KALA BIO, Inc.

KALA BIO, Inc. is a biopharmaceutical company that is transitioning its business focus to evaluate the development of a dedicated, on-premises artificial intelligence (AI) infrastructure platform for the biotechnology industry. The company is currently leveraging its mesenchymal stem cell secretome ("MSC-S") platform to test the development of a scalable AI platform-as-a-service business. This service aims to deploy secure, purpose-built AI systems directly within biotech and pharmaceutical client environments. Historically, KALA BIO was involved in the research, development, and commercialization of therapies for rare and severe eye diseases. Its lead product candidate was KPI-012, an MSC-S therapy acquired from Combangio, Inc. on November 15, 2021. KPI-012 was in clinical development for persistent corneal epithelial defects ("PCED"), a rare corneal healing disorder. Following a Phase 1b clinical trial, an investigational new drug application was accepted by the U.S. Food and Drug Administration ("FDA") in December 2022. In February 2023, the company began its CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial of KPI-012 for PCED. However, by September 2025, the CHASE trial did not meet its primary endpoints, leading KALA BIO to discontinue development of KPI-012 and the MSC-S platform. The company is now evaluating strategic alternatives for its legacy MSC-S assets and utilizing the intellectual property, proprietary biological datasets, and research experience from the clinical trials to develop an AI platform. On March 3, 2026, KALA BIO entered into an exclusive license for the Researgency AI research platform from Younet AI to assess the feasibility of becoming a dedicated AI infrastructure partner for the biotechnology industry.