KALA BIO Q2 2024 Financial Results and Corporate Update

KALA BIO, Inc., a clinical-stage biopharmaceutical company specializing in innovative therapies for rare and severe eye diseases, has released its financial results for the second quarter ending June 30, 2024, and provided a comprehensive corporate update.

Mark Iwicki, Chair and CEO of KALA BIO, announced that the company secured $12.5 million through a private placement led by SR One and participated in by ADAR1 Capital Management and another life sciences-focused investor. This infusion positions the company to advance its lead candidate, KPI-012, towards a late-stage clinical readout and to further explore the potential of its MSC-S platform for developing treatments for severe eye diseases. KALA targets topline results from the Phase 2b CHASE trial of KPI-012 for Persistent Corneal Epithelial Defect (PCED) by the first quarter of 2025.

KPI-012 is poised to become the first treatment addressing all underlying causes of PCED, potentially improving patient outcomes and quality of life significantly. Iwicki highlighted the broader potential of KPI-012 to treat other severe corneal diseases like Limbal Stem Cell Deficiency (LSCD). Additionally, KALA is focused on KPI-014, aimed at treating inherited retinal diseases such as Retinitis Pigmentosa and Stargardt Disease.

KALA’s proprietary mesenchymal stem cell secretome (MSC-S) platform underpins its innovative pipeline. This platform technology, with its multifactorial mechanism of action, holds promise for treating a range of ocular diseases. The company is evaluating this technology across multiple rare, front- and back-of-the-eye conditions.

KPI-012 contains various biofactors like growth factors, protease inhibitors, and neurotrophic factors, which may address impaired corneal healing, a common etiology in severe ocular diseases. Initially, KALA is focusing on developing KPI-012 for PCED, a condition with no currently FDA-approved broad indication treatments. PCED affects an estimated 100,000 people in the U.S. and can lead to severe complications if untreated. KALA is actively enrolling patients in the Phase 2b CHASE (Corneal Healing After Secretome Therapy) clinical trial for KPI-012 and anticipates reporting topline data in early 2025.

Beyond PCED, KALA is exploring the use of KPI-012 for treating LSCD and other corneal diseases. LSCD involves the loss or deficiency of limbal epithelial stem cells, leading to various complications, including vision impairment. Like PCED, LSCD represents a significant market opportunity, affecting approximately 100,000 individuals in the U.S.

KALA’s KPI-014 program, still in preclinical stages, aims to treat inherited retinal degenerative diseases. This program leverages the MSC-S platform's potential to protect and preserve retinal cell function through various biofactors. The company is conducting preclinical studies to evaluate KPI-014's efficacy in conditions like Retinitis Pigmentosa and Stargardt Disease, pursuing a gene-agnostic treatment approach.

From a financial perspective, as of June 30, 2024, KALA reported cash and cash equivalents totaling $54.2 million, up from $48.5 million on March 31, 2024. This increase reflects the proceeds from the June 2024 private placement, offset by operational expenses. KALA anticipates these resources, along with additional funding, will support its operations into the fourth quarter of 2025.

For the quarter ending June 30, 2024, KALA’s general and administrative expenses were $4.3 million, down from $5.0 million in the same period in 2023. This decrease was mainly due to reduced administrative costs. However, research and development expenses rose to $5.3 million from $4.3 million in the prior year, driven by increased KPI-012 development costs and employee-related expenses.

KALA reported a net loss of $9.6 million for the second quarter of 2024, compared to a net loss of $10.4 million in the same period in 2023. Despite these losses, the company remains focused on advancing its clinical programs and leveraging its MSC-S platform to develop breakthrough therapies for rare and severe ocular diseases.