Recent Highlights
-- Acquisition of SynthRx completed April 2011
-- $46.6 million in cash at March 31, 2011
SAN DIEGO, May 9, 2011 /PRNewswire via COMTEX/ --
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today
reported financial results for the first quarter ended
March 31, 2011.
"We are pleased to have completed the acquisition of
SynthRx and look forward to meeting with the FDA this year
to reach agreement on the protocol for a pivotal phase 3
study of ANX-188 for the treatment of sickle cell crisis,"
said Brian M. Culley, Chief
Executive Officer of ADVENTRX. "In addition, we continue to
prepare for the commercial launch of Exelbine and to develop
the protocol for a phase 3 study of ANX-514, our polysorbate
80-free formulation of docetaxel, to provide the additional
safety data requested by the FDA."
"Our strong balance sheet and cash position at
March 31, 2011 will help fund
these phase 3 studies while allowing us to continue to
evaluate strategic acquisitions that we believe will further
enhance our product pipeline and create value for our
stockholders," Mr. Culley concluded.
First Quarter 2011 Operating Results
ADVENTRX's net loss applicable to common stock for the
first quarter of 2011 was $3.0
million, or $0.13 per
share, compared to a net loss applicable to common stock of
$4.9 million, or
$0.48 per share, for the same
period in 2010. Included in the net loss applicable to
common stock for the first quarter of 2010 was a non-cash,
deemed dividend expense of $2.5
million incurred in connection with the Company's
January 2010 equity financing.
Research and development (R&D) expenses for the first
quarter of 2011 were $0.6 million,
a decrease of $0.6 million, or
51%, compared to $1.2 million
for the same period in 2010. The decrease was due primarily
to a $0.7 million decrease in
external nonclinical study fees and expenses. The decrease
in external nonclinical study fees and expenses resulted
largely from a $0.5 million
decrease in research-related manufacturing expenses for
ANX-514 and a $0.2 million
decrease in fees for regulatory consulting services related
to ANX-514.
Selling, general and administrative (SG&A) expenses for
the first quarter of 2011 were $1.6
million, an increase of $0.4
million, or 34%, compared to
$1.2 million for the same period in 2010. The
increase was due primarily to a $0.2
million increase in personnel costs, mainly due to an
accrual for estimated bonus expense related to 2011
performance, and a $0.2 million
increase in fees for legal services primarily related to
commercial-readiness activities for Exelbine(TM).
Transaction-related expenses for the first quarter of
2011 were $0.8 million
compared to $0 for the same period in 2010.
Transaction-related expenses consist of legal, accounting,
financial and business development advisory fees associated
with the acquisition of SynthRx and the evaluation of
potential acquisition targets.
Balance Sheet Highlights
As of March 31, 2011, the
Company had cash totaling $46.6
million. Stockholders' equity amounted to
$44.8 million as of
March 31, 2011.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical
company focused on acquiring, developing and commercializing
proprietary product candidates. The Company's current lead
product candidates are Exelbine and ANX-514, novel emulsion
formulations of currently marketed chemotherapy drugs, and
ANX-188, a novel, purified, rheologic and antithrombotic
compound initially being developed as a first-in-class
treatment for pediatric patients with sickle cell disease in
acute crisis. More information can be found on the Company's
web site at
www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this
press release that are not a description of historical facts
are forward-looking statements that are based on ADVENTRX's
current expectations and assumptions. Such forward-looking
statements include, but are not limited to, statements
regarding ADVENTRX's expectations that its anticipated phase
3 clinical studies of ANX-188 and ANX-514 may provide the
basis for submission of NDAs for those product candidates,
the potential for receipt of and timing regarding FDA
approval to market Exelbine, and ADVENTRX's expectations
regarding strategic transactions that would enhance its
product pipeline and create value for its stockholders.
Actual events or results may differ materially from those
expressed or implied by the forward-looking statements in
this press release due to a number of risks and
uncertainties, including, without limitation: difficulties
or delays in obtaining regulatory approval for its product
candidates and the possibility that ADVENTRX does not
receive regulatory approval on a timely basis, or at all;
the potential for ADVENTRX to raise additional capital to
acquire new technologies, product candidates or products
and/or to fund development and/or commercialization
activities for current and/or future product candidates;
difficulties or delays in reaching agreement with the FDA on
the clinical development of ANX-188 and ANX-514; the risk
that the cost of the planned phase 3 clinical trials of
ANX-188 and ANX-514 will exceed the amounts projected for
such trials; the potential for the FDA to require
significant additional clinical and/or nonclinical studies
of ADVENTRX's lead product candidates, in addition to its
planned phase 3 clinical trials of ANX-188 and ANX-514, and
that ADVENTRX consequently determines to discontinue one or
more of those development programs; the potential for the
FDA to impose requirements to be completed before or after
approval of the Exelbine NDA; difficulties or delays in
manufacturing material for clinical studies; difficulties or
delays in manufacturing Exelbine and any other product
candidate on a commercial scale, if approved, including
validating commercial manufacturing processes and
manufacturers, as well as suppliers; difficulties or delays
in marketing Exelbine and any other product candidate, if
approved, including developing or acquiring marketing, sales
and distribution capabilities; ADVENTRX's reliance on third
parties to assist in the conduct of important aspects of its
product candidates' development programs, and that such
third parties may fail to perform as expected; the risk that
ADVENTRX will pursue acquisition and/or development
activities at levels on timelines, or will incur unexpected
expenses, that shorten the period through which its
operating funds will sustain it; the potential for ADVENTRX
to enter into a merger or other business combination in
connection with the acquisition of a new technology, product
candidate or product resulting in a successor entity that
focuses its resources on developing products and product
candidates other than ADVENTRX's current lead product
candidates; and other risks and uncertainties more fully
described in ADVENTRX's press releases and periodic filings
with the Securities and Exchange Commission. ADVENTRX's
public filings with the Securities and Exchange Commission
are available at www.sec.gov.
You are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date
when made. ADVENTRX does not intend to revise or update any
forward-looking statement set forth in this press release to
reflect events or circumstances arising after the date
hereof, except as may be required by law.
[Tables to Follow]
ADVENTRX Pharmaceuticals, Inc.
(A Development Stage Enterprise)
Condensed Consolidated Statements of Operations
(Unaudited)
(In 000's except per share data)
|
|
|
Three months ended March 31, |
|
|
2011 |
2010 * |
|
|
|
|
|
Total net revenues |
$ -- |
$ -- |
|
|
|
|
|
Operating expenses: |
|
|
|
Research and development |
611 |
1,239 |
|
Selling, general and administrative |
1,574 |
1,175 |
|
Transaction-related expenses |
799 |
-- |
|
Depreciation and amortization |
10 |
6 |
|
Total operating expenses |
2,994 |
2,420 |
|
|
|
|
|
Loss from operations |
(2,994) |
(2,420) |
|
|
|
|
|
Interest and other income |
38 |
17 |
|
|
|
|
|
Loss before income taxes |
(2,956) |
(2,403) |
|
|
|
|
|
Provision for income taxes |
-- |
-- |
|
|
|
|
|
Net loss |
(2,956) |
(2,403) |
|
|
|
|
|
Deemed dividends on preferred stock |
-- |
(2,515) |
|
|
|
|
|
Net loss applicable to common stock |
$ (2,956) |
$ (4,918) |
|
|
|
|
|
Net loss per share - basic and diluted |
$ (0.13) |
$ (0.48) |
|
|
|
|
|
Weighted average shares - basic and diluted |
22,755 |
10,144 |
|
|
|
|
* Share and per share information related to dates or
periods prior to April 23, 2010
have been restated to reflect retrospective application of
the 1-for-25 reverse split of outstanding common stock that
took place on that date.
ADVENTRX Pharmaceuticals, Inc.
(A Development Stage Enterprise)
Balance Sheet Data
(In 000's)
|
|
|
March 31, 2011 |
|
December 31, 2010 |
|
|
|
|
|
|
Total cash |
$ 46,552 |
|
$ 27,979 |
|
|
|
|
|
|
Working capital |
44,753 |
|
26,608 |
|
|
|
|
|
|
Total assets |
46,957 |
|
28,487 |
|
|
|
|
|
|
Total liabilities |
2,134 |
|
1,801 |
|
|
|
|
|
|
Stockholders' equity |
44,824 |
|
26,685 |
|
|
|
|
|
SOURCE ADVENTRX Pharmaceuticals, Inc.