• 04.05.2011, 07:30:42
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  • OTS0011 OTW0011

EANS-News: Agennix AG Reports Financial Results for First Quarter of 2011

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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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Subtitle: Quarter highlighted by completion of enrollment in talactoferrin Phase
III FORTIS-M trial and issuance of key U.S. patent for talactoferrin in
oncology

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 improve the
length and quality of life of critically ill patients in areas of major unmet
medical need, today announced financial results for the first quarter ended
March 31, 2011.

Torsten Hombeck, Ph.D., Chief Financial Officer, said: "The first quarter of
2011 was highlighted by the completion of patient enrollment in the
talactoferrin Phase III FORTIS-M trial, as well as the issuance of an important
U.S. patent covering the use of talactoferrin to treat our lead indication,
non-small cell lung cancer. We expect to continue making solid progress in the
months ahead with the planned initiation of the Phase II portion of a Phase
II/III trial in severe sepsis during the second quarter. We also expect data on
talactoferrin to be presented at several upcoming major medical meetings. In
addition, we are adding to our internal expertise with the selected hiring of
highly experienced individuals in critical areas as we prepare for topline data
from the FORTIS-M trial, expected in the first half of next year."

First quarter of 2011 compared to first quarter of 2010
The Company did not recognize any revenue for the three months ended March 31,
2011 and 2010.

Research and development (R&D) expenses for the three months ended March 31,
2011 were EUR 8.2 million compared to EUR 5.0 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 and
preparation for the planned Phase II/III trial with talactoferrin in severe
sepsis. Administrative expenses for the three months ended March 31, 2011 were
EUR 2.3 million compared to EUR 2.1 million for the same period in 2010 due
mainly to the Company engaging in certain critical pre-commercialization
activities.

Net loss before income tax benefit for the three months ended March 31, 2011 was
EUR 11.5 million compared to EUR 6.0 million for the same period in 2010. Income
tax benefit for the three months ended March 31, 2011 amounted to EUR 2.9
million (EUR 1.7 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. Net loss for the three months ended March 31, 2011 was EUR
8.6 million compared to EUR 4.3 million for the same period in 2010. Basic and
diluted loss per share was EUR (0.21) for the three months ended March 31, 2011,
compared to EUR (0.23) for the same period in 2010.

Cash position
As of March 31, 2011, cash, cash equivalents, other current financial assets and
restricted cash totaled EUR 66.2 million (December 31, 2010: EUR 79.3 million).
Net cash burn for the three months ended March 31, 2011 was EUR 11.5 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 2011 compared to fourth quarter
of 2010
The Company did not recognize any revenue in the first quarter of 2011 or in the
fourth quarter 2010. R&D expenses were EUR 8.2 million for the first quarter of
2011 compared to EUR 9.5 million for the fourth quarter of 2010. Administrative
expenses for the first quarter of 2011 were EUR 2.3 million compared to EUR 3.6
million for the fourth quarter of 2010. The Company had a net loss of EUR 8.6
million compared to EUR 7.6 million for the previous quarter. Net loss before
income tax benefit was EUR 11.5 million for the first quarter of 2011 compared
to net loss before income tax benefit of EUR 10.2 million for the fourth quarter
of 2010. Basic and diluted loss per share was EUR (0.21) for the first quarter
of 2011 compared to EUR (0.19) for the fourth quarter of 2010.

Financial guidance
The Company provided the following financial guidance, which is consistent with
the guidance provided in March 2011 at the time Agennix reported its fiscal year
2010 results:

Cash position: Management believes that the Company 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 in the FORTIS M trial, expected in the first
half of 2012, and to complete the Phase II portion of the planned Phase II/III
trial with talactoferrin in severe sepsis, assuming no significant changes to
currently projected timelines. This projected cash reach also assumes that the
EUR 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 portion of the Phase
II/III trial in severe sepsis. 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.

Revenues: Management expects no substantial cash-generating revenues during
2011. 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: For 2011, the Company expects R&D expenses to increase compared to
2010 due to an expected increase in talactoferrin clinical trial-related costs.
Enrollment in the Phase III FORTIS-M trial was completed in March 2011, and
Agennix is planning to initiate a Phase II/III trial with talactoferrin in
severe sepsis in the second quarter of this year.

Administrative expenses: 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
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 4th at 15:00 CET/9:00 AM ET. The dial-in numbers for the
call are as follows:

Participants from Europe:
0049 (0)69 71044 5598
0044 (0)20 3003 2666

Participants from the U.S.:
1 646 843 4608

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 II studies in non-small cell lung cancer, as well as in
severe sepsis. Talactoferrin is currently in Phase III 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. 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 results of the FORTIS-M trial or
other ongoing studies with talactoferrin will be obtained when expected, will be
positive or will be adequate to support a marketing approval. Additionally,
there can be no guarantee that talactoferrin will be approved for marketing in
any country or at all. There also can be no guarantee that the Company will
have sufficient monies to fund operations well into the second half 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 management report and condensed consolidated financial statements
and accompanying notes for the first three months ended March 31, 2011, please
see the Investor Relations section of the Agennix website at
http://www.agennix.com/index.php?option=com_content&view=article&id=161&Itemid=88&lang=en

Further inquiry note:
Agennix AG
Barbara Mueller
Manager, Investor Relations & Corporate Communications
Tel.: +49 89 8565-2693
[email protected]

In the USA: Laurie Doyle
Senior Director, Investor Relations & Corporate Communications
Tel.: 609-524-5884
[email protected]

Additional media contact for Europe:
MC Services AG
Raimund Gabriel
Tel.: +49 89 210 228 0
[email protected]

Additional investor contact for Europe:
Trout International LLC
Lauren Williams, Vice President
Tel.: +44 207 936 9325
[email protected]
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:        [email protected]
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

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