EANS-News: AGENNIX AG / Agennix AG Reports Financial Results For Third Quarter and First Nine Months of 2010 - Company Also Provides Update on Clinical Development Progress and Changes

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9-month report

Heidelberg (euro adhoc) - Planegg/Munich (Germany), Princeton, NJ and
Houston, TX, November 18, 2010 - Agennix AG (Frankfurt Stock
Exchange: AGX) today announced financial results for the third
quarter and first nine months ended September 30, 2010.

Agennix AG was formed by the business combination of Agennix
Incorporated and GPC Biotech AG, which became effective on November
5, 2009, and in which GPC Biotech AG was identified as the acquirer
for accounting purposes. Accordingly, the comparative historical
financial information of Agennix AG is that of GPC Biotech AG for the
respective comparative periods.

First nine months of 2010 compared to first nine months of 2009 The
Company recognized revenue of EUR 0.2 million for the nine months
ended September 30, 2010 compared to EUR 0.3 million for the same
period in 2009. Revenue for the nine months ended September 30, 2010,
was attributable to an out-license agreement for certain intellectual
property of the Company from a discontinued discovery program.
Revenue for the nine months ended September 30, 2009, was
attributable to the services agreement with Agennix Incorporated
prior to the effectiveness of the business combination.

Research and development (R&D) expenses for the nine months ended
September 30, 2010, increased to EUR 19.9 million compared to EUR 3.9
million for the same period in 2009. The increase in R&D expenses is
primarily due to the increased clinical trial costs related to the
Company´s Phase 3 trials with talactoferrin in non-small cell lung
cancer as a result of the inclusion of Agennix Incorporated´s
operations for the first nine months of 2010, and a credit to
compensation cost of EUR (1.5) million recognized for the first nine
months of 2009 as a result of the forfeiture of convertible bonds and
stock options, which did not occur in 2010.

Despite the inclusion of Agennix Incorporated´s operations for the
nine months ended September 30, 2010, administrative expenses
decreased to EUR 6.4 million compared to EUR 8.0 million for the same
period in 2009. Included in administrative expenses for the nine
months ended September 30, 2009, were approximately EUR 3.3 million
in one-time merger-related costs (banking fees, legal services, audit
and other related services) and a credit to compensation cost of EUR
(1.7) million as a result of the forfeiture of convertible bonds and
stock options. There were no such one-time charges in the nine months
ended September 30, 2010.

Net loss before tax for the nine months ended September 30, 2010,
increased to EUR (26.3) million compared to EUR (10.6) million for
the same period in 2009. Income tax benefit for the nine months ended
September 30, 2010 amounted to EUR 6.9 million (EUR 0 for the same
period in 2009) and related to the net operating losses incurred by
the Company´s subsidiary, Agennix Incorporated, during the period.
Net loss for the nine months ended September 30, 2010, increased to
EUR (19.4) million compared to EUR (10.6) million for the same period
in 2009. Basic and diluted loss per share was EUR (0.97) for the nine
months ended September 30, 2010, compared to EUR (1.44) for the same
period in 2009. The per share amount for 2009 has been
retrospectively adjusted to reflect the effect of the 5 to 1 merger
exchange ratio related to the merger of GPC Biotech AG into Agennix
AG.

Comparison to previous year: third quarter 2010 compared to third
quarter 2009 Revenues for the three months ended September 30, 2010,
were EUR 0.2 million compared to EUR 0.2 million for the same period
in 2009. R&D expenses increased for the third quarter of 2010 to EUR
8.3 million compared to EUR 1.3 million for the same period in 2009.
Administrative expenses for the third quarter of 2010 increased to
EUR 2.0 million compared to EUR 1.6 million for the same quarter in
2009. Net loss for the third quarter of 2010 was EUR (11.2) million
compared to EUR (2.1) million for the third quarter of 2009. Basic
and diluted loss per share was EUR (0.54) and EUR (0.29) for the
third quarter of 2010 and 2009, respectively. The per share amount
for 2009 has been retrospectively adjusted to reflect the effect of
the 5 to 1 merger exchange ratio related to the merger of GPC Biotech
AG into Agennix AG.

Quarter over quarter results: third quarter 2010 compared to second
quarter 2010 Revenues for the third quarter of 2010 were EUR 0.2
million compared to EUR 0 for the previous quarter. R&D expenses
increased to EUR 8.3 million for the third quarter of 2010 compared
to EUR 6.6 million in the second quarter of 2010. Administrative
expenses for the third quarter of 2010 decreased to EUR 2.0 million
compared to EUR 2.3 million for the previous quarter. The Company´s
net loss was EUR (11.2) million in the third quarter of 2010,
compared to a net loss of EUR (3.9) million for the previous quarter.
During the first six months of 2010 the Euro weakened against the
U.S. dollar. As a result, the Company recognized approximately EUR
4.0 million in net foreign exchange gains as other income (EUR 2.9
million in the second quarter and EUR 1.1 million in the first
quarter of 2010). During the three months ended September 30, 2010,
the Euro rebounded significantly against the U.S. dollar, almost
entirely erasing the unrealized gains from the first two quarters of
2010. As a result, the Company recognized approximately EUR 4.0
million in net foreign exchange losses in the third quarter of 2010.
This resulted in a swing in Other income/Other expense of
approximately EUR 8.0 million for the three months ended September
30, 2010. Basic and diluted loss per share was EUR (0.54) for the
third quarter of 2010 compared to a loss per share of EUR (0.19) for
the previous quarter.

Cash position and net cash burn As of September 30, 2010, cash, cash
equivalents and restricted cash totaled EUR 11.1 million (December
31, 2009: EUR 11.5 million). Net cash burn for the nine months ended
September 30, 2010, was EUR 25.3 million (September 30, 2009: EUR
15.5 million), with net cash burn of EUR 7.6 million in the first
quarter, EUR 9.9 million in the second quarter and EUR 7.8 million in
the third quarter of 2010. The increase in net cash burn compared to
the 2009 period is primarily due to the inclusion of Agennix
Incorporated´s operations for the first nine months of 2010 and
increased clinical trials costs due to the progression of the
Company´s two ongoing Phase 3 trials with talactoferrin. 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.

On October 1, 2010, the Company announced that it had raised
approximately EUR 76 million in net proceeds in a capital increase
via participation from both new and existing shareholders. The
execution of the capital increase was based on the resolution passed
at the Company´s annual general meeting on May 25, 2010, to issue
20,588,705 new shares. Subscription rights were granted to the
shareholders at a subscription price of EUR 3.81 per share. The
proceeds from the offering, net of the underwriting commission, were
received on October 5, 2010.

Clinical development update The Company provided an update on the
following clinical development programs: oral talactoferrin in
non-small cell lung cancer (NSCLC), oral talactoferrin in severe
sepsis and RGB-286638, the Company´s multi-targeted kinase inhibitor.

Oral talactoferrin in NSCLC: The Company reported that, as of
November 16, 2010, 542 patients (75% of the total planned 720
patients) had been enrolled in the Phase 3 FORTIS-M trial in NSCLC
patients whose disease has progressed following two or more prior
treatment regimens. The FORTIS-M trial remains on track to complete
enrollment in the first half of 2011, with top-line data expected
before the end of 2011.

Oral talactoferrin in severe sepsis: The Company has decided to
initiate a Phase 2/3 trial with talactoferrin in severe sepsis, which
is a change from previously disclosed plans for this indication.
This trial will have two distinct components: a randomized,
double-blind, placebo-controlled Phase 2 portion in approximately 350
adult patients with severe sepsis will be conducted prior to
initiating the Phase 3 portion. The Phase 2 component is expected to
be initiated in March/April 2011. The purpose of this Phase 2
component, which builds on the promising results seen in the first
Phase 2 trial conducted by the Company, is to generate additional
meaningful clinical data with talactoferrin in severe sepsis using
the Company´s existing financial resources.

The Phase 2/3 trial involves one protocol, which is expected to
enable the Phase 3 component to quickly be initiated after completion
of the Phase 2 portion, assuming results from the Phase 2 are
positive and consistent with the earlier Phase 2 study. Important
findings from the Phase 2 portion can also be incorporated into the
Phase 3 portion of the protocol as appropriate to maximize the
potential for success in Phase 3. As previously announced, the FDA
has strongly recommended that Agennix conduct two adequate and
well-controlled Phase 3 studies to support a potential Biologic
License Application (BLA) submission, and the planned Phase 2/3 trial
incorporates the initial Phase 3 trial the Company plans to conduct.

RGB-286638 multi-targeted kinase inhibitor: Preliminary data from
the ongoing Phase 1 trial in solid tumors are being presented today
at the EORTC-NCI-AACR conference in Berlin, Germany. This is the
first-in-human study with this compound. RGB-286638 is being
administered once a day intravenously on days 1-5 of a 28 day
schedule. The trial objectives are to determine the maximum tolerated
dose and dose limiting toxicities and to evaluate the pharmacokinetic
and pharmacodynamic profile of RGB-286638. Today´s presentation
reports that 25 patients have been enrolled to date at dose levels
between 10-160 mg/day. RGB-286638 was well tolerated at doses up to
80 mg; the maximum tolerated dose was exceeded at a dose level of 160
mg and the 120 mg dose level is currently enrolling patients.
Prolonged disease stabilization was seen across dose levels.

As part of its plan to focus existing financial resources on
generating important data with talactoferrin in both NSCLC and severe
sepsis, Agennix has made the decision to defer the initiation of the
planned Phase 1 trial in hematological tumors with RGB-286638. The
Company plans to complete the ongoing Phase 1 trial in solid tumors
and hopes to be able to conduct further testing when more financial
resources are available to allocate to this program.

Torsten Hombeck, Ph.D., Chief Financial Officer, said: "Our top
development priorities continue to be the advancement of oral
talactoferrin for the treatment of non-small cell lung cancer and
severe sepsis, two areas of major unmet medical need. We have
carefully reviewed all of our programs and plans for the year ahead
and have made important decisions and changes to ensure that we can
achieve meaningful results from these two programs using our existing
financial resources. With the recent successful completion of our
financing that netted proceeds of approximately EUR 76 million, we
believe we now have sufficient resources to get to top-line data in
our FORTIS-M trial with talactoferrin in non-small cell lung cancer
and to conduct the Phase 2 portion of our planned Phase 2/3 trial
with talactoferrin in severe sepsis."

Supervisory Board resignation Agennix was informed on November 3,
2010 that Robert van Leen, Ph.D. has resigned from the Supervisory
Board. The Company will provide an update in the near future
regarding a replacement for Dr. van Leen.

Financial guidance
The Company updated its financial guidance as follows:

Management believes that, including the approximately EUR 76 million
in net proceeds received from the recent capital increase, the
Company will have sufficient cash to fund its operations through the
second quarter of 2012, assuming the EUR 15 million loan made to the
Company in the third quarter of 2010 by dievini Hopp BioTech holding
GmbH & Co. KG is terminated and re-paid before that time.

Management expects no substantial cash generating revenues for the
remainder of 2010 or for 2011. This guidance does not consider cash
revenue from potential partnering of the Company´s product candidates
due to the uncertainty of the timing of such events.

For the remainder of 2010 and for 2011, the Company expects R&D
expenses to significantly increase compared to 2009 due to an
expected steady increase in clinical trial-related costs as the
Company´s Phase 3 trials in non-small cell lung cancer with
talactoferrin progress. In addition, the Company plans to initiate
the Phase 2 portion of a Phase 2/3 trial with talactoferrin in severe
sepsis in March/April 2011.

Administrative expenses will be lower in 2010 compared to 2009 as the
one-time costs associated with the merger that were incurred in 2009
will not occur in the following years. 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 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 on November 18, 2010
at 15:00 CET/9:00 AM ET. The dial-in numbers for the call are as
follows:

Participants in Europe: 0049 (0)69 71044 5598
0044 (0)20 3003 2666
Participants in 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 therapy
that has demonstrated activity in randomized, double-blind,
placebo-controlled Phase 2 studies in non-small cell lung cancer, as
well as in severe sepsis. Talactoferrin is currently in Phase 3
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 and the
status of its clinical development programs for talactoferrin. 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 Company will move talactoferrin forward in
development for severe sepsis in a timely manner, if at all, or that
talactoferrin will ultimately be approved for sale in any country.
Additionally, there can be no guarantee that the Company will have
sufficient cash to fund its operations through the second quarter 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 interim management report and interim condensed
consolidated financial statements and accompanying notes for the
third quarter and first nine months of 2010, please visit the
Investor Relations section of the Agennix website at
http://www.agennix.com/index.php
option=com_content&view=article&id=122&Itemid=77&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

Investor Relations & Corporate Communications

Phone: +49 (0)89 8565 2693

ir@agennix.com

In the U.S.: Laurie Doyle

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

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