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 second quarter ended
June 30, 2023.
“Lyell continues to execute on our two Phase 1 clinical trials
assessing resistance to T-cell exhaustion and enhanced durable
stemness as key success factors to effective cell therapy for solid
tumors and we look forward to presenting initial data from both our
CAR T-cell and our TIL product candidates in 2024,” said Lynn
Seely, M.D., Lyell’s President and CEO. “Our research team
continues to advance innovative technologies to generate more
potent and long-lasting T cells, and we are on track to submit our
next investigational new drug application for our third clinical
program in the first half of 2024. We continue to diligently manage
our expenses and maintain a cash runway through multiple milestones
into 2026.”
Second Quarter Updates and Recent
Business Highlights
Lyell is advancing four wholly-owned product candidates with two
product candidates in Phase 1 clinical development, LYL797 and
LYL845. Two additional product candidates, LYL119 and a
second-generation tumor infiltrating lymphocyte (TIL) product
candidate, are in preclinical development.
LYL797 – A ROR1 Chimeric Antigen Receptor (CAR) T-cell
product candidate genetically reprogrammed to overexpress c-Jun and
epigenetically reprogrammed using Lyell’s proprietary
Epi-RTM 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 or non-small
cell lung cancer and is now open at 14 sites.
- Initial clinical data from the Phase 1
trial of LYL797 are expected in the first half of 2024.
- The Lyell START (Study of Tumor target
Analysis for Referrals to Trials) ROR1-biomarker screening protocol
was initiated in June 2023 to support the ongoing LYL797 Phase 1
trial, as well as potential future clinical trials with LYL797 and
our next-generation ROR1-targeted product candidate, LYL119. START
provides a decentralized mechanism for patients anywhere in the
United States to have their collected tumor tissue screened for
ROR1 expression and, for ROR1 positive patients, to be referred to
clinical study sites.
LYL845 – A novel epigenetically reprogrammed TIL product
candidate designed for differentiated potency and
durability
- Enrollment in the Phase 1 clinical
trial for LYL845 is ongoing. The study includes patients with
relapsed and/or refractory metastatic or locally advanced melanoma,
non-small cell lung cancer and colorectal cancer and is now open at
nine sites.
- Initial clinical data from the Phase 1
trial of LYL845 are expected in 2024.
LYL119 – A ROR1 CAR T-cell product candidate
incorporating Lyell’s four stackable reprogramming technologies for
enhanced cytotoxicity
- LYL119 is a ROR1-targeted CAR T-cell
product enhanced with Lyell’s four novel, stackable genetic and
epigenetic reprogramming technologies: c-Jun overexpression, NR4A3
knockout, Epi-R manufacturing protocol and Stim-RTM T-cell
activation technology.
- An investigational new drug (IND)
application for LYL119 is expected to be submitted in the first
half of 2024.
Rejuvenation – Novel partial reprogramming technology
designed to maintain T-cell identity while reducing cells’
epigenetic age
- Data demonstrating that T cells
rejuvenated with Lyell’s technology have improved expansion
capacity and increased expression of biomarkers associated with
T-cell stemness, and also exhibit improved antitumor properties
compared with non-rejuvenated T-cell controls in sequential
cell-killing assays, were presented at the International Society
for Stem Cell Research (ISSCR) 2023 Annual Meeting on June 14th in
Boston, MA.
Corporate and Operational Updates
- Matt Lang, J.D., was appointed Chief
Business Officer in July. He also serves as Lyell’s Chief Legal
Officer and Corporate Secretary. Mr. Lang is an experienced company
builder who has successfully led growth in complex organizations.
Mr. Lang is responsible for Lyell’s legal, compliance, human
resources, alliance management and early commercialization
teams.
Second Quarter Financial
Results
Lyell reported a net loss of $63.9 million for the second
quarter ended June 30, 2023, compared to a net loss of
$36.3 million for the same period in 2022. 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 charges, was
$45.6 million for the second quarter ended June 30, 2023,
compared to $10.3 million for the same period in 2022.
Revenue
- Revenue was approximately zero for the
second quarter ended June 30, 2023, compared to $35.7 million
for the same period in 2022. No research and development pursuant
to our collaboration and license agreement with GlaxoSmithKline
(GSK Agreement) was performed in the second quarter of 2023 due to
the termination of the GSK Agreement in December 2022, which drove
the $35.7 million decrease in revenue.
GAAP and Non-GAAP Operating Expenses
- Research and development (R&D)
expenses were $47.5 million for the second quarter ended
June 30, 2023, compared to $43.7 million for the same period
in 2022. The increase in second quarter 2023 R&D expenses was
primarily driven by personnel-related expenses, principally related
to an increase in headcount to expand our research, development and
manufacturing capabilities to support increases in clinical trial
enrollment, and an increase in research and laboratory costs
primarily associated with clinical trials. 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, 2023, were $41.6 million, compared to $35.9 million
for the same period in 2022. The increase in second quarter 2023
non-GAAP R&D expenses was driven by increased personnel-related
expenses, primarily related to an increase in headcount to expand
our clinical development and manufacturing capabilities in support
of our ongoing clinical trials.
- General and administrative (G&A)
expenses were $19.0 million for the second quarter ended
June 30, 2023, compared to $30.5 million for the same period
in 2022. The decrease in second quarter 2023 G&A expenses was
primarily driven by changes in non-cash stock-based compensation.
Non‑GAAP G&A expenses, which exclude non-cash stock-based
compensation, for the second quarter ended June 30, 2023, were
$10.1 million, compared to $12.2 million for the same period in
2022. The decrease in second quarter 2023 non-GAAP G&A expenses
was driven by a decrease in legal, consulting and other
administrative expenses.
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, 2023 were $632.7 million, compared to $710.3 million
as of December 31, 2022. Lyell believes that its cash, cash
equivalents and marketable securities balances will be sufficient
to meet working capital and capital expenditure needs into
2026.
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. 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 or 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 into 2026; Lyell’s plans to
submit an IND for LYL119 and the timing thereof; expectations
around patient profiles, enrollment and timing of initial clinical
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 and the lingering effects of the COVID-19
pandemic; 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 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 its Annual Report on Form 10-K for the year
ended December 31, 2022, filed with the Securities and
Exchange Commission (SEC) on February 28, 2023, and the
Quarterly Report on Form 10-Q for the quarter ended June 30,
2023, 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, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue |
$ |
27 |
|
|
$ |
35,741 |
|
|
$ |
92 |
|
|
$ |
36,294 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development(1) |
|
47,471 |
|
|
|
43,719 |
|
|
|
92,101 |
|
|
|
79,549 |
|
General and administrative |
|
19,030 |
|
|
|
30,454 |
|
|
|
38,309 |
|
|
|
64,875 |
|
Other operating income, net |
|
(569 |
) |
|
|
(1,171 |
) |
|
|
(1,857 |
) |
|
|
(2,293 |
) |
Total operating expenses |
|
65,932 |
|
|
|
73,002 |
|
|
|
128,553 |
|
|
|
142,131 |
|
Loss from operations |
|
(65,905 |
) |
|
|
(37,261 |
) |
|
|
(128,461 |
) |
|
|
(105,837 |
) |
Interest income, net |
|
5,264 |
|
|
|
952 |
|
|
|
9,761 |
|
|
|
1,349 |
|
Other (expense) income, net(1) |
|
(326 |
) |
|
|
(14 |
) |
|
|
774 |
|
|
|
21 |
|
Impairment of other investments |
|
(2,923 |
) |
|
|
— |
|
|
|
(12,923 |
) |
|
|
— |
|
Total other income (loss), net |
|
2,015 |
|
|
|
938 |
|
|
|
(2,388 |
) |
|
|
1,370 |
|
Net loss |
$ |
(63,890 |
) |
|
$ |
(36,323 |
) |
|
$ |
(130,849 |
) |
|
$ |
(104,467 |
) |
(1) As of December 31, 2022, the Company’s success payment
liability was recognized at fair value as Fred Hutchinson Cancer
Center (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 (expense) income, net in the
unaudited Condensed Consolidated Statements of Operations and
Comprehensive Loss. The change in the estimated fair value of Fred
Hutch success payment liabilities in 2022 was recognized within
research and development expenses in the unaudited Condensed
Consolidated Statements of Operations and Comprehensive Loss.
Balance
Sheet Data: |
|
|
As of June 30, 2023 |
|
As of December 31, 2022 |
|
|
|
|
Cash, cash equivalents and marketable securities |
$ |
632,700 |
|
|
$ |
710,269 |
|
Property and equipment,
net |
$ |
113,677 |
|
|
$ |
123,023 |
|
Total assets |
$ |
835,354 |
|
|
$ |
937,561 |
|
Total stockholders’
equity |
$ |
736,855 |
|
|
$ |
833,252 |
|
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. As of December 31, 2022, our Fred Hutch 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.
For the three and six months ended June 30, 2023 and future
periods, the change in the Fred Hutch success payment liability
fair value is recognized in other (expense) income, net, as the
requisite service obligation had been met, whereas it was
previously recognized within research and development expenses.
Non-GAAP net loss further adjusts non‑cash investment gains and
charges, as applicable, and for the income tax effect, if any, of
the non-GAAP adjustments. 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, non-cash expenses related to the
change 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, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net loss - GAAP |
$ |
(63,890 |
) |
|
$ |
(36,323 |
) |
|
$ |
(130,849 |
) |
|
$ |
(104,467 |
) |
Adjustments: |
|
|
|
|
|
|
|
Stock-based compensation expense |
|
14,223 |
|
|
|
22,410 |
|
|
|
28,105 |
|
|
|
44,438 |
|
Change in the estimated fair value of success payment
liabilities |
|
1,105 |
|
|
|
3,587 |
|
|
|
(603 |
) |
|
|
(264 |
) |
Impairment of other investments |
|
2,923 |
|
|
|
— |
|
|
|
12,923 |
|
|
|
— |
|
Net loss - Non-GAAP(1) |
$ |
(45,639 |
) |
|
$ |
(10,326 |
) |
|
$ |
(90,424 |
) |
|
$ |
(60,293 |
) |
(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 June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Research and development
expense - GAAP |
$ |
47,471 |
|
|
$ |
43,719 |
|
|
$ |
92,101 |
|
|
$ |
79,549 |
|
Adjustments: |
|
|
|
|
|
|
|
Stock-based compensation expense |
|
(5,279 |
) |
|
|
(4,195 |
) |
|
|
(9,891 |
) |
|
|
(7,959 |
) |
Change in the estimated fair value of success payment
liabilities(1) |
|
(605 |
) |
|
|
(3,587 |
) |
|
|
3 |
|
|
|
264 |
|
Research and development
expense - Non‑GAAP |
$ |
41,587 |
|
|
$ |
35,937 |
|
|
$ |
82,213 |
|
|
$ |
71,854 |
|
(1) As of December 31, 2022, the Company’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
(expense) income, net in the unaudited Condensed Consolidated
Statements of Operations and Comprehensive Loss. The change in the
estimated fair value of Fred Hutch success payment liabilities in
2022 was recognized within research and development expenses 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 June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
General and administrative
expense - GAAP |
$ |
19,030 |
|
|
$ |
30,454 |
|
|
$ |
38,309 |
|
|
$ |
64,875 |
|
Adjustments: |
|
|
|
|
|
|
|
Stock-based compensation expense |
|
(8,944 |
) |
|
|
(18,215 |
) |
|
|
(18,214 |
) |
|
|
(36,479 |
) |
General and administrative
expense - Non‑GAAP |
$ |
10,086 |
|
|
$ |
12,239 |
|
|
$ |
20,095 |
|
|
$ |
28,396 |
|
Contact:
Ellen RoseSenior Vice President, Communications
and Investor Relationserose@lyell.com
Lyell Immunopharma (NASDAQ:LYEL)
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De Ago 2024 a Sep 2024
Lyell Immunopharma (NASDAQ:LYEL)
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De Sep 2023 a Sep 2024