/CLOUDBREAK-B - VOLUNTARY ANNOUNCEMENT - BUSINESS UPDATE IN RELATION TO COMPLETION OF THE FINAL 12-MONTH ENDPOINT VISIT FOR CBT-001
NEWS

CLOUDBREAK-B - VOLUNTARY ANNOUNCEMENT - BUSINESS UPDATE IN RELATION TO COMPLETION OF THE FINAL 12-MONTH ENDPOINT VISIT FOR CBT-001

HKEXnews
2026/06/04[Other - Business Update]

CLOUDBREAK-B - VOLUNTARY ANNOUNCEMENT - BUSINESS UPDATE IN RELATION TO COMPLETION OF THE FINAL 12-MONTH ENDPOINT VISIT FOR CBT-001

CLOUDBREAK PHARMA INC.

撥康視雲製藥有限公司*

(Incorporated in the Cayman Islands with limited liability)

(Stock Code: 2592)

VOLUNTARY ANNOUNCEMENT

BUSINESS UPDATE IN RELATION TO

COMPLETION OF THE FINAL 12-MONTH ENDPOINT VISIT FOR CBT-001

This announcement is made by Cloudbreak Pharma Inc. (the "Company") together with its subsidiaries, (the "Group") on a voluntary basis for the purpose of keeping the shareholders and potential investors of the Company informed of the latest business development of the Group.

COMPLETION OF THE FINAL 12-MONTH ENDPOINT VISIT

The board of directors of the Company (the "Board") is pleased to announce that the final patient has completed the 12-month visit, at which the primary efficacy endpoints for CBT-001 — pterygium lesion reduction and bothersome ocular symptoms score — are assessed in the Phase 3 multi-regional clinical trial ("MRCT") (being one of the Core Products of the Group (as defined in Chapter 18A of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited) (each a "Core Product")).

As disclosed by the Company in its Annual Report 2025, CBT-001 is one of our Core Products, a potential first-in-class drug therapy using a multi-kinase inhibitor ("MKI") targeting vascular endothelial growth factor receptors ("VEGFRs"), platelet-derived growth factor receptors ("PDGFRs") and fibroblast growth factor receptors ("FGFRs"), indicated for the prevention of pterygium progression, reduction of conjunctival hyperaemia and related symptoms associated with pterygium.

Pterygium is a disease where the tissues on the surface of the eye abnormally grow over the cornea or front of the eye. Just under one billion people globally are impacted, especially those who are exposed to chronic ultraviolet light from working outside or spending time at the beach. In many cases, this progressive fibrovascular growth may cause persistent redness, irritation, foreign body sensation, and can lead to astigmatism and vision impairment. Depending on the location of the lesion, it may also make wearing contact lenses uncomfortable or impossible.

CBT-001, also known as nintedanib free base, is formulated as a topical ocular eye drop emulsion and is currently being studied in the Phase 3 MRCT. This addresses a significant unmet medical need, given that, according to the independent market research report for the purpose of the Company's prospectus dated 24 June 2025 and to the best knowledge, information and belief of the Directors having made all reasonable enquiries, there is currently no approved drug therapy for the treatment of pterygium globally, with surgical excision being the only existing treatment option. CBT-001 has been developed under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act ("FDCA"), a regulatory pathway commonly adopted by ophthalmic biotechnology companies (the "505(b)(2) pathway"), which allows us to leverage validated safety and efficacy data from previously approved drugs, thereby accelerating our development timeline and reducing costs.

The Company commenced its patient enrollment for this Phase 3 MRCT in the United States in June 2022 and expanded to China in September 2023. The Company also initiated additional clinical trials in New Zealand, Australia and India as part of its global Phase 3 MRCT programme to assess the efficacy of CBT-001 in May 2024, May 2024 and July 2024, respectively. In May 2025, the Company completed patient recruitment across all five jurisdictions, enrolling 660 patients in total. The Company has progressed the Phase 3 MRCT and expects to obtain the initial efficacy and safety data in the foreseeable future.

The Company considers the completion of the final 12-month endpoint visit to be a significant milestone in the development of CBT-001 and positions the Company to deliver top-line 12-month efficacy data in the third quarter of 2026. Such top-line data, if positive, could support multiple simultaneous commercial filings and could change the current "surgery only" treatment paradigm, if approved.

The Group will continue to closely monitor the evaluation progress and make further announcement(s) to keep the shareholders and potential investors of the Company informed of the latest developments in relation to the Group's business as and when appropriate.

Warning Statement: There is no guarantee that CBT-001 or any other Core Product of the Group will ultimately be successfully developed, launched or marketed.

Shareholders and potential investors of the Company should exercise caution and due care when dealing in the shares of the Company.

By order of the Board

Cloudbreak Pharma Inc.

Dr. NI Jinsong

Chairman of the Board, Executive Director and Chief Executive Officer

Hong Kong, 4 June 2026