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

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3-month report

Subtitle: PROVIDES UPDATE ON LEAD PRODUCT CANDIDATE, ORAL
TALACTOFERRIN

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 first quarter and three months ended March
31, 2012.

Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of
the Management Board, said: "I am pleased that we have attained
another important milestone in the development of our lead
investigational agent, talactoferrin, a first-in-class oral Dendritic
Cell Mediated Immunotherapy: We have reached the number of events
needed to perform the overall survival analysis in our ongoing Phase
III FORTIS-M trial in non-small cell lung cancer. We continue to
expect top-line data from this trial to be available in July/August
of this year."

Dr. Hombeck continued: "In addition to our focus on the FORTIS-M
trial, we are laying the groundwork to prepare for the future
commercial success of talactoferrin. This is reflected in the
commercial supply agreements that we announced earlier in the year to
ensure we will have sufficient supply to support a potential
commercial launch and beyond, and to continue to optimize the
manufacturing process. We also have increased our ongoing medical
educational activities for key opinion leaders and the lung cancer
community regarding the potential role of immunotherapy in treating
patients with non-small cell lung cancer."

First quarter of 2012 compared to first quarter of 2011

The Company did not recognize any revenue during the three months
ended March 31, 2012 and 2011.

Research and development ("R&D") expenses for the three months ended
March 31, 2012 were EUR 9.5 million compared to EUR 8.2 million for
the same period in 2011. The increase in R&D expenses was primarily
due to costs associated with the Phase II/III 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 for the three months ended March 31, 2012
were EUR 2.9 million compared to EUR 2.3 million for the same period
in 2011. Administrative expenses increased because the Company has
augmented certain critical pre-commercialization activities related
to a potential regulatory filing and commercial launch of
talactoferrin.

Net loss before income tax benefit for the three months ended March
31, 2012 was EUR 12.7 million compared to EUR 11.5 million for the
same period in 2011. Income tax benefit for the three months ended
March 31, 2012 was EUR 0 compared to EUR 2.9 million for the same
period in 2011. Income tax benefit relates 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
quarter of 2012, the Company did not recognize any income tax
benefit.

Net loss for the three months ended March 31, 2012 was EUR 12.7
million compared to EUR 8.6 million for the same period in 2011. This
increase was primarily due to the recognition of the non-cash
deferred tax asset during the first quarter of 2011, which did not
occur in the current period. Basic and diluted loss per share was
EUR (0.25) for the three months ended March 31, 2012, compared to EUR
(0.21) for the same period in 2011.

Cash position

As of March 31, 2012, cash, cash equivalents, other current financial
assets and restricted cash totaled EUR 32.8 million (December 31,
2011: EUR 44.0 million). Net cash burn for the three months ended
March 31, 2012 was EUR 10.8 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 2012 compared to
fourth quarter of 2011

The Company did not recognize any revenue in the first quarter of
2012 or in the fourth quarter of 2011. R&D expenses were EUR 9.5
million for the first quarter of 2012 compared EUR 12.0 million for
the fourth quarter of 2011. This decrease is because certain
manufacturing costs were expensed in the fourth quarter of 2011 and
clinical trial costs were higher in that quarter. Administrative
expenses for the first quarter of 2012 were EUR 2.9 million compared
to EUR 2.2 million for the fourth quarter of 2011. Administrative
expenses increased because the Company has increased certain critical
pre-commercialization activities related to a potential regulatory
filing and commercial launch of talactoferrin. The Company had a net
loss of EUR 12.7 million for the first quarter of 2012 compared to
EUR 16.7 million for the previous quarter. Income tax expense for
the first quarter of 2012 was EUR 0 compared to EUR 6.4 million for
the fourth quarter of 2011. Net loss before income tax expense was
EUR 12.7 million for the first quarter of 2012 compared to EUR 10.3
million in the fourth quarter of 2011. Basic and diluted loss per
share was EUR (0.25) for the first quarter of 2012 compared to EUR
(0.37) for the fourth quarter of 2011.

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, which is
expected to read out in July/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: The Company expects R&D expenses for the first half of
2012 to be reasonably 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 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.

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 operations into the first quarter of 2013. This
should enable the Company to obtain top-line data from the FORTIS-M
trial, expected in July/August of 2012, assuming no significant
changes to currently projected timelines, and to 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 operations beyond this
point.

Talactoferrin update

Agennix also provided an update on its lead product candidate,
talactoferrin, a first-in-class, oral Dendritic Cell Mediated
Immunotherapy (DCMI).

The Company reported that the pre-specified number of events required
for conducting the primary analysis of overall survival has been
reached for the ongoing Phase III FORTIS-M trial in non-small cell
lung cancer patients whose disease has progressed following two or
more prior therapies. Agennix confirmed its guidance that the
Company expects to report top-line data from the trial in July/August
2012.

The Company provided additional information from its ongoing review
of the available results from the OASIS Phase II/III trial in severe
sepsis. As previously reported, 28-day all-cause mortality, the
primary endpoint of the study, was 25% in the talactoferrin arm
compared to 18% in the placebo arm, which was an unexpectedly low
mortality rate for placebo compared to other recent late-stage
clinical trials in severe sepsis. The difference between the two
groups in the OASIS trial was not statistically significant. Further
analyses have indicated that the key predictors of mortality in the
study were age, site of infection, number of organ dysfunctions and
how sick the patients were before enrolling in the study (as measured
by APACHE II score and Charlson co-morbidity score). Imbalances
between the arms in favor of the placebo group in some of these
factors could have contributed to the outcome. Neither treatment
with talactoferrin versus placebo nor gender was a predictor of
mortality in the study. The results are based on 305 patients
enrolled in the study, with 153 in the talactoferrin group and 152 in
the placebo group. These results are still preliminary and subject
to change. Further analyses are ongoing, including evaluating
mortality over a longer time period.

As previously reported, the Company has discussed the results of the
OASIS trial with the Data Safety Monitoring Board (DSMB) of the
FORTIS trials. The FORTIS DSMB 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. The additional analyses that have been
performed have not changed this assessment by the Company.

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 9th
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, 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 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. 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 first quarter and three
months ended March 31, 2012, please see the Investor Relations
section of the Agennix website at http://www.agennix.com/index.php?op
tion=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