Cloudbreak Pharma Inc. (CLOUDBREAK-B) has issued a supplemental update to its 2025 Annual Report, detailing clinical progress across its ophthalmology-focused pipeline while confirming that trading in its shares remains suspended by the Hong Kong Stock Exchange at the directive of the Securities and Futures Commission since 10 September 2026. The suspension will continue until further notice.

CBT-001: Multi-regional clinical trials (MRCT) for the company’s lead asset have completed database lock, with top-line data slated for imminent release. Subject to positive results, Cloudbreak plans to engage both the U.S. FDA and China’s National Medical Products Administration on next-step strategy, including a potential New Drug Application. Management projects U.S. commercialisation between 2030 and 2032.

CBT-009: A global Phase 3 MRCT is being designed for the paediatric myopia indication. Assuming successful execution, market launch is anticipated in the 2032-2034 window.

CBT-199: The once-daily, preservative-free presbyopia candidate has secured FDA Investigational New Drug clearance to initiate Phase 2 trials. Study commencement is expected in 2027 following protocol alignment with the agency.

CBT-358: This combination therapy for dry eye disease also holds FDA authorisation to begin Phase 2 trials, projected to start in 2027 after minor protocol revisions requested by regulators.

CBT-004: Following a positive Phase 2 study for pinguecula, the FDA has endorsed Phase 3 trial design via the 505(b)(2) pathway. Ongoing animal toxicology studies aim to support trial initiation in late 2027.

Cloudbreak underscores that successful development and commercialisation of any candidate are not assured and will depend on future clinical outcomes and regulatory review.