2026. 08
Date： 2026.08.31 -
Caliway Biopharmaceuticals Highlights Global Phase 3 Progress and GLP-1 Combination Strategy at 2026 Second-Half Online Investor Conference
August 31, 2026—Caliway Biopharmaceuticals (TWSE: 6919), today hosted its 2026 Second-Half Online Investor Conference, highlighting the significant momentum of its global pivotal Phase 3 program for CBL-514. The Company also detailed the strategic expansion of its GLP-1 combination program and the steady progression of its international clinical development pipeline.
Global Phase 3 Program for CBL-514 Marches Forward with Patient Enrollment Underway
Caliway announced that SUPREME-01 (CBL-0301), its first global pivotal Phase 3 trial evaluating CBL-514 for abdominal subcutaneous fat reduction, has officially initiated patient enrollment across approximately 25 to 30 clinical sites in the U.S. and Canada. Concurrently, the parallel Phase 3 study, SUPREME-02 (CBL-0302), has secured regulatory clearances in the U.S., Canada, and Australia, and is poised to begin enrollment on schedule.
Following collaborative discussions with the U.S. FDA, Caliway refined the primary efficacy endpoint of CBL-0301 to focus on the proportion of subjects achieving at least a two-grade improvement on both the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS) and the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS). MRI-based measurement of abdominal subcutaneous fat volume reduction will serve as a key secondary endpoint, providing objective clinical validation while mitigating the regulatory risks typically associated with imaging-based primary endpoints.
Expanding its global clinical footprint, Caliway’s long-term follow-up study, CBL-0303, has successfully cleared the FDA's 30-day review period. In China, the Company has submitted an Investigational New Drug application for the CBL-0102 pharmacokinetic (PK) study to pave the way for the China Phase 3 trial, CBL-0304. Meanwhile, patient enrollment is steadily progressing in the Asia-Pacific Phase 2 study (CBL-0206) across Taiwan and Australia.
Between 2026 and 2028, Caliway expects to conduct nine clinical trials spanning five countries across four distinct indications. With cumulative enrollment projected to exceed 1,000 subjects, these efforts will establish a robust global database to support future regulatory filings and high-value strategic partnerships.
Phase 2b Data Reaffirms First-in-Class Efficacy Profile
Caliway highlighted the compelling efficacy outcomes from its completed CBL-0205 Phase 2b study, where CBL-514 demonstrated statistically significant superiority over placebo.
In the Full Analysis Set (FAS), 21.2% of CBL-514-treated subjects achieved a two-grade or greater improvement on the combined physician and patient assessments, compared to 0% in the placebo cohort (p<0.005). Furthermore, 63.6% of treated subjects achieved at least a one-grade improvement, compared to 10.8% in the placebo group (p<0.0001).
These results compare favorably with the historical pivotal data of currently approved aesthetic pharmaceuticals. For context, pivotal trials for Kybella® reported two-grade improvement responder rates between 13.4% and 18.6%, while Qwo® showed responder rates ranging from 5.6% to 7.6%.
While these historical figures represent different indications and study designs, CBL-514’s 21.2% responder rate underscores its potential to become the first FDA-approved pharmaceutical treatment specifically indicated for non-invasive abdominal subcutaneous fat reduction.
Synergistic CBL-514 + GLP-1 Strategy Addresses Crucial Unmet Needs in Weight Management
Caliway unveiled encouraging preclinical findings from its latest OI25 study, which further validate the therapeutic synergy of combining CBL-514 with the GLP-1 receptor agonist tirzepatide. The combination regimen not only enhanced overall fat reduction but also directly addressed critical limitations of current GLP-1 therapies, such as rapid weight regain and metabolic rebound following treatment cessation.
Four weeks post-treatment discontinuation, animal models receiving tirzepatide monotherapy experienced a 46.1% rebound in body weight. In contrast, the group receiving the CBL-514 + tirzepatide combination exhibited a rebound of just 17.1%, representing a 2.7-fold reduction in weight regain. Additionally, the combination therapy delivered superior reductions in both subcutaneous and visceral fat compared to tirzepatide alone. This dual mechanism offers a highly differentiated strategy to optimize lower-dose GLP-1 regimens and sustain long-term weight management.
On the clinical front, the Phase 2 trial CBL-0201WR, designed to evaluate the CBL-514 and tirzepatide combination, secured FDA IND clearance in August 2026. The trial is scheduled to enroll approximately 120 subjects across 10 U.S. clinical sites. The primary efficacy endpoint will measure MRI-assessed measured abdominal subcutaneous fat volume four weeks after treatment discontinuation, with body weight, visceral fat, body composition, and HOMA-IR evaluated as exploratory endpoints. Notably, preclinical data highlighting CBL-514's impact on visceral fat reduction have been selected for an oral presentation at the upcoming European Association for the Study of Diabetes (EASD) 2026 Annual Meeting.
In parallel, data collection for the Phase 2b trial (CBL-0202DD) evaluating CBL-514D for Dercum's Disease has concluded, with topline statistical results anticipated in September 2026.
Caliway management believes that the initiation of Phase 3 enrollment, key FDA clearances for the GLP-1 combination trial, upcoming Dercum’s Disease readouts, and advancing global out-licensing discussions collectively mark a pivotal inflection point. These milestones solidify CBL-514’s strategic positioning across aesthetics, weight management, and orphan diseases, reinforcing Caliway's competitive moat and accelerating its path toward global commercialization.
*About CBL-514
CBL-514 is a patented, first-in-class small-molecule 505(b)(1) injection developed by Caliway. It is designed to selectively induce adipocyte apoptosis to precisely reduce subcutaneous fat at the injection site without causing necrosis or damage to surrounding tissues or cells.
CBL-514 has demonstrated broad therapeutic potential across multiple indications, including non-surgical subcutaneous fat reduction and moderate-to-severe cellulite. A separate formulation, designated as CBL-514D, is being developed for the treatment of Dercum’s Disease, a rare disease. To date, more than 544 subjects have participated in clinical trials related to CBL-514. Across the 10 completed clinical trials with finalized statistical reports, all primary and key secondary efficacy endpoints have been met, demonstrating excellent safety and tolerability.
*About Caliway Biopharmaceuticals
Caliway Biopharmaceuticals Co., Ltd. (TWSE: 6919), founded in 2012, is dedicated to developing breakthrough therapeutics that redefine standards of care and transform clinical practices. Caliway aims to leverage Taiwan's robust pharmaceutical research and development capabilities to serve the global aesthetic medicine and biomedical markets. The company was officially listed on the Taiwan Stock Exchange (TWSE: 6919) on October 2, 2024.
*Disclaimer
This press release and related web pages contain forward-looking statements that are based on the Company's current expectations, forecasts, and assessments. These statements involve risks, uncertainties, and other factors beyond the Company’s control. Actual events or results may differ materially from those projected in these forward-looking statements due to various external factors. Caliway undertakes no obligation to update or revise any information in this press release.
*Media & Investor Relations Contact
ir@caliwaybiopharma.com
Global Phase 3 Program for CBL-514 Marches Forward with Patient Enrollment Underway
Caliway announced that SUPREME-01 (CBL-0301), its first global pivotal Phase 3 trial evaluating CBL-514 for abdominal subcutaneous fat reduction, has officially initiated patient enrollment across approximately 25 to 30 clinical sites in the U.S. and Canada. Concurrently, the parallel Phase 3 study, SUPREME-02 (CBL-0302), has secured regulatory clearances in the U.S., Canada, and Australia, and is poised to begin enrollment on schedule.
Following collaborative discussions with the U.S. FDA, Caliway refined the primary efficacy endpoint of CBL-0301 to focus on the proportion of subjects achieving at least a two-grade improvement on both the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS) and the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS). MRI-based measurement of abdominal subcutaneous fat volume reduction will serve as a key secondary endpoint, providing objective clinical validation while mitigating the regulatory risks typically associated with imaging-based primary endpoints.
Expanding its global clinical footprint, Caliway’s long-term follow-up study, CBL-0303, has successfully cleared the FDA's 30-day review period. In China, the Company has submitted an Investigational New Drug application for the CBL-0102 pharmacokinetic (PK) study to pave the way for the China Phase 3 trial, CBL-0304. Meanwhile, patient enrollment is steadily progressing in the Asia-Pacific Phase 2 study (CBL-0206) across Taiwan and Australia.
Between 2026 and 2028, Caliway expects to conduct nine clinical trials spanning five countries across four distinct indications. With cumulative enrollment projected to exceed 1,000 subjects, these efforts will establish a robust global database to support future regulatory filings and high-value strategic partnerships.
Phase 2b Data Reaffirms First-in-Class Efficacy Profile
Caliway highlighted the compelling efficacy outcomes from its completed CBL-0205 Phase 2b study, where CBL-514 demonstrated statistically significant superiority over placebo.
In the Full Analysis Set (FAS), 21.2% of CBL-514-treated subjects achieved a two-grade or greater improvement on the combined physician and patient assessments, compared to 0% in the placebo cohort (p<0.005). Furthermore, 63.6% of treated subjects achieved at least a one-grade improvement, compared to 10.8% in the placebo group (p<0.0001).
These results compare favorably with the historical pivotal data of currently approved aesthetic pharmaceuticals. For context, pivotal trials for Kybella® reported two-grade improvement responder rates between 13.4% and 18.6%, while Qwo® showed responder rates ranging from 5.6% to 7.6%.
While these historical figures represent different indications and study designs, CBL-514’s 21.2% responder rate underscores its potential to become the first FDA-approved pharmaceutical treatment specifically indicated for non-invasive abdominal subcutaneous fat reduction.
Synergistic CBL-514 + GLP-1 Strategy Addresses Crucial Unmet Needs in Weight Management
Caliway unveiled encouraging preclinical findings from its latest OI25 study, which further validate the therapeutic synergy of combining CBL-514 with the GLP-1 receptor agonist tirzepatide. The combination regimen not only enhanced overall fat reduction but also directly addressed critical limitations of current GLP-1 therapies, such as rapid weight regain and metabolic rebound following treatment cessation.
Four weeks post-treatment discontinuation, animal models receiving tirzepatide monotherapy experienced a 46.1% rebound in body weight. In contrast, the group receiving the CBL-514 + tirzepatide combination exhibited a rebound of just 17.1%, representing a 2.7-fold reduction in weight regain. Additionally, the combination therapy delivered superior reductions in both subcutaneous and visceral fat compared to tirzepatide alone. This dual mechanism offers a highly differentiated strategy to optimize lower-dose GLP-1 regimens and sustain long-term weight management.
On the clinical front, the Phase 2 trial CBL-0201WR, designed to evaluate the CBL-514 and tirzepatide combination, secured FDA IND clearance in August 2026. The trial is scheduled to enroll approximately 120 subjects across 10 U.S. clinical sites. The primary efficacy endpoint will measure MRI-assessed measured abdominal subcutaneous fat volume four weeks after treatment discontinuation, with body weight, visceral fat, body composition, and HOMA-IR evaluated as exploratory endpoints. Notably, preclinical data highlighting CBL-514's impact on visceral fat reduction have been selected for an oral presentation at the upcoming European Association for the Study of Diabetes (EASD) 2026 Annual Meeting.
In parallel, data collection for the Phase 2b trial (CBL-0202DD) evaluating CBL-514D for Dercum's Disease has concluded, with topline statistical results anticipated in September 2026.
Caliway management believes that the initiation of Phase 3 enrollment, key FDA clearances for the GLP-1 combination trial, upcoming Dercum’s Disease readouts, and advancing global out-licensing discussions collectively mark a pivotal inflection point. These milestones solidify CBL-514’s strategic positioning across aesthetics, weight management, and orphan diseases, reinforcing Caliway's competitive moat and accelerating its path toward global commercialization.
*About CBL-514
CBL-514 is a patented, first-in-class small-molecule 505(b)(1) injection developed by Caliway. It is designed to selectively induce adipocyte apoptosis to precisely reduce subcutaneous fat at the injection site without causing necrosis or damage to surrounding tissues or cells.
CBL-514 has demonstrated broad therapeutic potential across multiple indications, including non-surgical subcutaneous fat reduction and moderate-to-severe cellulite. A separate formulation, designated as CBL-514D, is being developed for the treatment of Dercum’s Disease, a rare disease. To date, more than 544 subjects have participated in clinical trials related to CBL-514. Across the 10 completed clinical trials with finalized statistical reports, all primary and key secondary efficacy endpoints have been met, demonstrating excellent safety and tolerability.
*About Caliway Biopharmaceuticals
Caliway Biopharmaceuticals Co., Ltd. (TWSE: 6919), founded in 2012, is dedicated to developing breakthrough therapeutics that redefine standards of care and transform clinical practices. Caliway aims to leverage Taiwan's robust pharmaceutical research and development capabilities to serve the global aesthetic medicine and biomedical markets. The company was officially listed on the Taiwan Stock Exchange (TWSE: 6919) on October 2, 2024.
*Disclaimer
This press release and related web pages contain forward-looking statements that are based on the Company's current expectations, forecasts, and assessments. These statements involve risks, uncertainties, and other factors beyond the Company’s control. Actual events or results may differ materially from those projected in these forward-looking statements due to various external factors. Caliway undertakes no obligation to update or revise any information in this press release.
*Media & Investor Relations Contact
ir@caliwaybiopharma.com