Bold Therapeutics is a clinical-stage biopharmaceutical company based in Vancouver, British Columbia, founded in 2018 to develop and commercialize BOLD-100, a first-in-class small molecule therapeutic for oncology applications.

Currently, Bold Therapeutics is advancing BOLD-100 as a novel anti-cancer therapy. The company successfully completed a Phase 1/2a clinical study in advanced gastrointestinal cancers (including late-line gastric, pancreatic, colorectal, and bile duct cancers) in combination with FOLFOX in Canada, Europe, South Korea and the US.

A key finding from the Phase 1/2a study was the unexpected yet significant reduction in Oxaliplatin-Induced Peripheral Neuropathy (OIPN) when BOLD-100 was combined with FOLFOX. Encouraged by its enhanced efficacy and safety profile, Bold Therapeutics is now advancing pivotal studies in earlier lines of treatment for these difficult-to-treat cancers. The company is currently conducting a second-line metastatic colorectal cancer (mCRC) trial in Canada, Europe, and South Korea, designed to align with the FDA’s Project Optimus while also gathering additional data on OIPN reduction. In early 2026, Bold Therapeutics will initiate a Phase 2/3 study in second-line metastatic bile tract cancer (mBTC) in combination with FOLFOX and a Phase 3 first-line mCRC trial combining FOLFOX with either a VEGFi or EGFRi.

Preclinical studies have shown that BOLD-100 significantly improves outcomes across a broad range of indications when used in combination with both traditional chemotherapy and targeted therapies. A Phase 1 monotherapy dose-escalation study confirmed that BOLD-100 is generally safe and well-tolerated, supporting its potential for combination therapy in cancer treatment.