拨康视云“四闯”港交所，三年亏逾20亿元下，仍不断加码研发

Core Viewpoint - Cloudbreak Pharma Inc. has submitted its prospectus for the fourth time to the Hong Kong Stock Exchange, indicating ongoing efforts to go public despite previous rejections [1]. Company Overview - Cloudbreak Pharma is a clinical-stage ophthalmic biotechnology company focused on developing various therapies for eye diseases. The company was established in the U.S. in September 2015 and registered in the Cayman Islands in November 2020 [4]. - The company has two core products: CBT-001 for treating pterygium and CBT-009 for juvenile myopia, both of which are in different stages of clinical trials [4][7]. Product Development - CBT-001 has entered Phase 3 clinical trials in the U.S. and China, while CBT-009 completed Phase 1/2 trials and plans to submit a new drug application to the FDA in July 2024 [4][7]. - Other candidates include CBT-006 and CBT-004 in clinical stages, and CBT-007, CBT-199, CBT-145, and CBT-011 in preclinical stages [4]. Financial Performance - The company has not recorded any revenue since its inception and has incurred significant losses, totaling approximately $295 million (about 2.12 billion RMB) over the past three years [7][8]. - Losses for 2022, 2023, and 2024 were approximately $67 million, $129 million, and $99 million, respectively [8][9]. - Expected revenue for 2024 is around $10 million (approximately 71.88 million RMB) [7][8]. Research and Development Expenditure - R&D expenses have been increasing, with amounts of $15 million, $27 million, and $38 million for the years 2022, 2023, and 2024, respectively [10]. - Clinical research costs for CBT-001 and CBT-009 accounted for significant portions of R&D spending, indicating a strong focus on these core products [10]. Market Potential - The global market for pterygium treatment is projected to reach approximately $8.8 million by 2028 and $2.296 billion by 2033, with a compound annual growth rate of 92.0% [7]. - However, the market is expected to remain limited until 2027 due to the time required for education and patient acceptance following regulatory approval of CBT-001 [7]. Operational Challenges - The company faces ongoing operational cash flow challenges, with negative cash flows recorded for each reporting period [10]. - Total liabilities have been increasing, with figures of $227 million, $328 million, and $392 million reported for the years 2022, 2023, and 2024, respectively [10]. Cybersecurity Incident - A cybersecurity incident in 2019 resulted in a loss of approximately $1.065 million (about 7.6562 million RMB) due to fraudulent emails leading to unauthorized fund transfers [11].