Lyell Immunopharma, Inc.

Lyell Immunopharma is a U.S.-based late-stage clinical cell therapy company developing next-generation autologous CAR T-cell therapies for cancer. Its lead programs, including ronde-cel (LYL314) and LYL273, are designed to improve durability and response rates in hematologic malignancies and solid tumors, while the company also operates its own manufacturing center to control supply and quality.

−716 291,7 %

−762 355,6 %

−41,0 %

5.28

— Lyell Immunopharma, Inc.
	%
Clinical CAR T-cell product candidates	0% Autologous cell therapies in clinical development for hematologic malignancies and solid tumors.
Manufacturing and supply capabilities	0% Internal cGMP manufacturing for patient-specific CAR T-cell products and viral vectors.
Research and process development	0% Technology development, translational research and manufacturing process optimization for pipeline assets.
Licensing and strategic collaboration activities	0% Technology and asset access through acquisitions and license agreements that expand the pipeline.

Lyell does not yet sell approved commercial products; its current 'customers' are primarily clinical trial patients,...

Clinical trial patientsprimary
Patients with relapsed/refractory large B-cell lymphoma and advanced mCRC enrolled in trials to test safety and efficacy.
Clinical investigators and trial sitesprimary
Hospitals and oncology centers that administer study treatment, monitor outcomes and support enrollment.
Future oncology treatment centerssecondary
Specialty centers that would prescribe and infuse approved CAR T products if Lyell reaches commercialization.
Payers and reimbursement stakeholderssecondary
Insurers and other payors that will determine access and adoption for premium-priced cell therapies.

Lyell is headquartered and manufactures in the United States, with its LyFE Manufacturing Center in Bothell, Washington...

•Headquartered in the United States and incorporated in 2018
•LyFE Manufacturing Center is in Bothell, Washington
•West Hills facility closure reduced U.S. manufacturing footprint
•Manufacturing designed to meet U.S. and EU cGMP standards
•LYL273 license excludes mainland China, Hong Kong, Macau and Taiwan

Lyell’s strategy is to build differentiated CAR T therapies with stronger potency and durability than first-generation...

Advance ronde-cel to potential approvalshort-term

It is the lead asset and the main near-term value driver in LBCL.

Transition manufacturing to LyFEshort-term

Internal manufacturing is intended to reduce supply risk and improve economics.

Expand into solid tumorsmedium-term

Solid tumors broaden the addressable market beyond hematologic cancers.

Build a broader next-generation CAR T platformlong-term

Platform breadth can improve differentiation and support future partnerships or launches.

Lyell is a pre-revenue clinical-stage company, so its business depends on successful trial outcomes, regulatory...

critical

Clinical development failure

Lead assets are still in trials and may not show sufficient safety or efficacy.

Scope: ronde-cel, LYL273 and other pipeline programs
Materiality: high

high

Manufacturing and supply disruption

Patient-specific CAR T production is complex and any transfer or quality issue can delay trials.

Scope: LyFE ramp-up, West Hills closure, clinical supply continuity
Materiality: high

high

Capital needs and dilution

The company has substantial losses and no commercial revenue to fund operations.

Scope: ongoing R&D, manufacturing and trial spend
Materiality: high

high

Competitive pressure

Approved CAR T therapies, bispecifics and other oncology drugs already have physician familiarity and payer coverage.

Scope: LBCL and mCRC markets
Materiality: high

medium

Integration and acquisition risk

ImmPACT and LYL273 integration may not deliver expected cost savings or pipeline benefits.

Scope: technology transfer, personnel retention, unknown liabilities
Materiality: medium

Fair value of SPA put/call instrument

Can affect other income/expense and net loss

Acquisition accounting

Can affect goodwill/intangibles, amortization and future impairment risk

Restructuring and facility closure accounting

Can affect operating expenses and cash outflows

Clinical and manufacturing asset recoverability

Potential impairment charges if programs or capacity plans change

Lyell Immunopharma, Inc.

Clinical development failure

Manufacturing and supply disruption

Capital needs and dilution

Competitive pressure

Integration and acquisition risk

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