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?option=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
Original content of: AGENNIX AG i.L., transmitted by news aktuell