XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, today announced its
operational highlights and financial results for the first quarter
ended March 31, 2014.
First Quarter 2014 Operational Highlights
- Met with the U.S. Food and Drug Administration (FDA) to
determine the requirements for a Phase 3 gevokizumab program in
patients with pyoderma gangrenosum (PG), a rare neutrophilic
dermatosis of painful expanding necrotic skin ulcers. The Company
is completing and will submit the Phase 3 protocols for final
comments from the Agency within the next several weeks.
- Announced gevokizumab had been granted Orphan Drug Designation
by the FDA for the treatment of PG.
- Reported data from the Company's erosive osteoarthritis of the
hand (EOA) proof-of-concept studies. Based upon the results, the
Company has elected not to pursue the broad EOA indication for
Phase 3 testing.
- XOMA's partner, SERVIER, continued to enroll patients in
EYEGUARD™-B, which is studying gevokizumab in patients who have
non-infectious uveitis (NIU) with underlying Behçet's disease, a
rare indication.
- Continued to enroll patients in EYEGUARD-A and EYEGUARD-C
studies investigating gevokizumab in patients with active and
controlled NIU involving the intermediate and/or posterior segment
of the eye.
- As of April 30, 2014, SERVIER, had opened EYEGUARD-A and -C
clinical trial sites in 15 countries representing 52 clinical study
centers. SERVIER also obtained approval in an additional 4
countries representing 12 clinical study sites.
"Our first quarter 2014 activities centered on advancing
gevokizumab towards a Biologics Licensing Application. We have
initiated a program to further increase patient enrollment at the
70 U.S. clinical sites conducting the EYEGUARD-A and C studies, and
we are starting to see the first signs that this new outreach
program could have the impact we are seeking. We conducted our
meeting with the FDA to determine the Agency's requirements for a
gevokizumab Phase 3 program in patients with pyoderma
gangrenosum. Based upon the oral and written comments, we are
submitting our Phase 3 protocol, and while we await any final
comments, we are very actively working with clinical sites in the
U.S. and in several other countries to ensure they are ready to
enroll patients in the PG studies as soon as they are launched,"
stated John Varian, Chief Executive Officer of XOMA. "SERVIER
is nearing their anticipated date for the pre-set final
exacerbation in the EYEGUARD-B study, which will give us our first
Phase 3 data in patients who have non-infectious uveitis and
underlying Behçet's disease. Our clinical team has been
working on the protocol for a supplemental Phase 3 study in this
indication, which will give us the option to pursue a Behçet's
uveitis-only label."
Financial Results
The financial results for the first quarter of 2014 reflect
reduced reimbursements from SERVIER associated with gevokizumab
development activities, as SERVIER met the initial $50 million cap
of fully reimbursable NIU costs during the third quarter of
2013. XOMA now pays 50% of the cost of gevokizumab development
costs in NIU. The comparisons between the first quarters ended
March 31, 2014 and 2013, reflect this development.
XOMA recorded total revenues of $3.4 million for the three
months ended March 31, 2014, compared with $9.5 million during the
corresponding period of 2013, which included a $3.9 million
milestone payment from SERVIER related to a product development
program that XOMA subsequently transferred to Symplmed.
Annual research and development (R&D) expenses for first
quarter ended 2014 were $21.5 million compared to $16.6 million in
the corresponding 2013 period. The increases reflect the increased
external clinical trial costs associated with XOMA's gevokizumab
clinical development programs, increased spending on preclinical
development activities related to the XMet platform, and an
increase in stock-based compensation. Selling, general and
administrative expenses (SG&A) were $5.3 million for the three
months ended March 31, 2014, compared to $4.1 million incurred
during the same period of 2013, primarily reflecting an increase in
stock-based compensation.
For the first quarter ended March 31, 2014, XOMA had a net loss
of $4.7 million, or $0.04 per share, compared with a net loss of
$24.9 million, or $0.30 per share, in the quarter ended March 31,
2013. The net losses in the three months ended March 31, 2014
and 2013, included a $20.0 million gain and $12.8 million loss,
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, 2014, was $24.7 million, or $0.23 per
share, compared with the net loss for the same reporting period in
2013 of $12.0 million, or $0.15 per share.
On March 31, 2014, XOMA had cash, cash equivalents, and
short-term investments of $93.7 million compared with $121.6
million at December 31, 2013.
"Our first quarter spend is well aligned with our expectations
of the cash requirements for XOMA's operations in 2014," commented
Fred Kurland, Vice President, Finance, Chief Financial Officer and
Secretary of XOMA. "Today we reaffirm our anticipated cash
used in ongoing operating activities of approximately $55.0 million
to $60.0 million during 2014. This guidance reflects the costs
associated with conducting two separate Phase 3 programs for the
gevokizumab, the EYEGUARD program and the pyoderma gangrenosum
program, and it includes the expectation we will receive license
and contract-related revenue during the year, which is consistent
with our history of entering into such agreements."
Investor Conference Call and Webcast
XOMA will host a conference call and webcast today, May 7, 2014,
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,
2014. 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 and 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 diverse array of disease states, including
non-infectious uveitis (including Behçet's uveitis), cardiovascular
disease, and other auto-inflammatory diseases.
Gevokizumab currently is being studied in a global Phase 3
clinical program, termed EYEGUARD™, which is being conducted by
SERVIER and XOMA. This program is designed to determine
gevokizumab's ability to treat acute non-infectious uveitis (NIU)
involving the intermediate and/or posterior segment of the eye in
EYEGUARD-A, to prevent disease flares in patients with Behçet's
uveitis in EYEGUARD-B, and to prevent disease flares in NIU
patients who are controlled with steroids in EYEGUARD-C.
XOMA has a Proof-of-Concept (POC) program underway in which the
Company is exploring the efficacy and safety of gevokizumab in
multiple indications. Separately, SERVIER initiated a Phase 2
study to determine gevokizumab's ability to reduce arterial wall
inflammation in patients with marked atherosclerotic plaque
inflammation and who have experienced an acute coronary syndrome
event in the previous twelve months, as well as POC studies in
polymyositis/dermatomyositis, giant cell arteritis, and Schnitzler
syndrome. Information about gevokizumab clinical studies can
be found at www.clinicaltrials.gov and
www.clinicaltrialsregister.eu.
About XOMA
XOMA has built a portfolio of innovative therapeutic antibodies,
both in late-stage clinical development and in preclinical
research. XOMA focuses its antibody research and development
on allosteric modulation, which offers opportunities for new
classes of therapeutic antibodies to treat a wide range of human
diseases. XOMA's lead product candidate, gevokizumab (IL-1
beta modulating antibody), is in a global Phase 3 program in
non-infectious uveitis with its partner SERVIER and multiple
proof-of-concept studies in other IL-1-mediated diseases.
XOMA's scientific research also produced the XMet program,
which consists of three classes of preclinical antibodies,
including Selective Insulin Receptor Modulators (SIRMs) that could
have a significant effect on the treatment of diabetes.
More detailed information can be found at www.xoma.com.
About SERVIER
Founded in 1954, SERVIER is an independent French pharmaceutical
research company. 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 2013, the company recorded a turnover of 4.2
billion euros. 91% of SERVIER drugs are consumed internationally.
27% of turnover from SERVIER drugs were reinvested in Research and
Development in 2013. With a strong international presence in 140
countries, SERVIER employs more than 21,000 people worldwide. The
SERVIER Group contributed 35% to the 2013 French trade surplus in
the pharmaceuticals sector.
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, Proof-of-Concept
trials, anticipated size of clinical trials, regulatory approval of
unapproved product candidates, 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) |
|
|
|
|
March
31 |
|
2014 |
2013 |
|
|
|
Revenues: |
|
|
License and collaborative
fees |
$ 964 |
$ 399 |
Contract and other |
2,446 |
9,054 |
Total revenues |
3,410 |
9,453 |
|
|
|
Operating expenses: |
|
|
Research and development |
21,546 |
16,636 |
Selling, general and
administrative |
5,254 |
4,124 |
Restructuring |
84 |
17 |
Total operating expenses |
26,884 |
20,777 |
|
|
|
Loss from operations |
(23,474) |
(11,324) |
|
|
|
Other income (expense): |
|
|
Interest expense |
(1,125) |
(1,172) |
Other (expense) income |
(90) |
449 |
Revaluation of contingent
warrant liabilities |
20,002 |
(12,840) |
Net loss |
$ (4,687) |
$ (24,887) |
|
|
|
Basic and diluted net loss per share of
common stock |
$ (0.04) |
$ (0.30) |
|
|
|
Shares used in computing basic and diluted
net loss per share of common stock |
106,158 |
82,595 |
|
|
|
Other comprehensive loss: |
|
|
Net loss |
$ (4,687) |
$ (24,887) |
Net unrealized gains on
available-for-sale securities |
7 |
3 |
Comprehensive loss |
$ (4,680) |
$ (24,884) |
|
XOMA
CORPORATION |
CONDENSED CONSOLIDATED
BALANCE SHEETS |
(in thousands, except
share and per share amounts) |
|
|
|
|
March 31, |
December 31, |
|
2014 |
2013 |
|
(unaudited) |
(audited) |
ASSETS |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ 73,706 |
$ 101,659 |
Short-term investments |
19,996 |
19,990 |
Trade and other receivables,
net |
4,312 |
3,781 |
Prepaid expenses and other
current assets |
2,558 |
1,630 |
Total current assets |
100,572 |
127,060 |
Property and equipment, net |
6,028 |
6,456 |
Other assets |
1,029 |
1,266 |
Total assets |
$ 107,629 |
$ 134,782 |
LIABILITIES AND STOCKHOLDER'S
EQUITY (DEFICIT) |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 8,851 |
$ 9,616 |
Accrued and other
liabilities |
4,895 |
9,934 |
Deferred revenue |
2,158 |
2,218 |
Interest bearing obligation -
current |
4,085 |
5,835 |
Accrued interest on bearing
obligations – current |
264 |
2,042 |
Total current liabilities |
20,253 |
29,645 |
Deferred revenue – long-term |
3,636 |
4,105 |
Interest bearing obligations – long-term |
34,658 |
35,150 |
Contingent warrant liabilities |
47,342 |
69,869 |
Total liabilities |
105,889 |
138,769 |
Stockholders' equity (deficit): |
|
|
Common stock, $0.0075 par
value, 138,666,666 shares authorized, 106,885,926 and 105,386,216
shares outstanding at March 31, 2014 and December 31, 2013,
respectively |
799 |
787 |
Additional paid-in capital |
1,086,798 |
1,076,403 |
Accumulated comprehensive
income |
6 |
(1) |
Accumulated deficit |
(1,085,863) |
(1,081,176) |
Total stockholders' equity
(deficit) |
1,740 |
(3,987) |
Total liabilities and
stockholders' equity (deficit) |
$ 107,629 |
$ 134,782 |
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:
Canale Communications
Carolyn Hawley
619-849-5375
carolyn@canalecomm.com
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