Business
Instil Bio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update
Instil confirms cash runway beyond 2026 ITIL-306 phase 1 study anticipated to receive CTA clearance from UK MHRA in 2H'2023 Anticipate initial clinical data
About this update from Instil Bio, Inc.
[{"type":"text","content":"Instil confirms cash runway beyond 2026 ITIL-306 phase 1 study anticipated to receive CTA clearance from UK MHRA in 2H'2023 Anticipate initial clinical data from ITIL-306 phase 1 program in 2024 DALLAS, March 31, 2023 (GLOBE NEWSWIRE) -- 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, today reported its fourth quarter and full-year 2022 financial results and provided a corporate update. 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 ca...