KALA BIO (NasdaqCM:KALA) FY Conference Transcript

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]