Lyell Immunopharma Reports Business Highlights and Financial Results for the Second Quarter 2025
Lyell Immunopharma (Nasdaq: LYEL) reported significant progress in Q2 2025, highlighted by positive clinical data for their lead program LYL314, a dual-targeting CD19/CD20 CAR T-cell therapy for large B-cell lymphoma. The Phase 1/2 trial showed impressive results with an 88% overall response rate and 72% complete response rate in 3L+ patients.
The company has initiated the PiNACLE pivotal trial for third-line or later treatment and plans to begin a second-line trial by early 2026. Additionally, Lyell secured a $100 million private placement, with an initial closing of $50 million. The company's pro-forma cash position of $347 million is expected to fund operations through mid-2027.
Q2 2025 financial results showed a net loss of $42.7 million, an improvement from $45.8 million in Q2 2024, with R&D expenses decreasing to $34.9 million from $40.3 million year-over-year.
Lyell Immunopharma (Nasdaq: LYEL) ha registrato progressi significativi nel 2° trimestre 2025, evidenziati da dati clinici positivi per il loro programma di punta LYL314, una terapia CAR‑T a doppio bersaglio CD19/CD20 per il linfoma a grandi cellule B. Lo studio di Fase 1/2 ha mostrato risultati notevoli con un 88% di risposta complessiva e un 72% di risposta completa nei pazienti in 3L+.
L'azienda ha avviato lo studio pivotale PiNACLE per il trattamento in terza linea o successiva e prevede di iniziare uno studio di seconda linea entro i primi mesi del 2026. Inoltre, Lyell ha ottenuto un collocamento privato da 100 milioni di dollari, con una chiusura iniziale di 50 milioni di dollari. La posizione di cassa pro‑forma di 347 milioni di dollari dovrebbe finanziare le operazioni fino alla metà del 2027.
I risultati finanziari del 2° trimestre 2025 hanno mostrato una perdita netta di 42,7 milioni di dollari, in miglioramento rispetto ai 45,8 milioni nel 2° trimestre 2024, con le spese di R&S in calo a 34,9 milioni di dollari rispetto a 40,3 milioni anno su anno.
Lyell Immunopharma (Nasdaq: LYEL) informó avances significativos en el 2T de 2025, destacados por datos clínicos positivos de su programa principal LYL314, una terapia CAR‑T de doble diana CD19/CD20 para el linfoma B de células grandes. El ensayo de Fase 1/2 mostró resultados impresionantes con una tasa de respuesta global del 88% y una tasa de respuesta completa del 72% en pacientes 3L+.
La compañía ha iniciado el ensayo pivotal PiNACLE para tratamiento de tercera línea o posterior y planea comenzar un ensayo en segunda línea a principios de 2026. Además, Lyell aseguró una colocación privada de 100 millones de dólares, con un primer cierre de 50 millones. La posición de caja pro‑forma de 347 millones de dólares debería financiar las operaciones hasta mediados de 2027.
Los resultados financieros del 2T 2025 mostraron una pérdida neta de 42,7 millones de dólares, una mejora respecto a los 45,8 millones del 2T 2024, con gastos de I+D que disminuyeron a 34,9 millones de dólares frente a 40,3 millones interanuales.
Lyell Immunopharma (Nasdaq: LYEL)은 2025년 2분기에 주요 성과를 보고했으며, 대형 B세포 림프종을 표적하는 이중 표적 CD19/CD20 CAR‑T 치료제인 주력 프로그램 LYL314의 긍정적 임상 데이터가 눈에 띕니다. 1/2상 임상에서 3L+ 환자군 기준으로 전체 반응률 88% 및 완전 관해율 72%라는 우수한 결과를 보였습니다.
회사는 3차 치료 또는 그 이후를 위한 피보탈 시험 PiNACLE을 시작했으며, 2026년 초까지 2차 치료용 임상을 개시할 계획입니다. 또한 Lyell은 1억 달러 규모의 사모 투자를 확보했으며 초기 클로징으로 5,000만 달러를 받았습니다. 프로포마 현금 잔액 3억4,700만 달러는 2027년 중반까지 운영 자금을 지원할 것으로 예상됩니다.
2025년 2분기 재무 결과는 4,270만 달러의 순손실을 기록해 2024년 2분기의 4,580만 달러에서 개선됐으며, 연구개발비는 전년 동기 대비 3,490만 달러로 감소(이전 4,030만 달러)했습니다.
Lyell Immunopharma (Nasdaq: LYEL) a annoncé des progrès significatifs au T2 2025, mis en évidence par des données cliniques positives pour son programme phare LYL314, une thérapie CAR‑T ciblant CD19/CD20 pour le lymphome B à grandes cellules. L'essai de phase 1/2 a montré des résultats remarquables avec un taux de réponse global de 88% et un taux de réponse complète de 72% chez des patients 3L+.
La société a lancé l'essai pivot PiNACLE pour le traitement en troisième ligne ou plus et prévoit d'initier un essai en deuxième ligne début 2026. Par ailleurs, Lyell a obtenu un placement privé de 100 millions de dollars, avec un premier closing de 50 millions. La trésorerie pro forma de 347 millions de dollars devrait financer les opérations jusqu'à la mi‑2027.
Les résultats financiers du T2 2025 font apparaître une perte nette de 42,7 millions de dollars, en amélioration par rapport à 45,8 millions au T2 2024, avec des dépenses R&D en baisse à 34,9 millions de dollars contre 40,3 millions en glissement annuel.
Lyell Immunopharma (Nasdaq: LYEL) meldete im 2. Quartal 2025 deutliche Fortschritte, insbesondere positive klinische Daten für das Leitprogramm LYL314, eine doppelt zielende CD19/CD20 CAR‑T‑Zelltherapie beim großzelligen B‑Zell‑Lymphom. Die Phase‑1/2‑Studie zeigte beeindruckende Ergebnisse mit einer Gesamtansprechrate von 88% und einer vollständigen Remissionsrate von 72% bei 3L+‑Patienten.
Das Unternehmen hat die zulassungsrelevante PiNACLE‑Studie für die Drittlinien‑ oder spätere Behandlung initiiert und plant den Beginn einer Zweitlinienstudie Anfang 2026. Zudem sicherte sich Lyell eine Privatplatzierung über 100 Mio. USD mit einem ersten Closing von 50 Mio. USD. Die pro‑forma‑Kassenlage von 347 Mio. USD sollte die Geschäftstätigkeit bis Mitte 2027 finanzieren.
Die Finanzergebnisse für Q2 2025 zeigten einen Nettoverlust von 42,7 Mio. USD, eine Verbesserung gegenüber 45,8 Mio. USD im Q2 2024, wobei die F&E‑Aufwendungen im Jahresvergleich auf 34,9 Mio. USD zurückgingen (vorher 40,3 Mio. USD).
- High efficacy rates in clinical trials: 88% overall response rate and 72% complete response rate in 3L+ patients
- Secured $100 million private placement financing
- Strong cash position of $347 million expected to fund operations through mid-2027
- FDA granted RMAT and Fast Track designations for LYL314
- Reduced net loss by $3.1 million year-over-year
- Decreased R&D expenses by $5.4 million compared to Q2 2024
- Continued net losses of $42.7 million in Q2 2025
- Cash position declined from $384 million in December 2024 to $297 million in June 2025
- Grade ≥ 3 ICANS reported in 14% of patients in clinical trials
Insights
Lyell's LYL314 shows exceptional 72% complete response rates in aggressive lymphoma with high durability and $100M financing extending runway through 2027.
Lyell Immunopharma's Q2 results highlight remarkable clinical data for their dual-targeting CD19/CD20 CAR T-cell therapy LYL314 in aggressive large B-cell lymphoma (LBCL). The therapy demonstrated an 88% overall response rate with an impressive 72% complete response rate in third-line+ patients, with 71% of complete responses maintained at 6+ months. These results significantly outperform current CD19-only CAR T therapies, which typically achieve complete response rates of 40-58%.
The safety profile appears manageable with no Grade 3+ cytokine release syndrome and limited neurotoxicity that resolved quickly with standard treatments. This favorable safety profile supports outpatient administration—a significant advantage for both patients and healthcare systems.
What's particularly striking is LYL314's efficacy in primary refractory disease, achieving 70% complete response rates in these typically difficult-to-treat patients. The dual CD19/CD20 targeting approach likely addresses CD19 antigen loss—a common mechanism of resistance to current CAR T therapies.
The company has now initiated the PiNACLE pivotal trial in third-line+ LBCL with plans for a second pivotal trial in second-line by early 2026. Both trials capitalize on FDA's Regenerative Medicine Advanced Therapy and Fast Track designations, potentially accelerating regulatory review. With BLA submission planned for 2027, Lyell is positioning LYL314 to potentially become a new standard of care in LBCL treatment.
Lyell secures crucial $100M financing while advancing potentially best-in-class lymphoma therapy with strong clinical data supporting upcoming pivotal trials.
Lyell's financial position has been significantly strengthened through a $100 million private placement with institutional investors, with $50 million already closed at a share price of
The company reports pro-forma cash of approximately
Financial metrics show disciplined expense management with R&D expenses decreasing to
Lyell's clinical execution timeline appears solid with the PiNACLE pivotal trial now enrolling, plans for a second pivotal trial in early 2026, and a BLA submission expected in 2027. The 120-patient single-arm trial design with overall response rate as the primary endpoint is consistent with previous CAR-T approvals, suggesting a potentially efficient path to market.
The company's proprietary manufacturing process—enriching for CD62L-positive cells to generate more stemlike CAR T cells—appears to be delivering the intended product characteristics with 95% of the final product containing the desired naïve T-cell phenotype. This manufacturing advantage could translate to both clinical and commercial differentiation in the competitive CAR-T landscape.
- Presented positive new clinical data demonstrating high rates of durable complete responses from the Phase 1/2 trial of LYL314 for the treatment of aggressive large B-cell lymphoma
- Initiated the PiNACLE pivotal trial of LYL314 in patients with large B-cell lymphoma receiving treatment in the third‑ or later-line (3L+) setting; remain on track to initiate a pivotal trial in the second-line (2L) setting by early 2026
- Entered into a securities purchase agreement for a private placement for gross proceeds of up to approximately
$100 million - Pro-forma cash of approximately
$347 million inclusive of the initial proceeds from the private placement to support advancing pipeline into mid-2027 through key clinical milestones
SOUTH SAN FRANCISCO, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, today reported financial results and business highlights for the second quarter ended June 30, 2025. Lyell’s lead clinical program, LYL314, is a next-generation autologous dual-targeting CD19/CD20 CAR T-cell product candidate under evaluation in PiNACLE, a single-arm pivotal trial enrolling patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) in the 3L+ setting and in a Phase 1/2 study in the 2L setting.
“Based on the high rate of durable complete responses achieved by LYL314 in patients with aggressive LBCL presented at the International Conference on Malignant Lymphoma in Lugano, Switzerland, in June, we believe that our CD19/CD20 CAR T-cell therapy will disrupt the therapeutic landscape by delivering meaningfully increased complete response rates and improved durability over the currently approved CD19 CAR T-cell therapies,” said Lynn Seely, M.D., President and CEO of Lyell. “Our recent private placement with well-respected investors significantly derisks our business, extends our cash runway into mid-2027 and enables us to focus on rapidly advancing the clinical development of LYL314. We have initiated the PiNACLE single-arm pivotal trial for patients with LBCL receiving treatment in the third- or later-line setting and are on track to begin a second pivotal trial of LYL314 for patients with LBCL in the second-line setting by early 2026.”
Second Quarter Updates and Recent Business Highlights
Lyell is advancing a pipeline of next-generation CAR T-cell product candidates targeting cancers with large unmet need and substantial patient populations. Its lead program, LYL314, is in pivotal development for patients with R/R LBCL and its preclinical programs target solid tumor indications.
LYL314: 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 LBCL
LYL314 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 that 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. Following a successful End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA), LYL314 is currently being evaluated in the pivotal PiNACLE trial, which is a seamless expansion of the 3L+ cohort of the Phase 1/2 trial of patients with R/R LBCL. The Phase 1/2 trial continues to enroll CAR T-cell therapy naïve patients receiving treatment in the 2L setting and a pivotal trial for these 2L patients is expected be initiated by early 2026. The FDA has granted LYL314 Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for the treatment of R/R diffuse LBCL in the 3L+ setting. RMAT provides all the benefits of the Fast Track and Breakthrough Therapy designation programs and enables increased frequency of communications with the FDA on the development of LYL314.
- PiNACLE is a single-arm pivotal trial evaluating LYL314 at a dose of 100 x 106 CAR T cells in patients with LBCL receiving treatment in the 3L+ setting. The trial is expected to enroll approximately 120 patients with R/R diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma or Grade 3B follicular lymphoma who have not previously received CAR T-cell therapy. Patients may be treated with LYL314 in either the inpatient or outpatient setting and there is no upper age limit for eligibility. The primary endpoint of the trial is the overall response rate, including an evaluation of duration of response.
- New clinical data from the Phase 1/2 multi-center clinical trial of LYL314 in patients with R/R LBCL were presented at the 18th International Conference on Malignant Lymphoma in June and included more mature data from patients treated in the 3L+ setting and initial data from patients treated in the 2L setting. The data were presented in an oral presentation titled “LYL314, a CD19/CD20 CAR T‑cell candidate enriched for CD62L+ stem-like cells, achieves high rates of durable complete responses in relapsed and/or refractory large B-cell lymphoma”. Highlights include:
- Fifty-one CAR T-naive patients with R/R LBCL received LYL314 as of April 15, 2025 (the data cutoff date for the presentation). The efficacy evaluable population consisted of 36 patients with Day 84 assessments or prior disease progression or death. Patient demographics and baseline disease characteristics were consistent with high-risk patient populations: median ages of 65 and 69 years in the 3L+ and 2L, respectively,
41% of 3L+ and65% of 2L patients had Stage IV disease at trial entry, and47% of 3L+ and82% of 2L patients had primary refractory disease. - In efficacy-evaluable 3L+ patients, with a median follow-up of 9 months (N = 25): The overall response rate was
88% (22/25 patients), with72% (18/25) of patients achieving a complete response.71% (10/14) of patients with complete response remained in complete response at ≥ 6 months. - In initial data from efficacy-evaluable 2L patients, with a median follow-up of 5 months (N = 11): The overall response rate was
91% (10/11 patients), with64% (7/11) achieving a complete response.100% (7/7) of patients with complete response were in complete response at their last assessment, including 3/3 patients at ≥ 6 months. In patients with primary refractory disease, a difficult to treat population,70% (7/10) achieved a complete response. - In 51 patients, including patients from both the 3L+ and the 2L cohorts, a manageable safety profile appropriate for outpatient administration was observed. No Grade ≥ 3 and low rates of Grade 1 (
22% ) or Grade 2 (35% ) cytokine release syndrome (CRS) were reported. Immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in6% (Grade 1),2% (Grade 2), and14% (Grade ≥ 3) of patients. The median time to complete resolution of all reports of ICANS was 5 days, with rapid improvement (median of 2 days) to Grade 2 or lower with standard therapy. No deaths were related to LYL314 administration. LYL314 demonstrated robust expansion with a time to peak of 10 days. The final drug product contained the desired CD62L-positive naïve T-cell phenotype (median,95% ). Rapid and durable depletion of B cells was demonstrated through month 6 and up to the month 12 assessment.
- Fifty-one CAR T-naive patients with R/R LBCL received LYL314 as of April 15, 2025 (the data cutoff date for the presentation). The efficacy evaluable population consisted of 36 patients with Day 84 assessments or prior disease progression or death. Patient demographics and baseline disease characteristics were consistent with high-risk patient populations: median ages of 65 and 69 years in the 3L+ and 2L, respectively,
- An update on the progress of the PiNACLE trial is planned for late 2025. Data from this trial 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.
- More mature data from the ongoing Phase 1/2 trial in the 2L setting are expected to be presented in late 2025.
- A Phase 3 randomized controlled trial of LYL314 is expected to be initiated by early 2026 in patients receiving treatment in the 2L setting with R/R LBCL.
Preclinical Pipeline, Technologies and Manufacturing Protocols
Lyell is advancing next-generation fully-armed CAR T-cell product candidates, each including multiple technologies, designed to overcome T-cell exhaustion and lack of durable stemness, as well as immune suppression within the hostile tumor microenvironment.
- The first IND for a fully-armed CAR T-cell product candidate with an undisclosed target for solid tumors is expected in 2026.
Corporate Updates
- In July, Lyell entered into a securities purchase agreement for a private placement with certain institutional and other accredited investors, for gross proceeds of up to approximately
$100 million . The initial closing of approximately$50 million of common stock at a price of$13.32 per share occurred on July 25, 2025. - After deducting offering expenses, Lyell expects to use net proceeds from the private placement, together with its existing cash, cash equivalents, and marketable securities, to advance two pivotal-stage clinical trials of LYL314 as well as working capital for other general corporate purposes.
Second Quarter 2025 Financial Results
Lyell reported a net loss of
GAAP and Non-GAAP Operating Expenses
- Research and development (R&D) expenses were
$34.9 million for the second quarter ended June 30, 2025, compared to$40.3 million for the same period in 2024. The decrease in second quarter 2025 R&D expenses of$5.4 million was primarily due to a$2.9 million reduction in research activities, collaborations and outside services due primarily to a reduction in costs associated with research and laboratory supplies and collaboration agreements and a$2.4 million decrease in personnel‑related expenses primarily due to reduced stock-based compensation expense resulting from lower headcount and the reduced value of new equity awards. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities for the second quarter ended June 30, 2025 were$32.6 million , compared to$37.2 million for the same period in 2024. - General and administrative (G&A) expenses were
$9.8 million for the second quarter ended June 30, 2025, compared to$12.3 million for the same period in 2024. The decrease in second quarter 2025 G&A expenses of$2.5 million was primarily due to a$1.7 million decrease in stock-based compensation expense primarily related to a decrease in the value of new awards granted and a$0.8 million decrease in outside services primarily due to a reduction in legal expenses. Non‑GAAP G&A expenses, which exclude non-cash stock‑based compensation, for the second quarter ended June 30, 2025 were$7.1 million , compared to$7.8 million for the same period in 2024.
A discussion of non-GAAP financial measures, including reconciliations of the most comparable 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 June 30, 2025 were approximately
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 endow CAR T cells with attributes needed to drive durable tumor cytotoxicity and high rates of long‑lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile tumor microenvironment. The Lyell LyFE Manufacturing Center™ has commercial launch capability and can manufacture more than 1,200 CAR T-cell doses at full capacity. 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 initiation by early 2026 of a pivotal trial for LYL314 for patients with LBCL in the 2L setting; expectations around the potential for CD19/CD20 CAR T-cell therapies to disrupt the therapeutic landscape; the anticipated benefits of RMAT and Fast Track designations for LYL314; Lyell’s expectations around the progress of the PiNACLE trial, including expectations around enrollment and timing of progress update in late 2025, and using data from the trial to form the basis of a Biologics License Application submission to the FDA in 2027 for patients with relapsed and/or refractory LBCL receiving treatment in the 3L+ setting; Lyell’s expectations around continued enrollment for and timing of more mature clinical data from its ongoing Phase 1/2 trial for LYL314 in the 2L setting in late 2025; the advancement of Lyell’s technology platform; Lyell’s advancement of its pipeline and its research, development and clinical capabilities; Lyell’s submission of an IND in 2026 for a CAR T-cell product candidate with an undisclosed target for solid tumors; Lyell’s plans for using the net proceeds from the private placement and its existing cash, cash equivalents and marketable securities, and its expectation that its financial position and cash runway will support advancement of its pipeline into mid-2027 through key clinical milestones; the sufficiency of the capacity of LyFE to manufacture drug supply for Lyell’s ongoing and planned pivotal trials and through potential commercial launch; Lyell’s anticipated progress, business plans, business strategy and clinical trials; the potential clinical benefits and therapeutic potential of Lyell’s product candidates, including meaningful increased complete response rates and prolonged duration of response; 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’s ability to submit planned INDs or initiate or progress clinical trials on the anticipated timelines, if at all; Lyell’s limited experience as a company in enrolling and conducting clinical trials, and lack of experience in completing clinical trials; the complexity of manufacturing cellular therapies, which subjects us to a multitude of manufacturing risks, any of which could substantially increase our costs, delay our programs or limit supply of our product candidates; the nonclinical profiles of Lyell’s product candidates or technology not translating in clinical trials; the potential for results from clinical trials to differ from nonclinical, early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with Lyell’s product candidates; the significant uncertainty associated with Lyell’s product candidates ever receiving any regulatory approvals; RMAT and Fast Track designations may not actually lead to faster development, regulatory review or approval process, and does not assure ultimate FDA approval; Lyell’s ability to obtain, maintain or protect intellectual property rights related to its product candidates; implementation of Lyell’s strategic plans for its business and product candidates; the sufficiency of Lyell’s capital resources and need for additional capital to achieve its goals; the effects of macroeconomic conditions, including the effects of disruption between the U.S. and its trading partners due to tariffs or other policies, and any geopolitical instability; potential changes to U.S. drug pricing, including the potential for “most-favored nations” pricing limitations; and other risks, including those described under the heading “Risk Factors” in Lyell’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, being filed with the SEC 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 June 30, | Six Months Ended June 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Revenue | $ | 8 | $ | 13 | $ | 15 | $ | 16 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development(1) | 34,857 | 40,261 | 78,304 | 83,435 | |||||||||||
| General and administrative | 9,786 | 12,256 | 23,832 | 25,750 | |||||||||||
| Other operating loss (income), net | 1,062 | (976 | ) | 943 | (2,066 | ) | |||||||||
| Impairment of long-lived assets | 1,443 | — | 1,443 | — | |||||||||||
| Total operating expenses | 47,148 | 51,541 | 104,522 | 107,119 | |||||||||||
| Loss from operations | (47,140 | ) | (51,528 | ) | (104,507 | ) | (107,103 | ) | |||||||
| Interest income, net | 3,276 | 6,364 | 7,138 | 13,183 | |||||||||||
| Other income (expense), net(1) | 1,180 | (645 | ) | 2,490 | 445 | ||||||||||
| Impairment of other investments | — | — | — | (13,001 | ) | ||||||||||
| Total other income, net | 4,456 | 5,719 | 9,628 | 627 | |||||||||||
| Net loss | $ | (42,684 | ) | $ | (45,809 | ) | $ | (94,879 | ) | $ | (106,476 | ) | |||
| (1) | As of October 1, 2024, the Company’s success payment liability was recognized at fair value as Stanford had provided the requisite service obligation to earn the potential success payment consideration. The change in the estimated fair value of Stanford success payment liabilities in the first half of 2025 was recognized within other income (expense), net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Stanford success payment liabilities in the first half of 2024 was recognized within research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss. |
Balance Sheet Data:
| As of June 30, | As of December 31, | ||||||
| 2025 | 2024 | ||||||
| Cash, cash equivalents and marketable securities | $ | 296,849 | $ | 383,541 | |||
| Property and equipment, net | $ | 39,115 | $ | 48,200 | |||
| Total assets | $ | 385,453 | $ | 490,859 | |||
| Total stockholders’ equity | $ | 298,923 | $ | 382,824 | |||
Non-GAAP Financial Measures
To supplement our financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), we present non-GAAP net loss, non-GAAP R&D expenses and non-GAAP G&A expenses. Non‑GAAP net loss and non-GAAP R&D expenses exclude non-cash stock-based compensation expense and non-cash expenses related to the change in the estimated fair value of success payment liabilities from GAAP net loss and GAAP R&D expenses, respectively. Non-GAAP net loss is further adjusted by non‑cash investment gains and charges, as applicable. Non‑GAAP G&A expenses exclude non-cash stock-based compensation expense from GAAP 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 non-cash investment gains and charges from our non‑GAAP financial measures because they are non-cash 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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net loss - GAAP | $ | (42,684 | ) | $ | (45,809 | ) | $ | (94,879 | ) | $ | (106,476 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation expense | 5,004 | 8,284 | 11,028 | 17,439 | ||||||||||||
| Change in the estimated fair value of success payment liabilities | (115 | ) | (1,534 | ) | (240 | ) | (566 | ) | ||||||||
| Impairment of other investments | — | — | — | 13,001 | ||||||||||||
| Net loss - Non-GAAP(1) | $ | (37,795 | ) | $ | (39,059 | ) | $ | (84,091 | ) | $ | (76,602 | ) | ||||
| (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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Research and development - GAAP | $ | 34,857 | $ | 40,261 | $ | 78,304 | $ | 83,435 | ||||||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation expense | (2,295 | ) | (3,865 | ) | (4,683 | ) | (7,657 | ) | ||||||||
| Change in the estimated fair value of success payment liabilities(1) | — | 793 | — | 268 | ||||||||||||
| Research and development - Non-GAAP | $ | 32,562 | $ | 37,189 | $ | 73,621 | $ | 76,046 | ||||||||
| (1) | As of October 1, 2024, the Company’s success payment liability was recognized at fair value as Stanford had provided the requisite service obligation to earn the potential success payment consideration. The change in the estimated fair value of Stanford success payment liabilities in the first half of 2025 was recognized within other income (expense), net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Stanford success payment liabilities in the first half of 2024 was recognized within research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss. |
| Lyell Immunopharma, Inc. | ||||||||||||||||
| Unaudited Reconciliation of GAAP to Non-GAAP General and Administrative Expenses | ||||||||||||||||
| (in thousands) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| General and administrative - GAAP | $ | 9,786 | $ | 12,256 | $ | 23,832 | $ | 25,750 | ||||||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation expense | (2,709 | ) | (4,419 | ) | (6,345 | ) | (9,782 | ) | ||||||||
| General and administrative - Non-GAAP | $ | 7,077 | $ | 7,837 | $ | 17,487 | $ | 15,968 | ||||||||
Contact:
Ellen Rose
Senior Vice President, Communications and Investor Relations
erose@lyell.com
FAQ
What were the key clinical results for Lyell's LYL314 CAR T-cell therapy in Q2 2025?
How much funding did Lyell Immunopharma (LYEL) secure in their private placement?
What is the cash runway for Lyell Immunopharma after the Q2 2025 results?
What are the safety results for Lyell's LYL314 therapy in clinical trials?
When does Lyell expect to submit the Biologics License Application for LYL314?
