Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical
company developing engineered antibodies for the treatment of
cancer and other serious diseases, today reported financial results
for the second quarter ended June 30, 2024 and provided a review of
recent business updates and internal clinical-stage programs.
“Xencor’s clinical focus is developing high-potential,
first-in-class bispecific T-cell engagers and additional XmAb®
candidates that leverage our differentiated technology platforms.
The expanding opportunities for engineered antibodies, T-cell
engagers and other bispecifics have encouraged us to advance a
range of new XmAb candidates, and we plan to announce our next
candidates for clinical development in the coming months,” said
Bassil Dahiyat, Ph.D., president and chief executive officer of
Xencor. “We remain enthusiastic by the progress of our
clinical-stage T-cell engager programs and advancements within the
platform to date in 2024. Our dose-escalation studies of XmAb819
(ENPP3 x CD3) in clear cell renal cell carcinoma and XmAb808 (B7-H3
x CD28) in advanced solid tumors remain on track to reach target
dose levels by year end, and XmAb541 (CLDN6 x CD3) is off to a
strong clinical start with initial study enrollment.”
Bispecific Antibody Programs Advancing in Internal Clinical
Development
- XmAb819 (ENPP3 x CD3): XmAb819 is a bispecific T-cell
engager in Phase 1 clinical development for patients with advanced
clear cell renal cell carcinoma (ccRCC). XmAb819 is designed to
engage the immune system, activating T cells for highly potent and
targeted killing of tumor cells expressing ENPP3, an antigen highly
expressed in ccRCC. Xencor’s XmAb 2+1 multivalent format used in
XmAb819 enables greater selectivity of ENPP3-expressing tumor cells
compared to normal cells, which express lower levels of ENPP3.
Xencor is advancing through dose-escalation cohorts in an ongoing
Phase 1 study, and the Company anticipates reaching target dose
levels by year end.
- XmAb808 (B7-H3 x CD28): XmAb808 is a tumor-selective,
co-stimulatory bispecific T-cell engager in Phase 1 clinical
development, in combination with pembrolizumab for patients with
advanced solid tumors. XmAb808 binds to the broadly expressed tumor
antigen B7-H3 and is constructed with the XmAb 2+1 format.
Co-stimulation is required for T cells to achieve full activation,
and targeted CD28 bispecific antibodies may provide conditional
co-stimulation of T cells when the antibodies are bound to tumor
cells. Xencor is advancing through dose-escalation cohorts in an
ongoing Phase 1 study, and the Company anticipates reaching target
dose levels by year end.
- XmAb541 (CLDN6 x CD3): XmAb541 is a bispecific T-cell
engager in Phase 1 clinical development for patients with advanced
ovarian cancer and other solid tumor types. XmAb541 is designed to
engage the immune system, activating T cells for highly potent and
targeted killing of tumor cells expressing Claudin-6 (CLDN6), a
tumor-associated antigen. Xencor’s XmAb 2+1 multivalent format used
in XmAb541 enables greater selectivity for cells expressing CLDN6
over similarly structured Claudin family members, which may be
expressed on normal tissue. The first patient was dosed in a Phase
1 dose-escalation study earlier this year.
- Vudalimab (PD-1 x CTLA-4): Vudalimab, a selective dual
checkpoint inhibitor of PD-1 and CTLA-4, is advancing in multiple
clinical studies, including a monotherapy study in patients with
clinically defined high-risk metastatic castration-resistant
prostate cancer (mCRPC; Study XmAb717-05), a study in combination
with docetaxel in patients with mCRPC (Study XmAb717-04), and a
study in combination with chemotherapy in patients with non-small
cell lung cancer (Study XmAb717-06). Xencor continues to anticipate
a data update and decision whether to advance vudalimab for
patients with mCRPC in the first half of 2025.
Recent Business Updates
- Regained exclusive worldwide rights to plamotamab (CD20 x CD3),
a Phase 2 ready, subcutaneously administered, immune-cell directed
bispecific T-cell engager. Xencor advanced plamotamab through Phase
1 clinical development and is reviewing its potential for
addressing unmet medical needs of patients.
- Concluded Phase 1 studies of XmAb564 (IL2-Fc in autoimmune
disease) and XmAb662 (IL12-Fc in solid tumors) in the first half of
2024, consistent with prior guidance.
Financial Guidance: Based on current operating plans,
Xencor expects to end 2024 with between $475 million and $525
million in cash, cash equivalents and marketable debt securities,
and to have cash to fund research and development programs and
operations into 2027.
Financial Results for the Second Quarter and Six Months Ended
June 30, 2024
Cash, cash equivalents and marketable debt securities totaled
$585.0 million as of June 30, 2024, compared to $697.0 million as
of December 31, 2023.
Revenues for the second quarter ended June 30, 2024 were $17.0
million, compared to $45.5 million for the same period in 2023.
Revenues earned in the second quarter of 2024 were primarily
non-cash royalty revenue from Alexion and MorphoSys/Incyte and
licensing revenue from multiple licensees, compared to the same
period in 2023, which were primarily research revenue from the
second J&J collaboration, royalty revenue from Alexion and
milestone revenue from Zenas. Revenues for the six months ended
June 30, 2024 were $29.8 million, compared to $64.5 million for the
same period in 2023. Revenue for the six-month period in 2024 were
primarily non-cash royalty revenue from Alexion and
MorphoSys/Incyte, compared to the same period in 2023, which were
primarily research revenue from the second J&J collaboration,
royalty revenue from Alexion and milestone revenue from J&J and
Zenas.
Research and development (R&D) expenses for the second
quarter ended June 30, 2024 were $61.5 million, compared to $60.1
million for the same period in 2023. R&D expenses for the six
months ended June 30, 2024 were $118.4 million, compared to $125.6
million for the same period in 2023. Increased R&D spending for
the second quarter of 2024 compared to 2023 and decreased R&D
spending for the first six months of 2024 compared to 2023 are
primarily due to increased spending on research and early-stage
programs and decreased spending on XmAb104 (PD-1 x ICOS).
General and administrative (G&A) expenses for the second
quarter ended June 30, 2024 were $17.7 million, compared to $11.5
million for the same period in 2023. G&A expenses for the six
months ended June 30, 2024 were $31.5 million, compared to $25.6
million for the same period in 2023. Increased G&A spending for
the second quarter and first six months of 2024 compared to 2023 is
primarily due to increased spending on corporate activities,
including stock-based compensation costs related to employees
retiring in April 2024.
Other income (expense) for the second quarter ended June 30,
2024 was $(5.0) million, compared to $4.0 million for the same
period in 2023. Other expense for the second quarter of 2024,
compared to other income for the same period in 2023, is primarily
due to unrealized and realized losses recognized from the change in
fair value and the sale of equity investments. Other income
(expense) for the six months ended June 30, 2024 was $(15.8)
million, compared to $4.0 million for the same period in 2023.
Other expense for the first six months of 2024, compared to other
income for the same period in 2023, is primarily due to an
impairment charge on an equity investment without a readily
determinable fair value.
Non-cash, stock-based compensation expense for the six months
ended June 30, 2024 was $28.6 million, compared to $26.2 million
for the same period in 2023.
Net loss attributable to Xencor for the second quarter ended
June 30, 2024 was $66.0 million, or $(1.07) on a fully diluted per
share basis, compared to net loss of $22.0 million, or $(0.37) on a
fully diluted per share basis, for the same period in 2023. For the
six months ended June 30, 2024, net loss attributable to Xencor was
$134.0 million, or $(2.18) on a fully diluted per share basis,
compared to net loss of $82.7 million, or $(1.38) on a fully
diluted per share basis, for the same period in 2023.
The total shares outstanding were 61,766,054 as of June 30,
2024, compared to 60,600,060 as of June 30, 2023.
About Xencor
Xencor is a clinical-stage biopharmaceutical company developing
engineered antibodies for the treatment of patients with cancer and
other serious diseases. More than 20 candidates engineered with
Xencor's XmAb® technology are in clinical development, and three
XmAb medicines are marketed by partners. Xencor's XmAb engineering
technology enables small changes to a proteins structure that
result in new mechanisms of therapeutic action. For more
information, please visit www.xencor.com.
Forward-Looking Statements
Certain statements contained in this press release may
constitute forward-looking statements within the meaning of
applicable securities laws. Forward-looking statements include
statements that are not purely statements of historical fact, and
can generally be identified by the use of words such as
“potential,” “can,” “will,” “plan,” “may,” “could,” “would,”
“expect,” “anticipate,” “seek,” “look forward,” “believe,”
“committed,” “investigational,” and similar terms, or by express or
implied discussions relating to Xencor’s business, including, but
not limited to, statements regarding expectations for clinical
progress, planned presentations of clinical data, new XmAb
candidates, planned clinical trials, projected financial resources,
the quotations from Xencor's president and chief executive officer,
and other statements that are not purely statements of historical
fact. Such statements are made on the basis of the current beliefs,
expectations, and assumptions of the management of Xencor and are
subject to significant known and unknown risks, uncertainties and
other factors that may cause actual results, performance or
achievements and the timing of events to be materially different
from those implied by such statements, and therefore these
statements should not be read as guarantees of future performance
or results. Such risks include, without limitation, the risks
associated with the process of discovering, developing,
manufacturing and commercializing drugs that are safe and effective
for use as human therapeutics and other risks, including the
ability of publicly disclosed preliminary clinical trial data to
support continued clinical development and regulatory approval for
specific treatments, in each case as described in Xencor's public
securities filings. For a discussion of these and other factors,
please refer to Xencor's annual report on Form 10-K for the year
ended December 31, 2023 as well as Xencor's subsequent filings with
the Securities and Exchange Commission. You are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof. This caution is made under the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, as amended to date. All forward-looking statements are
qualified in their entirety by this cautionary statement and Xencor
undertakes no obligation to revise or update this press release to
reflect events or circumstances after the date hereof, except as
required by law.
Xencor, Inc. Selected Consolidated Balance Sheet Data
(in thousands) June 30, December 31,
2024
2023
(Unaudited) Cash, cash equivalents and marketable debt securities -
current
$
480,140
$
551,515
Other current assets
74,330
71,645
Marketable debt securities - long term
104,862
145,512
Other long-term assets
166,835
184,020
Total assets
$
826,167
$
952,692
Total current liabilities
80,076
84,709
Deferred income - long term
104,081
125,183
Other long term liabilities
79,469
73,667
Total liabilities
263,626
283,559
Total stockholders' equity
562,541
669,133
Total liabilities and stockholders’ equity
$
826,167
$
952,692
Xencor, Inc. Consolidated Statements of Loss and
Comprehensive Loss (in thousands, except share and per share
data) Three Months EndedJune 30, Six Months
EndedJune 30,
2024
2023
2024
2023
(Unaudited)
Revenue
$
16,960
$
45,523
$
29,765
$
64,485
Operating expenses Research and development
61,531
60,060
118,404
125,612
General and administrative
17,746
11,460
31,533
25,613
Total operating expenses
79,277
71,520
149,937
151,225
Loss from operations
(62,317
)
(25,997
)
(120,172
)
(86,740
)
Other income (expense), net
(4,974
)
4,043
(15,828
)
4,023
Loss before income tax
(67,291
)
(21,954
)
(136,000
)
(82,717
)
Income tax expense
117
—
117
—
Net loss
(67,408
)
(21,954
)
(136,117
)
(82,717
)
Net loss attributable to non-controlling interest
(1,445
)
—
(2,121
)
—
Net loss attributable to Xencor, Inc.
(65,963
)
(21,954
)
(133,996
)
(82,717
)
Other comprehensive income (loss) Net unrealized gain
(loss) on marketable debt securities
(498
)
1,765
(1,942
)
5,093
Comprehensive loss attributable to Xencor, Inc.
$
(66,461
)
$
(20,189
)
$
(135,938
)
$
(77,624
)
Net loss per common share attributable to Xencor,
Inc.: Basic and Diluted
$
(1.07
)
$
(0.37
)
$
(2.18
)
$
(1.38
)
Weighted average common shares used to compute net loss per
share attributable to Xencor, Inc. Basic and Diluted
61,676,444
59,807,558
61,444,384
59,922,784
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version on businesswire.com: https://www.businesswire.com/news/home/20240805093501/en/
For Investors: Charles Liles cliles@xencor.com (626)
737-8118
For Media: Cassidy McClain Inizio Evoke
cassidy.mcclain@inizioevoke.com (619) 694-6291
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