Kolon TissueGene(950160) caused confusion as key figures were recorded differently across a disclosure, press release, and presentation while unveiling the results of the U.S. phase 3 trial of its cell and gene therapy for osteoarthritis, "TG-C (formerly Invossa)."
The company explained it as a "simple error in the process of preparing the materials," but it left questions about whether basic verification procedures functioned properly as the internal analysis team directly released the clinical data externally. Some also noted that the "opacity in decision-making and business handling" that the court pointed out during the 2019 Invossa incident is still recurring.
◇ Numbers all over the place despite in-house analysis…verification system under scrutiny
Kolon TissueGene disclosed topline (key metric) results for the U.S. phase 3 trial of TG-C (TGC15302) on the 20th and held a press briefing on the 21st to explain the details.
However, the key figures differed from one set of materials to another that the company released to investors and the media.
The biggest confusion arose in the WOMAC total score assessing joint function. The summary table in the press briefing presentation listed the 12-month WOMAC change as -27.57 for the TG-C arm and -26.34 for the placebo arm. In contrast, the trend graph within the same presentation and the press release distributed the previous day showed -26.34 for the TG-C arm and -27.57 for the placebo arm, with the two arms' figures reversed.
The final figures disclosed on the Financial Supervisory Service's DART system were -27.61 for the TG-C arm and -26.54 for the placebo arm.
For the pain index (VAS), the press release and presentation listed -38.6 for the TG-C arm and -39.1 for the placebo arm, but the disclosure showed -38.7 and -39.2, respectively. The p-value for statistical significance also differed, with the disclosure showing 0.8322 and the presentation 0.8494.
Kolon TissueGene said it was a simple error that occurred while preparing materials after receiving the data from the U.S. subsidiary, and that the disclosure figures are the final data.
However, because the topline analysis for this trial was conducted directly by the company's internal analysis team rather than an external contract research organization (CRO), the discrepancy in figures across materials during public release raised questions about whether the internal approval system and data verification procedures functioned adequately.
◇ Gaps repeated even after "criminal acquittal"…lessons of Invossa forgotten?
This confusion also brings back the trust issue facing Kolon Group after the Invossa incident that rocked Korea's biotech industry in 2019.
Invossa was approved in 2017 as Korea's first gene therapy, but its marketing authorization was canceled after it was belatedly confirmed that the component recorded in the approval documents as "chondrocyte-derived cells" was actually kidney-derived cells (GP2-293).
From the approval application to sales and administration to more than 3,700 people, this fact was reflected neither in disclosures nor in the business report.
In the subsequent criminal trial, a final acquittal was confirmed for Kolon Group Honorary Chairman Lee Woong-yeol and employees on the grounds that it was difficult to conclude the company recognized the difference in cell origin at the time of approval.
However, the absence of criminal intent did not exempt the company from management responsibility.
At the time, the court noted in its ruling, "In the drug development process, where uncertainty is high, the opacity in the defendant company's decision-making and business handling exacerbated the problem."
In the process of announcing this phase 3 trial as well, key figures conflicted across materials, drawing criticism that the internal control gaps the court identified still have not been fixed.
Kolon TissueGene redistributed a revised press release reflecting the disclosure figures about six hours after the briefing, around 5 p.m.
◇ Backlash likely to spread across affiliates…"TG-C" dependence under test
Some say this confusion damaged market trust more than the clinical results themselves.
On the 21st, when the press briefing was held, Kolon TissueGene, Kolon Life Science, and holding company Kolon all hit the daily lower limit. At the briefing venue, some shareholders demanded a response and had a scuffle with company officials.
Brokerages also sharply cut expectations. Korea Investment & Securities Co. lowered TG-C's likelihood of approval (LOA) to 50%, down 45 percentage points from before, and reduced its risk-adjusted net present value (rNPV) from about 9.9 trillion won to 4.5 trillion won. It also downgraded its investment rating to "neutral."
Industry watchers also say that if TG-C's commercialization is delayed, the burden could spread across the group's biotech business. Currently, Kolon's biotech operations are effectively vertically integrated around TG-C, so delays in commercialization could affect asset value reassessments, additional fundraising, and operation of production facilities.
If the results of the second U.S. phase 3 trial (TGC12301), scheduled for release in October, fall short of expectations, a heavy burden of large-scale fundraising needed for additional trials would be unavoidable. The company plans to complete, by year-end, an effort led by Chief Medical Officer (CMO) Andy Wayman to identify the causes of this failure and, if necessary, to establish response measures such as additional trials.
However, Kolon TissueGene Chief Financial Officer (CFO) Kim Jeong-in said, "At this point, it is not the stage to discuss additional fundraising," adding, "If needed, we will consult with the largest shareholder (Kolon)."