Instil Bio(US:TIL)2023-11-13 22:03Part I. Financial Information Item 1. Financial Statements (Unaudited) Unaudited consolidated financial statements, including balance sheets, operations, equity, cash flows, and notes, reflect a strategic restructuring for ITIL-306 Condensed Consolidated Balance Sheets | Metric | Sep 30, 2023 (in thousands) | Dec 31, 2022 (in thousands) | | :--- | :--- | :--- | | Total Assets | $340,272 | $482,128 | | Total Liabilities | $106,248 | $118,523 | | Total Stockholders' Equity | $234,024 | $363,605 | | Cash and Cash Equivalents | $9,133 | $43,716 | | Marketable Securities | $174,315 | $217,204 | Condensed Consolidated Statements of Operations and Comprehensive Loss | Metric | 3 Months Ended Sep 30, 2023 (in thousands) | 3 Months Ended Sep 30, 2022 (in thousands) | 9 Months Ended Sep 30, 2023 (in thousands) | 9 Months Ended Sep 30, 2022 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $8,492 | $39,660 | $37,621 | $120,334 | | General and administrative | $11,941 | $16,989 | $36,681 | $49,325 | | Restructuring and impairment charges | $46,283 | — | $71,847 | — | | Total operating expenses | $66,716 | $56,649 | $146,149 | $169,659 | | Loss from operations | $(66,716) | $(56,649) | $(146,149) | $(169,659) | | Net loss | $(67,432) | $(56,224) | $(143,162) | $(169,333) | | Net loss per share, basic and diluted | $(0.52) | $(0.43) | $(1.10) | $(1.31) | Condensed Consolidated Statements of Stockholders' Equity | Metric | Balance - Dec 31, 2022 (in thousands) | Balance - Sep 30, 2023 (in thousands) | | :--- | :--- | :--- | | Additional Paid-in Capital | $788,992 | $802,605 | | Accumulated Deficit | $(424,894) | $(568,056) | | Total Stockholders' Equity | $363,605 | $234,024 | - Stock-based compensation for the nine months ended September 30, 2023, was $13,613 thousand16 Condensed Consolidated Statements of Cash Flows | Cash Flow Activity (9 Months Ended Sep 30) | 2023 (in thousands) | 2022 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(68,648) | $(143,188) | | Net cash provided by investing activities | $27,178 | $81,739 | | Net cash provided by financing activities | $8,082 | $65,684 | | Net (decrease) increase in cash, cash equivalents, and restricted cash | $(33,388) | $4,235 | | Cash, cash equivalents and restricted cash—end of period | $10,146 | $41,618 | Notes to Condensed Consolidated Financial Statements - Instil Bio, Inc. is a clinical-stage biopharmaceutical company focused on developing an innovative cell therapy pipeline of autologous tumor infiltrating lymphocyte (TIL) therapies for the treatment of patients with cancer, with principal operations commencing in Q1 201926 - A restructuring plan was approved in December 2022 and expanded in January 2023, discontinuing the ITIL-168 program and prioritizing ITIL-306, transitioning clinical manufacturing and trial operations to the United Kingdom272875 - The company operates in a single operating segment32 | Asset Category (in thousands) | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Land | $31,243 | $31,243 | | Laboratory equipment | $7,936 | $19,050 | | Buildings | $23,198 | $32,778 | | Office and computer equipment | $818 | $4,969 | | Leasehold improvements | $1,365 | $4,340 | | Manufacturing equipment | $1,933 | $8,803 | | Vehicles | — | $64 | | Construction work-in-progress | $79,235 | $104,117 | | Total property, plant and equipment, net | $139,435 | $196,880 | - Impairment charges of $41.5 million for buildings and construction work-in-progress, and $4.6 million for assets held for sale, were recognized in Q3 2023 due to restructuring and strategic prioritization4748 | Accrued Liability (in thousands) | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Accrued construction costs | $60 | $12,359 | | Accrued compensation and benefits | $3,294 | $3,273 | | Accrued operational expenses | $1,387 | $2,203 | | Accrued restructuring costs | $3,188 | $5,434 | | Accrued research, development and clinical trial expenses | $1,773 | $3,827 | | Operating lease liabilities, current | $1,796 | $2,381 | | Other current liabilities | $324 | $592 | | Total accrued expenses and other current liabilities | $11,822 | $30,069 | - The outstanding principal amount under the construction loan was $82.8 million as of September 30, 2023, with the building substantially complete62 - Total restructuring and impairment charges for the nine months ended September 30, 2023, amounted to $71.8 million, primarily from asset impairments and employee termination benefits76 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and results of operations, highlighting significant operating losses, strategic reprioritization of clinical programs to focus on ITIL-306, and the impact of restructuring charges - The company is a clinical-stage biopharmaceutical company focused on developing autologous TIL therapies for cancer, utilizing its CoStAR platform for genetically engineered TILs83 - Net loss was $67.4 million for the three months and $143.2 million for the nine months ended September 30, 2023, with an accumulated deficit of $568.1 million90 - Cash, cash equivalents, restricted cash, and marketable securities totaled $184.5 million as of September 30, 2023, which is believed to be sufficient to fund operating expenses and capital expenditure requirements beyond 202690125128 - Research and development expenses decreased by $31.2 million (QoQ) and $82.7 million (YoY) due to reduced headcount and discontinuation of the ITIL-168 program, but are anticipated to increase as the ITIL-306-202 clinical trial progresses106114116117 - Restructuring and impairment charges totaled $46.3 million for the three months and $71.8 million for the nine months ended September 30, 2023, primarily due to the impairment of commercial and clinical buildings, assets held for sale, and right-of-use assets, as well as severance payments109111119[