Lyell Immunopharma Reports Business Highlights and Financial Results for the Fourth Quarter and Full Year 2024
Lyell Immunopharma (LYEL) reported its Q4 and full-year 2024 results, highlighting significant developments in its CAR T-cell therapy pipeline. The company's lead program, IMPT-314, showed promising Phase 1 data with a 94% overall response rate and 71% complete response rate in large B-cell lymphoma patients.
Key financial metrics include a net loss of $191.9M for Q4 and $343.0M for full-year 2024. Cash position stands at $383.5 million, expected to fund operations into 2027. The company plans to initiate pivotal trials for IMPT-314 in mid-2025 for 3rd line treatment and early 2026 for 2nd line treatment.
Research and development expenses were $48.7M in Q4 and $171.6M for the full year. The company acquired ImmPACT Bio, incurring $87.2M in IPR&D expenses, and recorded a $51.3M impairment charge on long-lived assets due to stock price decline.
Lyell Immunopharma (LYEL) ha riportato i risultati del quarto trimestre e dell'intero anno 2024, evidenziando sviluppi significativi nel suo pipeline di terapia con cellule T CAR. Il programma principale dell'azienda, IMPT-314, ha mostrato dati promettenti della Fase 1 con un tasso di risposta complessivo del 94% e un tasso di risposta completa del 71% nei pazienti con linfoma a grandi cellule B.
I principali indicatori finanziari includono una perdita netta di 191,9 milioni di dollari per il quarto trimestre e 343,0 milioni di dollari per l'intero anno 2024. La posizione di cassa è di 383,5 milioni di dollari, prevista per finanziare le operazioni fino al 2027. L'azienda prevede di avviare studi pivotal per IMPT-314 a metà del 2025 per il trattamento di terza linea e all'inizio del 2026 per il trattamento di seconda linea.
Le spese per ricerca e sviluppo sono state di 48,7 milioni di dollari nel quarto trimestre e di 171,6 milioni di dollari per l'intero anno. L'azienda ha acquisito ImmPACT Bio, sostenendo spese di 87,2 milioni di dollari in IPR&D, e ha registrato un addebito di svalutazione di 51,3 milioni di dollari su attività durevoli a causa del calo del prezzo delle azioni.
Lyell Immunopharma (LYEL) informó sobre sus resultados del cuarto trimestre y del año completo 2024, destacando desarrollos significativos en su pipeline de terapia con células T CAR. El programa principal de la compañía, IMPT-314, mostró datos prometedores de la Fase 1 con una tasa de respuesta general del 94% y una tasa de respuesta completa del 71% en pacientes con linfoma de células B grandes.
Los principales indicadores financieros incluyen una pérdida neta de 191,9 millones de dólares para el cuarto trimestre y de 343,0 millones de dólares para el año completo 2024. La posición de efectivo es de 383,5 millones de dólares, que se espera que financie las operaciones hasta 2027. La compañía planea iniciar ensayos pivotal para IMPT-314 a mediados de 2025 para el tratamiento de tercera línea y a principios de 2026 para el tratamiento de segunda línea.
Los gastos en investigación y desarrollo fueron de 48,7 millones de dólares en el cuarto trimestre y de 171,6 millones de dólares para el año completo. La compañía adquirió ImmPACT Bio, incurriendo en gastos de 87,2 millones de dólares en IPR&D, y registró un cargo por deterioro de 51,3 millones de dólares en activos de larga duración debido a la caída del precio de las acciones.
Lyell Immunopharma (LYEL)는 2024년 4분기 및 연간 실적을 발표하며 CAR T세포 치료 파이프라인의 중요한 발전을 강조했습니다. 회사의 주요 프로그램인 IMPT-314는 대형 B세포 림프종 환자에서 94%의 전체 반응률과 71%의 완전 반응률을 기록하며 유망한 1상 데이터를 보여주었습니다.
주요 재무 지표로는 4분기 순손실이 1억 9190만 달러, 2024년 전체 연도 순손실이 3억 4300만 달러입니다. 현금 보유액은 3억 8350만 달러로, 2027년까지 운영을 지원할 것으로 예상됩니다. 회사는 2025년 중반에 IMPT-314의 3차 치료를 위한 주요 시험을 시작하고, 2026년 초에 2차 치료를 위한 시험을 시작할 계획입니다.
연구 및 개발 비용은 4분기에 4870만 달러, 전체 연도에 1억 7160만 달러였습니다. 회사는 ImmPACT Bio를 인수하며 8720만 달러의 IPR&D 비용이 발생했으며, 주가 하락으로 인해 장기 자산에 대해 5130만 달러의 손상 차손을 기록했습니다.
Lyell Immunopharma (LYEL) a annoncé ses résultats du quatrième trimestre et de l'année complète 2024, mettant en avant des développements significatifs dans son pipeline de thérapie par cellules T CAR. Le programme phare de l'entreprise, IMPT-314, a montré des données prometteuses de Phase 1 avec un taux de réponse global de 94 % et un taux de réponse complète de 71 % chez les patients atteints de lymphome à grandes cellules B.
Les principaux indicateurs financiers comprennent une perte nette de 191,9 millions de dollars pour le quatrième trimestre et de 343,0 millions de dollars pour l'année complète 2024. La position de trésorerie est de 383,5 millions de dollars, prévue pour financer les opérations jusqu'en 2027. L'entreprise prévoit de lancer des essais pivotaux pour IMPT-314 à la mi-2025 pour le traitement de troisième ligne et au début de 2026 pour le traitement de deuxième ligne.
Les dépenses de recherche et développement se sont élevées à 48,7 millions de dollars au quatrième trimestre et à 171,6 millions de dollars pour l'année complète. L'entreprise a acquis ImmPACT Bio, entraînant des dépenses de 87,2 millions de dollars en IPR&D, et a enregistré une charge de dépréciation de 51,3 millions de dollars sur des actifs à long terme en raison de la baisse du prix des actions.
Lyell Immunopharma (LYEL) hat seine Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 bekannt gegeben und bedeutende Entwicklungen in seiner CAR-T-Zelltherapie-Pipeline hervorgehoben. Das Hauptprogramm des Unternehmens, IMPT-314, zeigte vielversprechende Phase-1-Daten mit einer Gesamtansprechrate von 94 % und einer vollständigen Ansprechrate von 71 % bei Patienten mit großzelligem B-Zell-Lymphom.
Wichtige Finanzkennzahlen umfassen einen Nettoverlust von 191,9 Millionen US-Dollar für das vierte Quartal und 343,0 Millionen US-Dollar für das gesamte Jahr 2024. Die Liquiditätsposition beträgt 383,5 Millionen US-Dollar, die voraussichtlich die Betriebe bis 2027 finanzieren wird. Das Unternehmen plant, Mitte 2025 für IMPT-314 entscheidende Studien für die 3. Behandlungslinie und Anfang 2026 für die 2. Behandlungslinie zu starten.
Die Forschungs- und Entwicklungskosten beliefen sich im vierten Quartal auf 48,7 Millionen US-Dollar und im gesamten Jahr auf 171,6 Millionen US-Dollar. Das Unternehmen erwarb ImmPACT Bio und verursachte dabei 87,2 Millionen US-Dollar an IPR&D-Kosten, und verbuchte einen Wertminderungsaufwand von 51,3 Millionen US-Dollar auf langlebige Vermögenswerte aufgrund des Rückgangs des Aktienkurses.
- Strong clinical data: 94% overall response rate and 71% complete response rate for IMPT-314
- Healthy cash position of $383.5M providing runway into 2027
- FDA Fast Track Designation received for IMPT-314
- R&D expenses decreased by $11.3M year-over-year
- Net loss increased to $343.0M in 2024 from $234.6M in 2023
- $51.3M impairment charge due to declining stock price
- $87.2M expense from ImmPACT Bio acquisition
- Reduction in workforce implemented in November 2023
Insights
Lyell's Q4 and FY2024 results present a bifurcated financial picture - significant accounting losses paired with strong underlying fundamentals and long-term potential.
The reported net loss of
The cash position of
Management's disciplined expense management is evident in their projected 2025 net cash use of
The current valuation presents a compelling risk/reward proposition - investors are essentially getting the clinical pipeline for free while the company has sufficient runway to reach multiple value-inflection points over the next 24 months.
IMPT-314's clinical data demonstrates potentially best-in-class efficacy for CAR T therapy in LBCL. The reported
Two key technical differentiators explain these results: 1) The dual-targeting CD19/CD20 approach with a true 'OR' logic gate addresses CD19 antigen loss, a primary mechanism of CAR T therapy failure; 2) The manufacturing process enriches for CD62L+ cells, producing more naïve and central memory CAR T cells with enhanced stemlike features that improve persistence and anti-tumor activity.
The safety profile is equally promising - no Grade 3+ cytokine release syndrome was observed in 23 patients, with Grade 3 ICANS (immune effector cell-associated neurotoxicity) in only
The FDA's Fast Track Designation affirms the unmet need and therapeutic potential. Lyell's acceleration to pivotal trials in both 3rd line+ (mid-2025) and 2nd line (early 2026) settings demonstrates confidence in the data. Moving into earlier treatment lines is strategically sound, as efficacy typically improves in less heavily pretreated patients.
Beyond hematologic malignancies, Lyell's work on next-generation solid tumor CAR Ts incorporating anti-exhaustion technology addresses key limitations of current cell therapies, potentially expanding this treatment modality to much larger patient populations.
- Acquired ImmPACT Bio and strengthened clinical pipeline with the addition of IMPT-314, a next-generation dual-targeting CD19/CD20 CAR T-cell product candidate for the treatment of aggressive large B-cell lymphoma (LBCL)
- Presented positive initial data from Phase 1 multi-center clinical trial of IMPT-314 in patients with aggressive LBCL in the 3rd line and later setting at the American Society of Hematology 2024 Annual Meeting
- Acceleration of development of IMPT-314 in LBCL; remain on track to initiate a pivotal trial in the 3rd line and later setting in mid-2025 and expect to initiate a pivotal trial in the 2nd line setting by early 2026
- Advancing next-generation CAR T-cell product candidates with new targets and technologies; first IND for fully‑armed solid tumor product candidate expected in 2026
- Cash, cash equivalents and marketable securities of
$383.5 million as of December 31, 2024, support advancing pipeline into 2027 through multiple clinical milestones
SOUTH SAN FRANCISCO, Calif., March 11, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, today reported financial results and business highlights for the fourth quarter and year ended December 31, 2024.
“Last year was transformative for Lyell and now, based on promising emerging clinical data, we are poised to initiate pivotal development of IMPT-314, our next-generation dual-targeting CD19/CD20 CAR T-cell product candidate for patients with aggressive large B‑cell lymphoma,” said Lynn Seely, M.D., Lyell’s President and CEO. “We believe IMPT-314 has the potential to deliver improved outcomes for patients by increasing complete response rates and prolonging the duration of response over approved CD19 CAR T-cell therapies, and this year we expect to share more mature data from the ongoing Phase 1/2 trial of IMPT-314. We also plan to initiate two pivotal programs for IMPT-314: one for patients in the 3rd line and later setting by the middle of this year and a second program for patients in the 2nd line setting by early 2026. In addition, we expect to submit a new IND in 2026 for a next-generation solid tumor CAR T-cell product candidate with a new target that is fully-armed with a suite of technologies, including our proprietary clinically-validated anti-exhaustion technology. Our strong cash position enables us to advance our pipeline through important clinical milestones and fund operations into 2027.”
Fourth Quarter Updates and Recent Business Highlights
Lyell is advancing a pipeline of next-generation CAR T-cell product candidates. Its lead program, IMPT-314, is in Phase 1/2 clinical development for relapsed or refractory aggressive large B-cell lymphoma (LBCL) and its preclinical programs target solid tumor indications. Lyell’s programs target cancers with large unmet need with substantial patient populations.
IMPT-314: 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 the approved CD19‑targeted CAR T-cell therapies for the treatment of LBCL
IMPT-314 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+ cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. The ongoing Phase 1/2 clinical trial is a multi-center, open-label study designed to evaluate the tolerability and clinical benefit of IMPT-314 in patients with relapsed/refractory LBCL and determine a recommended Phase 2 dose. IMPT-314 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of relapsed/refractory aggressive B-cell lymphoma in the 3rd line and later (3rd line+) setting.
- A Phase 1/2 clinical trial is ongoing and currently enrolling patients in the 3rd line+ and 2nd line settings who have not previously received CAR T-cell therapy.
- Initial data from the Phase 1/2 trial was presented at the American Society for Hematology 2024 Annual Meeting on December 9, 2024. Data from 23 patients with relapsed or refractory, CAR T-naive LBCL who received IMPT-314 were reported. The efficacy evaluable population consisted of 17 patients. The overall response rate was
94% (16/17 patients), with71% (12/17 patients) achieving a complete response by three months. The median follow up was 6.3 months (range 1.2 – 12.5 months) and71% of patients were experiencing a response at last follow-up. In the safety evaluable population of 23 patients, no Grade 3+ CRS was reported. Grade 3 ICANS was reported in13% (3/23) of patients with a median time to ICANS resolution of 5 days, and rapid improvement to Grade 2 or lower with standard therapy. - More mature data from the ongoing Phase 1/2 trial in the 3rd line+ setting and initial data from patients in the 2nd line setting are expected to be presented in mid-2025.
- Pivotal trial in the 3rd line+ setting is expected to be initiated in mid-2025 in patients with relapsed/refractory aggressive LBCL who have not previously received CAR T-cell therapy.
- Pivotal trial in the 2nd line setting expected to be initiated by early 2026 in patients with relapsed/refractory aggressive LBCL who have not previously received CAR T-cell therapy.
Preclinical Pipeline, Technologies and Manufacturing Protocols
- The first IND for a fully-armed CAR T-cell product candidate with an undisclosed target for solid tumors is expected in 2026. Lyell is advancing next-generation fully-armed CAR T-cell product candidates, meaning they are armed with multiple technologies, each designed to address different barriers to effective cell therapies, including T-cell exhaustion, lack of durable stemness, as well as immune suppression within the hostile tumor microenvironment.
- Presented nonclinical and clinical data from cell therapy product candidates incorporating anti‑exhaustion and manufacturing technologies that demonstrated the potential of Lyell’s technologies to improve T‑cell function in solid tumors. These presentations, from multiple scientific conferences throughout the year, can be found on the Lyell website here.
Corporate Updates
- Streamlined expenses and expect net cash use in 2025 to be between
$175 million -$185 million . The disciplined expense management will be accomplished by focusing clinical development efforts on the pivotal trials of IMPT-314 and research efforts on developing next-generation fully-armed CAR T-cell programs for solid tumors.
Fourth Quarter and Full Year 2024 Financial Results
Lyell reported a net loss of
GAAP and Non-GAAP Operating Expenses
- Research and development (R&D) expenses were
$48.7 million and$171.6 million for the fourth quarter and year ended December 31, 2024, respectively, compared to$47.0 million and$182.9 million for the same periods in 2023. The increase in fourth quarter 2024 R&D expenses of$1.7 million was primarily due to increased facilities costs. The decrease in annual 2024 R&D expenses of$11.3 million was primarily driven by a$14.0 million decrease in personnel-related expenses mainly due to lower headcount following the Company’s November 2023 reduction in workforce, partially offset by a$3.2 million increase in research activities primarily driven by clinical trial activity. 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 fourth quarter and year ended December 31, 2024 were$45.4 million and$157.3 million , respectively, compared to$42.9 million and$165.7 million for the same periods in 2023. The$2.5 million increase in fourth quarter 2024 non-GAAP R&D expenses was primarily driven by increased facilities costs. The$8.3 million decrease in annual 2024 non-GAAP R&D expenses was primarily driven by the decrease in personnel-related expenses mainly due to lower headcount following the Company’s November 2023 reduction in workforce. - General and administrative (G&A) expenses were
$14.5 million and$52.0 million for the fourth quarter and year ended December 31, 2024, respectively, compared to$13.2 million and$67.0 million for the same periods in 2023. The decrease in annual 2024 G&A expenses of$14.9 million was primarily driven by a decrease in non‑cash stock-based compensation. Non‑GAAP G&A expenses, which exclude non-cash stock‑based compensation, for the fourth quarter and year ended December 31, 2024 were$9.7 million and$33.5 million , respectively, compared to$8.5 million and$38.1 million for the same periods in 2023. The$1.3 million increase in fourth quarter 2024 non-GAAP G&A expenses was primarily driven by acquisition-related personnel expenses. The$4.6 million decrease in annual 2024 non-GAAP G&A expenses was primarily driven by the decrease in personnel-related expenses mainly due to lower headcount following the Company’s November 2023 reduction in workforce. - Operating expenses for the fourth quarter and year ended December 31, 2024, include
$87.2 million of acquired IPR&D expenses recognized as a part of the acquisition of ImmPACT Bio. Additionally, operating expenses for the fourth quarter and year ended December 31, 2024, include an impairment charge of$51.3 million for long-lived assets, resulting from the continued decline in our stock price and related market capitalization.
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 December 31, 2024 were
About Lyell Immunopharma, Inc.
Lyell is a clinical-stage 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 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. Lyell is based in South San Francisco, California with facilities in West Hills, California and Seattle and Bothell, Washington. 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: the anticipated benefits of Lyell’s acquisition of ImmPACT Bio; Lyell’s ability to accelerate the development of IMPT-314 and deliver improved outcomes for patients by increasing complete response rates and prolonging the duration of response over approved CD19 CAR T‑cell therapies; Lyell’s initiation of pivotal trials in 2025 and 2026 for IMPT-314; timing of Lyell’s submission of a new IND in 2026 for a next-generation solid tumor CAR T-cell product candidate; the ability of Lyell’s technology to enable and generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response; Lyell’s anticipated progress, business plans, business strategy and clinical trials; Lyell’s advancement of its pipeline and its research, development and clinical capabilities; the potential clinical benefits and therapeutic potential of Lyell’s product candidates; the advancement of Lyell’s technology platform; Lyell’s expectation that its financial position and cash runway will support advancement of its pipeline through multiple clinical milestones and fund operations into 2027; expectations around enrollment and the timing of initial and updated clinical data from Lyell’s Phase 1/2 trial for IMPT-314; 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: the inability to recognize the anticipated benefits of acquiring ImmPACT Bio and successful integration of ImmPACT Bio’s business with Lyell’s, including a successful manufacturing technology transfer of IMPT-314 to Lyell’s LyFE manufacturing facility; the effects of macroeconomic conditions, including any geopolitical instability and actual or perceived changes in interest rates and economic inflation; 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; Lyell’s ability to manufacture and supply its product candidates for its clinical trials; 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; 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; and other risks, including those described under the heading “Risk Factors” in Lyell’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the Securities and Exchange Commission (SEC) on November 7, 2024, and its Annual Report on Form 10-K for the year ended December 31, 2024, being filed with the SEC later 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 December 31, | Year Ended December 31, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenue | $ | 11 | $ | 13 | $ | 61 | $ | 130 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development(1) | 48,668 | 46,995 | 171,603 | 182,945 | |||||||||||
| General and administrative | 14,522 | 13,167 | 52,041 | 66,983 | |||||||||||
| Other operating income, net | (513 | ) | (641 | ) | (3,309 | ) | (2,790 | ) | |||||||
| Acquired in-process research and development | 87,184 | — | 87,184 | — | |||||||||||
| Impairment of long-lived assets | 51,297 | — | 51,297 | — | |||||||||||
| Total operating expenses | 201,158 | 59,521 | 358,816 | 247,138 | |||||||||||
| Loss from operations | (201,147 | ) | (59,508 | ) | (358,755 | ) | (247,008 | ) | |||||||
| Interest income, net | 4,920 | 7,084 | 24,068 | 23,453 | |||||||||||
| Other income (loss), net(1) | 4,292 | (506 | ) | 4,694 | 1,846 | ||||||||||
| Impairment of other investments | — | — | (13,001 | ) | (12,923 | ) | |||||||||
| Total other income, net | 9,212 | 6,578 | 15,761 | 12,376 | |||||||||||
| Net loss | $ | (191,935 | ) | $ | (52,930 | ) | $ | (342,994 | ) | $ | (234,632 | ) | |||
| (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 beginning in Q4 2024 was recognized within other income (loss), net in the Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Stanford success payment liabilities in 2023 and the first nine months of 2024 were recognized within research and development expenses in the Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Fred Hutch success payment liabilities was recognized within other income (loss), net in the Consolidated Statements of Operations and Comprehensive Loss. |
Balance Sheet Data:
| As of December 31, | |||||
| 2024 | 2023 | ||||
| Cash, cash equivalents and marketable securities | $ | 383,541 | $ | 562,729 | |
| Property and equipment, net | $ | 48,200 | $ | 102,654 | |
| Total assets | $ | 490,859 | $ | 750,029 | |
| Total stockholders’ equity | $ | 382,824 | $ | 654,952 | |
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. Non-GAAP net loss further adjusts non-cash acquired IPR&D expense, non‑cash long-lived asset impairment expense and 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, acquired IPR&D expense, long-lived asset impairment expense 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 December 31, | Year Ended December 31, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Net loss - GAAP | $ | (191,935 | ) | $ | (52,930 | ) | $ | (342,994 | ) | $ | (234,632 | ) | |||
| Adjustments: | |||||||||||||||
| Stock-based compensation expense | 8,083 | 8,463 | 33,144 | 47,084 | |||||||||||
| Change in the estimated fair value of success payment liabilities | (496 | ) | 529 | (1,165 | ) | (2,780 | ) | ||||||||
| Impairment of other investments | — | — | 13,001 | 12,923 | |||||||||||
| Acquired in-process research and development expense | 87,184 | — | 87,184 | — | |||||||||||
| Impairment of long-lived assets | 51,297 | — | 51,297 | — | |||||||||||
| Net loss - Non-GAAP(1) | $ | (45,867 | ) | $ | (43,938 | ) | $ | (159,533 | ) | $ | (177,405 | ) | |||
| (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 December 31, | Year Ended December 31, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Research and development - GAAP | $ | 48,668 | $ | 46,995 | $ | 171,603 | $ | 182,945 | |||||||
| Adjustments: | |||||||||||||||
| Stock-based compensation expense | (3,295 | ) | (3,768 | ) | (14,577 | ) | (18,207 | ) | |||||||
| Change in the estimated fair value of success payment liabilities(1) | — | (319 | ) | 308 | 930 | ||||||||||
| Research and development - Non-GAAP | $ | 45,373 | $ | 42,908 | $ | 157,334 | $ | 165,668 | |||||||
| (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 beginning in Q4 2024 was recognized within other income (loss), net in the Consolidated Statements of Operations and Comprehensive Loss. The changes in the estimated fair value of Stanford success payment liabilities in 2023 and the first nine months of 2024 were recognized within research and development expenses in the Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Fred Hutch success payment liabilities was recognized within other income (loss), net in the 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 December 31, | Year Ended December 31, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| General and administrative - GAAP | $ | 14,522 | $ | 13,167 | $ | 52,041 | $ | 66,983 | |||||||
| Adjustments: | |||||||||||||||
| Stock-based compensation expense | (4,788 | ) | (4,695 | ) | (18,567 | ) | (28,877 | ) | |||||||
| General and administrative - Non-GAAP | $ | 9,734 | $ | 8,472 | $ | 33,474 | $ | 38,106 | |||||||
Contact:
Ellen Rose
Senior Vice President, Communications and Investor Relations
erose@lyell.com
FAQ
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