‘KALA BIO, incorporated Reports Third Quarter 2023 Financial Results and Provides Corporate Update\n\nArlington, Mass., November 13, 2023 – KALA BIO, incorporated (NASDAQ:KALA), a clinical-stage biopharmaceutical company, announced its financial results for the third quarter ended September 30, 2023, and provided a corporate update. The company is focused on developing innovative therapies for rare and severe eye diseases.\n\n”We are pleased with our progress in executing our corporate priorities,” said Mark Iwicki, Chair and Chief Executive Officer of KALA BIO. “We are actively enrolling patients in our CHASE Phase 2b trial of KPI-012 for PCED and are on track to announce topline safety and efficacy data in the second half of 2024. In addition, we are exploring the potential of our MSC-S platform technology for multiple rare, front
‘KALA BIO, incorporated Reports Third Quarter 2023 Financial Results and Provides Corporate Update\n\nArlington, Mass., November 13, 2023 – KALA BIO, incorporated (NASDAQ:KALA), a clinical-stage biopharmaceutical company, announced its financial results for the third quarter ended September 30, 2023, and provided a corporate update. The company is focused on developing innovative therapies for rare and severe eye diseases.\n\n”We are pleased with our progress in executing our corporate priorities,” said Mark Iwicki, Chair and Chief Executive Officer of KALA BIO. “We are actively enrolling patients in our CHASE Phase 2b trial of KPI-012 for PCED and are on track to announce topline safety and efficacy data in the second half of 2024. In addition, we are exploring the potential of our MSC-S platform technology for multiple rare, front- and back-of-the-eye diseases.”\n\nKPI-012 is a mesenchymal stem cell secretome (MSC-S) that combines growth factors, protease inhibitors, matrix proteins, and neurotrophic factors to potentially correct impaired corneal healing, which is an underlying cause of multiple severe ocular diseases. KALA is currently evaluating the potential development of KPI-012 for additional rare, front-of-the-eye diseases, such as Limbal Stem Cell Deficiency and other corneal diseases that threaten vision.\n\nThe company’s CHASE Phase 2b clinical trial, which is actively enrolling patients, is evaluating KPI-012 for the treatment of Persistent Corneal Epithelial Defect (PCED). This is a persistent, non-healing corneal defect or wound that can lead to significant infection, corneal perforation, scarring, and vision loss if left untreated. KALA is targeting to announce topline data in the second half of 2024. If the results are positive, and subject to discussion with regulatory authorities, KALA believes the CHASE Phase 2b trial could serve as the first of two pivotal trials to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for KPI-012.\n\nIn addition to its ongoing clinical trials, KALA has also initiated preclinical studies for its KPI-014 program. This program is evaluating the potential of its MSC-S platform for inherited retinal degenerative diseases such as Retinitis Pigmentosa and Stargardt Disease.\n\nAs of September 30, 2023, KALA had cash and cash equivalents of $56.1 million, compared to $70.5 million as of December 31, 2022. This decrease reflects cash used in operations and a $2.5 million milestone payment to the former Combangio, shareholders following the dosing of the first patient in the CHASE trial, as well as a prepayment of approximately $10.0 million in principal and fees under KALA’s loan agreement, partially offset by net proceeds of $18.0 million raised under KALA’s at-the-market offering program. Based on its current plans, KALA anticipates that its cash resources as of September 30, 2023, together with anticipated remaining funding under the CIRM award, will enable it to fund operations into the second quarter of 2025.’$KALA2023-12-22T06:59:18.335Z
