Cloudbreak Pharma Targets Billion-Dollar Ophthalmology Market with Hong Kong IPO

July 3,Cloudbreak Pharma Officially Listed on HKEX, CCB International and Huatai International as Joint Sponsors, Offering Price at HKD 10.10 per Share, Net Proceeds of HKD 522.2 Million.

The prospectus shows that Cloudbreak Pharma plans to use the net proceeds from the offeringApproximately 62.4% for ongoing clinical development activities of the core product CBT-001, as well as registration filings and post-approval studies., approximately 27.6% was used for ongoing clinical R&D activities and the registration filing of the core product CBT-009,Approximately 5.5% is used for production facilities and commercialization activities.

Cloudbreak Pharma, established in 2015, is a clinical-stage ophthalmic biotechnology company. Before going public, the company had completed four roundsFinancing, with a total amount exceeding 1 billion yuan($145.5 million)。In this IPO, Cloudbreak Pharma introducedFuce Holdings(Indirectly wholly owned by Gong Hongjia)、Reynold Lemkins As the baseStone investors, subscription amount is$22.8 million。

 Two Major Platforms + Eight Innovative Products

After a decade of development, Cloudbreak Pharma has successfully developed two proprietary technology platforms, namelyMulti-Kinase Inhibitor（MKI）And Antibody Drug Synergistic Effects（ADS）Platform。

MKI Platform CanEffectively Identify, Validate, and Develop Novel Multi-Kinase Inhibitor Candidates for Anterior Eye DiseasesCompared with existing anti-vascular endothelial growth factor antibody therapies, such treatments can exert a stronger inhibitory effect and achieve optimal efficacy and patient compliance through local application.

ADS Platform CanDeveloping drug entities for posterior segment ocular diseases by conjugating antibodies with small molecule drugs through proprietary linkers.. Such conjugates overcome the limitations of single-mode treatment while targeting multiple pathogenic pathways, creating a synergistic effect on therapeutic efficacy.

Based on its proprietary technology platform, Cloudbreak Pharma has built a rich pipeline of innovative products covering diseases of the anterior and posterior segments of the eye.

Source: Cloudbreak Pharma Prospectus

Core product CBT-001 is aPotential First-in-Class Ophthalmic Drug, using multi-kinase inhibitors, targeting platelet-derived growth factor receptor, fibroblast growth factor receptor, and vascular endothelial growth factor receptor, forPrevent the development of pterygium and reduce conjunctival congestion. Currently, this product is undergoing Phase III clinical trials in both China and the U.S. Once approved, it is expected to become the world's first treatment forPterygium Medication.

Source: Cloudbreak Pharma Prospectus

It is worth noting that,The Greater China production and commercialization rights for CBT-001 have been granted to Grand Pharmaceutical, while the rights for countries and regions such as South Korea and Japan have been granted to Santen Pharmaceutical Co., Ltd.

Another core product, CBT-009, is aNovel Non-Aqueous Atropine Ophthalmic Formulations, for the treatment of adolescent myopia(5 to 19 years old)。CBT-009 is formulated in an organic medium, which leads to minimal hydrolysis of atropine, maintains stability during long-term storage, and has been proven to enhance ocular comfort. Currently, Cloudbreak Pharma is planning to conduct Phase III clinical trials for this product in the United States and China.

Other products are still in the relatively early stages of development, including two clinical-stage drug candidates.（CBT-006、CBT-004）and four preclinical-stage candidate drugs（CBT-007、CBT-199、CBT-145、CBT-011）。

 Financial Terms

Since its establishment, Cloudbreak Pharma has not yet made a profit.As of the years ended December 31, 2022, 2023, and 2024, Cloudbreak Pharma's annual losses were $66.8 million, $129.4 million, and $99.1 million, respectively, with the vast majority of the losses coming from research and development expenses and general administrative expenses.

Notably, in 2024, Cloudbreak Pharma (Cloudbreak Pharma Biomedical Technology (Guangzhou) Co., Ltd.) obtainedThe $10 million one-time upfront payment paid by Santen under the license agreement。

Source: Cloudbreak Pharma Prospectus

Cloudbreak Pharma's R&D expenditure increased from US$27.5 million in 2023 to US$37.9 million in 2024, primarily due to the ongoing Phase III multi-regional clinical trial of CBT-001.

Cover source: Visual China

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Editor: Crescent Moon

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