Cloudbreak Pharma (2592) investor relations material

Platform and pipeline

• Multi-kinase inhibitors target multiple receptor tyrosine kinase pathways linked to angiogenesis and fibrosis in fibrovascular eye diseases; the platform has multiple successful Phase 2 studies.

• CBT-001 (nintedanib) is in Phase 3 in multiple regions for pterygium, affecting 15M people in the U.S.; CBT-004 (axitinib) is entering Phase 3 for pinguecula, affecting 50M people in the U.S.

• CBT-007 is a glaucoma-surgery candidate; CBT-009 targets pediatric progressive myopia, CBT-199 targets presbyopia, and CBT-358 and CBT-277 target dry eye.

• CBT-011 targets DME and age-related macular degeneration; its U.S. IND was accepted, while an IND for Phase 2 is scheduled for Q2 2026.

Clinical evidence and market opportunity

• CBT-001 Phase 2 results showed statistically significant vascularity improvement versus vehicle and a 10% reduction in corneal lesion length after 4 weeks (p<0.014).

• CBT-001 is being evaluated in a Phase 3 MRCT for hyperemia reduction and prevention of pterygium progression; planned milestones include hyperemia NDA submission and a progression sNDA submission.

• CBT-004 Phase 2 met efficacy endpoints, with statistically significant results for hyperemia and foreign body sensation; vascularity improvement persisted 28 days after treatment ended.

• Pinguecula affects 50M people in the U.S., with 3.9M diagnosed and treated annually; pterygium affects 15M, with 3.7M diagnosed and treated annually.

• Neither condition has an FDA-approved drug therapy; CBT-001 and CBT-004 are positioned as potential first disease-modifying drug treatments for their respective conditions.

Development plans and financing

• Q3 2026: CBT-001 top-line 12-month results from its first Phase 3 study; Q4 2026: potential CBT-199 Phase 2 results in the U.S. and China.

• Q1 2027: planned initiation of the CBT-004 Phase 3 program; Q4 2027: 90-day results from the second, confirmatory CBT-001 Phase 3 study.

• A $25M equity investment is intended to accelerate enrollment and reduce NDA timelines; the stated impact is six months for CBT-001 and nine months for CBT-004.

• The proposed acceleration could move CBT-001 NDA filing to mid-2028 and CBT-004 NDA filing to early 2029, while reducing time to potential $100M regulatory milestones.