1. Date of Event: June 18, 2026 2. Name or Code of Investigational Drug: CBL-514 3. Indications: A. Reduction of subcutaneous fat B. Improvement of moderate to severe cellulite C. Treatment of the rare disease Sogen Syndrome 4. All Planned Development Stages: A. Phase 1 Clinical Trial: Completed. B. Phase 2 Clinical Trial: Multiple Phase 2 trials (e.g., CBL-0205) completed. CBL-0206 has received IND approval from Australia’s HREC and Taiwan’s TFDA. C. Phase 3 Clinical Trial: The first pivotal Phase 3 trial, CBL-0301, has been approved in the U.S. and Canada. The second pivotal Phase 3 trial, CBL-0302, has been approved in the U.S., Canada, and Australia. The 3b Phase long-term follow-up trial, CBL-0303, has submitted an IND application to the FDA. D. New Drug Application (NDA): Not yet initiated. 5. Current Development Stage: (1) Status of Application/Approval/Rejection, Clinical Trial Results (Including Interim Analyses), and Other Major Events: The second global, multicenter pivotal Phase 3 clinical trial, CBL-0302 (SUPREME-02), supporting the NDA for CBL-514 injection for reducing abdominal subcutaneous fat, has received clinical trial approval from Australia’s reviewing authority, HREC (Human Research Ethics Committee), on June 18, 2026. This trial will use both MRI-measured changes in abdominal subcutaneous fat volume and the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS) as primary efficacy endpoints, and is expected to enroll approximately 320 subjects across the U.S., Canada, and Australia. A. Clinical Trial Design Overview (including trial name, objective, phase, drug name, indication, endpoints, and number of participants): 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 Reducing Abdominal Subcutaneous Fat (SUPREME-02). b. Objective: To evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat. c. Trial Phase: Phase 3 d. Drug Name: CBL-514 e. Indication: Reduction of abdominal subcutaneous fat f. Endpoints: Primary efficacy endpoints are changes in abdominal subcutaneous fat volume measured by MRI and improvement in abdominal fat grade assessed by PR-AFRS (Patient-Reported Abdominal Fat Rating Scale). g. Number of Participants: Approximately 320 B. Statistical Results of Primary and Secondary Endpoints (including p-values) and Statistical Significance: Not applicable. C. Market Entry Plan Upon Knowledge of Phase 3 Clinical Trial (including interim analysis) Statistical Data: Not applicable. D. A single clinical trial result (including statistical p-values and significance for primary and secondary endpoints) is insufficient to fully predict the success or failure of future drug development and commercialization. Investors should exercise caution. (2) Risks and Mitigation Measures if Not Approved by Regulatory Authorities, Trial Results Fail to Reach Statistical Significance, or Other Major Events Occur: Not applicable. (3) Future Business Direction if Approval is Obtained, Statistical Significance is Achieved, or Other Major Events Occur: Under company evaluation. (4) Cumulative R&D Expenditure Incurred: For strategic marketing reasons and to protect company and investor interests, this information will not be disclosed at this time. 6. Next Development Stage: (1) Expected Completion Time: Actual timeline subject to clinical trial progress. (2) Expected Obligations: None. 7. Market Overview: The primary goal of localized fat reduction is to decrease subcutaneous fat in targeted areas. Current treatments include invasive surgical procedures and non-invasive product-based therapies. While surgical methods offer more noticeable fat reduction, they involve significant tissue and nerve damage, higher risks, noticeable side effects, and longer recovery periods. As a result, non-surgical fat reduction products have rapidly gained popularity in recent years. However, currently available non-surgical products have limited efficacy, fail to significantly reduce subcutaneous fat, require multiple treatment sessions, and may carry severe or irreversible risks. The fat reduction market is large and continues to have substantial unmet demand. 8. Other Disclosures: Not applicable. 9. Drug development involves long timelines, high investment costs, and no guarantee of success, which may expose investors to risks. Investors should make careful judgments and invest prudently.

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  • Source: PR Times
  • Category: News
  • Products / services: CBL-514