KALA BIO, Inc. reported its financial results for the second quarter ended June 30, 2025, on August 8, 2025. The company announced cash and cash equivalents of $31.9 million as of June 30, 2025, a decrease from $42.2 million at March 31, 2025. This cash position is projected to fund operations only into the first quarter of 2026, leading management to express substantial doubt about its ability to continue as a going concern without securing additional capital.
For the second quarter of 2025, KALA reported a net loss of $11.155 million, an increase from a net loss of $9.579 million in the prior-year quarter. The net loss per share was $1.71 (GAAP), marginally wider than the analyst estimate of $1.70 (GAAP). Research and development expenses increased by $0.9 million to $6.232 million, primarily due to higher employee-related costs and KPI-012 development activities, reflecting the intensified R&D focus.
Despite the financial challenges, KALA achieved a significant operational milestone by completing patient enrollment in its Phase 2b CHASE trial for KPI-012 in Persistent Corneal Epithelial Defect (PCED). Topline safety and efficacy data from this trial are expected by the end of September 2025. The company believes positive results could enable the CHASE trial to serve as a pivotal study for a Biologics License Application (BLA) submission to the FDA.
The accumulated deficit reached $688.0 million as of June 30, 2025, underscoring the capital-intensive nature of biopharmaceutical development. The company's strategy to address its funding needs includes pursuing further equity or debt financings, collaborations, or licensing transactions. The existing cash is explicitly stated as insufficient to complete the clinical development of KPI-012 for PCED or any other indication.
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