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Lyell(LYEL) - 2025 Q3 - Quarterly Results
2025-11-12 21:12
Financial Performance - Lyell reported a net loss of $38.8 million for Q3 2025, a decrease from a net loss of $44.6 million in Q3 2024, primarily due to reduced personnel expenses[13]. - Revenue for Q3 2025 was $15,000, compared to $34,000 in Q3 2024, representing a decrease of 56%[21]. - Total operating expenses for Q3 2025 were $37,268,000, down from $50,539,000 in Q3 2024, a reduction of 26%[21]. - Net loss for Q3 2025 was $38,846,000, compared to a net loss of $44,583,000 in Q3 2024, showing an improvement of 13%[25]. - Non-GAAP net loss for Q3 2025 was $29,124,000, compared to $37,064,000 in Q3 2024, reflecting a 21% improvement[25]. - Cash, cash equivalents, and marketable securities were approximately $320 million as of September 30, 2025, expected to support operations into 2027[17]. - Cash, cash equivalents, and marketable securities as of September 30, 2025, totaled $319,624,000, down from $383,541,000 as of December 31, 2024[22]. Research and Development - Research and development (R&D) expenses were $28.2 million for Q3 2025, down from $39.5 million in Q3 2024, reflecting a $11.3 million decrease attributed to lower research activities and personnel-related expenses[14]. - Research and development expenses for Q3 2025 were $28,172,000, a decrease of 29% from $39,500,000 in Q3 2024[27]. - Lyell plans to submit an IND in 2026 for a CAR T-cell product candidate targeting solid tumors[20]. - The company expects to present new clinical and translational data at the upcoming ASH meeting[20]. Product Development - Lyell's lead product candidate, ronde-cel, is in pivotal development for relapsed/refractory large B-cell lymphoma (LBCL) with a Phase 3 trial (PiNACLE – H2H) expected to begin enrollment by early 2026[3][11]. - The FDA granted RMAT designation for ronde-cel for the treatment of patients with relapsed or refractory LBCL in the second-line setting, enhancing communication frequency with the FDA[9][11]. - The company acquired exclusive global rights to LYL273, a CAR T-cell product candidate for refractory metastatic colorectal cancer (mCRC), which achieved a 67% overall response rate in a Phase 1 trial[4][6]. - The overall response rate for patients treated with LYL273 at the highest dose level was 67%, with an 83% disease control rate observed in the ongoing Phase 1 trial[4][15]. - Two abstracts from the Phase 1/2 trial of ronde-cel have been accepted for oral presentation at the ASH 67th Annual Meeting in December 2025[6][11]. Operational Efficiency - General and administrative (G&A) expenses decreased to $10.7 million in Q3 2025 from $11.8 million in Q3 2024, primarily due to lower stock-based compensation and outside services[16]. - General and administrative expenses for Q3 2025 were $10,687,000, compared to $11,769,000 in Q3 2024, a decrease of 9%[30]. - Lyell's manufacturing facility can produce over 1,200 CAR T-cell doses at full capacity, supporting commercial launch capabilities[18].
Lyell Immunopharma Reports Business Highlights and Financial Results for the Third Quarter 2025
Globenewswire· 2025-11-12 21:05
Core Insights - Lyell Immunopharma, Inc. reported financial results and business highlights for Q3 2025, focusing on its advanced CAR T-cell therapies for cancer treatment [1] Clinical Programs - The lead clinical program, rondecabtagene autoleucel (ronde-cel), is in pivotal trials for relapsed and/or refractory large B-cell lymphoma (LBCL) [2] - Ronde-cel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for both second-line and third-line settings [2][8] - Lyell acquired global rights to LYL273, a CAR T-cell product candidate for refractory metastatic colorectal cancer (mCRC), which showed a 67% overall response rate in a Phase 1 trial [3][5] Financial Performance - The company reported a net loss of $38.8 million for Q3 2025, an improvement from a net loss of $44.6 million in Q3 2024 [12] - Research and development expenses decreased to $28.2 million in Q3 2025 from $39.5 million in Q3 2024, primarily due to reduced personnel costs [13] - Cash, cash equivalents, and marketable securities were approximately $320 million as of September 30, 2025, expected to support operations into 2027 [16] Upcoming Developments - Two pivotal trials, PiNACLE and PiNACLE – H2H, are set to advance, with patient enrollment for PiNACLE – H2H expected to begin by early 2026 [4][10] - New clinical data for ronde-cel will be presented at the upcoming ASH meeting in December 2025 [5][10] Pipeline and Manufacturing - Lyell's pipeline includes next-generation CAR T-cell therapies targeting significant unmet needs in cancer treatment [5] - The LyFE Manufacturing Center™ has the capacity to produce over 1,200 CAR T-cell doses, supporting both clinical trials and potential commercial launches [17]
Lyell Immunopharma (NasdaqGS:LYEL) Update / Briefing Transcript
2025-11-10 14:30
Summary of Lyell Immunopharma Conference Call Company Overview - **Company**: Lyell Immunopharma (NasdaqGS:LYEL) - **Focus**: Development of next-generation CAR T cell therapies for cancer, including hematologic malignancies and solid tumors [6][7] Key Industry Insights - **Acquisition**: Lyell has acquired exclusive global rights to a novel CAR T cell product candidate, LYLE-273, in clinical development for metastatic colorectal cancer [3][7] - **Market Potential**: Colorectal cancer is the second leading cause of cancer death globally, with a market projected to grow from $6 billion to $12 billion by 2032 [12] - **Clinical Need**: Current therapies for metastatic colorectal cancer have poor outcomes, with overall response rates of less than 6% and median overall survival of less than 12 months [13][20] Clinical Data Highlights - **Phase One Trial Results**: - LYLE-273 showed a 67% overall response rate and an 83% disease control rate in patients with refractory metastatic colorectal cancer [10][20] - The median overall survival was 17 months at dose level one, with data not yet reached at dose level two [31] - The trial included patients who had received 2-6 prior lines of therapy, indicating a high-risk population [25][26] Mechanism of Action - **Target**: Guanylyl cyclase C (GCC) is expressed in 95% of colorectal cancers, making it a promising target for CAR T cell therapy [11][22] - **Enhancements**: LYLE-273 is designed with CD19 CAR expression and controlled cytokine release to improve T cell expansion and infiltration into tumors [22][39] - **Safety Profile**: The therapy has a manageable safety profile, with adverse events primarily including grade one or two cytokine release syndrome (CRS) and diarrhea [27][30] Strategic Rationale - **Pipeline Expansion**: The acquisition of LYLE-273 strengthens Lyell's pipeline in oncology, particularly in solid tumors, which represent over 90% of all cancers [7][47] - **Future Development**: There is potential to explore LYLE-273 in earlier lines of therapy and other GCC-expressing tumors, such as pancreatic cancer [62][76] Financial Terms of Acquisition - **Payment Structure**: ICT received $40 million and 1.9 million shares of Lyell stock, with additional payments based on clinical, regulatory, and commercial milestones [11][47] Future Outlook - **Clinical Trials**: Enrollment in the phase one trial of LYLE-273 continues, with further data expected in 2026 [36][52] - **Manufacturing Capacity**: Lyell operates a manufacturing facility capable of producing over 1,200 doses annually, supporting both clinical and early commercial needs [52] Conclusion - **Optimism for Impact**: The promising initial clinical data for LYLE-273 positions Lyell favorably in the competitive landscape of colorectal cancer therapies, with a focus on delivering significant clinical benefits to patients [52][70]
Lyell Immunopharma (NasdaqGS:LYEL) Earnings Call Presentation
2025-11-10 13:30
LYL273 Acquisition and Pipeline - Lyell Immunopharma strengthens its CAR T-cell pipeline with LYL273, a novel GCC-targeted product candidate for metastatic colorectal cancer (mCRC)[1] - LYL273 targets GCC, which is expressed on over 95% of mCRC and a majority of pancreatic cancers[12] - The acquisition includes an upfront payment of $40 million and 1.9 million shares, with potential for additional clinical, regulatory, and commercial milestones plus tiered royalties[12] - Lyell's LyFE manufacturing facility has a capacity for >1,200 doses/year at full capacity[75] Clinical Trial Data and Efficacy of LYL273 - In a U S Phase 1 clinical trial, LYL273 showed a 67% overall response rate at Dose Level 2 in patients with refractory mCRC[12, 32] - The disease control rate was 83% at the highest dose of LYL273 evaluated in the U S Phase 1 clinical trial[12] - In a Chinese study, at Dose Level 2, median OS was 25 months (95% CI, 13 4 to 26 1), median PFS was 6 0 months (95% CI, 3 0 to NA)[24] - One patient in the U S trial achieved a pathological complete response at autopsy[32, 42] Market and Future Milestones - The worldwide projected net sales for colorectal cancer are a $6+ billion market[13, 16] - Lyell anticipates the next data update for LYL273 in the first half of 2026[57, 81] - The company's cash runway extends into 2027, through multiple clinical milestones[81, 85]
Lyell Immunopharma Acquires Exclusive Global Rights to a Next-Generation CAR T-Cell Product Candidate in Clinical Development for Metastatic Colorectal Cancer
Globenewswire· 2025-11-10 12:30
Core Insights - Lyell Immunopharma has acquired global rights to LYL273, a novel CAR T-cell therapy targeting guanylyl cyclase-C (GCC) for metastatic colorectal cancer (mCRC) and other GCC-expressing cancers, enhancing its solid tumor pipeline [1][9] - In a Phase 1 clinical trial, LYL273 demonstrated a 67% overall response rate and an 83% disease control rate in patients with refractory mCRC, indicating promising efficacy and a manageable safety profile [1][4][5] - The acquisition includes an upfront payment of $40 million and potential milestone payments totaling up to $675 million, along with royalties on future net sales [9] Company Developments - The Phase 1 clinical trial data showed that at the highest dose level, 67% of patients achieved an overall response, with one patient experiencing a pathological complete response [4][5] - The treatment-related adverse events were more common at the higher dose level, with cytokine release syndrome occurring in 83% of patients [5][6] - Lyell expects its cash resources to be sufficient to fund operations into 2027, supported by ongoing clinical trials and prudent expense management [10][11] Industry Context - Colorectal cancer is the second leading cause of cancer deaths globally, with a rising incidence among individuals under 55 years old, highlighting the urgent need for innovative therapies like LYL273 [2][7] - The Fast Track designation granted by the U.S. FDA for LYL273 underscores its potential as a significant advancement in treating mCRC, an area with substantial unmet medical needs [7]
Lyell Announces Two Oral Presentations from the Phase 1/2 Clinical Trial of Ronde-Cel for the Treatment of Aggressive Large B-Cell Lymphoma at the 67th ASH Annual Meeting and Exposition
Globenewswire· 2025-11-03 14:00
Core Insights - Lyell Immunopharma, Inc. is advancing a pipeline of next-generation CAR T-cell therapies, specifically focusing on rondecabtagene autoleucel (ronde-cel) for aggressive large B-cell lymphoma (LBCL) [1][8] - Ronde-cel has received FDA designations as Regenerative Medicine Advanced Therapy (RMAT) and Fast Track for treating relapsed and/or refractory diffuse LBCL in later lines of therapy [1][8] Clinical Data Presentation - New clinical and translational data from the Phase 1/2 trial of ronde-cel will be presented at the 67th American Society of Hematology (ASH) Annual Meeting, highlighting high overall response and complete response rates in high-risk LBCL patients [2][3] - The ongoing PiNACLE trial continues to enroll patients with LBCL in the third- or later-line setting, and a randomized controlled trial comparing ronde-cel to an approved CD19 CAR T-cell therapy is set to begin in the second-line setting [2] Manufacturing and Technology - Ronde-cel is manufactured using a process that enriches for CD62L-positive cells, resulting in enhanced naïve and central memory CAR T cells with improved antitumor activity [4][8] - The Lyell LyFE Manufacturing Center™ has the capacity to produce over 1,200 CAR T-cell doses at full capacity, supporting both ongoing and future clinical trials [8]
Lyell Immunopharma (NasdaqGS:LYEL) FY Conference Transcript
2025-09-10 15:02
Summary of Lyell Immunopharma FY Conference Call Company Overview - **Company**: Lyell Immunopharma (NasdaqGS:LYEL) - **Focus**: Clinical stage oncology company specializing in next-generation cell therapy for cancer, targeting both hematologic malignancies and solid tumors [3][4] Key Initiatives and Pipeline - **Lead Program**: RondaCell, a dual-targeting CD19/20 CAR T cell therapy for relapsed and refractory aggressive large B-cell lymphoma [3][4] - **Clinical Trials**: - Pivotal single-arm study for third-line treatment underway - Phase 3 randomized head-to-head trial launched for second-line treatment [3][4] Competitive Landscape - **RondaCell vs. Existing Therapies**: - RondaCell shows an 88% overall response rate and a 70% complete response rate in patients with relapsed disease, compared to 70% and 50% respectively for currently approved CD19 CARs [4][5] - Duration of complete response is emphasized as a critical metric for success [8][12] Data and Efficacy - **Response Rates**: - RondaCell's complete response rate at six months is 71%, significantly higher than Yescarta's 40% [8][12] - The company aims to demonstrate superior efficacy in harder-to-treat patient populations [10][12] Safety Profile - **Safety Data**: - RondaCell shows lower rates of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) compared to competitors [16] - 47% to 57% CRS rates for RondaCell versus 80% for Kite/Gilead products [16] Market Potential - **Market Disruption**: - The emergence of CD19/CD20 CAR therapies is expected to disrupt the existing CD19 CAR market, with potential for significant market share capture [17][18] - The company is confident in its product profile and aims to position RondaCell as a best-in-class therapy [18] Trial Design and Regulatory Path - **Pivotal Trials**: - Two pivotal trials are ongoing, with the third-line study being a single-arm study and the second-line study designed as a head-to-head trial against Yescarta and Breyanzi [19][22] - Primary endpoint for the second-line trial is event-free survival [23] Commercial Strategy - **Self-Sufficiency**: - The company believes it can independently commercialize RondaCell, with a manufacturing capacity of up to 1,200 doses per year [27][28] - Open to strategic partnerships but not urgent due to current capital and manufacturing capabilities [28] Future Outlook - **Data Readouts**: - Significant data updates expected by the end of the year for both third-line and second-line trials [30] - Continued data flow anticipated, with a focus on maturing trial results [30][31] Conclusion - Lyell Immunopharma is positioned to potentially redefine treatment paradigms in large B-cell lymphoma with RondaCell, leveraging strong clinical data, a favorable safety profile, and a strategic approach to market entry and commercialization [3][4][18]
Lyell Immunopharma (NasdaqGS:LYEL) FY Conference Transcript
2025-09-08 14:17
Summary of Lyell Immunopharma FY Conference Call Company Overview - **Company**: Lyell Immunopharma (NasdaqGS:LYEL) - **Industry**: Biotechnology, specifically focused on oncology and CAR T cell therapy - **Key Product**: RONDACELL, a dual-targeting CD19/CD20 CAR T cell therapy for aggressive relapse refractory large B-cell lymphoma [2][3] Core Points and Arguments - **Clinical Focus**: Lyell Immunopharma is dedicated to developing next-generation CAR T cell therapies for both hematologic malignancies and solid tumors [2] - **Lead Program**: RONDACELL is currently in pivotal clinical trials, including a single-arm trial in the third-line setting and a randomized controlled trial in the second-line setting [2][6] - **Unique Selling Proposition**: - RONDACELL targets both CD19 and CD20, reducing the chance of antigen escape and increasing the likelihood of complete responses [3][4] - The manufacturing process selects for naïve T cells, which are believed to provide better durability and response rates [4][28] - **Trial Design**: The second-line trial, known as Pinnacle head-to-head, will compare RONDACELL against existing therapies (axicabtagene ciloleucel or Breyanzi) with a primary endpoint of event-free survival [7][9] Key Data and Expectations - **Response Rates**: Recent data showed an 88% overall response rate and a 72% complete response rate in the third-line setting, significantly better than existing CD19 CAR therapies [15][16] - **Enrollment Plans**: The company plans to enroll 200 patients per arm in the head-to-head trial, with expectations to begin patient enrollment by early 2026 [9][10] - **Market Opportunity**: Approximately 30,000 patients in the U.S. with DLBCL, with about 12,000 progressing to second-line therapy, representing a significant market potential [24] Financials and Funding - **Cash Position**: Lyell has $347 million in cash, sufficient to support operations through mid-2027, although additional funding will be needed for the second-line pivotal study [48][50] - **Recent Financing**: A recent PIPE financing raised up to $100 million, with structured tranches based on performance milestones [51] Competitive Landscape - **Market Share**: Yescarta holds about 52% of the market share in the CD19 CAR T space, with Breyanzi slightly behind [23] - **Competitive Edge**: Lyell believes its dual-targeting approach and safety profile will allow it to capture market share from existing therapies [38][39] - **Intellectual Property**: The company claims a dominant IP position dating back to 2014, which is crucial for maintaining competitive advantage [44] Safety and Manufacturing - **Safety Profile**: RONDACELL has shown a favorable safety profile, with lower rates of cytokine release syndrome (CRS) and neurotoxicity compared to competitors [30][32] - **Manufacturing Capacity**: The Bothell, Washington facility can produce approximately 1,200 doses per year, supporting both clinical and potential commercial needs [33] Future Directions - **Solid Tumor Program**: Lyell is developing a solid tumor CAR T therapy, with an IND submission planned for 2026 [45] - **AI Utilization**: The company is exploring AI applications primarily in R&D to enhance efficiency and effectiveness [56][58] Regulatory Environment - **Focus on FDA**: The company is closely monitoring FDA regulations as it prepares for pivotal trials and BLA submissions [59][60] Conclusion Lyell Immunopharma is positioned to disrupt the CAR T cell therapy market with its innovative dual-targeting approach, strong clinical data, and robust manufacturing capabilities, while also navigating a competitive landscape and regulatory challenges effectively.
Lyell Immunopharma Announces the Initiation of a Phase 3 Head-to-Head CAR T-Cell Therapy Clinical Trial in Aggressive Large B-Cell Lymphoma and Formation of Expert Steering Committee
Globenewswire· 2025-09-03 12:00
Core Viewpoint - Lyell Immunopharma has initiated the PiNACLE - H2H Phase 3 trial to evaluate its dual-targeting CAR T-cell therapy, rondecabtagene autoleucel (ronde-cel), against existing CD19-targeting therapies for relapsed or refractory large B-cell lymphoma [1][10] Group 1: Trial Details - The PiNACLE - H2H trial is a head-to-head randomized controlled trial comparing ronde-cel to either lisocabtagene maraleucel (liso-cel) or axicabtagene ciloleucel (axi-cel) in patients with relapsed or refractory large B-cell lymphoma [1][10] - The trial aims to enroll approximately 400 patients and will assess event-free survival as the primary endpoint [10] - Ronde-cel is designed to target B cells expressing either CD19, CD20, or both, with a focus on improving complete response rates and duration of responses compared to existing therapies [5][6] Group 2: Product Information - Ronde-cel has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA for the treatment of patients with relapsed or refractory large B-cell lymphoma [7] - The manufacturing process of ronde-cel aims to produce a higher proportion of naïve and central memory T cells, enhancing its antitumor activity [6][8] - The company is also conducting a single-arm pivotal trial (PiNACLE) for ronde-cel in the third-line or later setting, expected to enroll around 120 patients [10] Group 3: Expert Collaboration - A Steering Committee of distinguished lymphoma experts has been established to guide the trial's design and execution [2][3] - Experts involved include members from prominent institutions such as the University of Chicago and the Moffitt Cancer Center [4][10] - The collaboration aims to provide robust clinical data to support the potential benefits of ronde-cel over existing therapies [2][3]
Lyell(LYEL) - 2025 Q2 - Quarterly Report
2025-08-12 20:13
[Special Note Regarding Forward-Looking Statements](index=5&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Statements) This section highlights forward-looking statements in the 10-Q report, subject to risks and uncertainties that could cause actual results to differ materially [Overview of Forward-Looking Statements](index=5&type=section&id=Overview%20of%20Forward-Looking%20Statements) This section highlights forward-looking statements in the 10-Q report, subject to risks and uncertainties that could cause actual results to differ materially - The report contains forward-looking statements about future results, financial position, business strategy, product candidates, clinical trials, R&D costs, regulatory approvals, and commercialization plans[12](index=12&type=chunk) - These statements involve known and unknown risks, uncertainties, and other important factors that may cause actual results to be materially different from those expressed or implied[12](index=12&type=chunk) - Key forward-looking statements include the sufficiency of cash to fund operations, accuracy of expense estimates, scope and results of LYL314 development, timing of regulatory approvals, commercialization plans, market opportunities, reliance on third parties, and intellectual property protection[13](index=13&type=chunk)[16](index=16&type=chunk) [PART I—FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This part presents the unaudited condensed consolidated financial statements and management's discussion and analysis [Item 1. Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents Lyell Immunopharma's unaudited condensed consolidated financial statements, including balance sheets, operations, equity, cash flows, and detailed notes [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance sheets show decreased total assets and equity from December 2024 to June 2025, due to reduced marketable securities and increased accumulated deficit Balance Sheet Summary (in thousands) | ASSETS (in thousands) | June 30, 2025 | December 31, 2024 | | :---------------------- | :------------ | :---------------- | | Cash and cash equivalents | $98,804 | $105,597 | | Marketable securities | $177,986 | $264,930 | | Total current assets | $282,214 | $379,594 | | Total assets | $385,453 | $490,859 | | LIABILITIES AND STOCKHOLDERS' EQUITY (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------------------------- | :------------ | :---------------- | | Total current liabilities | $36,903 | $53,788 | | Total liabilities | $86,530 | $108,035 | | Total stockholders' equity | $298,923 | $382,824 | | Accumulated deficit | $(1,439,985) | $(1,345,106) | - Total assets decreased by approximately **$105.4 million** from December 31, 2024, to June 30, 2025, primarily due to a reduction in marketable securities[19](index=19&type=chunk) - Total stockholders' equity decreased by approximately **$83.9 million**, largely driven by an increase in accumulated deficit[19](index=19&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a reduced net loss for Q2 and YTD June 2025, driven by lower operating expenses and increased other income, net Statements of Operations and Comprehensive Loss Summary (in thousands, except per share amounts) | (in thousands, except per share amounts) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $8 | $13 | $15 | $16 | | Research and development | $34,857 | $40,261 | $78,304 | $83,435 | | General and administrative | $9,786 | $12,256 | $23,832 | $25,750 |\ | Total operating expenses | $47,148 | $51,541 | $104,522 | $107,119 | | Net loss | $(42,684) | $(45,809) | $(94,879) | $(106,476) | | Net loss per common share, basic and diluted | $(2.89) | $(3.59) | $(6.42) | $(8.36) | - Net loss for the three months ended June 30, 2025, was **$(42.7) million**, a decrease from $(45.8) million in the prior year period[24](index=24&type=chunk) - Net loss for the six months ended June 30, 2025, was **$(94.9) million**, an improvement from $(106.5) million in the prior year period, driven by lower operating expenses and higher other income, net[24](index=24&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased from December 2024 to June 2025 due to net loss, partially offset by stock-based compensation; a 1-for-20 reverse stock split was effected Stockholders' Equity Summary (in thousands) | (in thousands) | Balance as of Dec 31, 2024 | Net Loss | Stock-based Compensation | Issuance of Common Stock | Balance as of Jun 30, 2025 | | :------------- | :------------------------- | :------- | :----------------------- | :----------------------- | :------------------------- | | Total Stockholders' Equity | $382,824 | $(94,879) | $11,028 | $184 | $298,923 | - Total stockholders' equity decreased from **$382.8 million** at December 31, 2024, to **$298.9 million** at June 30, 2025[27](index=27&type=chunk) - The company effected a **1-for-20 reverse stock split** on May 30, 2025, retroactively adjusting all historical per share data and share counts[41](index=41&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased for the six months ended June 30, 2025, while cash provided by investing activities also increased due to marketable securities maturities Cash Flows Summary (in thousands) | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------- | :----------------------------- | :----------------------------- |\ | Operating activities | $(89,196) | $(80,110) | | Investing activities | $82,113 | $67,001 | | Financing activities | $184 | $889 | | Net decrease in cash, cash equivalents and restricted cash | $(6,899) | $(12,220) | | Cash, cash equivalents and restricted cash at end of period | $100,388 | $133,711 | - Net cash used in operating activities was **$89.2 million** for the six months ended June 30, 2025, compared to $80.1 million in the prior year, reflecting a higher net loss and a decrease in accrued liabilities[188](index=188&type=chunk)[189](index=189&type=chunk) - Net cash provided by investing activities increased to **$82.1 million** in 2025 from $67.0 million in 2024, primarily due to net maturities and purchases of marketable securities[190](index=190&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=14&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes provide detailed explanations of the company's financial statements, covering organization, accounting policies, contingent liabilities, and recent events [1. Organization](index=14&type=section&id=1.%20Organization) Lyell Immunopharma is a late-stage clinical cell therapy company developing next-generation autologous CAR T-cell product candidates for hematologic malignancies and solid tumors, with LYL314 as its lead - Lyell Immunopharma, Inc. is a late-stage clinical cell therapy company developing proprietary next-generation autologous CAR T-cell product candidates[37](index=37&type=chunk) - The lead product candidate, LYL314, is a dual-targeting CD19/CD20 CAR T-cell therapy in a pivotal clinical trial for large B-cell lymphoma (3L+) and a Phase 1/2 study (2L)[37](index=37&type=chunk) [2. Summary of Significant Accounting Policies](index=14&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the basis of presentation for the unaudited condensed consolidated financial statements, detailing the 1-for-20 reverse stock split and affirming liquidity for the next 12 months - The company effected a **1-