MONROVIA, Calif., May 9, 2017 /PRNewswire/ -- Xencor,
Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical
company developing engineered monoclonal antibodies for the
treatment of autoimmune diseases, asthma and allergic diseases and
cancer, today reported financial results for the first quarter
ended March 31, 2017 and provided a
review of business and clinical highlights.
"We have been focused on advancing our clinical development
pipeline across the breadth of our portfolio," said Bassil Dahiyat, Ph.D., president and chief
executive officer of Xencor. "Today, we are pleased to announce
data from our Phase 1 trial of subcutaneously administered
XmAb5871, which support use of this formulation as a simpler, more
flexible treatment option for patients and doctors. We look forward
to further advancing our XmAb5871 program in the months ahead, with
topline data from our ongoing Phase 2 study in IgG4-Related Disease
and additional clarity on the clinical and regulatory path forward
expected this year. Also in the quarter, we initiated our
Phase 1 study of XmAb®13676 in non-Hodgkin lymphoma and chronic
lymphocytic leukemia, and continued to enroll patients in our Phase
1 study of XmAb®14045 in acute myeloid leukemia."
Recent Business Highlights and Anticipated Upcoming
Milestones
XmAb5871: XmAb5871 is a first-in-class monoclonal
antibody that targets CD19 with its variable domain, and
uses Xencor's XmAb immune inhibitor Fc domain to target
FcγRIIb, a receptor that inhibits B-cell function. XmAb5871 is
currently in Phase 2 clinical studies for the treatment of
IgG4-Related Disease (IgG4-RD) and systemic lupus erythematosus
(SLE).
- Topline data from IgG4-RD Phase 2 trial expected in 2017
- Initial data from SLE Phase 2 trial expected in late 2018/early
2019
Xencor recently completed its subcutaneous (SC) administration
Phase 1 study of XmAb5871. Multiple dose SC administration of
XmAb5871 was safe and well tolerated at doses of 125 to 375 mg in
all 40 subjects administered SC XmAb5871. Treatment emergent
adverse events (TEAEs) occurring in subjects receiving any dose of
SC XmAb5871 were mild in severity. The only drug-related TEAE
occurring in more than two subjects who received any dose of SC
XmAb5871 was injection site bruising (three subjects, 8%). No
subject receiving SC XmAb5871 discontinued the study due to an
adverse event and there were no serious adverse events during the
study. Pharmacokinetic and bioavailability data from the
study support an every other week dosing schedule. Based on
these results, Xencor plans to implement SC administration in
newly-initiated clinical trials.
At the 3rd International Symposium on IgG4-Related
Disease and Fibrosis in February
2017, investigators from Xencor's ongoing Phase 2 study of
XmAb5871 in IgG4-RD presented an update on IgG4-RD biomarker
development, including flow cytometry methods for measuring
circulating B cells, plasmablasts and CD4-positive cytotoxic T
lymphocytes. The presentation also included preliminary flow
cytometry data for patients enrolled in the ongoing Phase 2 study,
which showed a partial reduction in B cells, consistent with
previous clinical experience, and a rapid reduction of circulating
plasmablasts following treatment with XmAb5871. No significant
apoptosis of B cells or CD4 T cells was induced by XmAb5871
therapy.
XmAb®7195: XmAb7195 is a first-in-class monoclonal
antibody that targets IgE with its variable domain and
uses Xencor's XmAb Immune Inhibitor Fc domain to target
FcγRIIb, resulting in three distinct mechanisms of action for
reducing IgE levels. A subcutaneously administered formulation
of XmAb7195 is currently in a Phase 1b study for the treatment of
allergic disease.
- Topline data from subcutaneous administration Phase 1b trial
expected in 2017
Bispecific Oncology Pipeline: Xencor's initial bispecific
antibody programs are tumor-targeted antibodies that contain both a
tumor antigen binding domain and a cytotoxic T-cell binding domain
(CD3). These bispecific antibodies activate T cells for highly
potent and targeted killing of malignant cells. Their XmAb Fc
domains confer long circulating half-lives, stability and ease of
manufacture. XmAb14045 is currently in a Phase 1 study for the
treatment of acute myeloid leukemia (AML) and other
CD123-expressing hematologic malignancies, and XmAb13676 is
currently in a Phase 1 study for the treatment of B-cell
malignancies.
- Initial data from XmAb14045 Phase 1 trial expected in 2017,
pending alignment on timing with Novartis
- Initial data from XmAb13676 Phase 1 trial expected in 2018,
pending alignment on timing with Novartis
- Investigational New Drug (IND) application filing for
XmAb®18087, a somatostatin receptor 2 (SSTR2) x CD3 bispecific
antibody for the treatment of neuroendocrine tumors, expected in
2017
- IND application filing for XmAb®20717, a PD-1 x CTLA-4 dual
checkpoint inhibitor for the treatment of multiple oncology
indications, expected in 2018
At the American Association for Cancer Research (AACR) 2017
Annual Meeting in April, Xencor presented preclinical data
supporting the development of XmAb18087 for the treatment of SSTR2+
cancers, including neuroendocrine tumors and small cell lung cancer
(SCLC). In in vitro and mouse models, XmAb18087 eliminated
SSTR2+ tumor cells by stimulating redirected T cell-mediated
cytotoxicity, and in cynomolgus monkeys, XmAb18087 stimulated
SSTR2-dependent T cell activation, T cell margination and cytokine
release. Xencor also presented preclinical data on additional
bispecific antibodies deploying its XmAb bispecific and half-life
extension technology, highlighting a bispecific antibody targeting
PD-1 and an undisclosed co-stimulatory receptor (PD1 x costim) and
IL15/IL15Rα heterodimeric Fc-fusions.
Partnered XmAb Programs: Nine pharmaceutical companies
and the National Institutes of Health are advancing novel drug
candidates either discovered at Xencor or that rely on Xencor's
proprietary XmAb® technology. Seven such programs are currently
undergoing clinical testing.
- In March 2017, Xencor was
notified by its partner, CSL Limited, that CSL licensee Janssen
Biotech Inc. advanced CSL362 (now called talacotuzumab) to the
Phase 3 portion of its ongoing Phase 2/3 study for the potential
treatment of patients with AML. Talacotuzumab uses Xencor's XmAb
Cytotoxic Fc Domain. The trial initiation triggered a milestone
payment to Xencor from CSL Limited of $3.5
million.
Corporate:
- In April 2017, Xencor announced
the appointment of Kevin Gorman,
Ph.D., to its Board of Directors. In March and April 2017, respectively, Xencor also announced
that Bruce Carter, Ph.D., and
Robert Baltera will not stand for
re-election to the Board of Directors at the 2017 Annual Meeting of
Stockholders.
First Quarter Ended March 31,
2017 Financial Results
Cash, cash equivalents, and marketable securities totaled
$392.7 million as of March 31, 2017, compared to $403.5 million on December
31, 2016. The decrease reflects net spending on
operations in the first quarter of 2017.
Revenues for the first quarter ended March 31, 2017 were $4.3
million, compared to $7.3
million in the same period of 2016. Decreased revenue for
the first quarter of 2017 over revenue for the same period in 2016
is primarily the result of revenue earned from our Amgen
collaboration in the first quarter of 2016 compared to milestone
revenue received from CSL in the first quarter of 2017.
Research and development expenditures for the first quarter
ended March 31, 2017 were
$15.0 million, compared to
$10.0 million for the same period in
2016. Increased research and development spending in the first
quarter of 2017 over the same period in 2016 reflects increased
spending on our bispecific pipeline of candidates including our
first two clinical candidates, XmAb14045 and XmAb13676 and
development spending on the next two candidates, XmAb18087 and
XmAb20717.
General and administrative expenses in the first quarter ended
March 31, 2017 were $4.8 million, compared to $4.0 million for the same period in 2016.
Increased spending on general and administration in the first
quarter of 2017 over the comparable period in 2016 reflects
increases in stock based compensation charges in 2017.
Non-cash, share based compensation expense for the first quarter
ended March 31, 2017 was $3.2 million, compared to $2.0 million for the same period in 2016.
Net loss for the first quarter ended March 31, 2017 was $14.6
million, or $(0.31) on a fully
diluted per share basis, compared to a net loss of $6.4 million, or ($0.16) on a fully diluted per share basis, for
the same period in 2016. The increased loss for the first
quarter ended March 31, 2017 compared
to 2016 is primarily due to lower revenue of $2.9 million and increased spending of
$5.9 million in the first quarter of
2017 compared to the first quarter of 2016.
The weighted-average shares outstanding used to compute net loss
per share was 46,598,797 for the quarter ended March 31, 2017, compared to 40,626,729 for the
quarter ended March 31, 2016.
Financial Guidance
Based on current operating plans, Xencor expects to
have cash to fund research and development programs and operations
beyond the end of 2020. Xencor expects to end 2017 with
approximately $340 million in cash,
cash equivalents, and marketable 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 these first
quarter 2017 financial results and provide a corporate
update.
The live call may be accessed by dialing (877) 359-9508 for
domestic callers or (224) 357-2393 for international callers, and
referencing conference ID number: 10271460. A live webcast of
the conference call will be available online from the investor
relations section of the company website
at www.xencor.com. The webcast will be archived on the
company website for 30 days.
About Xencor, Inc.
Xencor is a clinical-stage biopharmaceutical company
developing engineered monoclonal antibodies for the treatment of
autoimmune diseases, asthma and allergic diseases and cancer.
Currently, 11 candidates engineered with Xencor's XmAb®
technology are in clinical development internally and with
partners. Xencor's internal programs include: XmAb®5871
in Phase 2 development for the treatment of IgG4-Related Disease,
and also for the treatment of Systemic Lupus Erythematosus;
XmAb®7195 in Phase 1 development for the treatment of asthma and
allergic diseases; XmAb®14045 in Phase 1 development for acute
myeloid leukemia; XmAb®13676 in Phase 1 development for B-cell
malignancies; XmAb®18087 in pre-clinical development for the
treatment of neuroendocrine tumors; and XmAb®20717 in pre-clinical
development for the treatment of multiple
cancers. Xencor's XmAb antibody engineering technology
enables small changes to the structure of monoclonal antibodies
resulting in new mechanisms of therapeutic
action. Xencor partners include Novartis, Amgen,
MorphoSys, Merck, CSL/Janssen, Alexion and Boehringer
Ingelheim. For more information, please
visit www.xencor.com.
Forward Looking Statements:
Statements contained in
this press release regarding matters that are not historical facts
are forward-looking statements within the meaning of applicable
securities laws, including the quotation from Xencor's President
and CEO and any expectations relating to its financial expectations
and business, its research and development programs, including
XmAb®5871, XmAb®7195, and bispecific programs, including
XmAb®14045, XmAb®13676, XmAb®20717 and XmAb®18087, its partnering
efforts or its capital requirements. Such statements involve 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 described in Xencor's public securities filings. All
forward-looking statements are based on Xencor's current
information and belief as well as assumptions made by Xencor.
Readers are cautioned not to place undue reliance on such
statements and Xencor disclaims any intention or obligation to
update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
Xencor, Inc.
|
Condensed Balance
Sheets
|
(in
thousands)
|
|
|
|
March
31,
|
|
December
31,
|
|
|
|
2017
|
|
2016
|
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets
|
|
|
|
|
|
Cash and cash
equivalents
|
$13,561
|
|
$14,528
|
|
|
Short-term marketable
securities
|
141,225
|
|
115,608
|
|
|
Accounts
receivable
|
6,938
|
|
8,616
|
|
|
Prepaid expenses and
other current assets
|
4,365
|
|
2,901
|
Total current
assets
|
166,089
|
|
141,653
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
3,360
|
|
3,105
|
|
|
Long-term marketable
securities
|
237,865
|
|
273,340
|
|
|
Intangible assets,
net
|
10,886
|
|
10,362
|
|
|
Other
assets
|
103
|
|
103
|
|
|
|
|
|
|
Total
assets
|
$418,303
|
|
$428,563
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$10,912
|
|
$10,700
|
|
|
Current portion of
deferred revenue
|
95,788
|
|
95,521
|
|
|
Income
taxes
|
175
|
|
65
|
Total current
liabilities
|
106,875
|
|
106,286
|
|
|
|
|
|
|
|
|
Deferred rent, less
current portion
|
361
|
|
397
|
|
|
Deferred revenue,
less current portion
|
7,319
|
|
7,926
|
Total
liabilities
|
114,555
|
|
114,609
|
|
|
|
|
|
|
Stockholders'
equity
|
303,748
|
|
313,954
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$418,303
|
|
$428,563
|
|
|
|
|
|
|
|
The 2016 balance
sheet was derived from the 2016 annual financial statements
included in the form 10-K that was filed on March 1,
2017.
|
Xencor
Inc.
|
Condensed
Statements of Comprehensive Income (Loss)
|
(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
Three months ended
March 31,
|
|
|
|
2017
|
|
2016
|
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
|
|
|
|
|
Revenues
|
$4,340
|
|
$7,252
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
15,048
|
|
10,035
|
|
General and
administrative
|
4,811
|
|
3,950
|
Total operating
expenses
|
19,859
|
|
13,985
|
|
|
|
|
|
|
Loss from
operations
|
(15,519)
|
|
(6,733)
|
|
|
|
|
|
|
Other income,
net
|
1,054
|
|
335
|
|
|
|
|
|
|
Loss before income
tax expense
|
(14,465)
|
|
(6,398)
|
|
Income tax
expense
|
170
|
|
—
|
Net loss
|
(14,635)
|
|
(6,398)
|
|
|
|
|
|
|
Other
comprehensive income
|
|
|
|
|
Net unrealized gain
on marketable securities
|
245
|
|
619
|
Comprehensive
loss
|
$(14,390)
|
|
$(5,779)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
net loss per common share
|
$(0.31)
|
|
$(0.16)
|
Basic and diluted
weighted average number of common shares
|
46,598,797
|
|
40,626,729
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/xencor-reports-first-quarter-2017-financial-results-300454645.html
SOURCE Xencor, Inc.