Lyell(LYEL) - 2024 Q1 - Quarterly Report

Special Note Regarding Forward-Looking Statements This section outlines the report's forward-looking statements and associated risks that may cause actual results to differ - The report contains forward-looking statements regarding future financial position, business strategy, product candidates, clinical trials, R&D costs, regulatory approvals, and commercialization plans[9][12] - Key forward-looking statements include the sufficiency of cash to fund operations, accuracy of expense estimates, scope and results of product candidate development (LYL797, LYL845, LYL119), timing of regulatory approvals, commercialization plans, market opportunities, reliance on third parties, and intellectual property protection[10][14] PART I—FINANCIAL INFORMATION This part presents the company's unaudited financial statements and management's analysis of financial condition and operational results Item 1. Financial Statements (unaudited) This item presents the unaudited condensed consolidated financial statements and their accompanying notes Condensed Consolidated Balance Sheets Condensed Consolidated Balance Sheet (in thousands): | Metric | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $125,650 | $145,647 | | Marketable securities (current) | $400,650 | $400,576 | | Marketable securities (non-current) | $— | $16,506 | | Total current assets | $534,165 | $554,686 | | Total assets | $694,220 | $750,029 | | Total current liabilities | $32,353 | $34,519 | | Total liabilities | $91,063 | $95,077 | | Total stockholders' equity | $603,157 | $654,952 | - Total assets decreased by $55.8 million from $750.0 million at December 31, 2023, to $694.2 million at March 31, 2024, primarily due to a reduction in cash and cash equivalents and non-current marketable securities[17] Condensed Consolidated Statements of Operations and Comprehensive Loss Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands): | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Revenue | $3 | $65 | | Research and development expenses | $43,174 | $44,630 | | General and administrative expenses | $13,494 | $19,279 | | Total operating expenses | $55,578 | $62,621 | | Loss from operations | $(55,575) | $(62,556) | | Interest income, net | $6,819 | $4,497 | | Impairment of other investments | $(13,001) | $(10,000) | | Net loss | $(60,667) | $(66,959) | | Net loss per common share, basic and diluted | $(0.24) | $(0.27) | - Net loss improved by $6.3 million, from $(66.9) million in Q1 2023 to $(60.7) million in Q1 2024, primarily due to reduced operating expenses and higher interest income, despite increased impairment of other investments[19] Condensed Consolidated Statements of Stockholders' Equity Condensed Consolidated Statements of Stockholders' Equity (in thousands): | Metric | Balance as of Dec 31, 2023 | Issuance of common stock upon exercise of stock options | Issuance of common stock in connection with restricted stock units, net of tax | Stock-based compensation | Other comprehensive income | Net loss | Balance as of Mar 31, 2024 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Common Stock (Shares) | 253,958 | 869 | 100 | — | — | — | 254,927 | | Common Stock (Amount) | $25 | $— | $— | $— | $— | $— | $25 | | Additional Paid-in Capital | $1,657,133 | $103 | $(76) | $9,155 | $— | $— | $1,666,315 | | Accumulated Other Comprehensive Loss | $(94) | $— | $— | $— | $(310) | $— | $(404) | | Accumulated Deficit | $(1,002,112) | $— | $— | $— | $— | $(60,667) | $(1,062,779) | | Total Stockholders' Equity | $654,952 | $103 | $(76) | $9,155 | $(310) | $(60,667) | $603,157 | - Total stockholders' equity decreased by $51.8 million from $654.9 million at December 31, 2023, to $603.2 million at March 31, 2024, primarily due to the net loss incurred and accumulated other comprehensive loss[22] Condensed Consolidated Statements of Cash Flows Condensed Consolidated Statements of Cash Flows (in thousands): | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(42,016) | $(46,212) | | Net cash provided by investing activities | $21,994 | $32,154 | | Net cash provided by (used in) financing activities | $27 | $(69) | | Net decrease in cash, cash equivalents and restricted cash | $(19,995) | $(14,127) | | Cash, cash equivalents and restricted cash at end of period | $125,936 | $109,707 | - Net cash used in operating activities improved by $4.2 million, from $(46.2) million in Q1 2023 to $(42.0) million in Q1 2024[27] - Overall cash, cash equivalents, and restricted cash decreased by $20.0 million in Q1 2024, compared to a $14.1 million decrease in Q1 2023[27] Notes to Unaudited Condensed Consolidated Financial Statements Note 1. Organization - Lyell Immunopharma, Inc is a clinical-stage cell therapy company developing product candidates for solid tumors using proprietary ex vivo genetic and epigenetic T-cell reprogramming technologies[30] - Primary activities include T-cell therapy development, R&D, technology acquisition, strategic collaborations, manufacturing, business planning, intellectual property, regulatory submissions, clinical trials, and capital raising[30] Note 2. Summary of Significant Accounting Policies - Financial statements are prepared in accordance with U.S. GAAP and include the company and its wholly-owned subsidiary[31] - The company believes its available cash, cash equivalents, and marketable securities as of March 31, 2024, will fund operations for at least the next 12 months[34] - No material changes to significant accounting policies from the 2023 Annual Report on Form 10-K, except for the stock-based compensation policy for performance-based restricted stock units (PSUs)[38] Note 3. License, Collaboration and Success Payment Agreements - The company has license and collaboration agreements with Fred Hutchinson Cancer Center and Stanford, involving annual maintenance payments and research funding[45][47][51][54] Aggregate Potential Success Payments (in millions) Aggregate Potential Success Payments (in millions): | Multiple of initial equity value at issuance | 10x | 20x | 30x | 40x | 50x | | :--- | :--- | :--- | :--- | :--- | :--- | | Per share common stock price required for payment | $18.29 | $36.58 | $54.86 | $73.15 | $91.44 | | Aggregate success payment(s) | $10 | $40 | $90 | $140 | $200 | - As of March 31, 2024, no success payments have been incurred as the common stock fair value was below the required thresholds[49][56] Note 4. Cash Equivalents and Marketable Securities Cash Equivalents and Fixed Income Marketable Securities (in thousands) Cash Equivalents and Fixed Income Marketable Securities (in thousands): | Security Type | March 31, 2024 Fair Value | December 31, 2023 Fair Value | | :--- | :--- | :--- | | Money market funds | $50,808 | $62,075 | | U.S. Treasury securities | $343,194 | $374,356 | | U.S. government agency securities | $38,427 | $48,750 | | Corporate debt securities | $68,682 | $59,606 | | Total | $501,111 | $544,787 | - As of March 31, 2024, the fair value of cash equivalents and fixed income marketable securities was $501.1 million, down from $544.8 million at December 31, 2023[59] - Most securities were in an unrealized loss position, but the company does not intend to sell them before recovery of amortized cost, and no material change in credit risk was determined[59] Note 5. Other Investments Other Investments (in thousands) Other Investments (in thousands): | Metric | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Aggregate carrying amount of strategic investments | $19,000 | $32,000 | | Cumulative impairments of strategic investments | $23,000 | $15,000 | - Impairment expense of $13.0 million was recorded for the three months ended March 31, 2024, and $10.0 million for the same period in 2023, due to the full impairment of one investment in each period[62] - Impairment indicators included anticipated funding not secured within expected timeframe and underlying companies' inability to raise funds[62] Note 6. Fair Value Measurements Fair Value Measurements (in thousands) - March 31, 2024 Fair Value Measurements (in thousands) - March 31, 2024: | Financial Assets | Level 1 | Level 2 | Level 3 | Total | | :--- | :--- | :--- | :--- | :--- | | Money market funds | $50,808 | $— | $— | $50,808 | | U.S. Treasury securities | $— | $343,194 | $— | $343,194 | | U.S. government agency securities | $— | $38,427 | $— | $38,427 | | Corporate debt securities | $— | $68,682 | $— | $68,682 | | Marketable equity securities | $1,535 | $— | $— | $1,535 | | Total financial assets | $52,343 | $450,303 | $— | $502,646 | | Financial Liabilities | | | | | | Success payment liabilities | $— | $— | $2,544 | $2,544 | | Total financial liabilities | $— | $— | $2,544 | $2,544 | - Success payment liabilities are Level 3 financial instruments, estimated using Monte Carlo simulations (through Dec 31, 2023) and management's historical experience of correlation to stock price (as of Mar 31, 2024)[66] - A small change in common stock valuation can significantly impact the estimated fair value of success payment liabilities[68] Note 7. Leases - The company's lease portfolio consists of operating leases for laboratory, office, and manufacturing facilities in California and Washington, with terms expiring between December 2028 and March 2031[69] Future Minimum Operating Lease Commitments (in thousands) as of March 31, 2024 Future Minimum Operating Lease Commitments (in thousands) as of March 31, 2024: | Year | Amount | | :--- | :--- | | 2024 (remaining nine months) | $8,688 | | 2025 | $11,859 | | 2026 | $12,209 | | 2027 | $12,569 | | 2028 | $12,940 | | Thereafter | $22,585 | | Total undiscounted lease payments | $80,850 | | Less: imputed interest | $(19,024) | | Total operating lease liabilities | $61,826 | - Operating lease costs were $2.3 million for the three months ended March 31, 2024, up from $2.1 million in the prior year[70] Note 8. Stockholders' Equity - As of March 31, 2024, there were 254,926,880 shares of common stock outstanding, an increase from 253,957,709 shares at December 31, 2023[77] - The company is authorized to issue 10.0 million shares of preferred stock and 500.0 million shares of common stock; no preferred stock was outstanding[76][77] - In February 2024, the company entered a sales agreement to offer and sell up to $150.0 million of common stock via at-the-market offerings, but no sales have been made yet[78] Note 9. Stock-based Compensation Stock-based Compensation Expense (in thousands) Stock-based Compensation Expense (in thousands): | Classification | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $3,792 | $4,612 | | General and administrative | $5,363 | $9,270 | | Total | $9,155 | $13,882 | - Total stock-based compensation expense decreased by $4.7 million, from $13.9 million in Q1 2023 to $9.2 million in Q1 2024, primarily due to significant awards being fully expensed in prior periods and a decrease in headcount[85][131] - In November 2023, the company repriced 23.4 million stock options for 200 grantees to an exercise price of $1.87 per share, resulting in $8.9 million in incremental stock-based compensation expense[86] Note 10. Net Loss Per Share Net Loss Per Common Share Net Loss Per Common Share: | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net loss per common share, basic and diluted | $(0.24) | $(0.27) | | Weighted-average shares used (basic and diluted) | 254,252 | 249,591 | - Potentially dilutive shares (unvested RSUs, PSUs, and stock options) were excluded from diluted net loss per share calculations in all periods due to their anti-dilutive effects[92] Note 11. Commitments and Contingencies - The company has license and collaboration agreements with third parties that include potential future milestone and royalty payments upon achievement of pre-established developmental, regulatory, and/or commercial milestones[93] - These future potential payments are inherently uncertain, and no amounts had been recorded for them as of March 31, 2024, and December 31, 2023[93] Note 12. Related-party Transactions - The company has a sublease agreement with Sonoma Biotherapeutics, Inc, a related party with common stockholders and board seats, for approximately 18,000 square feet of space[94] Sonoma Related-Party Income (in thousands) Sonoma Related-Party Income (in thousands): | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Sonoma other operating income, net | $807 | $669 | | Sonoma sublease income | $465 | $465 | Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on financial condition, operational results, and future outlook Overview - Lyell Immunopharma is a clinical-stage cell therapy company developing product candidates for solid tumors using proprietary ex vivo genetic and epigenetic T-cell reprogramming technologies[97] - The company's technologies aim to generate T cells with enhanced persistence, self-renewal, and durable tumor cytotoxicity to address T-cell exhaustion and lack of durable stemness in solid tumors[97] - Lead product candidates LYL797 (ROR1-targeted CAR T-cell) and LYL845 (TIL) are in Phase 1 clinical development, while LYL119 (ROR1-targeted CAR T-cell) and a second-generation TIL are in preclinical development[98] Pipeline Programs and Operational Updates - Lyell is advancing four wholly-owned product candidates: LYL797 (ROR1-targeted CAR T-cell) and LYL845 (TIL) in Phase 1 clinical development, and LYL119 (ROR1-targeted CAR T-cell) and a second-generation TIL in preclinical development[99] - LYL797, targeting ROR1-positive TNBC and NSCLC, is expected to have initial data from at least 20 patients in 1H24[100][102] - LYL845, an autologous TIL therapy for advanced melanoma, NSCLC, and CRC, received Orphan Drug Designation for melanoma, with initial clinical data expected in 2H24[101][103][107] - LYL119, a ROR1-targeted CAR T-cell product enhanced with four reprogramming technologies, is expected to have an IND application submitted in 1H24, showing enhanced cytotoxicity and reduced exhaustion in preclinical data[104][108] Our Manufacturing Capabilities - The company operates the LyFE Manufacturing Center in Bothell, Washington (73,000 sq ft), designed for cGMP compliance and flexible production of CAR T-cell, TIL, TCR T-cell, and cGMP viral vectors[111] - The facility currently produces clinical supply for Phase 1 trials and is expected to manufacture approximately 500 infusions per year at full capacity and staffing[112] - Lyell is evaluating third-party manufacturing options, such as a collaboration with Cellares for CAR T-cell manufacturing, and advancing its Epi-R P2 protocol to shorten TIL product delivery time[112] Macroeconomic Environment - Global macroeconomic challenges, including geopolitical conflicts, inflation, interest rate fluctuations, banking instability, and supply constraints, may negatively impact the company's business and operations[113] - Economic uncertainty is expected to persist in 2024, potentially affecting manufacturing suppliers, collaborators, CROs, and employees[113] Components of Results of Operations - The company has no products approved for sale and has never generated revenue from product sales, expecting future revenue from collaborations, licensing, or product sales[115] - Research and development expenses, a significant portion of operating expenses, include costs for discovery, development, collaborations, licensing, personnel, facilities, and research activities, and are expected to increase in the foreseeable future[116][120] - General and administrative costs include personnel, legal, finance, accounting, and public company operating expenses, which are anticipated to increase[122][123] Results of Operations Summary of Results of Operations (in thousands) Summary of Results of Operations (in thousands): | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Revenue | $3 | $65 | | Total operating expenses | $55,578 | $62,621 | | Loss from operations | $(55,575) | $(62,556) | | Interest income, net | $6,819 | $4,497 | | Impairment of other investments | $(13,001) | $(10,000) | | Net loss | $(60,667) | $(66,959) | - Net loss improved by $6.3 million, from $(67.0) million in Q1 2023 to $(60.7) million in Q1 2024, driven by a $7.0 million decrease in total operating expenses and higher interest income[128] Research and Development Expenses Research and Development Expenses Components (in thousands) Research and Development Expenses Components (in thousands): | Component | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Personnel | $16,474 | $19,644 | | Facilities and technology | $12,897 | $13,138 | | Research activities, collaborations and outside services | $13,278 | $12,456 | | Success payments | $525 | $(608) | | Total R&D expenses | $43,174 | $44,630 | - R&D expenses decreased by $1.5 million to $43.2 million in Q1 2024, primarily due to a $3.2 million reduction in personnel-related expenses from a November 2023 workforce reduction[130] - This decrease was partially offset by a $1.1 million increase in success payment liabilities and an $0.8 million increase in research activities, collaborations, and outside services, mainly due to clinical trials[130] General and Administrative Expenses General and Administrative Expenses (in thousands) General and Administrative Expenses (in thousands): | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | General and administrative expenses | $13,494 | $19,279 | - G&A expenses decreased by $5.8 million to $13.5 million in Q1 2024, primarily due to a $4.7 million reduction in personnel costs, including a $3.9 million decrease in stock-based compensation and an $0.8 million decrease from the November 2023 workforce reduction[131] Other Operating Income, Net Other Operating Income, Net (in thousands) Other Operating Income, Net (in thousands): | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Other operating income, net | $(1,090) | $(1,288) | - Other operating income, net, was $1.1 million in Q1 2024, a slight decrease from $1.3 million in Q1 2023, primarily consisting of service and occupancy fees from subleases[124][132] Interest Income, Net Interest Income, Net (in thousands) Interest Income, Net (in thousands): | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Interest income, net | $6,819 | $4,497 | - Interest income, net, increased by $2.3 million to $6.8 million in Q1 2024, primarily driven by higher interest rates[133] Other Income, Net Other Income, Net (in thousands) Other Income, Net (in thousands): | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Other income, net | $1,090 | $1,100 | - Other income, net, remained stable at $1.1 million for both Q1 2024 and Q1 2023, primarily reflecting changes in the fair value of success payment liabilities to Fred Hutch and adjustments to marketable equity securities (for 2024)[134] Impairment of Other Investments Impairment of Other Investments (in thousands) Impairment of Other Investments (in thousands): | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Impairment of other investments | $(13,001) | $(10,000) | - Impairment of other investments increased to $13.0 million in Q1 2024 from $10.0 million in Q1 2023, representing the full impairment of one investment in each period due to funding issues[135][62] Liquidity and Capital Resources - As of March 31, 2024, the company had $526.3 million in cash, cash equivalents, and marketable securities[136] - The company has incurred significant operating losses since inception and expects to continue incurring losses for the foreseeable future[136][138] - Existing cash, cash equivalents, and marketable securities are believed to be sufficient to fund operations into 2027[138] - Additional capital will be required in the future to fund operations, including product development and commercialization, potentially through equity/debt financings or strategic collaborations[138][140] Material Cash Requirements - Material cash requirements as of March 31, 2024, include salaries and benefits, clinical trial administration, research, manufacturing improvements, technology and facility support, operating lease obligations, and payments for collaborative agreements[141] Cash Flows Summary of Cash Flows (in thousands) Summary of Cash Flows (in thousands): | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(42,016) | $(46,212) | | Net cash provided by investing activities | $21,994 | $32,154 | | Net cash provided by (used in) financing activities | $27 | $(69) | | Net decrease in cash, cash equivalents and restricted cash | $(19,995) | $(14,127) | - Net cash used in operating activities was $42.0 million in Q1 2024, an improvement from $46.2 million in Q1 2023[142] Operating Activities - Net cash used in operating activities was $42.0 million in Q1 2024, reflecting a net loss of $60.7 million, partially offset by non-cash items such as $13.0 million impairment of other investments and $9.2 million stock-based compensation expense[143] - The decrease in cash used in operating activities compared to Q1 2023 ($46.2 million) was also influenced by a $3.2 million decrease in net operating assets and liabilities in Q1 2024[143][144] Investing Activities - Cash provided by investing activities was $22.0 million in Q1 2024, consisting of net maturities and purchases of marketable securities[145] - In Q1 2023, cash provided by investing activities was $32.2 million, primarily from net maturities and purchases of marketable securities ($33.7 million) offset by purchases of property and equipment ($1.5 million)[145] Financing Activities - Cash provided by financing activities was approximately zero in Q1 2024, with $0.1 million from stock option exercises offset by $0.1 million in taxes paid for equity award settlements[146] - In Q1 2023, cash used in financing activities was $0.1 million, consisting of taxes paid related to net share settlement of equity awards[146] Off-Balance Sheet Arrangements - The company has not had any off-balance sheet arrangements since its inception[147] Critical Accounting Policies and Significant Judgments and Estimates - Financial statements are prepared in accordance with GAAP, requiring management judgments, estimates, and assumptions[148] - No material changes to critical accounting policies and estimates from the 2023 Annual Report, except for the stock-based compensation policy for performance-based restricted stock units[149] Item 3. Quantitative and Qualitative Disclosures About Market Risk This item discusses the company's exposure to market risks, primarily interest rate, currency, and inflation sensitivities Interest Rate Risk - As of March 31, 2024, the company had $102.0 million in cash equivalents and $399.1 million in fixed income marketable securities, primarily short-term[151] - The company's exposure to interest rate risk is not significant, and a hypothetical 10% change in interest rates would not materially affect its financial statements[151] Foreign Currency Exchange Risk - The company is not currently exposed to significant foreign currency exchange risk, as all employees and operations are in the U.S, and expenses are primarily in U.S dollars[152] - Foreign currency transaction gains and losses have not been material, and a hypothetical 10% change in exchange rates would not have a material effect on financial statements[152] Effects of Inflation - Inflation affects the company by increasing labor and clinical trial costs[153] - The company believes inflation has not had a material effect on its financial statements[153] Item 4. Controls and Procedures This item reports on the effectiveness of the company's disclosure controls and procedures and changes in internal control over financial reporting Evaluation of Disclosure Controls and Procedures - As of March 31, 2024, the company's disclosure controls and procedures were evaluated by management, with CEO and CFO participation, and concluded to be effective at a reasonable assurance level[154][155] Changes in Internal Control over Financial Reporting - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2024[156] PART II—OTHER INFORMATION This part covers legal proceedings, risk factors, equity sales, and other required disclosures Item 1. Legal Proceedings The company is not currently party to any material legal proceedings or aware of any contemplated by a government authority - The company is not currently party to any material legal proceedings or aware of any contemplated by a government authority[158] - Any future legal proceedings or claims could be costly, divert management attention, and adversely impact the business, with no assurance of favorable outcomes[159] Item 1A. Risk Factors This section details significant risks that could harm the company's business, financial condition, and growth prospects Summary of Risk Factors - The company is an early clinical-stage biopharmaceutical company with substantial losses and anticipates continued losses, requiring significant additional capital[162][165][166] - Risks include the difficulty in evaluating business success due to limited operating history, unproven novel technologies, and the uncertainty of achieving profitability or generating product sales revenue[162][167][170] - Operational risks involve manufacturing complexities, reliance on third parties for R&D and manufacturing, substantial competition, and heightened regulatory scrutiny for novel cellular therapies[162][182][204][219][240][245] Risks Related to Our Financial Condition, Limited Operating History and Need for Additional Capital - The company is an early clinical-stage biopharmaceutical company with a limited operating history (since June 2018) and has incurred substantial net losses since inception, expecting these losses to increase as R&D and manufacturing efforts expand[165][166][167] - The company has no products approved for sale and has never generated revenue from product sales, with profitability dependent on successful development, regulatory approval, and commercialization of product candidates[170][171] - Substantial additional capital will be required to achieve goals, and failure to obtain it could force delays or termination of product development or commercialization efforts[172][175] Risks Related to Our Business and Industry - The company is early in R&D, with product candidates based on novel, unproven technologies, making it difficult to predict development time, cost, and regulatory approval[180][182] - High dependence on attracting and retaining highly qualified managerial, scientific, and medical personnel; a November 2023 workforce reduction of approximately 25% may lead to unintended consequences like difficulty retaining employees and loss of expertise[184][186][187] - The company lacks marketing, sales, and distribution infrastructure, and establishing or outsourcing this function carries substantial risks, potentially leading to lower product revenue or commercialization failure[191][192] - Unstable market and economic conditions, including geopolitical conflicts, inflation, and banking instability, may seriously affect the business, financial condition, and stock price, potentially hindering financing or operations[193][195][198] Risks Related to Manufacturing - The company's sole clinical manufacturing facility in Bothell, Washington, is subject to delays in qualification, regulatory approvals, and capacity expansion, which could limit development activities[199][200] - Manufacturing cellular therapies is complex and susceptible to product loss due to low cell viability, contamination, equipment failure, or operator error, potentially increasing costs and delaying programs[204][205][207] - Reliance on third-party manufacturers introduces risks of non-compliance with cGMP regulations, inability to meet specifications, and potential delays or termination of agreements, impacting development and commercialization[212][213][215] Risks Related to Our Dependence on Third Parties - The company relies on third parties (CROs, medical institutions, clinical investigators) to conduct research and clinical trials, and their failure to perform or comply with regulations could delay or terminate development[219][221][222] - Collaborators have significant discretion and may not commit sufficient resources, pursue development, or maintain intellectual property rights, leading to potential disputes, delays, or termination of agreements[227][228] - Dependence on patient enrollment and retention in clinical trials is critical; delays due to patient population size, eligibility criteria, competition, or adverse events could materially affect R&D efforts[234][235][239] Risks Related to Regulation and Legal Compliance - Future success depends on obtaining regulatory approval for novel cellular therapy product candidates, a lengthy, expensive, and unpredictable process with heightened scrutiny due to limited FDA experience in this field[241][243][245][266] - Product candidates may cause undesirable side effects, leading to clinical trial delays/halts, restrictive labels, or denial of regulatory approval, and post-approval issues could result in market withdrawal or significant negative consequences[258][259][260][261] - Changes in healthcare policies, laws, and regulations (e.g, ACA, IRA, drug pricing initiatives) may impact the ability to obtain approval or commercialize products, and failure to obtain adequate coverage and reimbursement could limit market access[291][292][294][296] - The company is subject to stringent data privacy and security laws (HIPAA, CCPA, GDPR), and non-compliance or security incidents could lead to regulatory actions, litigation, fines, business disruptions, and reputational harm[299][301][303][306] Risks Relating to Our Intellectual Property - Inability to obtain and maintain sufficient intellectual property protection (patents, trademarks, trade secrets) for product candidates, or if the scope is not broad enough, could adversely affect commercialization and competitive position[307][308][309] - Lawsuits for infringing or misappropriating third-party intellectual property could be costly, time-consuming, and delay development, potentially requiring licenses on unfavorable terms or cessation of activities[320][322][324] - Intellectual property from government-funded programs may be subject to 'march-in' rights (e.g, related to drug pricing) and U.S-based manufacturing preferences, potentially limiting exclusive rights[331] Risks Related to Ownership of Our Common Stock - Delaware law and provisions in the company's charter and bylaws may discourage, delay, or prevent changes in control or management, potentially depressing the common stock trading price[341][342][343] - The market price of common stock has been and may continue to be volatile due to factors like clinical trial results, competitive products, regulatory developments, key personnel changes, and macroeconomic conditions[349][350] - Sales of a substantial number of shares by existing stockholders or future capital raising efforts (including through the $150 million at-the-market offering) could cause dilution to existing stockholders and depress the stock price[353][355] General Risk Factors - Disclosure controls and procedures, no matter how well-designed, can only provide reasonable assurance and may not prevent or detect all errors or acts of fraud[348] - Changes in tax laws or regulations, such as the Tax Cuts and Jobs Act of 2017 (Tax Act) and the Inflation Reduction Act of 2022 (IRA), could adversely affect the business, cash flow, and financial performance[358] - Compromises to information technology systems or data, whether internal or via third parties, could lead to regulatory investigations, litigation, fines, business disruptions, and reputational harm[360][361][363] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This item states that there were no unregistered sales of equity securities or use of proceeds during the reporting period - No unregistered sales of equity securities or use of proceeds occurred during the first quarter of 2024[367] Item 3. Defaults Upon Senior Securities This item states that it is not applicable to the company - This item is not applicable[368] Item 4. Mine Safety Disclosures This item states that it is not applicable to the company - This item is not applicable[369] Item 5. Other Information This item reports that no directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement during Q1 2024 - No directors or executive officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q1 2024[370] Item 6. Exhibits This item lists the exhibits filed with the Quarterly Report on Form 10-Q - The report includes various exhibits, such as certifications of principal executive and financial officers, and XBRL instance documents[373][374] Signature This section contains the official signature authenticating the report - The report was signed by Charles Newton, Chief Financial Officer, on behalf of Lyell Immunopharma, Inc on May 6, 2024[378]