Canopy's Fat-Reduction Drug CBL-514 Gets US FDA Go-Ahead for Second Pivotal Phase 3 Trial

Publication Date: 1150519 Spokesperson Date: 1150518 Spokesperson Time: 170707 Company Code: 6919 Company Name: Canopy* Subject: The application for our new drug CBL-514 injection's second multi-national, multi-center pivotal Phase 3 clinical trial, CBL-0302, for reducing abdominal subcutaneous fat has passed the US FDA IND 30-day review period, and the CBL-0302 clinical trial will be initiated. Compliant Clause: Article 10 Date of Occurrence: 1150518 Explanation: 1. Date of Occurrence: 115/05/18 2. R&D New Drug Name/Code: CBL-514 3. Use: A. Reduction of subcutaneous fat B. Improvement of moderate to severe cellulite C. Treatment of the rare disease Dercum's disease 4. All planned R&D stages: A. Phase 1 Clinical Trial: Completed. B. Phase 2 Clinical Trial: Completed multiple Phase 2 trials including CBL-0205. CBL-0206 clinical trial application approved by HREC in Australia, application submitted to TFDA in Taiwan. C. Phase 3 Clinical Trial: First pivotal Phase 3 trial CBL-0301 approved for execution in the US and Canada. Second pivotal Phase 3 trial CBL-0302 approved for execution in the US, application submitted in Canada. D. New Drug Application (NDA) review: Not yet conducted. 5. Current R&D stage: (1) Application/Approval/Disapproval/Clinical Trial Results/Other material events: The second multi-national, multi-center pivotal Phase 3 clinical trial CBL-0302 (SUPREME-02) for the New Drug Application (NDA) of our new drug CBL-514 for reducing abdominal subcutaneous fat, has passed the US FDA 30-day IND review period on May 18, 2026, without comment, and the CBL-0302 trial will be initiated. This trial will use both MRI measurement of abdominal subcutaneous fat volume change and the Patient Report-Abdominal Fat Rating Scale (PR-AFRS) to assess abdominal fat grade improvement 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 Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for the Reduction of 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 MRI-measured change in abdominal subcutaneous fat volume and improvement in abdominal fat grade assessed by PR-AFRS. g. Enrollment: Approx. 320 subjects. B. Statistical results of primary and secondary endpoints: N/A. C. Future market plans upon knowing Phase 3 results: N/A. D. A single trial's results are insufficient to reflect future success; investors should exercise caution. (2) Risks and measures for non-approval: N/A. (3) Future direction upon approval/significant results: Under company evaluation. (4) Accumulated R&D expenses: Temporarily not disclosed to protect company and investor interests. 6. Next R&D stage: (1) Estimated completion time: To be adjusted based on trial progress. (2) Obligations: None. 7. Market status: Over 80% of fat reduction procedures are still invasive surgeries with significant side effects. Non-surgical options often have poor efficacy or other side effects, indicating a large, unmet market need. 8. Other matters: None. 9. New drug development is long, expensive, and not guaranteed to succeed; investors should exercise caution.