Caliway's CBL-514 Phase 2 Study (CBL-0202) Accepted for Publication in the Aesthetic Surgery Journal

Advancing Scientific Recognition in Non-Surgical Fat Reduction

• Caliway's CBL-514 Phase 2 study (CBL-0202) has been accepted for publication in Aesthetic Surgery Journal (ASJ), the top-ranked journal in aesthetic medicine and plastic surgery.
• Clinical data (ITT population) showed that over 60% of CBL-514-treated participants reduced at least 200mL of subcutaneous fat within 8 weeks, demonstrating efficacy comparable to liposuction, along with good safety, favorable tolerability, and no downtime required.
• Caliway is advancing toward two pivotal Phase 3 studies for localized fat reduction in Q3 2025, aiming to bring the first injectable fat reduction therapy for large treatment areas to market.

TAIPEI, March 12, 2025 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919) announced that clinical results from the CBL-0202 Phase 2 study of its novel localized fat reduction drug, CBL-514, have been accepted for publication in the Aesthetic Surgery Journal (ASJ), the world's leading academic journal in aesthetic medicine and plastic surgery. This publication further validates the efficacy and safety of CBL-514 in localized fat reduction, highlighting its clinical value as an innovative non-surgical therapy. Following the publication of the CBL-16001 Phase 2a clinical results in ASJ in 2022, this marks another significant achievement as CBL-514 gains continued international recognition.

Caliway consistently adheres to the U.S. FDA's statistical principles, utilizing complete Intent-to-treat (ITT) population and Full Analysis Set (FAS) population data analyses in clinical publications, ensuring the integrity and credibility of its research results.

The accepted study was co-authored by Caliway's R&D team and renowned dermatologists and plastic surgeons, including Dr. Michael Gold, Dr. Joel Schlessinger, Dr. Steven Dayan, and Dr. Greg Goodman, all recognized leaders in aesthetic medicine and body contouring research. Caliway's CEO and Chief R&D Officer, Vivian Ling, was also directly involved in the study as a co-author.

Clinical results from the Phase 2 CBL-0202 study (ITT population) revealed that 8 weeks after the final treatment, over 60% of participants in the CBL-514 group achieved a reduction of at least 200mL of subcutaneous fat in the treated area, compared to 0% in the placebo group, achieving statistical significance (p< 0.0001).

Notably, 42.9% of these participants achieved at least a 150mL reduction in subcutaneous fat after only one treatment. Moreover, Per-Protocol (PP) analysis showed that participants experienced an average reduction of 28.1% of subcutaneous fat volume compared with placebo (p < 0.001).

In comparison, according to a study published in Aesthetic Surgery Journal in 2012, abdominal liposuction removed an average of 183mL of subcutaneous fat, indicating that CBL-514's fat reduction efficacy could potentially surpass traditional liposuction. Additionally, the study demonstrated a favorable safety profile, with no severe adverse events (SAE) reported.

Principal investigators emphasized that CBL-514 achieved a fat reduction effect comparable to liposuction, with significantly improved safety, shorter treatment duration, and no required downtime, positioning CBL-514 as a promising alternative for non-invasive body contouring.

Caliway's CEO, Vivian Ling, stated, "The acceptance of CBL-514's Phase 2 clinical data in ASJ once again affirms our research outcomes and capabilities, reinforcing CBL-514's significant potential in the localized fat reduction market. We will actively pursue further publications of CBL-0204 Phase 2b results, to strengthen Caliway's academic and commercial presence globally in the aesthetic medicine industry."

With the global demand for non-invasive fat reduction solutions continuing to rise, Caliway will accelerate subject recruitment for two pivotal global Phase 3 studies for localized fat reduction in Q3 2025, actively expanding international collaborations, and steadily progressing toward the goal of developing the world's first FDA-approved injectable drug for large-area localized fat reduction.

The study is expected to be officially published in ASJ in Q2 2025.

About ASJ

The Aesthetic Surgery Journal (ASJ) is a globally recognized, peer-reviewed medical journal specializing in aesthetic surgery and medicine. As the official publication of The Aesthetic Society, ASJ serves as the leading English-language journal for multiple major aesthetic, plastic, and reconstructive surgery societies worldwide.

ASJ is currently ranked #1 among all aesthetic surgery journals and #2 among all plastic surgery journals. It is dedicated to advancing the science, artistry, and safety of aesthetic surgery, making it a highly influential platform for groundbreaking innovations in the field. (Source: The Aesthetic Society)

About CBL-514

CBL-514, a 505(b)(1) and first-in-class small-molecule drug developed by Caliway, is the world's first injectable lipolysis drug that induces adipocyte apoptosis to reduce subcutaneous fat in targeted areas without causing any systematic side effects on the central nervous system, cardiovascular system, and respiratory system. CBL-514 has demonstrated fewer side effects, superior efficacy, and fewer required treatments compared with existing surgical procedures and other non-invasive localized fat reduction solutions.

Caliway is currently investigating multiple indications for CBL-514, including non-surgical fat reduction and moderate-to-severe cellulite. A derivative compound, CBL-514D, is being developed for indications including rare diseases such as Dercum's disease and Obstructive Sleep Apnea (OSA). As of the end of November 2024, Caliway has enrolled a total of 520 subjects in clinical studies related to CBL-514. To date, 10 clinical studies have been completed with results available, and all these studies have met their efficacy endpoints and safety parameters. CBL-514 has demonstrated precise efficacy with a favorable safety profile across multiple indications, showing outstanding statistical significance (p<0.00001 or p<0.0001) in both ITT and FAS populations. Caliway plans to initiate subject recruitment for two pivotal global Phase 3 studies for localized fat reduction in the second half of 2025.

About Caliway Biopharmaceuticals

Caliway Biopharmaceuticals (Caliway) is a clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the Taiwan Exchange (TWSE-6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, please visit: https://www.caliway.com.tw/en

Disclaimer

This article and related information on this site contain forward-looking statements. The forward-looking information requires the Company to make numerous assumptions and is subject to inherent risks, uncertainties, and other factors that are beyond the control of the Company which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Company undertakes no obligation to timely inform, update, or revise the information on this site if circumstances should change.

SOURCE Caliway Biopharmaceuticals