Instil Bio (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 second quarter 2022 financial results and provided a corporate update.
Second 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 in 1H 2023 for the registrational cohort and expects top-line safety and efficacy data in early 2024, which could potentially support a biologics license application (BLA) submission and a European Medicines Agency marketing authorization application (MAA) filing.
- Cash runway expected to extend from 2024 into 2025 with anticipated sale-leaseback of Tarzana, CA manufacturing site: Instil expects its current cash reserves along with expected proceeds from a potential sale-leaseback of its Tarzana, CA, manufacturing site to fund Company operations into 2025.
- Enrolling Phase 1 study of ITIL-306, Instil’s first CoStAR-TIL: Instil has initiated a Phase 1 study of ITIL-306, its first CoStAR-TIL product candidate. CoStAR is a genetic modification designed to enhance the activity of TILs within the tumor microenvironment. The Phase 1 study of ITIL-306 features a TIL treatment regimen free of IL-2 and will enroll patients with non-small cell lung cancer (NSCLC), ovarian cancer (OC), and renal cell carcinoma (RCC).
- Initiated DELTA-2, a Phase 1 study of ITIL-168 in combination with pembrolizumab: Instil has initiated DELTA-2, a Phase 1 study of ITIL-168 in combination with pembrolizumab, which will enroll patients with NSCLC, cervical cancer, and squamous cell carcinoma of the head and neck.
- Tarzana, CA manufacturing facility operational: Instil was cleared by the US Food and Drug Administration (FDA) for manufacturing of both ITIL-168 and ITIL-306 at its Tarzana, CA manufacturing facility, which will support DELTA-1, DELTA-2, and ITIL-306 clinical trials.
- Presented Preclinical Data on CoStAR T cells at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting: Instil presented findings from preclinical studies evaluating anti-FOLR1 CoStAR T cells in vitro as well as a murine solid tumor model in vivo demonstrating enhanced T cell function and tumor control by CoStAR-modified T cells.
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.
- Presented Product Characterization Data from Unmodified TILs in Cutaneous Melanoma at the American Society of Gene and Cell Therapy (ASGCT): Instil presented advanced correlative analyses from a cohort of melanoma patients enrolled in a compassionate use program that were treated with TIL products made by Instil at the 25th Annual ASGCT meeting.
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.
Second Quarter 2022 Financial and Operating Results:
As of June 30, 2022, we had $354.6 million in total cash and cash equivalents and marketable securities, comprised of $42.5 million in cash and cash equivalents and $312.1 million in marketable securities compared to $454.1 million in total cash and cash equivalents 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. The Company expects that its cash, cash equivalents and marketable securities as of June 30, 2022 will enable it to fund its operating plan into 2025 upon completion of the anticipated sale-leaseback of its Tarzana, CA manufacturing site.
Research and development expenses were $41.5 million and $80.7 million for the three and six months ended June 30, 2022, respectively, compared to $21.2 million and $35.6 million for the three and six months ended June 30, 2021, respectively.
General and administrative expenses were $17.2 million and $32.3 million for the three and six months ended June 30, 2022, respectively, compared to $14.2 million and $23.2 million for the three and six months ended June 30, 2021, respectively.
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