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KALA Bio Inc (NASDAQ: KALA) is a clinical-stage biopharmaceutical company focused on developing therapies for rare and serious eye diseases. Headquartered in Arlington, Massachusetts, the company utilizes a proprietary mesenchymal stem cell secretome (MSC-S) platform to create biologics aimed at addressing ocular surface and retinal disorders.
Corporate Structure and Leadership
Founded in 2009, KALA Bio employs between 11 and 50 individuals. Its leadership team includes Todd Bazemore, who served as interim Chief Executive Officer from February to September 2025 and as Chief Operating Officer from 2017 to 2025. Dr. Frank Brazzell has held the position of Chief Medical Officer since February 2013. Darius Kharabi, Chief Business Officer since November 2021, co-founded Combangio Inc., a stem cell secretome company acquired by KALA Bio. The finance team is led by Chief Financial Officer Susan Reumuth, who has been in the role since July 2017. Mark Iwicki serves as chair of the board, with over 25 years of experience in biopharmaceutical R&D and commercialization.
Biopharmaceuticals by little plant
Recent Developments and News
– On September 29, 2025, KALA Bio filed an SEC Form 8-K (Items 2.05, 8.01, and 9.01), indicating significant corporate developments. Specific details were not disclosed.
– On September 18, 2025, the company submitted another Form 8-K (Items 5.08 and 8.01), typically related to material agreements or charter amendments.
– A Schedule 13G filed on September 11, 2025, indicates that Point72 Asset Management, L.P., and related entities hold 469,229 shares, representing 6.7% of the company's outstanding common stock.
– On July 16, 2025, KALA Bio hosted a webcast with key opinion leaders from Scripps Clinic, Jules Stein Eye Institute, Baylor College of Medicine, and Toyos Clinic to discuss the Phase 2b CHASE trial for persistent corneal epithelial defect (PCED).
Financial and Strategic Analysis
As of September 29, 2025, KALA Bio's stock closed at $1.48 on NASDAQ, reflecting a 92.23% decline from its previous reference price, with a trading volume of approximately 4.47 million shares. Proceeds from the July 2022 sale of its commercial ophthalmic products (EYSUVIS® and INVELTYS®) to Alcon Inc. have been directed toward its biologics pipeline. The lead candidate, KPI-012, is currently in Phase 2b for PCED and holds FDA Orphan Drug and Fast Track designations. Another program, KPI-014, is in preclinical development targeting inherited retinal degenerations. The company's ability to secure additional financing and achieve favorable clinical trial results will be essential for its strategic objectives.
Market Position and Industry Context
KALA Bio operates within a specialized segment of the biotechnology research sector, focusing on underserved ophthalmic indications. The MSC-S approach distinguishes it from small-molecule and gene-therapy competitors by leveraging a diverse range of biofactors—including protease inhibitors, growth factors, and matrix proteins—for corneal healing. Currently, few FDA-approved therapies target PCED or limbal stem cell deficiency across all etiologies. In the retinal area, most development pipelines primarily focus on gene-specific treatments, while KPI-014 aims to provide a gene-agnostic, neuroprotective effect for conditions such as retinitis pigmentosa and Stargardt disease.
TL;DR
On September 29, 2025, KALA Bio shares closed at $1.48 (−92.23%) on NASDAQ, with a trading volume of approximately 4.47 million shares. SEC filings on September 18 and 29 indicated undisclosed material updates, while a September 11 Schedule 13G revealed a 6.7% stake held by Point72. A webcast on July 16 discussed insights from the Phase 2b CHASE trial for KPI-012 in PCED. KPI-012 has received Orphan Drug and Fast Track designation, while KPI-014 progresses in preclinical development for inherited retinal diseases. Clinical trial results and funding strategies will influence the company's near-term prospects.
