Financial Performance - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities of $142.6 million, up from $12.1 million as of December 31, 2024, primarily due to the merger completion and a $75.0 million private placement[11] - The net loss for Q3 2025 was $24.8 million, compared to $3.2 million for the same period in 2024, reflecting increased operating costs related to the merger[15] - License revenue for Q3 2025 was $0, compared to $3.5 million in Q3 2024[19] - Total operating expenses for Q3 2025 were $26.6 million, a significant increase from $5.5 million in Q3 2024[19] - Net loss for Q3 2025 was $24.8 million, compared to a net loss of $3.2 million in Q3 2024[19] - Loss per share for common stock in Q3 2025 was $(2.91), compared to $(2.58) in Q3 2024[19] Research and Development - Research and Development (R&D) expenses for Q3 2025 were $15.6 million, an increase of $11.7 million compared to $3.9 million in Q3 2024, driven by higher clinical trial expenses and stock-based compensation[12] - The ongoing Phase 2b ADAPTIVE trial is designed to evaluate the efficacy and safety of various dose regimens of IMG-007 in adults with moderate-to-severe atopic dermatitis, with topline data expected in 2027[4][8] - In a Phase 1b/2a study, IMG-007 demonstrated a mean reduction in EASI score of 77% from baseline at week 16 among 13 patients treated with up to 3 doses over 4 weeks[8] - EASI-75 response was achieved by 54%, 54%, and 46% of participants at weeks 16, 20, and 24, respectively, while EASI-90 response was achieved by 31% of participants at week 16[8] - The company plans to submit a protocol amendment to expand dosing regimens and evaluate patient-friendly dosing intervals in the ongoing Phase 2b trial[8] General and Administrative Expenses - General and Administrative (G&A) expenses for Q3 2025 were $11.0 million, up from $1.7 million in Q3 2024, with a $5.2 million increase in stock-based compensation contributing to the rise[13] Assets and Liabilities - Cash and cash equivalents increased to $103.2 million as of September 30, 2025, up from $12.1 million at the end of 2024[21] - Total current assets rose to $147.5 million in Q3 2025, compared to $12.5 million at the end of 2024[21] - Total liabilities decreased to $21.0 million as of September 30, 2025, down from $17.4 million at the end of 2024[21] - Stockholders' equity improved to $139.8 million in Q3 2025, compared to a negative equity of $(160.6) million at the end of 2024[21] Leadership Changes - The leadership team was strengthened with the addition of Dr. Kristin Yarema as CEO, Dr. Kurinji Pandiyan as Chief Strategy and Operations Officer, and Dr. Renuka Sivendran as Chief Technical Officer[9][10] Upcoming Events - Upcoming presentations at the 6th Annual Inflammatory Skin Disease Summit will include data on IMG-007's clinical activity in alopecia areata and atopic dermatitis[6][7]
Ikena Oncology(IKNA) - 2025 Q3 - Quarterly Results