Cloudbreak Pharma Submits Third Hong Kong IPO Application with Core Ophthalmic Candidates CBT-001 and CBT-009

On December 2, 2024, the Hong Kong Stock Exchange's official website showed,Cloudbreak PharmaSubmitted an application for listing on the Hong Kong Stock Exchange, with UBS Group, CCB International, and Huatai International as joint sponsors.(Click to download:Cloudbreak Pharma Prospectus)

It is reported that this is Cloudbreak Pharma's third submission to the Hong Kong Stock Exchange in half a year.

FigureSource: HKEX Official Website

The prospectus shows that Cloudbreak Pharma is a clinical-stage ophthalmic biotechnology company dedicated to developing various therapies. Its pipeline includes two core products (CBT-001 and CBT-009), both of which are self-developed.

FigureSource: Cloudbreak Pharma Prospectus (Same as below)

Among them, the core product CBT-001 is applicable for the treatment of pterygium (a benign hyperplastic ocular surface disease), and Phase 3 multi-regional clinical trials were initiated in June 2022 in the United States and in September 2023 in China.Currently, CBT-001 is the world's first drug to enter Phase 3 clinical trials for this indication, and there are no approved drug therapies available globally.

The core product, CBT-009, is used for treating juvenile myopia (myopia in children and adolescents aged 5 to 19). It completed Phase 1/2 clinical trials in January 2023 and submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in July 2024.

In addition, Cloudbreak Pharma has two other clinical-stage drug candidates, CBT-006 and CBT-004, as well as four preclinical-stage drug candidates, CBT-007, CBT-199, CBT-145, and CBT-011.

According to the MedAlpha Global Innovative Drug Investment and Financing Database by PharmaCube, Cloudbreak Pharma has completed multiple rounds of financing. Notably, on January 12, 2022, the company closed its Series C round with an amount as high as 130 million US dollars. Investors included Gaocheng Capital, Oriental Fortune Capital, Industrial Securities Capital, CDH Investments, CCB International, Decheng Capital, Yingke Capital, YF Capital, and CMB International.

The prospectus shows that its post-money valuation in the latest round reached HK$3.66 billion.

Financially, Cloudbreak Pharma has not yet generated any revenue. As of 2021, 2022, 2023, and the first half of 2024, Cloudbreak Pharma reported losses of $35.4 million, $66.8 million, $129.4 million, and $52.1 million, respectively.

Cloudbreak Pharma Equity Structure

As of the date of this prospectus, Dr. Ni Jinsong, Ms. Leng, Water Lily Consultants, Ni Legacy Trust, Ice Tree LLC, Ice Tree Consultants, and Leng Legacy Trust are the single largest shareholder of Cloudbreak Pharma.

The prospectus shows that Dr. Ni Jinsong, 55, is the Chairman of the Board, Executive Director, Chief Executive Officer, and one of the largest single shareholders. He was appointed as a director on November 20, 2020, and was appointed as Chairman of the Board and re-designated as Executive Director on November 9, 2023. Dr. Ni is responsible for overseeing Cloudbreak Pharma's overall drug development, daily operational management, as well as strategy and business development.

Dr. Ni, together with Director Dinh and Dr. Li Junzhi, co-founded the Group in September 2015, establishing Cloudbreak USA, the first major operating subsidiary of Cloudbreak Pharma at that time. Dr. Ni was one of the founding shareholders of Cloudbreak USA and served as one of its managers from December 2015 to December 2021. Dr. Ni also held the following positions in other member companies of Cloudbreak Pharma and was primarily responsible for decision-making in these companies:

• Has served as the Chairman, General Manager, and Legal Representative of Cloudbreak Pharma (Guangzhou) since September 2018;

• Has served as a director of Cloudbreak Cayman since November 2019;

• Has served as a director of Cloudbreak HK since November 2019;

• Has served as a director of Cloudbreak BVI since November 2019;

• Served as the manager of ADS USA from January 2017 to January 2021;

• Has served as the Executive Director of Cloudbreak Pharma (Suzhou) since September 2021, and as the legal representative from September 2021 to September 2023;

• Managing Director of Cloudbreak Germany since May 2022;

• Has been serving as a director of Cloudbreak Pharma HK since June 2022; and

• Has served as the Executive Director of Cloudbreak Pharma Yixing since September 2023.

Dr. Ni has nearly 30 years of experience in the life sciences industry. Before joining Cloudbreak Pharma, from November 1994 to October 1996, Dr. Ni served as a postdoctoral researcher in the Department of Medicinal Chemistry at the College of Pharmacy, University of Utah, where he was responsible for studying the interactions between potential anti-tumor drug molecules and nucleic acids. In October 1996, he joined the American Health Foundation as a research scientist, responsible for investigating and researching the absorption, distribution, metabolism, and elimination of potent carcinogens. From October 1997 to May 2000, he worked as a research scientist at Pfizer Inc., where he was responsible for supporting drug discovery and development. From May 2000 to June 2015, he served as the Scientific Director of the Drug Safety Evaluation Department at Allergan, Inc., responsible for strategy formulation, resource management, and non-clinical development.

Dr. Ni obtained his Ph.D. in Philosophy from the University of Toronto, Canada, in June 1995. He received his M.Sc. in Chemistry from Brock University, Canada, in June 1992, and graduated with a B.Sc. in Chemistry from Nanjing University, China, in July 1989.

Mr. Van Son DINH, 55, Chief Operating Officer and Executive Director. He was appointed as a director on July 22, 2021, and transferred to the role of Executive Director on November 9, 2023. Mr. Dinh is responsible for overseeing the operational logistics and milestones of Cloudbreak Pharma's R&D activities.

In September 2015, when Cloudbreak USA, the first major operating subsidiary of Cloudbreak Pharma, was established, Mr. Dinh, along with directors Dr. Ni and Dr. Li Junzhi, co-founded Cloudbreak Pharma. Mr. Dinh was one of the founding shareholders of Cloudbreak USA and served as one of its managers from May 2017 to December 2021. Mr. Dinh also held the following positions in other member companies of Cloudbreak Pharma and was primarily responsible for decision-making in these companies:

• Director of Cloudbreak Pharma (Guangzhou) since October 2020;

• Director of Cloudbreak Cayman since April 2020;

• Served as the ADS USA Manager from November 2020 to January 2021; and

• Director of ADS Australia since March 2021.

Mr. Dinh has over 26 years of experience in the pharmaceutical industry, covering a wide range of areas from drug development to business management. Prior to joining this group, Mr. Dinh worked at Allergan from September 1997 to July 2015, where his last position was Chief Scientist of the Drug Safety Evaluation Department. He was mainly responsible for providing scientific support for drug development projects and managing research directors and analysts to ensure that research plans were executed accordingly.

Mr. Dinh obtained a Master of Business Administration degree from Webster University in the United States in March 2016, and a Bachelor of Science degree from the University of California, Irvine in June 1995.

Dr. Yang Rong, 60, Chief Scientific Officer and Executive Director. He was appointed as a director on November 24, 2021, and re-designated as an executive director on November 9, 2023. Dr. Yang is primarily responsible for overseeing and managing drug development at Cloudbreak Pharma.

Dr. Yang joined Cloudbreak Pharma in February 2016 as the Research Director, responsible for the development of ophthalmic and dermatological drugs. Dr. Yang also served as the Manager of ADS USA from January 2017 to January 2021, primarily overseeing and managing its business operations.

Dr. Yang has approximately 24 years of experience in drug development. Before joining Cloudbreak Pharma, from November 1999 to June 2015, he served as a research biologist at Allergan Plc., primarily responsible for drug development in ophthalmology, dermatology, and neuroscience.

Dr. Yang received his Ph.D. in Philosophy from the University of Wisconsin-Madison, USA, in December 1992. He obtained his Master of Science degree from the University of Oklahoma, USA, in May 1989, and his Bachelor of Science degree in Biochemistry from Peking University, China, in July 1985.