EANS-News: AGENNIX AG / Agennix Reports Financial Results for Third Quarter and First Nine Months of 2011

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quarterly report/9-month report

Subtitle: Provides update on expected timing for top-line data from
ongoing talactoferrin trials

Planegg/Munich (Germany), Princeton, NJ and Houston, TX, November 3,
2011 (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 third quarter and nine
months ended September 30, 2011.

Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of
the Management Board, said: "We are pleased with our continued good
progress in the development of our oral immunotherapy, talactoferrin.
Our achievements for the year to date include the completion of
patient enrollment in the FORTIS-M Phase III registration trial in
non-small cell lung cancer, as well as the initiation of the OASIS
Phase II/III trial in severe sepsis at the end of June. Enrollment
in the OASIS trial is progressing faster than anticipated, with 45%
of the 350 patients already enrolled. We now expect top-line data
from both the FORTIS-M trial and the Phase II portion of the OASIS
trial in the second quarter of 2012."

Dr. Hombeck continued: "Additionally this year, talactoferrin data
from Phase II trials were published in peer-reviewed medical journals
and presented at major medical meetings. We have also been very
fortunate to have hired several highly experienced executives in key
areas as we prepare for a possible regulatory filing for
talactoferrin and a potential commercial launch."

First nine months of 2011 compared to first nine months of 2010 The
Company did not recognize any revenue during the nine months ended
September 30, 2011, compared to E 0.2 million during the nine months
ended September 30, 2010. The latter was attributable to an
out-license agreement for certain intellectual property from a
discontinued discovery program.

Research and development (R&D) expenses for the nine months ended
September 30, 2011 were E 24.6 million compared to E 19.9 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 in non-small cell lung cancer
(NSCLC) and the Phase II/III OASIS trial with talactoferrin in severe
sepsis, which was initiated at the end of the second quarter of 2011.

Administrative expenses for the nine months ended September 30, 2011
and 2010, were E 6.6 million and E 6.4 million, respectively.

Net loss before tax for the nine months ended September 30, 2011, was
E 32.4 million compared to E26.3 million for the same period in
2010. Income tax benefit for the nine months ended September 30,
2011, amounted to E 7.2 million (E 6.9 million for the same period in
2010) and related to the recognition of deferred tax asset on net
operating losses incurred by the Company's subsidiary, Agennix
Incorporated, during the period. Net loss for the nine months ended
September 30, 2011, was E 25.2 million compared to E 19.4 million for
the same period in 2010. Basic and diluted loss per share was E(0.60)
for the nine months ended September 30, 2011, compared to E (0.97)
for the same period in 2010.

Third quarter of 2011 compared to third quarter of 2010 The Company
did not recognize any revenue during the three months ended September
30, 2011 and recognized E 0.2 million for the same period in 2010.
R&D expenses were E8.1 million for the third quarter of 2011 compared
to E 8.3 million for the same period in 2010. The decrease in R&D
expenses was primarily due to decreases in drug development
activities in the third quarter of 2011 as the enrollment in the
Phase III FORTIS-M trial was completed in March 2011. Administrative
expenses for the third quarter of 2011 were E 2.1 million compared to
E 2.0 million for the same quarter in 2010. Net loss for the third
quarter of 2011 was E 8.2 million compared to E 11.2 million for the
third quarter of 2010 primarily due to foreign exchange gain of
approximately E 0.7 million in the third quarter of 2011 compared to
foreign exchange loss of approximately E 4.1 million for the same
period in 2010. Basic and diluted loss per share was E (0.20) and E
(0.54) in the third quarter of 2011 and 2010, respectively.

Quarter over quarter results: third quarter 2011 compared to second
quarter 2011 The Company did not recognize any revenue during the
third or second quarter of 2011. R&D expenses for the third quarter
of 2011 were E 8.1 million compared to E8.3 million for the second
quarter of 2011. Administrative expenses for the third quarter of
2011 were E 2.1 million compared to E 2.2 million for the second
quarter of 2011. Net loss for the third quarter of 2011 was E 8.2
million compared to E8.3 million for the second quarter of 2011.
Basic and diluted loss per share was E (0.20) for the third quarter
of 2011 as well as for the second quarter of 2011.

Cash position As of September 30, 2011, cash, cash equivalents, other
current financial assets and restricted cash totaled E 43.3 million
(December 31, 2010: E 79.3 million). Net cash burn for the nine
months ended September 30, 2011, was E34.9 million (September 30,
2010: E25.3 million) with net cash burn of E 11.5 million in the
first quarter, E 11.6 million in the second quarter and E 11.8
million in the third quarter of 2011. The increase in net cash burn
was mainly due to clinical trial costs related to increased patient
enrollment in the Phase III FORTIS-M trial and the Phase II portion
of the OASIS trial. 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

Financial guidance The Company provided the following financial
guidance for the remainder of 2011 and for 2012:

Revenues Management expects no substantial cash generating revenues
for the remainder of 2011 or for 2012. 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 The Company expects R&D expenses for fiscal year 2011 to
be higher than in 2010 due to increased talactoferrin clinical
trial-related costs. During 2011, patients continue to be treated in
the Phase III FORTIS-M trial, and the OASIS Phase II/III trial was
initiated in June 2011. Agennix expects R&D expenses in 2012 to
increase compared to 2011. The OASIS trial is expected to continue
to enroll patients, and Agennix expects to incur additional
production and other costs in preparation for a potential regulatory
filing and commercial launch of talactoferrin.

Administrative expenses Administrative expenses for fiscal year 2011
are expected to be slightly higher than for 2010 as the Company
engages in certain critical pre-commercialization activities.
Administrative expenses are expected to increase in 2012 compared to
2011 because pre-commercialization activities are planned to increase
as the Company gets closer to a potential regulatory filing and
commercial launch.

Cash position Management believes that Agennix 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 from the FORTIS-M
trial as well as the Phase II portion of the OASIS trial, both
expected in the second quarter of 2012, assuming no significant
changes to current projected timelines. This projected cash reach
also assumes that the E 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 part of the OASIS trial.Management
plans to raise additional funds through licensing agreements and/or
through equity or debt investments to fund the Company's operations
beyond the second half of 2012.

Talactoferrin update The Company provided an update on its lead
program, the oral immunotherapy, talactoferrin.

Top-line data from Phase III FORTIS-M registration trial expected in
the second quarter of 2012. The Company tightened its guidance,
indicating that it now anticipates top-line data from the FORTIS-M
trial in the second quarter of 2012. The FORTIS-M trial is a
randomized, double-blind, placebo-controlled study evaluating
talactoferrin plus best supportive care compared to placebo plus best
supportive care in non-small cell lung cancer patients whose disease
has progressed following two or more prior lines of therapy.

Forty-five percent of patients enrolled in Phase II part of OASIS
Phase II/III trial. Agennix provided an update on enrollment in its
ongoing Phase II/III OASIS trial in severe sepsis. As of October 31,
2011, 157 patients - or 45% of the planned 350 patients - had been
enrolled in the Phase II part of the OASIS trial. The study was
initiated at the end of June 2011. Top-line results are now expected
in the second quarter of 2012.

Enrollment expected to complete in NIH-sponsored Phase I/II study for
nosocomial infections in pre-term infants by year-end 2011. Agennix
also reported that enrollment in an NIH-sponsored Phase I/II trial
evaluating talactoferrin's potential to reduce the incidence of
late-onset infections in infants born prematurely is expected to
complete by the end of 2011. Data are expected in mid-2012. Agennix
does not currently plan to pursue this indication further. The
Company's therapeutic focus on oncology and severe sepsis remains
unchanged.

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, November 3rd at 9 AM ET/2 PM CET. The
dial-in numbers for the call are as follows:

Participants from Europe: 0049 (0)69 710445598
0044 (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 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
immunotherapy that has demonstrated activity in randomized,
double-blind, placebo-controlled Phase II studies in non-small cell
lung cancer and in severe sepsis. Talactoferrin is currently in Phase
III clinical trials in non-small cell lung cancer and in a Phase
II/III trial in severe sepsis. 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. 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. There can be no guarantee
that the Company will have sufficient cash to fund operations into
the second half of 2012. 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. 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(TM) is a trademark of the Agennix group.

For the full interim management report and unaudited interim
condensed consolidated financial statements and accompanying notes
for the third quarter and nine months ended September 30, 2011,
please see the Investor Relations section of the Agennix website at h
ttp://www.agennix.com/index.php?option=com_content&view=article&id=16
1&Itemid=88&lang=en

Further inquiry note:
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, 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: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Hamburg, Düsseldorf, Hannover, München
language: English