Financial Performance - KALA BIO reported a net loss of $9.0 million, or $1.93 per share, for Q3 2024, compared to a net loss of $8.7 million, or $3.41 per share, for the same period in 2023[10]. - For the nine months ended September 30, 2024, net loss was $30.3 million, or $8.68 per share, compared to a net loss of $33.6 million, or $14.36 per share, for the same period in 2023[12]. - Net loss for September 2024 was $8,950,000, compared to a net loss of $8,704,000 in September 2023, indicating a slight increase in losses of about 3%[16]. - Net loss per share attributable to common stockholders was $(1.93) for September 2024, compared to $(3.41) for September 2023, showing an improvement of approximately 43%[16]. - Loss from operations for September 2024 was $(9,988,000), compared to $(8,762,000) in September 2023, reflecting an increase in operational losses of approximately 14%[16]. Cash and Expenses - As of September 30, 2024, KALA had cash and cash equivalents of $49.2 million, down from $54.2 million as of June 30, 2024, reflecting cash used in operations[9]. - The company anticipates that its cash resources will fund operations into the fourth quarter of 2025[9]. - Total costs and expenses for September 2024 were $9,988,000, an increase from $8,762,000 in September 2023, representing a 14% rise[16]. - General and administrative (G&A) expenses for Q3 2024 were $4.4 million, down from $5.0 million in Q3 2023, mainly due to a decrease in stock-based compensation and employee-related costs[10]. - General and administrative expenses decreased to $4,400,000 in September 2024 from $4,952,000 in September 2023, a reduction of about 11%[16]. Research and Development - Research and development (R&D) expenses for Q3 2024 were $5.2 million, a decrease from $5.6 million in Q3 2023, primarily due to the timing of manufacturing costs related to KPI-012 development[10]. - Research and development expenses decreased to $5,168,000 in September 2024 from $5,554,000 in September 2023, a reduction of approximately 7%[16]. - KALA continues to enroll patients in the Phase 2b CHASE trial for KPI-012, targeting topline results in Q2 2025[6]. - KALA has initiated five clinical trial sites in Argentina for the CHASE trial, with additional sites in Latin America in progress[6]. - KALA's lead product candidate, KPI-012, is being developed for PCED and has received Orphan Drug and Fast Track designations from the FDA[13]. Market Opportunity - The estimated incidence of Persistent Corneal Epithelial Defect (PCED) in the U.S. is approximately 100,000 patients, representing a significant market opportunity[5]. Income and Shares - Interest income decreased to $570,000 in September 2024 from $708,000 in September 2023, a decline of about 19%[16]. - Grant income for September 2024 was $1,946,000, down from $2,970,000 in September 2023, representing a decrease of approximately 34%[16]. - Total other income (expense) for September 2024 was $1,038,000, compared to $58,000 in September 2023, indicating a significant increase[16]. - Weighted average shares outstanding increased to 4,627,578 in September 2024 from 2,550,210 in September 2023, reflecting a growth of 81%[16].
Kala Pharmaceuticals(KALA) - 2024 Q3 - Quarterly Results