Company Announcements

• Caliway Biopharmaceuticals' preclinical research was highlighted at the 25th Annual Congress of the Taiwan Medical Association for the Study of Obesity, held in conjunction with the 9th Japan-Korea-Taiwan Symposium on Obesity.
• The animal study explored CBL-514 in combination with a dual GLP-1/GIP receptor agonist (tirzepatide), evaluating body weight and adipose tissue–related parameters in animal models.

NEW TAIPEI CITY, Dec. 15, 2025 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company developing novel small-molecule therapeutics, announced that preclinical research involving CBL-514 was presented at the 25th Annual Congress of the Taiwan Medical Association for the Study of Obesity (TMASO 2025), held jointly with the 9th Japan–Korea–Taiwan Symposium on Obesity at National Taiwan University Hospital.

The congress brought together leading academic and clinical experts from Taiwan, Japan, and Korea to examine emerging challenges in obesity management, particularly in the context of widespread adoption of incretin-based therapies. Scientific discussions increasingly emphasized the need for multi-mechanism strategies that extend beyond appetite regulation and address adipose tissue biology, fat distribution, and post-treatment weight dynamics.

Scientific Context: Beyond Weight Loss Toward Durability and Fat Biology
According to publicly reported remarks, Dr. Kuo-Chin Huang, Vice Superintendent of National Taiwan University Hospital and former President of both the Taiwan Medical Association for the Study of Obesity and the Asia-Pacific Association for the Study of Obesity, highlighted a field-wide transition from single-pathway obesity models toward integrated frameworks encompassing energy balance, adipocyte function, hormonal signaling, and long-term metabolic risk.

These perspectives reflect growing recognition that weight rebound following discontinuation of incretin-based therapies remains a clinically relevant challenge, and that fat quality and visceral adiposity may play an important role in long-term outcomes.

Preclinical Study: CBL-514 in Combination With a Dual Incretin Receptor Agonist
As reported by local media, a preclinical animal study proposed by Caliway Biopharmaceuticals was presented during the congress by Dr. Tzu-Jung Chou, Attending Physician at National Taiwan University Hospital, Hsinchu Branch.

The study evaluated CBL-514, a small-molecule drug that selectively induces adipocyte apoptosis, in combination with a dual GLP-1/GIP receptor agonist (tirzepatide) in diet-induced obese (DIO) rat models. The study design included an observation period following incretin withdrawal, enabling assessment of weight maintenance and adipose tissue outcomes beyond active incretin treatment.

Under the specific conditions of the animal model, the combination group demonstrated statistically significant differences compared with incretin monotherapy across multiple parameters, including:

• Body-weight reduction: –21.8% (combination) vs –14.5% (monotherapy)
• Post-treatment weight regain: +25.2% vs +55.9% after incretin withdrawal
• Subcutaneous fat reduction: –43.5% vs –15.4%
• Visceral fat reduction: –41.6% vs –8.9%

Mechanistic Rationale: Targeting Adipocyte Number as a Complement to Incretin Therapy
During the presentation, Dr. Chou described CBL-514 as offering a mechanistically distinct approach compared with incretin-based therapies. While incretins primarily modulate appetite and energy intake, CBL-514 selectively induces apoptosis of adipocytes, thereby reducing adipocyte number rather than adipocyte size.

CBL-514 was described as targeting intracellular signaling pathways, including DYRK1B, leading to decreased anti-apoptotic signaling and increased pro-apoptotic activity in adipocytes. From a scientific perspective, this mechanism provides a rationale for exploring whether combining incretin-based therapies with agents that directly modulate adipose tissue biology could influence fat distribution and post-treatment weight dynamics.

Dr. Chou emphasized that additional research is required to determine optimal treatment sequencing, duration, and patient selection, as well as to assess potential clinical relevance in humans.

Implications for Future Obesity Research and Drug Development
Discussions at TMASO 2025 reflected a broader evolution in obesity research toward durability of response, visceral fat reduction, and maintenance strategies following pharmacologic weight loss. Within this context, the presented preclinical data were discussed as contributing to ongoing scientific exploration of multi-mechanism therapeutic paradigms, particularly in combination with incretin-based agents.

Caliway noted that the study supports further investigation into whether adipocyte-targeted mechanisms may complement existing incretin pipelines, including potential roles in combination or maintenance-phase strategies, subject to future clinical evaluation.

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 with no systematic safety risks identified and well tolerated. 

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 management. 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.

Media Contact:
ir@caliwaybiopharma.com

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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