KALA BIO, Inc.

In this Annual Report on Form 10-K, unless the context otherwise requires, references to we, us, our, our company, KALA, KALA BIO and Company refer to KALA BIO, Inc. and its subsidiaries. Overview We are a biopharmaceutical company in transition, evaluating the development of a dedicated, on-premises artificial intelligence (AI) infrastructure platform for the biotechnology industry. Our current focus is leveraging our mesenchymal stem cell secretome ( MSC-S ) platform to test development of a scalable AI platform-as-a-service business to deploy secure, purpose-built AI systems directly within biotech and pharmaceutical client environments. We have historically been engaged in the research, development and commercialization of innovative therapies for rare and severe diseases of the front and back of the eye. Our lead product candidate was KPI-012, MSC-S, which we acquired from Combangio, Inc. ( Combangio ) on November 15, 2021. KPI-012 was in clinical development for the treatment of persistent corneal epithelial defects ( PCED ), a rare disease of impaired corneal healing. Based on the results of a Phase 1b clinical safety and efficacy trial of KPI-012 in patients with PCED, we submitted an investigational new drug application to the U.S. Food and Drug Administration ( FDA ), which was accepted in December 2022. In February 2023, we dosed our first patient in the United States in our CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial of KPI-012 for PCED (the CHASE trial ).