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
