To: Clinical Research Department Department of Health – Abu Dhabi P.O. Box 5674, Abu Dhabi, United Arab Emirates Subject: Clinical Trial Authorization Application — CARDIO-SHIELD Phase III Study (Protocol CS-401-301) Dear Director of Clinical Research, We respectfully submit this Clinical Trial Authorization (CTA) application for the CARDIO-SHIELD Phase III study (Protocol CS-401-301), a randomized, double-blind, placebo-controlled, multi-center study evaluating the efficacy and safety of CS-401 in patients with Acute Coronary Syndrome. This application is submitted in accordance with UAE Federal Law No. 8 of 2019 concerning Medical Products and the Department of Health Abu Dhabi Clinical Trials Regulation (DoH/CRD/2024/01). All required documentation is enclosed as specified in the DoH Clinical Trial Application Checklist. ملاحظة: تم إعداد هذا الطلب وفقاً للقانون الاتحادي رقم 8 لسنة 2019 بشأن المنتجات الطبية ولوائح التجارب السريرية الصادرة عن دائرة الصحة - أبوظبي [Note: This application has been prepared in accordance with UAE Federal Law No. 8 of 2019 concerning Medical Products and the Department of Health Abu Dhabi Clinical Trials Regulation] Study Details: - Protocol Number: CS-401-301 - Study Phase: Phase III - Therapeutic Area: Cardiovascular — Acute Coronary Syndrome - Study Population: Adults aged 18-80 years - Planned UAE Sites: 4 sites across Abu Dhabi and Dubai - Estimated UAE Enrollment: 250 patients - Study Duration: 24 months The Investigational Medicinal Product CS-401 has completed Phase II evaluation with favorable safety and efficacy signals in ACS populations. The enclosed Investigator Brochure (Edition 7) contains comprehensive preclinical and clinical data supporting the Phase III program. We confirm that all participating sites hold valid healthcare facility licenses issued by the DoH or equivalent authority, and all principal investigators meet the qualification requirements set forth in the DoH Clinical Trials Regulation. Enclosed documents: 1. Completed CTA Application Form (DoH-CTA-001) 2. Clinical Trial Protocol (CS-401-301, Version 3.0) 3. Investigator Brochure (Edition 7) 4. Ethics Committee Approval (Abu Dhabi Health Research Ethics Committee) 5. Informed Consent Form (Arabic and English versions) 6. Principal Investigator CVs and Medical Licenses 7. Site Qualification Documentation 8. Insurance Certificate 9. Financial Disclosure Statements We respectfully request expedited review consideration given the unmet medical need in ACS management in the UAE. Sincerely, Dr. Sarah Al-Mansouri Vice President, Regulatory Affairs — MENA Region Wonderful Therapeutics