Ophthalmic Biotech Cloudbreak Pharma Files for Hong Kong IPO with H1 R&D Expenditure of $11.95 Million

According to the Zhisheng Finance APP, CLOUDBREAK PHARMA INC. (Cloudbreak Pharma) submitted an application for listing on the Main Board of the Hong Kong Stock Exchange as disclosed by the exchange on November 30. UBS Group, CCB International, and Huatai International are the joint sponsors.

The prospectus shows,Cloudbreak Pharma is an innovation-driven ophthalmic biotech company at the clinical stage., dedicated to developing novel and differentiated therapies. At the same time, the company is committed to the internal discovery, development, and commercialization of first-in-class and best-in-class ophthalmic treatments to meet unmet global medical needs.

In terms of market spaceAccording to the Frost & Sullivan report, the global ophthalmic drugs market size increased from US$32.4 billion in 2018 to US$38.7 billion in 2022, with a compound annual growth rate (CAGR) of 4.5%. It is expected to reach US$57.0 billion by 2027 and US$85.8 billion by 2032, with a CAGR of 8.1% during 2022-2027 and 8.5% during 2027-2032. Several ophthalmic diseases, such as pterygium and vascularized pinguecula, lack targeted and available drug treatment options, representing a significant underserved market globally.

In R&D，Cloudbreak Pharma has established an extensive and innovative pipeline consisting of seven drug candidates., covering major diseases of the anterior and posterior segments of the eye. Among them, there are four clinical-stage drug candidates (namely, CBT-001, CBT-009, CBT-006, and CBT-004) and three preclinical-stage drug candidates (namely, CBT-007, CBT-145, and CBT-011).

Cloudbreak Pharma stated that, once approved,CBT-001 and CBT-004They are expected to be the world's first-in-class drugs for the treatment of pterygium and vascularized pinguecula, respectively. According to a Frost & Sullivan report,CBT-001 and CBT-004Expected to become a drug that addresses the issues faced by patients with pterygium and vascularized pinguecula globally, with the number of patients expected to reach 1.0771 billion and 1.2838 billion respectively by 2032. Meanwhile, once approved,CBT-006Expected to be the world's first-in-class drug for treating dry eye disease associated with meibomian gland dysfunction (MGD-related dry eye disease). Once approved, CBT-009 is expected to be the world's best-in-class drug for treating juvenile myopia.

In addition,Cloudbreak Pharma has developed two proprietary technology platforms, namely the MKI and ADS platforms., respectively, for the development of candidate drugs to treat anterior and posterior eye diseases. The MKI platform and ADS platform aim to develop small-molecule drugs and antibody-small molecule drug conjugates, respectively. The combination of these two technology platforms provides a comprehensive solution covering various ophthalmic diseases.

Financial aspectsFor the years 2021 and 2022, and the six months ended June 30, 2023, Cloudbreak Pharma's research and development expenditures were approximately US$8.457 million, US$15.29 million, and US$11.947 million, respectively; during the same periods, the company's losses were approximately US$35.398 million, US$66.838 million, and US$56.257 million, respectively.

According to Cloudbreak Pharma in the prospectus,The Company is exposed to risks related to the development, clinical trials, and regulatory approval of its candidate drugs.The Company’s ability to succeed in the foreseeable future depends significantly on the successful completion of clinical trials, regulatory approval, and commercialization of its drug candidates. Unfavorable clinical trial results, delays in obtaining regulatory approval, failure to obtain such approval, or unsuccessful commercialization of the drug candidates could delay or otherwise impair the ability to generate revenue and severely harm the Company’s prospects.