Cloudbreak Pharma Inc. 撥康視雲製藥有限公司﹡ (Incorporated in the Cayman Islands with limited liability) （於開曼群島註冊成立的有限公司） Stock Code 股份代號 : 2592 INTERIM REPORT 2025 中期報告 Contents 目錄 1. Corporate Information 2 公司資料 2. Condensed Consolidated Interim Statement of Comprehensive Income 5 簡明綜合中期全面收益表 3. Condensed Consolidated Interim Statement of Financial Position 6 簡明綜合中期財務狀況表 4. Condensed Consolidated Interim Statement of Changes in Equity 7 簡明綜合中期權益變動表 5. Condensed Consolidated Interim Statement of Cash Flows 9 簡明綜合中期現 ...

格隆汇9月18日丨拨康视云-B(02592.HK)公告，董事会议决根据首次公开发售后股权激励计划的条款向 承授人授出首次公开发售后股权激励计划项下的受限制股份单位奖励，惟须获承授人接纳，方可作实。 将予授出的奖励：向四名雇员参与者授出4,284,189份受限制股份单位，相当于4,284,189股相关股份。 ...

拨康视云-B(02592)发布公告，于2025年9月18日，根据首次公开发售后股权激励计划向四名雇员参与者 授出428.42万份受限制股份单位，但须获承授人接纳，方可作实。 ...

智通财经APP讯，拨康视云-B(02592)发布公告，于2025年9月18日，根据首次公开发售后股权激励计划 向四名雇员参与者授出428.42万份受限制股份单位，但须获承授人接纳，方可作实。 ...

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，概不對因本公告全部或任何部分內容而產生或因倚賴該等內 容而引致之任何損失承擔任何責任。 CLOUDBREAK PHARMA INC. 撥康視雲製藥有限公司 * （於開曼群島註冊成立的有限公司） （股份代號：2592） 根據首次公開發售後股權激勵計劃授出受限制股份單位 本公告乃由本公司根據上市規則第17.06A條、17.06B條及17.06C條作出。茲提述本公司日期為2025 年6月24日的招股章程，內容有關（其中包括）首次公開發售後股權激勵計劃。 根據首次公開發售後股權激勵計劃授出受限制股份單位 董事會議決根據首次公開發售後股權激勵計劃的條款向承授人授出首次公開發售後股權激勵計劃項 下的受限制股份單位獎勵，惟須獲承授人接納，方可作實。 所授出受限制股份單位獎勵的詳情 建議行使價 ： 無 行使 ： 受限制股份單位在未歸屬前不得行使。根據計劃規則及相關授出函 件的條款，是項授出項下的受限制股份單位一經歸屬將自動行使。 股份於授出日期的收市價 ： 每股股份4.96港元 1 授出日期 ： 2025 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 重新提交 致：香港交易及結算所有限公司 公司名稱: Cloudbreak Pharma Inc. 呈交日期: 2025年9月17日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02592 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 2,000,000,000 | USD | | 0.0001 | USD | | 200,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 2,000,000,000 | USD | | 0.0001 | USD | | 200,000 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | 2025年8月31日 | | | | | 狀態: 新提交 | | | --- | --- | --- | --- | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | | | | | 公司名稱: | Cloudbreak Pharma Inc. | | | | | | | | 呈交日期: | 2025年9月1日 | | | | | | | | I. 法定/註冊股本變動 | | | | | | | | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | 是 | | | 證券代號 (如上市) | 02592 | 說明 | | | | | | | | | 法定/註冊股份數目 | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 2,000,000,000 USD | | 0.0001 USD | | 200,000 | 本月底法定/註冊股本總額： USD 200,000 第 1 頁 共 10 頁 v ...

Core Viewpoint - The company reported a significant improvement in its financial performance for the six months ending June 30, 2025, with a return to profitability and increased research and development spending [1] Financial Performance - Research and development expenses amounted to $23.732 million, representing a year-on-year increase of 5.54% [1] - The net profit reached $5.186 million, marking a turnaround from a loss in the previous year [1] - Basic earnings per share were reported at $0.01 [1]

Group 1 - The company reported a mid-term performance for the six months ending June 30, 2025, with R&D expenses amounting to 23.732 million USD, representing a year-on-year increase of 5.54% [1] - The net profit for the company reached 5.186 million USD, marking a turnaround from a loss to profitability compared to the previous year [1] - The basic earnings per share were reported at 0.01 USD [1]

[Interim Results Announcement](index=1&type=section&id=Interim%20Results%20Announcement) [Interim Results Overview](index=1&type=section&id=Interim%20Results) The Group announced its unaudited condensed consolidated interim results for the six months ended June 30, 2025, prepared under IAS 34 and Listing Rules - The Group's unaudited condensed consolidated interim results for the six months ended June 30, 2025, were prepared in accordance with IAS 34 and the applicable disclosure requirements of the Listing Rules[3](index=3&type=chunk) [Condensed Consolidated Interim Financial Statements](index=2&type=section&id=Condensed%20Consolidated%20Interim%20Financial%20Statements) [Condensed Consolidated Interim Statement of Comprehensive Income](index=2&type=section&id=Condensed%20Consolidated%20Interim%20Statement%20of%20Comprehensive%20Income) The Group reported a $5,186 thousand profit for H1 2025, a significant turnaround from a $52,111 thousand loss in H1 2024, primarily due to fair value gains Condensed Consolidated Interim Statement of Comprehensive Income (For the six months ended June 30) | Metric | 2025 (USD '000) | 2024 (USD '000) | | :--- | :--- | :--- | | Revenue | – | – | | Other income | 28 | – | | Net other gains or losses | (594) | 729 | | General and administrative expenses | (9,365) | (4,818) | | Research and development expenses | (23,732) | (22,487) | | Operating loss | (33,663) | (26,576) | | Net finance income | 495 | 1,219 | | Fair value changes of financial liabilities at FVTPL | 38,421 | (26,779) | | Profit/(loss) before income tax | 5,253 | (52,136) | | Profit/(loss) for the period | 5,186 | (52,111) | | Total comprehensive income/(loss) for the period | 5,976 | (52,935) | | Basic earnings/(loss) per share | 0.01 | (0.11) | | Diluted earnings/(loss) per share | (0.04) | (0.11) | - Profit for the period shifted from a **$52,111 thousand loss** in H1 2024 to a **$5,186 thousand profit** in H1 2025[4](index=4&type=chunk) - Fair value changes of financial liabilities at FVTPL turned from a **($26,779) thousand loss** in H1 2024 to a **$38,421 thousand gain** in H1 2025, being the primary driver for the turnaround[4](index=4&type=chunk) [Condensed Consolidated Interim Statement of Financial Position](index=4&type=section&id=Condensed%20Consolidated%20Interim%20Statement%20of%20Financial%20Position) As of June 30, 2025, total assets decreased to $25,740 thousand, with net current liabilities of ($333,373) thousand, though preference shares converted post-period Condensed Consolidated Interim Statement of Financial Position (As of June 30, 2025) | Metric | June 30, 2025 (USD '000) | December 31, 2024 (USD '000) | | :--- | :--- | :--- | | Total assets | 25,740 | 40,009 | | Total deficit | (330,173) | (351,546) | | Total liabilities | 355,913 | 391,555 | | Net current liabilities | (333,373) | (353,837) | | Cash and cash equivalents | 15,090 | 34,862 | | Convertible redeemable preference shares (current liabilities) | 347,732 | 386,195 | - Total assets decreased from **$40,009 thousand** on December 31, 2024, to **$25,740 thousand** on June 30, 2025[6](index=6&type=chunk) - Net current liabilities amounted to **($333,373) thousand**, primarily due to convertible redeemable preference shares classified as current liabilities, which were automatically converted into shares upon listing on July 3, 2025[7](index=7&type=chunk)[14](index=14&type=chunk) [Notes to the Unaudited Condensed Consolidated Interim Financial Information](index=6&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Information) [1. General Information](index=6&type=section&id=1.%20General%20Information) The Company, incorporated in the Cayman Islands on November 20, 2020, focuses on therapeutic biologics R&D, with its principal place of business in Hong Kong changing on August 26, 2025 - The Company was incorporated in the Cayman Islands on **November 20, 2020**, primarily engaged in the research and development of therapeutic biologics[8](index=8&type=chunk)[9](index=9&type=chunk) - The Company's principal place of business in Hong Kong changed effective **August 26, 2025**[8](index=8&type=chunk) [2. Basis of Preparation](index=6&type=section&id=2.%20Basis%20of%20Preparation) The condensed consolidated interim financial information is prepared under IAS 34 and Listing Rules, using historical cost and fair value remeasurement for preference shares - The financial information is prepared in accordance with IAS 34 "Interim Financial Reporting" and the applicable disclosure requirements of the Listing Rules[11](index=11&type=chunk) - The condensed consolidated interim financial information is prepared on a historical cost basis, modified by the revaluation of convertible redeemable preference shares at fair value[12](index=12&type=chunk) [3. Going Concern](index=7&type=section&id=3.%20Going%20Concern) Despite net current liabilities of $333,373 thousand, directors believe there are no significant going concern doubts due to post-period share conversion and global offering proceeds - As of June 30, 2025, the Group's current liabilities exceeded current assets by approximately **$333,373 thousand**, with net liabilities of approximately **$330,173 thousand**[14](index=14&type=chunk) - All convertible redeemable preference shares were automatically and irrevocably converted into shares upon listing on **July 3, 2025**[14](index=14&type=chunk) - The Group received net proceeds of approximately **HK$524,658 thousand** from the global offering, leading directors to believe there are no significant going concern doubts[14](index=14&type=chunk) [4. Application of Amendments to IFRS](index=7&type=section&id=4.%20Application%20of%20Amendments%20to%20IFRS) Amendments to IFRS applied during the reporting period had no significant impact on the Group's consolidated financial position or performance - Amendments to IFRS applied during the reporting period had no significant impact on the Group's consolidated financial position and performance[15](index=15&type=chunk) [5. Segment Information](index=7&type=section&id=5.%20Segment%20Information) The Group operates solely in the R&D of therapeutic biologics, with non-current assets predominantly located in mainland China - The Group has only one operating and reportable segment, which is the research and development of therapeutic biologics[16](index=16&type=chunk) Non-current Assets by Geographical Location (USD '000) | Region | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Mainland China | 3,204 | 2,205 | | Hong Kong | 13 | 91 | | United States | 102 | 203 | | Others | 1 | 1 | | Total | 3,320 | 2,500 | [6. Operating Loss](index=8&type=section&id=6.%20Operating%20Loss) Operating loss primarily comprised clinical research, employee benefit, and listing expenses, with employee benefits and listing expenses significantly increasing in H1 2025 Key Components of Operating Loss (For the six months ended June 30, USD '000) | Item | 2025 | 2024 | | :--- | :--- | :--- | | Clinical research expenses | 9,210 | 14,014 | | Employee benefit expenses | 18,900 | 9,729 | | Listing expenses | 2,833 | 736 | - Employee benefit expenses increased from **$9,729 thousand** in H1 2024 to **$18,900 thousand** in H1 2025[18](index=18&type=chunk) - Listing expenses significantly increased from **$736 thousand** in H1 2024 to **$2,833 thousand** in H1 2025[18](index=18&type=chunk) [7. Income Tax Expense/(Credit)](index=8&type=section&id=7.%20Income%20Tax%20Expense%2F%28Credit%29) The Group recorded a current income tax expense of $67 thousand in H1 2025, with tax rates varying by jurisdiction, including 25% in Mainland China Current Income Tax Expense/(Credit) (For the six months ended June 30, USD '000) | Item | 2025 | 2024 | | :--- | :--- | :--- | | Current income tax | 67 | 51 | | Over-provision in prior periods | – | (76) | | Current income tax expense/(credit) | 67 | (25) | - The corporate income tax rate in Mainland China is **25%**[24](index=24&type=chunk) - The US federal income tax rate is **21%**, California is **8.84%**, and Delaware is **8.7%**[23](index=23&type=chunk) [8. Earnings/(Loss) Per Share](index=10&type=section&id=8.%20Earnings%2F%28Loss%29%20Per%20Share) Basic earnings per share were $0.01 in H1 2025, compared to a basic loss of $0.11 in H1 2024, with diluted loss per share at $0.04 due to fair value changes Basic Earnings/(Loss) Per Share (For the six months ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Profit/(loss) attributable to owners of the Company (USD '000) | 5,186 | (52,111) | | Weighted average number of ordinary shares in issue | 475,386,302 | 475,386,302 | | Basic earnings/(loss) per share (expressed in USD per share) | 0.01 | (0.11) | Diluted Loss Per Share Calculation (For the six months ended June 30) | Metric | 2025 (USD '000) | 2024 (USD '000) | | :--- | :--- | :--- | | Profit/(loss) attributable to owners of the Company | 5,186 | (52,111) | | Fair value changes of convertible redeemable preference shares | (38,421) | – | | Net loss attributable to owners of the Company | (33,235) | (52,111) | | Weighted average number of ordinary shares in issue for diluted loss per share | 776,085,874 | 475,386,302 | | Diluted loss per share (expressed in USD per share) | (0.04) | (0.11) | - Diluted loss per share for H1 2024 was the same as basic loss per share due to the anti-dilutive effect of potential ordinary shares[28](index=28&type=chunk) [9. Dividends](index=11&type=section&id=9.%20Dividends) No dividends were declared or proposed during the reporting period or the prior period - No dividends were declared or proposed during the reporting period[29](index=29&type=chunk) [10. Trade and Other Payables](index=11&type=section&id=10.%20Trade%20and%20Other%20Payables) Total trade and other payables increased to $7,739 thousand as of June 30, 2025, primarily due to higher trade payables, accrued legal, professional, and listing expenses Trade and Other Payables (USD '000) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Trade payables | 3,154 | 1,760 | | Accrued legal and professional expenses | 713 | 128 | | Accrued listing expenses | 2,755 | 947 | | Total | 7,739 | 4,766 | - Trade payables increased from **$1,760 thousand** on December 31, 2024, to **$3,154 thousand** on June 30, 2025[30](index=30&type=chunk) [11. Contingent Liabilities](index=11&type=section&id=11.%20Contingent%20Liabilities) The Group had no significant contingent liabilities at the end of the reporting period - The Group had no significant contingent liabilities at the end of the reporting period[31](index=31&type=chunk) [12. Capital Commitments](index=11&type=section&id=12.%20Capital%20Commitments) As of June 30, 2025, the Group's capital commitments were $1,048 thousand, primarily for property, plant, and equipment, with none on December 31, 2024 Capital Commitments (USD '000) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Property, plant and equipment | 1,048 | – | - Capital commitments increased from zero on December 31, 2024, to **$1,048 thousand** on June 30, 2025[32](index=32&type=chunk) [13. Events After Reporting Period](index=11&type=section&id=13.%20Events%20After%20Reporting%20Period) On July 3, 2025, shares were listed on the Main Board of the Stock Exchange, with 60,582,000 shares issued in a global offering at HK$10.10 per share - On **July 3, 2025**, shares were listed on the Main Board of the Stock Exchange, with **60,582,000 shares** issued in the global offering[33](index=33&type=chunk) - The subscription price for the global offering was **HK$10.10 per share**, with proceeds credited to the Company's share capital and share premium accounts[33](index=33&type=chunk) [I. Business Review](index=12&type=section&id=I.%20Business%20Review) [1. Overview](index=12&type=section&id=1.%20Overview) The Company is a clinical-stage ophthalmic biotechnology company focused on developing innovative therapies for eye diseases, operating primarily in the US and China, with eight internally developed drug candidates - The Company is a clinical-stage ophthalmic biotechnology company operating primarily in the United States and China[34](index=34&type=chunk) - The current pipeline includes **eight drug candidates**, with **four in clinical stage** and **four in pre-clinical stage**, all internally developed[34](index=34&type=chunk) [2. Pipeline](index=12&type=section&id=2.%20Pipeline) The Group's pipeline includes core products CBT-001 (pterygium) and CBT-009 (juvenile myopia), both in or approved for Phase 3 trials, along with other clinical and pre-clinical candidates - Core products **CBT-001 (pterygium)** and **CBT-009 (juvenile myopia)** have entered advanced clinical development stages[34](index=34&type=chunk) [2.1. Core Products](index=12&type=section&id=2.1.%20Core%20Products) CBT-001 (pterygium) is in global Phase 3 multi-regional clinical trials, expected to complete by June 2026; CBT-009 (juvenile myopia) completed Phase 1/2 in Australia and received US FDA approval for Phase 3 trials - CBT-001 completed patient enrollment across all five jurisdictions in **May 2025**, with a total of **660 patients** recruited, and Phase 3 multi-regional clinical trials are expected to conclude by **June 2026**[36](index=36&type=chunk) - CBT-001 has established commercialization partnerships with **Grand Pharma (Greater China)** and **Santen (Japan, Korea, and other APAC regions)**[36](index=36&type=chunk) - CBT-009 completed combined Phase 1 and Phase 2 clinical trials in Australia in **January 2023**, demonstrating good safety and efficacy[37](index=37&type=chunk) - The US FDA approved CBT-009 for Phase 3 clinical trials in the United States in **September 2023** and **September 2024**[37](index=37&type=chunk) [2.2. Other Clinical Stage Candidates](index=14&type=section&id=2.2.%20Other%20Clinical%20Stage%20Candidates) CBT-006 (MGD-related dry eye) completed US Phase 2 trials in May 2022, with plans for additional studies in Hong Kong; CBT-004 (vascularized pinguecula) completed Phase 2 trials in May 2025 with positive results, and Phase 3 discussions with the US FDA are planned - CBT-006 completed US Phase 2 clinical trials in **May 2022** and plans to initiate additional clinical studies in Hong Kong[39](index=39&type=chunk)[40](index=40&type=chunk) - CBT-004 completed Phase 2 clinical trials in **May 2025**, with results indicating achievement of primary efficacy endpoints, and a post-Phase 2 meeting with the US FDA is planned[42](index=42&type=chunk) - As of June 30, 2025, CBT-004 is the **only clinical-stage drug globally** for the treatment of vascularized pinguecula[41](index=41&type=chunk) [2.3. Pre-clinical Stage Candidates](index=15&type=section&id=2.3.%20Pre-clinical%20Stage%20Candidates) The Group has four pre-clinical stage candidates: CBT-007 (glaucoma filtration surgery success rate), CBT-199 and CBT-145 (presbyopia), and CBT-011 (diabetic macular edema) - CBT-007 aims to improve the success rate of glaucoma filtration surgery[43](index=43&type=chunk) - CBT-199 and CBT-145 are novel formulations and new chemical entities for treating presbyopia[43](index=43&type=chunk) - CBT-011 is an ADS conjugate for the treatment of diabetic macular edema[43](index=43&type=chunk) [2.4. Pipeline Development Summary](index=16&type=section&id=2.4.%20Pipeline%20Development%20Summary) This section provides a tabular overview of each drug candidate's development status, mechanism, indication, commercial rights, formulation, clinical stage, and projected milestones as of June 30, 2025 - **CBT-001** and **CBT-009** are core products, both having entered or been approved for Phase 3 clinical trials[45](index=45&type=chunk) - Most drug candidates are being developed in the US via the **505(b)(2) pathway** to accelerate development timelines and reduce costs[45](index=45&type=chunk) [3. Production Facilities](index=17&type=section&id=3.%20Production%20Facilities) The Group established a GMP-compliant pilot production facility in Suzhou, China, with an annual capacity of 3.5 million to 5.3 million bottles, and plans to complete Phase 1 of a large-scale commercial production facility by 2026 - A pilot production facility has been established in Suzhou, China, designed to comply with Good Manufacturing Practice standards of the **US, China, and the European Union**[47](index=47&type=chunk) - The pilot production facility has a designed annual capacity of **3.5 million to 5.3 million bottles** (0.2 ml/bottle)[47](index=47&type=chunk) - Construction of the planned commercial production facility commenced in **December 2024**, with Phase 1 construction expected to complete in **2026**[48](index=48&type=chunk) [4. Commercialization](index=17&type=section&id=4.%20Commercialization) The Group's short-term commercialization efforts will focus on core product CBT-001, including educating key opinion leaders and seeking third-party reimbursement; CBT-009's strategy will involve similar market education after Phase 3 trials commence - Commercialization preparations for CBT-001 include educating key opinion leaders and eye care professionals, and seeking third-party reimbursement from government and private insurance providers[49](index=49&type=chunk) - Exclusive commercialization licensing arrangements for CBT-001 have been established with **Grand Pharma (Greater China)** and **Santen (Asia Pacific region)**[50](index=50&type=chunk) - CBT-009 commercialization will focus on raising awareness for juvenile myopia through key opinion leader education and conference presentations, emphasizing the advantages of non-aqueous eye drops[51](index=51&type=chunk) [5. Collaboration and Licensing Arrangements](index=18&type=section&id=5.%20Collaboration%20and%20Licensing%20Arrangements) The Group has licensing agreements with Grand Pharma and Santen Pharmaceutical for CBT-001's development and commercialization, granting exclusive rights in Greater China and specific APAC regions, respectively - On **April 13, 2020**, the Grand Pharma License Agreement was entered into, granting exclusive manufacturing and commercialization rights for CBT-001 in Greater China to Grand Pharma[52](index=52&type=chunk) - On **August 6, 2024**, the Santen License Agreement was entered into, granting exclusive rights to develop, manufacture, and commercialize nintedanib-containing products (including CBT-001) in Japan, Korea, Vietnam, Thailand, Malaysia, Singapore, Philippines, and Indonesia to Santen[54](index=54&type=chunk) - Despite the license agreements, the Company retains effective control over all development activities for CBT-001 and is responsible for regulatory filings and approvals[53](index=53&type=chunk) [6. Intellectual Property](index=20&type=section&id=6.%20Intellectual%20Property) As of June 30, 2025, the Group holds 61 granted patents and 169 pending patent applications, with core products CBT-001 and CBT-009 having 46 and 2 granted patents, respectively - As of June 30, 2025, the Group holds **61 granted patents** and **169 pending patent applications**[55](index=55&type=chunk) - Core product **CBT-001** has **46 granted patents** and **63 pending patent applications** globally[55](index=55&type=chunk) - Core product **CBT-009** has **2 granted patents** and **23 pending patent applications** globally[55](index=55&type=chunk) [7. Human Resources](index=20&type=section&id=7.%20Human%20Resources) As of June 30, 2025, the Group had 60 full-time employees across China, the US, Hong Kong, and Germany, with the R&D team comprising 20 experienced professionals, 7 of whom hold master's degrees or higher - As of June 30, 2025, the Group had a total of **60 full-time employees**[56](index=56&type=chunk) Employee Functional Distribution | Function | Number of Employees | | :--- | :--- | | Management | 7 | | R&D | 15 | | Manufacturing | 5 | | Quality Control and Quality Assurance | 11 | | Administration | 22 | | Total | 60 | - The R&D team consists of **20 experienced professionals**, with **7 holding master's degrees or higher** and **5 holding doctoral degrees**[60](index=60&type=chunk) [8. Research and Development](index=20&type=section&id=8.%20Research%20and%20Development) The Group is dedicated to developing innovative ophthalmic drug candidates, all internally developed with potential to be first-in-class or best-in-class therapies, supported by three strategic R&D centers and two proprietary technology platforms - All drug candidates are internally developed, with the potential to be **first-in-class or best-in-class therapies**[58](index=58&type=chunk) - R&D operations are supported by **three strategic R&D centers** located in the United States and China[59](index=59&type=chunk) - The R&D strategy is based on two proprietary technology platforms: **multi-kinase inhibitors (MKI)** and **ADS**, used to develop drug candidates for anterior and posterior eye diseases, respectively[61](index=61&type=chunk) [9. Outlook](index=21&type=section&id=9.%20Outlook) The Group's long-term vision is to accelerate global clinical development of its drug pipeline, strengthen R&D capabilities and technology platforms, tailor diversified commercialization strategies, and expand organizational scale - Key focuses include advancing the drug pipeline, enhancing proprietary technology platforms, and preparing for the potential commercial launch of core products[62](index=62&type=chunk) - Strategies include accelerating global clinical development of the drug candidate pipeline, strengthening R&D capabilities, tailoring commercialization strategies, and expanding organizational scale[64](index=64&type=chunk) [10. Significant Events After Reporting Period](index=21&type=section&id=10.%20Significant%20Events%20After%20Reporting%20Period) CBT-004 eye drops achieved positive topline results in its Phase 2 clinical trial for vascularized pinguecula, showing significant improvements in conjunctival hyperemia and patient symptoms with a positive safety profile, and the Group plans to advance CBT-004 to Phase 3 development - CBT-004 eye drops achieved positive topline results in its Phase 2 clinical trial, showing statistically significant improvement in conjunctival hyperemia and significant improvement in all five common patient-reported symptoms[63](index=63&type=chunk) - No treatment-related adverse events were observed, with most adverse events being mild to moderate, indicating a positive safety profile[65](index=65&type=chunk) - The Group plans to advance CBT-004 to Phase 3 development and initiate discussions with the US FDA[65](index=65&type=chunk) [II. Financial Review](index=22&type=section&id=II.%20Financial%20Review) [Revenue](index=22&type=section&id=Revenue) As a clinical-stage ophthalmic biotechnology company, the Group generated no revenue from drug sales during the reporting period or the prior period - The Group generated no revenue from drug sales during the reporting period or the prior period[66](index=66&type=chunk) [Other Income](index=22&type=section&id=Other%20Income) Other income primarily stemmed from Suzhou local government grants for the Group's R&D activities, with grant amounts remaining largely stable compared to the prior period - Other income primarily refers to government grants received from the Suzhou local government for the Group's R&D activities[67](index=67&type=chunk) - The amount of grants received by the Group remained stable during the reporting period, largely consistent with the prior period[67](index=67&type=chunk) [Other Gains and Losses, Net](index=22&type=section&id=Other%20Gains%20and%20Losses%2C%20Net) The Group recorded a net exchange loss during the reporting period, primarily due to the conversion of US dollar deposits in China to Renminbi for daily operational use - The Group recorded an exchange loss during the reporting period due to the conversion of US dollar deposits in China to Renminbi for daily operational use[68](index=68&type=chunk) [General and Administrative Expenses](index=22&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses increased during the reporting period compared to the prior period, mainly due to higher listing expenses, increased headcount, and overall expenses from newly granted restricted share units - General and administrative expenses increased compared to the prior period, primarily due to higher listing expenses incurred by the Group during the reporting period[69](index=69&type=chunk) - Overall expenses also increased due to an increase in headcount and the granting of new restricted share units[69](index=69&type=chunk) [R&D Expenses](index=23&type=section&id=R%26D%20Expenses) R&D expenses increased during the reporting period compared to the prior period, primarily due to the granting of restricted share units to R&D personnel; clinical research expenses for CBT-001 decreased, and CBT-004's clinical research expenses also reduced following the completion of its Phase 2 clinical trial - The increase in R&D expenses compared to the prior period was due to the Company granting restricted share units to R&D personnel during the reporting period[70](index=70&type=chunk) Clinical Research Expenses Breakdown (For the six months ended June 30, USD '000) | Item | 2025 (USD '000) | 2025 (%) | 2024 (USD '000) | 2024 (%) | | :--- | :--- | :--- | :--- | :--- | | **Core Products** | | | | | | – CBT-001 | 8,200 | 89.0 | 12,413 | 88.6 | | – CBT-009 | 223 | 2.4 | 173 | 1.2 | | **Other Drug Candidates** | 787 | 8.6 | 1,428 | 10.2 | | **Total** | 9,210 | 100.0 | 14,014 | 100.0 | - Clinical research expenses for CBT-001 decreased as activities related to the second Phase 3 clinical trial are planned for H2 2025[70](index=70&type=chunk) [Finance Income](index=23&type=section&id=Finance%20Income) Finance income decreased during the reporting period, primarily due to the Group utilizing funds from deposit accounts for R&D activities and daily operations, resulting in reduced bank deposit balances - The decrease in finance income was due to the Group utilizing funds from deposit accounts for R&D activities and daily operations, leading to a reduction in bank deposit balances[72](index=72&type=chunk) [Finance Costs](index=24&type=section&id=Finance%20Costs) Finance costs, primarily comprising interest expenses on lease liabilities for leased properties, showed no significant fluctuations during the reporting period or the prior period - Finance costs primarily consist of interest expenses on lease liabilities for leased properties, with no significant fluctuations[74](index=74&type=chunk) [Fair Value Changes of Financial Liabilities at FVTPL](index=24&type=section&id=Fair%20Value%20Changes%20of%20Financial%20Liabilities%20at%20FVTPL) During the reporting period, fair value changes of financial liabilities at FVTPL resulted in a gain of approximately $38.4 million, primarily due to a slight decrease in the Group's valuation and the granting of restricted share units - The Group recorded a gain of approximately **$38.4 million**, with fair value turning positive in the reporting period from a negative value in the prior period[75](index=75&type=chunk) - Reasons for the change include a slight decrease in the Group's valuation and the granting of **94,886,451 restricted share units** during the reporting period[75](index=75&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) The Group funds its operations with cash inflows from equity financing; as of June 30, 2025, cash and cash equivalents were $15.1 million, down from $34.9 million on December 31, 2024, and the Group has $45.0 million in unutilized bank facilities - As of June 30, 2025, cash and cash equivalents amounted to **$15.1 million**, compared to **$34.9 million** on December 31, 2024[76](index=76&type=chunk) - The Group has **$45.0 million** in unutilized bank facilities, all of which are unrestricted[76](index=76&type=chunk) [Lease Liabilities](index=24&type=section&id=Lease%20Liabilities) Lease liabilities decreased from $0.5 million on December 31, 2024, to $0.3 million on June 30, 2025, primarily due to lease term expirations - Lease liabilities decreased from **$0.5 million** on December 31, 2024, to **$0.3 million** on June 30, 2025, primarily due to lease term expirations[77](index=77&type=chunk) [Capital Commitments](index=24&type=section&id=Capital%20Commitments) As of June 30, 2025, the Group's capital commitments for construction work amounted to $1.05 million, with none on December 31, 2024 - As of June 30, 2025, the Group's capital commitments for construction work amounted to **$1.05 million** (December 31, 2024: nil)[78](index=78&type=chunk) [Contingent Liabilities](index=25&type=section&id=Contingent%20Liabilities) As of June 30, 2025, the Group had no significant contingent liabilities, guarantees, or any material pending or potential litigation or claims that could significantly adversely affect any member of the Group - As of June 30, 2025, the Group had no significant contingent liabilities, guarantees, or any material pending or potential litigation or claims that could significantly adversely affect any member of the Group[79](index=79&type=chunk) [Capital Expenditure](index=25&type=section&id=Capital%20Expenditure) The Group's capital expenditure, primarily for property, plant, and equipment and intangible assets, remained stable at $0.1 million for both the reporting period and the prior period - Capital expenditure for the reporting period and the prior period was **$0.1 million** respectively[80](index=80&type=chunk) [Significant Investments](index=25&type=section&id=Significant%20Investments) The Group made no significant investments during the reporting period or the prior period, nor does it plan any significant investments or acquisitions of major capital assets - The Group made no significant investments during the reporting period or the prior period[81](index=81&type=chunk) [Significant Acquisitions and Disposals](index=25&type=section&id=Significant%20Acquisitions%20and%20Disposals) During the reporting period, the Group made no significant acquisitions or disposals of subsidiaries, associates, or joint ventures - During the reporting period, the Group made no significant acquisitions or disposals of subsidiaries, associates, or joint ventures[82](index=82&type=chunk) [Foreign Exchange Risk and Hedging](index=25&type=section&id=Foreign%20Exchange%20Risk%20and%20Hedging) The Group is exposed to foreign currency risk but currently holds no financial instruments for hedging purposes, managing risk through close monitoring of exchange rate fluctuations - The Group is exposed to foreign currency risk but currently holds no financial instruments for hedging purposes[83](index=83&type=chunk) [Pledge of Assets](index=25&type=section&id=Pledge%20of%20Assets) As of June 30, 2025, the Group had not pledged or charged any of its assets - As of June 30, 2025, the Group had not pledged or charged any of its assets[84](index=84&type=chunk) [Employees and Remuneration](index=26&type=section&id=Employees%20and%20Remuneration) As of June 30, 2025, the Group had 60 employees, with total remuneration costs significantly increasing to $18.3 million from $8.7 million in the prior period, reflecting the Group's commitment to competitive compensation and equity incentive arrangements - As of June 30, 2025, the Group had **60 employees** (June 30, 2024: 48 employees)[85](index=85&type=chunk) - During the reporting period, the Group incurred total remuneration costs of **$18.3 million**, compared to **$8.7 million** in the prior period[85](index=85&type=chunk) - The Company has also adopted equity incentive arrangements to provide incentives to its employees[86](index=86&type=chunk) [Borrowings and Gearing Ratio](index=26&type=section&id=Borrowings%20and%20Gearing%20Ratio) As of June 30, 2025, the Group had no outstanding borrowings, maintaining a net cash position, rendering the gearing ratio inapplicable - As of June 30, 2025, the Group had no outstanding borrowings[87](index=87&type=chunk) - The Group maintained a net cash position, thus the gearing ratio is not applicable[87](index=87&type=chunk) [Interim Dividend](index=26&type=section&id=Interim%20Dividend) The Board does not recommend the payment of an interim dividend for the six months ended June 30, 2025 - The Board does not recommend the payment of an interim dividend for the six months ended June 30, 2025[88](index=88&type=chunk) [Use of Proceeds from Global Offering](index=26&type=section&id=Use%20of%20Proceeds%20from%20Global%20Offering) Net proceeds from the global offering, approximately HK$524.6 million, are primarily allocated to ongoing clinical R&D for core products CBT-001 and CBT-009, as well as production facilities and commercialization activities, with no significant changes to the intended use of proceeds - Net proceeds from the global offering amounted to approximately **HK$524.6 million**[89](index=89&type=chunk) Allocation and Expected Timeline for Use of Net Proceeds from Global Offering (HK$ million) | Use of Proceeds | Amount (HK$ million) | Percentage of Total (%) | Expected Timeline | | :--- | :--- | :--- | :--- | | Funding ongoing clinical R&D activities for core product CBT-001 | 327.4 | 62.4 | Before 2027 | | Funding ongoing clinical R&D activities for core product CBT-009 | 144.8 | 27.6 | Before 2029 | | Funding production facilities and commercialization activities | 28.8 | 5.5 | Before 2031 | | Working capital and other general corporate purposes | 23.6 | 4.5 | Before 2026 | | Total | 524.6 | 100 | | - There are no significant changes to the intended use of net proceeds[89](index=89&type=chunk) [Other Information](index=27&type=section&id=Other%20Information) [Events Subsequent to the Reporting Period](index=27&type=section&id=Events%20Subsequent%20to%20the%20Reporting%20Period) Immediately prior to listing, all issued Class A, B, C ordinary shares and preference shares were converted into ordinary shares, and the authorized share capital increased; shares were listed on the Main Board of the Stock Exchange on July 3, 2025 - Immediately prior to the completion of the listing, all issued Class A, Class B, Class C ordinary shares, and preference shares were converted into ordinary shares at a **1:1 ratio**[91](index=91&type=chunk) - The Company's authorized share capital increased from **$100,000** to **$200,000**[91](index=91&type=chunk) - The shares have been listed on the Main Board of the Stock Exchange since the listing date[92](index=92&type=chunk) [Update on Equity Incentive Arrangements](index=28&type=section&id=Update%20on%20Equity%20Incentive%20Arrangements) The Company adopted several equity incentive arrangements, including Series B, Series C, the 2023 Equity Incentive Plan, and the Post-IPO Equity Incentive Plan; 94,886,451 restricted share units were granted to employees during the reporting period, and post-period, the Board resolved to cancel 4,509,673 unexercised restricted share units - The Company has adopted several equity incentive arrangements to incentivize and recognize the contributions of certain employees, officers, consultants, and/or service providers of the Group[93](index=93&type=chunk) - During the reporting period, share awards equivalent to **94,886,451 underlying shares** were granted to employees in the form of restricted share units[93](index=93&type=chunk) - On **August 29, 2025**, the Board resolved and approved the cancellation of **4,509,673 unexercised restricted share units**[96](index=96&type=chunk) [Changes in Directors' Information](index=29&type=section&id=Changes%20in%20Directors%27%20Information) From the prospectus date to this announcement date, there have been no changes in Board members or the Company's CEO, nor any changes in directors' and CEO's information requiring disclosure under Listing Rules 13.51(2) and 13.51B(1) - From the prospectus date to this announcement date, there have been no changes in Board members or the Company's CEO, nor any changes in directors' and CEO's information requiring disclosure under the Listing Rules[97](index=97&type=chunk) [Purchase, Sale or Redemption of Listed Securities](index=29&type=section&id=Purchase%2C%20Sale%20or%20Redemption%20of%20Listed%20Securities) As shares were not listed on the Stock Exchange during the reporting period, neither the Company nor its subsidiaries purchased, sold, or redeemed any of its listed securities during that period, with no such transactions from the listing date to this announcement date - As shares were not listed on the Stock Exchange during the reporting period, neither the Company nor its subsidiaries purchased, sold, or redeemed any of its listed securities during that period[98](index=98&type=chunk) [Corporate Governance Practices](index=29&type=section&id=Corporate%20Governance%20Practices) The Company adopted and complied with the Corporate Governance Code since its listing date, except for Dr. Ni holding both Chairman and CEO roles, which the Board believes ensures unified leadership and efficient decision-making - The Company has adopted and complied with all applicable provisions of the Corporate Governance Code[99](index=99&type=chunk) - The roles of Chairman and Chief Executive Officer are combined and held by Dr. Ni, deviating from Code Provision C.2.1[99](index=99&type=chunk) - The Board believes this combination ensures unified leadership, efficient strategic planning and execution within the Group, and facilitates information flow between management and the Board[99](index=99&type=chunk) [Standard Code for Securities Transactions by Directors](index=30&type=section&id=Standard%20Code%20for%20Securities%20Transactions%20by%20Directors) The Company adopted the Standard Code for securities transactions by directors and senior management since its listing date, with all directors confirming strict compliance since then - The Company adopted the Standard Code as its own code for securities transactions, applicable to all directors and senior management, since the listing date[101](index=101&type=chunk) - Each director confirmed strict compliance with the required standards set out in the Standard Code from the listing date to this announcement date[101](index=101&type=chunk) [Audit Committee](index=30&type=section&id=Audit%20Committee) The Company established an Audit Committee comprising Mr. Liu Chung Man (Chairman), Mr. Lai Hin Wing, and Ms. Nie Sijiang, which reviewed the Group's unaudited condensed consolidated interim financial information for the reporting period and deemed it compliant with applicable accounting standards and requirements - The Audit Committee comprises three directors: **Mr. Liu Chung Man (Chairman)**, **Mr. Lai Hin Wing**, and **Ms. Nie Sijiang**[102](index=102&type=chunk) - The Audit Committee's primary responsibilities include reviewing and monitoring the Group's financial reporting process, risk management, and internal control systems[102](index=102&type=chunk) - The Audit Committee reviewed the Group's unaudited condensed consolidated interim financial information contained in this announcement and deemed it prepared in accordance with applicable accounting standards and relevant requirements[102](index=102&type=chunk) [Publication of Interim Results Announcement and Interim Report](index=31&type=section&id=Publication%20of%20Interim%20Results%20Announcement%20and%20Interim%20Report) This announcement has been published on the Stock Exchange and the Company's websites; the interim report, containing all information required by the Listing Rules, will be dispatched to shareholders and published on both websites in due course - This announcement is published on the Stock Exchange website (www.hkexnews.hk) and the Company's website (https://cloudbreakpharma.com/)[103](index=103&type=chunk) - The interim report, containing all information required by the Listing Rules, will be dispatched to shareholders and published on the Stock Exchange and the Company's websites in due course[103](index=103&type=chunk) [Acknowledgement](index=31&type=section&id=Acknowledgement) The Board extends its sincere gratitude to shareholders, management, employees, and business partners for their support and contributions to the Group - The Board extends its sincere gratitude to shareholders, management, employees, and business partners for their support and contributions to the Group[104](index=104&type=chunk) [Glossary](index=31&type=section&id=Glossary) This section provides definitions for key terms and abbreviations used in the report, covering vocabulary related to corporate governance, finance, drug development, regulatory bodies, and geographical regions - The glossary provides definitions for key terms and abbreviations used in the report[105](index=105&type=chunk) - It covers terminology related to corporate governance, finance, drug development, regulatory bodies, and geographical regions[106](index=106&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk)[113](index=113&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk)[117](index=117&type=chunk)[118](index=118&type=chunk)