KALA BIO Q1 2024 Financial Results and Corporate Update

KALA BIO, Inc., a clinical-stage biopharmaceutical company specializing in the development and commercialization of therapies for severe and rare eye diseases, has recently published its financial results for the first quarter ending March 31, 2024. The company is presently focusing on advancing its clinical program for KPI-012, targeting persistent corneal epithelial defect (PCED), a condition characterized by non-healing corneal wounds that can lead to severe complications such as infection, scarring, and vision loss.

The ongoing Phase 2b CHASE trial is crucial for KPI-012's development, with topline data expected by the end of 2024. The success of this trial could potentially mark the first of two pivotal studies necessary to support a Biologics License Application (BLA) submission to the FDA. KALA BIO is committed to expanding its platform technology, aiming to become a leader in mesenchymal stem cell secretome therapy.

KPI-012, the company’s lead product candidate, leverages a multifactorial mechanism of action to address various impaired corneal healing processes. It combines growth factors, protease inhibitors, matrix proteins, and neurotrophic factors to provide a potentially effective and well-tolerated therapy for PCED. Given the absence of FDA-approved treatments for PCED, which affects an estimated 100,000 patients in the U.S., this represents a significant market opportunity.

In addition to PCED, KALA BIO is exploring the potential of KPI-012 in treating other corneal diseases such as Limbal Stem Cell Deficiency (LSCD). LSCD involves the loss or deficiency of limbal epithelial stem cells, leading to issues like recurrent epithelial breakdown, inflammation, and vision impairment. Similar to PCED, LSCD also presents a substantial market opportunity, affecting around 100,000 patients in the U.S.

KALA BIO is concurrently investigating KPI-014, another product candidate based on its mesenchymal stem cell secretome (MSC-S) platform, for rare inherited retinal diseases such as Retinitis Pigmentosa and Stargardt Disease. KPI-014 aims to protect and preserve retinal cell function through a combination of neurotrophic factors, growth factors, and anti-inflammatory agents. Preclinical studies have shown promising neuroprotective effects in both in vitro and in vivo models of retinal degeneration.

Financially, KALA BIO reported a cash position of $48.5 million as of March 31, 2024, a slight decrease from $50.9 million at the end of 2023. This reduction is attributed to operational expenditures, partially offset by gross proceeds of $8.6 million from a private placement financing in March 2024. The company anticipates that its current cash resources, along with expected funding from a CIRM award, will sustain operations into the third quarter of 2025.

For the first quarter of 2024, general and administrative expenses were reported at $5.4 million, down from $6.0 million in the same period in 2023. This decrease is mainly due to reduced administrative and professional service fees, despite increased stock-based compensation and employee-related costs. Research and development expenses rose to $6.4 million from $4.0 million in the previous year, driven by the progression of KPI-012’s clinical development and other R&D activities.

The company reported an operating loss of $11.9 million for the first quarter of 2024, compared to $11.7 million in the same period in 2023. The net loss for the quarter was $11.8 million, or $4.20 per share, a slight improvement from a net loss of $14.5 million, or $6.99 per share, in the first quarter of 2023.

KALA BIO remains dedicated to leveraging its MSC-S platform to develop new therapies for rare ocular diseases, with KPI-012 and KPI-014 at the forefront of its innovative pipeline. The company continues to focus on advancing clinical trials and exploring new therapeutic opportunities to address unmet medical needs in the field of ophthalmology.