Every 8-K that Lyell Immunopharma, Inc. (LYEL) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow LYEL and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full LYEL filings page.
Lyell Immunopharma, Inc. (LYEL) reported that it has successfully completed the planned technology transfer for its GCC-targeted CAR T-cell candidate LYL273 to the LyFE Manufacturing Center in Bothell, Washington, following review by the FDA. LyFE is implementing an improved manufacturing process and updated analytical methods to enhance manufacturing performance and increase capacity.
The ongoing Phase 1/2 trial of LYL273 in relapsed/refractory metastatic colorectal cancer continues to enroll patients to determine a recommended Phase 2 dose and optimize the safety management plan. Additional clinical data and a planned End-of-Phase 1 FDA meeting are now expected in 2027. Earlier trial data showed gastrointestinal prophylaxis reduced Grade ≥ 2 diarrhea/colitis from 55% without prophylaxis to 10% with prophylaxis, and LyFE is expected to have capacity to manufacture more than 1,200 CAR T-cell doses per year.
Lyell Immunopharma reported second quarter 2026 results, with a GAAP net loss of $44.8 million and non‑GAAP net loss of $40.6 million, both slightly higher than a year earlier as research and development expense rose to $39.5 million on increased clinical trial activity. Cash, cash equivalents and marketable securities were $228.0 million as of June 30, 2026, which the company believes will fund operations into the third quarter of 2027.
Clinically, Lyell highlighted progress in its CAR T programs. Ronde‑cel in relapsed/refractory large B‑cell lymphoma showed no Grade ≥3 CRS, low Grade ≥3 ICANS in more than 100 treated patients, and a 97% manufacturing success rate; pivotal PiNACLE data are expected mid‑2027 with a planned BLA filing in the second half of 2027. For LYL273 in metastatic colorectal cancer, adding a gastrointestinal prophylaxis regimen reduced Grade ≥2 diarrhea or colitis from 55% to 10% with no Grade ≥3 events, supporting expansion of the U.S. study to a Phase 1/2 design and a potential single‑arm pivotal Phase 2 trial pending regulatory discussions.
Lyell Immunopharma, Inc. reported the voting results from its 2026 annual meeting of stockholders. A quorum was established, with 15,706,826 shares represented, equal to 67.31% of the 23,332,254 shares outstanding as of April 14, 2026.
Stockholders elected Richard Klausner, M.D., Otis Brawley, M.D., and William Rieflin to the board, each receiving more than 11.8 million votes in favor. Stockholders also approved a proposal with 15,674,347 votes for and 30,758 against, and an additional proposal received 11,860,218 votes for and 3,429,286 broker non-votes.
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.
Lyell Immunopharma, Inc. reported a GAAP net loss of $140.7 million for Q4 2025 and $274.4 million for full year 2025, narrower than 2024. Non-GAAP net loss was $33.1 million for Q4 and $144.8 million for the year. Cash, cash equivalents and marketable securities were $247.2 million as of December 31, 2025, excluding a subsequent $50 million private placement tranche, which together are expected to fund operations into the second quarter of 2027.
Clinically, Lyell advanced ronde-cel, initiating patient dosing in the Phase 3 PiNACLE-H2H head‑to‑head CAR T trial in second‑line large B‑cell lymphoma and continuing the pivotal PiNACLE trial in later‑line disease. Updated Phase 1/2 ronde‑cel data showed high response rates and an outpatient‑appropriate safety profile.
For LYL273, a next‑generation GCC‑targeted CAR T for metastatic colorectal cancer, a U.S. Phase 1 trial is ongoing, with seven additional patients treated without dose‑limiting toxicity and encouraging dose‑dependent activity. Lyell also closed the second $50 million tranche of a $100 million equity private placement and appointed Smital Shah as Chief Financial and Business Officer.
Lyell Immunopharma, Inc. appointed Smital Shah as its Chief Financial and Business Officer and principal financial officer, effective March 9, 2026, replacing the interim role previously held by CEO Lynn Seely, M.D.
Under her offer letter, Shah will receive an initial annual base salary of $500,000 and a target annual bonus of up to 50% of base salary. She will also be granted an option to purchase 140,000 shares of common stock at fair market value on the grant date, vesting 25% after one year and the remainder in equal monthly installments over the following three years, contingent on continued employment.
Shah joins the company with prior senior finance and business leadership experience at ProQR Therapeutics, Gilead Sciences, major investment banks and other biotech roles, and will participate as a Tier I Employee in the company’s Officer Severance Plan.
Lyell Immunopharma, Inc. furnished an update on its financial results for the quarter ended September 30, 2025 via a Form 8‑K. The company attached a press release as Exhibit 99.1.
The disclosure under Item 2.02 is being furnished, not filed, and is therefore not subject to Section 18 liabilities and is not incorporated by reference except as specifically stated.
Lyell Immunopharma (LYEL) signed an Exclusive License Agreement with Innovative Cellular Therapeutics, gaining rights to research, develop, manufacture and commercialize certain cell therapy candidates worldwide except mainland China, Taiwan, Macau and Hong Kong. In return, Lyell will pay $40 million in cash and issue 1.9 million common shares to ICT Holdings.
The deal includes meaningful performance-based economics: a potential $30 million clinical milestone, up to $115 million in late-stage regulatory milestones, and up to $675 million in commercial sales milestones, plus up to an additional 1.85 million shares upon certain clinical and regulatory milestones. Tiered royalties apply, ranging from mid-single digits up to 10% on U.S. net sales and low to mid-single digits elsewhere in the licensed territory.
Lyell also entered a Registration Rights Agreement to provide ICT Holdings with shelf registration for the resale of shares issuable under the license. The securities were issued in a private placement in reliance on Section 4(a)(2) of the Securities Act.
Lyell Immunopharma (LYEL) announced leadership changes in its finance function. On October 31, 2025, the Board appointed CEO Lynn Seely, M.D., as interim principal financial officer and named Veronica Sanchez Bulis as principal accounting officer.
Bulis has served as Vice President, Corporate Controller since August 2021 and previously held senior finance roles at Sangamo Therapeutics (2018–2021) and Core-Mark International (2008–2018), with earlier public accounting experience at Ernst & Young and Deloitte.
Lyell Immunopharma, Inc. reported that Chief Financial Officer Charles Newton, who also serves as the company’s principal financial and accounting officer, has decided to resign. His resignation will be effective October 31, 2025. The company states there were no disagreements between Mr. Newton and Lyell.
Lyell plans to conduct a search for a new CFO to take over its financial leadership. To support continuity, the company and Mr. Newton entered into a consulting agreement under which he may provide consulting services from the resignation date through April 30, 2026, unless either party ends the consultancy earlier.
Lyell Immunopharma announced that it issued a press release reporting its financial results for the quarter ended June 30, 2025, and attached that release as Exhibit 99.1 to this Form 8-K. The filing states the information is being furnished and shall not be deemed filed for purposes of Section 18 of the Exchange Act, meaning it is not subject to the liabilities of that section and is not incorporated by reference into other filings unless expressly referenced. The document also lists the company’s common stock as LYEL on the NASDAQ Global Select Market and is signed on behalf of the company by Mark Meltz, General Counsel and Corporate Secretary.
Lyell Immunopharma (Nasdaq:LYEL) filed an 8-K (Item 3.02) disclosing that the clinical milestone embedded in its October 2024 ImmPACT Bio merger has been met. The achievement obligates Lyell to issue 625,000 unregistered common shares (post 1-for-20 reverse split) to former ImmPACT securityholders in a private placement relying on the Section 4(a)(2) exemption.
The shares represent additional equity consideration; no cash will be paid. While the filing does not quantify the percentage of outstanding stock, the issuance will incrementally dilute current holders. The milestone confirms progress for ImmPACT’s next-generation CAR T-cell candidate, potentially accelerating Lyell’s cell-therapy pipeline.
- Shares are restricted and cannot be publicly resold without registration or another exemption.
- No other material items were reported.