SOURCE: Agennix AG

Agennix AG

November 06, 2009 03:43 ET

Agennix AG Shares Begin Trading on Frankfurt Stock Exchange

Company Provides Business Update

MARTINSRIED/MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - November 6, 2009) - Agennix AG (FRANKFURT: AGX) (XETRA: AGX) today announced that its shares have begun trading on the Prime Standard of the Frankfurt Stock Exchange under the symbol AGX. The Company also provided an update on its business. As previously announced, additional details will be discussed in a conference call today, November 6, 2009 at 8:00 AM ET/14:00 CET.

Financial update

The Company reported that Agennix AG's cash and cash equivalents position (pro forma) at September 30, 2009 was EUR 17.9 million. The Company expects to have sufficient cash to fund operations into the second quarter of 2010. Agennix is considering different possible near-term financing options to further fund its ongoing clinical development efforts.

The Company also announced that financial results for the third quarter of 2009 will be reported on November 23, 2009. Since the merger did not close until after the end of the third quarter, the results will be those of GPC Biotech only. The Company will also provide more detailed guidance for 2010 at that time.

Development programs update

Agennix also provided an update on its clinical development programs.

Talactoferrin:

Enrollment in the FORTIS-M Phase 3 trial is on track and will soon be expanded to Europe and the rest of the world. The FORTIS-M trial is a randomized, double-blind, placebo-controlled trial evaluating talactoferrin plus best supportive care versus placebo plus best supportive care in non-small cell lung cancer (NSCLC) patients whose disease has progressed after two or more prior treatment regimens.

Enrollment in the FORTIS-C trial is ongoing at select sites in the U.S. The FORTIS-C trial is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating talactoferrin in combination with carboplatin and paclitaxel versus placebo in combination with carboplatin and paclitaxel as a first-line therapy in patients with locally advanced or metastatic NSCLC.

Agennix has conducted two open label Phase 2 trials that evaluated talactoferrin as a monotherapy in renal cell carcinoma (RCC). The data from these trials suggest that talactoferrin has anti-cancer activity and is well tolerated in patients with RCC. Given that the standard of care has changed since these studies were conducted, the Company would anticipate continuing development in RCC in combination with other therapies rather than as a monotherapy. Therefore, Agennix is considering initiating a Phase 2b trial in combination with Sutent® (sunitinib) in patients with RCC.

Data in the Phase 2 trial in severe sepsis is on target to be available at the end of the fourth quarter of 2009.

RGB-286638: Dose escalation in the ongoing Phase 1 trial in solid tumors continues, with initial data expected in the second half of 2010. A Phase 1 trial in hematological tumors is expected to start in the first half of 2010 and will be conducted at the Dana-Farber Cancer Institute/Massachusetts General Hospital in Boston, MA, USA.

Satraplatin: Discussions continue with the Company's partner for satraplatin in Japan, Yakult Honsha Co. Ltd., and other potential partners.

Reminder: conference call scheduled

Agennix AG will hold a conference call today, Friday, November 6, 2009 at 8 AM ET/14:00 CET to provide a business update. Participants may listen via live webcast, accessible through the Agennix Web site at www.agennix.com, or via telephone. A replay will be available on the Web site following the live event. The call will be conducted in English. The dial-in numbers for the call are as follows:

Participants from Europe:     0049 (0) 69 667775756
                              0044 (0) 20 3003 2666

Participants from the U.S.:   1-646-843-4608

Please dial in 10 minutes before the beginning of the meeting.

About Agennix AG

Agennix AG is a publicly traded biopharmaceutical company focused on developing novel anti-cancer therapies. The Company was formed by the combination of GPC Biotech AG and Agennix Incorporated. The Company's most advanced program is talactoferrin, an oral targeted therapy that is in Phase 3 clinical trials in non-small cell lung cancer. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase 1 testing; the oral platinum-based compound satraplatin; and a topical gel form of talactoferrin for wound healing. Agennix is a transatlantic company with sites in Munich, Germany; Princeton, New Jersey and Houston, Texas. For additional information, please visit the Agennix Web site at www.agennix.com.

This press release contains forward-looking statements, which express the current beliefs and expectations of the management of Agennix AG. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. Forward-looking statements speak only as of the date on which they are made and Agennix undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.

Sutent® is a registered trademark of Pfizer Inc.

Contact Information

  • For further information, please contact:

    Agennix AG
    Investor Relations & Corporate Communications
    Phone: +49 (0)89 8565-2693
    ir@agennix.com

    In the U.S.: Laurie Doyle
    Director, Investor Relations & Corporate Communications
    Phone: +1 713-552-1091 or +1 609-524-5884
    laurie.doyle@agennix.com

    Additional media contacts for Europe:
    MC Services AG
    Phone: +49 (0) 89 210 228 0
    Raimund Gabriel
    raimund.gabriel@mc-services.eu


    Hilda Juhasz
    hilda.juhasz@mc-services.eu

    Additional investor contact for Europe:
    Trout International LLC
    Lauren (Rigg) Williams, Vice President
    Phone: +44 207 936 9325
    lrigg@troutgroup.com