Core Viewpoint - Lyell Immunopharma, Inc. has announced a private placement agreement for gross proceeds of up to approximately $100 million to advance its CAR T-cell therapies for cancer patients [1] Group 1: Private Placement Details - The initial closing of approximately $50 million of common stock is expected to occur at a price of $13.32 per share [2] - The company has the option to require investors to purchase an additional $50 million of common stock or pre-funded warrants upon achieving specific clinical or corporate milestones within 12 months [3] - Investors can also purchase the same dollar amount of common stock at a price of $30.73 before the Milestone Closing [4] Group 2: Ownership and Securities - If an investor's purchase would result in owning more than 19.99% of Lyell's shares, they will instead buy pre-funded warrants at a price equivalent to the common stock [5] - The securities are being offered in a private transaction and have not been registered under the Securities Act, limiting their resale in the U.S. [7] Group 3: Use of Proceeds - Net proceeds from the private placement will be used to fund pivotal-stage clinical trials of LYL314 and for general corporate purposes [6] - The funding is expected to support operations into mid-2027, including a Biologics License Application for LYL314 targeting large B-cell lymphoma [6] Group 4: Company Overview - Lyell Immunopharma is focused on next-generation CAR T-cell therapies for hematologic malignancies and solid tumors [9] - The lead product candidate, LYL314, is designed to improve response rates compared to existing therapies for large B-cell lymphoma [10]

Group 1 - Lyell Immunopharma (NASDAQ: LYEL) has made significant progress with its CD19/CD20 CAR-T cell therapy targeting patients with aggressive 3rd-line + Large B-Cell Lymphoma (LBCL) [2] - The company is part of the Biotech Analysis Central service, which provides in-depth analysis of various pharmaceutical companies [2] Group 2 - The Biotech Analysis Central service includes a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2] - The service is available for $49 per month, with a yearly plan offering a 33.50% discount at $399 per year [1]

Summary of Lyell Immunopharma (LYEL) Conference Call - June 25, 2025 Company Overview - **Company**: Lyell Immunopharma - **Focus**: Development of next-generation cell therapies for cancer, specifically targeting hematologic malignancies and solid tumors with CAR T cell therapies [4][5] Core Points and Arguments Product Development - **Lead Program**: Autologous CAR T cell therapy targeting CD19 and CD20, aimed at achieving more complete responses and longer remission periods [4][5] - **Clinical Trials**: Currently in pivotal clinical trials for relapsed/refractory large B cell lymphoma, with a focus on outpatient administration due to a favorable safety profile [6][19] Clinical Data - **Third-Line Setting**: - Presented data from 51 patients showing an 88% overall response rate and a 72% complete response rate, significantly higher than the approximately 50% seen with existing CD19 CAR therapies [15][16] - 71% of patients who achieved complete response remained in remission at six months, compared to about 40% for CD19 CARs [16][43] - **Second-Line Setting**: - First data presented showed a 91% overall response rate and a 70% complete response rate in patients with primary refractory disease [18][19] - The patient population included older patients with no upper age limit, broadening the inclusion criteria compared to competitors [18][65] Competitive Landscape - **Comparison with Competitors**: - Lyell's dual-targeting approach (CD19 and CD20) is positioned as a significant advancement over existing CD19-only therapies, which have limitations in patient response [7][26] - Notable competitors include Yescarta (Axi-cel) and Breyanzi (Liso-cel), both of which have shown similar response rates but with higher rates of neurotoxicity [21][23][31] - Lyell's safety profile shows lower rates of cytokine release syndrome (CRS) and neurotoxicity compared to competitors [31][32] Regulatory and Market Strategy - **Regulatory Designation**: Received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, indicating strong early data and facilitating more frequent interactions with the agency [50][56] - **Pivotal Trial Design**: A seamless phase one/two design for the pivotal trial, with plans to accelerate patient recruitment by adding more centers [51][52] - **Market Opportunity**: Targeting a significant patient population in both the second and third-line settings, with an estimated 30,000 new DLBCL cases annually in the U.S. [60] Additional Important Insights - **Patient Demographics**: The focus on older patients and those with primary refractory disease highlights the unmet need in the market and the potential for Lyell's therapies to address this gap [18][62] - **Intellectual Property**: Lyell holds a strong intellectual property position, with patents originating from UCLA, which may provide a competitive edge in the market [36][37] - **Future Outlook**: The company is optimistic about the potential for national priority review vouchers, which could expedite the approval process for their therapies [56][57] This summary encapsulates the key points discussed during the conference call, highlighting Lyell Immunopharma's strategic positioning, clinical advancements, and competitive landscape in the CAR T cell therapy market.

Core Insights - Lyell Immunopharma, Inc. is participating in the H.C. Wainwright "HCW@Home" Series on June 25, 2025, to discuss new clinical data for its lead product candidate LYL314 [1][2] Group 1: Company Overview - Lyell Immunopharma is a clinical-stage company focused on next-generation CAR T-cell therapies for cancer patients, particularly those with hematologic malignancies and solid tumors [4] - The company utilizes advanced technologies to enhance CAR T cells, aiming for durable tumor cytotoxicity and long-lasting clinical responses [4] - Lyell's manufacturing facility, the LyFE Manufacturing Center™, has the capacity to produce over 1,200 CAR T-cell doses at full capacity [4] Group 2: Product Candidate Details - LYL314 is an autologous dual-targeting CD19/CD20 CAR T-cell product candidate, currently in pivotal-stage development for patients with relapsed and/or refractory large B-cell lymphoma (LBCL) [2] - The product has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. FDA, indicating its potential clinical benefits [2] - LYL314 aims to improve complete response rates and prolong the duration of responses compared to existing CD19-targeted CAR T-cell therapies for LBCL [2]

Core Insights - Lyell Immunopharma, Inc. announced positive clinical data for LYL314, a CAR T-cell therapy for relapsed/refractory large B-cell lymphoma (LBCL), showing an 88% overall response rate and a 72% complete response rate in patients treated in the third- or later-line setting [1][3][4] Clinical Data Summary - In a Phase 1/2 trial, 25 patients in the 3L+ setting demonstrated an 88% overall response rate and a 72% complete response rate, with 71% of those achieving complete response remaining so at ≥ 6 months [1][3][4] - The efficacy evaluable population included 36 patients, with a median follow-up of 9 months for 3L+ patients and 5 months for 2L patients [2][3] - Among 51 CAR T-naive patients, 70% of those with primary refractory disease achieved a complete response [4] Safety Profile - The safety profile of LYL314 was manageable for outpatient administration, with no Grade ≥ 3 cytokine release syndrome reported and low rates of Grade 1 (22%) and Grade 2 (35%) adverse events [3][5] - Immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 6% (Grade 1), 2% (Grade 2), and 14% (Grade ≥ 3) of patients, with a median resolution time of 5 days [5] Ongoing Trials - The pivotal single-arm PiNACLE trial is currently underway, targeting approximately 120 patients with relapsed/refractory LBCL in the third- or later-line setting [6][12] - The trial aims to evaluate the overall response rate as the primary endpoint [12] Regulatory Designations - LYL314 has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA for the treatment of relapsed/refractory aggressive B-cell lymphoma [11] Manufacturing and Technology - LYL314 is designed to target B cells expressing either CD19 or CD20, utilizing a proprietary manufacturing process to enhance T-cell activity [10][9] - The Lyell LyFE Manufacturing Center™ has the capacity to produce over 1,200 CAR T-cell doses at full capacity [13]

Financial Data and Key Metrics Changes - The company is in a strong capital position to advance pivotal studies without the need for immediate capital raising [10] - The current market for CAR T therapies is approximately $3 billion annually, with expectations to grow significantly [46] Business Line Data and Key Metrics Changes - The lead program, Lyle 314, has shown a 94% overall response rate and a 71% complete response rate in ongoing trials [5][19] - The company is expanding its focus from solid tumors to include hematologic malignancies, indicating a strategic shift [11] Market Data and Key Metrics Changes - The CD19 market is projected to grow from $3 billion to $5 billion over the next few years, highlighting significant commercial opportunities [14] - The competitive landscape includes existing CD19 CAR therapies, with a focus on demonstrating superior efficacy and safety [29] Company Strategy and Development Direction - The company aims to develop next-generation cell therapies that provide long-term disease-free periods for cancer patients [3] - The acquisition of Impact Bio and its lead asset is part of a broader strategy to enhance capabilities in hematologic malignancies [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the FDA's openness to cell therapies, which could facilitate future approvals [44] - The company is focused on executing its pivotal trial and is optimistic about the potential for its lead product to penetrate the market effectively [49] Other Important Information - The company has successfully transitioned the manufacturing process from an academic setting to its own facility, enhancing production capabilities [15] - The company is preparing for commercial launch with a manufacturing capacity of approximately 1,200 doses per year [46] Q&A Session Summary Question: What is the strategy behind the acquisition of Impact Bio? - The acquisition was driven by the desire to expand into hematologic malignancies and capitalize on the potential of the lead asset [11][12] Question: How does the company plan to differentiate its product in a competitive market? - The company aims to show superior efficacy and safety compared to existing CD19 CAR therapies, which is critical for market penetration [29][30] Question: What are the expectations for the upcoming data presentation at the International Conference of Malignant Lymphoma? - The focus will be on demonstrating durability of response, particularly the maintenance of complete responses beyond six months [18][19] Question: How is the company preparing for manufacturing and commercialization? - The company has a robust manufacturing facility capable of supporting both clinical and early commercial needs, with plans for potential expansion [46][47] Question: Are there plans for further acquisitions or partnerships? - The company is open to exploring additional opportunities but will maintain a disciplined approach given current market conditions [51]

Core Insights - Lyell Immunopharma, Inc. has appointed new leaders to strengthen its clinical and commercial capabilities as it advances its CAR T-cell therapy pipeline [1][2][6] Leadership Appointments - Mark J. Bachleda, PharmD, MBA has been appointed as an independent member of the Board of Directors, bringing extensive experience in cell therapy and commercial leadership [3][6] - David Shook, MD has been appointed as Chief Medical Officer, recognized for his pioneering work in cell therapy and experience in leading clinical development for CAR NK cell products [4][6] - Mark Meltz, JD has been appointed as General Counsel and Corporate Secretary, with over two decades of experience in legal and business roles within life sciences [5][7] - Jarrad Aguirre, MD, MBA has been appointed as Senior Vice President of Medical Affairs, previously co-founding a digital health company and holding leadership roles in other biotech firms [8][6] Strategic Focus - The company is preparing to advance LYL314 towards approval for patients with aggressive large B-cell lymphoma, indicating a focus on late-stage clinical trials and potential commercial launch [2][9] - The new leadership team is expected to enhance operational excellence and contribute to the rapid advancement of LYL314, an autologous CD19/CD20 CAR T-cell therapy [2][6]

Core Insights - Lyell Immunopharma, Inc. is a clinical-stage company focused on developing next-generation CAR T-cell therapies for cancer patients [1][3] - The company will present at the Goldman Sachs 46th Annual Global Healthcare Conference on June 11, 2025, at 10:00 am ET [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible afterward [2] Company Overview - Lyell Immunopharma is advancing a pipeline of CAR T-cell therapies targeting hematologic malignancies and solid tumors [3] - The company employs various technologies to enhance CAR T cells, aiming for durable tumor cytotoxicity and consistent clinical responses [3] - Key attributes of Lyell's CAR T cells include resistance to exhaustion, maintenance of stemness, and functionality in challenging tumor microenvironments [3]

PART I—FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements for the quarter ended March 31, 2025, including balance sheets, statements of operations, and cash flows [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $429.8 million from $490.9 million, primarily due to a reduction in marketable securities | | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Total Current Assets** | $309,178 | $379,594 | | **Total Assets** | $429,798 | $490,859 | | **Total Current Liabilities** | $41,285 | $53,788 | | **Total Liabilities** | $93,277 | $108,035 | | **Total Stockholders' Equity** | $336,521 | $382,824 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q1 2025, the company reported a net loss of **$52.2 million**, an improvement from **$60.7 million** in Q1 2024, mainly due to a non-recurring impairment in the prior year | | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Revenue** | $7 | $3 | | **Research and development** | $43,447 | $43,174 | | **General and administrative** | $14,046 | $13,494 | | **Loss from operations** | ($57,367) | ($55,575) | | **Net loss** | ($52,195) | ($60,667) | | **Net loss per common share, basic and diluted** | ($0.18) | ($0.24) | [Condensed Consolidated Statements of Stockholders' Equity](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Total stockholders' equity decreased from **$382.8 million** to **$336.5 million** as of March 31, 2025, primarily driven by the net loss for the quarter - The primary driver for the decrease in stockholders' equity during the first quarter of 2025 was the net loss of **$52.2 million**[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$54.7 million** in Q1 2025, while net cash provided by investing activities was **$69.5 million**, leading to a **$14.7 million** increase in total cash | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(54,738) | $(42,016) | | **Net cash provided by investing activities** | $69,466 | $21,994 | | **Net cash provided by financing activities** | $1 | $27 | | **Net increase (decrease) in cash, cash equivalents and restricted cash** | $14,729 | $(19,995) | [Notes to Unaudited Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, the ImmPACT Bio acquisition, collaboration agreements, and an ATM equity offering, confirming sufficient liquidity for the next 12 months - The company believes its available cash, cash equivalents, and marketable securities as of March 31, 2025, will be adequate to fund operations for at least the next 12 months[35](index=35&type=chunk) - Following the acquisition of ImmPACT Bio, a contingent consideration payable of **$6.4 million** was recorded related to potential future equity issuance upon achieving clinical or regulatory milestones[43](index=43&type=chunk) - The company has success payment agreements with Fred Hutch and Stanford, with potential aggregate payments of up to **$200.0 million** each, contingent on the company's stock price reaching certain thresholds[48](index=48&type=chunk)[49](index=49&type=chunk)[53](index=53&type=chunk) - In February 2024, the company entered into an at-the-market (ATM) sales agreement to offer and sell up to **$150.0 million** of its common stock, with no sales made to date[75](index=75&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of the company's clinical-stage cell therapy business, financial performance, and liquidity, highlighting the lead program LYL314 and manufacturing strategy [Overview](index=30&type=section&id=Overview) Lyell is a clinical-stage cell therapy company focused on its lead CAR T-cell product candidate, LYL314, for B-cell lymphomas, with a pivotal trial planned for mid-2025 - The company's lead program is LYL314, a dual-targeting CD19/CD20 CAR T-cell product candidate for B-cell lymphomas, acquired from ImmPACT Bio[99](index=99&type=chunk)[107](index=107&type=chunk) - A pivotal trial for LYL314 in 3rd-line+ large B-cell lymphoma is expected to start in mid-2025, with a second pivotal trial in the 2nd-line setting planned by early 2026[102](index=102&type=chunk)[139](index=139&type=chunk) | Best Overall Response (N=17) | Result | | :--- | :--- | | Overall Responses, n (%) | 16 (94%) | | Complete Responses, n (%) | 12 (71%) | | Partial Responses, n (%) | 4 (24%) | | Stable Disease, n (%) | 1 (6%) | - Manufacturing for LYL314 has been transferred to the company's LyFE Manufacturing Center in Bothell, Washington, and the acquired West Hills facility was closed, resulting in a workforce reduction of approximately **73 employees**[139](index=139&type=chunk)[144](index=144&type=chunk) [Results of Operations](index=42&type=section&id=Results%20of%20Operations) Q1 2025 R&D expenses slightly increased to **$43.4 million**, while G&A expenses rose to **$14.0 million**, and net loss decreased to **$52.2 million** due to a non-recurring impairment in Q1 2024 | Expense (in thousands) | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Research and development** | $43,447 | $43,174 | $273 | | **General and administrative** | $14,046 | $13,494 | $552 | - The slight increase in R&D expenses was primarily due to a **$3.1 million** increase in personnel-related expenses, mainly from severance costs related to the closure of the West Hills manufacturing facility[161](index=161&type=chunk) - The decrease in net loss was largely due to a non-recurring **$13.0 million** impairment of other investments in Q1 2024[160](index=160&type=chunk)[168](index=168&type=chunk) [Liquidity and Capital Resources](index=44&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$330.1 million** in cash and marketable securities, deemed sufficient for at least the next 12 months, with an ATM program for future funding - As of March 31, 2025, the company had **$330.1 million** in cash, cash equivalents, and marketable securities[169](index=169&type=chunk) - Management believes existing cash, cash equivalents, and marketable securities will be sufficient to meet working capital and capital expenditure needs for at least the next 12 months[171](index=171&type=chunk) - An at-the-market (ATM) sales agreement is in place for up to **$150.0 million**, with no sales made to date[170](index=170&type=chunk) | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | **Operating activities** | $(54,738) | $(42,016) | | **Investing activities** | $69,466 | $21,994 | | **Financing activities** | $1 | $27 | [Quantitative and Qualitative Disclosures About Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on short-term cash and marketable securities, which is not considered significant, and foreign currency risk is minimal - The primary market risk is interest rate sensitivity on cash and marketable securities, which is not considered significant due to their short-term nature[183](index=183&type=chunk) - Foreign currency exchange risk is not significant as operations are U.S.-based and expenses are in USD[184](index=184&type=chunk) [Controls and Procedures](index=47&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that disclosure controls and procedures were effective as of March 31, 2025[186](index=186&type=chunk) - No material changes to internal control over financial reporting occurred during the quarter ended March 31, 2025[187](index=187&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings and is unaware of any contemplated actions - The company is not currently party to any material legal proceedings[189](index=189&type=chunk) [Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks including financial condition, limited operating history, reliance on unproven product candidates, manufacturing complexities, competition, regulatory hurdles, and intellectual property protection - The company is a clinical-stage entity with a history of substantial losses and anticipates incurring substantial and increasing net losses for the foreseeable future[193](index=193&type=chunk) - The company will require substantial additional capital to achieve its goals, and failure to obtain it could force delays or termination of product development[200](index=200&type=chunk) - The company's product candidates are based on novel, unproven technologies, making development time, cost, and regulatory approval difficult to predict[214](index=214&type=chunk) - The company faces risks in manufacturing complex cell therapies, including challenges with the recent transfer of LYL314 manufacturing to its LyFE facility and the closure of its Los Angeles facility[243](index=243&type=chunk)[247](index=247&type=chunk) - The company received a Nasdaq notification for non-compliance with the **$1.00** minimum bid price requirement and may be delisted if compliance is not regained, with a reverse stock split being considered[403](index=403&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=93&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - None[428](index=428&type=chunk) [Defaults Upon Senior Securities](index=93&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Not applicable - Not applicable[429](index=429&type=chunk) [Mine Safety Disclosures](index=93&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - Not applicable[430](index=430&type=chunk) [Other Information](index=93&type=section&id=Item%205.%20Other%20Information) During the first quarter of 2025, no directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement - No directors or executive officers adopted or terminated a Rule 10b5-1 trading plan in Q1 2025[431](index=431&type=chunk) [Exhibits](index=94&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer - Lists exhibits filed with the report, including officer certifications under Rules 13a-14(a) and 15d-14(a), and Section 1350[434](index=434&type=chunk)

[Business Highlights](index=1&type=section&id=Business%20Highlights) Lyell Immunopharma reported significant progress in its clinical development for the first quarter of 2025, primarily centered on its lead CAR T-cell therapy candidate, LYL314 - The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to **LYL314** for treating relapsed/refractory diffuse large B-cell lymphoma (LBCL) in the third- or later-line setting[2](index=2&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) - Manufacturing of **LYL314** clinical supply has been successfully transferred to Lyell's **LyFE Manufacturing Center** following FDA clearance of an IND amendment[3](index=3&type=chunk)[6](index=6&type=chunk)[9](index=9&type=chunk) - Lyell plans to initiate a pivotal trial for **LYL314** in third- or later-line LBCL by **mid-2025** and a second pivotal trial in the second-line setting by **early 2026**[3](index=3&type=chunk)[6](index=6&type=chunk) - New clinical data for **LYL314**, including more mature third-line and initial second-line data, will be presented at the International Conference on Malignant Lymphoma in **June 2025**[3](index=3&type=chunk)[6](index=6&type=chunk)[9](index=9&type=chunk) [LYL314 Program Updates](index=1&type=section&id=LYL314%20Program%20Updates) LYL314 is a next-generation CAR T-cell product candidate designed to improve response rates and durability for LBCL - **LYL314** is a next-generation, autologous, dual-targeting (CD19/CD20) CAR T-cell product candidate designed to improve response rates and durability compared to existing CD19-targeted therapies for LBCL[2](index=2&type=chunk)[5](index=5&type=chunk) - Initial data from a Phase 1/2 trial presented in December 2024 showed a **94% overall response rate (ORR)** and a **71% complete response (CR) rate** in 17 efficacy-evaluable patients[9](index=9&type=chunk) - In a safety population of 23 patients, **LYL314** was well-tolerated, with **no Grade 3 or greater cytokine release syndrome (CRS)** reported. Grade 3 ICANS occurred in **13% of patients** and resolved quickly[9](index=9&type=chunk) [Preclinical Pipeline and Manufacturing](index=2&type=section&id=Preclinical%20Pipeline%20and%20Manufacturing) The company's preclinical pipeline focuses on fully-armed CAR T-cell candidates and robust manufacturing capabilities - The preclinical pipeline focuses on fully-armed CAR T-cell candidates designed to overcome T-cell exhaustion and the hostile tumor microenvironment in solid tumors[7](index=7&type=chunk) - The first Investigational New Drug (IND) application for a fully-armed CAR T-cell product candidate targeting solid tumors is expected in **2026**[9](index=9&type=chunk) - The **LyFE Manufacturing Center** has the capacity to produce over **1,000 CAR T-cell therapy doses per year**, sufficient for pivotal trials and potential commercial launch[9](index=9&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) For Q1 2025, Lyell reported a GAAP net loss of **$52.2 million**, a decrease from Q1 2024, with **$330.1 million** cash expected to fund operations into 2027 [Financial Performance Summary](index=2&type=section&id=Financial%20Performance%20Summary) Key financial metrics for Q1 2025 show a reduced net loss and stable operating expenses Q1 2025 Key Financial Metrics (GAAP) | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change | | :--- | :--- | :--- | :--- | | Net Loss | $52.2 | $60.7 | Decreased $8.5 | | R&D Expenses | $43.4 | $43.2 | Increased $0.2 | | G&A Expenses | $14.0 | $13.5 | Increased $0.5 | - The decrease in net loss was primarily driven by a **$13.0 million impairment expense** recognized in Q1 2024 that did not recur in Q1 2025[8](index=8&type=chunk) - Cash, cash equivalents, and marketable securities totaled **$330.1 million** as of March 31, 2025, which is expected to fund operations into **2027**[6](index=6&type=chunk)[12](index=12&type=chunk) Net Loss Comparison (in millions) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | GAAP Net Loss | $(52.2) | $(60.7) | | Non-GAAP Net Loss | $(46.3) | $(37.5) | Operating Expenses Comparison (in millions) | Expense Category | Q1 2025 (GAAP) | Q1 2024 (GAAP) | Q1 2025 (Non-GAAP) | Q1 2024 (Non-GAAP) | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $43.4 | $43.2 | $41.1 | $38.9 | | G&A Expenses | $14.0 | $13.5 | $10.4 | $8.1 | - The increase in R&D expenses was mainly due to a **$3.1 million rise in personnel costs**, including severance from a facility closure[15](index=15&type=chunk) - The increase in G&A expenses was driven by a **$2.4 million rise in personnel costs** from higher headcount and severance expenses[15](index=15&type=chunk) - Cash, cash equivalents, and marketable securities decreased from **$383.5 million** at year-end 2024 to **$330.1 million** at the end of Q1 2025[12](index=12&type=chunk)[18](index=18&type=chunk) [Selected Consolidated Financial Data](index=4&type=section&id=Selected%20Consolidated%20Financial%20Data) Detailed unaudited financial statements provide a comprehensive view of the company's Q1 2025 performance and balance sheet Unaudited Selected Consolidated Statement of Operations Data (in thousands) | | Three Months Ended March 31, | | | :--- | :--- | :--- | | | **2025** | **2024** | | Revenue | $7 | $3 | | Total operating expenses | $57,374 | $55,578 | | Loss from operations | $(57,367) | $(55,575) | | Net loss | $(52,195) | $(60,667) | Unaudited Selected Balance Sheet Data (in thousands) | | As of March 31, 2025 | As of December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $330,126 | $383,541 | | Total assets | $429,798 | $490,859 | | Total stockholders' equity | $336,521 | $382,824 | [Non-GAAP Financial Measures and Reconciliations](index=5&type=section&id=Non-GAAP%20Financial%20Measures%20and%20Reconciliations) Non-GAAP financial measures provide a clearer view of core operational performance by excluding specific non-cash items - The company uses non-GAAP measures to enhance comparability by excluding non-cash items like stock-based compensation, changes in fair value of success payment liabilities, and non-cash investment charges[19](index=19&type=chunk) Reconciliation of GAAP to Non-GAAP Net Loss (in thousands) | | Three Months Ended March 31, | | | :--- | :--- | :--- | | | **2025** | **2024** | | Net loss - GAAP | $(52,195) | $(60,667) | | Stock-based compensation expense | $6,024 | $9,155 | | Impairment of other investments | — | $13,001 | | Net loss - Non-GAAP | $(46,296) | $(37,543) | Reconciliation of GAAP to Non-GAAP R&D and G&A Expenses (in thousands) | Expense | GAAP (Q1 2025) | Non-GAAP (Q1 2025) | GAAP (Q1 2024) | Non-GAAP (Q1 2024) | | :--- | :--- | :--- | :--- | :--- | | R&D | $43,447 | $41,059 | $43,174 | $38,857 | | G&A | $14,046 | $10,410 | $13,494 | $8,131 |