SAN DIEGO, May 7, 2012 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) today reported financial
results for the first quarter ended March
31, 2012.
"In the first quarter, we focused our resources on ANX-188,
including manufacturing activities related to generating clinical
trial material for our planned phase 3 study in patients with
sickle cell disease," stated Brian M.
Culley, Chief Executive Officer of ADVENTRX. "Based in
part on a recent meeting with the FDA regarding the manufacture of
ANX-188, we continue to expect to initiate the phase 3 study later
this year."
First Quarter 2012 Operating Results
ADVENTRX's net loss applicable to common stock for the first
quarter of 2012 was $4.2 million, or
$0.09 per share (basic and diluted),
compared to a net loss applicable to common stock of $3.0 million, or $0.13 per share (basic and diluted), for the same
period in 2011.
Research and development (R&D) expenses for the first
quarter of 2012 were $2.2 million, an
increase of $1.6 million, or 262%,
compared to $0.6 million for the same
period in 2011. The increase was due to a $1.1 million increase in external nonclinical
study fees and expenses, a $0.3
million increase in personnel costs, and a $0.2 million increase in external clinical study
fees. The increases in external nonclinical study fees and
expenses were primarily related to increased research-related
manufacturing expenses of $0.9
million for ANX-188 and $0.5
million for ANX-514, offset by a $0.3
million decrease in research-related manufacturing expenses
related to Exelbine™. The increase in external
clinical study fees and expenses was primarily related to increased
clinical consulting expenses for ANX-188.
Selling, general and administrative (SG&A) expenses for the
first quarter of 2012 were $2.0
million, an increase of $0.4
million, or 30%, compared to $1.6
million for the same period in 2011. The increase was due
primarily to an increase of $0.2
million in personnel costs and a $0.2
million increase in share-based compensation expense.
Transaction-related expenses for the first quarter of 2012 were
negative $0.1 million compared to
positive $0.8 million for the same
period in 2011. Transaction-related expenses for the first
quarter of 2012 consisted of negative $0.1
million associated with changes since December 31, 2011 in the fair value of the
contingent asset and contingent liability related to the SynthRx
acquisition. Transaction-related expenses for the first quarter of
2011 consisted of $0.8 million
related to legal, financial and business development advisory fees
associated with the evaluation of potential acquisition targets,
including SynthRx.
Balance Sheet Highlights
As of March 31, 2012, the Company
had cash, cash equivalents and short-term investments totaling
$46.0 million. Stockholders'
equity amounted to $53.0 million as
of March 31, 2012.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company focused
on developing proprietary product candidates. The Company's
lead product candidate is ANX-188, a rheologic, antithrombotic and
cytoprotective agent that improves microvascular blood flow and has
potential application in treating a wide range of diseases and
conditions, such as complications arising from sickle cell
disease. We also are developing ANX-514, a novel,
detergent-free formulation of the chemotherapy drug
docetaxel. 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 the Company's
development plans for ANX-188, including the nature and timing of
future clinical studies, and the Company's expectations regarding
the FDA's agreement with such plans. Among the factors that could
cause or contribute to material differences between ADVENTRX's
actual results and those indicated from the forward-looking
statements are risks and uncertainties inherent in ADVENTRX's
business, including, but are not limited to: the potential
for ADVENTRX to delay, reduce or discontinue current and/or planned
development activities, partner its product candidates at
inopportune times or pursue less expensive but higher-risk
development paths if it is unable to raise sufficient additional
capital as needed; ADVENTRX's ability to obtain additional funding
on a timely basis or on acceptable terms, or at all; the potential
for delays in the commencement or completion of its planned
clinical studies including as a result of difficulties or delays in
completing manufacturing process development activities and
manufacturing clinical trial material or difficulties or delays in
obtaining regulatory approval or meeting applicable regulatory
requirements; the risk of suspension or termination of a clinical
study including due to lack of adequate funding; the risk that
planned clinical studies of our product candidates, including
ANX-188, are not successful and, even if they are successful, that
the FDA could determine they are not sufficient to support an NDAs
for the product candidate; the risk that the FDA does not grant
market approval of ADVENTRX's product candidates, including
ANX-188, on a timely basis, or at all; ADVENTRX's reliance on third
parties to assist in the conduct of important aspects of its
product candidates' development programs, including the manufacture
of clinical trial material, the conduct of clinical studies and
regulatory submissions related to product approval, and that such
third parties may fail to perform as expected; 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
(In thousands except per share data)
|
|
Three
months ended
March
31,
(Unaudited)
|
|
2012
|
|
2011
|
|
|
|
|
Total net
revenue
|
$
—
|
|
$
—
|
|
|
|
|
Operating
expenses:
|
|
|
|
Research and
development
|
2,210
|
|
611
|
Selling, general and
administrative
|
2,045
|
|
1,574
|
Transaction-related
expenses
|
(114)
|
|
799
|
Depreciation and
amortization
|
30
|
|
10
|
Total operating
expenses
|
4,171
|
|
2,994
|
|
|
|
|
Loss from
operations
|
(4,171)
|
|
(2,994)
|
|
|
|
|
Interest
and other income, net
|
18
|
|
38
|
|
|
|
|
Net loss
applicable to common stock
|
$
(4,153)
|
|
$
(2,956)
|
|
|
|
|
Net loss
per share – basic and diluted
|
$
(0.09)
|
|
$
(0.13)
|
|
|
|
|
Weighted
average shares – basic and diluted
|
47,716
|
|
22,755
|
|
|
|
|
ADVENTRX Pharmaceuticals, Inc.
(A Development Stage Enterprise)
Balance Sheet Data
(In thousands)
|
|
March 31,
2012
(Unaudited)
|
|
December
31, 2011
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
46,046
|
|
$
50,704
|
|
|
|
|
Working
capital
|
45,362
|
|
49,323
|
|
|
|
|
Total
assets
|
57,510
|
|
61,856
|
|
|
|
|
Total
liabilities
|
4,554
|
|
5,078
|
|
|
|
|
Stockholders' equity
|
52,956
|
|
56,779
|
SOURCE ADVENTRX Pharmaceuticals, Inc.