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EANS-News: Agennix AG Reports Financial Results for Second Quarter and First Half of 2012

Geschrieben am 31-07-2012

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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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6-month report

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 lengthen and improve the lives of critically ill
patients in areas of major unmet medical need, today announced
financial results for the second quarter and six months ended June
30, 2012.

Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of
the Management Board, said: "These are exciting times for Agennix as
we approach the top-line data readout from our Phase III FORTIS-M
trial with talactoferrin alfa in non-small cell lung cancer, expected
in August. We are preparing for the success of the Phase III trial,
and much of our effort during the first half of the year involved
activities to support future potential regulatory submissions and the
commercial launch of talactoferrin alfa. We believe we are well
positioned for the future and look forward to reporting the results
from this study in the coming month."

First six months of 2012 compared to first six months of 2011 The
Company did not recognize any revenue during the six months ended
June 30, 2012 and 2011.

Research and development (R&D) expenses for the six months ended June
30, 2012 were EUR 17.7 million compared to EUR 16.6 million for the
same period in 2011. The increase in R&D expenses was primarily due
to increased costs associated with the compiling of data from the
FORTIS-M Phase III trial of talactoferrin alfa (talactoferrin) for
analysis. The increase was partially offset by decreases in patient
costs as the FORTIS-M trial nears completion.

Administrative expenses for the six months ended June 30, 2012 were
EUR 5.8 million compared to EUR 4.5 million for the same period in
2011. Administrative expenses were higher as the Company engaged in
certain critical pre-commercialization activities related to a
potential regulatory filing and commercial launch of talactoferrin.

Net loss before tax for the six months ended June 30, 2012 was EUR
23.3 million compared to EUR 22.7 million for the same period in
2011. Income tax benefit for the six months ended June 30, 2012, was
EUR 0 compared to EUR 5.7 million for the same period in 2011. Income
tax benefit recorded in 2011 related to the recognition of deferred
tax asset on net operating losses incurred by the Company's
subsidiary, Agennix Incorporated, during the period. In the first six
months of 2012, the Company did not recognize any income tax benefit,
because, as of June 30, 2012, it was not probable that future taxable
profits or sufficient taxable temporary differences would be
available against which the accumulated tax losses could be utilized
before they expire.

Net loss for the six months ended June 30, 2012 was EUR 23.3 million
compared to EUR 16.9 million for the same period in 2011. This
increase was primarily due to the recognition of the deferred tax
asset during the first six months of 2011 which did not occur in the
current period. Basic and diluted loss per share was EUR (0.45) for
the six months ended June 30, 2012, compared to EUR (0.40) for the
same period in 2011.

Second quarter of 2012 compared to second quarter of 2011 The Company
did not recognize any revenue during the three months ended June 30,
2012 and 2011.

R&D expenses of EUR 8.2 million were virtually unchanged for the
second quarter of 2012 compared to the same period in 2011. This was
a result of the increased costs associated with the compiling of data
from the FORTIS-M trial for analysis in the second quarter of 2012,
which was offset by decreases in patient costs as the FORTIS-M trial
nears completion. Administrative expenses for the second quarter of
2012 were EUR 2.8 million compared to EUR 2.2 million for the same
quarter in 2011.

Net loss for the second quarter of 2012 was EUR 10.5 million compared
to EUR 8.3 million for the second quarter of 2011. Basic and diluted
loss per share was EUR (0.21) and EUR (0.20) for the second quarter
of 2012 and 2011, respectively.

Cash position As of June 30, 2012, cash, cash equivalents, other
current financial assets and restricted cash totaled EUR 22.7 million
(December 31, 2011: EUR 44.0 million). Net cash burn for the six
months ended June 30, 2012, was EUR 21.5 million, with net cash burn
of EUR 10.8 million in the first quarter and EUR10.7 million for the
second quarter. 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: second quarter of 2012 compared to
first quarter of 2012 The Company did not recognize any revenue in
the first or second quarter of 2012. R&D expenses were EUR 8.2
million for the second quarter of 2012 compared EUR 9.5 million for
the first quarter of 2012. This decrease was due to a decrease in
patient costs related to the FORTIS-M trial. Administrative expenses
for the second quarter of 2012 were EUR 2.8 million compared to EUR
2.9 million for the first quarter of 2012. The Company had a net
loss of EUR 10.5 million for the second quarter of 2012 compared to
EUR 12.7 million for the previous quarter. Basic and diluted loss
per share was EUR (0.21) for the second quarter of 2012 compared to
EUR (0.25) for the first quarter of 2012.

Financial guidance The Company's financial outlook for the remainder
of 2012 and 2013 is highly dependent on the outcome of the FORTIS-M
Phase III trial, which is expected to read out in August 2012. The
Company provided the following financial guidance:

Revenues: Management expects no substantial cash generating revenues
for 2012 or 2013. 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. However, if the
FORTIS-M trial is positive, Agennix expects to generate revenue from
one or more collaboration and license agreements for talactoferrin
during this time period.

R&D expenses: For the second half of 2012 and for 2013, the amount
of R&D expenses is dependent on the outcome of the FORTIS-M trial.
Should the FORTIS-M trial be positive, the Company expects to incur
additional costs related to regulatory filings and increased
manufacturing costs in preparation for a potential market launch. In
addition, in such a positive scenario, Agennix is likely to expand
its clinical development activities in 2013.

Administrative expenses: Administrative expenses in 2012 and 2013
are expected to increase compared to 2011 as the Company expects to
continue to moderately ramp up certain critical pre-commercialization
activities for a potential market launch of talactoferrin. Should the
FORTIS-M trial be positive, these activities and related expenses
would increase significantly, potentially including costs related to
beginning to build a commercial infrastructure in the U.S.

Cash position: Management believes that Agennix will have sufficient
cash to fund its current level of operations into the first quarter
of 2013. However, if the top-line data from the FORTIS-M trial,
currently expected in August 2012, are positive, the Company
anticipates significantly increasing its spending related to
talactoferrin production, as well as regulatory and
pre-commercialization activities, in anticipation of a Biologics
License Application (BLA) submission with the U.S. Food and Drug
Administration (FDA) and potential commercial launch. In this
positive scenario, Agennix believes that it will have sufficient cash
to fund operations into the middle of the fourth quarter of 2012. In
such a positive data scenario, the Company anticipates raising
additional funds through the issuance of equity or debt in the near
term to fund increased spending into 2013 and continue as a going
concern and would then expect to raise additional funds through
licensing agreements and/or the issuance of equity during 2013.

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 on the Web site
following the live event. The call, which will be conducted in
English, will be held today, July 31st at 15:00 CET/9 AM EDT. The
dial-in numbers for the call are as follows:

Participants from Europe:

+49 (0)69 710 445 598
+44 (0)20 3003 2666

Participants from the U.S.:

+1 212 999 6659

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 lengthen and improve the lives of
critically ill patients in areas of major unmet medical need. The
Company's most advanced investigational agent is talactoferrin alfa,
a first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI).
Talactoferrin alfa is currently in Phase III clinical trials in
non-small cell lung cancer. Other clinical development programs
include RGB-286638, a multi-targeted kinase inhibitor in Phase I
testing for cancer, 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 and the
timing of clinical trial results. 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 those
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. The
achievement of positive results in early stage clinical studies does
not ensure that later stage or large scale clinical studies will be
successful. Even if the results from our later stage trials with
talactoferrin, including the ongoing FORTIS-M trial in non-small cell
lung cancer, are considered positive, there can be no guarantee that
they will be sufficient to gain marketing approval in the United
States or any other country, and regulatory authorities may require
additional information, data and/or further pre-clinical or clinical
studies to support approval. In such event, there can be no
guarantee that the Company will have or be able to obtain the
financial resources to conduct any such additional studies or that
such studies will yield results sufficient for approval. Even if the
results from the FORTIS-M trial are considered positive, there can be
no guarantee that the Company will be able to partner talactoferrin
or obtain additional financial resources within the projected
timeframe. 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 Agennix AG.

For the full management report and condensed consolidated financial
statements and accompanying notes for the second quarter and three
months ended June 30, 2012, please see the Investor Relations section
of the Agennix website at http://www.agennix.com/index.php?option=com
_content&view=article&id=207&Itemid=104&lang=en

Further inquiry note:
Agennix AG
Barbara Mueller
Manager, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565 2693
ir@agennix.com

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

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

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

end of announcement euro adhoc
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company: AGENNIX AG
Im Neuenheimer Feld 515
D-69120 Heidelberg
phone: +49 89 8565 2693
FAX: +49 89 8565 2610
mail: ir@agennix.com
WWW: http://www.agennix.com
sector: Pharmaceuticals
ISIN: DE000A1A6XX4
indexes: CDAX, Prime All Share, Technology All Share
stockmarkets: free trade: Hannover, Berlin, München, Hamburg, Düsseldorf,
regulated dealing/prime standard: Frankfurt
language: English


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