, as Orum Therapeutics, Inc. plunged to the daily lower limit following another clinical setback, while ENCell Co., Ltd. and VUNO Inc. posted double-digit gains on patent and research news.

BMS Drops ORM-6151; Orum’s DAC Proof-of-Concept Back to Square One

According to KG Zeroin’s MP DOCTOR, Orum closed at 37,400 won, down 29.96%, after Bristol Myers Squibb (BMS) discontinued clinical development of ORM-6151, an acute myeloid leukemia candidate acquired from Orum. The stock had also hit the lower limit in the previous day’s after-hours market.

The reaction reflected more than just the loss of a single asset. The setback marked the second clinical-stage setback involving Orum’s core degrader-antibody conjugate (DAC) technology, raising uncertainty about the platform’s clinical proof of concept (PoC).

Orum discontinued a Phase 1 trial of ORM-5029 last year following a serious adverse event, while BMS has now halted Phase 1 development of ORM-6151 after reviewing patient data. The two candidates target HER2 and CD33, respectively, but both use Orum’s DAC technology to deliver a GSPT1 degrader.

ORM-6151 had been expected to provide external clinical validation of the platform. BMS acquired the program in 2023 for up to $180 million, including a $100 million upfront payment, and conducted Phase 1 trials in the United States, Europe, and Canada.

Orum’s next key candidate, ORM-1153, received U.S. Food and Drug Administration clearance for a Phase 1 trial last month but has not yet begun dosing patients. Other internal programs remain in the research or preclinical stages.

The financial impact may be secondary. Orum will lose up to $80 million in potential milestone payments, but does not have to return the $100 million upfront payment.

“This isn’t simply about losing one pipeline asset. Orum now has to demonstrate proof of concept (PoC) for its DAC platform all over again,” said a biotech industry official. “That puts the company’s valuation under pressure.”

ENCell Surges 26% as Patent News Sparks Trading Frenzy

ENCell surged to the daily upper limit of 6,820 won intraday before closing at 6,620 won, up 26.1%. Trading volume jumped to 2.77 million shares, about 182 times the previous day’s level.

The rally appeared to be driven by news that ENCell and the Samsung Life Public Welfare Foundation had secured a U.S. patent for mesenchymal stem cell culture technology. The technology, already used to manufacture EN001—ENCell’s investigational treatment for Charcot-Marie-Tooth disease type 1A (CMT1A)—is designed to suppress cellular aging while preserving stem cell differentiation and proliferation.

“This patent covers a core manufacturing technology for the stable production of high-quality source cells for EN001,” an ENCell official said, adding that it would strengthen global intellectual property protection for the drug candidate.

Still, the announcement did not involve newly developed technology or fresh clinical data. Rather, it secured U.S. intellectual property protection for technology already used in EN001’s manufacturing process, raising questions about whether the news alone justified a 26% jump in market value.

VUNO Jumps 16% on Month-Old Research

Medical AI company VUNO surged 16.3% to close at 5,030 won after announcing an AI model designed to predict atrial fibrillation risk using real-world data from its HATIV P30 portable electrocardiogram device.

The study analyzed 386,519 ECG recordings from 8,206 users. Unlike conventional ECG AI focused on detecting existing arrhythmias, VUNO’s model predicts the risk of atrial fibrillation within seven, 14, and 31 days based on a normal ECG. It achieved an AUROC of 0.787 for 31-day prediction, suggesting the potential to expand ECG AI from detection to prediction.

However, the findings were not new. They had already been published on August 20 in JMIR Medical Informatics. A separate analysis involved only 144 high-risk patients, with five newly detected cases of atrial fibrillation. The technology has also yet to secure new regulatory approvals or generate revenue.

“VUNO’s stock had fallen sharply following its decision to conduct a rights offering, so this news may have served as a catalyst for a short-term rebound,” said a medical device industry official.

VUNO announced on September 4 that it would raise 31.4 billion won through a rights offering to existing shareholders, followed by a public offering of any unsubscribed shares.