XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, today announced recent
achievements and financial results for the second quarter ended
June 30, 2016.
“The second quarter of 2016 marked our full
transition to a solely endocrine-focused business as we have
concluded all biodefense and Servier activities. During the
quarter, we strategically focused on two antibody programs that are
addressing areas of significant unmet medical need in endocrinology
and that could create significant value for XOMA,” said John
Varian, Chief Executive Officer of XOMA. “First, we continued to
advance our Phase 2 proof-of-concept study of XOMA 358 in the
United States and EU in patients with hypoglycemia due to
congenital hyperinsulinism. We also initiated a Phase 2
proof-of-concept study of XOMA 358 in patients who experience
severe hypoglycemia following gastric bypass surgery. We
remain on track to provide an update on our clinical experience
with this first-in-class compound later this summer.”
“Additionally, we advanced our second
endocrine-focused asset into mid-stage clinical development with
the initiation of a Phase 2 proof-of-concept study of XOMA 213 to
confirm its ability to curtail prolactin signaling. This monoclonal
antibody could be an important therapeutic option for people with
prolactinomas, benign tumors of the pituitary gland, who do not
respond to or are intolerant to current standard of care
medications.”
Recent Achievements
- Received Orphan Drug Designation in the European Union for XOMA
358 for the treatment of congenital hyperinsulinism, a rare genetic
disorder in which the insulin cells of the pancreas (beta cells)
secrete inappropriate and excessive insulin
- 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
- Initiated an open-label, mechanism of action, single-dose,
multi-center Phase 2 proof-of-concept study of XOMA 213
Second Quarter 2016 Financial
ResultsXOMA recorded total revenues of $0.4 million for
the three months ended June 30, 2016, compared with $2.5 million
during the corresponding period of 2015. The decrease in second
quarter 2016 revenues was due primarily to decreased revenues from
the National Institute of Allergy and Infectious Diseases (NIAID)
and Servier due to the Company’s decision to eliminate its
non-endocrine assets. Going forward, revenues are expected to
result from potential new transactions or payments under existing
contracts.
Research and development (R&D) expenses for
the second quarter of 2016 were $13.7 million, compared with $19.7
million in the corresponding 2015 period. The decrease was due
primarily to a $3.9 million reduction in salaries and related
expenses, a $1.2 million reduction in clinical trial costs, and a
$0.9 million reduction in outside consulting fees due to the
termination of the Servier Phase 3 program, partially offset by an
increase of over $2.0 million in manufacturing costs related to the
production of XOMA 358 material for the use in future clinical
trials.
Selling, general and administrative expenses
(SG&A) were $4.8 million for the three months ended June 30,
2016, compared with $5.1 million incurred during the same period in
2015, reflecting reduced salary and related personnel costs
following the Company’s restructuring activities that were
initiated in the third quarter of 2015.
For the second quarter ended June 30, 2016, XOMA
had a net loss of $15.2 million, compared with a net loss of $23.8
million in the quarter ended June 30, 2015. The net losses in the
three months ended June 30, 2016 and 2015, included a $3.3 million
gain and $0.2 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 June 30, 2016, was $18.5
million, compared with a net loss of $23.6 million for the same
reporting period in 2015.
On June 30, 2016, XOMA had cash and cash
equivalents of $33.9 million compared with $65.8 million at
December 31, 2015.
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. One Phase 2 study is being
conducted in patients with congenital hyperinsulinism at The
Children’s Hospital in Philadelphia (CHOP) and the Great Ormond
Street Hospital (GOSH) in London. A second multi-center Phase 2
study is being conducted in patients who experience hypoglycemia
post gastric bypass 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 trial may be found at www.clinicaltrials.gov and
www.clinicaltrialsregister.eu.
About Congenital Hyperinsulinismi, ii,
iii, ivCongenital 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 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 213XOMA 213
(formerly LFA 102) is a monoclonal antibody that neutralizes
prolactin-induced signaling. Prolactin is a protein that in
normal post-partum females enables the production of milk. XOMA 213
is being developed for diseases of hyperprolactinemia --
specifically, prolactinomas, benign tumors of the pituitary gland
that have serious medical consequences, particularly sexual
dysfunction, infertility and osteoporosis. Prolactinomas also can
lead to anti-psychotic-induced hyperprolactinemia, a side effect
seen in patients treated with commonly used antipsychotics,
antidepressants, and pain medications. Ten to twenty percent of
patients do not respond to or are intolerant of current standard of
care medications.
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 after bariatric
surgery. For more information, visit www.xoma.com.
Forward-Looking
StatementsCertain statements contained in this press
release including, but not limited to, statements characterizing
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.
i
ghr.nlm.nih.gov/condition/congenital-hyperinsulinism. Accessed June
11, 2015. ii
www.chop.edu/conditions-diseases/congenital-hyperinsulinism/about#.VXncFU3bKHt.
Accessed June 11, 2015.iii
www.chop.edu/conditions-diseases/congenital-hyperinsulinism/about#.VXneYE3bKHu.
Accessed June 11, 2015.iv
www.ojrd.com/content/pdf/1750-1172-6-63.pdf. Accessed June 11,
2015.
|
XOMA CORPORATION |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS |
(unaudited) |
(in thousands, except per share amounts) |
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
Revenues: |
|
|
|
|
|
|
|
|
License and collaborative fees |
|
$ |
275 |
|
|
$ |
945 |
|
|
$ |
2,766 |
|
|
$ |
1,207 |
|
Contract and other |
|
|
168 |
|
|
|
1,594 |
|
|
|
1,639 |
|
|
|
3,983 |
|
Total revenues |
|
|
443 |
|
|
|
2,539 |
|
|
|
4,405 |
|
|
|
5,190 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
13,703 |
|
|
|
19,692 |
|
|
|
27,313 |
|
|
|
39,696 |
|
Selling, general and
administrative |
|
|
4,779 |
|
|
|
5,060 |
|
|
|
9,084 |
|
|
|
10,280 |
|
Restructuring |
|
|
(21 |
) |
|
|
- |
|
|
|
15 |
|
|
|
- |
|
Total operating expenses |
|
|
18,461 |
|
|
|
24,752 |
|
|
|
36,412 |
|
|
|
49,976 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(18,018 |
) |
|
|
(22,213 |
) |
|
|
(32,007 |
) |
|
|
(44,786 |
) |
|
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(1,007 |
) |
|
|
(1,007 |
) |
|
|
(2,009 |
) |
|
|
(2,123 |
) |
Other income (expense), net |
|
|
602 |
|
|
|
(363 |
) |
|
|
296 |
|
|
|
1,648 |
|
Revaluation of contingent warrant
liabilities |
|
|
3,263 |
|
|
|
(176 |
) |
|
|
10,195 |
|
|
|
(216 |
) |
Net loss |
|
$ |
(15,160 |
) |
|
$ |
(23,759 |
) |
|
$ |
(23,525 |
) |
|
$ |
(45,477 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted net loss
per share of common stock |
|
$ |
(0.13 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.39 |
) |
Shares used in computing
basic and diluted net loss per share of common stock |
|
|
120,448 |
|
|
|
117,540 |
|
|
|
120,008 |
|
|
|
116,870 |
|
|
|
|
|
|
|
|
|
|
Other comprehensive
loss: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(15,160 |
) |
|
$ |
(23,759 |
) |
|
$ |
(23,525 |
) |
|
$ |
(45,477 |
) |
Net unrealized loss on marketable
securities |
|
|
(12 |
) |
|
|
- |
|
|
|
(54 |
) |
|
|
- |
|
Comprehensive loss |
|
$ |
(15,172 |
) |
|
$ |
(23,759 |
) |
|
$ |
(23,579 |
) |
|
$ |
(45,477 |
) |
|
|
|
|
|
|
|
|
|
XOMA CORPORATION |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(in thousands, except share and per share
amounts) |
|
|
|
June 30, 2016 |
|
December 31, 2015 |
|
|
(unaudited) |
|
(audited) |
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
33,854 |
|
|
$ |
65,767 |
|
Marketable securities |
|
|
442 |
|
|
|
496 |
|
Trade and other receivables,
net |
|
|
959 |
|
|
|
4,069 |
|
Prepaid expenses and other current
assets |
|
|
1,070 |
|
|
|
1,887 |
|
Total current assets |
|
|
36,325 |
|
|
|
72,219 |
|
Property and equipment,
net |
|
|
1,577 |
|
|
|
1,997 |
|
Other assets |
|
|
664 |
|
|
|
664 |
|
Total assets |
|
$ |
38,566 |
|
|
$ |
74,880 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
5,046 |
|
|
$ |
6,831 |
|
Accrued and other liabilities |
|
|
5,737 |
|
|
|
7,025 |
|
Deferred revenue |
|
|
1,024 |
|
|
|
3,198 |
|
Interest bearing obligations –
current |
|
|
12,138 |
|
|
|
5,910 |
|
Accrued interest on interest
bearing obligations – current |
|
|
288 |
|
|
|
331 |
|
Total current liabilities |
|
|
24,233 |
|
|
|
23,295 |
|
Interest bearing
obligations – non-current |
|
|
34,386 |
|
|
|
42,757 |
|
Contingent warrant
liabilities |
|
|
269 |
|
|
|
10,464 |
|
Other liabilities –
non-current |
|
|
123 |
|
|
|
673 |
|
Total liabilities |
|
|
59,011 |
|
|
|
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, 120,583,797 and 119,045,592 shares
issued and outstanding at June 30, 2016, and December 31, 2015,
respectively |
|
|
904 |
|
|
|
893 |
|
Additional paid-in capital |
|
|
1,142,313 |
|
|
|
1,136,881 |
|
Accumulated comprehensive loss |
|
|
(54 |
) |
|
|
- |
|
Accumulated deficit |
|
|
(1,163,608 |
) |
|
|
(1,140,083 |
) |
Total stockholders’ deficit |
|
|
(20,455 |
) |
|
|
(2,309 |
) |
Total liabilities and stockholders’
deficit |
|
$ |
38,566 |
|
|
$ |
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:
Taryn Ibach
W2O Group
415-658-9748
tibach@w2ogroup.com
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