Conference call scheduled for 1:30 p.m. (Pacific); simultaneous webcast at
http://www.adventrx.com
SAN DIEGO, May 7 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals,
Inc. (Amex: ANX) a biopharmaceutical research and development company
focused on commercializing proprietary product candidates for the treatment
of cancer and infectious diseases, today announced financial results for
the three months ended March 31, 2007. ADVENTRX's net loss was $5.1
million, or $0.06 per share for the three months ended March 31, 2007,
compared to a net loss of $4.0 million, or $0.06 per share, for the same
period in 2006.
"ADVENTRX has expanded its product candidate portfolio substantially
over the past year and is rapidly advancing its product candidates into the
clinic," stated Evan M. Levine, chief executive officer of ADVENTRX.
"Depending on preclinical results and anticipated discussions with the FDA,
we may have up to five product candidates in clinical development by the
end of the year. In the interim, we look forward to announcing results of
our 300- patient Phase 2b clinical trial of CoFactor for the treatment of
metastatic colorectal cancer and results from our marketing-enabling study
of ANX-530 later this year."
First Quarter 2007 Operating Results
Research and development, or R&D, expenses increased by $901,000, or
36%, to $3.4 million for the three months ended March 31, 2007 from $2.5
million for the same period a year ago. The increase in R&D expenses was
primarily due to a $377,000 increase related to pre-clinical development of
ANX-530 (vinorelbine emulsion) and preclinical development of ANX-201
(thiophosphonoformate), and a $390,000 increase in personnel and employee-
related costs. R&D expenses for the three months ended March 31, 2007
included $254,000 in non-cash, share-based compensation expense, compared
to $133,000 for the same period a year ago.
Selling, general and administrative, or SG&A, expenses increased by
$1.1 million, or 62%, to $2.8 million for the three months ended March 31,
2007 from $1.7 million for the same period a year ago. The increase in SG&A
expenses was primarily due to a $252,000 increase in legal fees related to
patent costs, a $179,000 increase in market research for our product
candidates, and a $472,000 increase in personnel and employee-related
costs. SG&A expenses for the three months ended March 31, 2007 included
$391,000 in non-cash, share-based compensation expense, compared to
$495,000 for the same period a year ago.
Revenue of $500,000 for the three months ended March 31, 2007
represented a license fee earned from licensing ANX-211 (ZANAFLU(R) in the
U.S.) to Theragenex, compared to no revenue for the comparable period in
2006. ADVENTRX expects that Theragenex's subsidiary, TRx Pharma, will
launch ZANAFLU during the 2007 cold and influenza season. Interest income
amounted to $622,000 for the three months ended March 31, 2007, compared to
$237,000 for the same period a year ago.
Effective January 1, 2007, the Company adopted FASB Staff Position on
No. EITF 00-19-2, Accounting for Registration Payment Arrangements, or FSP
EITF 00-19-2. Pursuant to FSP EITF 00-19-2, the Company determined that no
contingent liability was required to be recognized as of March 31, 2007
relating to a class of warrants issued in July 2005 that contained a
registration payment arrangement, and accordingly, the carrying amount of
the warrant liability that had been reported in previous periods was
eliminated. In applying the new method retrospectively, the comparative
financial statements of prior periods have been adjusted to eliminate the
fair value of the warrant liability.
Balance Sheet Highlights
As of March 31, 2007, the Company had cash, cash equivalents and
investments in securities totaling $47.4 million, including cash and cash
equivalents of $21.0 million and short-term investments in securities of
$26.4 million. Stockholders' equity amounted to $45.8 million as of March
31, 2007.
Product and Pipeline Update
Recent activities of the Company include the following:
* Continuation of patient recruitment in the Company's 1,200-patient
Phase 3 pivotal clinical trial of ANX-510, or CoFactor, for the
treatment of metastatic colorectal cancer. The Company anticipates
completing enrollment in 2008.
* Announcement of positive results from a multi-drug treatment regimen
including CoFactor at the American Association for Cancer Research
(AACR) Annual Meeting.
* Continuation of patient recruitment in the Company's 31-patient
Phase 2 clinical trial of CoFactor for the treatment of advanced
breast cancer. The Company anticipates completing enrollment by the
end of 2007.
* Continuation of patient recruitment in a 28-patient marketing enabling
study of ANX-530 (vinorelbine emulsion), a chemotherapy drug used
alone or in combination with other drugs to treat non-small cell lung
cancer. The U.S. Food and Drug Administration accepted our
Investigational New Drug Application in December 2006. The Company
expects to complete the study in 2007 and, if it demonstrates
bioequivalence with the currently marketed product, Navelbine(R)
(vinorelbine tartrate), submit a New Drug Application by the end of
the year.
* Presentation of preclinical results demonstrating synergistic activity
against human and avian influenza (bird flu) viruses when combining
ANX-201 with Tamiflu(R) (oseltamivir phosphate). Preclinical
development of ANX-201 (thiophosphonoformate) for the treatment of HIV
continues and could progress to Phase 1/2 clinical development in
2007. An abstract was accepted for presentation at the International
AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention.
* Presentation of positive results from preclinical testing of ANX-514
(docetaxel emulsion), a chemotherapy product candidate, in a
well-recognized animal model. Study results indicated bioequivalent
pharmacokinetics with a reduced risk of hypersensitivity reactions
with ANX-514, as compared to the currently marketed product,
Taxotere(R) (docetaxel). The Company currently plans to seek guidance
from the FDA with respect to the appropriateness of a
Section 505(b)(2) NDA regulatory path for ANX-514, and pending
agreement on clinical protocol design with the FDA, initiate a
marketing-enabling clinical trial of ANX-514 in 2007.
Conference Call and Webcast
Management will host a conference call with a simultaneous webcast that
will take place on Monday, May 7 at 1:30 P.M. Pacific/4:30 P.M. Eastern to
discuss the first quarter of 2007. Evan M. Levine, Chief Executive Officer,
and Gregory P. Hanson, Senior Vice President and Chief Financial Officer,
are scheduled to lead the call and will be joined by other members of the
Company's senior management team. The webcast will be available live via
the Internet by accessing ADVENTRX's web site at http://www.adventrx.com under
"Investors" or by telephone at (877) 502-9274 (domestic) or (913) 981-5584
(international). Replays of the webcast will be available for 30 days, and
a phone replay will be available through June 7, 2007 by dialing
888-203-1112 and entering the passcode 4320902.
About ADVENTRX Pharmaceuticals
ADVENTRX is a biopharmaceutical research and development company
focused on commercializing product candidates for the treatment of cancer
and infectious diseases. The Company seeks to improve the performance and
safety of existing therapeutic products by addressing significant problems
such as drug metabolism, bioavailability, excessive toxicity and treatment
resistance. ADVENTRX's lead product candidate, ANX-510 (CoFactor(R)), is in
pivotal Phase 3 and Phase 2b clinical trials for the treatment of
metastatic colorectal cancer, as well as in a Phase 2 clinical trial for
the treatment of advanced breast cancer. The Company's business is in the
development stage; it has not yet marketed any products or generated any
significant revenue. More information can be found on ADVENTRX's web site
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 anticipated or stated
goals and milestones; the ability to timely enroll subjects in ADVENTRX's
current and anticipated clinical trials; the timing and success of clinical
trials; the potential for CoFactor and ADVENTRX's other product candidates
to receive regulatory approval for one or more indications on a timely
basis or at all; the uncertain process of seeking regulatory approval;
other difficulties or delays in developing, testing, manufacturing and
marketing of CoFactor and ADVENTRX's other product candidates; the
potential for regulatory authorities to require additional preclinical work
or other clinical requirements to support regulatory filings; the scope and
validity of patent protection for CoFactor and ADVENTRX's other product
candidates; adverse side effects or inadequate therapeutic efficacy of
CoFactor or ADVENTRX's other product candidates; the risk that preclinical
results are not indicative of the success of subsequent clinical trials and
that products will not perform as preclinical and clinical data suggest or
as otherwise anticipated; 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 assumes no
obligation to revise or update any forward-looking statement, including as
set forth in this press release, to reflect events or circumstances arising
after the date on which it was made.
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:
Quarters Ended March 31,
2007 2006
(Unaudited) (Unaudited)
Revenues $500 $--
Operating expenses:
Research and development 3,385 2,484
Selling, general and administrative 2,809 1,735
Depreciation and amortization 52 37
Total operating expenses 6,246 4,256
Loss from operations (5,746) (4,256)
Interest income 622 236
Loss before income taxes (5,124) (4,020)
Provision for income taxes -- --
Net loss $(5,124) $(4,020)
Net loss per share - basic and diluted $(0.06) $(0.06)
Weighted average shares - basic and diluted 89,677 67,976
Balance Sheet Data:
March 31, December 31,
2007 2006
(Unaudited)
Total cash and investments in securities $47,440 $51,745
Net working capital 45,401 49,889
Total assets 48,630 52,798
Total liabilities 2,814 2,484
Stockholders' equity 45,816 50,314
SOURCE ADVENTRX Pharmaceuticals, Inc.
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Related links:
http://www.adventrx.com/
http://www.prnewswire.com/comp/920134.html/
CONTACT:
Investors, Ioana C. Hone of ADVENTRX
Pharmaceuticals, Inc., +1- 858-552-0866; or Media, Amy Martini of
WeissComm Partners, +1-212-301-7233, for ADVENTRX
Pharmaceuticals, Inc.
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