Bold Therapeutics Reaches Enrollment Midpoint in Randomized Phase 2 Trial of BOLD-100 in Second-Line Metastatic Colorectal Cancer

VANCOUVER, BC, Oct. 15, 2026 /PRNewswire/ -- Bold Therapeutics, a clinical-stage biopharmaceutical company developing novel metallotherapeutics for difficult-to-treat cancers, today announced the enrollment of 60 patients in Arm VII of its Phase 2 BOLD-100-001 trial (NCT04421820). Arm VII evaluates BOLD-100 in combination with FOLFOX-based chemotherapy in patients with second-line metastatic colorectal cancer (mCRC).

Arm VII is a randomized, controlled study comparing two dose levels of BOLD-100 (500 mg/m² and 625 mg/m²), each given with FOLFOX-based standard of care (SOC), against FOLFOX-based SOC alone. The study evaluates efficacy, safety, and tolerability. With 60 patients enrolled, Arm VII has reached the midpoint of its planned enrollment of 120 patients. This milestone triggers a pre-specified interim analysis comparing outcomes across the three treatment groups. The Company expects interim results before the end of 2026.

Bold is currently enrolling patients across more than 25 clinical sites in Canada, South Korea, Ireland, Germany, Italy, Spain, and the United Kingdom. This diverse global cohort supports the ongoing clinical development of BOLD-100 for an indication with significant unmet medical need.

"Second-line metastatic colorectal cancer remains a difficult-to-treat disease. Patients who progress after first-line treatment need access to innovative therapies like BOLD-100 as outcomes in this setting remain poor," said Dr. Grainne O'Kane, Professor of Medical Oncology, St. Vincent's University Hospital, Dublin, Ireland. "Reaching the enrollment midpoint of this clinical trial is an important step. The interim analysis will give us a first look at how BOLD-100 performs alongside standard chemotherapy."

"This milestone reflects the commitment of our employees, investigators, site teams, and the patients and families who chose to take part in this study," said Glenn Walthall, Chairman and Interim CEO of Bold Therapeutics.

Bold Therapeutics will attend BIO-Europe 2026 in Cologne, Germany, from November 9 to 11, where the Company will meet with current and prospective collaborators. The Company plans to share interim data from Arm VII in partnering meetings at the event.

About Bold Therapeutics

Bold Therapeutics is a clinical-stage biopharmaceutical company developing metallotherapeutic medicines for hard-to-treat gastrointestinal cancers. The company is based in Vancouver, British Columbia. For more information, visit bold-therapeutics.com.

About BOLD-100

BOLD-100 is a ruthenium-based small molecule. It acts on GRP78, a protein cancer cells depend on to manage cellular stress, and raises reactive oxygen species inside tumor cells, causing DNA damage and cancer cell death. BOLD-100 is in a randomized Phase 2 trial in second-line metastatic colorectal cancer.

Forward-looking statements

This news release contains forward-looking statements, including statements about the clinical development of BOLD-100 and anticipated milestones. These statements reflect current expectations and involve risks and uncertainties that could cause actual results to differ materially. The company undertakes no obligation to update these statements, except as required by law.

Contact
Jim Pankovich, EVP
(604) 262 – 9899
[email protected] 

SOURCE Bold Therapeutics Inc.