Summary of KALA BIO FY Conference Call Company Overview - **Company**: KALA BIO (NasdaqCM: KALA) - **Focus**: Development of treatments for rare ophthalmic diseases using a proprietary mesenchymal stem cell secretome platform - **Lead Program**: KPI-twelve, currently in Phase IIb clinical trial for persistent corneal epithelial defects (PCED) [3][10] Key Points and Arguments - **Clinical Trial Progress**: Enrollment for the KPI-twelve trial was completed in June 2025, with top-line data expected in September 2025 [3][34] - **Management Experience**: The management team has previously developed and obtained NDA approval for two ophthalmic products, which were divested to focus on the secretome platform [4] - **Secretome Technology**: The secretome consists of biomolecules secreted by mesenchymal stem cells, which are processed into a patient-friendly topical eye drop formulation [5][6] - **Mechanism of Action**: The product aims to promote wound healing, tissue repair, and has anti-inflammatory and neuroprotective effects [6][23] - **Market Opportunity**: The estimated incidence of PCED in the U.S. is about 100,000 cases per year, with a potential market exceeding $3 billion [13][19] - **Current Market Landscape**: The only FDA-approved product for PCED is Oxervate, which only addresses neurotrophic keratitis, covering about one-third of PCED cases [14][19] - **Efficacy Data**: In a Phase Ib trial, 75% of patients showed complete healing of PCED, which is comparable to Oxervate's reported efficacy [28][30] - **Regulatory Designations**: KPI-twelve has orphan drug and fast track designations, indicating a strong potential for expedited development [10][31] Additional Important Information - **Patient Burden**: Current treatments like Oxervate require complex dosing regimens and have significant adverse effects, highlighting the need for simpler and more tolerable options [17][18] - **Trial Design**: The ongoing trial includes a run-in phase to minimize placebo effects, which is expected to enhance the statistical power of the results [36] - **Future Outlook**: The company is optimistic about the upcoming data readout and the potential for KPI-twelve to be the first approved product for a broad indication in treating all patients with PCED [34][36]