• Clinical results from Caliway's CBL-0204 Phase 2b study of its fat reduction drug candidate CBL-514 for localized fat reduction have been accepted by the Aesthetic Surgery Journal (ASJ), a leading academic journal in aesthetic medicine and plastic surgery.
• Following the publication of CBL-16001 Phase 2a results in 2022 and CBL-0202 Phase 2 results in 2025, this marks another ASJ acceptance for CBL-514, reflecting continued recognition and attention from top international professional communities regarding its efficacy and safety in localized fat reduction, and representing the third time its clinical results have been recognized by an authoritative international journal.
• CBL-0204 Phase 2b is a key Phase 2 study approved by the U.S. FDA and Australia's HREC. As a multi-center, randomized, placebo-controlled study designed more closely in line with global pivotal Phase 3 studies, its acceptance by ASJ further strengthens the clinical value and commercial potential of CBL-514 in the global fat reduction market.

Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company advancing innovative small-molecule therapies in aesthetic medicine, metabolic diseases, and other unmet medical needs, announced that clinical results from CBL-0204 Phase 2b, a study of its first-in-class large-area localized fat reduction drug candidate, CBL-514, for subcutaneous fat reduction, have been accepted by the Aesthetic Surgery Journal (ASJ), a globally recognized authority in aesthetic medicine. This marks the third time that Phase 2 clinical results of CBL-514 for localized fat reduction have been accepted by ASJ, the world's top-ranked journal in aesthetic and plastic surgery, further validating CBL-514's outstanding efficacy and safety profile while reinforcing its clinical value and international academic standing as an innovative non-surgical localized fat reduction therapy.

CBL-0204 is a multi-center, randomized, placebo-controlled Phase 2b clinical study approved by both the U.S. Food and Drug Administration (FDA) and the Australia's Human Research Ethics Committee (HREC), enrolling a total of 107 participants. Both efficacy endpoints, including MRI and AFRS (Abdominal Fat Rating Scale), and the study design, are highly aligned with the framework of global pivotal Phase 3 studies, the acceptance of this study by ASJ further endorsed the global development of CBL-514 for subcutaneous fat reduction.

The first author of the accepted ASJ publication is Paul Lorenc, MD, a renowned U.S. board-certified plastic surgeon. Dr. Lorenc has also participated in multiple FDA meetings and provided expert input. Based on his clinical observations, Dr. Lorenc noted, "CBL-514 demonstrated great efficacy, even after just one treatment, 1-grade improvement could be observed on the abdominal fat rating scale." He further emphasized, "Compared with liposuction, CBL-514 has clear advantages over surgery, including providing similar results while lower invasiveness and almost no downtime. The vast majority of participants were highly satisfied with the overall treatment process and outcomes."

Final statistical results from CBL-0204 showed that both the primary and secondary efficacy endpoints were successfully met. In the Per-Protocol (PP) population, as many as 82.6% of participants achieved at least 1-grade improvement in the Clinician Reported Abdominal Fat Rating Scale (CR-AFRS), with more than half of participants achieving this result after only one treatment. Notably, 42.1% of participants also achieved at least a 2-grade improvement in the Patient Reported Abdominal Fat Rating Scale (PR-AFRS), compared with 0% in the placebo group, reaching statistical significance (p<0.001).

Overall data further showed that, in addition to visibly reducing abdominal fat accumulation, MRI assessments, which are currently recognized as one of the most objective and accurate methods for evaluating fat thickness and volume, demonstrated that more than 60% of participants achieved at least a 20% reduction in fat volume in the treated area (vs. 0% in the placebo group, p<0.00005), confirming significant localized fat reduction efficacy. Caliway noted that, compared with many existing fat reduction treatments, which are more difficult to objectively quantify volume changes across large treatment areas, CBL-514 clinical studies are able to use MRI to demonstrate fat volume differences before and after treatment, further enhancing the credibility and persuasiveness of its clinical data.

In terms of safety, CBL-514 demonstrated favorable overall safety and tolerability, with the major adverse events consisting primarily of common mild to moderate injection site reactions.

In the current localized fat reduction market, invasive procedures such as liposuction can deliver visible efficacy, but are accompanied by higher recovery burden and surgical risks. Meanwhile, existing non-surgical localized fat reduction therapies still broadly face challenges in fully balancing efficacy, safety, and tolerability. This underscores the significant unmet need for innovative therapies that can provide both strong efficacy and a favorable safety profile. As the world's first drug candidate designed to induce adipocyte apoptosis and precisely reduce subcutaneous fat in large treatment areas, CBL-514 has continued to demonstrate its differentiated advantages through multiple strong clinical datasets recognized by international renowned journals.

Vivian Ling, CEO of Caliway, stated, "The acceptance of CBL-0204 Phase 2b clinical results by ASJ is highly meaningful to Caliway. This not only marks the third time that CBL-514 has received recognition from the internationally renowned ASJ, following CBL-16001 Phase 2a and CBL-0202 Phase 2 clinical results, but more importantly, CBL-0204's study design and efficacy endpoints are even highly aligned with the pivotal Phase 3 setting. This further underscores CBL-514's academic standing, clinical value, and future commercial potential. The highly consistent clinical outcomes of CBL-514, which continue to be recognized by international industry experts, also give us greater confidence in the upcoming global pivotal Phase 3 studies."