On May 16, 2022 Instil Bio, Inc. ("Instil" or the "Company") (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 2022 financial results and provided a corporate update (Press release, Instil Bio, MAY 16, 2022, View Source [SID1234614592]).

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First Quarter 2022 Highlights and Anticipated Milestones:

Enrollment Ongoing in DELTA-1, a Phase 2 trial of ITIL-168 in advanced melanoma with registrational intent: Instil is targeting completion of enrollment by 2022 for the registrational cohort and expects top-line safety and efficacy data in 2023, which could potentially support a biologics license application (BLA) submission and a European Medicines Agency marketing authorization application (MAA) filing.

On track with DELTA-2, a Phase 1 trial of ITIL-168 with pembrolizumab in additional cancers with unmet need: Study is expected to initiate in non-small cell lung cancer (NSCLC), cervical cancer and squamous cell carcinoma of head and neck (HNSCC) in the second quarter of 2022. The study will evaluate ITIL-168 with pembrolizumab in patients who have failed standard therapies.

Readiness to Initiate Phase 1 Study of ITIL-306, the first product candidate from the CoStAR platform, in the second quarter: Instil is on track to initiate a Phase 1 study of ITIL-306, its first genetically engineered TIL using the CoStAR platform in the second quarter of 2022.

Presenting Preclinical Data on the CoStAR Platform at ASCO (Free ASCO Whitepaper) 2022: Instil plans to present in vivo and supporting in vitro data at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. Abstract details are below:

Title: Antitumor activity of T cells expressing a novel anti-folate receptor alpha (FOLR1) costimulatory antigen receptor (CoStAR) in a human xenograft murine solid tumor model and implications for in-human studies.
Presenting Product Characterization Data From Unmodified TILs in Cutaneous Melanoma: Instil plans to present advanced correlative analyses on TIL products administered to patients in a compassionate use program at the 25th Annual ASGCT (Free ASGCT Whitepaper) meeting. Abstract details are below:

Title: Characterization of the Transcriptomic and TCR Clonal Heterogeneity of TIL Therapy Infusion Products by Single-Cell Sequencing and Correlative Analyses With Clinical Efficacy in Patients with Advanced Cutaneous Melanoma. ASGCT (Free ASGCT Whitepaper) link.
Cash Runway Into 2024 through key clinical data expected in 2023: Instil expects its current cash reserves to fund Company operations into 2024.
First Quarter 2022 Financial and Operating Results:

As of March 31, 2022, we had $61.5 million in cash and cash equivalents and $318.0 million in marketable securities, compared to $37.6 million in cash and cash equivalents and $416.5 million in marketable securities as of December 31, 2021. The Company expects that its cash, cash equivalents and marketable securities as of March 31, 2022, will enable it to fund its operating plan into 2024.

Research and development expenses were $39.2 million for the three months ended March 31, 2022, compared to $14.4 million for the three months ended March 31, 2021.

General and administrative expenses were $15.1 million for the three months ended March 31, 2022, compared to $9.0 million for the three months ended March 31, 2021.