KALA BIO Reports $11.2 Million Net Loss in Q2 2025, Advances KPI-012 Clinical Trial

KALA BIO, Inc. reported a net loss of $11.2 million for the second quarter of 2025, compared to a loss of $9.6 million in the same period of 2024. For the six months ending June 30, 2025, the company recorded a net loss of $20.1 million, a slight improvement from the $21.4 million loss reported for the first half of 2024. The increase in losses was attributed to higher research and development expenses, which rose to $6.2 million in Q2 2025 from $5.3 million in Q2 2024, primarily due to increased employee-related costs and development expenses for the company's lead product candidate, KPI-012.

KALA BIO's total operating expenses for the second quarter of 2025 were $11.0 million, up from $9.6 million in the prior year. The company’s general and administrative expenses also saw a rise, totaling $4.6 million in Q2 2025 compared to $4.3 million in Q2 2024. The company’s accumulated deficit reached $688.0 million as of June 30, 2025, reflecting its ongoing investment in research and development without generating significant revenue since the sale of its commercial business to Alcon in July 2022.

In terms of operational developments, KALA BIO is advancing its clinical trial for KPI-012, which is being evaluated for the treatment of persistent corneal epithelial defects (PCED). The company has completed patient enrollment in its CHASE Phase 2b clinical trial, which includes 79 patients across 37 sites in the U.S. and Latin America. The primary endpoint of the trial is the complete healing of PCED, with topline data expected by the end of September 2025. The company has received Orphan Drug and Fast Track designations from the FDA for KPI-012, which may facilitate its regulatory approval process.

KALA BIO's cash and cash equivalents decreased to $31.9 million as of June 30, 2025, down from $51.2 million at the end of 2024. The company anticipates that its current cash reserves will be sufficient to fund operations into the first quarter of 2026. However, it has expressed substantial doubt about its ability to continue as a going concern beyond that period without raising additional capital. The company plans to seek further funding through equity or debt financing, collaborations, or licensing agreements, but there is no assurance that it will be able to secure the necessary capital on favorable terms.

Looking ahead, KALA BIO expects to continue incurring significant expenses as it advances the clinical development of KPI-012 and potentially other product candidates. The company is also exploring additional indications for KPI-012 and has initiated preclinical studies for its KPI-014 program targeting inherited retinal degenerative diseases. The success of these initiatives is critical for KALA BIO's future financial stability and growth, as it aims to transition from a clinical-stage company to one that can generate revenue from approved products.