On May 13, 2025 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, reported its first quarter 2025 financial results and provided a corporate update (Press release, Instil Bio, MAY 13, 2025, View Source [SID1234652970]).

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Recent Highlights:

ImmuneOnco’s Phase 1b/2 trial of AXN-2510/IMM2510 in combination with chemotherapy in 1L NSCLC in China is ongoing and ImmuneOnco anticipates initial clinical data from first-line NSCLC patients 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.
First Quarter 2025 Financial and Operating Results:

As of March 31, 2025, Instil had $111.8 million in total cash, cash equivalents, restricted cash, marketable securities and long-term investments, which consisted of $15.4 million in cash and cash equivalents, approximately $1.0 million in restricted cash, $88.3 million in marketable securities and $7.2 million in long-term investments, compared to $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, as of December 31, 2024. Instil expects that its cash, cash equivalents, marketable securities and long-term investments as of March 31, 2025 will enable it to fund its current operating plan beyond 2026.

Research and development expenses were $5.4 million for the three months ended March 31, 2025, compared to $7.3 million for the three months ended March 31, 2024.

General and administrative expenses were $9.1 million for the three months ended March 31, 2025, compared to $12.4 million for the three months ended March 31, 2024.

Restructuring and impairment charges were $16.1 million for the three months ended March 31, 2025, compared to $4.3 million for the three months ended March 31, 2024.

Net loss per share, basic and diluted were $4.32 for the three months ended March 31, 2025, compared to $3.74 for the three months ended March 31, 2024. Non-GAAP net loss per share, basic and diluted were $1.32 for the three months ended March 31, 2025, compared to $2.39 for the three months ended March 31, 2024.

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.