KALA BIO (NASDAQ:KALA) has successfully raised $10.75 million through a private placement of common stock and Series I Convertible Non-Redeemable Preferred Stock, strengthening its position in developing innovative therapies for rare eye diseases. The financing round attracted both new and existing investors, including prominent firms SR One, Cormorant Asset Management, and Woodline Partners.
The financing agreement includes the sale of 1,340,603 common stock shares at $6.44 per share and 3,286 shares of Series I Preferred Stock at $644.00 per share. The transaction is expected to close by December 31, 2024, subject to standard closing conditions.
Clinical Development Progress
The funding comes at a crucial time for KALA BIO's development of KPI-012, the company's lead candidate for treating persistent corneal epithelial defect (PCED). The ongoing Phase 2b CHASE trial has achieved significant momentum, with over 40 clinical sites actively recruiting and enrolling patients. Notably, the trial has already reached more than 80% of its target enrollment.
Mark Iwicki, Chair and Chief Executive Officer of KALA BIO, expressed optimism about the trial's progress: "With over 80% of enrollment now complete in the CHASE trial, we remain on track to report topline data in the second quarter of 2025. If successful, this trial may serve as the first of two pivotal trials required to support a BLA submission."
Therapeutic Platform and Pipeline
KPI-012 represents an innovative approach to treating severe eye diseases, utilizing KALA's proprietary mesenchymal stem cell secretome (MSC-S) platform. The therapy contains multiple human-derived biofactors, including growth factors, protease inhibitors, matrix proteins, and neurotrophic factors, designed to address impaired corneal healing.
The U.S. Food and Drug Administration has already granted both Orphan Drug and Fast Track designations to KPI-012 for PCED treatment, highlighting the therapy's potential significance in addressing this rare disease. Beyond PCED, KALA is exploring KPI-012's potential applications in Limbal Stem Cell Deficiency and other rare corneal diseases.
Financial Outlook
The newly secured funding, combined with existing cash resources, is expected to sustain KALA's operations into the first quarter of 2026. The company plans to primarily utilize the proceeds to advance KPI-012's clinical development program and support general corporate operations.
Future Development Plans
KALA BIO is also conducting preclinical studies to evaluate its MSC-S platform's potential in treating retinal degenerative diseases, including Retinitis Pigmentosa and Stargardt Disease, demonstrating the company's commitment to expanding its therapeutic reach in severe eye diseases.
