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 first quarter ended March 31, 2024 and provided a review of
recent clinical and business highlights.
“We have focused our XmAb® clinical pipeline and discovery
activities on bispecific CD3 and CD28 T cell engagers, which
continue to show clinical validation for their potential in
treating patients with serious diseases. Our key clinical-stage
oncology programs in solid tumors include XmAb819 (ENPP3 x CD3) in
clear cell renal cell carcinoma, XmAb808 (B7-H3 x CD28) in prostate
cancer and other cancers, and XmAb541 (CLDN6 x CD3) in ovarian
cancer and other cancers, which are all now advancing in Phase 1
clinical studies. We plan to select our next T cell engager IND
candidate later this year,” said Bassil Dahiyat, Ph.D., president
and chief executive officer at Xencor. “Additionally, Xencor’s
best-in-class Xtend™ antibody half-life extension technology
continues to support improved outcomes for patients, with
Ultomiris® now approved in the U.S. for certain patients with
NMOSD, and we are especially delighted by recently published
results demonstrating an investigational antibody with Xtend was
effective in preventing malaria.”
Recent Clinical and Business Highlights
- First Patient Dosed in Phase 1 Study of XmAb®541 (CLDN6 x
CD3): XmAb541 is a bispecific antibody being developed for
patients with CLDN6-positive tumors including advanced ovarian
cancer. 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 recently dosed in a Phase 1 dose-escalation
study.
- FDA Approves Ultomiris® (Alexion Pharmaceuticals, Inc.) for
Adults with NMOSD: In March 2024, Ultomiris®
(ravulizumab-cwvz), which incorporates Xencor’s Xtend™ Fc Domain,
was approved in the United States as the first and only long-acting
C5 complement inhibitor for the treatment of adult patients with
anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis
optica spectrum disorder (NMOSD). Ultomiris is also approved for
certain adults with NMOSD in Japan and the European Union (EU). As
part of Xencor’s recent Ultomiris royalty monetization, the Company
remains eligible for certain future royalties and milestone
payments. Ultomiris is a registered trademark of Alexion
Pharmaceuticals, Inc.
- Single Dose of Investigational Antibody with Xtend™ Confers
Protection Against Malaria Infection: Results from a Phase 2
National Institutes of Health (NIH)-sponsored clinical trial
published in the New England Journal of Medicine showed that a
single dose of L9LS, an experimental monoclonal antibody that
incorporates Xencor’s Xtend™ Fc Domain, was up to 77% effective in
preventing malaria in children in Mali for six months,
demonstrating the long duration of action that Xtend technology can
provide.
- New Chief Financial Officer Appointed: Bart Cornelissen
was appointed as Xencor’s senior vice president and chief financial
officer. He was most recently vice president, corporate finance at
Seagen Inc.
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 First Quarter Ended March 31,
2024
Cash, cash equivalents and marketable debt securities totaled
$646.7 million as of March 31, 2024, compared to $697.4 million on
December 31, 2023.
Revenues for the first quarter ended March 31, 2024 were $12.8
million, compared to $19.0 million for the same period in 2023.
Total revenues earned in the first quarter of 2024 included
non-cash royalty revenue from Xencor’s Alexion and Morphosys/Incyte
agreements, compared to milestone revenue earned from the J&J
collaboration and royalties from the Alexion agreement in the first
quarter of 2023.
Research and development expenses for the first quarter ended
March 31, 2024 were $56.9 million, compared to $65.6 million for
the same period in 2023. Decreased research and development
spending for the first quarter of 2024 compared to 2023 reflects
changes in spending across multiple clinical-stage programs and
wind-down costs on terminated programs.
General and administrative expenses for the first quarter ended
March 31, 2024 were $13.8 million and were in line with $14.2
million for the same period in 2023.
Other expense, net, for the first quarter ended March 31, 2024
was $10.8 million, compared to $0.02 million for the same period in
2023. Increased other expense for the first quarter of 2024
compared to 2023 reflects impairment charge on equity investments,
partially offset by interest income earned on investments and
unrealized gain on equity investments.
Non-cash, stock-based compensation expense for the first quarter
ended March 31, 2024 was $11.4 million, compared to $12.6 million
for the same period in 2023.
Net loss for the first quarter ended March 31, 2024 was $68.0
million, or $(1.11) on a fully diluted per share basis, compared to
$60.8 million, or $(1.02) on a fully diluted per share basis, for
the same period in 2023.
The total shares outstanding were 61,634,685 as of March 31,
2024, compared to 60,381,600 as of March 31, 2023.
Upcoming Investor Conferences
Company management will participate at multiple upcoming
investor conferences:
- RBC Capital Markets Global Healthcare Conference Date:
Tuesday, May 14, 2024 Presentation Time: 2:05 p.m. ET / 11:05 a.m.
PT Location: New York City
- BofA Securities Health Care Conference Date: Wednesday,
May 15, 2024 Presentation Time: 4:40 p.m. ET / 1:40 p.m. PT
Location: Las Vegas
Live webcasts of the presentations will be available under
“Events & Presentations” in the Investors section of the
Company’s website located at www.xencor.com. Replays of the events
will be available on the Xencor website for at least 30 days
following the presentations.
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 planned presentations of
clinical data, 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)
March 31,
December 31,
2024
2023
(Unaudited) Cash, cash equivalents and marketable debt securities -
current
$
491,401
$
551,515
Other current assets
70,851
71,645
Marketable debt securities - long term
155,342
145,892
Other long term assets
166,661
183,640
Total assets
$
884,255
$
952,692
Total current liabilities
79,402
84,709
Deferred income - long term
113,367
125,183
Other long term liabilities
79,299
73,667
Total liabilities
272,068
283,559
Total stockholders' equity
612,187
669,133
Total liabilities and stockholders’ equity
$
884,255
$
952,692
Xencor, Inc. Consolidated Statements of Loss and
Comprehensive Loss (in thousands, except share and per share
data)
Three months Ended March
31,
2024
2023
(Unaudited)
Revenue
$
12,805
$
18,962
Operating expenses Research and development
56,873
65,552
General and administrative
13,787
14,154
Total operating expenses
70,660
79,706
Loss from operations
(57,855
)
(60,744
)
Other income (expense), net
(10,854
)
(19
)
Loss before income tax
(68,709
)
(60,763
)
Income tax expense
—
—
Net loss
(68,709
)
(60,763
)
Net loss attributable to non-controlling interest
(676
)
—
Net loss attributable to Xencor, Inc.
(68,033
)
(60,763
)
Other comprehensive income (loss): Net unrealized gain
(loss) on marketable debt securities available-for-sale
(1,445
)
3,327
Comprehensive loss attributable to Xencor, Inc.
$
(69,478
)
$
(57,436
)
Net loss per common share attributable to Xencor,
Inc.: Basic and Diluted
$
(1.11
)
$
(1.02
)
Weighted average common shares used to compute net loss per
share attributable to Xencor, Inc. Basic and Diluted
61,212,324
59,771,674
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version on businesswire.com: https://www.businesswire.com/news/home/20240507540009/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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