Instil Bio(US:TIL)2025-11-13 12:08Financial Performance - For the three months ended September 30, 2025, the net loss was $13.6 million, a decrease of $9.4 million compared to a net loss of $23.0 million for the same period in 2024[127]. - The company reported a net loss of $63.2 million for the nine months ended September 30, 2025, compared to a net loss of $62.2 million in 2024, reflecting a decrease of $941,000[133]. - Cash used in operating activities for the nine months ended September 30, 2025 was $29.5 million, consisting of a net loss of $63.2 million and non-cash charges of $34.3 million[159]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $15.0 million, down from $23.6 million in 2024, reflecting a decrease of $8.6 million[127]. - General and administrative expenses decreased to $5.9 million for the three months ended September 30, 2025, from $10.7 million in 2024, a net decrease of $4.8 million[131]. - In-process research and development expenses were nil for the three months ended September 30, 2025, compared to $10.0 million for the same period in 2024, reflecting a net decrease of $10.0 million[128]. Research and Development - Research and development expenses increased to $9.1 million for the three months ended September 30, 2025, compared to $0.6 million in 2024, an increase of $8.6 million[127]. - Total research and development expenses for the nine months ended September 30, 2025, were $21.2 million, up from $10.7 million in 2024, representing a net increase of $10.5 million[135]. - Research and development expenses increased to $9.1 million for the three months ended September 30, 2025, from $0.6 million in 2024, a net increase of approximately $8.6 million primarily due to costs related to the ImmuneOnco collaboration[129]. Cash and Investments - As of September 30, 2025, the company had cash, cash equivalents, restricted cash, marketable securities, and long-term investments totaling $83.4 million[107]. - Cash provided by investing activities for the nine months ended September 30, 2025 was $17.7 million, primarily from marketable securities investments[161]. - Cash provided by financing activities for the nine months ended September 30, 2025 was $7.3 million, mainly from net proceeds of $6.6 million from the ATM Program[163]. Clinical Trials and Product Development - The lead product candidate, AXN-2510, is a bispecific antibody targeting PD-L1 and VEGFs, currently in clinical trials for solid tumor cancers[102]. - ImmuneOnco has enrolled 150 patients in a Phase 1 trial of AXN-2510 in China as of June 30, 2025[104]. - The company initiated a Phase 1 clinical trial of AXN-2510 in the U.S. after receiving IND clearance from the FDA in July 2025[106]. - The company plans to pursue additional clinical trials for AXN-2510 in combination with other therapies for advanced solid tumors[105]. Future Outlook - The company expects to continue incurring net losses for the foreseeable future due to ongoing research and development activities[107]. - Axion Bio expects to incur significant expenses in R&D and business development, with future operating expenditures dependent on various factors[150]. - The company plans to fund operations through equity offerings, debt financings, or other capital sources until substantial revenue is generated[157]. Financing and Capital Structure - The company raised net proceeds of $339.0 million in its IPO in the first quarter of 2021, selling 920,000 shares of common stock[140]. - The company has a term loan of $85.6 million with a fixed interest rate of 6.35% per annum, with interest-only payments during the loan term[142]. - The company sold 185,837 shares under its ATM Program for net proceeds of $6.6 million during the nine months ended September 30, 2025[145]. Collaboration and Milestones - Axion Bio made a $10.0 million upfront payment to ImmuneOnco as part of the IO Collaboration Agreement, fully expensed as IPR&D in 2024[151]. - ImmuneOnco is eligible for potential payments of up to $2.1 billion in milestones and royalties on global net sales of licensed products[154]. - Axion Bio achieved IND clearance for a Phase 1 trial of '2510 in June 2025, triggering a $10.0 million development payment[153]. Asset Management - The company plans to sell the Tarzana facility, which could potentially extend its cash runway if successful[149]. - Future minimum lease payments under committed lease agreements were $0.3 million as of September 30, 2025[155].