On May 11, 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 first quarter 2023 financial results and provided a corporate update (Press release, Instil Bio, MAY 11, 2023, View Source [SID1234631514]).

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First Quarter 2023 Highlights and Anticipated Milestones:

ITIL-306 phase 1 study in UK anticipated to initiate in 2H’2023: Instil has recently received positive initial feedback from the Medicines and Healthcare products Regulatory Agency, or MHRA, on the proposed study design for the phase 1 dose escalation study of ITIL-306 in the United Kingdom, and anticipates initiating such study in the second half of 2023 following anticipated Clinical Trial Application, or CTA, clearance from the MHRA. Instil expects to report initial clinical data from the ITIL-306 program in 2024.
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, UK operations have extensive experience in the manufacture and development of TIL and other cell therapies since 2011. Instil continues to pursue a potential lease or sale of its manufacturing facility in Tarzana, California. Under the current operating plan, starting in the second half of 2023, Instil expects quarterly cash burn of less than $10 million through the end of 2024.
First Quarter 2023 Financial and Operating Results:

As of March 31, 2023, Instil had cash, cash equivalents, restricted cash and marketable securities of $223.9 million, which consists of $27.4 million in cash and cash equivalents, $0.7 million in restricted cash and $195.8 million in marketable securities, compared to $260.9 million in total cash and cash equivalents and marketable securities, consisting 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 and marketable securities as of March 31, 2023 will enable it to fund its operating plan beyond 2026.

Research and development expenses were $20.7 million for the three months ended March 31, 2023, compared to $39.2 million for the three months ended March 31, 2022.

General and administrative expenses were $13.2 million for the three months ended March 31, 2023, compared to $15.1 million for the three months ended March 31, 2022.

Restructuring and impairment charges were $24.6 million for the three months ended March 31, 2023.