On August 14, 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 second quarter 2023 financial results and provided a corporate update (Press release, Instil Bio, AUG 14, 2023, View Source [SID1234634374]).

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"Successful manufacturing of ITIL-306 in our Manchester, UK facility is a major milestone on our path to clinical development of ITIL-306," said Mark Dudley, Chief Scientific Officer of Instil Bio. "We have implemented improvements to the manufacturing process of ITIL-306 that were shown to result in a doubling of the number of CoStAR-TILs in the final product, which we believe could be meaningful for the therapeutic profile of ITIL-306 in patients with advanced cancer."

Second Quarter 2023 Highlights and Anticipated Milestones:

ITIL-306, first CoStAR-TIL in clinical development, anticipated to start clinical trial ITIL-306-202 in 2H 2023: Instil anticipates initiating phase 1 clinical trial ITIL-306-202 with an updated trial design versus ITIL-306-201; the ITIL-306-202 trial design has received positive initial feedback from the Medicines and Healthcare products Regulatory Agency, or MHRA in the United Kingdom. Instil expects Clinical Trial Application, or CTA, clearance from the MHRA in the second half of 2023 and initial clinical data from the ITIL-306-202 clinical trial in 2024.

ITIL-306 operational in Manchester, UK manufacturing facility: Instil has successfully established ITIL-306, including multiple successful verification runs, in its Manchester, UK manufacturing facility. Instil has designed and implemented manufacturing process improvements that resulted in a doubling of the final yield of CoStAR-TILs from verification runs.

Cash runway beyond 2026: Instil Bio confirms its previous guidance of cash runway beyond 2026.
Second Quarter 2023 Financial and Operating Results:

As of June 30, 2023, Instil had cash, cash equivalents, restricted cash and marketable securities of $202.9 million, which consists of $21.8 million in cash and cash equivalents, $1.2 million in restricted cash and $179.9 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 June 30, 2023 will enable it to fund its operating plan beyond 2026.

Research and development expenses were $8.5 million and $29.1 million for the three and six months ended June 30, 2023, respectively, compared to $41.5 million and $80.7 million for the three and six months ended June 30, 2022, respectively.

General and administrative expenses were $11.5 million and $24.7 million for the three and six months ended June 30, 2023, respectively, compared to $17.2 million and $32.3 million for the three and six months ended June 30, 2022, respectively.

Restructuring and impairment charges were $1.0 million and $25.6 million for the three and six months ended June 30, 2023, respectively.