CG Oncology(US:CGON)2025-11-14 21:15Clinical Trial Results - Cretostimogene achieved a 24-month complete response rate of 41.8% in high-risk Non-Muscle Invasive Bladder Cancer patients, with 46 confirmed complete responses out of 110 patients [112]. - The trial reported a 75.5% complete response rate at any time, with a median duration of response of 28 months [113]. - 96.6% of patients were free from progression to muscle invasive disease at 24 months, with no Grade 3 or greater treatment-related adverse events reported [113]. - The company initiated a BLA submission for cretostimogene in the fourth quarter of 2025, having received Fast Track and Breakthrough Therapy designations from the FDA [113]. Financial Performance - The company incurred net losses of $119.7 million for the nine months ended September 30, 2025, compared to $56.2 million for the same period in 2024 [116]. - Total revenues for the nine months ended September 30, 2025, were $1.7 million, up from $683,000 in the same period in 2024, reflecting a $1.0 million increase [146]. - Commercial and development revenue for Q3 2025 was $1.5 million, a significant increase from zero in Q3 2024, attributed to the Conversion Event in July 2025 [140]. - License and collaboration revenue recognized from agreements totaled $26.3 million since inception, with no revenue expected from cretostimogene product sales in the foreseeable future [125]. Expenses and Operating Costs - Research and development expenses for Q3 2025 were $27.9 million, an increase of $8.3 million from $19.6 million in Q3 2024, driven by higher external clinical trial costs and increased personnel-related expenses [143]. - General and administrative expenses for Q3 2025 reached $23.3 million, up $14.6 million from $8.7 million in Q3 2024, primarily due to increased professional fees and compensation costs [144]. - Total operating costs and expenses for Q3 2025 were $52.8 million, compared to $28.3 million in Q3 2024, marking a $24.5 million increase [139]. - Total research and development expenses increased to $86.7 million for the nine months ended September 30, 2025, compared to $55.3 million in 2024, marking a $31.4 million increase [151]. - General and administrative expenses rose to $55.5 million for the nine months ended September 30, 2025, up from $22.0 million in 2024, reflecting a $33.5 million increase [152]. Cash and Funding - Cash, cash equivalents, and marketable securities totaled $680.3 million as of September 30, 2025, expected to fund operations into the first half of 2028 [117][119]. - Net cash used in operating activities was $96.1 million for the nine months ended September 30, 2025, compared to $58.1 million in 2024 [161]. - Net cash provided by financing activities was $54.5 million for the nine months ended September 30, 2025, compared to $404.9 million in 2024 [166]. - The company expects existing cash resources to fund operations into the first half of 2028, based on current operating plans [157]. Investment and Financial Management - The primary objective of the company's investment activities is to preserve capital while maximizing income from investments without assuming significant risk [176]. - The company seeks to limit its exposure to interest rate risk due to the short-term duration and low risk profile of its investment portfolio [176]. - Inflation has not had a material effect on the company's business, financial condition, or results of operations for the periods covered by the Quarterly Report [177]. - The company does not currently have any off-balance sheet arrangements as defined by SEC regulations [173]. Other Financial Information - The company had an accumulated deficit of $337.7 million as of September 30, 2025, primarily due to research and development costs [116]. - Other income, net, increased to $22.4 million for the nine months ended September 30, 2025, compared to $20.4 million in 2024 [153]. - Recently issued accounting standards that may impact the company's financial position and results of operations are detailed in Note 2 of the Quarterly Report [174]. - There have been no material differences between the company's estimates of expenses and the amounts actually incurred to date [172]. - The company estimates the timing and level of effort for services performed, adjusting accruals or prepaid expenses as necessary [171].