Cloudbreak Pharma (2592) H2 2025 earnings summary

Executive summary

• Clinical-stage ophthalmology pipeline spans nine candidates: five clinical-stage and four preclinical; no approved products or drug-sales revenue in 2025.

• 2025 net loss narrowed to US$67.7m from US$99.1m, while operating loss widened to US$107.3m from US$36.6m; a US$38.4m fair-value gain on preferred shares benefited reported results.

Financial highlights

• Revenue was nil in 2025 versus US$10.0m in 2024, when licensing know-how generated revenue; no development or commercial milestone was achieved in either year.

• Operating loss widened to US$107.3m from US$36.6m; G&A rose to US$40.9m from US$9.5m and R&D to US$66.8m from US$37.9m.

• Net loss was US$67.7m versus US$99.1m; basic and diluted loss per share improved to US$0.10 from US$0.21.

• Employee benefit expense increased to US$71.7m from US$18.9m, including US$57.5m share-based payment expense versus US$11.3m.

• Cash and cash equivalents were US$40.2m at year-end versus US$34.9m; total assets were US$66.6m versus US$40.0m.

Outlook and guidance

• Significant expenses and operating losses are expected for at least the next several years as clinical development, regulatory work, commercialization preparation and hiring continue.

• CBT-001 Phase 3 recruitment reached 660 patients across five jurisdictions; first-trial completion is expected June 2026, with initial efficacy and safety data later in 2026.

• The second CBT-001 Phase 3 trial is planned for Q3 2026, with completion expected in late 2028; US and China NDA submissions are planned after completion.

• CBT-004 met its Phase 2 primary endpoint and several secondary endpoints; following FDA Phase 3 design discussions, the program is advancing toward Phase 3.

• A new FDA policy may allow a single pivotal trial to support marketing authorization; the potential impact on CBT-001’s second Phase 3 trial is under review.