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EANS-News: Agennix AG Reports Financial Results for First Quarter of 2011

Geschrieben am 04-05-2011

Quarter highlighted by completion of enrollment in talactoferrin
Phase III FORTIS-M trial and issuance of key U.S. patent for
talactoferrin in oncology

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Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
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quarterly report

Subtitle: Quarter highlighted by completion of enrollment in
talactoferrin Phase III FORTIS-M trial and issuance of key U.S.
patent for talactoferrin in oncology

Planegg/Munich (Germany), Princeton, NJ and Houston, TX (euro adhoc)
- Agennix AG (Frankfurt Stock Exchange: AGX), a biopharmaceutical
company focused on developing novel therapies that have the potential
to substantially improve the length and quality of life of critically
ill patients in areas of major unmet medical need, today announced
financial results for the first quarter ended March 31, 2011.

Torsten Hombeck, Ph.D., Chief Financial Officer, said: "The first
quarter of 2011 was highlighted by the completion of patient
enrollment in the talactoferrin Phase III FORTIS-M trial, as well as
the issuance of an important U.S. patent covering the use of
talactoferrin to treat our lead indication, non-small cell lung
cancer. We expect to continue making solid progress in the months
ahead with the planned initiation of the Phase II portion of a Phase
II/III trial in severe sepsis during the second quarter. We also
expect data on talactoferrin to be presented at several upcoming
major medical meetings. In addition, we are adding to our internal
expertise with the selected hiring of highly experienced individuals
in critical areas as we prepare for topline data from the FORTIS-M
trial, expected in the first half of next year."

First quarter of 2011 compared to first quarter of 2010 The Company
did not recognize any revenue for the three months ended March 31,
2011 and 2010.

Research and development (R&D) expenses for the three months ended
March 31, 2011 were EUR 8.2 million compared to EUR 5.0 million for
the same period in 2010. The increase in R&D expenses was primarily
due to increased patient enrollment in the Company´s Phase III
FORTIS-M trial with talactoferrin and preparation for the planned
Phase II/III trial with talactoferrin in severe sepsis.
Administrative expenses for the three months ended March 31, 2011
were EUR 2.3 million compared to EUR 2.1 million for the same period
in 2010 due mainly to the Company engaging in certain critical
pre-commercialization activities.

Net loss before income tax benefit for the three months ended March
31, 2011 was EUR 11.5 million compared to EUR 6.0 million for the
same period in 2010. Income tax benefit for the three months ended
March 31, 2011 amounted to EUR 2.9 million (EUR 1.7 million for the
same period in 2010) and related to the net operating losses incurred
by the Company´s subsidiary, Agennix Incorporated, during the period.
Net loss for the three months ended March 31, 2011 was EUR 8.6
million compared to EUR 4.3 million for the same period in 2010.
Basic and diluted loss per share was EUR (0.21) for the three months
ended March 31, 2011, compared to EUR (0.23) for the same period in
2010.

Cash position As of March 31, 2011, cash, cash equivalents, other
current financial assets and restricted cash totaled EUR 66.2
million (December 31, 2010: EUR 79.3 million). Net cash burn for the
three months ended March 31, 2011 was EUR 11.5 million. Net cash burn
is derived by adding net cash used in operating activities and
purchases of property, equipment and intangible assets. The figures
used to calculate net cash burn are contained in the Company´s
interim consolidated cash flow statement for the respective periods.

Quarter over quarter results: first quarter of 2011 compared to
fourth quarter of 2010 The Company did not recognize any revenue in
the first quarter of 2011 or in the fourth quarter 2010. R&D expenses
were EUR 8.2 million for the first quarter of 2011 compared to EUR
9.5 million for the fourth quarter of 2010. Administrative expenses
for the first quarter of 2011 were EUR 2.3 million compared to EUR
3.6 million for the fourth quarter of 2010. The Company had a net
loss of EUR 8.6 million compared to EUR 7.6 million for the previous
quarter. Net loss before income tax benefit was EUR 11.5 million for
the first quarter of 2011 compared to net loss before income tax
benefit of EUR 10.2 million for the fourth quarter of 2010. Basic and
diluted loss per share was EUR (0.21) for the first quarter of 2011
compared to EUR (0.19) for the fourth quarter of 2010.

Financial guidance The Company provided the following financial
guidance, which is consistent with the guidance provided in March
2011 at the time Agennix reported its fiscal year 2010 results:

Cash position: Management believes that the Company will have
sufficient cash to fund its operations well into the second half of
2012. This should enable the Company to obtain top-line data in the
FORTIS M trial, expected in the first half of 2012, and to complete
the Phase II portion of the planned Phase II/III trial with
talactoferrin in severe sepsis, assuming no significant changes to
currently projected timelines. This projected cash reach also assumes
that the EUR 15 million loan made to the Company by dievini Hopp
BioTech holding GmbH & Co. KG in 2010 will not need to be re-paid
prior to the release of top-line results from both the FORTIS-M trial
and the Phase II portion of the Phase II/III trial in severe sepsis.
The Company will need to raise additional funds through licensing
agreements and/or through strategic and/or public equity or debt
investments to fund the Company´s operations beyond that point.

Revenues: Management expects no substantial cash-generating revenues
during 2011. This guidance does not consider cash revenue from the
potential partnering of the Company´s product candidates due to the
uncertainty of the timing of such events.

R&D expenses: For 2011, the Company expects R&D expenses to increase
compared to 2010 due to an expected increase in talactoferrin
clinical trial-related costs. Enrollment in the Phase III FORTIS-M
trial was completed in March 2011, and Agennix is planning to
initiate a Phase II/III trial with talactoferrin in severe sepsis in
the second quarter of this year.

Administrative expenses: Administrative expenses in 2011 are expected
to increase compared to 2010 as the Company plans to initiate certain
critical pre-commercialization efforts.

Conference call scheduled As previously announced, the Company has
scheduled a conference call to which participants may listen via live
webcast, accessible through the Agennix Web site at www.agennix.com
or via telephone. A replay will be available via the Web site
following the live event. The call, which will be conducted in
English, will be held today, May 4th at 15:00 CET/9:00 AM ET. The
dial-in numbers for the call are as follows:

Participants from Europe:
0049 (0)69 71044 5598
0044 (0)20 3003 2666

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

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

About Agennix Agennix AG is a publicly listed biopharmaceutical
company that is focused on the development of novel therapies that
have the potential to substantially improve the length and quality of
life of critically ill patients in areas of major unmet medical need.
The Company´s most advanced program is talactoferrin, an oral therapy
that has demonstrated activity in randomized, double-blind,
placebo-controlled Phase II studies in non-small cell lung cancer, as
well as in severe sepsis. Talactoferrin is currently in Phase III
clinical trials in non-small cell lung cancer, and Agennix plans to
develop this program further for the treatment of severe sepsis.
Other clinical development programs include RGB-286638, a
multi-targeted kinase inhibitor in Phase I testing, and a topical gel
form of talactoferrin for diabetic foot ulcers. Agennix´s registered
seat is in Heidelberg, Germany. The Company has three sites of
operation: Planegg/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,
including statements about the Company´s future cash position. Such
statements are based on current expectations and are subject to risks
and uncertainties, many of which are beyond the control of the
Company, 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. There can be
no guarantee that the results of the FORTIS-M trial or other ongoing
studies with talactoferrin will be obtained when expected, will be
positive or will be adequate to support a marketing approval.
Additionally, there can be no guarantee that talactoferrin will be
approved for marketing in any country or at all. There also can be
no guarantee that the Company will have sufficient monies to fund
operations well into the second half of 2012. Actual results could
differ materially depending on a number of factors, and management
cautions 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.

Agennix™ is a trademark of the Agennix group.

For the full management report and condensed consolidated financial
statements and accompanying notes for the first three months ended
March 31, 2011, please see the Investor Relations section of the
Agennix website at http://www.agennix.com/index.php?option=com_conten
t&view=article&id=161&Itemid=88&lang=en

end of announcement euro adhoc
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ots Originaltext: AGENNIX AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Agennix AG
Barbara Mueller
Manager, Investor Relations & Corporate Communications
Tel.: +49 89 8565-2693
ir@agennix.com

In the USA: Laurie Doyle
Senior Director, Investor Relations & Corporate Communications
Tel.: 609-524-5884
laurie.doyle@agennix.com

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

Additional investor contact for Europe:
Trout International LLC
Lauren Williams, Vice President
Tel.: +44 207 936 9325
lwilliams@troutgroup.com

Branche: Pharmaceuticals
ISIN: DE000A1A6XX4
WKN: A1A6XX
Index: CDAX, Prime All Share, Technology All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Düsseldorf / free trade
Hannover / free trade
München / free trade


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