-- Management to Host Conference Call at 4:30
p.m. ET Today --
Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical
company developing engineered antibodies and cytokines for the
treatment of patients with cancer and autoimmune diseases, today
reported financial results for the second quarter ended June 30,
2023 and provided a review of recent business and clinical
highlights.
“In the past quarter we continued to advance a clinical
portfolio of XmAb drug candidates, enrolling patients across
multiple Phase 1 and Phase 2 studies in oncology and autoimmune
diseases. By year end we anticipate opening a Phase 2 study to
evaluate vudalimab as a front-line treatment in metastatic
non-small cell lung cancer, a large patient population with high
unmet need,” said Bassil Dahiyat, Ph.D., president and chief
executive officer at Xencor. “Our ongoing studies with early-stage,
novel XmAb bispecific antibodies continue to generate exceptionally
strong interest among investigators, in particular our
ENPP3-targeted CD3 T-cell engager in renal cell carcinoma, XmAb819,
and our B7H3-targeted tumor-selective CD28 co-stimulatory T-cell
engager, XmAb808. Both candidates use novel antibody formats to
drive tumor-specific activity that has the potential to address
current gaps in treatment approaches.
“We also continue to expand the portfolio of XmAb programs. We
recently initiated a Phase 1 study of our potency-tuned IL12-Fc,
XmAb662, to be developed in oncology, and we expect to submit an
IND application later this year for XmAb541, a 2+1 format CLDN6 x
CD3 bispecific antibody that we are developing for patients with
ovarian cancer and other tumor types. Additionally, we anticipate
submitting an IND for our second internal CD28 program in
2024.”
Program Updates
- Vudalimab (PD-1 x CTLA-4): Xencor plans to evaluate
vudalimab, a T-cell selective checkpoint inhibitor, as a first-line
treatment in patients with locally advanced or metastatic non-small
cell lung cancer. Part 1 of a Phase 2 study would randomize a
limited number of patients at one of two doses of vudalimab, in
combination with chemotherapy. The study’s second part would
randomize patients to either vudalimab plus chemotherapy or
pembrolizumab plus chemotherapy. The primary outcome measure of
Part 2 would be a comparison of progression-free survival. Xencor
anticipates initiating the study by the end of 2023.
Xencor is conducting an ongoing Phase 2 study
evaluating vudalimab as a monotherapy in patients with high-risk
metastatic castration-resistant prostate cancer (mCRPC) or advanced
gynecologic malignancies and an ongoing Phase 2 study evaluating
vudalimab in combination with chemotherapy or a PARP inhibitor in
patients with mCRPC. Clinical data from these studies are
anticipated to be presented at a medical conference in early
2024.
- XmAb564 (IL2-Fc): Results from a Phase 1a clinical study
in healthy volunteers were presented at the European Congress of
Rheumatology (EULAR) in May 2023. Data continue to indicate a
single dose of subcutaneously administered XmAb564 was well
tolerated and generated durable, dose-dependent and selective
expansion of regulatory T cells. Xencor is conducting a randomized,
double-blind, placebo-controlled Phase 1b study to evaluate the
safety and tolerability of multiple ascending doses of XmAb564 in
patients with atopic dermatitis or psoriasis.
- XmAb662 (IL12-Fc): XmAb662 is a potency-reduced
interleukin-12 Fc (IL12-Fc) fusion protein engineered to increase
anti-tumor activity and immunogenicity in the tumor
microenvironment by promoting high levels of interferon gamma
secretion from T cells and NK cells. In July 2023, Xencor initiated
a Phase 1 study in patients with advanced solid tumors.
Partnership Updates
- Alexion Pharmaceuticals, Inc.: In May 2023, Ultomiris®
(ravulizumab-cwvz), which incorporates Xencor’s Xtend™ Fc domain,
was approved in the EU and Japan for the treatment of certain adult
patients with neuromyelitis optica spectrum disorder (NMOSD). In
the second quarter of 2023, Xencor earned $11.2 million of royalty
revenue from Alexion on net sales of Ultomiris.
- Amgen Inc.: Interim results from a Phase 1 study of
xaluritamig (AMG 509), a STEAP1 x CD3 XmAb 2+1 bispecific antibody,
in patients with mCRPC were accepted for presentation at the
European Society for Medical Oncology (ESMO) Congress on October
20, 2023.
- Zenas BioPharma Ltd.: In the second quarter of 2023,
Xencor earned a $10 million development milestone related to Zenas’
Phase 3 study evaluating obexelimab in patients with immunoglobulin
G4-related disease (IgG4-RD). A manuscript with results from the
Phase 2 study, which was sponsored and conducted by Xencor, was
first published online in The Lancet Rheumatology in August
2023.
Ultomiris is a registered trademark of Alexion Pharmaceuticals,
Inc.
Financial Results for the Second Quarter and Six Months Ended
June 30, 2023
Cash, cash equivalents, receivables and marketable debt
securities totaled $531.4 million as of June 30, 2023, compared to
$613.5 million as of December 31, 2022.
Total revenue for the second quarter ended June 30, 2023 was
$45.5 million, compared to $30.2 million for the same period in
2022. Revenues earned in the second quarter of 2023 were primarily
from research revenue from our second Janssen Biotech
collaboration, royalty revenue from Alexion and milestone revenue
from Zenas, compared to the same period in 2022, which were
primarily royalties from Alexion and Vir Biotechnology. Revenues
for the six months ended June 30, 2023 were $64.5 million, compared
to $115.7 million for the same period in 2022. Revenue for the
six-month period in 2023 were primarily from research revenue from
our second Janssen collaboration, royalty revenue from Alexion and
milestone revenue from Janssen and Zenas, compared to the same
period in 2022, which were earned primarily from milestone revenue
from Astellas and royalty revenue from Alexion, MorphoSys and
Vir.
Research and development (R&D) expenses for the second
quarter ended June 30, 2023 were $60.1 million, compared to $47.1
million for the same period in 2022. Increased R&D spending for
the second quarter of 2023 compared to 2022 is primarily due to
increased spending on development programs including vudalimab,
plamotamab, XmAb819 and XmAb541 and other research and early-stage
programs. R&D expenses for the six months ended June 30, 2023
were $124.4 million, compared to $94.8 million for the same period
in 2022. Increased R&D spending for the first six months of
2023 compared to 2022 is primarily due to an increase in spending
on development programs including vudalimab, XmAb541 and XmAb564
and other research and early-stage programs.
General and administrative (G&A) expenses for the second
quarter ended June 30, 2023 were $11.5 million, compared to $11.1
million for the same period in 2022. G&A expenses for the six
months ended June 30, 2023 were $25.4 million, compared to $22.4
million for the same period in 2022. Increased G&A spending for
the second quarter and first six months of 2023 compared to the
same periods in 2022 reflects increased spending on professional
services and additional facility costs.
Other income (expense) for the second quarter ended June 30,
2023 was $4.0 million, compared to $(6.0) million for the same
period in 2022. Other income (expense) for the six months ended
June 30, 2023 was $2.6 million, compared to $(8.8) million for the
same period in 2022. The increase in other income for the three and
six months ended June 30, 2023 over other expense for the same
periods in 2022 is due to additional interest income earned and
lower unrealized loss recorded from equity investments.
Non-cash, stock-based compensation expense for the six months
ended June 30, 2023 was $26.2 million, compared to $23.4 million
for the same period in 2022.
Net loss for the second quarter ended June 30, 2023 was $22.0
million, or $(0.37) on a fully diluted per share basis, compared to
net loss of $34.0 million, or $(0.57) on a fully diluted per share
basis, for the same period in 2022. Decreased net loss in the
second quarter of 2023 compared to 2022 is primarily due to
additional income and interest earned. For the six months ended
June 30, 2023, net loss was $82.7 million, or $(1.38) on a fully
diluted per share basis, compared to net loss of $10.4 million, or
$(0.17) on a fully diluted per share basis, for the same period in
2022. Increased net loss in the first six months of 2023 compared
to 2022 is primarily due to decreased royalties from Vir and
increased R&D expenses.
The total shares outstanding were 60,600,060 as of June 30,
2023, compared to 59,684,420 as of June 30, 2022.
Financial Guidance
Based on current operating plans, Xencor expects to have cash to
fund research and development programs and operations through the
end of 2025. The Company expects to end 2023 with between $425
million and $475 million in cash, cash equivalents, receivables and
marketable debt securities.
Conference Call and Webcast
Xencor will host a conference call and webcast today at 4:30
p.m. ET (1:30 p.m. PT) to discuss the second quarter 2023 financial
results and provide a corporate update.
The live webcast may be accessed through “Events &
Presentations” in the Investors section of the Company’s website,
located at investors.xencor.com. Telephone participants may
register to receive a dial-in number and unique passcode that can
be used to access the call. A recording will be available for at
least 30 days.
About Xencor, Inc.
Xencor is a clinical-stage biopharmaceutical company developing
engineered antibodies and cytokines for the treatment of patients
with cancer and autoimmune 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
protein's 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 planned additional clinical
trials, the quotations from Xencor's president and chief executive
officer, our projected financial resources 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, 2022 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. Condensed Balance Sheets (in
thousands) June 30, December 31,
2023
2022
(unaudited) Assets Current assets Cash and
cash equivalents
$
34,710
$
53,942
Marketable debt securities
476,667
526,689
Marketable equity securities
39,995
42,431
Accounts receivable
20,019
28,997
Prepaid expenses
22,171
23,283
Total current assets
593,562
675,342
Property and equipment, net
67,997
59,183
Intangible assets, net
18,708
18,500
Marketable debt securities - long term
—
3,826
Marketable equity securities - long term
64,210
54,383
Right of use asset
33,046
34,419
Other assets
598
613
Total assets
$
778,121
$
846,266
Liabilities and stockholders’ equity Current
liabilities Accounts payable and accrued liabilities
$
32,537
$
28,816
Deferred revenue
7,865
30,320
Lease liabilities
4,228
4,708
Total current liabilities
44,630
63,844
Lease liabilities, net of current portion
54,615
54,926
Total liabilities
99,245
118,770
Stockholders’ equity
678,876
727,496
Total liabilities and stockholders’ equity
$
778,121
$
846,266
The 2022 balance sheet was derived from the 2022 annual
financial statements included in the Form 10-K that was filed on
February 24, 2023 Xencor Inc. Condensed Statements of
Comprehensive Income (Loss) (in thousands, except share and
per share data) Three months ended June 30,
Six months ended June 30,
2023
2022
2023
2022
(unaudited)
Revenues $
45,523
$
30,175
$
64,485
$
115,670
Operating expenses: Research and development
60,060
47,084
124,439
94,839
General and administrative
11,460
11,091
25,408
22,364
Total operating expenses
71,520
58,175
149,847
117,203
Loss from operations
(25,997
)
(28,000
)
(85,362
)
(1,533
)
Other income (expense), net
4,043
(5,975
)
2,645
(8,847
)
Net loss
(21,954
)
(33,975
)
(82,717
)
(10,380
)
Other comprehensive gain (loss) Net unrealized gain (loss)
on marketable debt securities
1,765
(1,823
)
5,093
(7,435
)
Comprehensive loss $
(20,189
)
$
(35,798
)
$
(77,624
)
$
(17,815
)
Net loss per share: Basic and diluted net
loss per share $
(0.37
)
$
(0.57
)
$
(1.38
)
$
(0.17
)
Weighted-average number of common shares used in net loss per
share applicable to common stockholders - basic and diluted
59,807,558
59,567,139
59,922,784
59,487,924
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version on businesswire.com: https://www.businesswire.com/news/home/20230803603819/en/
For Investors: Charles Liles cliles@xencor.com (626)
737-8118
For Media: Jason I. Spark Evoke Canale
jason.spark@evokegroup.com (619) 849-6005
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