EANS-News: Agennix Reports Financial Results for Second Quarter and First Six
Months 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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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.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
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