Caliway Biopharmaceuticals (6919) investor relations material

Business highlights

• Market capitalization reached US$4.9B with a cash position of US$287.5M as of June 30, 2026, and a robust patent portfolio with 215 applications and 109 granted patents, protecting assets up to 2045.

• Eight drug indications are in the pipeline, with 10 clinical trials and 544 enrolled participants, and all primary efficacy and safety endpoints met in completed studies.

• Leadership and advisory teams include industry veterans with decades of experience in biotech, clinical research, and global commercialization.

Clinical development and scientific achievements

• In 2026, multiple clinical milestones were achieved, including regulatory approvals and trial initiations across the US, Canada, Australia, Taiwan, and China.

• CBL-514 demonstrated significant efficacy in reducing subcutaneous and visceral fat, with results published in leading journals and presented at major international conferences (ECO, ADA, EASD).

• Phase 2 studies for Dercum's Disease and abdominal fat reduction met all primary endpoints, showing meaningful pain improvement and fat volume reduction.

Product pipeline and clinical programs

• CBL-514 is positioned as a first-in-class injectable inducing adipocyte apoptosis for localized fat reduction, cellulite, Dercum's Disease, and as a combination therapy with GLP-1RA for weight management.

• Nine clinical studies are ongoing across five countries, with over 1,000 subjects expected to be enrolled globally.

• Pivotal Phase 3 studies (SUPREME-01 & SUPREME-02) are recruiting in North America and Asia-Pacific, targeting ≥2-grade improvement in abdominal fat with MRI validation.