XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, today announced recent
operational achievements and financial results for the first
quarter ended March 31, 2016.
“Our efforts are squarely focused on generating
the data for XOMA 358 and understanding its potential impact in
patients with rare hyperinsulinemia indications. Our top
priority is our ongoing Phase 2 proof-of-concept study of XOMA 358
in patients with hypoglycemia due to congenital hyperinsulinism,
which is progressing as anticipated. We are in the process of
opening a third clinical site in Germany to offer European
congenital hyperinsulinism patients increased opportunity to
participate. We also recently opened our Phase 2
proof-of-concept study of XOMA 358 to post gastric bypass patients
who develop a condition where they experience severe hypoglycemia
after eating a meal. These actions are driving XOMA 358
towards our first data readouts in hyperinsulinemia patients, and
we continue to believe we will be able to provide an update on our
clinical experience with XOMA 358 later this summer,” said John
Varian, Chief Executive Officer of XOMA. “In addition to unmet
medical need for a potential long-acting antibody to treat
hyperinsulinemia indications, we believe there is an unmet medical
need for a short-acting antibody treatment for severe acute
hypoglycemia. The first data from XOMA 129, a novel antibody
fragment derived from our XMetD program, were presented in April at
the Endocrine Society's Annual Meeting (ENDO 2016). These data
support our continued development of XOMA 129 as a first-in-class
targeted therapy for the treatment of acute hypoglycemic
conditions.”
“Our first quarter financial results show that
we are executing our business priorities on budget,” stated Tom
Burns, Vice President, Finance and Chief Financial Officer of XOMA.
“We out-licensed a phage display library, which generated
$1.5 million in revenue, and we reduced our debt balance by paying
the first €3.0 million installment on the Servier loan. We
are confident we have the financial resources to fund our
operations through at least the first quarter of 2017.”
Recent Achievements
- Initiated XOMA 358 proof-of-concept study in patients with
hypoglycemia post gastric bypass surgery, representing the second
rare hypoglycemic indication in which this first-in-class insulin
receptor antibody is being studied.
- Presented preclinical data from XOMA 129 at the ENDO 2016
conference. XOMA 129, the lead antibody fragment (Fab) from the
XMetD program, binds to an allosteric site on the insulin receptor
and was designed to have a rapid onset and limited duration of
action, two important clinical requirements in reversing an acute
hypoglycemic event. The data showed XOMA 129 exhibits the
preclinical profile required to pursue further study as a novel
potential treatment for severe acute hypoglycemic episodes.
- Effected a novation of the Company’s existing contracts with
the National Institutes of Allergy and Infectious Diseases (NIAID)
for biodefense-related development activities to Nanotherapeutics,
Inc. All associated assets, contracts, and materials have been
transferred to Nanotherapeutics.
- Terminated remaining XOMA clinical development of gevokizumab
and initiated formal licensing activities.
First Quarter 2016 Financial
ResultsXOMA recorded total revenues of $4.0 million for
the three months ended March 31, 2016, compared with $2.7 million
during the corresponding period of 2015. The increase in
first quarter 2016 revenues was due primarily to the receipt of
$1.5 million from the licensure of a phage display library, an
increase of $0.5 million in revenue recognized related to the loan
agreement with Servier, and an increase of $0.2 million in
milestone payments related to assets the Company previously
licensed to other parties, which were partially offset by decreased
revenues from NIAID and Servier.
Research and development (R&D) expenses for
the first quarter of 2016 were $13.6 million compared with $20.0
million in the corresponding 2015 period. The decrease
reflects a $5.0 million reduction in salaries and related expenses,
a decrease of $0.7 million in depreciation and facility expenses
due to the sale of the Company’s manufacturing facilities to Agenus
Inc. in late 2015, and a decrease of $0.6 million in outside
consulting fees due to the termination of the EYEGUARD Phase 3
program.
Selling, general and administrative expenses
(SG&A) were $4.3 million for the three months ended March 31,
2016, compared with $5.2 million incurred during the same period in
2015, reflecting the reduction in salary and related personnel
costs following the Company’s restructuring initiated in the third
quarter of 2015.
For the first quarter ended March 31, 2016, XOMA
had a net loss of $8.4 million compared with a net loss of $21.7
million in the quarter ended March 31, 2015. The net losses
in the three months ended March 31, 2016 and 2015, included a $6.9
million gain and $40,000 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,
2016, was $15.3 million compared with a net loss of $21.7 million
for the same reporting period in 2015.
On March 31, 2016, XOMA had cash and cash
equivalents of $46.2 million compared with $65.8 million at
December 31, 2015. In January 2016, XOMA paid €3.2 million in
principal and interest to Servier as stipulated in the companies’
amended loan agreement.
The Company expects its available capital will
be sufficient to fund operations through at least the first quarter
of 2017.
About XOMA 358Insulin is the major physiologic
hormone for controlling 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 brain damage, seizures and epilepsy. XOMA, leveraging its
scientific expertise in allosteric monoclonal antibodies, developed
the XMet platform, consisting of separate classes of selective
insulin receptor modulators (SIRMs) that could have a major effect
on treating patients with abnormal metabolic states. XOMA 358 binds
selectively to insulin receptors and attenuates insulin action.
XOMA 358 is being investigated as a novel
treatment for non-drug-induced, endogenous hyperinsulinemic
hypoglycemia, as well as hypoglycemia after bariatric surgery and
other related disorders. XOMA recently initiated Phase 2
development activities for XOMA 358 in patients with congenital
hyperinsulinism, and in patients with hypoglycemia post bariatric
surgery. 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. More information
on the XOMA 358 clinical trials may be found at
www.clinicaltrials.gov.
About Congenital
HyperinsulinismCongenital Hyperinsulinism (CHI) is a
genetic disorder in which the insulin cells of the pancreas (beta
cells) secrete inappropriate and excessive insulin. Ordinarily,
beta cells secrete just enough insulin to keep blood sugar in the
normal range. In people with CHI, the secretion of insulin is not
properly regulated, causing excess insulin secretion and frequent
episodes of low blood sugar (hypoglycemia). In infants and young
children, these episodes are characterized by a lack of energy
(lethargy), irritability or difficulty with feeding. Repeated
episodes of low blood sugar increase the risk for serious
complications, such as breathing difficulties, seizures,
intellectual disability, vision loss, brain damage, coma, and
possibly death. About 60 percent of infants with CHI experience a
hypoglycemic episode within the first month of life. Other affected
children develop hypoglycemia by early childhood. Current
treatments for CHI are limited to medical therapy and surgical
removal of part or all of the pancreas (pancreatectomy).
About Hypoglycemia Post Gastric Bypass
Surgery As the number of gastric bypass surgeries to treat
severe obesity has increased, so too has the awareness that this
population may experience postprandial hypoglycemia (low blood
glucose following a meal) with symptoms developing months or years
following the gastric bypass surgery. Postprandial
hypoglycemia occurs with a range of severity in post-gastric bypass
patients. The mild end of the spectrum may be managed largely
through diet modification. The most severe forms are more
prevalent in patients who underwent a Roux-en-Y procedure, and
result in severe refractory postprandial hyperinsulinemic
hypoglycemia with neuroglycopenic symptoms (altered mental status,
loss of consciousness, seizures) that cannot be managed through
diet modification. If currently available pharmacologic
agents do not resolve the condition, these patients are treated
with either a partial pancreatectomy or reversal of the gastric
bypass.
About XOMA 129XOMA 129 is a
fully human, high affinity monoclonal antibody fragment that
specifically targets the human insulin receptor. Insulin is
the major hormone for lowering blood glucose levels. Profound
hypoglycemia can result in significant morbidities, including organ
damage and potentially death. There are acute and more
persistent hypoglycemia conditions associated with abnormally high
insulin levels, which represent unmet medical needs. As a negative
allosteric modulator, XOMA 129 binds with high affinity to a site
distinct from insulin binding and dampens insulin signaling.
This drug candidate has been designed to provide a rapid onset of
action and a duration of action tailored to meet the
pharmacotherapy needs in certain conditions. The Company
intends to pursue an Investigational New Drug (IND) application in
the US for XOMA 129 upon completion of its IND-enabling nonclinical
development activities.
About XOMA CorporationXOMA
Corporation is a leader in the discovery and development of
therapeutic antibodies. The Company's innovative product candidates
result from its expertise in developing ground-breaking monoclonal
antibodies, including allosteric antibodies, which have created new
opportunities to potentially treat a wide range of human diseases.
XOMA's scientific research has produced a portfolio of five
endocrine assets, each of which has the opportunity to address
multiple indications. The Company's lead product candidate, XOMA
358, is an allosteric monoclonal antibody that reduces insulin
receptor activity, which could have a major impact on the treatment
of hyperinsulinism. The Company recently initiated Phase 2
development activities for XOMA 358 in patients with congenital
hyperinsulinism, and in patients with hypoglycemia post bariatric
surgery. For more information, visit www.xoma.com.
Forward-Looking
StatementsCertain statements contained in this press
release including, but not limited to, statements related to
anticipated timing of clinical trials, anticipated timing of the
release of clinical data, regulatory approval of unapproved product
candidates, the anticipated process of clinical data analysis, the
anticipated success of any clinical trial, cash usage, 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, |
|
|
2016 |
|
|
|
2015 |
|
Revenues: |
|
|
|
License and collaborative fees |
$ |
2,491 |
|
|
$ |
263 |
|
Contract and other |
|
1,471 |
|
|
|
2,388 |
|
Total revenues |
|
3,962 |
|
|
|
2,651 |
|
|
|
|
|
Operating expenses: |
|
|
|
Research and development |
|
13,610 |
|
|
|
20,004 |
|
Selling, general and
administrative |
|
4,305 |
|
|
|
5,220 |
|
Restructuring |
|
36 |
|
|
|
- |
|
Total operating expenses |
|
17,951 |
|
|
|
25,224 |
|
|
|
|
|
Loss from operations |
|
(13,989 |
) |
|
|
(22,573 |
) |
|
|
|
|
Other income
(expense) |
|
|
|
Interest expense |
|
(1,002 |
) |
|
|
(1,115 |
) |
Other income (expense), net |
|
(306 |
) |
|
|
2,010 |
|
Revaluation of contingent warrant
liabilities |
|
6,932 |
|
|
|
(40 |
) |
Net loss |
$ |
(8,365 |
) |
|
$ |
(21,718 |
) |
|
|
|
|
Basic and diluted net loss
per share of common stock |
$ |
(0.07 |
) |
|
$ |
(0.19 |
) |
Shares used in computing
basic and diluted net loss per share of common stock |
|
119,568 |
|
|
|
116,193 |
|
|
|
|
|
Other comprehensive
loss: |
|
|
|
Net loss |
$ |
(8,365 |
) |
|
$ |
(21,718 |
) |
Net unrealized loss on marketable
securities |
|
(42 |
) |
|
|
- |
|
Comprehensive loss |
$ |
(8,407 |
) |
|
$ |
(21,718 |
) |
|
|
|
|
|
XOMA CORPORATION |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(in thousands, except share and per share
amounts) |
|
|
March 31, 2016 |
|
December 31, 2015 |
|
(unaudited) |
|
(audited) |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
46,153 |
|
|
$ |
65,767 |
|
Marketable securities |
|
454 |
|
|
|
496 |
|
Trade and other receivables,
net |
|
1,977 |
|
|
|
4,069 |
|
Prepaid expenses and other current
assets |
|
1,568 |
|
|
|
1,887 |
|
Total curent assets |
|
50,152 |
|
|
|
72,219 |
|
Property and equipment,
net |
|
1,793 |
|
|
|
1,997 |
|
Other assets |
|
664 |
|
|
|
664 |
|
Total assets |
$ |
52,609 |
|
|
$ |
74,880 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
4,593 |
|
|
$ |
6,831 |
|
Accrued and other liabilities |
|
4,387 |
|
|
|
7,025 |
|
Deferred revenue |
|
899 |
|
|
|
3,198 |
|
Interest bearing obligations –
current |
|
10,244 |
|
|
|
5,910 |
|
Accrued interest on interest
bearing obligations – current |
|
327 |
|
|
|
311 |
|
Total current liabilities |
|
20,450 |
|
|
|
23,295 |
|
Interest bearing
obligations – non-current |
|
36,007 |
|
|
|
42,757 |
|
Contingent warrant
liabilities |
|
3,532 |
|
|
|
10,464 |
|
Other liabilities –
non-current |
|
148 |
|
|
|
673 |
|
Total liabilities |
|
60,137 |
|
|
|
77,189 |
|
|
|
|
|
|
|
|
|
Stockholders’
deficit: |
|
|
|
Preferred stock, $0.05 par value,
1,000,000 shares authorized, 0 issued and outstanding |
|
- |
|
|
|
- |
|
Common stock, $0.0075 par value,
277,333,332 shares authorized, 120,367,541 and 119,045,592 shares
issued and outstanding at March 31, 2016, and December 31, 2015,
respectively |
|
903 |
|
|
|
893 |
|
Additional paid-in capital |
|
1,140,059 |
|
|
|
1,136,881 |
|
Accumulated comprehensive loss |
|
(42 |
) |
|
|
- |
|
Accumulated deficit |
|
(1,148,448 |
) |
|
|
(1,140,083 |
) |
Total stockholders’ deficit |
|
(7,528 |
) |
|
|
(2,309 |
) |
Total liabilities and stocholders’
deficit |
$ |
52,609 |
|
|
$ |
74,880 |
|
|
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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