Caliway’s CBL-514 Follow-Up Study CBL-0303 Allowed by U.S. FDA to Proceed Following Completion of 30-Day IND Review; CBL-0206 Begins Subject Enrollment in Australia

• Completion of FDA 30-Day IND Review—Caliway Biopharmaceuticals (TWSE: 6919) announced that the U.S. FDA has completed the 30-day review period for the Investigational New Drug (IND) application of CBL-0303, a follow-up clinical study of CBL-514 for abdominal subcutaneous fat reduction. The Company will proceed with study initiation as planned.

 

• Continued Strengthening of Global Phase 3 Clinical Program—CBL-0303 is designed to bridge the two global pivotal Phase 3 clinical trials (CBL-0301 and CBL-0302) and serves as a long-term follow-up study required as part of the New Drug Application (NDA) process in the United States, continuing to evaluate long-term safety and durability of treatment effects, while also supporting future commercialization efforts following potential regulatory approval.

• Initiation of Subject Enrollment in Phase 2 Asia-Pacific Study—The Asia-Pacific Phase 2 clinical trial CBL-0206 has initiated subject enrollment in Australia, further expanding safety and efficacy data in an Asian population.

July 3, 2026—Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company developing innovative small-molecule therapies in aesthetic medicine, metabolic diseases, and other unmet medical needs, today announced that the U.S. FDA has completed the 30-day review period for the IND application of CBL-0303, a follow-up clinical study of CBL-514 for abdominal subcutaneous fat reduction, and has allowed the study to proceed.

CBL-0303 is a multicenter, two-stage Phase 3b long-term follow-up study designed to evaluate the long-term safety and durability of efficacy of CBL-514 following treatment discontinuation. The study is expected to enroll approximately 300 subjects in the United States who have completed either the CBL-0301 or CBL-0302 pivotal Phase 3 studies (including post-treatment follow-up), serving as a long-term observational cohort.

The first stage is a double-blind long-term follow-up period, during which subjects will be monitored for up to 12 months following treatment discontinuation to assess safety and durability of efficacy. The second stage is an open-label extension, in which eligible subjects may voluntarily receive repeat treatment courses of CBL-514 to further explore its safety and efficacy profile under repeated administration.

Caliway stated that the long-term follow-up study is a standard component of the clinical development program supporting a NDA in the United States. Together with the two global pivotal Phase 3 studies, CBL-0301 and CBL-0302, this study will establish a comprehensive clinical development package, further strengthening the long-term safety profile and durability of efficacy data for CBL-514 in reducing abdominal subcutaneous fat. The Company emphasized that the future NDA submission for CBL-514 will continue to be primarily supported by the two global pivotal Phase 3 studies, CBL-0301 and CBL-0302, as the key efficacy and safety data package.

In addition, the Asia-Pacific Phase 2 clinical study of CBL-514 (CBL-0206) has recently begun enrolling participants in Australia. This study is expected to further expand the safety and efficacy database of CBL-514 in Asian populations while increasing the overall safety exposure across treated subjects. The resulting data will provide a more comprehensive clinical foundation to support future regulatory submissions, regional commercialization strategies, and global licensing opportunities.

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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.

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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