KALA BIO to cut 51% of workforce, ends KPI-012 after Phase 2b trial misses endpoint

KALA BIO, Inc. (Nasdaq: KALA) said on September 29, 2025 that it will stop developing its lead product candidate, KPI-012, and cut its workforce by approximately 19 employees, or about 51%, after a Phase 2b trial missed its main goal. The company disclosed the workforce reduction under Item 2.05 of a Form 8-K. Item 2.05 is the item companies use to report costs tied to exit or disposal activities, such as staff cuts. Mary Reumuth, Chief Financial Officer and Corporate Secretary, signed the filing.

What the board decided

The board determined on September 28, 2025 to cease development of KPI-012 and of the company's mesenchymal stem cell secretome platform. It also decided to take steps to preserve cash while the company explores its strategic options. The board approved the reduction in workforce, which KALA expects to substantially complete in the fourth quarter of 2025.

KALA says it cannot yet estimate the charges the reduction will create under generally accepted accounting principles. It will file an amendment to the 8-K within four business days after it determines the amount.

The CHASE trial results

The company's press release says the CHASE Phase 2b trial of KPI-012 for persistent corneal epithelial defect (PCED) did not meet its primary endpoint of complete healing of the defect at Week 8, measured by corneal fluorescein staining. The secondary endpoints also did not achieve statistical significance. The trial showed no meaningful difference between either KPI-012 treatment arm and the placebo arm. The release says KPI-012 was well-tolerated, with no treatment-related serious adverse events observed.

CHASE was a multicenter, randomized, double-masked, vehicle-controlled study. It compared two doses of KPI-012 ophthalmic solution, 3 U/mL and 1 U/mL, against vehicle, dosed topically four times a day for 56 days. The release says the trial randomized 79 patients across 37 sites in the United States and Latin America. Of those patients, the defects were verified at baseline, and the release says those patients will be eligible for inclusion in the primary efficacy analysis.

Kim Brazzell, Ph.D., Head of R&D and Chief Medical Officer, said, "We are disappointed to see the results of the CHASE study given the positive results KPI-012 yielded in the Phase 1b study." The release adds that KPI-012 continued to be well-tolerated and demonstrated a favorable safety profile but did not demonstrate the efficacy results that would warrant advancing the program for treatment of front-of-the-eye diseases.

Secured lender and strategic options

KALA plans to evaluate its strategic options and, as part of that evaluation, to engage in discussions with its secured lender. The filing lists what, if any, actions the secured lender may take to recover amounts owed by the company as a risk. It also lists the company's ability to identify and pursue a strategic option on attractive terms, or at all, and whether the reduction will produce the anticipated savings and be completed when anticipated. The 8-K does not name the lender or describe the amount it is owed.

Company background

KALA BIO is based in Arlington, Massachusetts, and trades on the Nasdaq Capital Market. The release describes it as a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye. KPI-012 received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for persistent corneal epithelial defect.

The company's annual report for 2024 says it acquired KPI-012 from Combangio, Inc. on November 15, 2021. The same report lists the timing, progress and results of preclinical studies for a KPI-014 program among its forward-looking statements. The 8-K itself does not say what KALA will do with the KPI-014 program.

Report an error

Companies in this story

KALAKALA BIO, Inc.NASDAQ · United StatesOpen the starter desk