Cloudbreak Pharma (2592) H1 2025 earnings summary

Executive summary

• H1 net profit was $5.186m versus a $52.111m loss, largely due to a $38.421m CRPS fair-value gain; operating loss widened to $33.663m from $26.576m.

• No drug-sales revenue; the ophthalmology pipeline comprised 8 candidates, including 4 clinical-stage and 4 preclinical-stage candidates, with no approved drugs for commercial sale.

• CBT-001 Phase 3 recruitment concluded in May 2025 with 660 patients across five jurisdictions; completion is expected in June 2026.

Financial highlights

• Drug-sales revenue was nil in H1 2025 and H1 2024; other income was mainly local government R&D grants and remained stable year over year.

• R&D expense was $23.7m versus $22.5m; operating loss widened to $33.663m from $26.576m.

• The $38.421m CRPS fair-value gain reversed a $26.779m loss in H1 2024, driving reported net profit; total comprehensive income was $5.976m versus a $52.935m loss.

• Operating cash outflow was $19.604m versus $20.019m; cash and equivalents were $15.090m at June 30, down from $34.862m at December 31, 2024.

• G&A expense rose to $9.4m from $4.8m, mainly due to listing costs, staffing growth and RSUs; listing expenses were $2.833m and share-based payment expense was $15.397m.

Outlook and guidance

• CBT-001 Phase 3 MRCT completion is expected in June 2026, followed by planned FDA and NMPA NDA submissions.

• CBT-009 China juvenile-animal toxicity study began in February 2025; NMPA IND filing was expected in Q3 2025, with Phase 3 expected to start by end-2025 and finish in 2029.

• CBT-004 Phase 2 met its primary efficacy endpoint and several secondary endpoints; Phase 3 development and FDA discussions are planned, with study design and timing updates expected in coming months.

• Global Offering proceeds were allocated mainly to CBT-001 R&D through 2027 ($327.4m) and CBT-009 R&D through 2029 ($144.8m).