Caliway's CBL-514 Combination Therapy Cleared by U.S. FDA for Phase 2 Trial; Pivotal Phase 3 Trial SUPREME-01 Initiates Enrollment

• FDA IND Clearance for CBL-0201WR—Caliway has cleared its Investigational New Drug application for CBL-0201WR, a Phase 2 trial evaluating CBL-514 in combination with tirzepatide.
• U.S. IRB Approval for Pivotal Phase 3 Trial SUPREME-01 (CBL-0301)—The protocol amendment for the pivotal Phase 3 clinical trial SUPREME-01 has been approved by the North American central Institutional Review Board (IRB) in the US, officially initiating subject enrollment.
• CBL-514 "Visceral Fat Reduction" Data Selected for EASD Oral Presentation—Breakthrough research demonstrating CBL-514's efficacy in reducing visceral fat has been selected for an oral presentation at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) on September 30, 2026 (local time).

NEW TAIPEI CITY, Aug. 25, 2026 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company developing innovative small-molecule therapeutics, today announced two major clinical milestones in its new drug development program. The Investigational New Drug application for CBL-0201WR, a Phase 2 clinical trial combining its first-in-class local fat-reducing new drug CBL-514 with Eli Lilly's Zepbound® (Tirzepatide), has been cleared by the U.S. FDA. In addition, the pivotal Phase 3 clinical trial SUPREME-01, evaluating large-area abdominal fat reduction, has received approval from the IRB and has officially initiated enrollment.

CBL-0201WR Receives FDA Approval, Targeting Weight Regain and Stubborn Fat Post-GLP-1 Treatment

The CBL-0201WR study is a randomized, single-blind, placebo-controlled trial designed to "reduce abdominal subcutaneous fat in overweight or obese adults," with an anticipated enrollment of 120 subjects in the U.S. The trial will use magnetic resonance imaging (MRI) to precisely measure volumetric changes in abdominal subcutaneous fat volume to evaluate the efficacy, safety, and tolerability of CBL-514 combined with Tirzepatide. The exploratory endpoints will also assess key indicators such as body weight, visceral fat, and lean body mass.

With the growing popularity of GLP-1 receptor agonists, the global weight management markets are rapidly shifting towards a post-weight management era focused on "post-treatment maintenance," "body composition improvement," and "metabolic health." While current mainstream GLP-1 drugs effectively suppress appetite, they only temporarily shrink fat cells, leading to a high risk of weight regain and an inability to eliminate stubborn localized fat after discontinuation.

CBL-514's unique mechanism of "action selectively induces adipocyte apoptosis" fundamentally reduces the number of fat cells. The powerful combination of these two drugs is expected not only to help patients eliminate stubborn localized fat in areas like the abdomen on top of general weight loss but also to address the dual crisis of post-treatment weight rebound, potentially achieving a synergistic effect where 1 + 1 > 2. The clearance of CBL-0201WR IND marks CBL-514's formal expansion from local fat reduction into the post-weight management market centered on "post-treatment maintenance," "body composition improvement," and "metabolic health."

SUPREME-01 Initiates Enrollment, Aiming for World's First Non-Surgical Drug Approval for Large-Area Fat Reduction

Concurrently, significant progress has been made on the pivotal Phase 3 clinical trial SUPREME-01 which has received IRB approval in the U.S. and enrollment has now commenced.

This trial is designed to evaluate the efficacy of CBL-514 for large-area abdominal fat reduction. If the trial successfully meets its endpoints, CBL-514 could become the world's first and only revolutionary drug administered via non-surgical injection to achieve a 2-grade improvement on the Abdominal Fat Rating Scale (AFRS).

Academic Breakthrough Research Gains Further International Recognition, with Data on CBL-514's Combined Weight Loss and Visceral Fat Reduction Data Selected for EASD Oral Presentation

Beyond its outstanding clinical progress, Caliway's scientific advancements continue to receive top-tier global academic recognition. Integrating preclinical studies on CBL-514 combined GLP-1 drugs and Phase 2 clinical trial analysis "visceral fat reduction" has been selected for an 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, 2026 (local time) in Italy by W. Timothy Garvey, MD, an international authority in obesity medicine and a scientific advisor to Caliway. The presentation will unveil to the global medical community for the first time how CBL-514 precisely reduces MRI-measured L2-L3 visceral adipose tissue volume while simultaneously reducing subcutaneous fat.

Caliway Biopharmaceuticals stated that the concurrent advancement of the two key trials, CBL-0201WR and SUPREME-01, combined with the upcoming presentation of visceral fat data, fully demonstrates the company's strong execution capabilities in global clinical development and scientific validation. Looking ahead, Caliway will continue to deepen CBL-514's global footprint, aiming to provide a safer, more effective, and transformative treatment solution for patients worldwide suffering from obesity and metabolic diseases by leveraging its unique dual advantages of improving subcutaneous fat and metabolic indicators.

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.

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