XOMA Reports Third Quarter 2016 Achievements and Financial Results
November 09 2016 - 9:00AM
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, today announced recent
achievements and financial results for the third quarter ended
September 30, 2016.
“In the third quarter, we accelerated activity
in our XOMA 358 clinical trials in patients with hypoglycemia due
to congenital hyperinsulinism (CHI) or post-bariatric surgery
(PBS). In mid-September, we presented promising initial data
from the first nine patients in these studies, which clearly
demonstrated that XOMA 358 impacts insulin signaling. We also
opened our first clinical site in Germany, which is actively
enrolling patients age 12 years and older into our CHI study.
Additionally, our proposal to UK regulators to initiate a
multi-dose Phase 2 clinical study of XOMA 358 in children over the
age of two with CHI was accepted in principle. We are pleased
with the progress we are making in the XOMA 358 development program
and are optimistic this first-in-class allosteric modulating
antibody will offer a significant benefit for the treatment of CHI
and PBS patients,” said John Varian, Chief Executive Officer of
XOMA.
Recent Achievements
- Announced promising initial Phase 2 proof-of-concept data from
the first nine patients enrolled in the Company’s ongoing XOMA 358
studies. This data confirm the novel antibodies’
proof-of-mechanism is impacting insulin signaling in patients with
hypoglycemia due to CHI or PBS.
- Continued to advance the XOMA 358 clinical program and made
significant steps toward generating additional patient data.
- Treated 14 additional patients with XOMA 358 since the
September data presentation.
- Met with the UK’s Medicines and Healthcare Regulatory Authority
(MHRA) and proposed a multi-dose Phase 2 clinical study of XOMA 358
in children older than age two diagnosed with hypoglycemia due to
CHI. The Agency agreed in principle with the proposal.
- Opened the Company’s first clinical site in Germany to conduct
a repeat-dose study of XOMA 358 in CHI patients over the age of
12.
- Unveiled a novel new IL-2 immuno-oncology antibody
program. Preclinical data will be presented on November 12th
at The Society for Immunotherapy of Cancer 31st Annual
Meeting. XOMA anticipates out-licensing the asset to help
fund its endocrine drug development programs.
- Executed a reverse split of XOMA’s common stock to regain
compliance with NASDAQ listing requirements.
Third Quarter 2016 Financial
ResultsXOMA recorded total revenues of $0.6 million for
the three months ended September 30, 2016, compared to $2.1 million
during the third quarter of 2015. The decrease in third quarter
2016 revenues was due primarily to a reduction in revenues from the
National Institute of Allergy and Infectious Diseases (NIAID) and
Servier. Going forward, revenues are expected to result from
potential new strategic partnerships and arrangements or payments
under existing contracts.
Research and development (R&D) expenses for
the third quarter of 2016 decreased 51 percent to $8.7 million,
compared to $17.6 million in the corresponding 2015 period. The
decrease was due primarily to a $3.6 million reduction in clinical
trial costs, a $2.7 million reduction in salaries and related
expenses, a $1.0 million reduction in external manufacturing
activities, a $0.5 million reduction in outside consulting fees due
to the termination of the Servier Phase 3 program, and a $0.5
million reduction in depreciation and facility expenses due to the
sale of our manufacturing facility to Agenus West LLC.
Selling, general and administrative expenses
(SG&A) decreased 28 percent to $4.1 million for the three
months ended September 30, 2016, compared to $5.6 million during
the same period in 2015. The decrease was due primarily to reduced
consulting services and reduced salary and related personnel costs
following the Company’s restructuring activities that were
initiated in the third quarter of 2015.
“Our financial results for the quarter reflect
the significant progress we have made over the past year to reduce
our operating expenses across every sector of the Company. Third
quarter R&D expenses were 51 percent lower year-over-year and
37 percent lower compared with the second quarter of 2016. We
also reduced our SG&A expenses by 28 percent from a year ago
and by 15 percent from the second quarter,” said Tom Burns, Vice
President, Finance and Chief Financial Officer of XOMA. “In
addition, we continued our out-licensing and partnering efforts to
monetize our non-core assets, as our deep pipeline of early-stage
antibodies is of interest to multiple companies focused on
addressing a wide variety of medical conditions. These
transactions have been and continue to be an important source of
non-dilutive financing for the Company. For example, we
expect to earn a $10 million milestone payment within the next few
months under one of our existing license or collaboration
agreements.”
For the third quarter ended September 30, 2016,
XOMA had a net loss of $12.5 million, compared to a net loss of
$0.5 million in the quarter ended September 30, 2015. The net
losses in the three months ended September 30, 2016 and 2015,
included a $0.3 million and $24.4 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 September 30,
2016, was $12.8 million, compared to a net loss of $24.9 million
for the same reporting period in 2015.
On September 30, 2016, XOMA had cash and cash
equivalents of $20.6 million compared with $65.8 million at
December 31, 2015.
The Company expects its available capital will
be sufficient to fund operations into the first quarter of
2017. The anticipated milestone, referenced above, is not
included in this projection.
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 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 statements related to optimism about the
beneficial impact of XOMA 358, the expected sources of future
revenues, other companies’ interest in our pipeline of early-stage
antibodies, the sufficiency of our capital resources,
anticipated regulatory approval of product candidates, 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 law.
XOMA
CORPORATION |
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS |
(unaudited) |
(in thousands,
except per share amounts) |
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
Revenues: |
|
|
|
|
|
|
|
License and collaborative fees |
$ |
430 |
|
|
$ |
645 |
|
|
$ |
3,196 |
|
|
$ |
1,852 |
|
Contract and other |
|
205 |
|
|
|
1,429 |
|
|
|
1,844 |
|
|
|
5,412 |
|
Total revenues |
|
635 |
|
|
|
2,074 |
|
|
|
5,040 |
|
|
|
7,264 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
8,674 |
|
|
|
17,559 |
|
|
|
35,986 |
|
|
|
57,255 |
|
Selling, general and
administrative |
|
4,053 |
|
|
|
5,632 |
|
|
|
13,138 |
|
|
|
15,913 |
|
Restructuring |
|
- |
|
|
|
2,561 |
|
|
|
15 |
|
|
|
2,561 |
|
Total operating expenses |
|
12,727 |
|
|
|
25,752 |
|
|
|
49,139 |
|
|
|
75,729 |
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(12,092 |
) |
|
|
(23,678 |
) |
|
|
(44,099 |
) |
|
|
(68,465 |
) |
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
Interest expense |
|
(982 |
) |
|
|
(1,030 |
) |
|
|
(2,991 |
) |
|
|
(3,152 |
) |
Other income (expense), net |
|
289 |
|
|
|
(194 |
) |
|
|
585 |
|
|
|
1,453 |
|
Revaluation of contingent warrant
liabilities |
|
260 |
|
|
|
24,422 |
|
|
|
10,455 |
|
|
|
24,206 |
|
Net loss |
$ |
(12,525 |
) |
|
$ |
(480 |
) |
|
$ |
(36,050 |
) |
|
$ |
(45,958 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss
per share of common stock |
$ |
(2.08 |
) |
|
$ |
(0.08 |
) |
|
$ |
(6.00 |
) |
|
$ |
(7.83 |
) |
Shares used in computing
basic and diluted net loss per share of common stock |
|
6,029 |
|
|
|
5,928 |
|
|
|
6,010 |
|
|
|
5,872 |
|
|
|
|
|
|
|
|
|
XOMA
CORPORATION |
CONDENSED
CONSOLIDATED BALANCE SHEETS |
(unaudited) |
(in thousands,
except share and per share amounts) |
|
|
September 30, 2016 |
|
December 31, 2015 |
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
20,618 |
|
|
$ |
65,767 |
|
Marketable securities |
|
- |
|
|
|
496 |
|
Trade and other receivables,
net |
|
756 |
|
|
|
4,069 |
|
Prepaid expenses and other current
assets |
|
1,251 |
|
|
|
1,887 |
|
Total curent assets |
|
22,625 |
|
|
|
72,219 |
|
Property and equipment,
net |
|
1,402 |
|
|
|
1,997 |
|
Other assets |
|
664 |
|
|
|
664 |
|
Total assets |
$ |
24,691 |
|
|
$ |
74,880 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
4,530 |
|
|
$ |
6,831 |
|
Accrued and other liabilities |
|
4,814 |
|
|
|
7,025 |
|
Deferred revenue |
|
899 |
|
|
|
3,198 |
|
Interest bearing obligations –
current |
|
12,461 |
|
|
|
5,910 |
|
Accrued interest on interest
bearing obligations – current |
|
310 |
|
|
|
331 |
|
Total current liabilities |
|
23,014 |
|
|
|
23,295 |
|
Interest bearing
obligations – non-current |
|
32,758 |
|
|
|
42,757 |
|
Contingent warrant
liabilities |
|
9 |
|
|
|
10,464 |
|
Other liabilities –
non-current |
|
97 |
|
|
|
673 |
|
Total liabilities |
|
55,878 |
|
|
|
77,189 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
deficit: |
|
|
|
Preferred stock, $0.05 par value,
1,000,000 shares authorized, 0 issued and outstanding on September
30, 2016, and December 31, 2015 |
|
- |
|
|
|
- |
|
Common stock, $0.0075 par value,
277,333,332 shares authorized, 6,029,544 and 5,952,264 shares
issued and outstanding at September 30, 2016, and December 31,
2015, respectively |
|
904 |
|
|
|
893 |
|
Additional paid-in capital |
|
1,144,042 |
|
|
|
1,136,881 |
|
Accumulated deficit |
|
(1,176,133 |
) |
|
|
(1,140,083 |
) |
Total stockholders’ deficit |
|
(31,187 |
) |
|
|
(2,309 |
) |
Total liabilities and stocholders’
deficit |
$ |
24,691 |
|
|
$ |
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:
Julie Normart
W2O Group
415-946-1087
jnormart@w2ogroup.com
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