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Caliway to Present First Preclinical Data on CBL-514 for GLP-1 Weight Rebound Management at BIO 2025

PR Newswire by PR Newswire
10 June 2025
in PR Newswire
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Caliway Announces Successful EOP2 Meeting with the FDA for CBL-514 in Reduction of Abdominal Subcutaneous Fat
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  • Caliway to deliver a corporate presentation on June 17 at the BIO International Convention 2025, the world’s largest biotech industry event.
  • For the first time at an international conference, Caliway will share preclinical results on CBL-514’s potential new indication: combined with GLP-1 therapies to prevent post-treatment weight rebound.

NEW TAIPEI CITY, June 10, 2025 /PRNewswire/ — Caliway Biopharmaceuticals (TWSE: 6919) announced today its participation in the 2025 BIO International Convention, to be held from June 16 to 19 in Boston, U.S.A. Caliway’s Vice President, April Yuan, will deliver an oral presentation on June 17, highlighting the company’s latest progress in R&D and pipeline development.

The presentation will cover recent updates on CBL-514, first-in-class injectable drug candidate for large-area, site-specific fat reduction, including its development across multiple indications—subcutaneous fat reduction, cellulite, and Dercum’s disease.

For the first time at an international conference, Caliway will also share preclinical data on a potential new indication: weight rebound management through a combination therapy with GLP-1 receptor agonists.

As GLP-1 receptor agonists gain widespread use globally, post-discontinuation weight rebound has become a significant, yet unmet clinical concern. According to published studies, only 10% of patients are able to maintain weight loss after stopping GLP-1 treatment.

Based on Caliway’s preclinical data, co-administration of CBL-514 with GLP-1 significantly reduced post-discontinuation body weight regain and fat replenishment rate — suggesting that CBL-514 may help maintain weight loss outcomes after GLP-1 therapy.

CBL-514 works by directly targeting the root cause—subcutaneous fat—through selective induction of adipocyte apoptosis. It may serve as a complementary combination therapy to GLP-1s, pairing systemic weight loss with precise body contouring.

Caliway plans to submit a Phase 2 IND application to the U.S. FDA for this new indication in Q4 2025.

“We believe post-weight-loss weight rebound is a promising unmet market need,” said Vivian Ling, CEO of Caliway. “CBL-514 has the potential to serve as a complementary combination therapy with GLP-1 treatments — with GLP-1s driving weight reduction, and CBL-514 reshaping and maintaining outcomes through localized fat reduction, enhancing the overall treatment impact and long-term value.”

The BIO International Convention is the world’s largest and most influential biotechnology event, attracting over 20,000 professionals and 5,000 companies from 80+ countries. It serves as a global platform for business development, innovation exchange, and investment.

Caliway Presentation at BIO 2025:

  • Date & Time: Tuesday, June 17, 2025 | 11:45 AM – 12:00 PM (EDT)
  • Location: Room 154 | Boston Convention & Exhibition Center
  • Speaker: April Yuan, VP, Caliway Biopharmaceuticals
  • Session Info: https://convention.bio.org/speaker/april-yuan

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 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/

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.

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