Instil Bio, Inc. reported a net loss of $74.1 million for the year ended December 31, 2024, a significant improvement from the $156.1 million net loss reported in 2023. The company attributed the improvement primarily to a decrease in research and development expenses, driven by reduced headcount and the discontinuation of the ITIL-168 clinical manufacturing activities. General and administrative expenses also decreased slightly, primarily due to lower personnel costs. Offsetting these improvements were $10 million in in-process research and development expenses related to payments made to ImmuneOnco under a collaboration agreement, and $7.5 million in restructuring and impairment charges. As of December 31, 2024, the company had an accumulated deficit of $655.1 million and $115.1 million in cash, cash equivalents, restricted cash, and marketable securities.
A key development during the fiscal year was the in-licensing of bispecific antibodies AXN-2510/IMM2510 and AXN-27M/IMM27M from ImmuneOnco Biopharmaceuticals (Shanghai) Inc. in August 2024. AXN-2510/IMM2510 is Instil Bio's lead product candidate, a PD-L1xVEGF bispecific antibody currently in clinical development for multiple solid tumor cancers. ImmuneOnco is conducting Phase 1 trials in China, with over 100 patients enrolled as of January 13, 2025. Preliminary data from these trials showed confirmed partial responses in three patients and stable disease in seven. Instil Bio plans to initiate clinical development of AXN-2510/IMM2510 in patients with advanced/metastatic NSCLC outside of China. AXN-27M/IMM27M, targeting CTLA-4, is also undergoing Phase 1 trials in China.
The company's employee count stood at 14 full-time employees as of December 31, 2024. Instil Bio is evaluating options to sell its Tarzana, California facility, currently leased to AstraZeneca. The company's headquarters are located in Dallas, Texas, with additional leased laboratory and office space in Thousand Oaks, California, and Alderley Park, United Kingdom. Instil Bio stated that its current facilities are adequate for its current needs. The company's strategy focuses on advancing the development of AXN-2510/IMM2510 and pursuing additional in-licensing or acquisition opportunities. They are no longer actively pursuing the development of cell therapies.
Instil Bio faces significant competition from major pharmaceutical and biotechnology companies developing similar therapies. The company acknowledges the challenges of obtaining regulatory approvals and the inherent uncertainties in clinical trials. They highlight the need for substantial additional funding to meet their financial obligations and pursue their business objectives. The company's financial projections indicate that they expect to continue incurring losses for the foreseeable future.
The company's 10-K filing includes extensive discussion of various risks, including those related to clinical development, regulatory approvals, manufacturing, commercialization, intellectual property, and financial resources. The filing also details the company's compliance with various U.S. and international regulations, including those related to data privacy, cybersecurity, and healthcare fraud and abuse. The company's outlook is contingent upon successful clinical development, regulatory approvals, and market acceptance of its product candidates.
About Instil Bio, Inc.
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