On March 21, 2024 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 2023 financial results and provided a corporate update (Press release, Instil Bio, MAR 21, 2024, View Source [SID1234641339]).
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Recent Highlights:
Announced entering into a strategic collaboration to develop an autologous folate receptor α (FRα)-CoStAR enhanced TIL for a potential investigator-initiated trial (IIT) in non-small cell lung cancer in China
Announced a strategic update to the ITIL-306 program, including closure of Instil’s UK manufacturing and cessation of ITIL-306 clinical trial activities
Exploring opportunities to in-license/acquire and develop novel therapeutic candidates in diseases with significant unmet medical need
Cash runway expected beyond 2026
Fourth Quarter and Full Year 2023 Financial and Operating Results:
As of December 31, 2023, Instil had $175.0 million in total cash, cash equivalents, restricted cash, marketable securities and long-term investments, 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, compared to $260.9 million in total cash, cash equivalents and marketable securities, which consisted of $43.7 million in cash and cash equivalents and $217.2 million in marketable securities, as of December 31, 2022. Instil expects that its cash, cash equivalents, marketable securities and long-term investments as of December 31, 2023 will enable it to fund its operating plan beyond 2026.
Research and development expenses were $2.0 million and $39.6 million for the fourth quarter and full year ended December 31, 2023, respectively, compared to $20.7 million and $141.1 million for the fourth quarter and full year ended December 31, 2022, respectively.
General and administrative expenses were $10.9 million and $47.6 million for the fourth quarter and full year ended December 31, 2023, respectively, compared to $12.9 million and $62.2 million for the fourth quarter and full year ended December 31, 2022, respectively.
Restructuring and impairment charges were $0.2 million and $72.0 million for the fourth quarter and full year ended December 31, 2023, respectively, compared to $23.2 million for the fourth quarter and full year ended December 31, 2022.
Net loss per share, basic and diluted were $1.99 and $24.00 for the fourth quarter and full year ended December 31, 2023, respectively, compared to $8.29 and $34.46 for the fourth quarter and full year ended December 31, 2022. Non-GAAP net loss per share, basic and diluted were $1.26 and $10.14 for the fourth quarter and full year ended December 31, 2023, respectively, compared to $3.70 and $26.18 for the fourth quarter and full year ended December 31, 2022.
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 restructuring and impairment charges and non-cash stock-based compensation expense. 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.