Caliway Biopharmaceuticals (6919) Investor presentation summary

Clinical pipeline and scientific progress

• Advanced multiple clinical programs, including CBL-0206 Phase 2 in Asia-Pacific and CBL-0302 pivotal Phase 3 studies, with regulatory approvals and IND submissions in Australia, Taiwan, Canada, and the US.

• Published positive Phase 2 results for Dercum's Disease in JAAD International, showing significant reduction in painful lipomas and pain improvement.

• CBL-514 Phase 2b results accepted by leading medical aesthetics journals, with preclinical combination data selected for major international congress presentations.

• Expanded advisory network with global experts in obesity and metabolic medicine.

• Cash position of NT$9.41 billion as of March 31, 2026, supporting ongoing and future development.

Company overview and leadership

• Market cap of approximately US$5 billion, with inclusion in MSCI Global Standard and FTSE TWSE Taiwan 50 Index.

• Robust patent portfolio with 188 applications and 107 granted patents, protecting assets up to 2045.

• Leadership team with decades of experience in biotech, drug development, commercialization, and finance.

• Advisory team includes renowned dermatologists, plastic surgeons, and metabolic disease experts from the US, Canada, Germany, and Asia.

Lead asset CBL-514: mechanism, efficacy, and safety

• CBL-514 is a first-in-class injectable for large-area, non-surgical precision fat reduction, inducing adipocyte apoptosis for targeted fat loss.

• Demonstrated complementary effects with GLP-1R agonists, achieving greater weight loss and improved maintenance in preclinical studies.

• Validated in over 500 patients across two Phase 2b studies, meeting all primary and secondary endpoints, with results published in top journals.

• Achieved up to 82.6% ≥1-grade improvement and 61.1% ≥20% fat volume loss in clinical trials, with significant improvements after just one treatment.

• Safety profile shows most adverse events were mild or moderate, primarily injection site reactions, with no systemic safety concerns.