Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical‑stage T-cell
reprogramming company advancing a diverse pipeline of cell
therapies for patients with solid tumors today reported financial
results and business highlights for the first quarter ended
March 31, 2024.
“The initial clinical and translational data from the Phase 1
trial of LYL797, our lead CAR T-cell product candidate, will
provide the first insights into our ability to reprogram ROR1 CAR T
cells that can expand, infiltrate solid tumors and kill cancer
cells in patients,” said Lynn Seely, M.D., Lyell’s President and
CEO. “Our strong cash position is expected to fund operations
through multiple milestones into 2027, including initial clinical
data from our lead TIL program in the second half of this year, and
to the continued advancement of multiple product candidates with
potential to offer better options for patients with cancer.”
First Quarter Updates and Recent
Business Highlights
Lyell is advancing four wholly-owned product candidates. Two
product candidates, LYL797 and LYL845 are in Phase 1 clinical
development. Two additional product candidates, LYL119, a
ROR1-targeted Chimeric Antigen Receptor (CAR) T‑cell product
candidate and a second-generation tumor infiltrating lymphocyte
(TIL) product candidate, are in preclinical development.
LYL797 – A ROR1-targeted CAR T-cell product candidate
genetically reprogrammed to overexpress c-Jun and epigenetically
reprogrammed using Lyell’s proprietary
Epi-R™ manufacturing protocol designed for
differentiated potency and durability
- Enrollment in the Phase 1 clinical
trial of LYL797 is ongoing. The study includes patients with
relapsed or refractory triple-negative breast cancer (TNBC) or
non-small cell lung cancer (NSCLC).
- Initial data from at least 20 patients
from the Phase 1 clinical trial of LYL797 are expected this
quarter.
LYL845 – A TIL product candidate epigenetically
reprogrammed using Lyell’s proprietary Epi-R manufacturing
protocol, designed for differentiated potency and
durability
- Enrollment in the Phase 1 clinical
trial of LYL845 is ongoing. The study includes patients with
relapsed or refractory metastatic or locally advanced melanoma,
NSCLC and colorectal cancer.
- Initial clinical and translational data
from the Phase 1 trial of LYL845 are expected in the second half of
2024.
LYL119 – A ROR1-targeted CAR T-cell product candidate
incorporating Lyell’s four stackable and complementary
reprogramming technologies designed for enhanced
cytotoxicity
- LYL119 is a ROR1-targeted CAR T-cell
product enhanced with Lyell’s four novel genetic and epigenetic
reprogramming technologies: c-Jun overexpression, NR4A3 knockout,
Epi-R manufacturing protocol and Stim‑R™ T-cell activation
technology.
- An investigational new drug (IND)
application for LYL119 is expected to be submitted this
quarter.
- Presented a poster with new nonclinical
data on LYL119 at the American Association for Cancer Research
(AACR) Annual Meeting 2024. In this study, LYL119, compared to ROR1
CAR T cells reprogrammed with only two or three technologies,
demonstrated reduced CAR T‑cell exhaustion, enhanced CAR T‑cell
function, enhanced proliferation capacity and sustained antitumor
activity in a mouse xenograft tumor model across a 10-fold dose
range, including at very low cell doses. In addition, following
repeated rounds of tumor cell killing, LYL119 displayed reduced
expression of exhaustion-related gene signatures and retained
unique cell subsets characterized by upregulation of memory and
effector-associated gene signatures.
First Quarter Financial
Results
Lyell reported a net loss of $60.7 million for the first quarter
ended March 31, 2024, compared to a net loss of
$67.0 million for the same period in 2023. Non‑GAAP net loss,
which excludes non-cash stock-based compensation, non‑cash expenses
related to the change in the estimated fair value of success
payment liabilities and certain non-cash investment gains and
charges, was $37.5 million for the first quarter ended
March 31, 2024, compared to $44.8 million for the same period
in 2023.
GAAP and Non-GAAP Operating Expenses
- Research and development (R&D)
expenses were $43.2 million for the first quarter ended
March 31, 2024, compared to $44.6 million for the same period
in 2023. The decrease in first quarter 2024 R&D expenses of
$1.5 million was primarily driven by a decrease in
personnel-related expenses associated with Lyell’s
November 2023 reduction in workforce. 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 first quarter ended
March 31, 2024, were $38.9 million, compared to
$40.6 million for the same period in 2023. The decrease in
first quarter 2024 non-GAAP R&D expenses was primarily driven
by a decrease in personnel-related expenses.
- General and administrative (G&A)
expenses were $13.5 million for the first quarter ended
March 31, 2024, compared to $19.3 million for the same period
in 2023. The decrease in first quarter 2024 G&A expenses was
primarily driven by decreases in non-cash stock-based compensation.
Non‑GAAP G&A expenses, which exclude non-cash stock‑based
compensation, for the first quarter ended March 31, 2024, were
$8.1 million, compared to $10.0 million for the same
period in 2023. The decrease in 2024 non-GAAP G&A expenses was
primarily driven by a decrease in personnel-related expenses
associated with Lyell’s November 2023 reduction in workforce.
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
March 31, 2024, were $526.3 million, compared to $562.7
million as of December 31, 2023. Lyell believes that its cash,
cash equivalents and marketable securities balances will be
sufficient to meet working capital and capital expenditure needs
into 2027.
About Lyell Immunopharma, Inc.
Lyell is a clinical-stage T-cell reprogramming company advancing
a diverse pipeline of cell therapies for patients with solid
tumors. Lyell is currently enrolling a Phase 1 clinical trial
evaluating a ROR1-targeted CAR T-cell therapy in patients with
relapsed refractory triple-negative breast cancer and non-small
cell lung cancer (NSCLC) and a second Phase 1 clinical trial
evaluating reprogrammed tumor infiltrating lymphocytes (TIL) in
patients with advanced melanoma, NSCLC and colorectal cancer. The
technologies powering its product candidates are designed to
address barriers that limit consistent and long-lasting responses
to cell therapy for solid tumors: T-cell exhaustion and lack of
durable stemness, which includes the ability to persist and
self-renew to drive durable tumor cytotoxicity. Lyell is applying
its proprietary ex vivo genetic and epigenetic reprogramming
technologies to address these barriers in order to develop new
medicines with improved durable clinical outcomes. Lyell is based
in South San Francisco, California with facilities in 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:
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 into 2027; Lyell’s plans to submit an IND for LYL119 and
the timing thereof; expectations around enrollment and the timing
of initial clinical and translational data from Lyell’s Phase 1
trials for LYL797 and LYL845; 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 geopolitical instability;
macroeconomic conditions, including 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;
anticipated benefits and financial impact of Lyell’s workforce
restructuring; and other risks, including those described under the
heading “Risk Factors” in Lyell’s Annual Report on Form 10-K for
the year ended December 31, 2023, filed with the Securities
and Exchange Commission (SEC) on February 28, 2024, and the
Quarterly Report on Form 10-Q for the quarter ended March 31,
2024, 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 March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
| Revenue |
$ |
3 |
|
|
$ |
65 |
|
| Operating expenses: |
|
|
|
|
Research and development(1) |
|
43,174 |
|
|
|
44,630 |
|
|
General and administrative |
|
13,494 |
|
|
|
19,279 |
|
|
Other operating income, net |
|
(1,090 |
) |
|
|
(1,288 |
) |
|
Total operating expenses |
|
55,578 |
|
|
|
62,621 |
|
| Loss from operations |
|
(55,575 |
) |
|
|
(62,556 |
) |
|
Interest income, net |
|
6,819 |
|
|
|
4,497 |
|
|
Other income, net(1) |
|
1,090 |
|
|
|
1,100 |
|
|
Impairment of other investments |
|
(13,001 |
) |
|
|
(10,000 |
) |
|
Total other loss, net |
|
(5,092 |
) |
|
|
(4,403 |
) |
| Net loss |
$ |
(60,667 |
) |
|
$ |
(66,959 |
) |
|
(1) |
Lyell’s success payment liability was recognized at fair value as
Fred Hutch had provided the requisite service obligation to earn
the potential success payment consideration under the continued
collaboration. The change in the estimated fair value of Fred Hutch
success payment liabilities beginning in Q1 2023 was recognized
within other income, net in the unaudited Condensed Consolidated
Statements of Operations and Comprehensive Loss. |
| |
|
Balance Sheet Data:
| |
As of March 31, 2024 |
|
As of December 31, 2023 |
| |
|
|
|
|
Cash, cash equivalents and marketable securities |
$ |
526,300 |
|
$ |
562,729 |
| Property and equipment,
net |
$ |
97,836 |
|
$ |
102,654 |
| Total assets |
$ |
694,220 |
|
$ |
750,029 |
| Total stockholders’
equity |
$ |
603,157 |
|
$ |
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 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 March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
| Net loss - GAAP |
$ |
(60,667 |
) |
|
$ |
(66,959 |
) |
| Adjustments: |
|
|
|
|
Impairment of other investments |
|
13,001 |
|
|
|
10,000 |
|
|
Stock-based compensation expense |
|
9,155 |
|
|
|
13,882 |
|
|
Change in the estimated fair value of success payment
liabilities |
|
968 |
|
|
|
(1,708 |
) |
| Net loss - Non-GAAP(1) |
$ |
(37,543 |
) |
|
$ |
(44,785 |
) |
|
(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 U.S. 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, |
|
|
|
2024 |
|
|
|
2023 |
|
| Research and development -
GAAP |
$ |
43,174 |
|
|
$ |
44,630 |
|
| Adjustments: |
|
|
|
|
Stock-based compensation expense |
|
(3,792 |
) |
|
|
(4,612 |
) |
|
Change in the estimated fair value of success payment
liabilities(1) |
|
(525 |
) |
|
|
608 |
|
| Research and development -
Non-GAAP |
$ |
38,857 |
|
|
$ |
40,626 |
|
|
(1) |
Lyell’s success payment liability was recognized at fair value as
Fred Hutch had provided the requisite service obligation to earn
the potential success payment consideration under the continued
collaboration. The change in the estimated fair value of Fred Hutch
success payment liabilities beginning in Q1 2023 was recognized
within other income, net in the unaudited 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 March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
| General and administrative -
GAAP |
$ |
13,494 |
|
|
$ |
19,279 |
|
| Adjustments: |
|
|
|
|
Stock-based compensation expense |
|
(5,363 |
) |
|
|
(9,270 |
) |
| General and administrative -
Non-GAAP |
$ |
8,131 |
|
|
$ |
10,009 |
|
Contact:
Ellen RoseSenior Vice President, Communications
and Investor Relationserose@lyell.com
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