Core Insights - 2025 is identified as a pivotal execution year for Cosmo's Vision 2030, focusing on scalable, innovation-driven growth in AI-enabled MedTech and pharmaceuticals [1] Financial Highlights - Cosmo Pharmaceuticals reported strong preliminary unaudited revenue of €104 million for 2025, with recurring revenues of €88 million and project-based revenues of €16 million [10] - Recurring revenues grew by €12 million compared to 2024, representing a 15% year-over-year increase, primarily driven by GI Genius™ and Winlevi® [10] - The year-end cash position exceeded €128 million, significantly above guidance, with zero debt, enabling strategic M&A and platform expansion [10][19] Business and Pipeline Update - GI Genius™ has evolved into a scalable AI platform, reinforcing Cosmo's leadership in AI-enabled endoscopy [4] - The GI Genius™ Module 300 rollout has progressed smoothly, confirming the robustness of the NVIDIA IGX-powered hardware platform [5] - ColonPRO received regulatory approval in Europe, supported by high-quality clinical evidence [6] - A clinical usability study integrating GI Genius™ with Apple Vision Pro was initiated, positioning Cosmo at the forefront of next-generation human-machine interfaces [7] - The latest iteration of Cosmo's polyp detection software has enhanced performance and introduced post-procedural AI-generated insights [8] Product Developments - Winlevi® has generated over 1.6 million prescriptions since its launch in 2021 and received regulatory approvals in multiple countries, with a European launch expected in the first half of 2026 [9][11] - Clascoterone 5% topical solution is progressing with 12-month safety and tolerability data expected in spring 2026, targeting androgenetic alopecia [12][13][14] Future Outlook - Cosmo is positioned for value creation in 2026 with expanding global reach for Winlevi, continued innovation in GI Genius, and the anticipated data readout for Clascoterone 5% [17] - The company plans to leverage its strong cash position and zero debt to accelerate growth through selective partnerships and capital deployment [17][19]

Group 1 - The core product GT20029 has successfully completed Phase II clinical trials for acne treatment, achieving primary endpoints with statistical significance and clinical relevance [1][2] - The recommended dosage for the upcoming Phase III clinical trial has been established at 0.5% [1] - The Phase II trial was a multi-center, randomized, double-blind, placebo-controlled study conducted at 10 centers across China, led by Professor Xiang Leihong from Huashan Hospital [1] Group 2 - GT20029 is developed based on the company's proprietary PROTAC platform and is positioned as a next-generation treatment for androgenetic alopecia and acne [2] - It is the first topical PROTAC compound globally to complete Phase II clinical trials, maintaining a leading position in the market [2] - The company is planning to initiate Phase III clinical trials for GT20029 in acne treatment to further expand its first-mover advantage in the topical PROTAC field [2] Group 3 - Winlevi® (clascoterone 1%) is the first acne medication approved by the FDA in nearly 40 years with a new mechanism of action, indicating the validation of targeting androgen receptors for acne treatment [2] - Winlevi® has become the most prescribed brand topical acne medication in the U.S., with over 1.3 million prescriptions written by more than 17,900 physicians since its launch [2] - The approval of acne medications targeting AR pathways suggests a promising market for GT20029 as an innovative, safe, and effective treatment option for dermatologists and patients [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部份內容而產生或因 倚賴該等內容而引致的任何損失承擔任何責任。 ( 股份代號 : 9939) 自願公告 GT20029 凝膠治療痤瘡中國 I I 期臨床試驗達到主要終點 本公告由開拓藥業有限公司*（「本公司」，連同其附屬公司統稱「本集團」）自願 刊發，以知會本公司股東及潛在投資者有關本集團的最新進展。 茲提述本公司日期為 2024 年 6 月 17 日的自願公告，內容有關 GT20029 凝膠治療痤 瘡的中國 II 期臨床試驗（「該項 II 期臨床試驗」），其已於 2024 年 6 月 17 日完成首 例受試者入組。 本公司董事（「董事」）會（「董事會」）欣然宣佈，其自主研發的新型靶向雄激素 受體（「AR」）的蛋白降解嵌合體（「PROTAC」）化合物 GT20029 治療痤瘡的 該項 II 期臨床試驗讀出頂線數據。數據顯示，該項 II 期臨床試驗成功達到主要研究終 點，結果具有統計學顯著性及臨床意義，且有效性、安全性和藥代動力學特徵均表現 出色，並確定 III 期臨床 ...