EANS-News: Agennix AG Reports Financial Results For Fiscal Year 2011

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Financial Figures/Balance Sheet

Subtitle: PROVIDES UPDATE ON LEAD PRODUCT CANDIDATE, ORAL
TALACTOFERRIN

Planegg/Munich (Germany), Princeton, NJ and Houston, TX, March 15,
2012 (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 fourth quarter and fiscal
year ended December 31, 2011.

Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of
the Management Board, said: "Our efforts in 2011 focused on
advancing the development of our lead product candidate, the
first-in-class oral Dendritic Cell Mediated Immunotherapy,
talactoferrin. We are preparing for success and have been putting in
place key elements to achieve our goals while keeping a watchful eye
on what we spend. Prior to Phase III data from our ongoing FORTIS-M
trial, which we now expect in the July/August 2012 timeframe, we are
investing only in those activities that we believe are on the
critical path for a timely and successful regulatory submission and
potential product launch."

Fiscal year 2011 compared to fiscal year 2010 The Company did not
recognize any revenues in 2011 compared to EUR 0.2 million recognized
in 2010. Research and development expenses were EUR 36.6 million for
the year ended December 31, 2011, compared with EUR 29.4 million for
the same period in 2010. The increase in R&D expenses was primarily
due to increased patient enrollment in the Phase III FORTIS-M trial
with talactoferrin in non-small cell lung cancer (NSCLC) and the
Phase II portion of the OASIS trial with talactoferrin in severe
sepsis, which was initiated at the end of the second quarter of 2011
and stopped in the first quarter of 2012. Administrative expenses
were EUR 8.8 million for the year ended December 31, 2011, compared
to EUR 10.0 million for the same period in 2010. The decrease was
primarily due to decreases in legal expenses related to shareholder
litigation and variable employee compensation expense, neither of
which were incurred in 2011. Net loss in 2011 was EUR 41.8 million
compared to EUR 27.0 million for the preceding year. Net loss before
income tax benefit was EUR 42.6 million in 2011 compared to EUR 36.5
million in 2010. Income tax benefit for the year ended December 31,
2011 was EUR 0.8 million (EUR 9.5 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. Basic
and diluted loss per share was EUR (0.98) for 2011 compared to EUR
(1.07) for 2010.

Cash position At December 31, 2011, the Company had cash, cash
equivalents, other current financial assets and restricted cash of
EUR 44.0 million (2010: EUR 79.3 million). Net cash burn for 2011 was
EUR 45.8 million (2010: EUR 34.5 million), with net cash burn of
EUR 11.5 million in the first quarter, EUR 11.6 million in the second
quarter, EUR 11.8 million in the third quarter and EUR 10.9 million
in the fourth quarter of 2011. 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 respective consolidated
statements of cash flows.

Comparison to previous year: fourth quarter 2011 compared to fourth
quarter 2010 The Company did not recognize any revenues for the three
months ended December 31, 2011 or 2010. R&D expenses for the fourth
quarter of 2011 were EUR 12.0 million compared to EUR 9.5 million for
the fourth quarter of 2010. Administrative expenses for the fourth
quarter of 2011 were EUR 2.2 million compared to EUR 3.6 million for
the same quarter in 2010. Net loss for the fourth quarter of 2011
was EUR 16.7 million compared to EUR 7.6 million for the fourth
quarter of 2010. Net loss before income tax expense/benefit was EUR
10.3 million for the fourth quarter of 2011 compared to EUR 10.2
million for the fourth quarter of 2010. Basic and diluted loss per
share was EUR (0.37) for the fourth quarter of 2011 compared to EUR
(0.19) for the same period in 2010.

Quarter over quarter results: fourth quarter 2011 compared to third
quarter 2011 The Company did not recognize any revenues for the
fourth quarter or third quarter of 2011. R&D expenses were EUR 12.0
million for the fourth quarter of 2011 compared to EUR 8.1 million
for the third quarter of 2011. Administrative expenses for the
fourth quarter of 2011 were EUR 2.2 million compared to EUR 2.1
million for the previous quarter. The Company had a net loss of EUR
16.7 million in the fourth quarter of 2011 compared to EUR 8.2
million for the previous quarter. Net loss before income tax
expense/benefit was EUR 10.3 million in the fourth quarter of 2011
compared to EUR 9.7 million for the third quarter of 2011. Basic and
diluted loss per share was EUR (0.37) for the fourth quarter of 2011
compared to EUR (0.20) for the previous quarter.

Talactoferrin update Agennix also provided an update on its lead
product candidate, the oral Dendritic Cell Mediated Immunotherapy
(DCMI), talactoferrin.

The Company reported that top-line results from the ongoing FORTIS-M
trial in NSCLC patients whose disease has progressed following two or
more prior therapies are now expected in the July/August 2012
timeframe, rather than in the second quarter of 2012 as previously
anticipated. The change is due to the fact that the analysis of the
FORTIS-M data is event driven and the rate at which events have
occurred to date is slower than previously projected. The number of
events needed to perform the analysis has not yet been reached.

Agennix reported that its review of the available results from the
OASIS Phase II/III trial with talactoferrin in severe sepsis
confirmed the finding of the trial´s Data Safety Monitoring Board
(DSMB), which had recommended that the study be stopped. The Company
reported that the latest data from the trial, which incorporates
additional patients´ data that were not available to the DSMB at the
time of its analysis, indicate that 28-day all-cause mortality, the
primary endpoint of the study, in the talactoferrin arm was 25%
compared to 18% in the placebo group. This difference was not
statistically significant. These results were based on 305 patients
treated in the study, with 153 in the talactoferrin group and 152 in
the placebo group. No other safety issues have been identified to
date.

Further evaluation of apparent differences in some baseline
characteristics between the two arms in the OASIS trial is ongoing.
Women in the talactoferrin arm, particularly those with
cardiovascular dysfunction (septic shock), had an apparent higher
28-day mortality compared to women in the placebo arm. Male patients
without cardiovascular dysfunction who received talactoferrin had an
apparent lower 28-day mortality than those who received placebo.
Further analyses are ongoing to more fully understand the findings.

The above results are still preliminary and subject to change. The
final results from the OASIS trial are expected to be presented at a
medical meeting later in the year.

Once the ongoing data review is completed and Agennix has held
further discussions with the critical care community and consultants,
the Company will make a decision on whether further development of
talactoferrin in severe sepsis is warranted. Until that time,
Agennix does not intend to invest further in the development of
talactoferrin in severe sepsis.

The Company has discussed the results of the OASIS trial with the
DSMB of the FORTIS trials. The FORTIS DSMB has agreed with Agennix´s
assessment that, based on the available data from the OASIS trial, no
changes to the conduct of the ongoing FORTIS-M trial are necessary
and the trial can continue as planned.

Financial guidance Agennix provided the following updated financial
guidance. The Company´s financial outlook for 2012 and 2013 is
highly dependent on the outcome of the FORTIS-M Phase III trial in
NSCLC.

Revenues: Management expects no substantial cash-generating revenues
for 2012 and 2013. This guidance does not consider any potential cash
revenue from future partnering of talactoferrin due to the
uncertainty of the timing of such events. If the FORTIS-M trial is
positive, Agennix plans to submit a Biologics License Application
(BLA) to the U.S. Food & Drug Administration (FDA), and a Marketing
Authorization Application (MAA) to the European Medicines Agency
(EMA), requesting marketing approval of talactoferrin.

R&D expenses: The Company expects R&D expenses for the first half of
2012 to be in line with the first half of 2011. For the second half
of 2012 and for 2013, R&D expenses are dependent on the outcome of
the FORTIS-M trial. Should the FORTIS-M trial be positive, the
Company would expect 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.

Administrative expenses: Administrative expenses in 2012 and 2013 are
expected to increase compared to 2011 as the Company expects to 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 operations into the first quarter of 2013. This
should enable the Company to obtain top-line data from the FORTIS-M
trial, now expected in July/August 2012, assuming no significant
changes to currently projected timelines, and to significantly
advance potential partnering discussions. 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.

2012 corporate calendar The Company reported the dates for its 2012
corporate calendar as follows:

First quarter financial results: May 9
Annual Shareholders Meeting: June 15 (previously August 7)
Second quarter financial results: July 31
Third quarter financial results: November 8

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, March 15th at 14:00 CET/9:00 AM EDT. The dial-in numbers for
the call are as follows:

Participants from Europe: 0049 (0)69 710 445 598
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, a
first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI).
Talactoferrin 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 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. 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™ is a trademark of the Agennix
group.

For the full management report, condensed consolidated financial
statements and accompanying notes for the fiscal year ended December
31, 2011, please see the Investor Relations section of the Agennix
website at http://www.agennix.com/index.php?option=com_content&view=a
rticle&id=161&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, 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