SAN DIEGO, March 7, 2012 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) today reported financial
results for the fourth quarter and year ended December 31, 2011.
"We are pleased to begin 2012 with a strong cash position of
over $50 million, which will be used
to fund our planned phase 3 study of ANX-188 in patients with
sickle cell disease," stated Brian M.
Culley, Chief Executive Officer of ADVENTRX.
Fourth Quarter 2011 Operating Results
ADVENTRX's net loss applicable to common stock for the fourth
quarter of 2011 was $2.4 million, or
$0.06 per share (basic and diluted),
compared to a net loss applicable to common stock of $2.3 million, or $0.15 per share (basic and diluted), for the same
period in 2010.
Research and development (R&D) expenses for the fourth
quarter of 2011 were $1.8 million, an
increase of $0.9 million, or 95%,
compared to $0.9 million for the same
period in 2010. The increase was due primarily to a $0.6 million increase in external nonclinical
study fees and expenses, a $0.2
million increase in personnel costs, and a $0.1 million increase in external clinical study
fees. The increases in external fees and expenses were
primarily related to research-related manufacturing activities and
consulting expenses for ANX-188. The increase in personnel
costs resulted from additional clinical and research-related
manufacturing staff hired in 2011.
Selling, general and administrative (SG&A) expenses for the
fourth quarter of 2011 were $1.8
million, an increase of $0.2
million, or 13%, compared to $1.6
million for the same period in 2010. The increase resulted
primarily from an increase in personnel costs, mainly due to
additional staff hired in 2011.
Transaction-related expenses for the fourth quarter of 2011 were
negative $1.1 million compared to
positive $0.3 million for the same
period in 2010. Transaction-related expenses for the fourth
quarter of 2011 consisted of negative $1.1
million associated with changes since September 30, 2011 in the fair value of the
contingent asset and contingent liability related to the SynthRx
acquisition. Transaction-related expenses for the fourth quarter of
2010 consisted of $0.3 million
related to legal, financial and business development advisory fees
associated with the evaluation of potential acquisition targets,
including SynthRx.
Full Year 2011 Operating Results
ADVENTRX's net loss applicable to common stock for the year
ended December 31, 2011 was
$13.3 million, or $0.47 per share (basic and diluted), compared to
a net loss applicable to common stock of $14.1 million, or $1.07 per share (basic and diluted), for 2010.
Included in the net loss applicable to common stock for the year
ended December 31, 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.
R&D expenses for the year ended December 31, 2011 were $5.8 million, an increase of $2.1 million, or 56%, compared to $3.7 million for 2010. The increase in R&D
expenses in 2011 compared to 2010 was due primarily to a
$1.0 million increase in external
nonclinical study fees and expenses, a $0.6
million increase in personnel costs and a $0.5 million increase in external clinical study
fees and expenses. The increase in external nonclinical study
fees and expenses was primarily related to research-related
manufacturing activities and consulting expenses of $1.0 million for ANX-188 and increased
commercial-readiness manufacturing and consulting expenses of
$0.5 million for Exelbine.
These increases were offset by a $0.5
million decrease in research-related manufacturing
activities and consulting expenses for ANX-514. The increase
in personnel costs resulted from additional clinical and
research-related manufacturing staff hired in 2011. The
increase in external clinical study fees and expenses was primarily
related to increased clinical consulting expenses of $0.4 million for ANX-188 and increased consulting
expenses of $0.1 million for Exelbine
related to study site inspections.
SG&A expenses for the year ended December 31, 2011 were $7.2 million, an increase of $2.2 million, or 44%, compared to $5.0 million for 2010. The increase resulted
primarily from a $0.9 million
increase in commercial-readiness activities for Exelbine, a
$0.9 million increase in personnel
costs, mainly due to additional staff hired in 2011, a $0.2 million increase in investor relations
consulting expenses, a $0.1 million
increase in share-based compensation expense and a $0.1 million increase in facility costs.
Transaction-related expenses for the year ended December 31, 2011 were $0.4 million compared to $0.3 million for 2010. Transaction-related
expenses for 2011 consisted of $1.9
million related to legal, accounting, financial and business
development advisory fees associated with the evaluation of
potential acquisition targets, including SynthRx, and execution of
the SynthRx acquisition, offset by a $1.5
million reduction due to changes since the acquisition date
in the fair value of the contingent asset and contingent liability
related to the SynthRx acquisition. Transaction-related
expenses for 2010 consisted of $0.3
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 December 31, 2011, the
Company had cash, cash equivalents and short-term investments
totaling $50.7 million.
Stockholders' equity amounted to $56.8
million as of December 31,
2011.
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. 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; 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 (1)
(In thousands except per share
data)
|
|
|
|
|
Three months
ended
December
31,
(Unaudited)
|
Year
ended
December
31,
|
|
|
2011
|
2010
|
2011 (2)
|
2010 (1)(2)
|
|
|
|
|
|
|
|
Total net
revenue
|
$ —
|
$ 489
|
$ —
|
$ 489
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
Research and
development
|
1,754
|
898
|
5,758
|
3,689
|
|
Selling, general
and administrative
|
1,810
|
1,595
|
7,190
|
4,990
|
|
Transaction-related expenses
|
(1,130)
|
302
|
411
|
330
|
|
Depreciation
and amortization
|
9
|
3
|
38
|
20
|
|
Total
operating expenses
|
2,443
|
2,798
|
13,397
|
9,029
|
|
|
|
|
|
|
|
Loss from operations
|
(2,443)
|
(2,309)
|
(13,397)
|
(8,540)
|
|
|
|
|
|
|
|
Interest and other income,
net
|
71
|
24
|
137
|
89
|
|
|
|
|
|
|
|
Net loss
|
(2,372)
|
(2,285)
|
(13,260)
|
(8,451)
|
|
|
|
|
|
|
|
Deemed dividends on preferred
stock
|
—
|
—
|
—
|
(5,640)
|
|
|
|
|
|
|
|
Net loss applicable to common
stock
|
$
(2,372)
|
$
(2,285)
|
$
(13,260)
|
$
(14,091)
|
|
|
|
|
|
|
|
Net loss per share – basic and
diluted
|
$
(0.06)
|
$
(0.15)
|
$
(0.47)
|
$
(1.07)
|
|
|
|
|
|
|
|
Weighted average shares – basic
and diluted
|
37,091
|
14,921
|
28,175
|
13,181
|
|
|
|
|
|
|
|
|
|
(1)
|
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.
|
|
|
|
|
(2)
|
The condensed consolidated
statements of operations for the years ended December 31, 2011 and
2010 have been derived from the audited financial statements but do
not include all of the information and footnotes required by
accounting principles generally accepted in the United States for
complete financial statements.
|
|
|
|
ADVENTRX
Pharmaceuticals, Inc.
(A Development Stage
Enterprise)
Balance Sheet
Data
(In thousands)
|
|
|
|
|
December
31,
2011
|
|
December
31,
2010
|
|
|
|
|
|
|
Cash, cash equivalents and
short-term investments
|
$ 50,704
|
|
$ 27,979
|
|
|
|
|
|
|
Working capital
|
49,323
|
|
26,608
|
|
|
|
|
|
|
Total assets
|
61,856
|
|
28,487
|
|
|
|
|
|
|
Total
liabilities
|
5,078
|
|
1,801
|
|
|
|
|
|
|
Stockholders'
equity
|
56,779
|
|
26,685
|
|
|
|
|
|
|
|
SOURCE ADVENTRX Pharmaceuticals, Inc.