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• Like **Gilead's Kite Pharma** or **Novartis's CAR-T division**, but dedicated to overcoming the toughest challenges in current T-cell cancer therapies.
• A specialized **Amgen** or **Genentech**, singularly focused on engineering next-generation T-cell immunotherapies for cancer.
• Like a **Moderna** or **BioNTech**, but pioneering advanced T-cell therapies instead of vaccines to fight cancer.

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• LYL-797: An investigational ROR1-targeted CAR T-cell therapy being developed for various solid tumors.
• LYL-846: An investigational T-cell therapy designed for solid tumors, leveraging Lyell's proprietary T-cell reprogramming technologies.
• T-cell Reprogramming Platforms: Proprietary technologies (e.g., SPARK, GENE-MOD, EPI-MOD) designed to enhance T-cell function, resist exhaustion, and improve the efficacy of cell therapies for cancer.

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Lyell Immunopharma (NASDAQ: LYEL) is a clinical-stage biotechnology company focused on developing novel T-cell therapies for cancer. As a clinical-stage company, Lyell has not yet commercialized any products and therefore does not have traditional "major customers" in the sense of companies or individuals purchasing their products.

Their business model at this stage primarily involves:

• Research and Development: Advancing their pipeline of investigational therapies through preclinical and clinical trials.
• Capital Generation: Funding their operations primarily through equity financing from investors and potentially strategic collaborations or grants.

Therefore, Lyell Immunopharma does not currently sell products to other companies or directly to individuals. Should Lyell successfully develop and commercialize a therapy, their eventual "customers" would typically be healthcare providers (such as hospitals, oncology clinics, and cancer treatment centers) who administer approved therapies to patients. In some cases, licensing agreements with larger pharmaceutical companies could also represent a form of "customer" or partner for commercialization rights.

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Lynn Seely, M.D. President & Chief Executive Officer

Lynn Seely, M.D., was appointed President and Chief Executive Officer of Lyell Immunopharma in December 2022. Prior to joining Lyell, Dr. Seely served as President and CEO of Myovant Sciences, where she oversaw the marketing approval and launch of ORGOVYX for prostate cancer and MYFEMBREE for uterine fibroids and endometriosis. She also spent a decade as Chief Medical Officer at Medivation, where she led the development and marketing approval of XTANDI. Dr. Seely has a history of leadership in the biopharmaceutical industry, building companies and developing new medicines in oncology and women's health. She also serves on the board of directors for Blueprint Medicines Corp.

Lynn Seely, M.D. Interim Principal Financial Officer

In addition to her role as President and Chief Executive Officer, Lynn Seely, M.D., was appointed interim principal financial officer on October 31, 2025. Her background is detailed above.

Veronica Sanchez Bulis Principal Accounting Officer

Veronica Sanchez Bulis was appointed Principal Accounting Officer on October 31, 2025. She has served as Vice President, Corporate Controller at Lyell Immunopharma since August 2021, overseeing financial operations, accounting, SEC reporting, audit, and SOX compliance, as well as international accounting functions. Before Lyell, Ms. Bulis held positions including Senior Director of Financial Reporting and Technical Accounting at Sangamo Therapeutics, Inc. and worked at Core-Mark International in corporate accounting and financial reporting roles. She began her career in public accounting with Ernst & Young and Deloitte.

David Shook, M.D. Chief Medical Officer

David Shook, M.D., was appointed Chief Medical Officer in June 2025. Dr. Shook is recognized for his pioneering contributions to cell therapy, having previously led R&D at Nkarta and conducted groundbreaking trials at St. Jude Children's Research Hospital. He is also a practicing pediatric oncologist.

Jarrad Aguirre, M.D., M.B.A. Senior Vice President, Medical Affairs

Jarrad Aguirre, M.D., M.B.A., joined Lyell Immunopharma as Senior Vice President, Medical Affairs in January 2025. Prior to Lyell, he co-founded and served as Chief Executive Officer of Miga Health, a digital health company, which was subsequently sold to Bitterroot Bio. He also held leadership positions at Myovant Sciences, including Head of Corporate Strategy. Dr. Aguirre holds an M.D. and M.B.A. from Stanford University.

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1. Clinical Trial and Regulatory Approval Risk: As a clinical-stage company, Lyell's success is heavily dependent on the ability of its product candidates to successfully complete clinical trials and obtain regulatory approvals. There is significant uncertainty regarding whether Lyell's product candidates will ever receive regulatory approvals, and clinical trial results could differ from nonclinical, early clinical, or preliminary expectations. The potential for significant adverse events, toxicities, or other undesirable side effects associated with Lyell's product candidates also poses a risk. For instance, failure to meet key endpoints in pivotal trials, such as the PiNACLE trial for LYL314, could lead to a sharp decline in the company's value. The inherent challenges of T-cell exhaustion in CAR T-cell therapies also present an obstacle to immunotherapy.
2. Financial Risk and Capital Resources: Lyell Immunopharma has a history of rapidly burning through cash and has reported a negative free cash flow yield. The company's operations require substantial capital, and there is a risk regarding the sufficiency of its capital resources and its need for additional funding to achieve its strategic goals and advance its pipeline. Previous events, such as the termination of a significant partnership with GSK, led to workforce reductions and the reprioritization of programs to conserve funds. The company has also faced notification from Nasdaq for non-compliance with the minimum bid price requirement, highlighting potential financial instability.
3. Manufacturing and Commercialization Risk: The complexity of manufacturing cellular therapies like Lyell's CAR T-cell product candidates subjects the company to various manufacturing risks. These risks could substantially increase costs, delay programs, or limit the supply of its product candidates for clinical trials and potential commercialization. Challenges in scaling up manufacturing, where real-world demand could outpace the production capacity of facilities like Lyell's LyFE Center, also present a significant risk. Furthermore, the company faces intensifying competition from other therapies, including bispecific antibodies, which could impact the commercial success of its products even if approved.

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The clear emerging threat to Lyell Immunopharma stems from the rapid advancement and increasing investment in allogeneic (off-the-shelf) T-cell therapies for cancer, particularly for solid tumors, which is Lyell's primary focus. While Lyell is developing sophisticated autologous (patient-specific) T-cell therapies designed for enhanced potency and durability, allogeneic approaches offer the potential for vastly improved scalability, reduced manufacturing costs, and immediate availability, sidestepping the logistical complexities and lengthy manufacturing times inherent in autologous treatments. Should allogeneic platforms effectively overcome current challenges such as host rejection, limited persistence, and potential graft-versus-host disease while demonstrating comparable efficacy and safety profiles to autologous therapies in solid tumors, they could significantly disrupt the market and limit the commercial viability and market share for Lyell's autologous product pipeline.

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Lyell Immunopharma (LYEL) is a clinical-stage cell therapy company focused on developing next-generation CAR T-cell and TIL therapies for treating hematologic malignancies and solid tumors. The addressable markets for their main products or services are as follows:

• LYL314 (formerly IMPT-314) for Large B-cell Lymphoma (LBCL): The global market size for Diffuse Large B-cell Lymphoma (DLBCL) was valued at approximately USD 3.9 billion in 2023 and is projected to reach USD 5.26 billion by 2034. In the leading markets (US, EU4, UK, and Japan), the DLBCL market size was USD 4.7 billion in 2024 and is expected to cross USD 11.5 billion by 2034 in the United States alone.
• LYL845 for Solid Tumors: This Tumor Infiltrating Lymphocyte (TIL) therapy is designed to target multiple solid tumor indications. The overall global solid tumors market was valued at approximately USD 360 billion in 2024 and is projected to reach between USD 1,557.42 billion and USD 1,817 billion by 2032-2033. More specific market sizes for indications targeted by LYL845 include:
  • Melanoma: The global melanoma therapeutics market was estimated at USD 9.16 billion in 2024 and is projected to reach USD 21.79 billion by 2033.
  • Non-Small Cell Lung Cancer (NSCLC): The global non-small cell lung cancer market was estimated at USD 20.2 billion in 2024 and is expected to grow to USD 53.9 billion by 2034.
  • Colorectal Cancer: The global colorectal cancer therapeutics market was estimated at USD 11.5 billion in 2022 and is expected to reach USD 16.7 billion by 2030.
  • Head and Neck Cancer: The global head and neck cancer market is anticipated to reach USD 11.1 billion by 2033.
  • Cervical Cancer: The global cervical cancer treatment market size was estimated at USD 8.16 billion in 2023 and is projected to reach USD 11.74 billion by 2030.
  • Breast Cancer: The global breast cancer therapeutics market size was USD 21.58 billion in 2019 and is projected to reach USD 55.27 billion by 2027.
  • Pancreatic Cancer: The global pancreatic cancer market size is calculated at USD 3.25 billion in 2025 and is projected to surpass approximately USD 10.25 billion by 2034.

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Lyell Immunopharma (NASDAQ: LYEL) is expected to drive future revenue growth over the next 2-3 years primarily through the advancement and potential commercialization of its pipeline of novel T-cell therapies. The key drivers include:

• Advancement and Potential Commercialization of LYL314 (formerly IMPT-314): This dual-targeting CD19/CD20 CAR T-cell therapy for relapsed and/or refractory large B-cell lymphoma (LBCL) is Lyell's lead program and a significant focus for near-term growth. LYL314 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for 3rd-line+ LBCL and is currently in a pivotal trial (PiNACLE trial) for this setting. The company plans to initiate a pivotal trial for 2nd-line LBCL by early 2026, which would expand its potential market significantly. Positive clinical data from Phase 1/2 trials, demonstrating high rates of durable complete responses, supports its potential to deliver improved outcomes compared to existing CD19 CAR T-cell therapies.
• Progress of LYL797 in Solid Tumors: LYL797, a ROR1-targeted CAR T-cell product candidate, is in Phase 1 clinical development for various solid tumors, including triple-negative breast cancer, non-small cell lung cancer, and gynecological and hematologic malignancies. Initial data from its Phase 1 trial has shown dose-dependent clinical activity, with CAR T cells demonstrating expansion, tumor infiltration, and cancer cell killing in patients. The company is actively enrolling patients in this trial and is excited about the incoming data.
• Development of LYL845, a TIL Product Candidate: LYL845 is a tumor-infiltrating lymphocyte (TIL) product candidate in Phase 1 development targeting solid tumors. Lyell anticipates releasing initial clinical data for this program in 2024.
• Advancement of LYL119, a Next-Generation CAR T-cell Therapy: LYL119 is a next-generation ROR1-targeted CAR T-cell product candidate incorporating multiple proprietary technologies designed to overcome T-cell exhaustion and enhance durable stemness. Site selection and initiation for its Phase 1 trial are currently progressing.
• Introduction of New "Fully-Armed" CAR T-Cell Candidates for Solid Tumors: Lyell is committed to developing new, "fully-armed" CAR T-cell product candidates for solid tumors, incorporating multiple technologies to resist T-cell exhaustion and immune suppression within the tumor microenvironment. The company expects to submit an Investigational New Drug (IND) application for its first fully-armed CAR T-cell product candidate with an undisclosed target for solid tumors in 2026.

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Share Issuance

• Lyell Immunopharma successfully completed its initial public offering (IPO) in June 2021, generating net proceeds of $391.8 million.
• In July 2025, Lyell entered into a private placement agreement for gross proceeds of up to approximately $100 million. An initial closing of approximately $50 million of common stock occurred on July 25, 2025, at $13.32 per share, with the potential for an additional $50 million upon achieving certain clinical milestones.
• Effective June 2, 2025, Lyell Immunopharma implemented a one-for-twenty (1-20) reverse stock split of its common stock.

Inbound Investments

• Lyell Immunopharma raised $493 million in a Series C funding round in March 2020, led by GSK.
• The company secured a "Post IPO" funding round of $100 million in July 2025, which corresponds to the private placement.
• An initial closing of approximately $50 million from institutional and accredited investors occurred on July 25, 2025, as part of a private placement, with potential for another $50 million tied to clinical milestones.

Outbound Investments

• Lyell Immunopharma completed the acquisition of ImmPACT Bio USA Inc. on October 31, 2024.

Capital Expenditures

• Lyell anticipates that its cash, cash equivalents, and marketable securities (totaling approximately $347 million inclusive of the initial private placement proceeds) will be sufficient to cover working capital and capital expenditure needs into mid-2027.
• The company reported increased infrastructure costs in 2021, indicating capital expenditures to support the expansion of its research and development (R&D) and manufacturing capabilities.
• Lyell operates its own manufacturing facilities for CAR, TIL, and Lentiviral therapies, with a current capacity of approximately 500 doses per year across these modalities.