Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 __________________________ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40502 __________________________ Lyell Immunopharma, Inc. (Exact Name of Registrant a ...

Exhibit 99.1 Lyell Immunopharma Reports Business Highlights and Financial Results for the Second Quarter 2025 SOUTH SAN FRANCISCO, Calif., August 12, 2025 --Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, today reported financial results and business highlights for the second quarter ended June 30, 2025. Lyell's lead clinical program, LYL314, is a next-generation autologous dual-targeting CD19/CD20 CAR T-cell pro ...

Presented positive new clinical data demonstrating high rates of durable complete responses from the Phase 1/2 trial of LYL314 for the treatment of aggressive large B-cell lymphomaInitiated the PiNACLE pivotal trial of LYL314 in patients with large B-cell lymphoma receiving treatment in the third‑ or later-line (3L+) setting; remain on track to initiate a pivotal trial in the second-line (2L) setting by early 2026Entered into a securities purchase agreement for a private placement for gross proceeds of up t ...

SOUTH SAN FRANCISCO, Calif., July 25, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing next-generation CAR T-cell therapies for patients with cancer, today announced that it has entered into a securities purchase agreement for a private placement with certain institutional and other accredited investors, for gross proceeds of up to approximately $100 million. The initial closing of approximately $50 million of common stock at a price of $13.32 per share is ...

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]