SAN DIEGO, Aug. 6, 2012 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE MKT: ANX) today reported financial
results for the quarter ended June 30,
2012.
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"We start the second half of 2012 with a strong cash position of
over $43 million, reflective of a
$3.0 million cash burn for the second
quarter," stated Brian M. Culley,
Chief Executive Officer of ADVENTRX. "With the advice of our
Regulatory Advisory Board, we are working to finalize the protocol
for our phase 3 study of ANX-188 in sickle cell disease.
Additionally, our manufacturing partner, Pierre Fabre, has begun manufacturing the active
ingredient for use in the study."
"To maximize the potential of ANX-188 to protect tissue from
ischemic injury and reduce end-organ damage, we have been
evaluating ANX-188 in other indicationsas part of our comprehensive
development program. Later this year, we expect to announce
our plans for ANX-188 in an indication outside of sickle cell
disease. We have been working with a leading university on
the protocol for a Phase 2 study that could begin in the first half
of 2013 and read-out approximately 18 monthsthereafter," Mr. Culley
continued.
Second Quarter 2012 Operating Results
ADVENTRX's net loss for the second quarter of 2012 was
$4.2 million, or $0.09 per share (basic and diluted), compared to
a net loss of $4.4 million, or
$0.17 per share (basic and diluted),
for the same period in 2011.
Research and development (R&D) expenses for the second
quarter of 2012 were $2.1 million, an
increase of $0.8 million, or 57%,
compared to $1.3 million for the same
period in 2011. The increase was primarily due to a $0.4 million increase in external nonclinical
study fees and expenses and a $0.4
million increase in personnel costs. The increase in
external nonclinical study fees and expenses was primarily related
to increased research-related manufacturing expenses of
$0.6 million for ANX-514 and
$0.5 million for ANX-188, offset by a
$0.7 million decrease in
research-related manufacturing expenses related to
Exelbine™. The increase in research-related
manufacturing expenses for ANX-514 was primarily due to recognition
of an impairment loss on equipment used to manufacture clinical
trial material and other expenses related to discontinuation of
ANX-514 manufacturing activities.
Selling, general and administrative (SG&A) expenses for the
second quarter of 2012 were $1.9
million, an increase of $0.1
million, or 3%, compared to $1.8
million for the same period in 2011. The increase was due
primarily to an increase of $0.3
million in personnel costs and a $0.2
million increase in share-based compensation expense, offset
by a $0.4 million decrease in
consulting fees and legal expenses. The decrease in
consulting fees and legal expenses was primarily due to
cost-savings realized by discontinuation of commercial-readiness
activities related to Exelbine.
Transaction-related expenses for the second quarter of 2012 were
$0.2 million compared to $1.2 million for the same period in 2011.
Transaction-related expenses for the second quarter of 2012
consisted of $0.2 million associated
with changes since March 31, 2012 in
the fair values of the contingent asset and contingent liability
related to our acquisition of SynthRx. Transaction-related expenses
for the second quarter of 2011 consisted of $1.0 million related to legal, 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 values of contingent consideration related to our
acquisition of SynthRx.
Year-to-Date Operating Results
ADVENTRX's net loss for the six months ended June 30, 2012 was $8.4
million, or $0.18 per share
(basic and diluted), compared to a net loss of $7.3 million, or $0.30 per share (basic and diluted), for the same
period in 2011.
R&D expenses for the six months ended June 30, 2012 were $4.3
million, an increase of $2.3
million, or 121%, compared to $2.0
million for the same period in 2011. The increase was
primarily due to a $1.5 million
increase in external nonclinical study fees and expenses, a
$0.7 million increase in personnel
costs, and a $0.1 million increase in
external clinical study fees and expenses. The increases in
external nonclinical study fees and expenses were primarily related
to increased research-related manufacturing expenses of
$1.4 million for ANX-188 and
$1.1 million for ANX-514, offset by a
$1.0 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 of $0.3 million for ANX-188, offset by a
$0.2 million decrease in clinical
consulting expenses for Exelbine.
SG&A expenses for the six months ended June 30, 2012 were $3.9
million, an increase of $0.5
million, or 15%, compared to $3.4
million for the same period in 2011. The increase was due
primarily to an increase of $0.6
million in personnel costs and a $0.4
million increase in share-based compensation expense, offset
by a $0.5 million decrease in
consulting fees and legal expenses.
Transaction-related expenses for the six months ended
June 30, 2012 were $0.1 million compared to $2.0 million for the same period in 2011.
Transaction-related expenses for the six months ended June 30, 2012 consisted of $0.1 million associated with changes since
December 31, 2011 in the fair values
of the contingent asset and contingent liability related to our
acquisition of SynthRx. Transaction-related expenses for the six
months ended June 30, 2011 consisted
of $1.8 million related to legal,
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 our
acquisition of SynthRx.
Balance Sheet Highlights
As of June 30, 2012, the Company
had cash, cash equivalents and short-term investments totaling
$43.1 million. Stockholders' equity
amounted to $49.1 million as of
June 30, 2012.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company
developing proprietary product candidates to treat various diseases
and conditions. The Company's lead product candidate, ANX-188, has
potential to reduce ischemic tissue injury and end-organ damage by
restoring microvascular function which is compromised in a
wide range of serious and life-threatening diseases and
conditions. The Company initially is developing ANX-188 as a
treatment for complications arising from sickle cell disease. 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 progress regarding the manufacture of
clinical trial material. 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 not limited to: the potential for delays in the
commencement or completion of 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
agreement on clinical study design or meeting applicable regulatory
requirements for 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 are not successful
and, even if they are successful, that the FDA could determine they
are not sufficient to support an NDA for the product candidate; the
potential for ADVENTRX to delay, reduce or discontinue current
and/or planned development activities, including clinical studies,
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 risk that the FDA does not grant marketing
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
preparation of 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
June
30,
(Unaudited)
|
Six
months ended
June
30,
(Unaudited)
|
|
2012
|
2011
|
2012
|
2011
|
|
|
|
|
|
|
Total net
revenue
|
$
—
|
$
—
|
$
—
|
$
—
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
2,108
|
1,343
|
4,318
|
1,954
|
Selling, general and
administrative
|
1,871
|
1,824
|
3,916
|
3,398
|
Transaction-related
expenses
|
206
|
1,229
|
92
|
2,029
|
Depreciation and
amortization
|
37
|
10
|
67
|
20
|
Total operating
expenses
|
4,222
|
4,406
|
8,393
|
7,401
|
|
|
|
|
|
Loss from
operations
|
(4,222)
|
(4,406)
|
(8,393)
|
(7,401)
|
|
|
|
|
|
Interest
and other income, net
|
11
|
14
|
29
|
52
|
|
|
|
|
|
Net
loss
|
$
(4,211)
|
$
(4,392)
|
$
(8,364)
|
$
(7,349)
|
|
|
|
|
|
Net loss
per share – basic and diluted
|
$
(0.09)
|
$
(0.17)
|
$
(0.18)
|
$
(0.30)
|
|
|
|
|
|
Weighted
average shares – basic and diluted
|
47,716
|
26,250
|
47,716
|
24,513
|
ADVENTRX Pharmaceuticals, Inc.
|
(A
Development Stage Enterprise)
|
Balance
Sheet Data
|
(In
thousands)
|
|
|
June
30,
2012
(Unaudited)
|
|
December 31,
2011
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
43,075
|
|
$
50,704
|
|
|
|
|
Working
capital
|
41,792
|
|
49,323
|
|
|
|
|
Total
assets
|
54,180
|
|
61,856
|
|
|
|
|
Total
liabilities
|
5,102
|
|
5,078
|
|
|
|
|
Stockholders' equity
|
49,078
|
|
56,779
|
SOURCE ADVENTRX Pharmaceuticals, Inc.