On March 31, 2023 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its fourth quarter and full-year 2022 financial results and provided a corporate update (Press release, Instil Bio, MAR 31, 2023, View Source [SID1234629664]).

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Fourth Quarter 2022 Highlights and Anticipated Milestones:

Instil confirms cash runway beyond 2026 with consolidation of R&D operations to the UK: In January 2023, the Company announced the consolidation of the Phase 1 clinical trial and related manufacturing of CoStAR-TIL to its active operations in Manchester, UK leading to an extension of the expected cash runway to beyond 2026. Instil’s Manchester, U.K. operations have extensive experience and success in the manufacture and development of TIL and other cell therapy products since 2011. Instil continues to pursue a potential lease or sale of its commercial manufacturing facility in Tarzana, California. Under the current operating plan, starting in the second half of 2023, we expect quarterly cash burn of less than $10 million through the end of 2024.

ITIL-306 phase 1 study in UK anticipated to initiate in 2H’2023: Instil anticipates initiating a phase 1 study of ITIL-306 in the United Kingdom in the second half of 2023 following anticipated Clinical Trial Application, or CTA, clearance from the Medicines and Healthcare products Regulatory Agency, or MHRA. Instil anticipates initial clinical data from the ITIL-306 program in 2024.

Prioritization of ITIL-306 after discontinuation of ITIL-168 and subsequent consolidation to the UK for manufacturing: After a voluntary pause of the DELTA-1 trial for ITIL-168 in October 2022 due to a decreased rate of successful manufacturing of ITIL-168, the Company discontinued the program in December 2022 and announced a reduction in U.S. headcount and prioritization of CoStAR-TIL programs, including ITIL-306.
Fourth Quarter 2022 Financial and Operating Results:

As of December 31, 2022, Instil had $260.9 million in total cash and cash equivalents and marketable securities, comprised of $43.7 million in cash and cash equivalents and $217.2 million in marketable securities, compared to $454.1 million in total cash and cash equivalent and marketable securities, comprised of $37.6 million in cash and cash equivalents and $416.5 million in marketable securities, as of December 31, 2021. Instil expects that its cash, cash equivalents and marketable securities as of December 31, 2022 will enable it to fund its operating plan beyond 2026.

Research and development expenses were $20.7 million and $141.1 million for the fourth quarter and full year ended December 31, 2022, respectively, compared to $42.6 million and $107.3 million for the fourth quarter and full year ended December 31, 2021, respectively.

General and administrative expenses were $12.9 million and $62.2 million for the fourth quarter and full year ended December 31, 2022, respectively, compared to $11.2 million and $48.3 million for the fourth quarter and full year ended December 31, 2021, respectively.

Restructuring and impairment charges were $23.2 million for the fourth quarter and full year ended December 31, 2022.

INSTIL BIO, INC.
SELECTED FINANCIAL DATA
(Unaudited; in thousands, except share and per share amounts)

Statements of Operations

Three Months Ended
December 31, Year Ended December 31,
2022 2021 2022 2021
Operating expenses:
Research and development $ 20,722 $ 42,577 $ 141,056 $ 107,251
General and administrative 12,910 11,175 62,235 48,309
Restructuring and impairment charges 23,167 — 23,167 —
Total operating expenses 56,799 53,752 226,458 155,560
Loss from operations (56,799) (53,752) (226,458) (155,560)
Interest income 1,796 35 3,655 80
Interest expense (745) — (1,883) —
Other income (expense), net 1,299 (573) (564) (1,275)
Loss before income tax expense (54,449) (54,290) (225,250) (156,755)
Income tax benefit (expense) 605 (1,060) 2,073 (39)
Net loss $ (53,844) $ (55,350) $ (223,177) $ (156,794)
Net loss per share, basic and diluted $ (0.41) $ (0.43) $ (1.72) $ (1.48)
Weighted-average shares used in computing net loss per share, basic and diluted 129,872,810 128,952,362 129,512,610 105,993,230

Selected Balance Sheet Data

December 31,
2022 December 31,
2021
Cash, cash equivalents and marketable securities $ 260,920 $ 454,099
Total assets $ 482,128 $ 609,983
Total liabilities $ 118,523 $ 54,784
Convertible preferred stock and stockholders’ equity $ 363,605 $ 555,199

Note Regarding Use of Non-GAAP Financial Measures

In this press release, Instil Bio 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. Instil Bio believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Instil Bio’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Instil Bio’s operating results. In addition, these non-GAAP financial measures are among the indicators Instil Bio’s management uses for planning purposes and to measure Instil Bio’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 Bio 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.

Three Months Ended
December 31, Year Ended December 31,
2022 2021 2022 2021
Net loss $ (53,844) $ (55,350) $ (223,177) $ (156,794)
Adjustments:
Non-cash stock-based compensation expense 6,643 8,904 30,441 26,197
Non-GAAP net loss $ (47,201) $ (46,446) $ (192,736) $ (130,597)
Non-GAAP net loss per share, basic and diluted $ (0.41) $ (0.43) $ (1.72) $ (1.48)
Adjustments
Non-cash stock-based compensation expense per share 0.05 0.07 0.24 0.25
Non-GAAP net loss per share, basic and diluted*. $ (0.36) $ (0.36) $ (1.48) $ (1.23)
Weighted-average shares used in computing net loss per share, basic and diluted 129,872,810 128,952,362 129,512,610 105,993,230
* Non-GAAP net loss per share, basic and diluted may not total due to rounding.