<img src="https://ml.globenewswire.com/Resource/Download/7326396b-d69e-4cfd-be25-5b15a903a935?size=2" nborder="0" align="left" hspace="5" vspace="5" title="Kolon_TissueGene_Logo.jpg" alt="Kolon TissueGene"/><ul type="disc"><li style="margin-top:6pt; margin-bottom:6pt;">ACTiVION-II, the first of two US Phase 3 clinical trials, did not meet co-primary endpoints of VAS pain score and WOMAC® total score at Month 12</li><li style="margin-top:12pt; margin-bottom:6pt;">Results from ACTiVION-I, the second Phase 3 trial of TG-C targeting OA of the knee, anticipated in October 2026</li><li style="margin-top:12pt; margin-bottom:6pt;">Kolon TissueGene to further analyze complete ACTiVION-II data </li></ul> ROCKVILLE, Md., July 20, 2026 <a href="https://www.globenewswire.com" target="_blank">(GLOBE NEWSWIRE)</a> -- Kolon TissueGene, Inc. (“the Company”) (KOSDAQ: 950160), a biotechnology company developing novel advanced cell therapies for orthopedic diseases and other unmet medical needs, today announced topline results from the first of two US Phase 3 clinical trials of TG-C, a potential first-in-class cell and gene therapy targeting osteoarthritis of the knee (OAK). The Phase 3 ACTiVION-II study (<a href="https://www.globenewswire.com/Tracker?data=74D2b-ksauoP14FKwbMQCQGNsFBXbAd-J6Ve6-WcY-tcpVudHSiK5T0APxuSXYncyBB9e82g8yTKKaS4w_n4WBvMuBsr1gPEHImeu9V1ZVNTNZblmv9NIVd7riobiA_5" rel="nofollow" target="_blank" title="NCT03291470">NCT03291470</a>) evaluated the efficacy and safety of a single intraarticular injection of TG-C versus placebo in patients with Kellgren–Lawrence (KL) Grade 2 or 3 OAK. The Phase 3 ACTiVION-II study enrolled 531 randomized subjects across 27 U.S. clinical trial sites. TG-C did not demonstrate statistically significant improvements versus placebo in pain and function, and did not meet the co-primary endpoints of change from baseline in VAS (Visual Analogue Scale) pain and WOMAC® (Western Ontario and McMaster Universities Osteoarthritis Index) total score at Month 12. Additionally, the study did not meet any of the key secondary endpoints. TG-C was generally safe and well-tolerated with no new or unexpected safety signals identified. The overall incidence, severity, and pattern of treatment-emergent adverse events were comparable between the TG-C and placebo groups, with the majority of events reported as Grade 1 or Grade 2 in severity. The observed safety findings were consistent with the known safety profile of TG-C and did not indicate any clinically meaningful safety concerns. “While we are disappointed by the results from the first of two Phase 3 clinical trials of TG-C, we remain committed to advancing cell and gene therapy innovation targeting osteoarthritis of the knee,” said Moon Jong Noh, PhD, Co-CEO of Kolon TissueGene. Co-CEO of Kolon TissueGene, Seng Ho Jeon, added, “We are deeply grateful to the study participants, investigators and clinical trial sites for their contributions to the ACTiVION-II study over the last several years. We continue to analyze the full data set for additional insights and anticipate reporting results from the second Phase 3 clinical trial of TG-C in October 2026.” Topline results from ACTiVION-I, the second Phase 3 clinical trial of TG-C (<a href="https://www.globenewswire.com/Tracker?data=74D2b-ksauoP14FKwbMQCZFkBHnssSW99IgJrTqhJhzmS-89egDcF_tQPJCdaQNY_flBEKC4TKPa8GVN_NrApGdLiVD7zHNYVOqpBHfX0SK-rzQaorcE8fDpIROmKbuQ" rel="nofollow" target="_blank" title="NCT03203330">NCT03203330</a>) targeting OA in the knee, are anticipated in October 2026, after which Kolon TissueGene will determine next steps. About Kolon TissueGene, Inc. Kolon TissueGene, Inc., is a clinical stage biotechnology company developing first-in class cell and gene therapy candidates utilizing its cell-gene platform technology. The Company's lead product, TG-C, is an allogeneic cell and gene therapy candidate being evaluated in a Phase 3 clinical program, comprising two Phase 3 clinical trials, in the US under a Special Protocol Assessment (SPA) agreement reached with the US FDA. For additional information about Kolon TissueGene, Inc., please visit <a href="https://www.globenewswire.com/Tracker?data=hSJN89yGmM7msM0dsT5SgC6TGO5t72gYXqqGXw8YN6qvkEEV-Sq8zYMpj3fRkvVElBfjMvj9wk0bHYarahiU72tgLqu_DhkzJxTD7KPZK3I=" rel="nofollow" target="_blank" title="www.tissuegene.com">www.tissuegene.com</a>. About TG-C TG-C is a first-in-class cell and gene therapy targeting OA of the knee through a single intraarticular injection. As an allogeneic (off-the-shelf) therapy, TG-C could provide an alternative to traditional treatment and surgery, or delay the progression of OA to minimize the need for multiple surgical interventions. Phase 2 clinical trials held in the US have demonstrated pain relief and increased mobility, as well indicators towards decreased progression of OA and improvements in joint structure. In a concluded US Phase 2 clinical trial, TG-C also demonstrated a two-year improvement of pain and function. TG-C is being evaluated in a Phase 3 program comprising two Phase 3 clinical trials. SOURCE Kolon TissueGene, Inc. Contacts: Media and Investor Relations ICR Healthcare kolontissuegene@icrhealthcare.com <img alt="" src='https://ml.globenewswire.com/media/OWIzZDJhN2UtZjBkOC00ODE0LTkxNTQtYWNhYTQzM2VlODMxLTEzMzQ4NTctMjAyNi0wNy0yMC1lbg==/tiny/Kolon-TissueGene.png' referrerpolicy='no-referrer-when-downgrade' />

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Kolon TissueGene Reports Topline ACTiVION-II Phase 3 Clinical Trial Results for TissueGene-C (TG-C) Targeting Osteoarthritis (OA) of the Knee

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