Instil Bio(US:TIL)2024-11-13 12:39Financial Performance - For the three months ended September 30, 2024, the net loss was $23.0 million, and for the nine months ended September 30, 2024, the net loss was $62.2 million, with an accumulated deficit of $643.2 million as of September 30, 2024[100]. - Net loss for the three months ended September 30, 2024, was $23.0 million, a decrease of $52.9 million compared to a net loss of $67.4 million in the same period of 2023[116]. - The net loss for the nine months ended September 30, 2024, was $62.2 million, a decrease from a net loss of $143.2 million for the same period in 2023[144][145]. - The company incurred cash used in operating activities of $45.1 million for the nine months ended September 30, 2024, compared to $68.6 million for the same period in 2023, indicating a reduction of approximately 34.3%[143][145]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $0.2 million, a significant decrease from $8.1 million in the same period of 2023[149]. Cash and Investments - As of September 30, 2024, the company had cash, cash equivalents, marketable securities, and long-term investments totaling $122.9 million, which includes $6.7 million in cash and cash equivalents[100]. - Cash provided by investing activities for the nine months ended September 30, 2024, was $41.0 million, an increase from $27.2 million in the same period of 2023, representing a growth of approximately 50.0%[146][147]. - The outstanding principal amount under the Loan as of September 30, 2024, was $82.8 million, with unamortized debt issuance costs of $0.7 million[133]. - Future funding requirements are anticipated to be met with existing cash and marketable securities, with potential opportunities for the sale of the Tarzana manufacturing site to extend cash runway[134]. Research and Development - The lead product candidate, SYN-2510, is a bispecific antibody targeting PD-L1 and VEGF, currently in a Phase I trial in China, with 65 patients dosed, showing a median age of 57 years and a median of 3 prior lines of therapy[91][93]. - Among 25 response evaluable patients treated with SYN-2510, 3 patients achieved confirmed partial responses, with tumor shrinkage of 46%, 32%, and over 53% respectively[95]. - Treatment-related adverse events occurred in 97% of patients, with the most common being infusion-related reactions (72.7%) and decreased platelet count (39.4%)[94]. - The recommended phase 2 dose for SYN-2510 was determined to be 20.0 mg/kg, with a half-life of approximately 6.8 days[96]. - The company is pursuing additional novel therapeutic candidates to address significant unmet medical needs in its pipeline[89]. Operating Expenses and Restructuring - Operating expenses for the three months ended September 30, 2024, were $23.6 million, a decrease of $53.1 million compared to $66.7 million in the same period of 2023[116]. - In-process research and development expenses increased by $10.0 million to $10.0 million for the three months ended September 30, 2024, primarily due to payments made to ImmuneOnco[117]. - Research and development expenses decreased by $7.9 million to $0.6 million for the three months ended September 30, 2024, mainly due to the discontinuation of ITIL-168 clinical manufacturing activities[118]. - General and administrative expenses decreased by $1.2 million to $10.7 million for the three months ended September 30, 2024, primarily due to reduced headcount[119]. - Restructuring and impairment charges decreased by $43.9 million to $2.4 million for the three months ended September 30, 2024, mainly due to a reduction in costs related to the impairment of the Tarzana manufacturing facility[120]. - The restructuring plan adopted in January 2023 resulted in a 96% reduction of the U.S. workforce and a 42% reduction of the UK workforce, incurring charges of $7.1 million for the nine months ended September 30, 2024[109]. - The company expects to incur additional restructuring and impairment charges in 2024 due to workforce reductions and other actions related to its 2024 Plan[121]. - The company plans to incur additional charges of up to $0.5 million in 2024 related to the 2024 Plan, which includes employee termination costs and contract termination costs[140]. Collaborations and Agreements - The company has entered into a collaboration for the development of an autologous folate receptor alpha CoStAR-TIL for a potential trial in non-small cell lung cancer in China[99]. - The company entered into an IO Collaboration Agreement with ImmuneOnco, involving an upfront payment of $10.0 million and potential payments up to $2.1 billion in milestones[138]. - The maximum contingent consideration remaining unpaid from the acquisition of Immetacyte was $13.3 million as of September 30, 2024[137].