-- XmAb564, engineered IL-2 cytokine, is
well-tolerated and generates a durable, dose-dependent and
selective expansion of Tregs in single-dose, healthy volunteer
study --
-- 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 cancer and autoimmune diseases, today reported
financial results for the third quarter ended September 30, 2022
and provided a review of recent business and clinical
highlights.
“Xencor’s XmAb® technologies and protein engineering
capabilities enable us to address challenging areas of biology and
to continually grow our portfolio, both internally and together
with our many partners. Today we presented very encouraging data
from our second clinical-stage cytokine program, XmAb564, a
regulatory T-cell targeting IL2-Fc fusion protein for development
in autoimmune disease. The selective T-cell increases, their
durability and the tolerability in our data provide us additional
clinical validation for Xencor’s long-acting, low-potency approach
to cytokine engineering and offers a potentially differentiated
profile for this autoimmune program,” said Bassil Dahiyat, Ph.D.,
president and chief executive officer at Xencor. “In the coming
weeks, we will also present new data from two additional clinical
programs—for vudalimab, data from the safety run-in portion of our
Phase 2 prostate cancer study at SITC and, for plamotamab, updated
Phase 1 expansion data in patients with lymphoma at ASH—as well as
preclinical data from emerging platforms.”
Dr. Dahiyat continued, “Altogether, these updates reflect
Xencor’s steady commitment to the priorities we laid out at the
beginning of this year: to execute on development plans for our
mid-stage bispecific antibodies, vudalimab and plamotamab; to
advance potency-reduced cytokines for oncology and autoimmune
disease; and to expand our portfolio with novel formats enabled by
our protein engineering expertise and suite of leading XmAb
technologies.”
Recent Portfolio Highlights
- XmAb564 (IL2-Fc): Today, Xencor announced initial
results from its single-dose Phase 1a study of XmAb564,
administered subcutaneously in healthy volunteers. XmAb564 is a
wholly owned, monovalent interleukin-2 Fc (IL-2-Fc) fusion protein,
engineered to selectively activate and expand regulatory T cells
(Tregs) for the potential treatment of patients with autoimmune
diseases. XmAb564 is engineered with reduced binding affinity for
IL-2’s beta receptor and increased binding affinity for its alpha
receptor (CD25). The study enrolled 48 subjects, with six
dose-level cohorts each randomizing six subjects to XmAb564 and two
subjects to placebo. The study demonstrated that a single dose of
XmAb564 is well tolerated and generates durable, dose-dependent and
selective expansion of Tregs. In the highest dose cohort (0.065
mg/kg; Cohort 6), a 117-fold mean peak expansion over baseline in
CD25bright cells was observed, with an 8-fold expansion in the bulk
Treg population. The ratio of Tregs to conventional T cells also
increased significantly in a dose-dependent manner. At day 21, both
CD25bright and total Treg counts remained markedly elevated,
potentially supporting a multi-week dosing profile. All adverse
events (AEs) were either Grade 1 or 2 and resolved without
intervention. Injection site reaction was the most reported AE.
Xencor has dosed the first patient in a newly initiated Phase 1b,
multiple-ascending dose study of XmAb564 in patients with atopic
dermatitis and psoriasis.
- Vudalimab (PD-1 x CTLA-4): Xencor is advancing
vudalimab, a selective dual checkpoint inhibitor, in multiple Phase
2 clinical studies. Xencor is conducting a Phase 2 study of
vudalimab in patients with metastatic castration-resistant prostate
cancer (mCRPC), as a monotherapy or in combination with
standard-of-care chemotherapy or a PARP inhibitor. Initial data
from the first patients in the study will be presented in a
trials-in-progress poster at the Annual Meeting of the Society for
Immunotherapy of Cancer (SITC) this month. Xencor is also
conducting a Phase 2 monotherapy study in patients with advanced
gynecologic and clinically-defined high-risk mCRPC.
- Plamotamab (CD20 x CD3): Xencor is advancing plamotamab
as part of highly active chemotherapy-free regimens across B-cell
cancers. The Phase 2 study of plamotamab in combination with
tafasitamab plus lenalidomide is currently enrolling patients with
relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Data
from expansion cohorts in the first-in-human, Phase 1 monotherapy
study in patients with relapsed or refractory non-Hodgkin’s
lymphoma will be presented at the 64th American Society of
Hematology Annual Meeting on Monday, December 12, 2022. These
expansion cohorts are actively recruiting patients with relapsed or
refractory DLBCL and follicular lymphoma and are dosing using the
intravenous recommended Phase 2 regimen to evaluate the safety and
efficacy of plamotamab monotherapy. Subcutaneous administration of
plamotamab is currently being incorporated into the study.
- Preclinical Data Presentations: New data from four
preclinical-stage programs, including Xencor’s IL-18-Fc and
LAG3-targeted IL-15-Fc cytokine programs, CD28 trispecific
antibodies targeting PDL1 and PDL2 and its NK cell engager
platform, will also be presented at the SITC Annual Meeting.
Progress Across Partnerships
- Vir Biotechnology, Inc.: In the third quarter of 2022,
Xencor reported $17.8 million in royalty revenue under the
Company’s agreement with Vir. Sotrovimab, an antibody that targets
the SARS-CoV-2 virus and incorporates Xencor’s Xtend™ Fc domain for
longer duration of action, has been made available by Vir and its
partner GSK. Sotrovimab currently has emergency use authorization,
temporary authorization or marketing approval (under the brand name
Xevudy®️) for early treatment of COVID-19 in more than 40
countries, and remains in use outside of the U.S. For the first
nine months of 2022, the Company has received $110.1 million in
royalty revenue under the Vir Agreement.
- Zenas Biopharma Ltd.: Today, Zenas announced that it
raised $118 million in additional capital in connection with the
issuance of Series B shares. Xencor had owned a warrant and a
convertible note in Zenas, which as a result of the financing
converted into additional equity. Zenas also announced plans to
initiate a global Phase 3 registration study of obexelimab, which
was acquired from Xencor, in patients with IgG4-related disease in
late 2022.
Corporate: In September, Xencor appointed Nancy Valente,
M.D., to its board of directors. Dr. Valente is a recognized and
accomplished biotechnology executive with broad expertise in
late-stage oncology clinical development, and she served a critical
role for numerous product launches. She most recently served as a
senior vice president at Genentech, a member of the Roche Group,
and as its global head and co-lead of global product development of
its oncology and hematology therapeutic area.
Xevudy® is a registered trademark of the GSK group of
companies.
Financial Results for the Third Quarter Ended September 30,
2022
Cash, cash equivalents, receivables and marketable debt
securities totaled $654.6 million as of September 30, 2022,
compared to $664.1 million on December 31, 2021. During the first
nine months of 2022, the Company received royalty and milestone
payments from partners of $140.9 million, which offset net spending
on operations of $170.3 million through September 30, 2022.
Total revenue for the third quarter ended September 30, 2022 was
$27.3 million, compared to $19.7 million for the same period in
2021. Revenues earned in the third quarter of 2022 were primarily
royalties from the Alexion and Vir agreements, compared to the same
period in 2021, which were primarily from the Janssen
collaboration, and royalty revenue from Alexion and Vir. Revenues
for the nine months ended September 30, 2022 were $143.0 million,
compared to $121.1 million for the same period in 2021. Revenues
for the nine-month period in 2022 were primarily from milestone
revenue from Astellas and royalty revenue from Alexion, MorphoSys
and Vir, compared to the same period in 2021, which were earned
primarily from the collaborations with Janssen and Novartis,
milestone revenue from MorphoSys and the royalties from Alexion and
Vir.
Research and development (R&D) expenses for the third
quarter ended September 30, 2022 were $53.3 million, compared to
$50.6 million for the same period in 2021. Increased R&D
spending for third quarter of 2022 compared to 2021 reflects
increased spending on IL-12 and IL-18 cytokine programs offset by
lower spending on CD3 programs. R&D expenses for the nine
months ended September 30, 2022 were $148.1 million, compared to
$141.5 million for the same period in 2021. Increased R&D
spending for the first nine months of 2022 reflects additional
spending on XmAb808 (B7-H3 x CD28) and cytokine programs offset by
lower spending on CD3 programs.
General and administrative (G&A) expenses for the third
quarter ended September 30, 2022 were $12.4 million, compared to
$10.4 million for the same period in 2021. G&A expenses for the
nine months ended September 30, 2022 were $34.7 million, compared
to $27.5 million for the same period of 2021. Increased G&A
spending for the third quarter and first nine months of 2022
compared to amounts for the same periods in 2021 reflects
additional general and administrative staffing and increased
spending on professional services and facility costs.
Other income for the third quarter ended September 30, 2022 was
$6.7 million compared to $1.1 million in the same period in 2021.
Other income for these periods represents unrealized gain from the
change in fair value of equity securities and interest income
earned on investments. Other expenses for the nine months ended
September 30, 2022 were $2.2 million, compared to other income of
$57.5 million in the same period in 2021. Other expenses for nine
months ended September 30, 2022 consists of unrealized losses from
the change in the fair value of equity investments and interest
income earned, while other income for the first nine months of 2021
includes realized gains on the sale of an investment equity
security and an increase in unrealized gains on the Company’s
marketable equity investments.
Non-cash, stock-based compensation expense for the nine months
ended September 30, 2022 was $36.2 million, compared to $26.6
million for the same period in 2021.
Net loss for the third quarter ended September 30, 2022 was
$32.8 million, or $(0.55) on a fully diluted per share basis,
compared to net loss of $40.2 million, or $(0.69) on a fully
diluted per share basis, for the same period in 2021. For the nine
months ended September 30, 2021, net loss was $43.1 million, or
$(0.72) on a fully diluted per share basis, compared to net income
of $9.6 million, or $0.16 on a fully diluted per share basis, for
the same period in 2021. Net loss reported for the third quarter
ended September 30, 2022 compared to the net loss reported for the
same period in 2021 is lower due to increased revenue and interest
income in 2022 compared to 2021. Net loss for the first nine months
of 2022, compared to the net income reported for the same periods
in 2021, is primarily due to realized gain on an equity investment
and an increase in unrealized gains on marketable equity securities
during the nine months ended September 30, 2021.
The total shares outstanding were 59,773,337 as of September 30,
2022, compared to 58,454,811 as of September 30, 2021.
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 2022 with between $575
million and $600 million in cash, cash equivalents, receivables and
marketable debt securities.
Conference Call and Webcast
Xencor will host a conference call today at 4:30 p.m. ET (1:30
p.m. PT) to discuss the third quarter 2022 financial results,
provide a corporate update and present results from the Phase 1a
study of XmAb564.
The live webcast will be available under "Events &
Presentations" in the Investors section of the Company's website at
investors.xencor.com and will be archived for at least 30 days.
Active participants in the conference call may receive credentials
for telephone access by registering at the following link:
https://register.vevent.com/register/BIb8a7d450f24d42068f4bb86e717257fe.
About Xencor
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 presentations of
clinical data, 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, 2021 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) September 30, December 31,
2022
2021
(unaudited) Assets Current assets Cash and
cash equivalents
$
52,654
$
143,480
Marketable debt securities
515,398
153,767
Marketable equity securities
32,184
36,860
Accounts receivable
44,876
66,384
Prepaid expenses
22,886
23,877
Total current assets
667,998
424,368
Property and equipment, net
51,040
28,240
Intangible assets, net
18,094
16,493
Marketable debt securities - long term
41,720
300,465
Marketable equity securities - long term
31,124
31,262
Notes receivable - long term
5,000
5,000
Right of use asset
19,680
31,730
Other assets
613
653
Total assets
$
835,269
$
838,211
Liabilities and stockholders’ equity Current
liabilities Accounts payable and accrued liabilities
33,907
$
33,444
Deferred revenue
35,186
37,294
Lease liabilities
20,551
—
Income tax liability
388
—
Total current liabilities
90,032
70,738
Lease liabilities, net of current portion
22,539
33,969
Total liabilities
112,571
104,707
Stockholders’ equity
722,698
733,504
Total liabilities and stockholders’ equity
$
835,269
$
838,211
The 2021 balance sheet was derived from the 2021 annual
financial statements included in the Form 10-K that was filed on
February 24, 2022 Xencor Inc. Condensed Statements of
Comprehensive Income (Loss) (in thousands, except share and
per share data) Three months ended September 30,
Nine months ended September 30,
2022
2021
2022
2021
(unaudited)
Revenues $
27,299
$
19,683
$
142,969
$
121,096
Operating expenses: Research and development
53,273
50,610
148,111
141,519
General and administrative
12,374
10,373
34,738
27,462
Total operating expenses
65,647
60,983
182,849
168,981
Loss from operations
(38,348
)
(41,300
)
(39,880
)
(47,885
)
Other income (expense), net
6,677
1,109
(2,171
)
57,455
Income (loss) before income taxes
(31,671
)
(40,191
)
(42,051
)
9,570
Income tax expense
1,088
—
1,088
—
Net income (loss)
(32,759
)
(40,191
)
(43,139
)
9,570
Other comprehensive loss Net unrealized loss on marketable
debt securities
(931
)
(59
)
(8,366
)
(149
)
Comprehensive income (loss) $
(33,690
)
$
(40,250
)
$
(51,505
)
$
9,421
Net income (loss) per share: Basic net
income (loss) per share $
(0.55
)
$
(0.69
)
$
(0.72
)
$
0.16
Diluted net income (loss) per share $
(0.55
)
$
(0.69
)
$
(0.72
)
$
0.16
Weighted-average number of common shares used in net income
(loss) per share applicable to common stockholders - basic
59,716,594
58,350,647
59,564,985
58,199,928
Weighted-average number of common shares used in net income
(loss) per share applicable to common stockholders - diluted
59,716,594
58,350,647
59,564,985
60,346,480
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221107006010/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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