[Canpep*] Company's New Drug CBL-514 Injection for Abdominal Subcutaneous Fat Reduction, Second Pivotal Phase 3 Trial (CBL-0302) Clears US FDA IND 30-Day Review, Trial to be Initiated

1. Date of occurrence: 2026/05/18 2. Name/code of new drug: CBL-514 3. Indications: A. Reduction of subcutaneous fat B. Improvement of moderate to severe cellulite C. Treatment of rare disease Dercum's disease 4. All planned development stages: A. Phase 1: Completed. B. Phase 2: Multiple Phase 2 trials including CBL-0205 completed. CBL-0206 approved by Australia HREC, application submitted to Taiwan TFDA. C. Phase 3: First pivotal Phase 3 trial CBL-0301 approved in the US and Canada. Second pivotal Phase 3 trial CBL-0302 approved in the US, application submitted in Canada. D. New Drug Application (NDA): Not yet initiated. 5. Current development stage: (1) The second multi-national, multi-center pivotal Phase 3 clinical trial CBL-0302 (SUPREME-02) for the New Drug Application (NDA) of CBL-514 injection for reducing abdominal subcutaneous fat, passed the U.S. FDA's 30-day IND review period on May 18, 2026, with no comments, and the CBL-0302 trial will be initiated. The trial will use MRI to measure changes in abdominal subcutaneous fat volume and the Patient Report-Abdominal Fat Rating Scale (PR-AFRS) to assess improvement in abdominal fat grade as primary efficacy endpoints. It is expected to enroll 320 subjects in the US, Canada, and Australia. A. Clinical trial design: a. Trial Name: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat (SUPREME-02). b. Purpose: To evaluate the efficacy, safety, and tolerability of CBL-514. c. Phase: Phase 3 d. Drug Name: CBL-514 e. Indication: Reduction of abdominal subcutaneous fat f. Endpoints: Primary efficacy endpoints are change in abdominal subcutaneous fat volume measured by MRI and improvement in abdominal fat grade assessed by PR-AFRS. g. Subjects: Approximately 320. (2) Other details: Not applicable. 6. Next development stage: (1) Expected completion time: To be adjusted according to trial progress. (2) Expected obligations: None. 7. Market status: The fat reduction market still has significant unmet needs. 8. Other matters: None. 9. New drug development is lengthy, costly, and not guaranteed to succeed, posing risks to investors. Please invest prudently.