Caliway Advances Dual Global Phase 3 Program as SUPREME-02 Enrollment Begins

• SUPREME-02 Enrollment Initiated—Enrollment has commenced in SUPREME-02 (CBL-0302), Caliway’s second global pivotal Phase 3 trial evaluating CBL-514 for abdominal subcutaneous fat reduction. Together with the ongoing SUPREME-01 (CBL-0301) study, the two trials will generate key clinical data to support future NDA submissions.
• CBL-0206 Enrollment Ongoing in Taiwan and Australia—Patient enrollment continues across Taiwan and Australia in the Phase 2 CBL-0206 trial, supporting regional clinical development and expanding clinical data in Asian populations.
• New Combination Therapy Data to Be Presented at ObesityWeek 2026—Preclinical data demonstrated that CBL-514, in combination with either the GLP-1 receptor agonist semaglutide or the amylin receptor agonist eloralintide, provided additive weight-loss benefits and mitigated post-treatment weight regain.

October 29, 2026—Caliway Biopharmaceuticals (TWSE: 6919) today announced the initiation of enrollment in SUPREME-02 (CBL-0302), the Company's second global, multicenter Phase 3 pivotal trial evaluating CBL-514, its first-in-class investigational drug for the reduction of abdominal subcutaneous fat. The launch of SUPREME-02 marks another key milestone in Caliway's global development program and will complement the ongoing SUPREME-01 (CBL-0301) study. Together, the two pivotal Phase 3 trials are expected to generate the clinical evidence required to support future regulatory submissions for CBL-514.

Alongside its global Phase 3 program, Caliway is also advancing regional clinical development in the Asia-Pacific region through CBL-0206, an ongoing Phase 2 study currently enrolling participants in Taiwan and Australia.

SUPREME-02 Enrollment Begins as Global and Asia-Pacific Development Programs Advance

SUPREME-02 is a randomized, double-blind, placebo-controlled, multinational Phase 3 clinical trial designed to evaluate the efficacy, safety, and tolerability of CBL-514 for the reduction of abdominal subcutaneous fat.

The study is expected to enroll approximately 320 subjects across 30 to 35 clinical sites in the United States, Canada, and Australia. Eligible participants include adults with a body mass index (BMI) between 18.5 and 30 kg/m², body weight greater than 50 kilograms, and an abdominal fat rating scale (AFRS) score of Grade 3 or 4. The trial will assess treatment outcomes using both patient-reported and clinician-reported evaluation scales, supplemented by objective imaging assessments, including magnetic resonance imaging (MRI), to comprehensively evaluate treatment efficacy and safety.

Meanwhile, Caliway's Asia-Pacific Phase 2 clinical trial, CBL-0206, continues to enroll participants in Australia and Taiwan following implementation of protocol-related amendments. The study is expected to further expand clinical data in Asian populations and support future regulatory, commercialization, and partnering strategies across regional markets.

CBL-514 Combination Therapy Data to Be Presented at ObesityWeek 2026

Beyond its lead indication in localized fat reduction, Caliway continues to explore the broader therapeutic potential of CBL-514 in weight management and metabolic health.

New preclinical combination therapy data will be presented at ObesityWeek 2026, one of the world's leading scientific meetings focused on obesity research and treatment. The presentation, titled "CBL-514, an Adipocyte Apoptosis Inducer, Enhances GLP-1 Weight Management and Reduces Visceral Fat," will be delivered on November 15, 2026, in Washington, D.C. by internationally recognized obesity expert and Caliway Scientific Advisor W. Timothy Garvey, M.D.

The study will present preclinical data evaluating CBL-514 in combination with the GLP-1 receptor agonist (GLP-1RA) semaglutide and the amylin receptor agonist eloralintide. The findings will assess their effects on weight reduction and mitigation of weight regain following treatment discontinuation, further highlighting CBL-514's potential as a complementary therapy across multiple obesity treatment pathways, including GLP-1-, amylin-, and other emerging weight management mechanisms.


*About CBL-514
CBL-514 is a patented, first-in-class small-molecule 505(b)(1) injection developed by Caliway. It is designed to selectively induce adipocyte apoptosis to precisely reduce subcutaneous fat at the injection site without causing necrosis or damage to surrounding tissues or cells.

CBL-514 has demonstrated broad therapeutic potential across multiple indications, including non-surgical subcutaneous fat reduction and moderate-to-severe cellulite. A separate formulation, designated as CBL-514D, is being developed for the treatment of Dercum’s Disease, a rare disease. To date, more than 544 subjects have participated in clinical trials related to CBL-514. Across the 10 completed clinical trials with finalized statistical reports, all primary and key secondary efficacy endpoints have been met, demonstrating excellent safety and tolerability.

*About Caliway Biopharmaceuticals
Caliway Biopharmaceuticals Co., Ltd. (TWSE: 6919), founded in 2012, is dedicated to developing breakthrough therapeutics that redefine standards of care and transform clinical practices. Caliway aims to leverage Taiwan's robust pharmaceutical research and development capabilities to serve the global aesthetic medicine and biomedical markets. The company was officially listed on the Taiwan Stock Exchange (TWSE: 6919) on October 2, 2024.

*Disclaimer
This press release and related web pages contain forward-looking statements that are based on the Company's current expectations, forecasts, and assessments. These statements involve risks, uncertainties, and other factors beyond the Company’s control. Actual events or results may differ materially from those projected in these forward-looking statements due to various external factors. Caliway undertakes no obligation to update or revise any information in this press release.

*Media & Investor Relations Contact
ir@caliwaybiopharma.com