Lyell Immunopharma Reports Second Quarter Financial Results and Business Highlights
- Cash, cash equivalents and marketable securities of
$787.0 million as ofJune 30, 2022 provides funding into 2025 and supports advancement of multiple product candidates through key clinical milestones
“As a clinical stage company, we continue to make progress advancing our pipeline and growing our capabilities,” said Liz Homans, CEO of
Recent Business Highlights
- Presented preclinical data for LYL797, Lyell’s CAR T-cell therapy targeting ROR1+ solid tumors that incorporates Gen-R and Epi-R, at the
American Society of Gene & Cell Therapy (ASGCT) demonstrating that Gen-R and Epi‑R reprogramming technologies can enhance and prolong anti-tumor functions of ROR1-targeting CAR T-cell therapy in solid tumor model systems. - Presented preclinical data for LYL132, a TCR therapy targeting NY-ESO-1+ solid tumors that incorporates Epi-R and is being developed in collaboration with GSK, at ASGCT demonstrating that Epi-R reprogramming technology creates populations of stemlike NY-ESO-1-targeting TCR T cells that lead to products with increased proliferative capacity and prolonged functional activity in the presence of persistent antigen exposure.
- Presented preclinical data at the
International Society for Stem Cell Research 2022 Annual Meeting (ISSCR) demonstrating the application of Lyell’s rejuvenation technology yielded improvements in antitumor properties of engineered adoptive T-cell products as compared to non-rejuvenated T-cell controls.
Second Quarter 2022 Financial Results
Revenue
- Revenue was
$35 .7 million and$2 .6 million for the three months endedJune 30, 2022 and 2021, respectively, primarily related to the recognized portion of the upfront license fee of Lyell’s Collaboration and License Agreement entered into in 2019 and amended inJune 2020 andDecember 2021 (GSK Agreement) with GlaxoSmithKline Intellectual Property (No. 5) Limited andGlaxo Group Limited (together, GSK). The increase of$33 .1 million was primarily related to recognizing$35.3 million in revenue due to a mutual agreement with GSK to conclude research activities on an undisclosed target for hematological cancers.
GAAP and Non-GAAP Operating Expenses
- Lyell reported a net loss of
$36.3 million for the second quarter endedJune 30, 2022 , compared to a net loss of$62.6 million for the same period in 2021. Non-GAAP net loss, which excludes non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities, was$10 .3 million for the second quarter endedJune 30, 2022 compared to$38.1 million for the same period in 2021. - Research and development (R&D) expenses were
$43.7 million for the second quarter endedJune 30, 2022 , compared to$46.4 million for the same period in 2021. The decrease in R&D expense was primarily driven by a reduction in the success payment liability balance, which offset increases in facilities and technology costs to support the expansion of our R&D and manufacturing capabilities. 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 endedJune 30, 2022 , were$35 .9 million, compared to$32 .1 million for the same period in 2021. - General and administrative (G&A) expenses were
$30.5 million for the second quarter endedJune 30, 2022 , compared to$19.1 million for the same period in 2021. The increase in G&A expense was primarily due to an$8 .1 million increase in stock-based compensation expense, primarily related to award modifications and new awards granted. Non‑GAAP G&A expenses, which exclude non-cash stock-based compensation, for the second quarter endedJune 30, 2022 were$12 .2 million, compared to$9 .0 million for the same period in 2021. The increase in non-GAAP G&A expenses was driven by litigation-related expenses and public company operating costs.
A discussion of these 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
About
Lyell is a clinical-stage T-cell reprogramming company dedicated to developing curative cell therapies for patients with solid tumors. The Company is advancing a pipeline of therapies designed to address what it believes are the primary barriers that limit consistent, reliable and curative responses to adoptive T-cell therapy: T-cell exhaustion and lack of durable stemness, which includes the ability to proliferate, persist and self-renew, as well as generate differentiated effector cell progenies to provide durable anti-tumor functionality. Lyell is applying its proprietary ex vivo genetic and epigenetic reprogramming technology platforms, Gen-RTM and Epi-RTM, to address these barriers in order to develop new medicines with improved, durable and potentially curative clinical outcomes. Lyell is based in
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 anticipated progress, business plans, business strategy and clinical trials; Lyell advancing its pipeline or growing its capabilities; the potential clinical benefits and therapeutic potential of Lyell’s product candidates; the sufficiency of Lyell’s cash resources to advance multiple product candidates through key milestones; Lyell’s belief that its cash resources will be sufficient to meet working capital and capital expenditure needs into 2025; the timing of initial clinical data from Lyell’s Phase 1 trial for LYL797; the potential of Lyell reprogramming technologies to help resist cell-exhaustion; our expectations regarding GSK’s plans for the NY-ESO-1 programs; 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 effects of the evolving COVID-19 pandemic; geopolitical instability; Lyell’s ability to submit planned INDs or initiate clinical trials on the anticipated timelines, if at all; Lyell’s ability to manufacture and supply its product candidates for its clinical trials; the preclinical profiles of Lyell’s product candidates not translating in clinical trials; the potential for results from clinical trials to differ from preclinical, 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; Lyell’s reliance on GSK to advance the development of its NY-ESO-1 programs; 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 most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings with the
Unaudited Selected Consolidated Financial Data
(in thousands)
Statement of Operations Data:
Three Months Ended |
Six Months Ended |
||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Revenue | $ | 35,741 | $ | 2,628 | $ | 36,294 | $ | 5,073 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 43,719 | 46,446 | 79,549 | 87,975 | |||||||||||
General and administrative | 30,454 | 19,112 | 64,875 | 35,943 | |||||||||||
Other operating income, net | (1,171 | ) | (223 | ) | (2,293 | ) | (768 | ) | |||||||
Total operating expenses | 73,002 | 65,335 | 142,131 | 123,150 | |||||||||||
Loss from operations | (37,261 | ) | (62,707 | ) | (105,837 | ) | (118,077 | ) | |||||||
Interest income, net | 952 | 218 | 1,349 | 572 | |||||||||||
Other (expense) income, net | (14 | ) | (106 | ) | 21 | (133 | ) | ||||||||
Total other income, net | 938 | 112 | 1,370 | 439 | |||||||||||
Net loss | $ | (36,323 | ) | $ | (62,595 | ) | $ | (104,467 | ) | $ | (117,638 | ) |
Balance Sheet Data:
Cash, cash equivalents and marketable securities | $ | 787,002 | $ | 898,325 | |
Property and equipment, net | $ | 127,559 | $ | 120,098 | |
Total assets | $ | 1,021,674 | $ | 1,127,406 | |
Total stockholders’ equity | $ | 868,042 | $ | 929,787 |
Non-GAAP Financial Measures
To supplement our financial results and guidance presented in accordance with
Unaudited Reconciliation of GAAP to Non-GAAP Net Loss
(in thousands)
Three Months Ended |
Six Months Ended |
||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Net loss - GAAP | $ | (36,323 | ) | $ | (62,595 | ) | $ | (104,467 | ) | $ | (117,638 | ) | |||
Adjustments: | |||||||||||||||
Stock-based compensation expense | 22,410 | 15,249 | 44,438 | 27,981 | |||||||||||
Change in the estimated fair value of success payment liabilities | 3,587 | 9,266 | (264 | ) | 19,233 | ||||||||||
Net loss - Non-GAAP(1) | $ | (10,326 | ) | $ | (38,080 | ) | $ | (60,293 | ) | $ | (70,424 | ) |
(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
Unaudited Reconciliation of GAAP to
(in thousands)
Three Months Ended |
Six Months Ended |
||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Research and development - GAAP | $ | 43,719 | $ | 46,446 | $ | 79,549 | $ | 87,975 | |||||||
Adjustments: | |||||||||||||||
Stock-based compensation expense | (4,195 | ) | (5,091 | ) | (7,959 | ) | (9,942 | ) | |||||||
Change in the estimated fair value of success payment liabilities | (3,587 | ) | (9,266 | ) | 264 | (19,233 | ) | ||||||||
Research and development - Non-GAAP | $ | 35,937 | $ | 32,089 | $ | 71,854 | $ | 58,800 |
Unaudited Reconciliation of GAAP to Non-GAAP General and Administrative Expenses
(in thousands)
Three Months Ended |
Six Months Ended |
||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
General and administrative - GAAP | $ | 30,454 | $ | 19,112 | $ | 64,875 | $ | 35,943 | |||||||
Adjustments: | |||||||||||||||
Stock-based compensation expense | (18,215 | ) | (10,158 | ) | (36,479 | ) | (18,039 | ) | |||||||
General and administrative - Non-GAAP | $ | 12,239 | $ | 8,954 | $ | 28,396 | $ | 17,904 |
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Senior Vice President, Communications and Investor Relations
Source: Lyell Immunopharma, Inc