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Kala Bio, Inc. (NASDAQ:KALA), a small-cap biotech with a market capitalization of $33.29 million, announced Wednesday the completion of patient enrollment in its CHASE Phase 2b clinical trial evaluating KPI-012, a human mesenchymal stem cell secretome, as a treatment for persistent corneal epithelial defect (PCED). The company expects to report topline data from the trial in the third quarter of 2025, ahead of its next earnings release scheduled for August 13, 2025. According to InvestingPro analysis, the company maintains a healthy current ratio of 1.99, though it’s currently burning through cash reserves.
According to a statement in the SEC filing, the CHASE study is a multicenter, randomized, double-masked, vehicle-controlled, parallel-group trial. It is designed to assess the safety and efficacy of two doses of KPI-012 ophthalmic solution (3 U/mL and 1 U/mL) compared to a vehicle, with dosing administered topically four times daily for 56 days. While the company holds more cash than debt on its balance sheet, InvestingPro data reveals it hasn’t achieved profitability in the last twelve months.
The trial enrolled 79 patients across 37 sites in the United States and Latin America. All participants had verified PCEDs at baseline and will be included in the primary efficacy analysis. The primary endpoint is defined as complete healing of PCED, measured by corneal fluorescein staining photographs analyzed by a masked central reading center.
Kala Bio stated that, depending on the results and discussions with regulatory authorities, the CHASE trial could potentially serve as a pivotal study to support a future Biologics License Application submission to the U.S. Food and Drug Administration.
All information is based on a press release statement included in the company’s Form 8-K filing with the Securities and Exchange Commission.
In other recent news, Kala Bio reported a first-quarter net loss of $8.9 million, or $1.41 per share, which was slightly better than the projected loss of $9.6 million. The company is advancing its Phase 2b CHASE trial of KPI-012 for persistent corneal epithelial defect (PCED), with topline results expected in the third quarter of 2025. Oppenheimer has maintained an Outperform rating with a $15 price target, highlighting optimism about the trial’s progress. Meanwhile, H.C. Wainwright adjusted its price target from $15 to $12 but retained a Buy rating, reflecting continued confidence in the company’s prospects. Kala Bio’s management has expanded the trial sites into Latin America to enroll 90 participants, emphasizing the company’s commitment to meeting its clinical milestones. The drug candidate KPI-012 has been granted Fast Track Designation by the FDA, underscoring its potential in a market with no FDA-approved treatments for PCED. Additionally, Kala Bio announced retention bonuses for key executives, including Interim CEO Todd Bazemore, CFO Mary Reumuth, and Head of Research and Development Kim Brazzell, to ensure leadership stability during this critical period. These bonuses are contingent on the executives remaining with the company until the announcement of the CHASE trial results. The retention agreements are part of a strategic effort to maintain executive stability as the company navigates its clinical developments.
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