-- Study did not meet primary endpoint of complete healing of PCED at Week 8; secondary endpoints also did not achieve statistical significance -- -- KPI-012 was well-tolerated with no treatment-related serious adverse events observed -- -- KALA to cease clinical development of KPI-012, preserve cash and explore strategic options -- ARLINGTON, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commerci ...

Core Insights - KALA BIO, Inc. is focused on developing innovative therapies for rare and severe eye diseases, with a pivotal second quarter marked by the completion of patient enrollment in the Phase 2b CHASE trial for KPI-012 targeting Persistent Corneal Epithelial Defect (PCED) [2][5][13] - The company anticipates topline results from the CHASE trial by the end of September 2025, which could support a Biologics License Application (BLA) to the FDA, contingent on positive outcomes [2][7] - KALA's lead product candidate, KPI-012, has received Orphan Drug and Fast Track designations from the FDA, highlighting its potential in addressing a significant unmet medical need for approximately 100,000 patients with PCED in the U.S. [5][9] Financial Performance - As of June 30, 2025, KALA reported cash and cash equivalents of $31.9 million, down from $42.2 million as of March 31, 2025, primarily due to operational expenses and a $2.5 million debt prepayment [9][15] - For the second quarter of 2025, KALA's general and administrative expenses were $4.6 million, an increase from $4.3 million in the same period of 2024, mainly due to higher stock-based compensation [12][17] - Research and development expenses for the same quarter were $6.2 million, up from $5.3 million in 2024, reflecting increased employee-related costs and KPI-012 development expenses [12][17] Clinical Development - The CHASE trial enrolled 79 patients across 37 sites in the U.S. and Latin America, with the primary efficacy analysis focusing on verified PCED cases [7] - KALA is also exploring KPI-012 for other rare ocular diseases, including Limbal Stem Cell Deficiency (LSCD), which similarly presents a substantial market opportunity with an estimated 100,000 patients in the U.S. [8] - The company is advancing KPI-014, a preclinical program targeting inherited retinal degenerative diseases, which may offer a gene-agnostic treatment approach [8][13]