ADVENTRX Provides Business Update Following Recent Financing Activity
October 20 2009 - 6:00AM
PR Newswire (US)
NDA Submission for ANX-530 on Track SAN DIEGO, Oct. 20
/PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE
Amex: ANX) today provided an update on its business that included
the intended use of proceeds from recent financings, the status of
its product candidates ANX-530 and ANX-514, and its plan for the
listing of its common stock. The Company also commented on the
recent resignations of Alexander J. Denner and Mark N.K. Bagnall
from its Board of Directors. The Company's current outlook reflects
its bolstered cash position following the closing of a financing
earlier this month that provided approximately $6 million in
proceeds (after deducting amounts placed in an escrow account to
make dividend and other payments due with respect to the
convertible preferred stock sold in the financing, but before
deducing placement agent fees and offering expenses). The Company
also raised approximately $3.8 million in proceeds in three
separate offerings in June, July and August of 2009. "This latest
equity offering eliminated a substantial amount of financing risk,"
said Brian M. Culley, Principal Executive Officer at ADVENTRX. "We
believe we now have the funds to support operations well into 2010
and, importantly, through the significant milestone of an FDA
decision on ANX-530. Our ability to attract investment capital on
four separate occasions in a difficult market is a positive
testimonial for our cost-effective business model, our lower-risk
product candidates and our core formulation technology." ADVENTRX
stated it plans to use the majority of the proceeds from its latest
offering to fund its operations during the FDA review period of an
ANX-530 NDA. The Company reiterated that it intends to submit the
NDA for ANX-530 by the end of 2009. ADVENTRX also continues to
evaluate its options for ANX-514, a reformulation of docetaxel. "We
remain confident in the potential of this product candidate, and
look forward to discussing the results of our clinical
bioequivalence study of ANX-514 with the FDA," said Mr. Culley. The
Company also announced that is has indefinitely postponed a
previously announced plan to voluntarily withdraw its common stock
listing from the NYSE Amex and list on the NASDAQ Capital Market.
The Company will remain on the NYSE Amex under the symbol "ANX."
Finally, ADVENTRX commented on the resignation of Alexander J.
Denner from its Board of Directors, noting that the resignation was
not the result of a disagreement with the Company on any matter
relating to its operations, policies or practices. "Dr. Denner's
recent resignation, as well as Mark's in August, are consistent
with our transformation to a leaner, specialty pharmaceutical
company leveraging an innovative drug development strategy that
seeks to bring improved versions of existing therapies to patients
in a quick and efficient manner. Alex's views and advice, over the
past year in particular, have been invaluable, and we wish him the
best." About ADVENTRX Pharmaceuticals ADVENTRX Pharmaceuticals is a
specialty pharmaceutical company whose product candidates are
designed to improve the safety of existing cancer treatments. More
information can be found on the Company'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 have insufficient capital to support its
operations during the FDA review of an ANX-530 NDA, including as a
result of ADVENTRX not submitting an ANX-530 NDA by December 31,
2009, or at all, the FDA requesting or ADVENTRX providing
additional information or clarification with respect to such
submission or the FDA not completing its review by the ANX-530
"PDUFA date;" the risk that ADVENTRX will be unable to raise
sufficient additional capital to commercialize ANX-530 or to
continue the development of ANX-514; the risk that ADVENTRX will be
unable to raise sufficient additional capital on a timely basis to
continue as a going concern; the risk that ADVENTRX will seek
protection under the provisions of the U.S. Bankruptcy Code; the
risk that ADVENTRX will reassess the results of the ANX-530
bioequivalence study and determine to conduct additional
bioequivalence studies of ANX-530, including in humans; the
potential for regulatory authorities to require additional
preclinical work and/or clinical activities to support regulatory
filings, including prior to the submission or the approval of an
NDA for ANX-530, which activities may increase the cost and
timeline to NDA submission or approval; the risk the FDA will
determine that ANX-530 and Navelbine® are not bioequivalent,
including as a result of performing pharmacokinetic equivalence
analysis based on a patient population other than the population on
which ADVENTRX based its analysis; the risk of investigator bias in
reporting adverse events as a result of the open-label nature of
the ANX-530 bioequivalence 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, including validating commercial
manufacturing processes and manufacturers, as well as suppliers;
the risk that the performance of third parties on whom ADVENTRX
relies to conduct its 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; the risk that
ADVENTRX's common stock will be delisted by the NYSE Amex,
including as a result of failing to maintain sufficient
stockholders' equity or a sufficient stock price; 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. DATASOURCE: ADVENTRX Pharmaceuticals, Inc.
CONTACT: Company, Brian Culley, Principal Executive Officer of
ADVENTRX Pharmaceuticals, +1-858-552-0866; or Investors, Don
Markley of Lippert/Heilshorn & Associates, Inc.,
+1-310-691-7100, Web Site: http://www.adventrx.com/
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