KALA BIO (KALA) H.C. Wainwright 27th Annual Global Investment Conference summary

Strategic focus and platform overview

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

• Lead program KPI-012 targets persistent corneal epithelial defects (PCED) and is in a pivotal phase IIb trial.

• Previous ophthalmic products were divested to focus resources on the secretome platform.

• Manufacturing uses a master cell bank and GMP methods for scalable, patient-friendly eye drop formulation.

• Secretome offers cell therapy benefits without direct cell administration.

Clinical development and trial progress

• Enrollment for the phase IIb trial completed in June 2025, with top-line data expected by end of September.

• KPI-012 has Orphan Drug and Fast Track designations for PCED.

• Phase IIb trial showed 75% complete healing in PCED patients, with rapid and sustained results.

• Significant pain relief observed; all patients with baseline pain reported zero pain post-therapy.

• Ongoing trial includes 79 evaluable patients, with a unique run-in phase to minimize placebo effect.

Market opportunity and competitive landscape

• PCED affects about 100,000 people annually in the U.S., with a global market potential exceeding $3 billion.

• Only one approved product, OXERVATE, addresses a third of PCED cases and had $1.1 billion in U.S. sales in 2024.

• OXERVATE's complex administration and side effects highlight the need for simpler, more tolerable therapies.

• KPI-012 aims to be the first broadly indicated product for all PCED etiologies.