Caliway Announces First Patient Dosed in Global Phase 3 SUPREME-01 Trial of CBL-514; New Preclinical Data Accepted for Presentation at ObesityWeek 2026

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September 23, 2026—Caliway Biopharmaceuticals (TWSE: 6919) today announced that SUPREME-01 (CBL-0301), its global pivotal Phase 3 clinical trial evaluating CBL-514 for large-area abdominal fat reduction, has successfully dosed its first participant (First Patient In, FPI). The trial has now formally entered the treatment phase and continues to enroll participants across North America.

In addition, the Company announced that new preclinical combination therapy data (OI26) have been accepted for presentation at ObesityWeek 2026, one of the world's leading scientific conferences focused on obesity research and treatment. The findings suggest that CBL-514 has the potential to complement both currently available GLP-1 receptor agonists (GLP-1RAs) and emerging Amylin receptor agonists by enhancing weight-loss outcomes while reducing post-treatment weight regain.

First Patient Dosed in Global Phase 3 SUPREME-01 Trial

SUPREME-01 recently achieved its FPI milestone and has commenced active treatment. The study is designed as a randomized, double-blind, placebo-controlled Phase 3 trial and is expected to enroll approximately 320 participants across the United States and Canada.

The study's co-primary efficacy endpoints require a two-grade improvement in both the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS) and the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS). Together with MRI-based assessments as a key secondary endpoint, these measures form a comprehensive efficacy framework that integrates patient perception, physician evaluation, and objective imaging evidence. This approach is intended to better reflect clinically meaningful and patient-recognized treatment outcomes in real-world settings.

If SUPREME-01 successfully meets its predefined endpoints, CBL-514 could become the first pharmaceutical product worldwide to support a regulatory label claim based on a two-grade improvement in abdominal subcutaneous fat reduction, representing a new benchmark for non-surgical body contouring therapies.

New OI26 Data Highlight Potential of CBL-514 in Combination with Weight-Loss Therapies

GLP-1-based therapies have transformed the treatment landscape for obesity in recent years, while Amylin receptor agonists have emerged as a promising next-generation therapeutic class. Acting through complementary mechanisms that enhance satiety and slow gastric emptying, these agents are increasingly being developed alongside GLP-1 therapies to achieve greater and more durable weight-loss outcomes. However, post-treatment weight regain remains a significant challenge across the obesity treatment landscape

Unlike appetite-suppressing therapies, CBL-514 reduces adipose tissue by inducing adipocyte apoptosis, resulting in a direct reduction in fat cell number. This differentiated mechanism of action may complement existing weight-loss therapies and contribute to more durable treatment outcomes following discontinuation. To further explore these opportunities, Caliway has evaluated CBL-514 in combination with multiple classes of weight-management therapies across a series of preclinical studies.

The Company's latest preclinical study, OI26, evaluated the effects of CBL-514 in combination with the GLP-1 receptor agonist Semaglutide and the Amylin receptor agonist Eloralintide. Results demonstrated that CBL-514 delivered additive weight-loss benefits when combined with either agent and significantly reduced the degree of weight regain following treatment cessation. These findings further support the potential of CBL-514 to serve as a complementary therapy alongside both current and next-generation obesity treatments. The abstract has been accepted for presentation at ObesityWeek 2026, which will be held in Washington, D.C. this November.

In addition, Caliway previously announced on August 25 that integrated findings from its preclinical GLP-1 combination studies and a Phase 2 clinical study evaluating visceral fat reduction were selected for oral presentation at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD). The presentation will be delivered on September 30 by the Company's Scientific Advisor, W. Timothy Garvey, M.D. MRI analyses showed that, in addition to its established effects on subcutaneous fat reduction, CBL-514 also produced significant reductions in visceral fat volume compared with controls. With the initiation of patient dosing in SUPREME-01 and continued recognition from leading international scientific conferences, Caliway remains committed to advancing the global development of CBL-514 and unlocking its potential across aesthetic medicine, weight management, and metabolic health.


*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