KALA BIO Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

Core Insights - KALA BIO, Inc. is advancing its clinical development of KPI-012 for Persistent Corneal Epithelial Defect (PCED) and has randomized 87 patients in the Phase 2b CHASE trial, with topline data expected in Q3 2025 [1][2] - The company raised $10.75 million through private placement financing, enhancing its financial position and extending its cash runway into Q1 2026 [2][8] - KALA's cash and cash equivalents stood at $51.2 million as of December 31, 2024, reflecting an increase from $49.2 million as of September 30, 2024 [9] Clinical Development - KPI-012 is being developed to address the underlying causes of PCED, which affects approximately 100,000 patients in the U.S. and currently lacks FDA-approved treatments [5][14] - The CHASE trial could serve as the first of two pivotal studies needed for a Biologics License Application (BLA) submission to the FDA [5][2] - KALA is also exploring KPI-012 for other ocular diseases, including Limbal Stem Cell Deficiency (LSCD), which has a similar estimated incidence of 100,000 patients in the U.S. [6][5] Financial Performance - For Q4 2024, KALA reported a net loss of $8.2 million, or $1.74 per share, an improvement from a net loss of $8.6 million, or $3.18 per share, in Q4 2023 [12][22] - Full-year 2024 net loss was $38.5 million, or $10.15 per share, compared to a net loss of $42.2 million, or $17.35 per share, in 2023 [16][22] - General and administrative expenses decreased to $4.2 million in Q4 2024 from $4.6 million in Q4 2023, while research and development expenses increased to $5.3 million from $4.7 million in the same period [12][21] Corporate Updates - KALA's innovative pipeline is based on its proprietary mesenchymal stem cell secretome (MSC-S) platform, which is believed to have a multifactorial mechanism of action for treating various ocular orphan diseases [3][14] - The company has activated clinical trial sites in Latin America for the CHASE trial [5] - KALA's lead product candidate, KPI-012, contains various biofactors aimed at correcting impaired corneal healing associated with severe ocular diseases [4][14]