SAN DIEGO, Oct. 20 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.
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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.
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"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 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 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.
SOURCE ADVENTRX Pharmaceuticals, Inc.
