KALA BIO, Inc. reported a net loss of $7.6 million for the third quarter of 2025, a decrease from the $8.9 million loss recorded in the same period of 2024. For the nine months ending September 30, 2025, the company’s net loss was $27.7 million, compared to $30.3 million for the same period in the previous year. The reduction in losses was attributed to a decrease in total operating expenses, which fell to $28.9 million from $31.5 million year-over-year. General and administrative expenses slightly increased to $4.5 million, while research and development costs rose to $6.1 million, reflecting ongoing investments in the company's product candidate, KPI-012.
The company experienced significant operational changes during the quarter, notably the decision to cease development of KPI-012 following the failure of its CHASE Phase 2b clinical trial to meet primary endpoints. This led to a workforce reduction of approximately 51%, resulting in costs of $0.4 million related to severance and benefits. Additionally, KALA BIO faced a default notice from Oxford Finance, which declared that all obligations under a loan agreement were immediately due, totaling approximately $29.1 million. This situation prompted the company to explore strategic options, including potential asset sales or mergers, while also engaging a financial advisor to assist in these efforts.
KALA BIO's cash and cash equivalents decreased significantly to $21.1 million as of September 30, 2025, down from $51.2 million at the end of 2024. The company reported cash used in operating activities of $27.4 million for the nine months ended September 30, 2025, compared to $24.8 million for the same period in 2024. The decrease in cash was primarily due to increased working capital needs and ongoing operational losses. The company has indicated that its current cash reserves may not be sufficient to cover operating expenses through November 2025, raising concerns about its ability to continue as a going concern.
In terms of strategic developments, KALA BIO has entered into a Convertible Loan Agreement with an individual lender, providing $375,000 to facilitate negotiations for additional financing. The loan bears a 15% interest rate and is due one year from the date of receipt. The company is also eligible for milestone payments from Alcon Pharmaceuticals, totaling up to $325 million based on the performance of EYSUVIS and INVELTYS, although no payments have been received to date. The company’s future plans hinge on securing additional funding to resume research and development activities, which are currently on hold due to financial constraints.
About KALA BIO, Inc.
KALA Bio is a biopharmaceutical company focused on developing innovative, cell-free therapies for rare and severe eye diseases. Its lead candidate, KPI-012, targets persistent corneal epithelial defects, leveraging mesenchymal stem cell secretome technology. The company advances clinical trials, seeks regulatory approval, and explores platform applications for other ocular conditions, aiming to improve healing and vision preservation through proprietary biologic solutions.
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