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 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.
INSTIL BIO, INC.
SELECTED FINANCIAL DATA
(Unaudited; in thousands, except share and per share amounts)
Selected Balance Sheet Data
| June 30, 2022 | December 31, 2021 | ||||||
| Cash, cash equivalents and marketable securities | $ | 354,607 | $ | 454,099 | |||
| Total assets | $ | 568,536 | $ | 609,983 | |||
| Total liabilities | $ | 110,204 | $ | 54,784 | |||
| Stockholders’ equity | $ | 458,332 | $ | 555,199 | |||
Statements of Operations
| Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 41,500 | $ | 21,186 | $ | 80,674 | $ | 35,610 | |||||||
| General and administrative | 17,224 | 14,195 | 32,336 | 23,174 | |||||||||||
| Total operating expenses | 58,724 | 35,381 | 113,010 | 58,784 | |||||||||||
| Loss from operations | (58,724 | ) | (35,381 | ) | (113,010 | ) | (58,784 | ) | |||||||
| Interest income | 486 | 15 | 583 | 23 | |||||||||||
| Interest expense | (331 | ) | — | (331 | ) | — | |||||||||
| Other expense, net | (1,032 | ) | (104 | ) | (1,448 | ) | (41 | ) | |||||||
| Loss before income tax benefit | (59,601 | ) | (35,470 | ) | (114,206 | ) | (58,802 | ) | |||||||
| Income tax benefit | 609 | 159 | 1,097 | 363 | |||||||||||
| Net loss | $ | (58,992 | ) | $ | (35,311 | ) | $ | (113,109 | ) | $ | (58,439 | ) | |||
| Net loss per share, basic and diluted | $ | (0.46 | ) | $ | (0.27 | ) | $ | (0.88 | ) | $ | (0.71 | ) | |||
| Weighted-average shares used in computing net loss per share, basic and diluted | 129,367,833 | 128,743,123 | 129,244,334 | 82,478,284 | |||||||||||
Note Regarding Use of Non-GAAP Financial Measures
In this press release, Instil Bio has presented certain financial information that has not been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). These non-GAAP financial measures include non-GAAP net loss and non-GAAP net loss per share, which are defined as net loss and net loss per share, respectively, excluding non-cash stock-based compensation expense. Instil Bio believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Instil Bio’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Instil Bio’s operating results. In addition, these non-GAAP financial measures are among the indicators Instil Bio’s management uses for planning purposes and to measure Instil Bio’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Instil Bio may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer below for a reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.
INSTIL BIO, INC.
Reconciliation of GAAP to Non-GAAP Net Loss
(Unaudited; in thousands, except share and per share amounts)
| Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Net loss—GAAP | $ | (58,992 | ) | $ | (35,311 | ) | $ | (113,109 | ) | $ | (58,439 | ) | |||
| Adjustments: | |||||||||||||||
| Non-cash stock-based compensation expense | 8,323 | 5,745 | 15,816 | 8,557 | |||||||||||
| Net loss—Non-GAAP | $ | (50,669 | ) | $ | (29,566 | ) | $ | (97,293 | ) | $ | (49,882 | ) | |||
| Net loss per share, basic and diluted—GAAP | $ | (0.46 | ) | $ | (0.27 | ) | $ | (0.88 | ) | $ | (0.71 | ) | |||
| Adjustments: | |||||||||||||||
| Non-cash stock-based compensation expense per share | 0.06 | 0.04 | 0.12 | 0.10 | |||||||||||
| Net loss per share, basic and diluted—Non-GAAP | $ | (0.40 | ) | $ | (0.23 | ) | $ | (0.76 | ) | $ | (0.61 | ) | |||
| Weighted-average shares outstanding, basic and diluted | 129,367,833 | 128,743,123 | 129,244,334 | 82,478,284 | |||||||||||
About Instil Bio
Instil Bio, Inc. (Nasdaq: TIL) is a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer. Instil has assembled an accomplished management team with a successful track record in the development, manufacture, and commercialization of cell therapies. Using Instil’s proprietary, optimized, and scalable manufacturing processes at its in-house manufacturing facilities, Instil is advancing its lead TIL product candidate, ITIL-168, for the treatment of advanced melanoma and other solid tumors as well as ITIL-306, a next-generation, genetically-engineered TIL therapy using the CoStAR platform, for multiple solid tumors. For more information visit www.instilbio.com.