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 third quarter ended September 30, 2024 and provided a
review of recent business and clinical-stage program updates.
“In September, we provided updates across our clinical pipeline
of XmAb® bispecific T-cell engagers in oncology and introduced our
new autoimmune programs, including the B-cell depleting bispecific
antibodies plamotamab and XmAb657, and XmAb942, our high potency
anti-TL1A antibody with extended half-life in development for
patients with inflammatory bowel disease. This week, we announced
that XmAb942 advanced into a Phase 1 dose-escalation study in
healthy volunteers,” said Bassil Dahiyat, Ph.D., president and
chief executive officer at Xencor. “We have been rebalancing our
broad portfolio to focus on programs that leverage our protein
engineering strengths and reduce exposure to biological
uncertainties to increase our overall opportunities for clinical
success. We also remain highly encouraged by our partner Amgen’s
progress with developing xaluritamig, a STEAP1 x CD3 XmAb T-cell
engager for patients with prostate cancer, which Amgen announced is
starting a Phase 3 study later this year.”
Recent Corporate Activities
New XmAb Drug Candidates in Autoimmune Disease: In
September 2024, Xencor announced new clinical development plans for
plamotamab (CD20 x CD3) and announced new XmAb drug candidates to
be evaluated for the treatment of patients with autoimmune and
inflammatory diseases. Plamotamab and XmAb657 (CD19 x CD3) could
potentially address significant unmet needs for patients with a
wide-range of autoimmune diseases that could be responsive to
targeted B-cell depletion. XmAb942 (Xtend™ anti-TL1A) and a drug
candidate to potentially emerge from the XmAb TL1A x IL-23 program
could address significant unmet medical needs for patients with
inflammatory bowel disease (IBD), such as Crohn’s disease and
ulcerative colitis, the two most common forms of IBD.
Public Offering Raised $201.3 Million in Gross Proceeds:
On September 12, 2024, Xencor announced the closing of an
underwritten public offering of common stock and pre-funded
warrants, and the gross proceeds to Xencor from the offering were
$201.3 million, before deducting underwriting discounts and
commissions and offering expenses.
Internal Clinical-Stage Program Updates
XmAb942 (Xtend anti-TL1A): In the fourth quarter of 2024,
preclinical data were presented during United European
Gastroenterology (UEG) Week and a Phase 1 first-in-human study was
initiated and began dosing healthy volunteers. XmAb942 is a
high-potency, extended half-life, investigational anti-TL1A
antibody in development for patients with IBD. Xencor expects to
present initial data from the single-ascending dose portion of the
Phase 1 study in the first half of 2025.
Plamotamab (CD20 x CD3): Xencor previously completed a
Phase 1 clinical study of plamotamab in hematologic cancers. Data
from subcutaneous dosing cohorts in patients with relapsed or
refractory non-Hodgkin’s lymphoma will be presented at the 66th
American Society of Hematology Annual Meeting in a poster titled
“First Presentation of Subcutaneous Administration in a Phase 1
Dose Escalation Study in Heavily Pretreated R/R NHL Patients Who
Had Prior CAR-T Cell Therapy.”
In September 2024, Xencor presented results from the study
showing favorable tolerability and comparable preliminary efficacy
data, when cross compared to results from studies of a competitor
molecule within the class and with similar patient baseline
characteristics. Based on these clinical outcomes, deep and durable
B-cell depletion observed in preclinical studies, and the emergent
biology supportive of B-cell targeted T cell engagers for the
treatment of patients with autoimmune diseases, Xencor plans to
evaluate plamotamab in rheumatoid arthritis, in which patients have
progressed through prior standard-of-care treatment. Xencor plans
to initiate a Phase 1b/2a proof-of-concept study in the first half
of 2025.
XmAb808 (B7-H3 x CD28): In the ongoing Phase 1 study’s
highest dose cohort to date, within the range of expected active
doses, two patients experienced dose-limiting toxicities as defined
in the study protocol. One patient experienced an infusion-related
reaction during administration of the first dose of XmAb808. A
second patient experienced immune-related hepatitis with Grade 4
elevation of transaminases and Grade 3 elevation of bilirubin,
after the second dose. The patient with liver toxicity was
asymptomatic, and the laboratory abnormalities are resolving. The
maximum tolerated dose has not been defined per protocol. As the
data from these recent events are analyzed, back-fill enrollment is
proceeding in the next lower dose cohort, a dose within the range
of target doses, which was determined to be tolerable. Xencor
anticipates that dose escalation will continue per protocol if the
currently enrolling cohort continues to be tolerable.
In September 2024, Xencor announced that most patients enrolled
into the Phase 1 dose-escalation study were men with metastatic
castration-resistant prostate cancer (mCRPC), and in this group,
prostate specific antigen (PSA) declines had been observed during
the four-week monotherapy safety run-in period. Xencor plans to
provide a clinical update around initiation of dose expansion
cohorts during the first half of 2025.
XmAb819 (ENPP3 x CD3): In September 2024, Xencor
announced that initial evidence of anti-tumor activity was observed
in the ongoing Phase 1 dose-escalation study in patients with
advanced clear cell renal cell carcinoma, including RECIST
responses, and the duration of treatment for several patients in
earlier dose cohorts had extended beyond one year. Cytokine release
syndrome remained manageable, no maximum tolerated dose had been
reached and the tolerability profile from recent dose cohorts
supported continued dose escalation toward target dose levels.
Xencor continues to anticipate reaching target dose levels by year
end and plans to provide a clinical update around initiation of the
first dose expansion cohort during the first half of 2025.
Collaboration Partner Amgen’s Xaluritamig Advancing into
Phase 3 Development
Results from a Phase 1 study evaluating xaluritamig, a
first-in-class STEAP1 x CD3 XmAb 2+1 bispecific T-cell engager, in
patients with mCRPC were presented at the European Society for
Medical Oncology (ESMO) Congress in September 2024. With a median
follow-up time of 27.9 months, the median overall survival (OS) was
17.7 months across all cohorts. A PSA90 rate of 45.1% was also
observed in high-dose cohorts, and PSA90 response was associated
with survival (p = 0.0044), which Amgen believes could potentially
serve as an early indicator for benefit in these patients. Amgen
has indicated that a Phase 3 study in patients with post-taxane
mCRPC will be initiated in the fourth quarter of 2024. Multiple
Phase 1 studies evaluating xaluritamig as a monotherapy or in
combination are enrolling patients with earlier prostate
cancer.
Financial Results for the Third Quarter Ended September 30,
2024
Cash, cash equivalents and marketable debt securities totaled
$754.3 million as of September 30, 2024, compared to $697.0 million
as of December 31, 2023. Net proceeds from Xencor’s September 2024
underwritten public offering were $189.2 million.
Revenues for the third quarter ended September 30, 2024 were
$10.7 million, compared to $59.2 million for the same period in
2023. Revenues earned in the third quarter of 2024 were primarily
non-cash royalty revenue from Alexion and Incyte, compared to the
same period in 2023, which were primarily royalty and milestone
revenue from Alexion and milestone revenue from Janssen, Gilead and
Omeros.
Research and development (R&D) expenses for the third
quarter ended September 30, 2024 were $58.2 million, compared to
$64.9 million for the same period in 2023. Decreased R&D
spending for the third quarter of 2024 compared to 2023 is
primarily due to decreased spending on wind down costs of
terminated programs, partially offset by increased spending on
programs such as XmAb942, XmAb819 and plamotamab.
General and administrative (G&A) expenses for the third
quarter ended September 30, 2024 were $14.8 million, compared to
$12.5 million for the same period in 2023. Increased G&A
spending for the third quarter of 2024 compared to 2023 is
primarily due to increased spending on professional fees.
Other income, net, for the third quarter ended September 30,
2024 was $16.0 million, compared to other expense, net of $6.0
million for the same period in 2023. Other income, net, for the
third quarter of 2024, compared to other expense, net, for the same
period in 2023, is primarily due to unrealized and realized gains
from the change in fair value and sale of equity investments and
interest income from investments.
Net loss attributable to Xencor for the third quarter ended
September 30, 2024 was $45.1 million, or $(0.71) on a fully diluted
per share basis, compared to net loss of $24.3 million, or $(0.40)
on a fully diluted per share basis, for the same period in
2023.
Financial Guidance
Based on current operating plans, Xencor expects to end 2024
with between $690 million and $710 million in cash, cash
equivalents and marketable debt securities, and to have cash to
fund research and development programs and operations into
2028.
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 multiple
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 statements regarding
expectations for clinical progress, planned receipt and
presentations of clinical data, including timing thereof, new XmAb
candidates and programs, planned and ongoing clinical trials,
projected financial resources and financial guidance, including
estimated cash at year end and cash runway, the quotations from
Xencor's 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) September 30, December
31,
2024
2023
(Unaudited) Cash, cash equivalents and marketable debt securities -
current
$
464,074
$
551,515
Other current assets
109,254
71,645
Marketable debt securities - long term
290,274
145,512
Other long-term assets
120,033
184,020
Total assets
$
983,635
$
952,692
Total current liabilities
91,972
84,709
Deferred income - long term
94,107
125,183
Other long term liabilities
76,658
73,667
Total liabilities
262,737
283,559
Total stockholders' equity
720,898
669,133
Total liabilities and stockholders’ equity
$
983,635
$
952,692
Xencor, Inc. Consolidated Statements of Comprehensive
Loss (in thousands, except share and per share data)
Three Months EndedSeptember 30, Nine Months
EndedSeptember 30,
2024
2023
2024
2023
(Unaudited)
Revenue
$
10,710
$
59,164
$
40,475
$
123,649
Operating expenses Research and development
58,226
64,941
176,630
190,553
General and administrative
14,767
12,493
46,300
38,107
Total operating expenses
72,993
77,434
222,930
228,660
Loss from operations
(62,283
)
(18,270
)
(182,455
)
(105,011
)
Other income (expense), net
15,986
(5,999
)
158
(1,975
)
Loss before income tax
(46,297
)
(24,269
)
(182,297
)
(106,986
)
Income tax expense
—
—
117
—
Net loss
(46,297
)
(24,269
)
(182,414
)
(106,986
)
Net loss attributable to non-controlling interest
(1,154
)
—
(3,275
)
—
Net loss attributable to Xencor, Inc.
(45,143
)
(24,269
)
(179,139
)
(106,986
)
Other comprehensive income Net unrealized gain on marketable
debt securities
2,452
1,151
510
6,244
Comprehensive loss attributable to Xencor, Inc.
$
(42,691
)
$
(23,118
)
$
(178,629
)
$
(100,742
)
Net loss per common share attributable to Xencor,
Inc.: Basic and Diluted
$
(0.71
)
$
(0.40
)
$
(2.87
)
$
(1.77
)
Weighted average common shares used to compute net loss per
share attributable to Xencor, Inc. Basic and Diluted
64,022,547
60,621,534
62,310,045
60,387,163
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241106077662/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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