third quarter 2026
Filed Nov 4, 2026Lyell Immunopharma Reports Business Highlights and Financial Results for the Third Quarter 2026
Updated ronde-cel data and an $80.0 million private placement supported clinical and liquidity milestones, while third-quarter net loss and R&D expense increased versus the prior-year period and revenue remained nominal.
Key metrics
shortened, hover for the filing’s print| Metric | Value | q/q | y/y |
|---|---|---|---|
| Revenue, three months ended September 30, 2026GAAP | $ 3 | – | – |
| Research and development expenses, three months ended September 30, 2026GAAP | $40.9M | – | $12.7 million increase |
| General and administrative expenses, three months ended September 30, 2026GAAP | $9.3M | – | – |
| Other operating income, net, three months ended September 30, 2026GAAP | −$1.90M | – | – |
| Impairment of long-lived assets, three months ended September 30, 2026GAAP | — | – | – |
| Total operating expenses, three months ended September 30, 2026GAAP | $48.30M | – | – |
| Loss from operations, three months ended September 30, 2026GAAP | −$48.30M | – | – |
| Interest income, net, three months ended September 30, 2026GAAP | $1.91M | – | – |
| Other income (expense), net, three months ended September 30, 2026GAAP | $861K | – | – |
| Total other income (loss), net, three months ended September 30, 2026GAAP | $2.77M | – | – |
| Net loss, three months ended September 30, 2026GAAP | $45.5M | – | $6.7 million increase |
| Net loss, three months ended September 30, 2026GAAP | −$45.53M | – | – |
| Net loss, three months ended September 30, 2026non-GAAP | $41.3M | – | $12.2 million increase |
| Net loss, three months ended September 30, 2026non-GAAP | −$41.28M | – | – |
| Research and development expenses, three months ended September 30, 2026non-GAAP | $38.8M | – | – |
| Research and development expenses, three months ended September 30, 2026non-GAAP | $38.77M | – | – |
| General and administrative expenses, three months ended September 30, 2026non-GAAP | $6.9M | – | – |
| General and administrative expenses, three months ended September 30, 2026non-GAAP | $6.91M | – | – |
| Revenue, nine months ended September 30, 2026GAAP | $ 9 | – | – |
| Research and development expenses, nine months ended September 30, 2026GAAP | $117.0M | – | – |
| General and administrative expenses, nine months ended September 30, 2026GAAP | $28.43M | – | – |
| Other operating income, net, nine months ended September 30, 2026GAAP | −$5.55M | – | – |
| Impairment of long-lived assets, nine months ended September 30, 2026GAAP | — | – | – |
| Total operating expenses, nine months ended September 30, 2026GAAP | $139.9M | – | – |
| Loss from operations, nine months ended September 30, 2026GAAP | −$139.9M | – | – |
| Interest income, net, nine months ended September 30, 2026GAAP | $6.28M | – | – |
| Other income (expense), net, nine months ended September 30, 2026GAAP | $19.17M | – | – |
| Total other income (loss), net, nine months ended September 30, 2026GAAP | $25.46M | – | – |
| Net loss, nine months ended September 30, 2026GAAP | −$114.4M | – | – |
| Net loss, nine months ended September 30, 2026non-GAAP | −$119.7M | – | – |
| Research and development expenses, nine months ended September 30, 2026non-GAAP | $110.5M | – | – |
| General and administrative expenses, nine months ended September 30, 2026non-GAAP | $21.59M | – | – |
Amounts quoted below without a unit are in thousands, as in the filing’s tables. Per-share figures are as printed.
2027 and into 2028 outlook
- NotePivotal data are expected in mid-2027.
- NoteSubmission of a Biologics License Application (BLA) to the FDA expected to follow in the second half of 2027.
- NoteAdditional clinical data from the Phase 1/2 trial of LYL273 in patients with 3L+ R/R mCRC and an End-of-Phase 1 meeting with the FDA are expected in 2027.
- NoteCash, cash equivalents and marketable securities balances, together with the net proceeds from the $80.0 million private placement in November 2026, will be sufficient to meet working capital and capital expenditure needs into 2028.
- NoteLyFE has commercial launch capability and is expected to have the capacity to manufacture more than 3,000 CAR T-cell doses per year.
What drove it
- The increase in net loss was primarily due to a $12.7 million increase in research and development expenses driven by increased clinical trial activity, partially offset by a $4.0 million prior-year loss on the securities purchase agreement put/call that did not recur.
- The increase in R&D expenses was primarily due to a $12.2 million increase in research activities, collaborations and outside services due to increased clinical trial activity.
- G&A expenses were lower primarily due to lower professional services expenses.
- The PiNACLE pivotal trial and PiNACLE-H2H trial continue to enroll patients.
- Lyell completed the planned technology transfer for LYL273 to LyFE following FDA review of an improved manufacturing process and updated analytical methods.
Concerns
- Revenue was $ 3 for the three months ended September 30, 2026.
- Net loss was $45.5 million for the third quarter ended September 30, 2026, compared to a net loss of $38.8 million for the same period in 2025.
- Non-GAAP net loss increased by $12.2 million to $41.3 million for the third quarter ended September 30, 2026, compared to $29.1 million for the same period in 2025.
- Interest income, net was $1,905 for the three months ended September 30, 2026, compared to $3,266 for the same period in 2025.
- Cash, cash equivalents and marketable securities declined to $194.0 million as of September 30, 2026 from $247.2 million as of December 31, 2025.
- The filing identifies risks involving clinical development, enrollment and retention, manufacturing cellular therapies, regulatory approvals, competition, reliance on third parties and the need for additional capital.
What to watch
- PiNACLE pivotal data expected in mid-2027 and the expected BLA submission in the second half of 2027.
- PiNACLE trial enrollment, which Lyell expects to complete by year end.
- PiNACLE-H2H enrollment and its event-free-survival primary endpoint.
- Additional Phase 1/2 LYL273 clinical data, determination of the recommended Phase 2 dose and the End-of-Phase 1 FDA meeting expected in 2027.
- Implementation of the improved LYL273 manufacturing process and updated analytical methods at LyFE.
- Completion and proceeds of the $80.0 million private placement and the stated runway into 2028.
Balance sheet and cash flow
- Cash, cash equivalents and marketable securities as of September 30, 2026 were $194.0 million compared to $247.2 million as of December 31, 2025.
- Cash, cash equivalents and marketable securities: $ 193,988 as of September 30, 2026; $ 247,220 as of December 31, 2025.
- Property and equipment, net: $ 28,531 as of September 30, 2026; $ 34,771 as of December 31, 2025.
- Total assets: $ 273,854 as of September 30, 2026; $ 340,052 as of December 31, 2025.
- Total stockholders’ equity: $ 192,721 as of September 30, 2026; $ 248,202 as of December 31, 2025.
- In November 2026, the Company announced a private placement of $80.0 million.
Analysis
Lyell reported nominal revenue of $ 3 for the third quarter ended September 30, 2026 and remained focused on clinical development rather than commercial operations. GAAP net loss was $45.5 million, compared with $38.8 million for the same period in 2025. Non-GAAP net loss was $41.3 million, compared with $29.1 million. The filing attributes the higher loss primarily to increased clinical trial activity and lower interest income, with the GAAP comparison partly offset by a $4.0 million prior-year loss on the securities purchase agreement put/call that did not recur.
The cost profile reflects increased investment in the pipeline. GAAP R&D expense was $40.9 million compared with $28.2 million, driven by a $12.2 million increase in research activities, collaborations and outside services due to increased clinical trial activity. Non-GAAP R&D expense was $38.8 million compared with $26.2 million. GAAP G&A expense declined to $9.3 million from $10.7 million, primarily because of lower professional services expenses, while non-GAAP G&A expense was $6.9 million compared with $7.5 million.
The main operating developments were clinical and manufacturing milestones. In the 3L+ PiNACLE trial, the company reported a 91% overall response rate and a 77% complete response rate among 44 efficacy-evaluable patients. The median duration of complete response and median progression-free survival were not reached, while the estimated continued complete response rate was 92% at six months and 75% at 12 months. No Grade ≥ 3 CRS was observed and Grade ≥ 3 ICANS was reported in 9% of patients. The company also completed technology transfer of LYL273 to LyFE after FDA review of an improved manufacturing process and updated analytical methods.
Liquidity remains central to the development plan. Cash, cash equivalents and marketable securities were $194.0 million as of September 30, 2026, compared with $247.2 million as of December 31, 2025. Lyell announced a private placement of $80.0 million in November 2026 and stated that existing cash together with net proceeds is expected to fund working capital and capital expenditure needs into 2028. The timeline now centers on PiNACLE pivotal data in mid-2027, an expected BLA submission in the second half of 2027, and additional LYL273 data and an End-of-Phase 1 FDA meeting expected in 2027.
Management, verbatim
The updated ronde-cel data accepted for presentation at ASH further strengthen our conviction in ronde-cel’s potential to meaningfully improve outcomes for patients with large B-cell lymphoma.
Lynn Seely, M.D., President and Chief Executive Officer of Lyell
Not in the filing
stated, not guessed- GAAP and non-GAAP earnings per share
- Gross profit and gross margin
- Operating cash flow
- Free cash flow
- Debt balances
- Share repurchases
- Dividends
- Segment revenue
- Quarter-over-quarter comparisons
- Financial revenue, gross margin, operating expense or tax-rate guidance
- Prior outlook for comparison
Written by an AI language model from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was checked against the filing text, and a metric whose value, prior period and change do not add up is dropped from the metrics. The model can still misread a table, in the metrics or in the text, so check a number in the filing before you rely on it. Consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.