Xilio Therapeutics(US:XLO)2025-11-13 12:40Financial Performance - The company reported net losses of $45.4 million and $45.1 million for the nine months ended September 30, 2025 and 2024, respectively, and a net loss of $58.2 million for the year ended December 31, 2024[124]. - The net loss for the three months ended September 30, 2025, was $16.3 million, compared to a net loss of $14.0 million for the same period in 2024, indicating a decline of $2.3 million[140]. - For the nine months ended September 30, 2025, collaboration and license revenue increased by $25.5 million to $30.1 million from $4.6 million in the same period in 2024[150]. - Total operating expenses for the nine months ended September 30, 2025, were $60.2 million, compared to $51.6 million for the same period in 2024, reflecting an increase of $8.7 million[149]. - The loss from operations for the nine months ended September 30, 2025, was $30.1 million, a decrease of $16.8 million compared to a loss of $47.0 million for the same period in 2024[149]. Cash and Capital Resources - As of September 30, 2025, the company had an accumulated deficit of $429.1 million[124]. - The company had cash and cash equivalents of $103.8 million as of September 30, 2025, which, along with a $17.5 million development milestone received from Gilead, is expected to fund operations into the first quarter of 2027[125]. - Financing activities provided net cash of $51.9 million for the nine months ended September 30, 2025, compared to $21.0 million for the same period in 2024[166]. - The company anticipates substantial future capital requirements to support ongoing research and development activities, with expected continued operating losses and negative cash flows[168]. - The company filed a universal shelf registration statement to register for sale up to $250.0 million of various securities, effective May 8, 2025[160]. Revenue and Expenses - Collaboration and license revenue increased by $16.8 million from $2.3 million for the three months ended September 30, 2024, to $19.1 million for the three months ended September 30, 2025[141]. - Total revenue for the three months ended September 30, 2025, was $19.1 million, compared to $2.3 million for the same period in 2024, reflecting a significant increase[140]. - Research and development expenses rose by $3.6 million from $10.8 million for the three months ended September 30, 2024, to $14.3 million for the same period in 2025[143]. - General and administrative expenses increased by $0.4 million from $6.3 million for the three months ended September 30, 2024, to $6.7 million for the same period in 2025[143]. - General and administrative expenses increased by $4.0 million from $18.3 million in the nine months ended September 30, 2024, to $22.3 million in the same period of 2025[153]. Clinical Development - The company is advancing vilastobart in a Phase 2 clinical trial for MSS mCRC and anticipates reporting additional data in the first half of 2026[120]. - Efarindodekin alfa's Phase 2 trial for advanced solid tumors was initiated in Q3 2025, achieving a $17.5 million milestone under the agreement with Gilead[120]. - The company is actively seeking a partner to develop vilastobart in combination with PD-(L)1 or PD1-VEGF in MSS mCRC and other tumor types[120]. - The company is currently engaged in clinical trials for vilastobart and efarindodekin alfa, with ongoing preclinical development for future product candidates[175]. Market and Operational Risks - The company faces substantial doubt about its ability to continue as a going concern without securing additional capital or implementing other strategies[177]. - The company is subject to market risks, including volatility from economic conditions and potential impacts on capital access[177]. - The company is focused on the costs and timing of future commercialization activities for product candidates that receive regulatory approval[175]. Accounting and Compliance - The company has not generated any revenue from product sales since inception and does not expect to do so for at least the next several years[128]. - The company has incurred significant operating losses and will need substantial additional capital to support ongoing operations and strategies[125]. - The company recognized no restructuring expenses for the nine months ended September 30, 2025, compared to $0.9 million in the same period of 2024[154]. - There have been no material changes to the company's contractual obligations during the nine months ended September 30, 2025[178]. - The company has not made changes to its critical accounting policies, except for estimates related to the fair value of common stock warrant liabilities[179].