Celcuity(US:CELC)2025-11-12 21:06Financial Performance - Net loss for Q3 2025 was $43.8 million, or $0.92 loss per share, compared to a net loss of $29.8 million, or $0.70 loss per share, in Q3 2024[14] - Non-GAAP adjusted net loss for Q3 2025 was $37.2 million, or $0.78 loss per share, compared to a non-GAAP adjusted net loss of $27.6 million, or $0.65 loss per share, in Q3 2024[14] - The net loss for the three months ended September 30, 2025, was $43,804,000, compared to a net loss of $29,792,000 in the same period of 2024, reflecting a 47% increase in losses[23] - Non-GAAP adjusted net loss for the three months ended September 30, 2025, was $37,155,000, compared to $27,605,000 in 2024, indicating a 35% increase[27] - The company reported a net loss per share of $0.92 for the three months ended September 30, 2025, compared to $0.70 in the same period of 2024[27] Operating Expenses - Total operating expenses for Q3 2025 were $42.8 million, up from $30.1 million in Q3 2024, representing a 42% increase[10] - Research and development expenses increased to $34.9 million in Q3 2025 from $27.6 million in Q3 2024, a rise of 27%[11] - General and administrative expenses rose to $7.9 million in Q3 2025, compared to $2.5 million in Q3 2024, marking a 216% increase[12] - Total operating expenses for the nine months ended September 30, 2025, reached $122,991,000, compared to $76,837,000 in 2024, marking an increase of 60%[23] Assets and Liabilities - Total assets increased to $476,004,000 as of September 30, 2025, up from $245,123,000 on December 31, 2024, representing a growth of 94%[21] - Current assets rose to $475,497,000, a significant increase of 94% from $244,571,000 in the previous year[21] - Cash and cash equivalents increased significantly to $74,252,000 as of September 30, 2025, from $22,515,000 at the end of 2024, a growth of 230%[21] - Total liabilities surged to $359,041,000 as of September 30, 2025, compared to $129,504,000 at the end of 2024, representing an increase of 177%[21] Clinical Developments - The gedatolisib-triplet reduced the risk of disease progression or death by 76% compared to fulvestrant, with a median progression-free survival of 9.3 months[7] - The gedatolisib doublet reduced the risk of disease progression or death by 67%, with a median progression-free survival of 7.4 months[7] - The FDA accepted the request for a New Drug Application for gedatolisib under the Real-Time Oncology Review program, with submission targeted for Q4 2025[8] - The PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled, with topline data expected in late Q1 2026 or Q2 2026[6] Share Information - The weighted average common shares outstanding for the three months ended September 30, 2025, were 47,589,731, up from 42,793,047 in the same period of 2024[27]