• Caliway has completed the End-of-Phase 2 (EOP2) meeting with the U.S. FDA for CBL-514, the world's first investigational drug for large-area subcutaneous fat reduction developed under the 505(b)(1) regulatory pathway.
• The company has received the EOP2 meeting minutes, confirming the primary endpoints and pivotal study design for the Approval in Reduction of Abdominal Subcutaneous Fat.

TAIPEI , May 14, 2025 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919) today announced the successful End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for CBL-514, the company's proprietary first-in-class injectable drug candidate for large-area subcutaneous fat reduction. Caliway has received the official meeting minutes, confirming the pivotal Phase 3 design to support the New Drug Application (NDA) filing, including the primary endpoints and proposed indication.

A key outcome of the meeting was the FDA's support for the proposed indication of "reduction of abdominal subcutaneous fat" for CBL-514 in its upcoming New Drug Application (NDA). Previous aesthetic drugs have been approved solely on the "improvement in appearance." In contrast, CBL-514 targets the actual reduction of fat volume—a measurable physiological change.

"We are pleased to have reached alignment with the FDA on both study design and indication," said Vivian Ling, Chief Executive Officer of Caliway. "The Agency agrees that the 'reduction of abdominal subcutaneous fat' as the proposed indication reinforces our confidence in CBL-514's differentiated value, and its potential to redefine standards in aesthetic medicine."

Caliway plans to submit two global pivotal Phase 3 IND as follows: 

• CBL-0301 to the U.S. and Canada in Q2 2025, and
• CBL-0302 to the U.S., Canada, and Australia in Q3 2025

The EOP2 meeting outcome provides Caliway with regulatory clarity and a strong foundation for advancing CBL-514 through final-stage development. Caliway plans to submit Its global pivotal Phase 3 clinical trial application (CBL-0301) to the U.S. FDA and Health Canada in Q2 2025.

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 systemic side effects on the central nervous system, cardiovascular system, and respiratory system. As of May 2025, 10 clinical trials with a total of 520 subjects have been completed with all efficacy and safety endpoints met.

Caliway is currently investigating multiple indications for CBL-514, including non-surgical fat reduction, moderate-to-severe cellulite, and weight rebound management through a combination therapy with GLP-1-based treatments. CBL-514D, the same active pharmaceutical ingredients (APIs) but under different formulation, is being studied for additional indications such as Dercum's disease and more.

About AFRS (Abdominal Fat Rating Scale)

AFRS is a five-grade rating scale developed by Caliway and validated in accordance with U.S. FDA guidance and relevant regulations, including the FDA's guideline on Patient-Focused Drug Development. The Clinician Reported-AFRS (CR-AFRS) and the Patient Reported-AFRS (PR-AFRS) are used to assess treatment response based on the physician's evaluation and the participant's self-assessment, respectively.

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.caliwaybiopharma.com/en/

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