Caliway Announces IND Submission to U.S. FDA for CBL-514 Long-Term Follow-Up Phase 3 Trial (CBL-0303)

 

​​​​​TAIPEI, June 4, 2026 – Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company focused on breakthrough aesthetic and local fat reduction therapeutics, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CBL-0303, a Phase 3b long-term follow-up study of CBL-514 for abdominal subcutaneous fat reduction.

Seamless Extension of Twin Pivotal Phase 3 Trials
CBL-0303 is designed to seamlessly extend Caliway's two ongoing global pivotal Phase 3 trials, CBL-0301 (SUPREME-01) and CBL-0302 (SUPREME-02). The study will enroll approximately 300 subjects in the U.S. who have completed either of the twin pivotal trials, including their post-treatment follow-up. Its goal is to establish comprehensive long-term safety and efficacy durability data up to 12 months after treatment discontinuation, thereby strengthening the data foundation for future New Drug Applications (NDA).

Two-Phase Design: Long-Term Follow-Up and Repeated Treatment Exploration
CBL-0303 consists of two phases:

• Phase 1 (Double-Blind Long-Term Follow-Up) – Evaluates the long-term safety (primary endpoint) and efficacy durability (secondary endpoint) of CBL-514 for up to 12 months post-treatment discontinuation.
• Phase 2 (Open-Label Extension) – Subjects who complete Phase 1 and meet eligibility criteria may voluntarily enter this phase to receive repeated courses of CBL-514. This exploratory phase will generate critical clinical evidence on the efficacy and safety of multiple treatment courses for real-world medical application.

Meeting Standard Regulatory Requirements for NDA
CBL-0303 fulfills a routine FDA requirement for NDA submissions: demonstrating long-term safety over 12 months after drug discontinuation. Together with the core data from the twin pivotal Phase 3 trials (CBL-0301 and CBL-0302), this study will further strengthen the clinical differentiation, global market appeal, and licensing potential of CBL-514.

Global Progress of the Twin Pivotal Phase 3 Trials
CBL-0302 (SUPREME-02) is progressing smoothly. It cleared the 30-day U.S. FDA IND review on May 18, 2026; an IND application was submitted to Australia's HREC on May 20; and Clinical Trial Application (CTA) approval was received from Health Canada on May 28. The trial is expected to enroll approximately 320 subjects across the United States, Canada, and Australia. Meanwhile, Caliway will soon initiate subject enrollment for CBL-0301 (SUPREME-01).

Strategic Outlook
With the simultaneous advancement of the twin global pivotal Phase 3 trials and the CBL-0303 long-term follow-up study, Caliway's clinical and regulatory pathway for CBL-514 in subcutaneous fat reduction has become highly comprehensive. The company will continue to accumulate robust data on long-term safety, durability, and repeated treatment, further enhancing the product's clinical differentiation and maximizing its global commercial licensing value and market potential.

 

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 the Caliway website:
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 (TWSE: 6919) on October 2, 2024.

Media Contact
Caliway Biopharmaceuticals Co., Ltd.
Investor Relations (IR)
Email: 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.