SAN DIEGO, Aug. 8, 2011 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) today reported financial
results for the periods ended June 30,
2011.
"As we head into the second half of the year, we are taking
steps to prepare for our launch of Exelbine™ into the U.S. market,
should it be approved on or around FDA's PDUFA goal date of
September 1, 2011," said Brian M. Culley, Chief Executive Officer of
ADVENTRX. "Having a commercial infrastructure will expand our
strategic options and increase stockholder value."
"In parallel, we are working to finalize the protocol for a
phase 3 pediatric study of ANX-188, our first-in-class treatment
for sickle cell crisis, for which FDA has granted orphan drug
designation. We plan to initiate this study in 2012. There
are no FDA-approved drugs designed to treat patients in crisis,
making this an area of significant unmet need," Mr. Culley
continued.
"We also are excited about ANX-514, our detergent-free
reformulation of the blockbuster drug Taxotere®, which recently
went off-patent. We plan to meet with FDA in the next quarter
to discuss a single, additional study in which we compare the
safety profiles of Taxotere with corticosteroid premedication and
ANX-514 without corticosteroid premedication. We believe this
single study will provide sufficient clinical data to support a new
drug application, should the study demonstrate comparable safety
profiles between ANX-514 and Taxotere, and a competitive advantage
over Taxotere and other detergent-containing formulations of
docetaxel," Mr. Culley concluded.
Second Quarter 2011 Operating Results
ADVENTRX's net loss applicable to common stock for the second
quarter of 2011 was $4.4 million, or
$0.17 per share, compared to a net
loss applicable to common stock of $5.0
million, or $0.39 per share,
for the same period in 2010. Included in the net loss applicable to
common stock for the second quarter of 2010 was a non-cash, deemed
dividend expense of $3.1 million
incurred in connection with the Company's May 2010 equity financing.
Research and development (R&D) expenses for the second
quarter of 2011 were $1.3 million, an
increase of $0.7 million, or 112%,
compared to $0.6 million for the same
period in 2010. The increase was due primarily to a $0.5 million increase in external nonclinical
study fees and expenses and a $0.2
million increase in external bioequivalence and clinical
trial fees and expenses. The increase in external nonclinical
study fees and expenses resulted primarily from a $0.5 million increase in research-related
manufacturing expenses for Exelbine™. The increase in
external bioequivalence and clinical trial fees and expenses is
primarily related to increased clinical trial work of $0.1 million for Exelbine™ and clinical
consulting expenses of $0.1 million
for ANX-188.
Selling, general and administrative (SG&A) expenses for the
second quarter of 2011 were $1.8
million, an increase of $0.5
million, or 40%, compared to $1.3
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 $0.3 million increase in commercial-readiness
activities for Exelbine™.
Transaction-related expenses for the second quarter of 2011 were
$1.2 million compared to $0 for the same period in 2010.
Transaction-related expenses consisted of $1.0 million related to legal, accounting,
financial and business development advisory fees associated with
the evaluation of potential acquisition targets, including SynthRx,
and $0.2 million related to changes
in the fair value of contingent consideration related to the
SynthRx acquisition.
Year-to-Date Operating Results
ADVENTRX's net loss applicable to common stock for the six
months ended June 30, 2011 was
$7.3 million, or $0.30 per share, compared to a net loss
applicable to common stock of $10.0
million, or $0.86 per share,
for the same period in 2010. Included in the net loss applicable to
common stock for the six months ended June
30, 2010 was a non-cash, deemed dividend expense of
$5.6 million incurred in connection
with the Company's January and May
2010 equity financings.
Research and development (R&D) expenses for the six months
ended June 30, 2011 were $2.0 million, an increase of $0.1 million, or 4%, compared to $1.9 million for the same period in 2010. The
increase was due primarily to a $0.3
million increase in external bioequivalence and clinical
trial fees and expenses, a $0.1
million increase in personnel costs, offset by a
$0.3 million decrease in external
nonclinical study fees and expenses. The increase in external
bioequivalence and clinical trial fees and expenses is primarily
related to increased clinical trial work of $0.2 million for Exelbine™ and clinical
consulting expenses of $0.1 million
for ANX-188. The decrease in external nonclinical study fees
and expenses resulted primarily from a $0.5
million decrease in research-related manufacturing expenses
for ANX-514, a $0.4 million decrease
in regulatory consulting services for ANX-514, offset by an
increase of $0.5 million in research
related manufacturing expenses for Exelbine™ and an increase of
$0.1 million in analytical
development expenses for ANX-188.
Selling, general and administrative (SG&A) expenses for the
six months ended June 30, 2011 were
$3.4 million, an increase of
$0.9 million, or 37%, compared to
$2.5 million for the same period in
2010. The increase was due primarily to a $0.4 million increase in personnel costs, mainly
due to an accrual for estimated bonus expense related to 2011
performance and additional staff hired in 2011, and a $0.5 million increase in commercial-readiness
activities for Exelbine™.
Transaction-related expenses for the six months ended
June 30, 2011 were $2.0 million compared to $0 for the same period in 2010.
Transaction-related expenses consisted of $1.8 million related to legal, accounting,
financial and business development advisory fees associated with
the evaluation of potential acquisition targets, including SynthRx,
and $0.2 million related to changes
in the fair value of contingent consideration related to the
SynthRx acquisition.
Balance Sheet Highlights
As of June 30, 2011, the Company
had cash totaling $42.0 million.
Stockholders' equity amounted to $46.4
million as of June 30, 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 regarding the potential for receipt of and timing
regarding FDA approval to market Exelbine, its estimated sales and
marketing and launch expenses for Exelbine and the commercial and
profitability potential of Exelbine, ADVENTRX's ability to generate
clinical trial material and the timing of initiating clinical
studies of ANX-188 and ANX-514. 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: the risk that
ADVENTRX does not receive FDA approval of Exelbine on a timely
basis, or at all; the potential for the FDA to impose requirements
to be completed before or after approval of the Exelbine NDA;
difficulties or delays in marketing Exelbine, if approved,
including developing or acquiring additional marketing, sales and
distribution capabilities; difficulties or delays in manufacturing
Exelbine at commercial scale, if approved, including validating
commercial manufacturing processes and manufacturers, as well as
other suppliers, and the risk of supply shortages; the risk that
Exelbine, if approved, does not achieve broad market acceptance,
including as a result of limited differentiation (or ability to
promote differentiation) from Navelbine® and its generic
equivalents; the risk that Exelbine cannot be priced at levels that
exceed its fully-burdened manufacturing cost or that provide a
reasonable return on investment to ADVENTRX; the risk that any
patent issued to ADVENTRX may not provide sufficient protection and
market exclusivity for Exelbine and may be challenged, invalidated,
infringed or circumvented by third parties, including by ADVENTRX's
competitors; ADVENTRX's dependence on the success of Exelbine as
its first product candidate to be submitted for regulatory
approval; difficulties or delays in reaching agreement with the FDA
on the clinical development of ANX-188 and ANX-514; 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 clinical trials of ANX-188 and ANX-514, and
that ADVENTRX consequently determines to discontinue one or more of
those development programs; difficulties or delays in manufacturing
material for clinical studies; 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 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; 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; 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 June 30,
|
|
Six months
ended June 30,
|
|
|
2011
|
|
2010
|
|
2011
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
Total net
revenue
|
$
—
|
|
$
—
|
|
$
—
|
|
$
—
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
1,343
|
|
634
|
|
1,954
|
|
1,873
|
|
Selling, general
and administrative
|
1,824
|
|
1,303
|
|
3,398
|
|
2,478
|
|
Transaction-related expenses
|
1,230
|
|
—
|
|
2,029
|
|
—
|
|
Depreciation
and amortization
|
10
|
|
6
|
|
20
|
|
12
|
|
Total
operating expenses
|
4,407
|
|
1,943
|
|
7,401
|
|
4,363
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
(4,407)
|
|
(1,943)
|
|
(7,401)
|
|
(4,363)
|
|
|
|
|
|
|
|
|
|
|
Interest and other
income
|
15
|
|
24
|
|
52
|
|
41
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes
|
(4,392)
|
|
(1,919)
|
|
(7,349)
|
|
(4,322)
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
—
|
|
—
|
|
—
|
|
—
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
(4,392)
|
|
(1,919)
|
|
(7,349)
|
|
(4,322)
|
|
|
|
|
|
|
|
|
|
|
Deemed dividends on preferred
stock
|
—
|
|
(3,125)
|
|
—
|
|
(5,640)
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common
stock
|
$
(4,392)
|
|
$
(5,044)
|
|
$
(7,349)
|
|
$
(9,962)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share – basic and
diluted
|
$
(0.17)
|
|
$
(0.39)
|
|
$
(0.30)
|
|
$
(0.86)
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares – basic
and diluted
|
26,250
|
|
12,887
|
|
24,513
|
|
11,523
|
|
|
|
|
|
|
|
|
|
|
* 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)
|
|
|
|
|
June
30,
2011
|
|
December
31,
2010
|
|
|
|
|
|
|
Total cash
|
$ 41,956
|
|
$ 27,979
|
|
|
|
|
|
|
Working capital
|
40,368
|
|
26,608
|
|
|
|
|
|
|
Total assets
|
50,162
|
|
28,487
|
|
|
|
|
|
|
Total
liabilities
|
3,764
|
|
1,801
|
|
|
|
|
|
|
Stockholders'
equity
|
46,398
|
|
26,685
|
|
|
|
|
|
|
|
SOURCE ADVENTRX Pharmaceuticals, Inc.