Kala Bio Reports $38.5 Million Net Loss for 2024, Highlights KPI-012 Development Progress

Kala Bio, Inc. (formerly Kala Pharmaceuticals, Inc.) reported a net loss of $38.5 million for the year ended December 31, 2024, compared to a net loss of $42.2 million in 2023. This improvement is primarily attributed to a $2.2 million decrease in general and administrative expenses, offset by a $3.5 million increase in research and development expenses. The company's accumulated deficit as of December 31, 2024, stood at $667.9 million. Revenue was limited prior to the July 2022 sale of its commercial business to Alcon, generating only limited revenue from sales of EYSUVIS and INVELTYS.

The increase in research and development expenses reflects a $2.5 million rise in KPI-012 development costs, driven by the advancement of its Phase 2b clinical trial (CHASE) for persistent corneal epithelial defects (PCED). The CHASE trial, initiated in February 2023, includes two cohorts; positive safety data from the first cohort were announced on March 27, 2023. As of the filing date, 87 patients had been randomized, with enrollment extended to account for discrepancies in PCED verification. Topline safety and efficacy data are expected in the third quarter of 2025. The company also initiated preclinical studies for KPI-014, targeting inherited retinal degenerative diseases.

Kala Bio's financing activities during 2024 included gross proceeds of approximately $31 million from private placements of common and preferred stock, and $3.4 million in net proceeds from at-the-market common stock offerings. The company also received $5.7 million in disbursements from the California Institute for Regenerative Medicine (CIRM) during the year. Outstanding borrowings under the Loan Agreement with Oxford Finance totaled $29.3 million as of December 31, 2024. The company expects its current cash resources to fund operations into the first quarter of 2026, but anticipates needing substantial additional funding to complete the clinical development of KPI-012 and pursue other initiatives.

The company's financial performance is significantly impacted by the success of KPI-012, its dependence on third-party manufacturers and clinical trial partners, and the uncertainties inherent in the regulatory approval process. The company acknowledges substantial competition from major pharmaceutical companies with significantly greater financial resources. The company also highlights risks associated with intellectual property protection, potential product liability lawsuits, and compliance with evolving data privacy regulations.

Kala Bio's outlook is contingent upon the successful completion of the CHASE trial, regulatory approvals for KPI-012, and the ability to secure additional funding. The company intends to commercialize KPI-012 in the United States, potentially exploring collaborations for international markets. The company's financial condition and operating results are expected to fluctuate significantly due to various factors, including the timing of milestone payments from Alcon and the progress of its clinical trials.