EANS-News: Agennix Reports Financial Results for Second Quarter and First Six
Months of 2011
Geschrieben am 04-08-2011 |
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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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Financial Figures/Balance Sheet/6-month report
Subtitle: Quarter highlighted by initiation of talactoferrin Phase
II/III OASIS trial in severe sepsis
Planegg/Munich (Germany), Princeton, NJ and Houston, TX (euro adhoc)
- August 4, 2011 - 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 second quarter and six
months ended June 30, 2011.
Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of
the Management Board, said: "We had a very productive first half of
2011, highlighted by solid progress with our clinical programs for
our oral immunotherapy, talactoferrin. During the first half of the
year, enrollment completed in the FORTIS-M Phase III trial in
non-small cell lung cancer, and the OASIS Phase II/III trial in
severe sepsis was initiated. These trials both are on track for data
readouts in 2012 using our existing financial resources.
Additionally, data on talactoferrin were presented at a variety of
major medical meetings in the U.S. and Europe. We were also very
pleased to hire several highly experienced executives in key areas as
we prepare for a possible regulatory filing for talactoferrin and a
potential commercial launch."
First six months of 2011 compared to first six months of 2010 The
Company did not recognize any revenue during the six months ended
June 30, 2011 and 2010.
Research and development (R&D) expenses for the six months ended June
30, 2011, were EUR 16.6 million compared to EUR 11.6 million for the
same period in 2010. The increase in R&D expenses is primarily due to
increased patient enrollment in the Phase III FORTIS-M trial with
talactoferrin in non-small cell lung cancer (NSCLC) and preparation
for 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 six months ended June 30, 2011, were
EUR 4.5 million compared to EUR 4.4 million for the same period in
2010.
Net loss before tax for the six months ended June 30, 2011, was EUR
22.7 million compared to EUR 12.1 million for the same period in
2010. Income tax benefit for the six months ended June 30, 2011,
amounted to EUR 5.7 million (EUR 3.9 million for the same period in
2010) and related to the deferred tax asset on net operating losses
incurred by the Company´s subsidiary, Agennix Incorporated, during
the period. Net loss for the six months ended June 30, 2011, was EUR
16.9 million compared to EUR 8.2 million for the same period in 2010.
Basic and diluted loss per share was EUR (0.40) for the six months
ended June 30, 2011, compared to EUR (0.42) for the same period in
2010.
Second quarter of 2011 compared to second quarter of 2010 The Company
did not recognize any revenue during the three months ended June 30,
2011 and 2010. R&D expenses for the second quarter of 2011 were EUR
8.3 million compared to EUR 6.6 million for the same period in 2010.
The increase in R&D expenses is primarily due to increased patient
enrollment in the Phase III FORTIS-M trial and preparation for the
Phase II/III OASIS trial, which was initiated at the end of the
second quarter of 2011. Administrative expenses for the second
quarter of 2011 were EUR 2.2 million compared to EUR 2.3 million for
the same quarter in 2010. Net loss for the second quarter of 2011 was
EUR 8.3 million compared to EUR 3.9 million for the second quarter of
2010. Basic and diluted loss per share was EUR (0.20) and EUR (0.19)
for the second quarter of 2011 and 2010, respectively.
Quarter over quarter results: second quarter 2011 compared to first
quarter 2011 The Company did not recognize any revenue during the
three months ended June 30, 2011 and the first quarter of 2011. R&D
expenses for the second quarter of 2011 were EUR 8.3 million compared
to EUR 8.2 million in the first quarter 2011. Administrative expenses
for the second quarter of 2011 were EUR 2.2 million compared to EUR
2.3 million for the first quarter of 2011. Net loss for the second
quarter of 2011 was EUR 8.3 million compared to EUR 8.6 million for
the first quarter of 2011. Basic and diluted loss per share was EUR
(0.20) for the second quarter of 2011 compared to EUR (0.21) for the
first quarter of 2011.
Cash position As of June 30, 2011, cash, cash equivalents, other
current financial assets and restricted cash totaled EUR 54.2 million
(December 31, 2010: EUR 79.3 million). Net cash burn for the six
months ended June 30, 2011, was EUR 23.1 million (June 30, 2010: EUR
17.5 million) with net cash burn of EUR 11.5 million in the first
quarter and EUR 11.6 million in the second quarter of 2011. The
increase in net cash burn compared to the 2010 period was mainly due
to clinical trial costs related to increased patient enrollment in
the FORTIS-M trial and preparations for 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 confirmed its financial guidance that was provided in May
2011:
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: For 2011 and 2012, 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. Agennix initiated the
OASIS Phase II/III trial in June 2011.
Administrative expenses: Administrative expenses for the remainder of
2011 and 2012 are expected to increase slightly compared to 2010 as
the Company engages in certain critical pre-commercialization
activities.
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 Phase II/III OASIS trial, assuming no
significant changes to current projected timelines. This projected
cash reach also assumes that the EUR 15 million loan made to the
Company by dievini Hopp BioTech 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 OASIS trial. 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 this point.
Talactoferrin update
The Company confirmed that management continues to expect top-line
data from the FORTIS-M trial evaluating talactoferrin in third-line+
NSCLC in the first half of 2012. Accrual for this study was
completed in March 2011. The Company also reported that patients in
both the United States and Europe have already been enrolled in the
Phase II/III OASIS trial in severe sepsis. The OASIS trial was
initiated at the end of the second quarter of 2011. The Phase II
part of the trial is planned to enroll approximately 350 patients,
and data are expected in mid-2012.
Agennix also reported data from an exploratory single center study,
which was initiated prior to the establishment of Agennix AG and
funded in part by a grant from the U.S. National Institutes of
Health. The study evaluated the effect of talactoferrin versus
placebo in 47 patients with acute myelogenous leukemia (AML) in
preventing neutropenic fever and oral mucositis, which are common
side effects of chemotherapies used to treat AML. There was no
difference between the arms regarding neutropenic fever. More cases
of clinically relevant mucositis were reported in the talactoferrin
arm, but the difference was not statistically significant. No
increase in mucositis has been reported in other clinical studies
with talactoferrin. Talactoferrin was well tolerated with a safety
profile similar to placebo. Management does not 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, August 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
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 a Phase II/III
trial with talactoferrin in severe sepsis is underway. 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 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. 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 interim management report and unaudited interim
condensed consolidated financial statements and accompanying notes
for the second quarter and six months ended June 30, 2011, please see
the Investor Relations section of the Agennix website at http://www.a
gennix.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
ir@agennix.com
In the U.S.: Laurie Doyle
Senior Director, Investor Relations & Corporate Communications
Tel.: 609-524-5884
laurie.doyle@agennix.com
Additional media contact for Europe:
MC Services AG
Raimund Gabriel
Tel.: +49 89 210 228 0
raimund.gabriel@mc-services.eu
Additional investor contact for Europe:
Trout International LLC
Lauren Williams, Vice President
Tel.: +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
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