ADVENTRX's second quarter net loss decreases to $4.4 million

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today reported financial results for the periods ended June 30, 2011.

"As we head into the second half of the year, we are taking steps to prepare for our launch of Exelbine™ into the U.S. market, should it be approved on or around FDA's PDUFA goal date of September 1, 2011," said Brian M. Culley, Chief Executive Officer of ADVENTRX.  "Having a commercial infrastructure will expand our strategic options and increase stockholder value."

"In parallel, we are working to finalize the protocol for a phase 3 pediatric study of ANX-188, our first-in-class treatment for sickle cell crisis, for which FDA has granted orphan drug designation. We plan to initiate this study in 2012.  There are no FDA-approved drugs designed to treat patients in crisis, making this an area of significant unmet need," Mr. Culley continued.  

"We also are excited about ANX-514, our detergent-free reformulation of the blockbuster drug Taxotere®, which recently went off-patent.  We plan to meet with FDA in the next quarter to discuss a single, additional study in which we compare the safety profiles of Taxotere with corticosteroid premedication and ANX-514 without corticosteroid premedication.  We believe this single study will provide sufficient clinical data to support a new drug application, should the study demonstrate comparable safety profiles between ANX-514 and Taxotere, and a competitive advantage over Taxotere and other detergent-containing formulations of docetaxel," Mr. Culley concluded.  

Second Quarter 2011 Operating Results

ADVENTRX's net loss applicable to common stock for the second quarter of 2011 was $4.4 million, or $0.17 per share, compared to a net loss applicable to common stock of $5.0 million, or $0.39 per share, for the same period in 2010. Included in the net loss applicable to common stock for the second quarter of 2010 was a non-cash, deemed dividend expense of $3.1 million incurred in connection with the Company's May 2010 equity financing.

Research and development (R&D) expenses for the second quarter of 2011 were $1.3 million, an increase of $0.7 million, or 112%, compared to $0.6 million for the same period in 2010. The increase was due primarily to a $0.5 million increase in external nonclinical study fees and expenses and a $0.2 million increase in external bioequivalence and clinical trial fees and expenses.  The increase in external nonclinical study fees and expenses resulted primarily from a $0.5 million increase in research-related manufacturing expenses for Exelbine™.  The increase in external bioequivalence and clinical trial fees and expenses is primarily related to increased clinical trial work of $0.1 million for Exelbine™ and clinical consulting expenses of $0.1 million for ANX-188.

Selling, general and administrative (SG&A) expenses for the second quarter of 2011 were $1.8 million, an increase of $0.5 million, or 40%, compared to $1.3 million for the same period in 2010. The increase was due primarily to a $0.2 million increase in personnel costs, mainly due to an accrual for estimated bonus expense related to 2011 performance, and a $0.3 million increase in commercial-readiness activities for Exelbine™.

Transaction-related expenses for the second quarter of 2011 were $1.2 million compared to $0 for the same period in 2010.  Transaction-related expenses consisted of $1.0 million related to legal, accounting, financial and business development advisory fees associated with the evaluation of potential acquisition targets, including SynthRx, and $0.2 million related to changes in the fair value of contingent consideration related to the SynthRx acquisition.

Year-to-Date Operating Results

ADVENTRX's net loss applicable to common stock for the six months ended June 30, 2011 was $7.3 million, or $0.30 per share, compared to a net loss applicable to common stock of $10.0 million, or $0.86 per share, for the same period in 2010. Included in the net loss applicable to common stock for the six months ended June 30, 2010 was a non-cash, deemed dividend expense of $5.6 million incurred in connection with the Company's January and May 2010 equity financings.

Research and development (R&D) expenses for the six months ended June 30, 2011 were $2.0 million, an increase of $0.1 million, or 4%, compared to $1.9 million for the same period in 2010. The increase was due primarily to a $0.3 million increase in external bioequivalence and clinical trial fees and expenses, a $0.1 million increase in personnel costs, offset by a $0.3 million decrease in external nonclinical study fees and expenses.  The increase in external bioequivalence and clinical trial fees and expenses is primarily related to increased clinical trial work of $0.2 million for Exelbine™ and clinical consulting expenses of $0.1 million for ANX-188.  The decrease in external nonclinical study fees and expenses resulted primarily from a $0.5 million decrease in research-related manufacturing expenses for ANX-514, a $0.4 million decrease in regulatory consulting services for ANX-514, offset by an increase of $0.5 million in research related manufacturing expenses for Exelbine™ and an increase of $0.1 million in analytical development expenses for ANX-188.

Selling, general and administrative (SG&A) expenses for the six months ended June 30, 2011 were $3.4 million, an increase of $0.9 million, or 37%, compared to $2.5 million for the same period in 2010. The increase was due primarily to a $0.4 million increase in personnel costs, mainly due to an accrual for estimated bonus expense related to 2011 performance and additional staff hired in 2011, and a $0.5 million increase in commercial-readiness activities for Exelbine™.

Transaction-related expenses for the six months ended June 30, 2011 were $2.0 million compared to $0 for the same period in 2010.  Transaction-related expenses consisted of $1.8 million related to legal, accounting, financial and business development advisory fees associated with the evaluation of potential acquisition targets, including SynthRx, and $0.2 million related to changes in the fair value of contingent consideration related to the SynthRx acquisition.

Balance Sheet Highlights

As of June 30, 2011, the Company had cash totaling $42.0 million. Stockholders' equity amounted to $46.4 million as of June 30, 2011.  

Source:

ADVENTRX Pharmaceuticals, Inc.

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