[Edaily Reporter KIM SAE-MI ] On the 18th, the biotech sector was rocked by the shock of #Orum Therapeutics, Inc.’s decision to halt clinical development. Amid this turmoil, some stocks—including #ENCell Co., Ltd. and VUNO, Inc.(338220) —stood in stark contrast, surging by double digits on the back of patents and research achievements.

Even BMS Halts Development… Orum Therapeutics,

Inc.’s

DAC Platform ‘PoC’ Back to Square One

According to KG Zeroin MP DOCTOR on that day, Orum Therapeutics

,

Inc. closed at 37,400 won, a sharp drop of 16,000 won (29.96%) from the previous trading day.

This was in the wake of news, released after the market closed the previous day, that Bristol-Myers Squibb (BMS) had halted clinical development of “ORM-6151,” an acute myeloid leukemia (AML) treatment candidate it had licensed from Orum Therapeutics, Inc. Orum Therapeutics, Inc. had also hit the daily price limit down in after-hours trading the previous day.

The fact that this development halt immediately drove Orum Therapeutics, Inc.’s stock price to the daily limit-down was not merely due to the loss of a single pipeline asset. Rather, it was because Orum Therapeutics, Inc.’s core technology—the degradation-controlled conjugate (DAC)—suffered its second setback in the clinical phase, heightening uncertainty regarding the clinical proof of concept (PoC) for the platform itself.

Following the suspension of the Phase 1 clinical trial for “ORM-5029,” which it had been developing in-house last year, Orum Therapeutics, Inc. has now also halted development of “ORM-6151,” for which Bristol-Myers Squibb (BMS) was conducting a Phase 1 clinical trial. Although the two candidate compounds target different molecules, they share the common feature of utilizing Orum Therapeutics, Inc.’s core DAC technology.

ORM-5029 was designed to deliver a GSPT1 degrader by targeting HER2, while ORM-6151 targeted CD33 and utilized the same GSPT1 degradation mechanism. Development of ORM-5029 was halted after a serious adverse event occurred during the clinical trial, while BMS decided to discontinue further development of ORM-6151 after reviewing clinical data collected from actual patients.

In particular, ORM-6151 was a candidate drug that Orum Therapeutics, Inc. had high hopes for as a key asset to clinically validate its platform. In 2023, BMS acquired ORM-6151 for a total of $180 million (252 billion won) and paid an upfront payment of $100 million (140 billion won), after which it directly conducted Phase 1 clinical trials in the U.S., Europe, and Canada. With BMS now abandoning ORM-6151, expectations for the clinical validation of the DAC platform through a major external pharmaceutical company have effectively been reset to square one.

There is currently no clinical data available to fill this gap. The company’s next flagship candidate, “ORM-1153,” received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) last month and is preparing to begin Phase 1 clinical trials within the year, but it has not yet reached the patient dosing stage. The rest of the company’s in-house pipeline is in even earlier stages of research and preclinical development.

Some analysts suggest that the financial loss is actually a secondary concern. While BMS’s decision to halt development means Orum Therapeutics, Inc. will forgo up to $80 million (112 billion won) in additional milestone payments, the company is under no obligation to return the $100 million advance payment it has already received.

A biotech industry insider commented, “For Orum, this incident means not only the loss of a single pipeline but also the need to re-validate the proof of concept (PoC) for its DAC platform from the beginning,” adding, “Consequently, the company’s valuation has been shaken as well.”

Trading Volume Surges 182-Fold on a Single U.S. Patent… ENCell Co., Ltd. Shares Soar 26%

On that day, ENCell Co., Ltd.’s stock price briefly hit the daily upper limit of 6,820 won during trading on news of the U.S. patent, eventually closing at 6,620 won—up 1,370 won (26.1%) from the previous day. Notably, ENCell Co., Ltd.’s trading volume surged to 2,771,738 shares, reaching 182 times the previous day’s volume (15,268 shares).

The surge in the stock price is believed to have been driven by news of the decision to grant a U.S. patent for mesenchymal stem cell culture technology jointly filed by ENCell Co., Ltd. and the Samsung Life Insurance Public Welfare Foundation. This technology involves culturing stem cells in a way that suppresses aging while maintaining their differentiation and proliferation capabilities; it is applied to the manufacturing process of “EN001,” a treatment for Charcot-Marie-Tooth disease type 1A (CMT1A) currently under development by ENCell Co., Ltd. With this patent, ENCell Co., Ltd. has secured U.S. rights to the technology for producing the raw cells used in EN001.

ENCell Co., Ltd. official stated, “This patent is a core manufacturing technology for the stable production of high-quality source cells for EN001,” adding, “Together with the previously registered patent on the therapeutic mechanism, it provides multi-layered protection for EN001’s global rights, and we will accelerate the development of treatments for rare diseases, including CMT1A, based on our collaboration with Samsung Life Insurance Public Welfare Foundation.”

However, some observers point out that it is necessary to assess whether this patent represents a fundamental change significant enough to instantly boost ENCell Co., Ltd.’s enterprise value by 26%. This is because the patent secures U.S. intellectual property (IP) rights for technology already in use in the EN001 manufacturing process, rather than for newly developed technology or clinical data.

VUNO, Inc.’s Stock Jumps 16% on News of a Paper Published a Month Ago

On that day, medical AI company VUNO, Inc. closed at 5,030 won, up 705 won (16.3%) from the previous day. This surge is believed to have been driven by news that the company developed an AI model to predict the future risk of atrial fibrillation using real-world data collected by its portable electrocardiograph, the “HATIV P30.”

This study utilized 386,519 ECG readings taken by 8,206 HATIV users between March 2023 and November 2024. While existing portable ECG AI systems have focused on detecting arrhythmias occurring at the time of measurement, VUNO, Inc. has developed a model that predicts the risk of atrial fibrillation occurring within the next 7, 14, or 31 days based on a single normal ECG reading. The company explained that the model’s performance (AUROC) in predicting atrial fibrillation within 31 days—which recorded a value of 0.787—demonstrates the potential to expand the scope of ECG AI applications from “detection” to “prediction.”

However, today’s announcement does not represent a new research achievement. The findings were already published on the 20th of last month in the international academic journal *JMIR Medical Informatics*. Furthermore, in a separate analysis of high-risk patients, only 5 out of 144 were newly diagnosed with atrial fibrillation. This is why it is difficult to view this as a result that will immediately lead to new revenue or regulatory approvals.

A source in the medical device industry commented, “Given that VUNO, Inc.’s stock price had fallen significantly following the announcement of the capital increase, I suspect this news may have served as a catalyst for a short-term rebound in the stock price.” Previously, on the 4th, VUNO, Inc. had decided to conduct a capital increase worth 31.4 billion won through a rights offering followed by a public offering of unsubscribed shares.