Adiposis Dolorosa

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: 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: 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CBL-514, Caliway's novel small molecule drug, was selected for data presentation at the World Orphan Drug Congress USA 2025, highlighting its promising Phase 2 study results (CBL-0201DD) for Dercum's Disease Treatment. The Phase 2 topline results met all primary and secondary endpoints, with 64.5% of painful lipomas showing ≥ 50% dimension reduction or complete clearance (per-protocol population), and pain being reduced by 4.7 points (on a 10-point scale). The program has advanced to a U.S. FDA-approved Phase 2b study (CBL-0202DD), with subject recruitment expected to be completed by Q3 2025, representing a potential breakthrough for patients with no approved treatment options. TAIPEI, April 17, 2025 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919) announced today that it has been invited to present the clinical results of its CBL-514 Phase 2 study (CBL-0201DD) in Dercum's Disease at the upcoming World Orphan Drug Congress USA 2025, to be held in Boston on April 24, 2025. CBL-514 is a novel 505(b)(1) small-molecule drug developed by Caliway. It has previously demonstrated promising results in the field of medical aesthetics. CBL-514 is also being investigated for Dercum's Disease— a rare disease characterized by the growth of painful lipomas, with no approved treatment to date. According to the CBL-0201DD Phase 2 study results, 64.5% of painful lipomas showed dimensions reduction of more than 50% or complete clearance after CBL-514 treatments, with more than half of painful lipomas achieved this outcome after only one CBL-514 treatment. The pain score was also reduced by 4.7 points (out of 10). These results support CBL-514's potential as a first-in-class treatment for Dercum's disease, offering new hope to patients by significantly reducing lipoma size and pain. The World Orphan Drug Congress USA is a leading global conference focused on rare disease and orphan drug development. Bringing together over 2,000 participants from academia, regulatory agencies, pharmaceutical and biotech companies, patient advocacy groups, and investors. The event serves as a key platform for advancing scientific innovation, regulatory policies, and access strategies in rare disease therapies. Being selected to present at the most important event for all rare disease stakeholders, not only highlights the clinical potential of CBL-514 in rare disease treatment, but also underscores Caliway's ongoing commitment to addressing unmet medical needs. The drug has entered a U.S. FDA-approved Phase 2b clinical study (CBL-0202DD), which is currently ongoing and expected to complete patient recruitment by Q3 2025. If successful, CBL-514 could become the first approved treatment for Dercum's Disease, offering a long-awaited therapeutic option for patients worldwide. CBL-514 Study Presentation Info at World Orphan Drug Congress USA: Conference: World Orphan Drug Congress USA 2025 Date & Time: April 24, 2025 (Thursday), 10:40 AM (Eastern Time) Presentation Title: Efficacy and Safety of CBL-514, a Novel Lipolytic Injectable, in the Treatment of Dercum's Disease: Phase 2 Study Results Location: Boston Convention & Exhibition Center | Theater 2 – Hall C For more details on the World Orphan Drug Congress USA 2025, please visit: the official website. About Dercum's Disease Dercum's disease is a rare disorder characterized by the development of painful lipomas primarily located on the trunk region, and the extremities close to the trunk. The pain is chronic (>3 months), symmetrical, often disabling, and resistant to traditional analgesics. The etiology of Dercum's disease remains unknown. There is no approved drug nor recommended standard treatment for Dercum's disease yet. The current treatment options, including surgical removal, liposuction, electrotherapy, and inflammation inhibitors, are symptomatic, and the efficacies are limited with numerous adverse events. The clinical need for Dercum's disease remains unmet. According to the Global Dercum's Disease Market Research Report, the global Dercum's disease treatment market size in 2022 was $11.8 billion. With a compound annual growth rate (CAGR) of 6.76%, the global market of Dercum's disease treatment in 2032 is estimated to expand to $22.7 billion. 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, moderate-to-severe cellulite and weight rebound management. 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 primary 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: 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The findings from the CBL-0204 Phase 2b clinical trial have been selected for presentation at IMCAS, the premier global congress in aesthetic medicine. The data will be highlighted in both the 2025 focus session on advances in fat reduction therapies and further detailed in the Non-surgical Body Contouring session through an oral presentation. The CBL-0204 Phase 2b results underscore the remarkable efficacy and safety profile of CBL-514 for localized adipose reduction. Both primary and secondary endpoints were met, establishing CBL-514 as the potentially first injectable therapy for large-area fat reduction. This trial was also the first trial adopted FDA-recommended metrics, including the SCALE and MRI-based assessments paving it's way for a pivotal global Phase 3 clinical trial slated to commence in 2025 NEW TAIPEI CITY, Dec. 18, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) is pleased to announce that the company will present CBL-514 Phase 2b study results (CBL-0204 Phase 2b) at the 26th IMCAS World Congress in Paris, France. CBL-514 is the first injectable for large-area fat reduction, with Phase 2b study results showing over 80% of CBL-514 treated participants achieved at least 1 grade of AFRS (abdominal fat rating scale) improvement. Dr. Michael H. Gold, the major principal investigator of Caliway's clinical trials for abdomen subcutaneous fat reduction, will present CBL-0204 Phase 2b topline results in the Non-surgical Body Contouring session on February 1st, 2025, at 3 PM (Central European Time, GMT+1 hour). Caliway CBL-0204 Study Results Presentation at IMCAS Information: Session 1 : IMCAS World Congress 2025 FOCUS Session Title: Fat Reduction Treatments in 2025 – What's New and What Works With EBD's and Injectables View Date/Time: Thursday 30 January 2025 at at 11:54 pm Venue: Room 402 - Level 4, Palais des Congrès de Paris(2 Pl de la Pte Maillot, 75017 Paris, France) Session 2: IMCAS World Congress 2025 | Non-surgical body contouring Title: A novel non-surgical fat reduction treatment: A Phase 2b study investigating CBL-514 injection's efficacy in reducing abdomen subcutaneous fat Date/Time: Saturday, 1 February 2025 at 3 PM (Central European Time, GMT+1 hour) Venue: Room 401 - Level 4, Palais des Congrès de Paris(2 Pl de la Pte Maillot, 75017 Paris, France) For more information regarding the session, please visit: About IMCAS World Congress IMCAS World Congress is a medical aesthetics-dedicated event that gathers over 18,700 healthcare and industry professionals to provide a global overview of the latest breakthroughs and innovations in the dermatology, plastic surgery, and aging science community. For more information, please visit: About CBL-514 CBL-514, a first-in-class small-molecule drug, is a lipolysis injectable that can induce adipocyte apoptosis and lipolysis to reduce subcutaneous adiposity in treatment areas without causing any systematic side effects on the central nervous system, cardiovascular system, and respiratory system. Caliway's preclinical studies have shown that CBL-514 upregulates the apoptosis mediators caspase 3 and Bax/Bcl-2 ratio and then induces adipocyte apoptosis in vivo and in vitro. Caliway is investigating multiple indications for CBL-514, including non-invasive subcutaneous fat reduction, Dercum's disease, and cellulite. To date, a total of 520 subjects have enrolled in CBL-514 clinical studies. According to 9 completed clinical studies of three indications, CBL-514 has demonstrated precise efficacy with a favorable safety profile. The global Pivotal Phase 3 study for non-surgical fat reduction will be conducted in 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 Taipei Exchange (TWSE-6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, please visit: 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. CONTACT: [email protected] SOURCE Caliway Biopharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED