UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 12, 2022
(Exact name of registrant as specified in its Charter)
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||||
(972 ) 499-3350
(Registrant’s Telephone Number, Including Area Code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 12, 2022, Instil Bio, Inc. (the “Company”) provided a corporate update and announced its financial results for the quarter ended June 30, 2022 in the press release attached hereto as Exhibit 99.1, which is incorporated herein by reference.
The information in this Item 2.02, including the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
| (d) | Exhibits | ||||
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 104 | The cover page of this report has been formatted in Inline XBRL. | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Instil Bio, Inc. | ||||||||||||||||||||
Dated: August 12, 2022 | By: | /s/ Sandeep Laumas, M.D. | ||||||||||||||||||
| Sandeep Laumas, M.D. | ||||||||||||||||||||
| Chief Financial Officer and Chief Business Officer (Principal Financial Officer and Principal Accounting Officer) | ||||||||||||||||||||
Instil Bio Reports Second Quarter 2022 Financial Results and
Provides Corporate Update
Cash runway expected to extend from 2024 into 2025 upon completion of anticipated sale-leaseback of Tarzana, CA manufacturing site
DELTA-1 trial of ITIL-168 in advanced melanoma with registrational intent anticipated to complete enrollment in 1H 2023 with top-line clinical data expected in early 2024
Phase 1 study initiated for ITIL-306, Instil’s first CoStAR-TIL product candidate
Phase 1 study initiated for ITIL-168 in combination with pembrolizumab (DELTA-2) for NSCLC, cervical cancer, and squamous cell carcinoma of the head and neck
DALLAS, TX, August 12, 2022 (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 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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “future,” “intends,” “potential,” “projects,” and “will” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the potential of our product candidates to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the timing of our ongoing and potential future clinical trials and studies and the availability of data therefrom, including our expectations concerning the completion of enrollment in our DELTA-1 clinical trial, the availability of top-line data from our DELTA-1 clinical trial, the potential for us to make submissions concerning, and for our product candidates to receive, regulatory approval from the FDA or equivalent
foreign regulatory agencies and whether, if approved, these product candidates will be successfully distributed and marketed, our expanded clinical manufacturing capabilities, the anticipated sale-leaseback of our Tarzana, CA manufacturing facility, our cash runway, and other statements that are not historical fact. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements, including risks and uncertainties associated with the costly and time-consuming cell therapy product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating, enrolling, reporting data from or completing clinical studies, as well as the risks that results obtained in clinical trials to date may not be indicative of results obtained in ongoing or future trials and that Instil’s product candidates may otherwise not be effective treatments in their planned indications; the ongoing COVID-19 pandemic, which could materially and adversely affect Instil’s business and operations, including Instil’s ability to timely initiate, enroll and complete its ongoing and future clinical trials; the time-consuming and uncertain regulatory approval process; risks inherent in manufacturing and testing of cell therapy products; the sufficiency of Instil’s cash resources, and other risks and uncertainties affecting Instil and its development programs, including those discussed in the section titled “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 available on the SEC’s website at www.sec.gov, and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 to be filed with the SEC. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.
Contacts:
Janhavi Mohite Stern Investor Relations 1-212-362-1200 janhavi.mohite@sternir.com | Investor Relations 1-972-499-3350 investorrelations@instilbio.com www.instilbio.com | ||||
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