STCube is on the verge of shedding its management risk designation after reducing its pre-tax loss ratio to 22.7 percent, a move that positions the company for an aggressive push in drug development and global partnerships. 

The Korean immunotherapy developer confirmed on Wednesday that the improvement clears regulatory hurdles, and once it submits its audit report in March, it will be officially removed from the watchlist.

The move follows a year of aggressive financial restructuring. The company raised 81.4 billion won ($56.6 million) through rights offerings and private placements in 2024, reinforcing its financial position as it accelerates drug development, particularly in oncology.

That same year, STCube also narrowed its net loss by 12.5 percent to 21.4 billion won in 2024 while increasing revenue by 93.9 percent to 11.3 billion won, driven by its cosmetics business and cost efficiencies from completing a phase 1 trial of nelmastobart in colorectal cancer, the company reported Tuesday. Additionally, its consolidated operating loss for last year decreased by 13.2 percent year-on-year to 22.6 billion won.

The improved financials have enabled STCube to accelerate its drug pipeline, including its phase 1b/2 trial of hSTTC810 (nelmastobart) in colorectal cancer and its ongoing phase 2 trial in small-cell lung cancer (SCLC)

Under Kosdaq regulations, companies are flagged as management risk stocks if their pre-tax net loss exceeds 50 percent of equity capital in at least two of the past three years. STCube fell into this category in 2023, after reporting pre-tax loss ratios of 69.2 percent in 2022, 36.9 percent in 2021, and 133.2 percent in 2020. 

By cutting that ratio to 22.7 percent in 2024, the company has not only resolved its regulatory burden but positioned itself for a more aggressive push into drug development and global partnerships.

CEO Jung Hyun-jin underscored the significance of 2025 as a pivotal year for STCube’s immunotherapy strategy. “We sincerely appreciate the trust and patience of our investors,” Jung said. “This year, we will focus on demonstrating the clinical utility of nelmastobart in the most promising treatment combinations while securing the best licensing opportunities in the global market.”

On Tuesday, STCube also submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) for a phase 1b/2 clinical trial of nelmastobart in metastatic colorectal cancer. The study, a company-sponsored clinical trial (SIT), will evaluate the drug’s efficacy and safety in patients who have shown resistance to standard chemotherapy.

The trial will be conducted at five university hospitals in Korea, including Korea University Anam Hospital. Patients will receive nelmastobart in combination with trifluridine/tipiracil (TAS-102) and bevacizumab (Avastin)—a regimen already considered one of the most effective treatments in late-line colorectal cancer. 

The phase 1b portion will determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), with dose-limiting toxicity (DLT) assessments expected in the first half of the year. The phase 2 study will measure progression-free survival (PFS) as the primary endpoint in patients with BTN1A1-positive tumors .

Nelmastobart targets BTN1A1, an immune checkpoint protein highly expressed across multiple tumor types. This could be a breakthrough in colorectal cancer, where PD-1/PD-L1 inhibitors benefit fewer than 5 percent of patients due to low biomarker expression.

STCube’s approach could significantly expand the reach of immunotherapy, as approximately 30 percent of colorectal cancer patients express BTN1A1 at high levels, making them strong candidates for nelmastobart.

“We’ve seen a clear correlation between BTN1A1 expression and treatment response,” said Yoo Seung-han, STCube’s chief scientific officer (CSO), emphasizing that phase 2 will selectively enroll BTN1A1-positive patients to maximize therapeutic benefit. “This trial is designed not just to validate efficacy, but to meet the standards of global regulators and potential commercial partners, building on the momentum from promising investigator-led studies.”

STCube has already generated strong early evidence supporting nelmastobart’s potential. 

In an investigator-initiated phase 1b trial across three U.S. and two Korean sites, nelmastobart showed promise in microsatellite stable (MSS) colorectal cancer, a group largely resistant to checkpoint inhibitors. Among 12 patients, the ORR hit 17 percent, with two partial responses and 10 cases of stable disease. At 16 weeks, the CBR reached 66.7 percent, highlighting its potential in BTN1A1-positive tumors. The data suggest BTN1A1 targeting could offer an alternative for patients unresponsive to PD-1/PD-L1 therapies.

Beyond the clinic, STCube is pushing forward with licensing-out deals for nelmastobart. At J.P. Morgan 2024, CSO Yoo held “pre-arranged one-on-one meetings with multiple global pharma companies,” a company official confirmed. While details remain confidential, the official said discussions have progressed beyond initial stages, signaling growing industry interest in nelmastobart’s potential.

The company is also moving quickly in lung cancer, where nelmastobart is currently in a phase 2 trial for SCLC. The study has been submitted to both the MFDS and the FDA, with plans to accelerate enrollment based on strong investigator-led data. The STCube official said the company is “pushing forward with this at a faster pace” after strong results from investigator-led studies. “The initial results have confirmed promising efficacy, so we are moving forward with a newly designed trial at an accelerated pace,” the official added.

STCube’s strategic shifts have not gone unnoticed by investors. The company’s November 2024 public offering saw an oversubscription rate of 19,834.19 percent, attracting 1.76 trillion won in deposits for an 8.9 billion won issuance.

This followed a 68.4 billion won shareholder rights offering, which saw a final subscription rate of 2,668.91 percent. Combined with a 13 billion won private placement in October, the company successfully raised 81.4 billion won in operating capital in 2024.