CLOUDBREAK-B - VOLUNTARY ANNOUNCEMENT - BUSINESS UPDATE IN RELATION TO INVESTIGATIONAL NEW DRUG APPLICATION FOR CBT-358 COMPLETION OF SAFETY REVIEW BY THE FOOD AND DRUG ADMINISTRATION OF THE UNITED STATES OF AMERICA

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

INVESTIGATIONAL NEW DRUG APPLICATION FOR CBT-358

COMPLETION OF SAFETY REVIEW BY THE FOOD AND

DRUG ADMINISTRATION OF THE UNITED STATES OF AMERICA

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.

SUBMISSION OF INVESTIGATIONAL NEW DRUG APPLICATION

The board of directors of the Company (the "Board") is pleased to announce that, on 14 July 2026, the review period of the investigational new drug application (the "IND Application") in respect of CBT- 358 submitted on 21 May 2026 to the Food and Drug Administration (the "FDA") of the United States of America has concluded. The FDA has completed its safety review of the IND Application and has raised no objection to the proposed clinical investigation proceeding.

As disclosed by the Company in the annual report 2025 of the Group dated 31 March 2026 and the voluntary announcement dated 22 May 2026 in relation to business update:

CBT-358, the latest addition to our product pipeline, which is a combination Semi-fluorinated Alkane ("SFA+") and transient receptor potential melastatin 8 ("TRPM8") agonist drug for dry eye disease, a multi-billion dollar global market. By combining these two agents together, CBT-358 has the potential for treating dry eye disease caused by insufficient tear production with great comfortness.

The Company considers that as the safety review of CBT-358 by the FDA is now completed, it represents a critical milestone in the clinical development of CBT-358. 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-358 or any other drug candidate 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, 17 July 2026