Conference call scheduled for November 6, 2008 at 1:30 p.m.
(Pacific Time); simultaneous webcast at www.adventrx.com SAN DIEGO,
Nov. 6 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc.
(AMEX:ANX), a biopharmaceutical company focused on in-licensing,
developing and commercializing proprietary product candidates
primarily for the treatment of cancer, today reported financial
results for the three-month and nine-month periods ended September
30, 2008. "We recently restructured the company to curtail spending
while allowing us to continue to advance our lead product
candidates towards commercialization," stated Mark Bagnall, the
Company's Executive Vice President and Chief Financial Officer. "We
believe the market is undervaluing ANX-530 and ANX-514, both of
which have the potential to generate revenues in 2010." Three-Month
Period Ended September 30, 2008 Operating Results ADVENTRX's net
loss was $6.8 million, or $0.08 per share, for the three-month
period ended September 30, 2008, compared to a net loss of $5.9
million, or $0.07 per share, for the same period in 2007. Included
in the net loss for the three-month period ended September 30, 2008
were non-cash, share-based compensation expenses amounting to $0.4
million, compared to $0.7 million for the same period in 2007.
Research and development, or R&D, expenses increased by $0.3
million, or 7%, to $4.7 million for the three-month period ended
September 30, 2008, from $4.4 million for the same period a year
ago. The increase was primarily due to a $1.7 million increase in
expenses related to external research-related manufacturing and
regulatory and quality assurance activities related to ANX-530 and
ANX-514, offset by a $1.2 million decrease in external clinical
trial expenses related to ANX-530 and ANX-510, or CoFactor, a $0.1
million decrease in personnel costs and a $0.1 million decrease in
share-based compensation expense. R&D expenses for the
three-month period ended September 30, 2008 included non-cash,
share-based compensation expense amounting to $0.2 million,
compared to $0.3 million for the same period a year ago. Selling,
general and administrative, or SG&A, expenses increased by $0.1
million, or 5%, to $2.1 million for the three-month period ended
September 30, 2008, from $2.0 million for the same period a year
ago. The increase was primarily due to an increase in consulting
expenses for market research for ANX-530. SG&A expenses for the
three-month period ended September 30, 2008 included non-cash,
share-based compensation expenses amounting to $0.2 million,
compared to $0.4 million for the same period a year ago. Interest
and other income amounted to $0.1 million for the three-month
period ended September 30, 2008, compared to $0.5 million for the
same period a year ago. Nine-Month Period Ended September 30, 2008
Operating Results ADVENTRX's net loss was $19.1 million, or $0.21
per share, for the nine-month period ended September 30, 2008,
compared to a net loss of $16.8 million, or $0.19 per share, for
the same period in 2007. Included in the net loss for the
nine-month period ended September 30, 2008 were non-cash,
share-based compensation expenses amounting to $1.4 million,
compared to $1.9 million for the same period in 2007. In May 2008,
the Company settled its dispute with Theragenex. In consideration
of and conditioned upon Theragenex paying the Company an additional
$0.6 million, the parties agreed to jointly move to dismiss the
underlying arbitration action, and in connection with dismissing
the arbitration, agreed to release each other from any and all
claims related to their past relationship, including Theragenex's
rights under their prior agreement. For the nine-month period ended
September 30, 2008, the Company recognized $0.5 million in
licensing revenue, which represents a portion of the $0.6 million
Theragenex settlement payment. The additional $0.1 million was
recognized as other income. For the nine-month period ended
September 30, 2007, the Company recognized $0.5 million in
licensing revenue under its license agreement with Theragenex.
Since January 2007, the Company has received $1.1 million from
Theragenex. R&D expenses increased by $1.0 million, or 9%, to
$13.1 million for the nine-month period ended September 30, 2008,
from $12.1 million for the same period a year ago. The increase was
primarily due to a $3.9 million increase in expenses related to
external research-related manufacturing and regulatory and quality
assurance activities related to ANX-530 and ANX-514 and an increase
of $0.1 million in personnel and related costs, offset by a $2.9
million decrease in external clinical trial expenses related to
ANX-530 and CoFactor and a $0.1 million decrease in share-based
compensation expense. R&D expenses for the nine-month period
ended September 30, 2008 included non-cash, share-based
compensation expense amounting to $0.7 million, compared to $0.8
million for the same period a year ago. SG&A expenses increased
by $0.3 million, or 4%, to $7.1 million for the nine-month period
ended September 30, 2008, from $6.8 million for the same period a
year ago. The increase was primarily due to a $0.2 million
severance expense related to the departure of the Company's former
chief financial officer in April 2008 and an increase in consulting
expenses for market research for ANX-530. SG&A expenses for the
nine-month period ended September 30, 2008 included non-cash,
share-based compensation expenses amounting to $0.7 million,
compared to $1.1 million for the same period a year ago. Interest
and other income amounted to $0.6 million for the nine-month period
ended September 30, 2008, compared to $1.7 million for the same
period a year ago. Balance Sheet Highlights As of September 30,
2008, the Company had cash and cash equivalents totaling $15.3
million. Stockholders' equity amounted to $13.3 million as of
September 30, 2008. Business Update In October 2008, the Company
implemented a restructuring plan designed to reduce operating
costs, which included an approximately 27% reduction of the
Company's workforce. The Company discontinued active work on all
product candidates other than ANX-530 and ANX-514, including its
CoFactor program. As previously announced, enrollment in our
discontinued Phase 3 clinical trial of CoFactor was stopped,
however, patients currently receiving CoFactor in this trial will
continue to receive treatment. With respect to ANX-530 and ANX-514,
until it has secured additional funding, the Company anticipates
focusing primarily on those activities relating to submitting NDAs
for ANX-530 and ANX-514 and will delay or significantly reduce
spending on other work. After adjusting to reflect anticipated
severance costs, the Company expects the reduction-in-force will
reduce its compensation expenses in 2009 by approximately $1.5
million. Also in October 2008, Evan M. Levine resigned his
positions as Chief Executive Officer and President to pursue other
opportunities. Mr. Levine will continue to serve on the Company's
Board of Directors. The Company has informally begun a search for a
replacement Chief Executive Officer. In the interim, consistent
with the Company's CEO succession planning, ADVENTRX will be led by
a committee of executive officers. Mr. Bagnall will serve as the
Company's principal executive officer in addition to continuing in
his other capacities. Conference Call and Webcast ADVENTRX
management will host a conference call with simultaneous webcast to
discuss third quarter results, provide a corporate update and take
investors' questions today at 1:30 p.m. Pacific/4:30 p.m. Eastern.
Mark N.K. Bagnall, Executive Vice President and Chief Financial
Officer, is scheduled to lead the call and will be joined by other
members of the Company's senior management. The conference call may
be accessed by dialing (866) 550-6338 for domestic callers and
(347) 284-6930 for international callers. The webcast will be
available live via the Internet by accessing ADVENTRX's website at
http://www.adventrx.com/ under "Investors". Replays of the webcast
will be available on ADVENTRX's website for 30 days and a phone
replay will be available through November 11th, 2008 by dialing
(888) 203-1112 and entering the pass code 1669546. About ADVENTRX
Pharmaceuticals ADVENTRX Pharmaceuticals is a biopharmaceutical
company focused on in-licensing, developing and commercializing
proprietary product candidates primarily for the treatment of
cancer. The Company seeks to improve the performance and commercial
potential of existing treatments by addressing problems associated
with these treatment regimens. More information can be found on the
Company's website at http://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 involve risks and assumptions that,
if they materialize or do not prove to be accurate, could cause
ADVENTRX's results to differ materially from historical results or
those expressed or implied by such forward-looking statements.
These risks and uncertainties include, but are not limited to: the
risk that ADVENTRX will be unable to raise sufficient capital to
fund the projects necessary to meet its goals, including funding
the continued development and commercialization of ANX-530 or ANX
514; the risk that restructuring costs may be greater than
anticipated and ADVENTRX's October 2008 workforce reduction and any
future workforce and expense reductions may have an adverse impact
on its business; the risk the FDA will determine that ANX-530 and
Navelbine(R) are not bioequivalent, including as a result of
performing pharmacokinetic equivalence analysis based a patient
population other than the population on which we based our
analysis; the risk that the on-going clinical study of ANX-514 does
not demonstrate pharmacokinetic equivalence or bioequivalence; the
risk of investigator bias in reporting adverse events as a result
of the open-label nature of the ANX-530 bioequivalence clinical
study, including bias that increased the reporting of adverse
events associated with Navelbine and/or that decreased the
reporting of adverse events associated with ANX-530; difficulties
or delays in manufacturing, obtaining regulatory approval for and
marketing ANX-530 and ANX-514, including validating commercial
manufacturers and suppliers and the potential for automatic
injunctions regarding FDA approval of ANX-514; the potential for
regulatory authorities to require additional preclinical work or
other clinical requirements to support regulatory filings,
including prior to the submission or the approval of an NDA for
ANX-530 and ANX-514; the risk that the resignation of ADVENTRX's
former Chief Executive Officer and President and/or leadership by a
committee of executive officers will negatively impact the
Company's ability to execute its business plan; the risk that the
performance of third parties on whom the Company relies to conduct
studies or evaluate the data, including clinical investigators,
expert data monitoring committees, contract laboratories and
contract research organizations, may be substandard, or they 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 http://www.sec.gov/. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date when made. ADVENTRX does not intend to update any
forward-looking statement as set forth in this press release to
reflect events or circumstances arising after the date on which it
was made. (Tables to Follow) ADVENTRX Pharmaceuticals, Inc. and
Subsidiaries (A Development Stage Enterprise) Summary Condensed
Consolidated Financial Information (In 000s except for per share
data) Consolidated Statement of Operations Data: Three months ended
Nine months ended September 30, September 30, 2008 2007 2008 2007
(unaudited) (unaudited) (unaudited) (unaudited) Revenues $- $- $500
$500 Operating expenses: Research and development 4,741 4,422
13,073 12,047 Selling, general and administrative 2,075 1,979 7,076
6,795 Depreciation and amortization 40 45 131 150 Total operating
expenses 6,856 6,446 20,280 18,992 Loss from operations (6,856)
(6,446) (19,780) (18,492) Interest income 79 532 644 1,731 Loss
before income taxes (6,777) (5,914) (19,136) (16,761) Provision for
income taxes - - - - Net loss $(6,777) $ (5,914) $(19,136)
$(16,761) Net loss per share - basic and diluted $(0.08) $(0.07)
$(0.21) $(0.19) Weighted average shares - basic and diluted 90,253
90,008 90,253 89,798 Balance Sheet Data: September December 30,
2008 31, 2007 (unaudited) (audited) Total cash, cash equivalents
and investments in securities $15,306 $33,463 Net working capital
12,930 30,658 Total assets 17,265 34,542 Total liabilities 4,007
3,507 Stockholders' equity 13,258 31,035 DATASOURCE: ADVENTRX
Pharmaceuticals, Inc. CONTACT: Investors, Ioana C. Hone of ADVENTRX
Pharmaceuticals, +1-858-552-0866 Web site: http://www.adventrx.com/
Copyright
Adventrx (AMEX:ANX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Adventrx (AMEX:ANX)
Historical Stock Chart
From Jul 2023 to Jul 2024