On March 4, 2025 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, reported its fourth quarter and full year 2024 financial results and provided a corporate update (Press release, Instil Bio, MAR 4, 2025, View Source [SID1234650882]).
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Recent Highlights:
Clinical data for AXN-2510 (formerly SYN-2510) /IMM2510 anticipated in 1H 2025: Instil announced today that ImmuneOnco anticipates providing a clinical data update for AXN-2510/IMM2510 monotherapy in relapsed or refractory (R/R) non-small cell lung cancer ("NSCLC") in the first half of 2025. Instil anticipates that ImmuneOnco will also release safety data from a total of approximately 100 patients treated with AXN-2510/IMM2510 as monotherapy across multiple solid tumors.
Initiation by ImmuneOnco of Phase 1b/2 trial of AXN-2510/IMM2510 in combination with chemotherapy in NSCLC in China: ImmuneOnco announced enrollment of the first patient in the safety run-in of a Phase 1b/2 trial of AXN-2510/IMM2510 in combination with chemotherapy in NSCLC in China in January 2025. ImmuneOnco anticipates enrollment of first-line NSCLC patients in this study to initiate in Q2 2025, with initial clinical data anticipated in 2H 2025.
U.S. clinical study of AXN-2510/IMM2510 in combination with chemotherapy in 1L NSCLC anticipated to commence before the end of 2025: Instil anticipates initiating a U.S. clinical trial of AXN-2510/IMM2510 in combination with chemotherapy for 1L NSCLC patients before the end of 2025, assuming the necessary regulatory approvals are obtained.
Fourth Quarter and Full Year 2024 Financial and Operating Results:
As of December 31, 2024, Instil had $115.1 million in total cash, cash equivalents, restricted cash and marketable securities, which consisted of $8.8 million in cash and cash equivalents, $1.8 million in restricted cash and $104.5 million in marketable securities, compared to $175.0 million in total cash, cash equivalents, restricted cash and marketable securities, which consisted of $9.2 million in cash and cash equivalents, $1.5 million in restricted cash, $141.2 million in marketable securities and $23.2 million in long-term investments, as of December 31, 2023. Instil expects that its cash, cash equivalents, restricted cash and marketable securities as of December 31, 2024 will enable it to fund its current operating plan beyond 2026.
In-process research and development expenses were nil and $10.0 million for the fourth quarter and full year ended December 31, 2024, respectively, compared to nil for the fourth quarter and full year ended December 31, 2023.
Research and development expenses were $1.1 million and $11.8 million for the fourth quarter and full year ended December 31, 2024, respectively, compared to $2.0 million and $39.6 million for the fourth quarter and full year ended December 31, 2023, respectively.
General and administrative expenses were $10.4 million and $44.2 million for the fourth quarter and full year ended December 31, 2024, respectively, compared to $10.9 million and $47.6 million for the fourth quarter and full year ended December 31, 2023, respectively.
Restructuring and impairment charges were $0.3 million and $7.5 million for the fourth quarter and full year ended December 31, 2024, respectively, compared to $0.2 million and $72.0 million for the fourth quarter and full year ended December 31, 2023, respectively.
Net loss per share, basic and diluted was $1.82 and $11.39 for the fourth quarter and full year ended December 31, 2024, respectively, compared to $1.99 and $24.00 for the fourth quarter and full year ended December 31, 2023, respectively. Non-GAAP net loss per share, basic and diluted was $1.08 and $7.59 for the fourth quarter and full year ended December 31, 2024, respectively, compared to $1.26 and $10.14 for the fourth quarter and full year ended December 31, 2023, respectively.
Note Regarding Use of Non-GAAP Financial Measures
In this press release, Instil has presented certain financial information that has not been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). These non-GAAP financial measures include non-GAAP net loss and non-GAAP net loss per share, which are defined as net loss and net loss per share, respectively, excluding non-cash stock-based compensation expense and restructuring and impairment charges. Instil believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Instil’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Instil’s operating results. In addition, these non-GAAP financial measures are among the indicators Instil’s management uses for planning purposes and to measure Instil’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Instil may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer to the below reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.