KALA BIO (KALA) investor relations material

Strategic focus and platform overview

• Leveraging a proprietary mesenchymal stem cell secretome platform to address rare ophthalmic diseases with unmet needs.

• Lead program KPI-twelve targets persistent corneal epithelial defects (PCED) and is in Phase IIb clinical trials.

• Management team has prior success with NDA approvals and product divestitures to focus on the secretome platform.

• Secretome-based therapy offers cell therapy benefits without direct cell administration, with mechanisms including wound healing and neuroprotection.

• Platform aims to expand into other rare ophthalmic conditions, such as limbal stem cell deficiency.

Clinical development and trial progress

• KPI-twelve is formulated as a patient-friendly, single-dose topical eye drop containing multiple biomolecules for corneal healing.

• Completed Phase 1b trial showed 75% complete healing in PCED patients, with rapid and sustained results and significant pain relief.

• Ongoing Phase IIb trial completed enrollment in June 2025, with top-line data expected in September.

• Trial design includes a run-in phase to minimize placebo effect and robust powering based on prior pivotal studies.

• FDA has granted orphan drug and fast track designations, and has been supportive of a broad PCED indication.

Market opportunity and competitive landscape

• PCED affects approximately 100,000 patients annually in the U.S., with significant pain and risk of vision loss.

• Only one approved product, Oxervate, addresses about a third of cases and is burdensome to administer.

• Oxervate achieved over $1.1 billion in U.S. sales in 2024, highlighting the market potential.

• KPI-twelve aims to be the first broadly indicated therapy for all PCED etiologies, addressing a $3 billion+ market.

• Product design and mechanism target multiple underlying causes, offering a differentiated and potentially superior solution.