[Edaily Reporter KIM SAE-MI ] “Right up until two days before we learned of the TG-C Phase 3 clinical trial topline data, I was still meeting with companies that could immediately commercialize the product. I myself only found out about the data recently, on the 18th.”

Kolon TissueGene, Inc.(950160) Jeon Seung-ho, Co-CEO of Kolon TissueGene, made these remarks at a press conference on the TG-C Phase 3 clinical trial held on the 21st. He denied the possibility that management had prior knowledge of the results immediately before the official announcement.

One of the key issues raised at the press conference that day was the possibility of a preemptive leak of the clinical data. In the market, suspicions arose that clinical results may have leaked externally during the statistical analysis process at the U.S. headquarters of KOLON CORPORATION, Inc., given that Kolon TissueGene, Inc.’s stock price plummeted by 20.28% on the 16th. The fact that the statistical analysis of the TG-C clinical trial’s top-line data was conducted by the company’s internal statistics team rather than an external contract research organization (CRO) also fueled skepticism.

CEO Jeon dismissed the allegations, stating, “I believe the claims that internal information was leaked are completely groundless,” and added, “I confirmed the results on the 18th, two days before the official announcement, and shared the details for the first time at the board meeting that same day.” He continued, “I believe such a thing could not have happened because we have maintained strict security measures.”

Based on CEO Jeon’s explanation in response to additional inquiries from Edaily, two members of the statistics team at the U.S. headquarters were the first to review the topline data, after which the initial analysis results were shared with CEO Jeon and Co-CEO Noh Moon-jong. At the board meeting held that same day, the relevant information was conveyed to board members including Vice Chairman Lee Kyu-ho, Jan Van Acker, and Robert Yuen Lee Ang, after which the public disclosure process proceeded.

It is also noteworthy that there was a two-day gap between the 18th—when the company’s management and board of directors officially acknowledged the topline results—and the 20th, the “date of occurrence” stated in the disclosure. The company maintains that there were no issues with the disclosure process. A Kolon TissueGene, Inc. official explained, “The ‘date of occurrence’ stated in the disclosure was determined after sufficient prior consultation with the Korea Exchange.”

Some market observers have also raised the possibility that clinical data may have been leaked to the outside since early May. According to ClinicalTrials, Trial 15302 (NCT03291470) was marked as “Completed” on May 6. The fact that Kolon TissueGene, Inc.’s stock price subsequently turned downward has fueled these suspicions. Kolon TissueGene, Inc.’s stock price had reached a one-year high of 149,000 won during intraday trading on May 12 before continuing its downward trend.

In response to these suspicions, Kolon TissueGene, Inc. refuted the claims, stating, “That is absolutely not the case,” and added, “May was a period when stock prices across the entire biotech sector were performing poorly, and Kolon TissueGene, Inc.’s trading volume was low at the time.”

Although Edaily requested disclosure of the database lock-up date, the date the blind period was lifted, and the timing of the initial analysis results, the company indicated that it would be difficult to disclose this information. It was also determined that the company did not conduct a separate internal investigation or review of suspicious trading records. The company maintains that the likelihood of a leak is low because it strictly restricted access to the information in advance.

Former CEO Jeon emphasized, “We managed access to clinical information by those who needed to know on a very strict basis.” However, some point out that simply explaining that access was restricted is insufficient to fully dispel market doubts. This is because, to objectively verify the possibility of a leak, it is necessary to examine the database lock-up date, the unblinding date, the date the initial analysis results were generated, data access logs, and the stock trading records of those involved.

In particular, the fact that some figures differed between the presentation materials disclosed at the press conference on the 21st and those listed in public disclosures and press releases has raised questions about the company’s data verification and management systems. Given that clinical results themselves are sensitive information that significantly impacts the market, there is a need for greater transparency in disclosing the consistency of figures and data management procedures—from analysis through public disclosure.

Former CEO Jeon is regarded as a leader with strengths in business development (BD) and commercialization. When he was appointed CEO of Kolon TissueGene, Inc., expectations began to grow in the market that the clinical success and commercialization of TG-C were imminent. Jeon himself maintains that he joined the company with confidence in the potential for clinical success.

He remarked, “The fact that I joined Kolon TissueGene, Inc. even though the commercialization of TG-C had not yet been confirmed shows just how confident I was in its clinical success,” adding, “The previous domestic Phase 1, 2, and 3 trials, as well as the U.S. Phase 2 trial, were conducted using evaluation criteria and protocols nearly identical to those of this current U.S. Phase 3 trial, and since we had confirmed clear efficacy at that time, I believed it would succeed.”

Former CEO Jeon explained that he believed the difference observed between the treatment group and the control group in past clinical trials would be sufficiently replicated in this trial as well. He said, “If a 15-point difference was observed in a trial involving 100 patients, that would be a statistically enormous difference,” adding, “Since this trial has a larger patient population, I judged that even a difference of about 6 points between the two groups would be sufficient to achieve statistical significance. I had no doubts whatsoever.”

As the number of patients increases, the likelihood of random variation in the results decreases, making it more likely that even relatively small differences will be recognized as statistically significant. Given that a difference of about 15 points had been observed between the drug group and the control group in previous small-scale clinical trials, CEO Jeon believed that in a large-scale Phase 3 trial, meeting the primary endpoint would be possible even if a smaller difference—around 6 points—were replicated.

However, in the actual 15302 trial, although the TG-C treatment group showed improvements in pain and function, the placebo group also exhibited stronger-than-expected and long-lasting improvements, resulting in a failure to achieve statistical significance between the two groups. CEO Jeon described this as “half a success,” but the market’s reaction was lukewarm. Kolon TissueGene, Inc.’s stock price hit the daily price limit down for three consecutive trading days before barely avoiding the limit down on the fourth day.

The market continues to demand verification not only of the clinical results but also of the transparency throughout the entire process of data generation, sharing, and disclosure. A biotech industry official stated, “Since the company reportedly analyzed the topline data internally, concerns about information leaks keep arising,” adding, “It seems the company needs to clearly address these suspicions.”

◇Profile of Jeon Seung-ho, Co-CEO of Kolon TissueGene, Inc.
△Born in October 1975
△Graduated from the Department of Pharmacy, Seoul National University
△Master’s and Ph.D. in Pharmaceutical Sciences, Yonsei University
△March 2018–March 2025: CEO of DAEWOONGPHARMACEUTICAL
△March 2025–Present: Full-time Advisor, KOLON CORPORATION
△March 2025–Present: Co-CEO of Kolon TissueGene, Inc.
△March 2026–Present: CEO of KOLON CORPORATION Pharmaceutical