Instil Bio(TIL) - 2022 Q4 - Annual Report

Part I Business Instil Bio is a clinical-stage biopharmaceutical company focused on developing autologous tumor-infiltrating lymphocyte (TIL) therapies, with a strategic shift in late 2022 to prioritize its CoStAR platform and consolidate operations to the UK - The company is a clinical-stage biopharmaceutical firm focused on developing autologous tumor-infiltrating lymphocyte (TIL) therapies for cancer[12] - A key strategic shift in December 2022 discontinued the ITIL-168 program to reallocate resources towards the ITIL-306 CoStAR platform and next-generation TIL technologies[25] - The lead product candidate, ITIL-306, is a genetically engineered CoStAR-TIL therapy targeting folate receptor alpha (FRα) expressed on numerous solid tumors[23] - A Phase 1 dose escalation trial for ITIL-306 was initiated in the U.S. in October 2022 for NSCLC, ovarian, and renal cancers, with a similar trial planned for the UK in 2023[12][23] - As part of a restructuring plan, the company reduced its US workforce by approximately 60% in Q1 2023 and consolidated operations to the United Kingdom[131][132] Risk Factors The company faces significant risks including substantial financial losses, high development uncertainties for novel clinical-stage products, complex manufacturing challenges, and potential Nasdaq delisting - The company reported significant net losses of $223.2 million in 2022 and $156.8 million in 2021, with an accumulated deficit of $424.9 million as of December 31, 2022[142] - All product candidates are in clinical or preclinical development, representing novel approaches with inherent uncertainties regarding development, market acceptance, and commercial potential[156][158] - Manufacturing of cell therapies is complex and has faced challenges, leading to a pause in clinical trial enrollment in October 2022 to analyze processes after decreased success rates for ITIL-168[162][166][233] - The company faces significant competition from other firms developing TIL, CAR-T, and TCR-T cell therapies, including Iovance Biotherapeutics, Adaptimmune Therapeutics, and subsidiaries of Bristol-Myers Squibb and Gilead[257] - On January 24, 2023, Nasdaq notified the company of non-compliance with the minimum bid price requirement of $1.00 per share, posing a risk of delisting[378] Unresolved Staff Comments The company reports no unresolved staff comments from the Securities and Exchange Commission - There are no unresolved staff comments[418] Properties The company operates manufacturing sites in Manchester, UK, and Tarzana, California, with headquarters in Dallas, Texas, and is evaluating monetization options for its Tarzana facility - The company owns a 128,097 sq. ft. clinical and commercial manufacturing facility in Tarzana, California, and operates a 13,596 sq. ft. manufacturing site in Manchester, United Kingdom[128][419] - The company is currently evaluating various monetization options for the Tarzana manufacturing facility, including a potential sale or lease, and subleasing other facilities[130][422] Legal Proceedings The company is not currently subject to any material legal proceedings - The company is not currently a party to any material legal proceedings[135][423] Mine Safety Disclosures This item is not applicable to the company - Not applicable[424] Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock has been listed on Nasdaq under "TIL" since March 2021, with no history or plans for cash dividends, retaining earnings for growth - Common stock is listed on the Nasdaq Global Select Market under the symbol "TIL" since March 19, 2021[427] - The company has never declared or paid cash dividends and does not plan to in the foreseeable future[429] Reserved This item is reserved Management's Discussion and Analysis of Financial Condition and Results of Operations The company's net loss increased to $223.2 million in 2022 due to higher expenses and a $23.2 million restructuring charge, with $260.9 million in cash expected to fund operations beyond 2026 Results of Operations (in thousands) | | Year Ended December 31, | Change | | :--- | :--- | :--- | | | 2022 | 2021 | $ | | Research and development | $141,056 | $107,251 | $33,805 | | General and administrative | $62,235 | $48,309 | $13,926 | | Restructuring and impairment charges | $23,167 | $— | $23,167 | | Total operating expenses | $226,458 | $155,560 | $70,898 | | Loss from operations | ($226,458) | ($155,560) | ($70,898) | | Net loss | ($223,177) | ($156,794) | ($66,383) | - The increase in R&D expenses by $33.8 million in 2022 was due to higher headcount costs ($14.0 million), increased clinical development and manufacturing activities ($8.2 million), and higher facility and overhead expenses ($11.6 million)[459] - Restructuring and impairment charges of $23.2 million in 2022 resulted from strategic reprioritization, including a $15.8 million goodwill and IPR&D impairment charge, $3.0 million in severance costs, and $2.4 million in contract termination fees[462][464] - As of December 31, 2022, the company had $260.9 million in cash, cash equivalents, and marketable securities, which management believes is sufficient to fund operations beyond 2026[467][471] Cash Flow Summary (in thousands) | | Years Ended December 31, | | :--- | :--- | | | 2022 | 2021 | | Cash used in operating activities | $(180,164) | $(122,138) | | Cash provided by (used in) investing activities | $114,541 | $(474,396) | | Cash provided by financing activities | $71,886 | $393,164 | Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk is interest rate fluctuations on its $260.9 million in cash and marketable securities, with a hypothetical 1% change not expected to materially impact financial statements - The company's main market risk is interest rate risk on its $260.9 million of cash, cash equivalents, and marketable securities[509] - A hypothetical 1% change in interest rates is not expected to have a material impact on the company's financial statements, partly due to an interest rate swap[510] Financial Statements and Supplementary Data This section presents the company's audited consolidated financial statements for 2021 and 2022, reflecting significant operating losses, no revenue, and reliance on financing as a clinical-stage entity Consolidated Balance Sheet Highlights (in thousands) | | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $43,716 | $37,590 | | Marketable securities | $217,204 | $416,509 | | Property, plant and equipment, net | $196,880 | $121,999 | | Total Assets | $482,128 | $609,983 | | Liabilities & Equity | | | | Loan payable | $72,350 | $— | | Total Liabilities | $118,523 | $54,784 | | Total Stockholders' Equity | $363,605 | $555,199 | Consolidated Statement of Operations Highlights (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Research and development | $141,056 | $107,251 | | General and administrative | $62,235 | $48,309 | | Restructuring and impairment charges | $23,167 | $— | | Loss from operations | ($226,458) | ($155,560) | | Net loss | ($223,177) | ($156,794) | | Net loss per share | ($1.72) | ($1.48) | - In December 2022, the company recognized a non-cash impairment charge of $15.8 million due to the discontinuation of the ITIL-168 program and stock price decline, comprising $10.1 million for IPR&D and $5.7 million for goodwill[498][500][590] - The company recorded total restructuring and impairment charges of $23.2 million in 2022, including asset impairments ($17.7 million), one-time employee termination benefits ($3.0 million), and contract terminations ($2.4 million)[645] Changes in and Disagreements With Accountants on Accounting and Financial Disclosure The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None reported[651] Controls and Procedures Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2022, with no material changes reported - Management concluded that as of December 31, 2022, the company's disclosure controls and procedures were effective[651] - Management's assessment concluded that internal control over financial reporting was effective as of December 31, 2022[653] Other Information The company reports no other information for this item - None reported[657] Disclosure Regarding Foreign Jurisdictions that Prevent Inspections This item is not applicable to the company - None reported[658] Part III Directors, Executive Officers and Corporate Governance Information on directors, executive officers, and corporate governance is incorporated by reference from the company's 2023 definitive proxy statement - Information is incorporated by reference from the registrant's definitive proxy statement for the 2023 Annual Meeting of Stockholders[660] Executive Compensation Information regarding executive and director compensation is incorporated by reference from the company's 2023 definitive proxy statement - Information is incorporated by reference from the 2023 Proxy Statement[662] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information on security ownership by beneficial owners and management, and equity compensation plans, is incorporated by reference from the company's 2023 definitive proxy statement - Information is incorporated by reference from the 2023 Proxy Statement[663] Certain Relationships and Related Transactions, and Director Independence Information regarding related party transactions and director independence is incorporated by reference from the company's 2023 definitive proxy statement - Information is incorporated by reference from the 2023 Proxy Statement[664] Principal Accountant Fees and Services Information regarding fees paid to and services provided by the principal accountant is incorporated by reference from the company's 2023 definitive proxy statement - Information is incorporated by reference from the 2023 Proxy Statement[665] Part IV Exhibits, Financial Statement Schedules This section lists financial statements from Item 8, notes the omission of schedules, and provides an index of exhibits filed or incorporated by reference - This section contains the index of exhibits filed with the Form 10-K[671] Form 10-K Summary The company did not provide a summary for this item - None provided[678]