Caliway Targets First-in-Class FDA "2-Grade Improvement" Claim with Upgraded CBL-514 Phase 3 Trial Enrolling in August

• Upgraded Efficacy Endpoint—Following recommendations from the U.S. FDA, the primary efficacy endpoint for the Phase 3 pivotal trial, CBL-0301 (SUPREME-01), has been upgraded to "the proportion of subjects achieving at least a 2-grade improvement on both the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) and the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS)." MRI-measured changes in subcutaneous fat volume have been designated as a secondary endpoint. IND and CTA amendments have been submitted to the U.S. FDA and Health Canada, respectively, with patient enrollment poised to begin pending IRB approval.
• Positioning Beyond Liposuction—Clinical literature indicates that abdominal liposuction typically achieves approximately a 1-grade improvement. CBL-514, upon successful clinical completion, could become the first non-surgical treatment to secure a "2-grade improvement" claim for abdominal fat reduction, setting a new benchmark in the market.
• Robust Phase 2b Data Supports Phase 3 Success—The completed Phase 2b study demonstrated that in the Full Analysis Set (FAS) population, 24%-32% of subjects in the CBL-514 group achieved a 2-grade improvement on PR-AFRS and 23%-30% on CR-AFRS four weeks post-treatment, showing high statistical significance compared to the placebo group (0%-2.5%).
• Asia-Pacific Clinical Development Advances—Following Australia, the Asia-Pacific Phase 2 clinical trial, CBL-0206, has now commenced patient enrollment in Taiwan. The trial is now proceeding concurrently in both regions, expanding the clinical data foundation for CBL-514 in the Asia-Pacific.

July 28, 2026—Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company developing first-in-class small-molecule therapeutics, today announced that it has submitted trial design amendments for its first-in-class, large-volume, local fat-reducing new drug, CBL-514. The amendments for the pivotal Phase 3 clinical trial, CBL-0301 (SUPREME-01), have been filed with the U.S. FDA as an IND amendment and with Health Canada as a Clinical Trial Application (CTA) amendment, in accordance with FDA recommendations. The trial protocol is concurrently under review by central Institutional Review Boards (IRBs) in the U.S. and Canada, with the first patient expected to be enrolled in August upon IRB approval.

Trial Design Upgrade: Constructing a "Three-Dimensional Validation Framework"

Based on FDA recommendations, the trial design has been amended to define the primary efficacy endpoint as "the proportion of subjects achieving at least a 2-grade improvement in the appearance of abdominal subcutaneous fat, as assessed by both the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS) and the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS), at 4 weeks after the last treatment." MRI-measured changes in abdominal subcutaneous fat volume and the proportion of subjects achieving a 1-grade improvement on both AFRS scales are now listed as secondary efficacy endpoints.

This adjustment aligns with the FDA's recent regulatory trend of promoting Patient-Reported Outcomes (PROs) as primary efficacy endpoints for New Drug Applications (NDAs) and better reflects the real-world patient perception of significant efficacy. This upgraded endpoint design establishes a three-dimensional validation framework for CBL-514, integrating subjective patient feedback, professional physician assessment, and objective MRI measurements to validate the reduction of subcutaneous fat. This not only strengthens the persuasiveness of the trial results but is also expected to become a powerful marketing and communication tool for CBL-514 post-launch.

Poised to Secure the First FDA "2-Grade Improvement" Claim in Abdominal Fat Reduction

According to clinical observations from the American Society of Plastic Surgeons (ASPS) and literature, conventional abdominal liposuction is limited by skin elasticity, requiring physicians to leave residual fat to avoid skin laxity and contour irregularities. This procedure typically results in an aesthetic improvement equivalent to only about a 1-grade change on the AFRS scale. Achieving a 2-grade improvement often requires abdominoplasty, a procedure involving general anesthesia, significant pain, long scars, and a recovery period of 16 to 30 days.

If the CBL-0301 and CBL-0302 Phase 3 trials successfully meet their endpoints, CBL-514 is poised to become the world's first non-surgical injection to obtain a label claim for a "2-grade improvement" in abdominal subcutaneous fat, a remarkably high standard.

Strong Phase 2b Clinical Data Provides Foundation for Phase 3 Success

The probability of Phase 3 success for CBL-514 is built upon robust Phase 2b clinical data. Results from the study showed that in the rigorous Full Analysis Set (FAS) population, 24% to 32% of subjects treated with CBL-514 achieved a 2-grade improvement on PR-AFRS, and 23% to 30% achieved the same on CR-AFRS. In contrast, only 0% to 2.5% of subjects in the placebo group met this endpoint. Furthermore, nearly 80% of subjects in the FAS population treated with CBL-514 achieved at least a 1-grade improvement on either the PR-AFRS or CR-AFRS, demonstrating the highly statistically significant efficacy of CBL-514. The Phase 3 trials will also utilize the optimized AFRS 8.0 scale, which offers enhanced stability and consistency to reduce assessment variability and further increase the likelihood of success.

Dual-Track Asia-Pacific Clinical Progress Accelerates Global Strategy

In parallel, the Asia-Pacific Phase 2 clinical trial, CBL-0206, has enrolled its first patient in Taiwan. Previously approved by the HREC in Australia and the TFDA in Taiwan, CBL-0206 has already commenced enrollment in Australia. This randomized, placebo-controlled study aims to enroll approximately 250 subjects across Taiwan and Australia, evaluating efficacy using both MRI and AFRS. Caliway stated that with patient enrollment now active in both Australia and Taiwan, the CBL-0206 trial will further expand the safety and efficacy data for CBL-514 in Asian populations and increase the overall size of the treatment group, laying a more comprehensive clinical foundation for future New Drug Application filings, regional market strategies, and international licensing collaborations.

For information on participating hospitals for CBL-0206 in Taiwan, please visit the Taiwan Clinical Trial Information website (https://e-sub.fda.gov.tw/ClinicalTrialInfo/home). Subject eligibility will be determined by each participating hospital based on inclusion criteria. To comply with regulations and maintain trial integrity, Caliway is not involved in any registration or subject screening matters.


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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