-- 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 fourth quarter and full year ended
December 31, 2022 and provided a review of recent business and
clinical highlights.
“In 2022, we focused on advancing our internal portfolio of
XmAb® drug candidates, including the ongoing Phase 2 studies for
vudalimab in combination with chemotherapy and as a monotherapy in
prostate and gynecological tumors. We also advanced XmAb564, our
regulatory T-cell targeting cytokine, into a multiple-ascending
dose study in atopic dermatitis and psoriasis, following
encouraging single-dose data that showed potentially differentiated
durability at boosting target cells,” said Bassil Dahiyat, Ph.D.,
president and chief executive officer at Xencor. “We continue to
leverage our XmAb technologies and protein engineering
capabilities, both internally and with partners, to address
challenging areas of biology and continually grow our portfolio. We
initiated Phase 1 studies for two novel T-cell engagers, XmAb819,
our 2+1 formatted CD3 bispecific for renal cell carcinoma, and
XmAb808, our first internal bispecific targeting CD28, a new class
of anti-tumor agent that we are at the forefront of
developing.”
“Looking ahead, in 2023, we expect to further expand our wholly
owned portfolio by initiating a Phase 1 study for XmAb662, our
engineered IL-12 for oncology and our third clinical-stage cytokine
using our reduced potency design. Then later this year, we
anticipate submitting an IND for XmAb541, a 2+1 formatted CLDN6 x
CD3 bispecific antibody that we are developing for patients with
ovarian cancer.”
Highlights from Xencor’s Wholly Owned Portfolio
- Vudalimab (PD-1 x CTLA-4): Two Phase 2 studies of
vudalimab, a selective dual checkpoint inhibitor, are enrolling
patients. Initial combination data from a study in patients with
metastatic castration-resistant prostate cancer (mCRPC) were
presented in November 2022, and the study continues to enroll
patients under a modified chemotherapy regimen. A second study in
patients with advanced gynecologic tumors and clinically defined
high-risk mCRPC is also enrolling patients who will receive
vudalimab as a monotherapy.
- XmAb564 (IL2-Fc): XmAb564 is a potency-reduced,
monovalent interleukin-2 Fc fusion protein, designed to selectively
activate and expand regulatory T cells (Tregs) for the potential
treatment of patients with autoimmune diseases. In November 2022,
Xencor presented data from a Phase 1a single-ascending dose study
in healthy volunteers, demonstrating that a single dose was well
tolerated and generates durable, dose-dependent and selective
expansion of Tregs. A Phase 1b, multiple-ascending dose study is
enrolling patients with atopic dermatitis and psoriasis and
exploring multi-week dosing regimens.
- XmAb819 (ENPP3 x CD3): XmAb819 is an XmAb 2+1 bispecific
antibody being developed for patients with renal cell carcinoma
(RCC). 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 on kidney cancers.
Xencor’s XmAb 2+1 bispecific antibody format enables greater
selectivity of ENPP3-expressing tumor cells compared to normal
cells, which express lower levels of ENPP3. A Phase 1
dose-escalation study is enrolling patients with advanced RCC.
- XmAb808 (B7-H3 x CD28): XmAb808 is a 2+1 formatted,
tumor-selective, co-stimulatory CD28 bispecific antibody that binds
to the broadly expressed tumor antigen B7-H3. Co-stimulatory
receptor engagement 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. A Phase 1 dose-escalation study in combination with
pembrolizumab is now enrolling patients with advanced solid
tumors.
- XmAb662 (IL12-Fc): XmAb662 is a potency-reduced IL12-Fc
fusion protein designed to increase tumor immunogenicity. Xencor’s
potency-reduced approach to cytokine engineering may improve the
therapeutic index and duration of action of its cytokine candidates
compared to engineered cytokines with native cytokine potency. A
Phase 1 study in patients with advanced solid tumors is expected to
start in mid-2023.
Recent Partnership Developments
- Janssen Biotech, Inc.: In the first quarter of 2023,
Janssen selected a CD28 bispecific antibody candidate under the
companies’ second collaboration agreement, which is focused on the
discovery of XmAb bispecific antibodies against CD28 and B-cell
targets. Janssen has an exclusive worldwide license to develop
selected CD28 molecules in combination with plamotamab (CD20 x CD3)
and other agents.
- Atreca, Inc.: Under the companies’ July 2020 agreement,
a CD3 bispecific antibody program was mutually selected for further
development and commercialization, with Atreca leading clinical
activities and Xencor sharing 50 percent of costs and profits.
- Caris Life Sciences: In January 2023, the Company
expanded its collaboration with Caris to create XmAb bispecific or
multi-specific antibodies with Caris’ unique human tissue bank and
bioinformatics approach to find addressable tumor markers.
- Zenas BioPharma Ltd.: In January 2023, Zenas dosed the
first patient in a Phase 3 study evaluating obexelimab in patients
with immunoglobulin G4-related disease (IgG4-RD).
Corporate: On Monday, February 27, Xencor will open its
Pasadena, California laboratory and corporate headquarters, which
has larger laboratories with expanded protein engineering
capabilities.
Financial Results for the Fourth Quarter and Full Year Ended
December 31, 2022
Cash, cash equivalents, receivables and marketable debt
securities totaled $613.5 million as of December 31, 2022, compared
to $664.1 million on December 31, 2021.
Total revenue for the fourth quarter ended December 31, 2022 was
$21.6 million compared to $154.0 million for the same period in
2021. Revenues earned in the fourth quarter of 2022 were primarily
royalties from the Alexion and Vir agreements and research
collaboration revenue from the second Janssen agreement, compared
to the same period in 2021, which were primarily from the Janssen
collaboration and royalty revenue from Alexion and Vir. Revenues
for the full year 2022 were $164.6 million compared to $275.1
million for the same period in 2021. Revenues for the full year
2022 were primarily royalties from Alexion, MorphoSys and Vir,
milestone revenue from Astellas and collaboration revenue from our
second Janssen collaboration, compared to the same period in 2021,
which were earned primarily from the collaborations with Janssen
and Novartis, milestone revenue from MorphoSys and royalties from
Alexion and Vir.
Research and development (R&D) expenses for the fourth
quarter ended December 31, 2022 were $51.5 million and is
comparable to R&D expenses for the same period in 2021 which
were $51.0 million. R&D expenses for the year ended December
31, 2022 were $199.6 million compared to $192.5 million for the
same period in 2021. Increased R&D spending for the full year
2022 reflects additional spending on our CD3, CD28 and cytokine
programs including XmAb808, XmAb662 and XmAb541.
General and administrative (G&A) expenses for the fourth
quarter ended December 31, 2022 were $12.8 million compared to
$11.4 million for the same period in 2021. G&A expenses for the
full year ended December 31, 2022 were $47.5 million compared to
$38.8 million for the same period in 2021. Increased G&A
spending for the fourth quarter and full year ended 2022 compared
to amounts for the same periods in 2021 reflects additional
compensation costs on general and administrative staffing,
additional spending on facilities and licensing fees.
Other income for the fourth quarter ended December 31, 2022 was
$30.1 million compared to other expense of $18.6 million in the
same period in 2021. Other income for the fourth quarter ended
December 31, 2022 represents unrealized gain from the change in
fair value of equity securities and interest income earned on
investments. Other expenses in the same period in 2021 represents
unrealized loss from the change in fair value of equity securities.
Other income for the full year ended December 31, 2022 was $28.0
million, compared to $38.9 million in the same period in 2021.
Other income in 2022 reflects unrealized gain from the change in
fair value of equity securities. In 2021, other income includes
realized gain from the sale of an equity security of $18.3 million
and unrealized gains of $20.5 million from the change in fair value
of equity securities.
Non-cash, stock-based compensation expense for the full year
ended December 31, 2022 was $48.9 million compared to $37.0 million
for the same period in 2021.
Net loss for the fourth quarter ended December 31, 2022 was
$12.0 million or $(0.20) on a fully diluted per share basis,
compared to net income of $73.1 million or $1.21 on a fully diluted
per share basis, for the same period in 2021. For the full year
ended December 31, 2022 net loss was $55.2 million or $(0.93) on a
fully diluted per share basis, compared to net income of $82.6
million or $1.37 on a fully diluted per share basis, for the same
period in 2021. Net loss reported for the fourth quarter ended
December 31, 2022 compared to net income reported for the same
period in 2021 is primarily due to decreased revenue reported in
2022 compared to amounts reported in 2021. Net loss for the full
year 2022, compared to net income reported for the same period in
2021, is primarily due to higher revenues and realized gain on
equity investments reported for the full year ended December 31,
2021 compared to amounts reported for the full year ended December
31, 2022.
The total shares outstanding were 59,997,713 as of December 31,
2022, compared to 59,355,558 as of December 31, 2021.
Financial Guidance
Based on current operating plans, Xencor expects to end 2023
with between $425 million and $475 million in cash, cash
equivalents, receivables and marketable debt securities, and to
have cash to fund research and development programs and operations
through the end of 2025.
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 full year 2022 financial results and
provide a corporate update.
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/BI70c60751330540e3909534dca3801239.
Upcoming Investor Conferences
Xencor management will participate at three upcoming investor
conferences:
- Cowen 43rd Annual Health Care Conference Date:
Wednesday, March 8, 2023 Presentation Time: 12:50 p.m. ET / 9:50
a.m. PT Location: Boston
- Inaugural Mizuho Oncology Therapeutics Summit Date:
Monday, March 13, 2023 Location: Virtual
- Barclays Global Healthcare Conference Date: Tuesday,
March 14, 2023 Presentation Time: 2:05 p.m. ET / 11:05 a.m. PT
Location: Miami
Live webcasts of the Cowen and Barclays 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 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
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 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) December 31,
2022
2021
Assets Current assets Cash and cash equivalents
$
53,942
$
143,480
Marketable debt securities
526,689
153,767
Marketable equity securities
42,431
36,860
Accounts receivable
28,997
66,384
Prepaid and other current assets
23,283
23,877
Total current assets
675,342
424,368
Property and equipment, net
59,183
28,240
Patents, licenses and other intangible asset, net
18,500
16,493
Marketable debt securities - long term
3,826
300,465
Equity securities
54,383
31,262
Notes receivable - long term
—
5,000
Right of use asset
34,419
31,730
Other assets
613
653
Total assets
$
846,266
$
838,211
Liabilities and stockholders’ equity Current
liabilities Accounts payable and accrued liabilities
$
28,816
$
33,444
Deferred revenue
30,320
37,294
Lease liabilities
4,708
—
Total current liabilities
63,844
70,738
Lease liability, net of current portion
54,926
33,969
Total liabilities
118,770
104,707
Stockholders’ equity
727,496
733,504
Total liabilities and stockholders’ equity
$
846,266
$
838,211
Xencor Inc. Condensed Statements of Comprehensive Income
(Loss) (in thousands, except share and per share data)
Three months ended December 31, Year ended
2022
2021
2022
2021
(unaudited)
Revenues
$ 21,610
$ 154,016
$ 164,579
$ 275,111
Operating expenses: Research and development
51,452
50,988
199,563
192,507
General and administrative
12,751
11,375
47,489
38,837
Total operating expenses
64,203
62,363
247,052
231,344
Income (loss) from operations
(42,593)
91,653
(82,473)
43,767
Other income (expense), net
30,136
(18,592)
27,965
38,864
Income (loss) before income tax expense
(12,457)
73,061
(54,508)
82,631
Income tax expense (benefit)
(415)
—
673
—
Net income (loss)
(12,042)
73,061
(55,181)
82,631
Other comprehensive income (loss) Net unrealized gain
(loss) on marketable securities
2,924
(1,435)
(5,442)
(1,584)
Comprehensive income (loss)
$ (9,118)
$ 71,626
$ (60,623)
$ 81,047
Net income (loss) per share: Basic net
income (loss) per share
$ (0.20)
$ 1.25
$ (0.93)
$ 1.42
Fully diluted net income (loss) per share
$ (0.20)
$ 1.21
$ (0.93)
$ 1.37
Weighted average number of shares used in computing net income
(loss), basic
59,912,038
58,277,543
59,652,461
58,379,641
Weighted average number of shares used in computing net income
(loss), fully diluted
59,912,038
60,338,462
59,652,461
60,495,455
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230223005854/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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