SAN DIEGO, May 9, 2011 /PRNewswire/ -- 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™.
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.