Lyell Immunopharma (NASDAQ: LYEL) trims Q1 loss and advances CAR T trials
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Lyell Immunopharma reported first quarter 2026 results while highlighting progress in its cell therapy pipeline. Net loss narrowed to $24.2 million from $52.2 million a year earlier, helped by a $17.6 million gain on its securities purchase agreement put/call asset and lower operating expenses.
R&D expenses were $36.6 million versus $43.4 million, and G&A expenses fell to $9.6 million from $14.0 million, reflecting reduced headcount and personnel costs. Non‑GAAP net loss was $37.8 million compared with $46.3 million. Cash, cash equivalents and marketable securities totaled $261.0 million at March 31, 2026, which Lyell believes will fund operations into the third quarter of 2027.
Clinically, the pivotal PiNACLE trial of ronde‑cel in later‑line LBCL remains on track for additional data in the second half of 2026 and pivotal data in mid‑2027, with a planned BLA submission in 2027. The Phase 3 PiNACLE‑H2H head‑to‑head trial in second‑line LBCL has begun dosing, and the Phase 1 trial of LYL273 in metastatic colorectal cancer has advanced to Dose Level 3, with safety and outcome updates expected during 2026. Lyell also closed the second $50 million tranche of its $100 million private placement at $25.61 per share.
Positive
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Insights
Lyell trimmed losses, strengthened cash, and advanced two key CAR T programs toward pivotal milestones.
Lyell Immunopharma cut its GAAP net loss to $24.2M from $52.2M, driven by lower R&D and G&A spending and a one‑time $17.6M gain on a securities purchase agreement asset. Non‑GAAP net loss improved to $37.8M, showing underlying cost discipline beyond accounting items.
Cash, cash equivalents and marketable securities rose to $261.0M as of March 31, 2026, and management expects this to fund operations into Q3 2027. That runway spans several catalysts, including additional PiNACLE data in the second half of 2026, pivotal ronde‑cel data in mid‑2027, and a planned BLA submission later in 2027.
The Phase 3 PiNACLE‑H2H study in second‑line LBCL has started dosing, while the Phase 1 trial of LYL273 in metastatic colorectal cancer has escalated to Dose Level 3 at 3 x 106 CAR T cells/kg. The filing outlines expected safety and outcomes readouts for LYL273 during 2026. Actual value for shareholders will depend on whether forthcoming data support regulatory approvals and commercialization, which remains uncertain at this stage.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
GAAP net loss: $24.2 million
GAAP net loss prior-year quarter: $52.2 million
Non-GAAP net loss: $37.8 million
+5 more
8 metrics
GAAP net loss
$24.2 million
Quarter ended March 31, 2026
GAAP net loss prior-year quarter
$52.2 million
Quarter ended March 31, 2025
Non-GAAP net loss
$37.8 million
Quarter ended March 31, 2026
R&D expense
$36.6 million
Quarter ended March 31, 2026
G&A expense
$9.6 million
Quarter ended March 31, 2026
Cash, cash equivalents and marketable securities
$261.0 million
As of March 31, 2026
Private placement total size
$100 million
Equity private placement completed with second tranche in March 2026
Second tranche share price
$25.61 per share
Purchase price in March 2026 $50 million tranche
Key Terms
Regenerative Medicine Advanced Therapy (RMAT) designation, Fast Track designation, Biologics License Application (BLA), CAR T-cell therapies, +2 more
6 terms
Regenerative Medicine Advanced Therapy (RMAT) designation regulatory
"The U.S. Food and Drug Administration (FDA) has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) designation"
A Regenerative Medicine Advanced Therapy (RMAT) designation is a U.S. regulatory status given to certain cell, gene, or tissue-based treatments that show promise for serious conditions and early clinical evidence of benefit. It signals that regulators will provide extra guidance and expedited review steps—like giving a promising project a “fast pass” through some development checkpoints—which can shorten time to market and reduce regulatory risk, making the program more valuable and noteworthy to investors.
Fast Track designation regulatory
"The FDA has granted ronde-cel ... as well as Fast Track designation for the treatment of adults with relapsed/refractory large B-cell lymphoma"
A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.
Biologics License Application (BLA) regulatory
"pivotal data are expected in mid-2027 with submission of a Biologics License Application (BLA) to the FDA expected to follow in 2027"
A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.
CAR T-cell therapies medical
"advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer"
CAR T-cell therapies are treatments that remove a patient’s immune cells, reprogram them to recognize specific cancer markers, and return them to the body so they act like specially trained soldiers hunting tumor cells. They matter to investors because they can offer powerful, long-lasting benefits for hard-to-treat cancers but come with high development, manufacturing and regulatory costs, pricing and reimbursement uncertainty, and concentrated market risk that can drive big gains or losses.
non-GAAP net loss financial
"Non‑GAAP net loss, which excludes non-cash stock-based compensation ... decreased by $8.5 million to $37.8 million"
success payment liabilities financial
"Non‑GAAP net loss excludes ... the change in the estimated fair value of success payment liabilities"
Earnings Snapshot
Revenue: $2 thousand · Guidance included
Q1 2026
Revenue
$2 thousand
vs $7 thousand Q1 2025
GAAP net loss
$24.2 million
vs $52.2 million Q1 2025
Non-GAAP net loss
$37.8 million
vs $46.3 million Q1 2025
R&D expense
$36.6 million
vs $43.4 million Q1 2025
G&A expense
$9.6 million
vs $14.0 million Q1 2025
Cash, cash equivalents and marketable securities
$261.0 million
vs $247.2 million at December 31, 2025
Guidance
Lyell believes existing cash, cash equivalents and marketable securities will fund working capital and capital expenditures into the third quarter of 2027.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
______________________________________________
FORM 8-K
______________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 6, 2026
______________________________________________
(Exact name of Registrant as Specified in Its Charter)
______________________________________________
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||||||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||||||||||
Registrant’s Telephone Number, Including Area Code: 650 695-0677
(Former Name or Former Address, if Changed Since Last Report)
Not Applicable
______________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 2.02 Results of Operations and Financial Condition.
On May 6, 2026, Lyell Immunopharma, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026. A copy of the press release is attached hereto as Exhibit 99.1.
The information in this Item 2.02, including the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description | |||||||
| 99.1 | Press Release Dated May 6, 2026 | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Lyell Immunopharma, Inc. | |||||||||||
| Date: | May 6, 2026 | By: | /s/ MARK MELTZ | ||||||||
| Mark Meltz | |||||||||||
| General Counsel and Corporate Secretary | |||||||||||
Exhibit 99.1
Lyell Immunopharma Reports Business Highlights and Financial Results for the First Quarter 2026
•PiNACLE pivotal clinical trial evaluating ronde-cel in patients with LBCL in third- or later-line setting on track to report additional data in second half of 2026, with pivotal data expected mid-2027 and BLA submission expected to follow in 2027
•PiNACLE-H2H, a first of its kind Phase 3 clinical trial evaluating ronde-cel head-to-head against standard-of-care CD19 CAR T-cell therapies in the LBCL second-line setting, commenced patient dosing
•Phase 1 clinical trial of LYL273 continues to enroll patients with metastatic colorectal cancer, with commencement of patient dosing at Dose Level 3
•Closed second $50 million tranche of $100 million private placement at $25.61 per share, with approximately $261 million in cash as of March 31, 2026, expected to provide runway into Q3 2027
SOUTH SAN FRANCISCO, Calif., May 6, 2026 -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today reported financial results and business highlights for the first quarter ended March 31, 2026.
First Quarter Updates and Recent Business Highlights
Ronde-cel: A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to approved CD19‑targeted CAR T-cell therapies for the treatment of large B-cell lymphoma (LBCL)
Ronde-cel is an autologous CAR T-cell product candidate with a true ‘OR’ logic gate to target B cells that express either CD19 or CD20 with full potency and is manufactured with a process that enriches for CD62L-positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. The U.S. Food and Drug Administration (FDA) has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) designation in the third- and later-line (3L+) and second-line (2L) settings, as well as Fast Track designation for the treatment of adults with relapsed/refractory large B-cell lymphoma (R/R LBCL). Two pivotal trials for ronde-cel in LBCL are underway.
•The ongoing PiNACLE pivotal single-arm trial, a seamless expansion of the 3L+ cohort in the Phase 1/2 multi‑cohort trial, is ongoing. Additional data from this trial are expected in the second half of 2026, and pivotal data are expected in mid-2027 with submission of a Biologics License Application (BLA) to the FDA expected to follow in 2027. The primary endpoint of the trial is the overall response rate, including an evaluation of duration of response.
•In February 2026, patient dosing commenced in PiNACLE-H2H, the first-of-its-kind Phase 3 randomized controlled trial evaluating ronde-cel versus investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel in patients with R/R LBCL in the 2L setting. The trial’s primary endpoint is event-free survival.
LYL273: A next-generation guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate for the treatment of metastatic colorectal cancer (mCRC) and other GCC-expressing cancers
LYL273 is a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release, designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile solid tumor microenvironment. In November 2025, Lyell acquired global rights (excluding mainland China, Hong Kong, Macau and Taiwan) to LYL273, which has shown promising dose-dependent clinical activity in patients with advanced mCRC in a Phase 1 trial conducted in the U.S. following proof of concept in 15 patients in China. The FDA granted LYL273 Fast Track designation for the treatment of mCRC.
•The U.S. Phase 1 clinical trial is continuing to enroll patients to determine the recommended Phase 2 dose. In March 2026, dosing commenced at Dose Level 3 (3 x 106 CAR T cells/kg). A data update focused on safety from this trial is expected in the first half of 2026, with a second data update including clinical outcomes expected in the second half of 2026.
Additional Business Highlights
•In March 2026, Lyell closed the second $50 million tranche of its July 2025 equity private placement, following the successful achievement of a clinical milestone in PiNACLE. In the second tranche of the financing, which completed the total $100 million private placement, shares of common stock were sold at a purchase price of $25.61 per share.
•In March 2026, Smital Shah was appointed Chief Financial and Business Officer.
First Quarter 2026 Financial Results
Lyell reported a net loss of $24.2 million for the first quarter ended March 31, 2026, compared to a net loss of $52.2 million for the same period in 2025. The $28.0 million decrease in net loss was primarily due to a $17.6 million gain on our Securities Purchase Agreement put/call asset relating to our July 2025 equity private placement. Non‑GAAP net loss, which excludes non-cash stock-based compensation, non-cash expenses related to the change in the estimated fair value of the Securities Purchase Agreement put/call asset and success payment liabilities, decreased by $8.5 million to $37.8 million for the first quarter ended March 31, 2026, compared to $46.3 million for the same period in 2025 primarily due to the decreased headcount from the successful technology transfer of ronde-cel to the Company’s LyFE Manufacturing CenterTM (LyFE) in 2025.
GAAP and Non-GAAP Operating Expenses
•Research and development (R&D) expenses were $36.6 million for the first quarter ended March 31, 2026, compared to $43.4 million for the same period in 2025. The $6.8 million decrease was primarily due to a $7.5 million reduction in personnel expenses, partially offset by a $3.4 million increase in clinical trials activity and outside services. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation, for the first quarter ended March 31, 2026 were $34.4 million compared to $41.1 million for the same period in 2025.
•General and administrative (G&A) expenses were $9.6 million for the first quarter ended March 31, 2026 compared to $14.0 million for the same period in 2025. The $4.5 million decrease was primarily due to a $4.0 million reduction in personnel‑related expenses, including a $1.5 million decrease in stock-based compensation expense. Non‑GAAP G&A expenses, which exclude non-cash stock‑based compensation, for the first quarter ended March 31, 2026 were $7.5 million compared to $10.4 million for the same period in 2025.
A discussion of non-GAAP financial measures, including reconciliations of the most comparable U.S. generally accepted accounting principles (GAAP) measures to non‑GAAP financial measures, is presented below under “Non-GAAP Financial Measures.”
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of March 31, 2026 were $261.0 million compared to $247.2 million as of December 31, 2025. Lyell believes that its current cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into the third quarter of 2027.
About Lyell Immunopharma, Inc.
Lyell is a late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. To realize the potential of cell therapy for cancer, Lyell utilizes a suite of technologies to arm CAR T cells with enhancements needed to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile tumor microenvironment. LyFE has commercial launch capability and is expected to have the capacity to manufacture more than 1,200 CAR T-cell doses per year. To learn more, please visit www.lyell.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: Lyell’s plans for its existing cash, cash equivalents and marketable securities, and its expectation that its financial position and cash runway will be sufficient to meet working capital and capital expenditure needs into the third quarter of 2027; Lyell’s expectations around the progress of the PiNACLE and PiNACLE-H2H trials, including the expected timing for release of additional and pivotal data from the PiNACLE trial; the use of pivotal data from the PiNACLE trial to support a BLA submission to the FDA in 2027 and other expectations around enrollment and regulatory submissions; Lyell’s expectations around the progress of the U.S. Phase 1 trial for LYL273, including the expected timing for release of clinical data from this trial; the anticipated benefits of RMAT and Fast Track designations for ronde-cel and Fast Track designation for LYL273; the capability of LyFE to manufacture drug supply through potential commercial
launch and its expected manufacturing capacity; the potential clinical benefits and therapeutic potential of Lyell’s product candidates; and other statements that are not historical fact. These statements are based on Lyell’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: Lyell operates in a rapidly evolving industry and has a limited operating history; Lyell’s ability to successfully develop, manufacture and commercialize product candidates or its experiencing significant delays in doing so; Lyell’s dependence on the enrollment and retention of patients in its current and planned clinical trials for its product candidates; the potential for results of Lyell’s research, nonclinical studies or earlier clinical trials to not be predictive of future results; clinical development involving a lengthy and expensive process with uncertain outcomes; Lyell’s product candidates and technologies being based on novel technologies that are unproven and may not result in approvable or marketable products; Lyell facing substantial competition in a rapidly changing industry, which may result in others discovering, developing or commercializing products before or more successfully than it does; Lyell’s ability to obtain and maintain sufficient intellectual property protection for its product candidates; the complexity of manufacturing cellular therapies; Lyell’s ability to manufacture drug products for its clinical trials itself and any potential delays in further qualifying or in receiving regulatory approvals for any manufacturing facility or product candidates or in expanding its manufacturing capacity; Lyell’s reliance on third parties; implementation of Lyell’s strategic plans for its business and product candidates and Lyell’s realization of the expected benefits of such plans; the potential reduction of Lyell’s cash resources and fluctuations in Lyell’s operating results and financial condition as a result of Lyell’s milestone, royalty and success payment obligations; the sufficiency of Lyell’s capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading “Risk Factors” in Lyell’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, being filed with the Securities and Exchange Commission today. Forward-looking statements contained in this press release are made as of this date, and Lyell undertakes no duty to update such information except as required under applicable law.
Lyell Immunopharma, Inc.
Unaudited Selected Consolidated Financial Data
(in thousands)
Statement of Operations Data:
| Three Months Ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
Revenue | $ | 2 | $ | 7 | |||||||
| Operating expenses: | |||||||||||
| Research and development | 36,604 | 43,447 | |||||||||
| General and administrative | 9,555 | 14,046 | |||||||||
Other operating income, net | (1,896) | (119) | |||||||||
| Total operating expenses | 44,263 | 57,374 | |||||||||
| Loss from operations | (44,261) | (57,367) | |||||||||
| Interest income, net | 2,194 | 3,862 | |||||||||
Other income, net | 17,914 | 1,310 | |||||||||
Total other income, net | 20,108 | 5,172 | |||||||||
| Net loss | $ | (24,153) | $ | (52,195) | |||||||
Balance Sheet Data:
| As of March 31, | As of December 31, | ||||||||||
| 2026 | 2025 | ||||||||||
| Cash, cash equivalents and marketable securities | $ | 260,977 | $ | 247,220 | |||||||
| Property and equipment, net | $ | 32,720 | $ | 34,771 | |||||||
| Total assets | $ | 350,626 | $ | 340,052 | |||||||
| Total stockholders’ equity | $ | 273,665 | $ | 248,202 | |||||||
Non-GAAP Financial Measures
To supplement our financial results and guidance presented in accordance with GAAP, we present non-GAAP net loss, non-GAAP R&D expenses and non-GAAP G&A expenses. Non‑GAAP net loss excludes non-cash stock-based compensation expense, non-cash expenses related to the change in the estimated fair value of success payment liabilities and the change in the estimated fair value of our securities purchase agreement put/call asset. Non‑GAAP R&D and G&A expenses exclude non-cash stock-based compensation expense from GAAP R&D and G&A expenses. We believe that these non‑GAAP financial measures, when considered together with our financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare our results from period to period, and to identify operating trends in our business. We have excluded stock-based compensation expense, changes in the estimated fair value of success payment liabilities and the change in the estimated fair value of our securities purchase agreement put/call asset from our non‑GAAP financial measures because they are gains and charges that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. We also regularly use these non‑GAAP financial measures internally to understand, manage and evaluate our business and to make operating decisions. These non-GAAP financial measures are in addition to, and not a substitute for or superior to, measures of financial performance prepared in accordance with GAAP. In addition, these non‑GAAP financial measures have no standardized meaning prescribed by GAAP and are not prepared under any comprehensive set of accounting rules or principles and, therefore, have limits in their usefulness to investors. We encourage investors to carefully consider our results under GAAP, as well as our supplemental non-GAAP financial information, to more fully understand our business.
Lyell Immunopharma, Inc.
Unaudited Reconciliation of GAAP to Non-GAAP Net Loss
(in thousands)
| Three Months Ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| Net loss - GAAP | $ | (24,153) | $ | (52,195) | |||||||
| Adjustments: | |||||||||||
Change in the estimated fair value of securities purchase agreement put/call asset | (17,561) | — | |||||||||
| Stock-based compensation expense | 4,295 | 6,024 | |||||||||
| Change in the estimated fair value of success payment liabilities | (353) | (125) | |||||||||
Net loss - Non-GAAP(1) | $ | (37,772) | $ | (46,296) | |||||||
(1)There was no income tax effect related to the adjustments made to calculate non-GAAP net loss because of the full valuation allowance on our net deferred tax assets for all periods presented.
Lyell Immunopharma, Inc.
Unaudited Reconciliation of GAAP to Non-GAAP Research and Development Expenses
(in thousands)
| Three Months Ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
Research and development - GAAP | $ | 36,604 | $ | 43,447 | |||||||
| Adjustments: | |||||||||||
| Stock-based compensation expense | (2,201) | (2,388) | |||||||||
| Research and development - Non-GAAP | $ | 34,403 | $ | 41,059 | |||||||
Lyell Immunopharma, Inc.
Unaudited Reconciliation of GAAP to Non-GAAP General and Administrative Expenses
(in thousands)
Three Months Ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| General and administrative - GAAP | $ | 9,555 | $ | 14,046 | |||||||
| Adjustments: | |||||||||||
| Stock-based compensation expense | (2,094) | (3,636) | |||||||||
| General and administrative - Non-GAAP | $ | 7,461 | $ | 10,410 | |||||||
Contact:
Pablo Fenton
Associate Director, Investor Relations and Corporate Communications
pfenton@lyell.com
FAQ
How did Lyell Immunopharma (LYEL) perform financially in Q1 2026?
Lyell reported a GAAP net loss of $24.2 million for Q1 2026, improving from $52.2 million a year earlier. The smaller loss reflected lower R&D and G&A expenses and a $17.6 million gain on a securities purchase agreement put/call asset.
What is Lyell Immunopharma’s cash runway after Q1 2026?
Lyell ended March 31, 2026 with $261.0 million in cash, cash equivalents and marketable securities. The company believes this balance will meet working capital and capital expenditure needs into the third quarter of 2027, covering multiple planned clinical data readouts.
What progress did Lyell Immunopharma report on the ronde-cel PiNACLE trials?
Lyell’s pivotal PiNACLE trial in later-line LBCL remains on track for additional data in the second half of 2026 and pivotal data in mid‑2027. The company expects these pivotal data to support a BLA submission to the FDA in 2027.
What is the status of Lyell Immunopharma’s PiNACLE-H2H Phase 3 trial?
The PiNACLE‑H2H Phase 3 trial has begun dosing patients with second‑line relapsed or refractory LBCL. It compares ronde‑cel head‑to‑head against standard‑of‑care CD19 CAR T-cell therapies, with event‑free survival as the primary endpoint in this randomized controlled design.
How is Lyell Immunopharma advancing its LYL273 colorectal cancer program?
The U.S. Phase 1 trial of LYL273 in metastatic colorectal cancer is enrolling and has started dosing at Dose Level 3 (3 x 106 CAR T cells/kg). Lyell expects a safety‑focused data update in the first half of 2026 and an outcomes‑focused update in the second half of 2026.
What equity financing activity did Lyell Immunopharma complete in March 2026?
In March 2026, Lyell closed the second $50 million tranche of its July 2025 $100 million private placement. Shares of common stock in this tranche were sold at a purchase price of $25.61 per share, following achievement of a clinical milestone in the PiNACLE program.