Lyell Immunopharma, Inc. (LYEL) Business Model Canvas

Lyell Immunopharma, Inc. (LYEL): Business Model Canvas [Dec-2025 Updated]

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You're looking at Lyell Immunopharma, Inc., a clinical-stage biotech whose entire business model is currently a high-stakes bet on next-generation cell therapies designed to finally conquer T-cell exhaustion. Honestly, the canvas paints a picture of a company deep in the R&D trenches, burning through about $28.2 million in the third quarter of 2025, but they've bought themselves time with roughly $320 million in cash and securities as of Q3 2025, plus a recent capital raise. The core question driving all their key activities and partnerships is whether lead asset ronde-cel can secure approval for Large B-cell Lymphoma, and if LYL273 can follow through on its 67% overall response rate in tough-to-treat metastatic colorectal cancer; let's dissect the nine building blocks to see exactly where the near-term risk and upside are hiding in Lyell Immunopharma, Inc.'s strategy.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Key Partnerships

You're looking at the external relationships Lyell Immunopharma, Inc. relies on to drive its pipeline forward, especially with those pivotal trials ramping up. These aren't just casual agreements; they are foundational to getting their next-generation CAR T-cell therapies, like ronde-cel and LYL273, through late-stage development.

Innovative Cellular Therapeutics: Acquired exclusive global rights to LYL273 (GCC CAR-T)

The deal to secure LYL273, a GCC-targeted CAR T-cell product candidate for metastatic colorectal cancer (mCRC), involved significant upfront and contingent commitments with Innovative Cellular Therapeutics (ICT). Lyell Immunopharma gained exclusive global rights, excluding mainland China, Hong Kong, Macau, and Taiwan.

Upfront Payment to ICT $40 million
Equity Issued to ICT 1.9 million shares of common stock
Potential Clinical Milestone Payments $30 million
Potential Late-Stage Regulatory Milestone Payments Up to $115 million
Potential Commercial Sales Milestone Payments As much as $675 million
U.S. Royalty Rate (Max) 10% on annual net sales
LYL273 Phase 1 ORR (Highest Dose) 67%
LYL273 Phase 1 Disease Control Rate (Highest Dose) 83%

Clinical Research Organizations (CROs) and academic centers for pivotal trials

Lyell Immunopharma is advancing two pivotal trials for its lead candidate, ronde-cel (LYL314). The company relies on established clinical infrastructure, supported by FDA designations like Regenerative Medicine Advanced Therapy (RMAT) and Fast Track, to execute these studies. The manufacturing capability is also a key operational partnership, whether internal or external.

  • PiNACLE (3L+ setting) expected enrollment: Approximately 120 patients.
  • PiNACLE - H2H (2L setting) designed enrollment: Approximately 400 patients.
  • LyFE Manufacturing Center capacity: Over 1,000 CAR T-cell therapy doses per year.

PiNACLE - H2H Steering Committee: Collaboration with lymphoma and cell therapy experts

The initiation of the PiNACLE - H2H Phase 3 head-to-head trial required forming a Steering Committee comprised of distinguished experts to advise on the design and conduct. This collaboration ensures the trial evaluates ronde-cel against investigator's choice of approved CD19 CAR T-cell therapies, like lisocabtagene maraleucel or axicabtagene ciloleucel, in the second-line (2L) setting.

Trial Design Endpoint (H2H) Event-free survival
Ronde-cel Dose in H2H Trial 100 x 106 CAR T cells
Expert Committee Institutions (Examples) University of Chicago, Moffitt Cancer Center, University of Colorado, University of Nebraska Medical Center

Institutional investors from the Q2 2025 PIPE financing of up to $100 million

To fund these pivotal programs and extend its operational runway, Lyell Immunopharma closed a private placement in July 2025. This financing was crucial for maintaining operations through key clinical milestones.

The initial closing provided a significant cash boost, which, combined with existing balances, provided financial certainty.

Gross Proceeds Target (PIPE) Up to approximately $100 million
Initial Closing Proceeds (July 2025) Approximately $50 million
Initial Closing Share Price $13.32 per share
Pro-forma Cash (Post-Initial Closing) Approximately $347 million (as of June 30, 2025)
Cash Runway Extension Into mid-2027
Estimated 2025 Net Cash Use (Excluding LYL273 Upfront) Between $155 million and $160 million

Suppliers for specialized cell therapy manufacturing materials

While specific supplier names aren't detailed, the company's ability to manufacture LYL314 clinical supply at its LyFE Manufacturing Center, following FDA clearance of an IND amendment, indicates a critical internal or closely managed external supply chain partnership for specialized materials.

  • Manufacturing Center Location: Bothell, Washington.
  • LYL314 clinical supply manufactured following FDA clearance of an IND amendment.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Key Activities

You're looking at the core engine driving Lyell Immunopharma, Inc.'s value right now-the activities that consume capital and generate clinical milestones. Honestly, for a late-stage biotech, this is where the rubber meets the road.

Conducting Pivotal Clinical Trials for LYL314 (ronde-cel) in LBCL

The primary focus remains on advancing rondecabtagene autoleucel (ronde-cel, or LYL314) in relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL). The company is running two distinct pivotal programs. The first is the PiNACLE trial, a single-arm study targeting patients in the third- or later-line (3L+) setting. Data from this trial are targeted for a Biologics License Application (BLA) submission to the FDA in 2027. The second, and newer, pivotal effort is the Phase 3 head-to-head trial, PiNACLE - H2H, which is randomized and is set to evaluate ronde-cel against an approved CD19 CAR T-cell therapy in the second-line (2L) setting. This 2L trial is planned to initiate by early 2026 and is expected to enroll approximately 400 patients.

We have some hard numbers from the earlier Phase 1/2 work that informs this pivotal development. As of the April 15, 2025, data cutoff, 51 CAR T-naive patients with R/R LBCL had received LYL314. Looking specifically at the 3L+ cohort presented in mid-2025, 25 subjects achieved an 88% overall response rate (ORR) and a 72% complete response rate (CRR). To show durability, 71% of those who achieved a complete response in that group maintained it for six months or more.

Here's a quick look at the pipeline activity:

  • Ronde-cel (LYL314) is in pivotal development for R/R LBCL.
  • PiNACLE trial is ongoing for the 3L+ setting.
  • PiNACLE - H2H (Phase 3) is planned for the 2L setting.
  • Mature data from the Phase 1/2 trial for the 2L setting are expected in late 2025.

Research and Development (R&D) of Proprietary Technologies

Lyell Immunopharma, Inc.'s R&D efforts are centered on its proprietary technology designed to overcome T-cell exhaustion and enhance T-cell persistence. Ronde-cel itself embodies this, utilizing a dual-targeting CD19/CD20 CAR design with an 'OR' logic gate for broader B-cell targeting. Furthermore, the manufacturing process is a key R&D component, as it is specifically designed to enrich for T cells expressing CD62L, aiming to generate a product with a greater memory phenotype and enhanced antitumor activity.

The financial commitment to this research is visible in the operating expenses. Research and development (R&D) expenses for the third quarter ended September 30, 2025, totaled $28.2 million. This was a notable decrease of $11.3 million compared to the same period in 2024, primarily driven by a $4.4 million reduction in costs for research activities, collaborations, and outside services.

Manufacturing Clinical Supply at the LyFE Manufacturing Center™

The company relies on its wholly-owned, state-of-the-art facility, the LyFE Manufacturing Center™ in Bothell, Washington, for clinical supply. Following a successful technology transfer and clearance by the FDA of an Investigational New Drug (IND) amendment, this center began manufacturing LYL314 clinical supply. The facility is a 70,000 square foot operation, initially completed at a cost of $65 million. Management expects this center to scale to meet demand through potential commercial launch, with an internal capacity stated to be over 1,000 CAR T-cell therapy doses per year.

To streamline operations, Lyell Immunopharma, Inc. approved the closure of the West Hills manufacturing facility on March 31, 2025, which was acquired as part of the ImmPACT Bio transaction. This closure involved a workforce reduction of approximately 73 employees in West Hills and was expected to incur aggregate expenses between $3.0 million to $4.0 million in the second and third quarters of 2025.

Here are the key manufacturing details:

Facility Location Primary Product Supplied Stated Capacity (Doses/Year) Status of Other Facilities
LyFE Manufacturing Center, Bothell, WA LYL314 clinical supply Over 1,000 West Hills facility closed as of March 31, 2025

Advancing LYL273 (GCC CAR-T) in Phase 1 for Metastatic Colorectal Cancer

A significant recent strategic activity was the acquisition of exclusive global rights to LYL273, a novel GCC-targeted CAR T-cell product candidate for refractory metastatic colorectal cancer (mCRC), which Lyell announced in November 2025. This move was supported by promising early data from an ongoing U.S. Phase 1 clinical trial.

The financial commitment for this asset included a $40 million payment related to the license acquisition. The clinical performance metrics reported for LYL273 at the highest dose level studied to date (data cutoff October 28, 2025, in 12 patients) are compelling:

Indication Dose Level Studied Overall Response Rate (ORR) Disease Control Rate (DCR)
Refractory mCRC (Phase 1) Highest Dose Level 67% 83%

At that highest dose, which was 2 x 106 CAR T cells/kg, the median progression-free survival (PFS) was reported as 7.8 months.

Securing Regulatory Approvals

Lyell Immunopharma, Inc. has successfully navigated key regulatory milestones for its lead program, LYL314. The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for ronde-cel in two separate settings, which is a big deal because RMAT designation provides all the benefits of both Fast Track and Breakthrough Therapy designation programs, allowing for early interactions with the FDA.

The regulatory achievements include:

  • RMAT designation for LYL314 in the third- or later-line (3L+) setting.
  • RMAT designation for LYL314 in the second-line (2L) setting, announced in November 2025.
  • Fast Track Designation for LYL314 in the 3L+ setting.

The company also has two abstracts accepted for oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition in December 2025, highlighting new clinical and translational data.

Financially, the company reported approximately $320 million in cash, cash equivalents, and marketable securities as of September 30, 2025. Management stated this cash position is expected to support advancing the pipeline into 2027 through key clinical milestones, including these regulatory and trial advancements.

Finance: draft 13-week cash view by Friday.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Key Resources

You're looking at the core assets Lyell Immunopharma, Inc. (LYEL) relies on to execute its strategy, especially given the capital-intensive nature of cell therapy development. These aren't just line items; they are the engine for their next-generation CAR T-cell candidates.

Financially, the immediate resource is liquidity. As of September 30, 2025, Lyell Immunopharma, Inc. reported cash, cash equivalents, and marketable securities of approximately $320 million. This balance, even after the $40 million upfront payment for LYL273, is projected to fund working capital and capital expenditures into 2027, giving them a clear runway past several critical clinical readouts.

The technological foundation is built upon proprietary T-cell reprogramming technologies. These are specifically designed to address what Lyell Immunopharma, Inc. identifies as the primary barriers to consistent, curative adoptive T-cell therapy: T-cell exhaustion and the lack of durable stemness. This proprietary know-how underpins their entire pipeline.

Manufacturing control is another significant resource. Lyell Immunopharma, Inc. owns and operates the Lyell Manufacturing Center™ in Bothell, Washington. This facility, completed in 2021 for $65 million, spans 70,000 square feet and is designed with advanced digital systems, including integration with Amazon Web Services, for real-time process monitoring. The facility has the capacity to produce over 1,000 CAR T-cell therapy doses per year, which is crucial for supporting their ongoing and planned pivotal trials.

This technology and manufacturing capability are protected by a substantial intellectual property portfolio. This IP covers the specific CAR T-cell enhancements, like the CD62L+ enrichment for ronde-cel, and the proprietary manufacturing protocols themselves, which are integral to product consistency and performance.

The most visible resources are the lead clinical assets, which represent the near-term value drivers. Here's a quick look at the two main programs as of late 2025:

Asset Modality/Target Indication Key Status/Data Point (Late 2025)
LYL314 (ronde-cel) Dual-targeting CD19/CD20 CAR T-cell Aggressive Large B-Cell Lymphoma (LBCL) RMAT designation for 2L setting (Nov 2025); PiNACLE-H2H Phase 3 expected enrollment start by early 2026.
LYL273 GCC-targeted CAR T-cell Refractory Metastatic Colorectal Cancer (mCRC) Acquired asset with 67% Overall Response Rate (ORR) at highest dose in Phase 1.

The strength of the pipeline is further detailed by the specific regulatory and trial milestones achieved or anticipated for these assets. You can see the immediate focus areas:

  • Ronde-cel (LYL314) received RMAT designation for the 3L+ setting in April 2025 and for the 2L setting in November 2025.
  • The PiNACLE pivotal trial for 3L+ LBCL is ongoing, with a progress update expected in late 2025.
  • The Phase 3 head-to-head trial (PiNACLE-H2H) for 2L LBCL is initiating sites, aiming for first patient in early 2026.
  • LYL273 data package includes an 83% disease control rate at the highest dose level studied.

These tangible assets-cash runway, proprietary science, controlled manufacturing, and two clinical-stage assets with recent positive data-form the bedrock of Lyell Immunopharma, Inc.'s current enterprise value.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Value Propositions

Lyell Immunopharma, Inc.'s value proposition centers on delivering next-generation CAR T-cell therapies engineered to overcome key limitations of current treatments, specifically targeting T-cell exhaustion and enhancing persistence, particularly in solid tumors.

The core technology is designed to create T cells with enhanced stemlike features, which is supported by their manufacturing process. The final drug product for LYL314 contained the desired CD62L-positive naïve T-cell phenotype with a median of 95%. Furthermore, LYL314 demonstrated robust expansion with a time to peak of 10 days in clinical settings. Lyell Immunopharma, Inc. is advancing these next-generation CAR T-cell product candidates, which are fully-armed with multiple technologies designed to address T-cell exhaustion and immune suppression within the hostile tumor microenvironment. The first Investigational New Drug (IND) application for a fully-armed solid tumor product candidate is expected in 2026.

The dual-targeting approach in the lead program, LYL314 (ronde-cel), is a key differentiator against antigen escape. This therapy targets both CD19 and CD20. Data from the Phase 1/2 trial in patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) in the third- or later-line (3L+) setting showed compelling efficacy:

Metric LYL314 (R/R LBCL, 3L+ Setting) LYL314 (R/R LBCL, 3L+ Setting, Prior Data Point)
Overall Response Rate (ORR) 88% (N = 25) 94% (16/17 patients)
Complete Response (CR) Rate 72% (N = 25) 71% (12/17 patients by three months)
Durability of CR ($\ge$ 6 months) 71% of CR patients N/A

For solid tumors, Lyell Immunopharma, Inc. is advancing LYL273, a guanylyl cyclase-C (GCC)-targeted CAR T-cell product candidate, which is also enhanced with CD19 CAR expression and controlled cytokine release. GCC expression is present on over 95% of metastatic colorectal cancer (mCRC) cases. The clinical activity observed in patients with refractory mCRC is a significant value driver:

  • LYL273 showed a 67% overall response rate at the highest dose level studied to date in patients with refractory mCRC.
  • The disease control rate reached 83% at the highest dose level.
  • At Dose Level 2, the median progression-free survival was 7.8 months.
  • The acquisition of global rights for LYL273 included an upfront payment of $40 million and 1.9 million shares.

Financially, Lyell Immunopharma, Inc. is positioned to support its pipeline advancement into 2027 through key clinical milestones, holding approximately $320 million in cash, cash equivalents, and marketable securities as of September 30, 2025. Research and development expenses for the third quarter ended September 30, 2025, were $28.2 million, contributing to a net loss of $38.8 million for that quarter.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Customer Relationships

You're building a commercial-ready cell therapy operation, so the relationship with the clinical sites, investigators, and the FDA is everything right now. For Lyell Immunopharma, Inc., this means managing complex logistics and proving durability to key opinion leaders (KOLs) before the product hits the market.

High-touch, specialized support for autologous cell collection and delivery logistics centers around the LyFE Manufacturing Center™ in Bothell, Washington. This facility is designed for scale, with the capacity to manufacture more than 1,200 CAR T-cell doses at full capacity, supporting both ongoing pivotal trials and potential commercial launch. This manufacturing capability is a direct relationship touchpoint, ensuring the supply chain for autologous products is robust.

Direct engagement with clinical investigators and key opinion leaders (KOLs) is evidenced by the structure of their pivotal trials. The PiNACLE trial, a single-arm study for patients with relapsed and/or refractory (R/R) B-cell lymphomas in the third- or later-line (3L+) setting, is expected to enroll approximately 120 patients. Furthermore, the planned Phase 3 head-to-head trial, PiNACLE - H2H, in the second-line (2L) setting, is expected to enroll approximately 400 patients, split into 200 per arm. To guide this, Lyell Immunopharma formed an expert steering committee of lymphoma and cell therapy experts to collaborate on the design and conduct of PiNACLE - H2H.

Management of the regulatory relationship with the FDA has secured critical designations for their lead candidate, ronde-cel (LYL314). The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for ronde-cel for patients with R/R LBCL receiving treatment in the second-line (2L) setting. This designation, along with the prior Fast Track status, signals a close working relationship aimed at expedited review. The data from the 3L+ setting trial is targeted to form the basis of a Biologics License Application (BLA) submission to the FDA in 2027.

Scientific communication is a key way Lyell Immunopharma engages the broader medical customer base. They had two abstracts accepted for oral presentation at the ASH 67th Annual Meeting and Exposition in December 2025, highlighting new clinical and translational data from the Phase 1/2 trial of ronde-cel. This direct scientific exchange builds credibility with prescribing physicians.

Building the commercial readiness team involved strategic hires in 2025 to align with late-stage clinical progress. The company appointed leaders with 'deep cell therapy expertise and highly relevant experience launching new medicines for patients' in June 2025. The addition of a new Board member brought 'experienced commercial leadership, including in cell therapy,' at the critical time as pivotal trials initiated.

Here's a quick look at the operational scale supporting these customer-facing activities as of late 2025:

Metric Value/Status
LyFE Manufacturing Center Capacity (Doses/Year) Over 1,200
PiNACLE Trial (3L+ LBCL) Expected Enrollment Approximately 120 patients
PiNACLE - H2H Trial (2L LBCL) Expected Enrollment (Total) Approximately 400 patients
FDA Designation for 2L LBCL RMAT designation
Planned BLA Submission Year (3L+ Data) 2027
Key Scientific Presentation Date December 2025 (ASH)

The focus on building out the executive and board structure shows a clear shift toward commercial readiness. For instance, personnel-related expenses in General and Administrative (G&A) increased due to higher headcount in Q1 2025, partly driven by these strategic additions.

You can see the relationship management is multi-faceted:

  • Logistics: Ensuring the LyFE Center can deliver over 1,200 doses.
  • Clinical: Initiating trials enrolling up to 400 patients in the 2L setting.
  • Regulatory: Securing RMAT for the 2L indication.
  • Scientific: Presenting data at the December 2025 ASH meeting.
  • Commercial: Adding leaders with launch experience in 2025.

Finance: draft 13-week cash view by Friday.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Channels

You're mapping out how Lyell Immunopharma, Inc. (LYEL) gets its product-or the promise of it-to the world, which, as a cell therapy company, is a complex dance between clinical sites and internal production. For late 2025, the channels are heavily weighted toward clinical execution and building the infrastructure for what comes next.

Specialized oncology treatment centers and hospitals (future commercialization)

The channel for future commercialization, which involves specialized oncology treatment centers and hospitals, is being built now through the readiness of the internal supply chain. Lyell Immunopharma, Inc. expects its manufacturing hub to provide drug supply not just for ongoing and planned pivotal trials but also through potential commercial launch. This readiness is a key indicator for future distribution channels.

The company's financial position as of September 30, 2025, with cash, cash equivalents, and marketable securities at approximately $320 million, is intended to support advancing the pipeline into 2027 through key clinical milestones, which directly underpins the timeline for establishing these commercial channels.

Clinical trial sites for patient enrollment and treatment delivery

Currently, the primary channel for patient access is the network of clinical trial sites supporting ongoing studies. Lyell Immunopharma, Inc. is actively enrolling patients in its pivotal trials. The company has noted that the number of qualified clinical investigators and clinical trial sites is limited, which can affect enrollment speed.

Key activities in late 2025 involved:

  • Initiating the PiNACLE pivotal trial for LYL314 in the third- or later-line (3L+) setting.
  • Remaining on track to initiate a pivotal trial in the second-line (2L) setting by early 2026.
  • The Phase 1/2 trial for LYL314 included 36 patients in the efficacy evaluable population as of the April 15, 2025, cutoff date.

LyFE Manufacturing Center™ as the central production and supply chain hub

The LyFE Manufacturing Center™ in Bothell, Washington, is the core of Lyell Immunopharma, Inc.'s supply channel. This facility successfully completed technology transfer and received clearance from the FDA via an Investigational New Drug Amendment to begin manufacturing LYL314 clinical supply. This center was built at a cost of $65 million.

Here's a look at the manufacturing channel status and related financial actions as of mid-to-late 2025:

Metric Value/Status Date/Period Reference
Capacity Over 1,000 CAR T-cell therapy doses per year Q1 2025 Data
Facility Closure Cost Expected aggregate expenses between $3.0 million to $4.0 million Q1 2025 Actions
Facility Closure Workforce Reduction Approximately 73 employees Q1 2025 Actions
Total Assets $408 million September 30, 2025
Cash, Cash Equivalents, Marketable Securities Approximately $320 million September 30, 2025

Scientific publications and medical conferences for data dissemination

Dissemination of clinical and translational data is a critical channel for establishing credibility and informing the medical community about Lyell Immunopharma, Inc.'s progress. This is done through peer-reviewed publications and presentations at major medical meetings. The company reported revenue of only $15,000 for the third quarter ending September 30, 2025, underscoring that data dissemination, not product sales, is the current focus of this channel.

Key dissemination events through late 2025 included:

  • Oral presentation of LYL314 data at the 18th International Conference on Malignant Lymphoma in June 2025.
  • Presentation of an abstract on Stim-R™ technology at the American Association for Cancer Research Annual Meeting in 2025.
  • Acceptance of two abstracts for oral presentation at the ASH 67th Annual Meeting and Exposition in December 2025.

The data presented at ASH is expected to form the basis of a Biologics License Application submission to the FDA in 2027 for patients with R/R LBCL receiving treatment in the 3L+ setting.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Customer Segments

You're looking at the core groups Lyell Immunopharma, Inc. (LYEL) needs to engage to bring its cell therapies to market. This isn't just about the patients; it's about the entire ecosystem that decides who gets treated and who pays for it.

Patients with relapsed or refractory (R/R) Large B-cell Lymphoma (LBCL) (2L/3L+)

This group represents the immediate, high-need population for ronde-cel (LYL314). The data from the ongoing trials show a clear potential to disrupt the current standard, where historical benchmarks like the SCHOLAR-1 study showed an objective response rate of only 26% and a complete remission rate of a mere 7% for refractory DLBCL patients. Lyell Immunopharma, Inc. (LYEL) is targeting this unmet need directly.

Here's a look at the clinical activity for LYL314 in this segment as of late 2025:

Patient Cohort / Trial Setting Patient Count (N) Median Follow-up Overall Response Rate (ORR) Complete Response (CR) Rate
PiNACLE (3L+ Pivotal Trial) - Efficacy Evaluable 25 9 months 88% 72%
Phase 1/2 (2L Setting) - Efficacy Evaluable 11 5 months 91% 64%
Primary Refractory (Subset of Efficacy Evaluable) 10 N/A N/A 70%

The durability of response is also a key factor for this segment. In the 3L+ cohort, 71% ($\text{10/14}$) of patients who achieved a complete response were still in complete response at $\ge \text{6 months}$ of follow-up. Furthermore, the company is preparing for the next step in the 2L setting, with the $\text{PiNACLE - H2H}$ Phase 3 trial expected to enroll approximately 400 patients, with enrollment starting early 2026.

Patients with refractory metastatic Colorectal Cancer (mCRC)

This segment is targeted by LYL273, a novel GCC-targeted CAR T-cell product candidate for which Lyell Immunopharma, Inc. (LYEL) acquired exclusive global rights in November 2025. The biological rationale is strong, as the target receptor, GCC, is expressed on more than 95% of colorectal cancers. The U.S. patient burden is significant, with approximately 53,000 people expected to die from CRC in the U.S. in 2025.

Early clinical activity in the ongoing U.S. Phase 1 trial for refractory mCRC showed promise:

  • Overall Response Rate (ORR) across both dose levels ($\text{N=12}$): 50%.
  • Disease Control Rate (DCR): 83%.

Oncologists and hematologists specializing in cellular immunotherapy

These are the prescribers and administrators who need to trust the safety and efficacy profile of LYL314 and LYL273. The data presented at the ASH 67th Annual Meeting in December 2025 is critical for their adoption. For LYL314, the safety profile observed in 51 patients was described as manageable and appropriate for outpatient administration.

The financial health of Lyell Immunopharma, Inc. (LYEL) directly impacts the continuity of clinical supply and data generation that these specialists rely on:

  • Cash, cash equivalents, and marketable securities as of September 30, 2025: Approximately $320 million.
  • Projected cash runway: Sufficient to meet needs into 2027.
  • Q2 2025 Financing: Gross proceeds of up to approximately $100 million from a private placement.
  • Q3 2025 Financing: Completed a PIPE financing raising $57.8 million.

Payers and government health systems (future reimbursement)

Payers become a primary customer segment upon potential commercial launch. Lyell Immunopharma, Inc. (LYEL) is positioning its therapies to justify premium pricing by demonstrating superior outcomes over existing standards. The Regenerative Medicine Advanced Therapy (RMAT) designation for ronde-cel in the third- or later-line setting is an early signal to payers regarding the drug's potential to address significant unmet needs.

The financial performance in the third quarter ended September 30, 2025, shows the investment required to reach this stage:

  • Net Loss for Q3 2025: $38.8 million.
  • Research and development (R&D) expenses for Q3 2025: $28.2 million.

The focus on durable responses, such as the 71% CR durability at $\ge \text{6 months}$ for LYL314 in 3L+ LBCL, is the core value proposition for securing favorable reimbursement terms from these entities.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Cost Structure

You're looking at the core expenditures for Lyell Immunopharma, Inc. as of late 2025. These costs are heavily weighted toward advancing their cell therapy pipeline, which is typical for a late-stage clinical company.

The primary cost drivers are centered on research, development, and maintaining the internal manufacturing capability. Here's a breakdown of the key financial figures from the third quarter ending September 30, 2025.

High Research and Development (R&D) expenses represent the single largest operational outlay, reflecting the commitment to clinical trials and platform technology refinement. For Q3 2025, GAAP R&D expenses were reported at $28.2 million, a notable decrease from $39.5 million in the same period last year.

This reduction in R&D spending was driven by specific cost-saving measures across key areas:

  • Reduction in research activities, collaborations, and outside services: $4.4 million decrease.
  • Decrease in personnel-related expenses: $4.2 million decrease.

The structure of these R&D costs directly relates to the clinical and manufacturing needs:

Cost Component Area Financial Implication/Metric
Clinical Trial Execution Costs R&D decrease driven by reduction in research activities, collaborations, and outside services, which includes costs associated with clinical trials.
Pivotal/Phase 1 Trial Funding Proceeds from a July 2025 private placement are intended to fund two pivotal-stage clinical trials of LYL314.
Manufacturing & Process Development Costs R&D decrease driven by reduction in research activities, collaborations, and outside services, which includes process development costs.
LyFE Center Capacity The Lyell LyFE Manufacturing Center™ has commercial launch capability and can manufacture over 1,200 CAR T-cell doses at full capacity.

General and Administrative (G&A) expenses were $10.7 million for Q3 2025, down from $11.8 million in Q3 2024. This G&A reduction was mainly due to lower stock-based compensation expense and a decrease in outside services, specifically legal expenses.

A significant, non-recurring or milestone-based cost impacting the balance sheet was the upfront license payment for LYL273, which amounted to approximately $40 million.

The company's cash position is a key factor in managing these costs. Cash, cash equivalents, and marketable securities stood at approximately $320 million as of September 30, 2025, which, after the $40 million LYL273 payment, is expected to fund working capital and capital expenditures into 2027.

Finance: draft 13-week cash view by Friday.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Revenue Streams

You're looking at the current and near-term revenue picture for Lyell Immunopharma, Inc. (LYEL) as of late 2025. For a company deep in late-stage clinical development, revenue is often minimal, coming from non-core activities until a product hits the market. The model here is clearly weighted toward future commercialization and potential upfront/milestone cash infusions.

The current, minimal revenue from product sales is quite small, reflecting the pre-commercial status of their pipeline. This is typical for a biotech firm focused on pivotal trials.

  • Minimal current revenue from sales: $15,000 in Q3 2025.

The primary focus for significant revenue generation rests on their lead asset, ronde-cel (LYL314), which is advancing through pivotal trials for relapsed/refractory Large B-cell Lymphoma (LBCL). The path to commercial sales is clearly defined, though the revenue itself is still a few years out.

  • Future commercial sales of LYL314 (ronde-cel) for LBCL.

Here's what the timeline looks like for LYL314:

Development Event Targeted Timing Indication Setting
Pivotal trial initiation (PiNACLE - H2H) By early 2026 2L R/R LBCL
Biologics License Application (BLA) submission to the FDA 2027 3L+ R/R LBCL

Also on the pipeline is LYL273, which targets solid tumors, offering a diversification of potential future revenue streams beyond hematologic malignancies. This asset is currently in an earlier stage of development.

  • Future commercial sales of LYL273 for mCRC and other solid tumors.

LYL273 is a GCC-targeted CAR T-cell product candidate. The receptor, GCC, is expressed on over 95% of colorectal cancers. Updated Phase 1 clinical data are expected in the first half of 2026.

Beyond product sales, Lyell Immunopharma, Inc. relies on non-operating income derived from its cash reserves. This interest income helps offset some operating burn, though it is sensitive to both the size of the cash balance and prevailing interest rates. You can see the cash balance has been managed, but interest income is a secondary, non-core revenue source.

Financial Metric Amount (Q3 2025)
Interest income on cash and marketable securities $3.3 million
Cash, cash equivalents and marketable securities (as of Sep 30, 2025) Approximately $320 million

The company also has the potential for non-dilutive funding through strategic partnerships, which is a common revenue stream for clinical-stage biotechs. These deals typically involve an upfront payment and subsequent payments tied to development or regulatory achievements.

  • Potential milestone payments from future licensing or collaboration agreements.

To be fair, while there was a recent report of Lyell Immunopharma, Inc. entering into an exclusive license agreement in November 2025, the specific dollar amounts for any milestone payments received or anticipated from that or other deals aren't detailed in the latest public filings, so we only list the potential for this type of revenue.

Finance: draft 13-week cash view by Friday.


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