XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, today announced recent
achievements and financial results for the first quarter ended
March 31, 2015.
"During the first quarter of this year, we made significant
progress toward achieving our goal of becoming a commercial
organization," said John Varian, Chief Executive Officer of XOMA.
"Servier is just one ocular exacerbation away from being able to
close the EYEGUARD™-B study database and expects to reach the
targeted ocular exacerbation event any day. If the study results
are positive, we will perform an analysis of the full EYEGUARD-B
dataset and plan to quickly request a pre-Biologics License
Application meeting with the U.S. Food and Drug
Administration."
He added, "We presented detailed results of our Phase 1 study of
XOMA 358 at the recent ENDO Conference, which generated significant
interest from the clinical community. We are in the process of
assessing optimal indications to pursue in the Phase 2 development
of this first-in-class compound that down-regulates the insulin
receptor and its downstream signaling. We hope to expedite the
clinical development of XOMA 358, as new treatment options are
urgently needed for patients who are affected by the overproduction
of insulin or atypical responses to insulin."
Recent Achievements
- One ocular exacerbation away from reaching the targeted number
of exacerbations in the pivotal Phase 3 EYEGUARD-B clinical study
of gevokizumab in Behçet's disease uveitis.
- Servier, XOMA's gevokizumab development partner, initiated a
370-patient Phase 2 study of gevokizumab in patients with diabetic
nephropathy.
- Presented positive Phase 1 data from XOMA 358 at the ENDO
Conference 2015. XOMA 358, a first-in-class, fully human,
allosteric monoclonal antibody that down-regulates the insulin
receptor, is being evaluated for the treatment of non-drug-induced,
endogenous hyperinsulinemic hypoglycemia (low blood glucose caused
by excessive insulin produced endogenously).
- Obtained a $20.0 million secured loan from Hercules Technology
III, L.P., as lender, and affiliate of Hercules Technology Growth
Capital, Inc., as agent. The Company used a portion of the proceeds
to repay General Electric Capital Corporation's outstanding
principle balance and interest of $5.5 million. The remaining
proceeds will be used for general corporate purposes.
- Renegotiated the terms of Servier's loan agreement.
- Announced the promotion of Thomas Burns to Chief Financial
Officer and the retirement of Fred Kurland.
First Quarter 2015 Financial Results
XOMA recorded total revenues of $2.7 million for the three
months ended March 31, 2015, compared with $3.4 million during the
corresponding period of 2014. The decrease in the first quarter
2015 revenues was due primarily to the receipt of a $0.5 million
milestone payment related to an out-licensing arrangement received
in the first quarter of 2014.
Research and development (R&D) expenses for the first
quarter of 2015 were $20.0 million compared with $21.5 million in
the corresponding 2014 period. The decrease reflects a
reduction in external manufacturing costs offset by increased
external clinical trial costs associated with XOMA's gevokizumab
clinical development programs.
Selling, general and administrative expenses (SG&A) were
$5.2 million for the three months ended March 31, 2015, compared
with $5.3 million incurred during the same period in 2014.
For the first quarter ended March 31, 2015, XOMA had a net loss
of $21.7 million compared with a net loss of $4.7 million in the
quarter ended March 31, 2014. The net losses in the three months
ended March 31, 2015 and 2014, included a $40,000 loss and $20.0
million gain, respectively, in non-cash revaluations of contingent
warrant liabilities, resulting primarily from fluctuations in
XOMA's stock price. Excluding those revaluations, the net loss for
the three months ended March 31, 2015 was $21.7 million compared
with a net loss of $24.7 million for the same reporting period in
2014.
On March 31, 2015, XOMA had cash, cash equivalents, and
short-term investments of $67.5 million compared with $78.4 million
at December 31, 2014.
2015 Guidance
The Company expects to spend approximately $60 million to $65
million in cash for ongoing operating activities during 2015. The
Company's principal expenditures are costs associated with its
gevokizumab Phase 3 clinical programs. The guidance assumes license
and contract-related revenue to be received during the course of
the year.
Investor Conference Call and Webcast
XOMA will host a conference call and webcast today, May 7, 2015,
at 4:30 p.m. ET / 1:30 PT. The webcast can be accessed via
the Investors and Media section of XOMA's website
at http://investors.xoma.com/events.cfm and will be available
for replay until close of business on August 7, 2015.
Telephone numbers for the live audiocast are 877-369-6589
(U.S./Canada) and 408-337-0122 (international).
About Gevokizumab
Gevokizumab is a potent monoclonal antibody with unique
allosteric modulating properties. It has the potential to treat
patients with a wide variety of inflammatory and other
diseases. Gevokizumab binds strongly to interleukin-1 beta
(IL-1 beta), a pro-inflammatory cytokine, and modulates the
cellular signaling events that produce inflammation. IL-1 beta has
been shown to be involved in a diverse array of disease states,
including non-infectious and Behçet's disease uveitis,
cardiovascular disease, and other auto-inflammatory diseases.
Gevokizumab currently is being studied in multiple indications.
Global Phase 3 clinical programs are underway, including in
Behçet's disease uveitis, non-infectious uveitis and pyoderma
gangrenosum. Information about gevokizumab clinical studies can be
found at www.clinicaltrials.gov and
www.clinicaltrialsregister.eu.
About XOMA 358
Insulin is the major hormone for lowering blood glucose levels.
Abnormal increases in insulin secretion can lead to profound
hypoglycemia (low blood sugar), a state that can result in
significant morbidities including cerebral damage and epilepsy. In
some instances, profound hypoglycemia can be fatal. XOMA 358
is a fully human allosteric modulating monoclonal antibody that
binds to insulin receptors and attenuates insulin action. XOMA 358
is being investigated as a novel treatment for non-drug-induced,
endogenous hyperinsulinemic hypoglycemia (low blood glucose caused
by excessive insulin production) and other related disorders. A
therapy that safely and effectively mitigates insulin-induced
hypoglycemia has the potential to address a significant unmet
therapeutic need for certain rare medical conditions associated
with hyperinsulinism.
About XOMA Corporation
XOMA Corporation is a leader in the discovery and development of
therapeutic antibodies. The Company's innovative product candidates
are the result of the Company's expertise in developing
ground-breaking monoclonal antibodies, including allosteric
modulating antibodies, which have created new opportunities to
potentially treat a wide range of human diseases. XOMA is
developing its lead product gevokizumab (IL-1 beta modulating
antibody) with Servier through a global Phase 3 program for
Behçet's disease uveitis and non-infectious uveitis. XOMA also
has an ongoing Phase 3 study of gevokizumab in pyoderma
gangrenosum. Additionally, XOMA's scientific research has produced
the XMet platform, which consists of three classes of Selective
Insulin Receptor Modulators (SIRMs) antibodies. XOMA 358, the
lead antibody in the XMetD program, is an allosteric monoclonal
antibody that reduces both the binding of insulin to its receptor
and down-regulates insulin signaling and could have a major effect
on the treatment of abnormal metabolic states. XOMA 358 recently
completed Phase 1 testing. For more information, visit
www.xoma.com.
About Servier
Servier is an independent French pharmaceutical research company
with a strong international presence in 146 countries that employs
more than 21,400 people worldwide. Its development is based on the
continuous pursuit of innovation in the therapeutic areas of
cardiovascular, metabolic, neurologic, psychiatric, bone and joint
diseases, as well as cancer. In 2014, the company recorded revenue
of 4 billion euros, 92 percent of which was generated from sales
outside of France, and reinvested 28 percent of the revenue in
Research and Development activities. More information is available
at: www.servier.com.
Forward-Looking Statements
Certain statements contained in this press release including,
but not limited to, statements related to anticipated timing of
initiation and completion of clinical trials, anticipated size and
rate of enrollment of clinical trials, regulatory approval of
unapproved product candidates, the anticipated success of any
product launch, statements related to our ability to become a
commercial company, anticipated license revenues, sufficiency of
our cash resources and anticipated levels of cash utilization, or
statements that otherwise relate to future periods are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934. These statements are based on assumptions that
may not prove accurate, and actual results could differ materially
from those anticipated due to certain risks inherent in the
biotechnology industry and for companies engaged in the development
of new products in a regulated market. Potential risks to XOMA
meeting these expectations are described in more detail in XOMA's
most recent filing on Form 10-K and in other SEC
filings. Consider such risks carefully when considering XOMA's
prospects. Any forward-looking statement in this press release
represents XOMA's views only as of the date of this press release
and should not be relied upon as representing its views as of any
subsequent date. XOMA disclaims any obligation to update any
forward-looking statement, except as required by applicable
law.
|
|
XOMA
CORPORATION |
CONDENSED CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS |
(unaudited) |
(in thousands, except
per share amounts) |
|
|
Three months
ended March 31, |
|
2015 |
2014 |
Revenues: |
|
|
License and collaborative
fees |
$ 263 |
$ 964 |
Contract and other |
2,388 |
2,446 |
Total revenues |
2,651 |
3,410 |
|
|
|
Operating expenses: |
|
|
Research and development |
20,004 |
21,546 |
Selling, general and
administrative |
5,220 |
5,254 |
Restructuring |
-- |
84 |
Total operating expenses |
25,224 |
26,884 |
|
|
|
Loss from operations |
(22,573) |
(23,474) |
|
|
|
Other income (expense): |
|
|
Interest expense |
(1,115) |
(1,125) |
Other income (expense),
net |
2,010 |
(90) |
Revaluation of contingent
warrant liabilities |
(40) |
20,002 |
Net loss |
$ (21,718) |
$ (4,687) |
|
|
|
Basic net loss per share of common stock |
$ (0.19) |
$ (0.04) |
Diluted net loss per share of common
stock |
$ (0.19) |
$ (0.21) |
|
|
|
Shares used in computing basic net loss per
share of common stock |
116,193 |
106,158 |
|
|
|
Shares used in computing diluted net loss per
share of common stock |
116,193 |
115,524 |
|
|
|
Other comprehensive loss: |
|
|
Net loss |
$ (21,718) |
$ (4,687) |
Net unrealized gains on
available-for-sale securities |
-- |
7 |
Comprehensive loss |
$ (21,718) |
$ (4,680) |
|
|
|
|
|
XOMA
CORPORATION |
CONDENSED CONSOLIDATED
BALANCE SHEETS |
(in thousands, except
share and per share amounts) |
|
|
March 31, 2015 |
December 31,
2014 |
|
(unaudited) |
|
ASSETS |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ 67,491 |
$ 78,445 |
Trade and other receivables,
net |
3,271 |
3,309 |
Prepaid expenses and other
current assets |
1,860 |
1,859 |
Total current assets |
72,622 |
83,613 |
Property and equipment, net |
4,783 |
5,120 |
Other assets |
664 |
669 |
Total assets |
$ 78,069 |
$ 89,402 |
|
|
|
LIABILITIES AND STOCKHOLDERS'
(DEFICIT) EQUITY |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 3,406 |
$ 5,990 |
Accrued and other
liabilities |
5,992 |
9,892 |
Deferred revenue - current |
1,089 |
1,089 |
Interest bearing obligations –
current |
15,605 |
19,018 |
Accrued interest on interest
bearing obligations – current |
335 |
257 |
Total current liabilities |
26,427 |
36,246 |
Deferred revenue – long-term |
1,574 |
1,939 |
Interest bearing obligations – long-term |
31,584 |
16,290 |
Contingent warrant liabilities |
31,868 |
31,828 |
Total liabilities |
$ 91,453 |
$ 86,303 |
|
|
|
|
|
|
Stockholders' (deficit) equity: |
|
|
Common stock, $0.0075 par
value, 277,333,332 shares authorized, 116,947,716 and 115,892,450
shares issued and outstanding at March 31, 2015 and December 31,
2014, respectively |
877 |
869 |
Additional paid-in capital |
1,126,934 |
1,121,707 |
Accumulated deficit |
(1,141,195) |
(1,119,477) |
Total stockholders' (deficit)
equity |
(13,384) |
3,099 |
Total liabilities and
stockholders' (deficit) equity |
$ 78,069 |
$ 89,402 |
CONTACT: XOMA Corporation
Company and investor contact:
Ashleigh Barreto
510-204-7482
barreto@xoma.com
Juliane Snowden
The Oratorium Group, LLC
jsnowden@oratoriumgroup.com
Media contact:
Ryan Flinn
W2O Group
415-946-1059
rflinn@w2ogroup.com
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