SOURCE: Pipex Pharmaceuticals, Inc.

November 14, 2007 17:24 ET

Pipex Pharmaceuticals to Host Webcast to Discuss Results of Elevated Levels of Free Copper in Alzheimer's Disease and Third Quarter 2007 Results

Webcast/Call Thursday, November 15, at 8:30 a.m. ET

ANN ARBOR, MI--(Marketwire - November 14, 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 nine month periods ended September 30, 2007. Pipex will also hold a conference call on Thursday, November 15, 2007 at 8:30 a.m. EST to discuss results of elevated levels of free copper in Alzheimer's disease patients generated with the FreeBound device along with the third quarter 2007 highlights and financial results. Steve H. Kanzer, Chairman and Chief Executive Officer of Pipex, will host the call.

In order to participate in the webcast/conference call, please call toll free: 866-542-4236 (US); international dial-in: 416-641-6125. A visual presentation will be available at: http://www.visualwebcaster.com/event.asp?id=44145. The audio recording and visual presentation will be available for replay at www.pipexinc.com for a period of at least 15 days after the call.

Steve H. Kanzer, Chairman and Chief Executive Officer of Pipex, commented, "During the quarter, we made substantial progress with our proposed NDA filing for COPREXA for the treatment of initially presenting neurologic Wilson's disease. We look forward to continuing to update investors on our upcoming NDA filing by the end of this month."

The highlights for the third quarter of 2007 include:

--  Completed a series of pre-NDA meetings with the FDA regarding the
    Company's lead drug candidate, COPREXA (oral tetrathiomolybdate) and
    announced that Pipex plans to submit its New Drug Application (NDA) for
    COPREXA for the treatment of initially-presenting neurologic Wilson's
    disease in November 2007;
    
--  Submitted a pre-IDE (Investigational Device Exemption) application
    with the FDA for FreeBound, Pipex's novel device for the rapid detection of
    free copper levels in blood serum;
    
--  Received a broadly issued European patent which covers the use of
    estrogens, including oral TRIMESTA in combination with other FDA-approved
    multiple sclerosis therapies for the treatment of autoimmune diseases;
    
--  Received a Michigan Economic Development Job Training Grant (EDJT) to
    support the training of Pipex employees involved in the cGMP pharmaceutical
    production of the Company's lead product, COPREXA (oral tetrathiomolybdate)
    for neurologically-presenting Wilson's disease and potential additional
    product candidates of Pipex;
    
--  Received an equipment loan from the Bank of Ann Arbor to support
    Pipex's new cGMP pharmaceutical production facility which is primarily used
    for the Company's lead product, COPREXA (oral tetrathiomolybdate) for
    neurologically-presenting Wilson's disease and potential additional product
    candidates of Pipex.
    

Financial Results for the Third Quarter 2007:

At September 30, 2007, Pipex had cash of $7.4 million, compared to $12.2 million at December 31, 2006. After the close of the quarter, Pipex received approximately $7 million in gross proceeds from the exercise of warrants issued in connection with our 2006 private placement. The decrease of $4.8 million over the last nine months is attributable primarily to net cash used in operations of approximately $4.4 million and net cash used to purchase property and equipment of approximately $1.7 million offset by the proceeds from a note payable of $1.1 million.

The net loss applicable to common shareholders for the quarter ended September 30, 2007 was $2,120,942, or $0.12 per share, compared to a net loss applicable to common shareholders of $757,599, or $0.50 per share, for the comparable quarter in 2006, representing an increase in net loss of $1,363,343. The increase in net loss was primarily attributable to an increase in research and development expenses totaling $1,032,143 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, anti-CD4 802-2, CORRECTA, SOLOVAX, Z-monocysteine and EFFIRMA.

The net loss applicable to common shareholders for the nine months ended September 30, 2007 was $19,142,602, or $1.12 per share, compared to the net loss applicable to common shareholders of $2,179,538, or $1.43 per share, for the nine months ended September 30, 2006, representing an increase of $16,963,064. 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 attributing to the increase in net loss is an increase in research and development expenses of $2,792,060 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, anti-CD4 802-2, CORRECTA, SOLOVAX, Z-monocysteine and EFFIRMA. The increase in net loss was also due to a $2,140,559 increase in general and administrative expense which includes a non-cash stock-based compensation charge of $1,107,022.

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.pipexinc.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 COPREXA for the treatment of Alzheimer's disease, inflammatory and fibrotic diseases, as well as the prospects for regulatory filings in the treatment of neurologic Wilson's disease, including filing an NDA with the FDA during November 2007 and that this NDA will be accepted for filing by the FDA and/or that the FDA will agree with our analysis of data supporting the safety, clinical efficacy, manufacturing, stability and other regulatory requirements necessary for COPREXA to be approved for use in neurologically presenting Wilson's disease or that even if approved for initial indication, that we will be able to conduct and complete necessary initial and registration clinical trials required to support and receive FDA approval for a Supplemental New Drug Application to market COPREXA for the treatment of Alzheimer's disease or other disease indications, such as, idiopathic pulmonary fibrosis. 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, anti-CD4 802-2, CORRECTA, SOLOVAX, Z-monocysteine or EFFIRMA, 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.pipexinc.com

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