What Lyell Immunopharma does

Lyell Immunopharma, Inc. (NASDAQ: LYEL) is a clinical-stage biotechnology company headquartered in South San Francisco, California, developing next-generation autologous CAR T-cell therapies for hematologic malignancies and solid tumors. The company was founded in 2018 by cell therapy pioneers Rick Klausner, Crystal Mackall, and Stan Riddell, and went public on NASDAQ in one of the largest biotech IPOs of its year. Lyell operates from three U.S. locations — South San Francisco (corporate headquarters), Seattle (clinical development, research, and process sciences), and Bothell, Washington (the LyFE Manufacturing Center, a wholly-owned cGMP cell therapy facility approved for clinical and commercial production with capacity for more than 1,200 patient products per year).

The company's pipeline is built around two lead autologous CAR T-cell product candidates supported by a proprietary cell therapy technology platform. The lead asset, ronde-cel (rondecabtagene autoleucel / LYL314), is a dual-targeting CD19/CD20 OR logic-gated CAR T-cell product candidate manufactured using a proprietary CD62L+ T-cell enrichment process. Ronde-cel is being evaluated in the PiNACLE single-arm pivotal trial (~120 patients, 3L+ aggressive large B-cell lymphoma) and the PiNACLE-H2H Phase 3 head-to-head randomized trial (~400 patients, 2L LBCL vs liso-cel or axi-cel) — the first randomized head-to-head comparison between CAR T-cell therapies. Phase 1/2 data has shown a 93% ORR and 76% CR rate with 18-month median PFS in 3L+ LBCL and a 97% manufacturing success rate. The second clinical asset, LYL273, is a guanylyl cyclase-C (GCC)-targeted CAR T-cell product candidate (with CD19 CAR and controlled cytokine release enhancements) in-licensed from Innovative Cellular Therapeutics in November 2025 for metastatic colorectal cancer, and is being evaluated in the Phase 1/2 CARABINER trial. Both assets hold FDA Fast Track designation, and ronde-cel additionally holds Regenerative Medicine Advanced Therapy (RMAT) designation.

Lyell is a pre-revenue company with no commercial product sales. Its business model is to advance clinical development, file a BLA for ronde-cel in the second half of 2027, and manufacture commercial supply in-house at the LyFE Manufacturing Center. Current operations are funded primarily through equity capital, including a ~$100 million two-tranche equity private placement closed in March 2026, against $134 million in annual R&D spending and a cash position of $254–280 million providing a runway into Q2 2027. The company serves the oncology and cell therapy community primarily through scientific conferences, peer-reviewed publications (including JAMA Oncology), its clinical trial sites in the U.S., Canada, and Australia, and direct engagement with treating centers and investigators.

Name

Lyell Immunopharma

Legal name

Lyell Immunopharma, Inc.

Website

https://lyell.com

Company type

Public

Founded year

2018

Operating status

Operating

Headcount range

101–250 employees

Short description

Lyell Immunopharma is a clinical-stage biotechnology company developing next-generation autologous CAR T-cell therapies for hematologic malignancies and solid tumors, using a proprietary CD62L+ enrichment manufacturing process and dual-targeting CAR constructs (ronde-cel for LBCL, LYL273 for metastatic colorectal cancer), with in-house cGMP manufacturing at its LyFE Manufacturing Center in Bothell, Washington.

Ownership category

akta.pro rank

Product category

Cell Therapy / CAR T-Cell Oncology

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

CAR-T & TCR-T Therapies (HLAAABAC)

akta.pro secondary industry

Hematologic Oncology (Leukemia/Lymphoma/Myeloma) (HLAKAFAD)

Keywords

• CAR T-cell therapy
• Cell therapy oncology
• Autologous cell therapy
• Cancer immunotherapy
• Clinical-stage biopharmaceutical

Headquarters

HQ city

South San Francisco

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Infrastructure

Revenue model

1. No Commercial Product Revenue: Lyell Immunopharma is a clinical-stage biotech with no commercial product sales. The company generated $134 million in annual R&D spending, held $254 million in cash with a 23-month runway, and is dependent on equity financings (e.g., $100 million private placement) to sustain operations through pivotal data and potential BLA filing in 2027.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels7 records

Core offering

Lyell Immunopharma is a clinical-stage cell therapy company developing next-generation autologous CAR T-cell product candidates for hematologic malignancies and solid tumors. Its lead asset, ronde-cel (rondecabtagene autoleucel / LYL314), is a dual-targeting CD19/CD20 CAR T-cell therapy in pivotal development for large B-cell lymphoma; its second asset, LYL273, targets guanylyl cyclase-C for metastatic colorectal cancer. All candidates are manufactured at Lyell's wholly-owned LyFE Manufacturing Center in Bothell, Washington.

Product overview

Lyell Immunopharma is a clinical-stage cell therapy company, not a multi-product SaaS platform. Its offering is a focused pipeline of next-generation autologous CAR T-cell product candidates supported by an integrated discovery-to-manufacturing capability. The lead asset ronde-cel (also known as LYL314) is being advanced in two pivotal programs — the single-arm PiNACLE trial in third- or later-line aggressive large B-cell lymphoma (LBCL) and the randomized PiNACLE-H2H Phase 3 head-to-head trial versus liso-cel or axi-cel in the second-line LBCL setting. Its second clinical asset LYL273 is a GCC-targeted CAR T-cell product candidate (with CD19 CAR and controlled cytokine release enhancements) in Phase 1/2 development for metastatic colorectal cancer, with an additional undisclosed preclinical solid tumor program. All programs are powered by Lyell's proprietary cell therapy technology platform — featuring CD62L+ enrichment and dual-targeting CD19/CD20 logic-gated CAR constructs — and manufactured at Lyell's wholly-owned LyFE Manufacturing Center in Bothell, Washington, which at full capacity can produce more than 1,200 patient CAR T-cell products per year. Together, these named products, the underlying science platform, and the in-house manufacturing facility form a single integrated cell therapy offering rather than a platform-plus-modules architecture.

Differentiator

Problem solved

Functional benefit

Brands

• LyFE Manufacturing Center: Lyell's state-of-the-art cell therapy manufacturing facility located in Bothell, Washington; a registered trademark of Lyell Immunopharma, Inc.
• PiNACLE
• PiNACLE-H2H

Products and services

• Ronde-cel (rondecabtagene autoleucel / LYL314) — 3L+ LBCL Pivotal Program Autologous dual-targeting CD19/CD20 CAR T-cell product candidate that recognizes and kills malignant B cells expressing either CD19 or CD20 antigens, manufactured using Lyell's proprietary CD62L+ enrichment process to enrich for naive and central memory T cells. Indicated for third- or later-line aggressive large B-cell lymphoma and currently in pivotal PiNACLE trial.
• Ronde-cel — 2L LBCL PiNACLE-H2H Phase 3 Program Phase 3 head-to-head randomized controlled trial of ronde-cel versus investigator's choice of liso-cel or axi-cel for second-line treatment of relapsed/refractory aggressive large B-cell lymphoma; first randomized head-to-head comparison between CAR T-cell therapies; primary endpoint is event-free survival.
• LYL273 Autologous guanylyl cyclase-C (GCC)-targeted CAR T-cell product candidate in Phase 1/2 development (CARABINER trial) for relapsed/refractory metastatic colorectal cancer; expresses GCC, CD19, and GCC/CD19 doublet CAR T cells and is enhanced with controlled cytokine release to overcome solid tumor microenvironment barriers; in-licensed from Innovative Cellular Therapeutics.
• LyFE Manufacturing Center Lyell's wholly-owned, state-of-the-art cell therapy manufacturing facility in Bothell, Washington, approved for clinical and commercial CAR T-cell production; provides supply chain control and the ability to rapidly incorporate manufacturing innovations into Lyell's product candidates.

Quantifiable outcome

• 93% overall response rate (ORR) and 76% complete response (CR) rate with 18-month median progression-free survival in third-line or later LBCL treatment (ronde-cel)
• +6 more outcomes

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature5 records

Partnerships

Three partnerships are on record, tiered core and flagship.

• SEC (Securities and Exchange Commission)coreOthers · 3 April 2026Lyell Immunopharma filed a Form S-3 with the U.S. Securities and Exchange Commission on April 3, 2026 as a regulatory requirement for securities offerings.
• Innovative Cellular TherapeuticsflagshipOEM/ Whitelabel/ Licensing Partner · 10 November 2025Lyell acquired exclusive global rights to LYL273, a next-generation CAR T-cell product candidate in clinical development for metastatic colorectal cancer, from Innovative Cellular Therapeutics. The Phase 1 U.S. trial demonstrated a 67% response rate. Lyell intends to advance LYL273's clinical development, with the FDA later granting Fast Track designation.
• ImmPACT BiocoreStrategic or Co-development Partner · 1 October 2024Lyell Immunopharma acquired ImmPACT Bio (a $30 million purchase reported as part of the October 16–31, 2024 oncology capital raises). Sumant Ramachandra, who served as CEO of ImmPACT Bio USA, joined Lyell's Board of Directors in October 2024 when ImmPACT was acquired by Lyell.

Scale indicators14 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Gilead Sciences (Kite Pharma): Gilead's Kite Pharma subsidiary markets Yescarta and Tecartus — CD19-directed autologous CAR T-cell therapies approved in large B-cell lymphoma and mantle cell lymphoma, directly competing with ronde-cel in the same indication and patient setting.
• Bristol Myers Squibb (Juno Therapeutics / Celgene): BMS markets Breyanzi (liso-cel) and Abecma, both autologous CAR T-cell therapies; liso-cel is an investigator's choice comparator in Lyell's PiNACLE-H2H Phase 3 trial, making BMS the most direct head-to-head competitor.
• Allogene Therapeutics: Allogene is an allogeneic (off-the-shelf) CAR T-cell company developing CD19 and BCMA candidates, including the Cemacabtagene ansegedleucel program for LBCL. It overlaps directly with ronde-cel's hematologic indications while pursuing a fundamentally different allogeneic manufacturing model.
• Nkarta: Nkarta is developing allogeneic and autologous CAR NK cell product candidates for hematologic malignancies and autoimmune disease, overlapping with Lyell's cell therapy modality and target indications. Lyell's incoming CMO David Shook was formerly Nkarta's CMO and Head of R&D.
• Caribou Biosciences: Caribou is a clinical-stage allogeneic CAR T-cell company (CB-010, CB-011, CB-012) targeting CD19 and other antigens in B-cell malignancies. It is a direct peer in cell-based cancer therapy modality and B-cell lymphoma indication.

Broad incumbents

• Novartis: Novartis markets Kymriah, the first FDA-approved CD19 CAR T-cell therapy, used in pediatric ALL and adult DLBCL. As a large incumbent with established global manufacturing and commercialization, Novartis is a key competitive reference point for Lyell's heme pipeline.

Emerging players

• CRISPR Therapeutics: CRISPR Therapeutics, partnered with Vertex, developed Casgevy (exa-cel), the first FDA-approved CRISPR-based cell therapy. The company is also advancing allogeneic CAR T programs in oncology, making it an adjacent cell-therapy peer with overlapping platform science.
• Iovance Biotherapeutics: Iovance commercializes Amtagvi (lifileucel), a tumor-infiltrating lymphocyte (TIL) therapy approved for advanced melanoma, and is expanding in solid tumors. Comparable to Lyell as a clinical-to-commercial cell therapy company targeting solid tumor indications, though using a different cell type and modality.
• Cellectis: Cellectis is a clinical-stage gene-editing company developing allogeneic CAR T-cell product candidates (including UCART19/ALLO-501) for hematologic malignancies. It is a peer in the CAR T-cell modality with overlapping heme targets but a distinct allogeneic platform.
• Adaptimmune Therapeutics: Adaptimmune commercializes Tecelra (afami-cel), an engineered TCR-T cell therapy approved for synovial sarcoma, and is developing next-generation cell therapies for solid tumors. Overlaps with Lyell's solid tumor ambitions in autologous engineered T-cell therapy, though it uses TCR rather than CAR recognition.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/lyell

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Subsidiaries1 record

Funding overview

Funding rounds3 records

Investors7 records

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M&A1 record

Investments6 records

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Lyell Immunopharma