SOURCE: Pipex Pharmaceuticals, Inc.

August 13, 2007 08:11 ET

Pipex Pharmaceuticals Announces Second Quarter 2007 Results

Webcast/Call Monday, August 13, at 8:30 a.m. ET

ANN ARBOR, MI--(Marketwire - August 13, 2007) - Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today its results and achievements for the three and six month periods ended June 30, 2007.

The highlights for the second quarter and first half of 2007 include:

--  Initiated patient enrollment for TRIMESTA (oral estriol) for multiple
    sclerosis (MS) in a multi-center Phase II/III clinical trial for the
    treatment of women with relapsing-remitting MS under a $5 million grant
    from the Southern California Chapter of the National MS Society, with
    participation of the NIH;
    
--  Presentation of results of the one year open-label phase I/II clinical
    trial of COPREXA (oral tetrathiomolybdate) for the treatment of refractory
    Idiopathic Pulmonary Fibrosis (IPF) at the American Thoracic Society (ATS)
    annual meeting;
    
--  Achieved listing on the American Stock Exchange (AMEX) on June 26th;
    
--  Scientific collaborators received a $300,000 grant from the NIH for
    COPREXA (oral tetrathiomolybdate) to support testing of its utility for the
    treatment for Alzheimer's disease (AD), a neurodegenerative disease in
    which copper dyshomeostasis is implicated.
    
--  Expanded the management team through the addition of key personnel in
    manufacturing and clinical affairs;
    
--  Built out and equipped a 15,000 sq. ft. pharmaceutical manufacturing
    facility in Ann Arbor, MI for the cGMP commercial production of COPREXA and
    potential follow-on products of Pipex.
    

Steve H. Kanzer, Chairman and Chief Executive Officer of Pipex, commented, "We made substantial progress during the second quarter and first half of 2007 in assembling our New Drug Application (NDA) for COPREXA (oral tetrathiomolybdate) for neurologically-presenting Wilson's disease, as well as building out and staffing our new pharmaceutical manufacturing facility in Ann Arbor, Michigan for the production and commercialization of COPREXA and potential follow-on products. Our goal remains to file the NDA for COPREXA in October of this year and we will be updating shareholders regarding this goal during the third week of September. Pipex has achieved substantial growth during the first half of this year and I wish to compliment our initial and new employees on their efforts including the successful transition to our new facilities."

Today, August 13th, at 8:30 a.m. ET, Pipex will host an investor conference call during which they will provide a brief financial overview of the Company's second quarter financial results.

Financial Results for the Second Quarter 2007:

At June 30, 2007, Pipex had cash of $9.1 million, compared to $12.2 million at December 31, 2006. The decrease of $3.1 million is attributable primarily to net cash used in operations of approximately $2.5 million and net cash used to purchase property and equipment of approximately $1.2 million offset by the proceeds from a note payable of $600,000.

The net loss applicable to common shareholders for the quarter ended June 30, 2007 was $1,762,503, or $0.10 per share, compared to a net loss applicable to common shareholders of $716,158, or $0.46 per share, for the comparable quarter in 2006, representing an increase in net loss of $1,046,345. The increase in net loss was primarily attributable to an increase in research and development expenses totaling $674,114 that primarily related to Pipex's COPREXA™ NDA directed activities, including establishing a GMP manufacturing facility in Ann Arbor, MI and hiring the necessary clinical, regulatory and manufacturing personnel, as well as activities associated with development of Pipex's other product candidates, TRIMESTA, CORRECTA, Anti-CD4 802-2 and EFFIRMA.

The net loss applicable to common shareholders for the six months ended June 30, 2007 was $17,021,660, or $1.00 per share, compared to the net loss applicable to common shareholders of $1,421,939, or $0.90 per share, for the six months ended June 30, 2006, representing an increase of $15,599,721. The increase in net loss was primarily attributable to a non-cash charge of $12,409,722 related to the acquisition of Effective Pharmaceuticals, Inc. ("EPI") in the first quarter of 2007. This charge was reflected through equal and offsetting adjustments to additional paid-in-capital with no net impact on stockholders' equity. Also contributing to the increase in net loss is an increase in research and development expenses of $1,759,918 that primarily related to Pipex's COPREXA NDA directed activities, including establishing a GMP manufacturing facility in Ann Arbor, MI and hiring the necessary clinical, regulatory and manufacturing personnel, as well as activities associated with development of Pipex's other product candidates, TRIMESTA, CORRECTA, Anti-CD4 802-2 and EFFIRMA. The increase in net loss was also due to a $1,757,304 increase in general and administrative expense which includes a non-cash stock-based compensation charge of $1,061,976.

In order to participate in the webcast/conference call, please call toll free: 866-696-5911 (US); international dial-in: 416-641-6111. A visual presentation will be available at: http://www.visualwebcaster.com/event.asp?id=41706. The audio recording and visual presentation will be available for replay at http://www.pipexpharma.com for a period of at least15 days after the call.

About Pipex Pharmaceuticals, Inc.

Pipex Pharmaceuticals, Inc. ("Pipex") is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of neurologic and fibrotic diseases. Pipex's strategy is to exclusively in-license proprietary, clinical-stage drug candidates and complete the further clinical testing, manufacturing and regulatory requirements sufficient to seek marketing authorizations via the filing of New Drug Applications (NDAs) with the FDA in the U.S. and Marketing Application Authorizations (MAAs) with the European Medicines Evaluation Agency (EMEA). For further information, please visit, www.pipexpharma.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect Pipex Pharmaceuticals, Inc. and subsidiaries ("we," "our" or "Company") current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential for a regulatory filing with the FDA, as well as uses of COPREXA for various uses including the treatment of Idiopathic Pulmonary Fibrosis (IPF), Alzheimer's disease, inflammatory and fibrotic diseases, its the prospects for regulatory filings in the treatment of neurologic Wilson's disease, our ability to manufacture COPREXA and our products under GMP, as well as our ability to meet the continued listing standards of the American Stock Exchange and the ability of our common stock to develop liquidity. Where possible, the Company has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. We cannot assure you that we will be able to successfully develop or commercialize products based on our technologies, including COPREXA, TRIMESTA, Z-MONOCYS, SOLOVAX, EFFIRMA or Anti-CD4 802-2, particularly in light of the significant uncertainty inherent in developing, manufacturing and conducting preclinical and clinical trials of new pharmaceuticals, and obtaining regulatory approvals, that our technologies will prove to be safe and effective, that our cash expenditures will not exceed projected levels, that we will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that we will be able to successfully obtain any further grants and awards, maintain our existing grants which are subject to performance, that we will be able to patent, register or protect our technology from challenge and products from competition or maintain or expand our license agreements with our current licensors, or that our business strategy will be successful. All forward-looking statements made in this press release are made as of the date hereof, and the Company assumes no obligation to update the forward-looking statements included in this news release whether as a result of new information, future events, or otherwise, other than as required by law. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements, including risks detailed in the Company's SEC reports, including the Company's Form 10-KSB and Form 10-QSB. Copies of the filings are available at www.sec.gov.

Contact Information

  • For Further Information Contact:

    Steve H. Kanzer, CPA, Esq.
    Chairman and Chief Executive Officer
    (734) 332-7800
    www.pipexpharma.com

    Redington, Inc. (Investor Relations)
    Thomas Redington
    203-222-7399
    www.redingtoninc.com