Business Context and Reporting Period
Company: Lyell Immunopharma, Inc. (LYEL)
Filing Type: Form 10-K (Annual Report)
Reporting Period: Fiscal year ended December 31, 2025
Business Overview: Lyell is a late-stage clinical cell therapy company developing next-generation autologous CAR T-cell therapies for hematologic malignancies and solid tumors. The company has no approved products and has never generated revenue from product sales.
Key Financial Metrics
| Metric (in thousands) | 2025 | 2024 |
|---|---|---|
| Revenue | $36 | $61 |
| Net Loss | $(274,448) | $(342,994) |
| Operating Expenses | $269,440 | $358,816 |
| Cash, Cash Equivalents & Marketable Securities | $247,200 | $370,527 |
| Accumulated Deficit | $(1,619,554) | $(1,345,106) |
| Net Cash Used in Operating Activities | $(150,024) | $(162,394) |
Note: Revenue consists of sublease income. The company has no debt outstanding as of December 31, 2025.
Material Changes vs. Prior Period
- Net Loss Reduction: Net loss decreased by approximately $68.5 million (20%) compared to 2024, primarily driven by a significant reduction in impairment charges and lower operating expenses.
- Acquired IPR&D: The company expensed $66.3 million in acquired in-process research and development (IPR&D) in 2025, related to the November 2025 acquisition of the LYL273 license from Innovative Cellular Therapeutics (ICT). This compares to $87.2 million in 2024 related to the ImmPACT acquisition.
- Impairment Charges: Impairment of long-lived assets dropped significantly from $51.3 million in 2024 to $1.4 million in 2025. The 2025 charge was associated with the closure of the West Hills, Los Angeles facility following the transition of manufacturing to the LyFE Manufacturing Center in Bothell, Washington.
- Other (Expense) Income: The company recorded a $19.2 million loss in 2025 due to the change in fair value of the Securities Purchase Agreement (SPA) put/call liability, contrasting with a gain in 2024.
- Capital Raise: In July 2025, the company raised approximately $50 million via a private placement (SPA). A subsequent closing in March 2026 raised an additional $50 million.
Guidance, Outlook, and Management Commentary
Clinical Pipeline Updates
- Ronde-cel (LYL314): The lead dual-targeting CD19/CD20 CAR T-cell therapy for large B-cell lymphoma (LBCL).
- PiNACLE Trial (3L+): Pivotal single-arm trial ongoing. Updated data presented at ASH 2025 showed a 93% best overall response rate and 76% complete response rate in 29 efficacy-evaluable patients.
- PiNACLE-H2H Trial (2L): Phase 3 head-to-head randomized controlled trial against axi-cel or liso-cel. Patient dosing commenced in February 2026.
- LYL273: Acquired in November 2025; a GCC-targeted CAR T-cell therapy for metastatic colorectal cancer (mCRC).
- Phase 1 U.S. trial ongoing. Data as of October 28, 2025, showed a 67% overall response rate and 83% disease control rate at the highest dose level.
Liquidity and Capital Resources
As of December 31, 2025, the company held $247.2 million in cash, cash equivalents, and marketable securities. Management believes these resources are sufficient to fund operations into the second quarter of 2027. However, the company anticipates needing additional capital to complete clinical development and commercialization efforts.
Risks and Contingencies
- Regulatory Approval: No products are approved; success depends on pivotal trial outcomes and FDA approval.
- Manufacturing: Transitioning manufacturing of LYL273 to the LyFE facility carries execution risk.
- Acquisition Integration: Risks associated with integrating ImmPACT (acquired Oct 2024) and LYL273 (acquired Nov 2025) programs.
- Financial Obligations: Significant contingent milestone payments and royalties are due to ICT and UCLA upon regulatory and commercial milestones.
Key Facts for Investor Verification
- Cash Runway: Verify the sufficiency of the $247.2 million cash balance to fund the expanded Phase 3 trials for ronde-cel and the Phase 1 expansion for LYL273 through Q2 2027.
- Acquisition Milestones: Review the specific clinical and regulatory milestones triggering the $30 million clinical milestone, up to $115 million in regulatory milestones, and up to $675 million in commercial milestones payable to ICT for LYL273.
- Manufacturing Transition: Confirm the successful transfer of LYL273 manufacturing from ICT to Lyell's LyFE Manufacturing Center in Bothell, Washington, to avoid supply delays.
- Stock-Based Compensation: Note the $19.7 million stock-based compensation expense recognized in 2025 related to the ICT equity milestone deemed probable of achievement.
- SPA Put/Call Liability: Monitor the fair value of the $11.4 million SPA put/call liability, which fluctuates with stock price and milestone probabilities.