Backed by International Authority — Caliway's latest preclinical data on its proprietary localized fat reduction candidate, CBL-514, in combination with GLP–1R–based weight–loss therapies, were presented at the American Diabetes Association 2026 Scientific Sessions (ADA 2026). The findings were delivered by Timothy Garvey, MD, an internationally renowned expert in obesity and metabolic medicine and a scientific advisor to Caliway, garnering significant interest from global experts and multinational pharmaceutical companies.

Attenuation of Post–Discontinuation Weight Regain — The newly disclosed OI25 animal study confirmed that CBL–514 combined with GLP–1R–based therapies achieved superior weight loss compared to monotherapy. Following treatment cessation, weight regain in the monotherapy group was 2.7 times that observed in the CBL–514 combination group, underscoring the potential of combination therapy to mitigate post–discontinuation weight rebound.

Improvements Across Multiple Metabolic Parameters — The data further demonstrated that adding CBL–514 to tirzepatide resulted in an additional 106.7% reduction in hepatic lipid content relative to tirzepatide alone, along with marked improvement in the HOMA–IR index of insulin resistance. These findings expand the scientific value of CBL–514 beyond localized fat reduction into the domains of weight management and metabolic health.

NEW TAIPEI CITY, June 11, 2026 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919) announced on June 10 that the latest preclinical study data on its first–in–class, large–area localized fat reduction drug candidate, CBL–514, in combination with the GLP–1R–based weight–loss therapy tirzepatide, were presented at the American Diabetes Association 2026 Scientific Sessions (ADA 2026), one of the world's premier clinical medicine conferences.

The presentation was delivered by Dr. Timothy Garvey, MD, a scientific advisor to Caliway and an internationally recognized authority in obesity and metabolic medicine. Dr. Garvey shared with global experts in diabetes, obesity, and metabolism, as well as leading international pharmaceutical companies, the latest breakthrough findings on CBL–514's applications in weight management and metabolic health.

The ADA Scientific Sessions is among the most authoritative international medical congresses in the field of diabetes, obesity, and metabolic diseases, convening more than 12,000 clinicians, researchers, and industry representatives annually. It serves as a premier platform for major pharmaceutical companies to identify emerging trends and innovative mechanisms in metabolic therapeutics. Dr. Garvey is a Professor of Endocrinology and Obesity Medicine at the University of Alabama at Birmingham (UAB) and has long chaired the development of multiple U.S. clinical guidelines on obesity and metabolism. His presentation further elevated the international academic visibility of CBL–514 and reinforced its substantial application potential in obesity and metabolic health.

First Disclosure of OI25 Data: Post–Discontinuation Weight Regain Reduced 2.7–Fold

The focal point of this ADA presentation was the first–time disclosure of the OI25 animal study data. The study evaluated the post–discontinuation weight maintenance effect of CBL–514 in combination with the GLP–1R–based weight–loss therapy tirzepatide, directly addressing a critical limitation of currently marketed weight–loss agents: weight regain after treatment cessation.

Key study results included:

• Tirzepatide monotherapy group: 46.1% weight regain following treatment discontinuation.
• CBL–514 combination group: Only 17.1% weight regain after treatment discontinuation.

These results confirmed that weight regain in the monotherapy group was 2.7 times that of the combination group, again validating that, in preclinical models, CBL–514 combined with tirzepatide produces a potent synergistic effect that not only enhances weight loss but also attenuates post–discontinuation weight regain, thereby prolonging the durability of weight–loss efficacy.

A Metabolic Bonus: Additional 106.7% Reduction in Hepatic Lipid Content and Improved Insulin Resistance

Beyond the robust weight–loss and regain–attenuation data, the presentation further revealed CBL–514's positive effects on hepatic lipid content and insulin resistance:

• Substantial reduction in hepatic lipid content: The CBL–514 plus tirzepatide combination group achieved an additional 106.7% reduction in hepatic lipid content compared to the tirzepatide monotherapy group.
• Significant improvement in insulin resistance (HOMA–IR): A marked improvement in HOMA–IR, a key indicator of insulin resistance, was observed in both the CBL–514 combination group and the monotherapy group.

These data indicate that, in addition to precision fat reduction and weight maintenance, CBL–514 may further improve systemic metabolic status, conferring high clinical application and commercial development value.

Strong Interest from Clinical Experts; Human Clinical Trials Planned for the Second Half of 2026

Laura Chung, Vice President of Caliway, stated:

"We are honored to have Dr. Timothy Garvey, an internationally influential authority in obesity medicine, present at this ADA Scientific Sessions. The on–site response was highly enthusiastic, attracting many cross–disciplinary experts and pharmaceutical company representatives who stopped to inquire. Several clinical trial investigators specifically sought updates on the latest clinical progress, noting that many patients are already eager to participate in the follow–up clinical trials."

Caliway noted that its previously completed OI21 and OI23 animal studies have consistently demonstrated that, whether combined with Novo Nordisk's semaglutide or Eli Lilly's tirzepatide—the two leading marketed GLP–1R–based weight–loss therapies—CBL–514 exhibits multiple benefits, including enhanced weight loss, attenuation of post–discontinuation weight regain, significant reduction of subcutaneous and visceral fat, and improvement in systemic metabolic indicators. The OI25 data disclosed for the first time at ADA 2026 provide even stronger scientific validation of this leading trend.

Caliway will continue to deepen its research on CBL–514 in combination with GLP–1R–based therapies and plans to advance to human clinical trials in the second half of 2026, while simultaneously strengthening the global clinical development and international licensing strategies for CBL–514.

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 possesses therapeutic potential across multiple indications, including non-surgical subcutaneous fat reduction and moderate-to-severe cellulite. A separate formulation, 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. CBL-514 has demonstrated superior, precise efficacy and solid safety profiles across different indications in both Intent-to-Treat (ITT) and Full Analysis Set (FAS) populations, reaching high statistical significance.

For more information about CBL-514, please visit : https://www.caliwaybiopharma.com/research/15/ 

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 on October 2, 2024.

Media Contact

ir@caliwaybiopharma.com 

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.