EANS-News: AGENNIX AG Agennix Reports Financial Results for Third Quarter and
First Nine Months of 2011
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Corporate news transmitted by euro adhoc. The issuer/originator is solely
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quarterly report/9-month report
Subtitle: Provides update on expected timing for top-line data from ongoing
talactoferrin trials
Planegg/Munich (Germany), Princeton, NJ and Houston, TX, November 3, 2011 (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 third
quarter and nine months ended September 30, 2011.
Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of the
Management Board, said: "We are pleased with our continued good progress in the
development of our oral immunotherapy, talactoferrin. Our achievements for the
year to date include the completion of patient enrollment in the FORTIS-M Phase
III registration trial in non-small cell lung cancer, as well as the initiation
of the OASIS Phase II/III trial in severe sepsis at the end of June. Enrollment
in the OASIS trial is progressing faster than anticipated, with 45% of the 350
patients already enrolled. We now expect top-line data from both the FORTIS-M
trial and the Phase II portion of the OASIS trial in the second quarter of
2012."
Dr. Hombeck continued: "Additionally this year, talactoferrin data from Phase
II trials were published in peer-reviewed medical journals and presented at
major medical meetings. We have also been very fortunate to have hired several
highly experienced executives in key areas as we prepare for a possible
regulatory filing for talactoferrin and a potential commercial launch."
First nine months of 2011 compared to first nine months of 2010
The Company did not recognize any revenue during the nine months ended September
30, 2011, compared to E 0.2 million during the nine months ended September 30,
2010. The latter was attributable to an out-license agreement for certain
intellectual property from a discontinued discovery program.
Research and development (R&D) expenses for the nine months ended September 30,
2011 were E 24.6 million compared to E 19.9 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 in non-small cell
lung cancer (NSCLC) and 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 nine months ended September 30, 2011 and 2010,
were E 6.6 million and E 6.4 million, respectively.
Net loss before tax for the nine months ended September 30, 2011, was E 32.4
million compared to E26.3 million for the same period in 2010. Income tax
benefit for the nine months ended September 30, 2011, amounted to E 7.2 million
(E 6.9 million for the same period in 2010) and related to the recognition of
deferred tax asset on net operating losses incurred by the Company's subsidiary,
Agennix Incorporated, during the period. Net loss for the nine months ended
September 30, 2011, was E 25.2 million compared to E 19.4 million for the same
period in 2010. Basic and diluted loss per share was E(0.60) for the nine months
ended September 30, 2011, compared to E (0.97) for the same period in 2010.
Third quarter of 2011 compared to third quarter of 2010
The Company did not recognize any revenue during the three months ended
September 30, 2011 and recognized E 0.2 million for the same period in 2010. R&D
expenses were E8.1 million for the third quarter of 2011 compared to E 8.3
million for the same period in 2010. The decrease in R&D expenses was primarily
due to decreases in drug development activities in the third quarter of 2011 as
the enrollment in the Phase III FORTIS-M trial was completed in March 2011.
Administrative expenses for the third quarter of 2011 were E 2.1 million
compared to E 2.0 million for the same quarter in 2010. Net loss for the third
quarter of 2011 was E 8.2 million compared to E 11.2 million for the third
quarter of 2010 primarily due to foreign exchange gain of approximately E 0.7
million in the third quarter of 2011 compared to foreign exchange loss of
approximately E 4.1 million for the same period in 2010. Basic and diluted loss
per share was E (0.20) and E (0.54) in the third quarter of 2011 and 2010,
respectively.
Quarter over quarter results: third quarter 2011 compared to second quarter 2011
The Company did not recognize any revenue during the third or second quarter of
2011. R&D expenses for the third quarter of 2011 were E 8.1 million compared to
E8.3 million for the second quarter of 2011. Administrative expenses for the
third quarter of 2011 were E 2.1 million compared to E 2.2 million for the
second quarter of 2011. Net loss for the third quarter of 2011 was E 8.2 million
compared to E8.3 million for the second quarter of 2011. Basic and diluted loss
per share was E (0.20) for the third quarter of 2011 as well as for the second
quarter of 2011.
Cash position
As of September 30, 2011, cash, cash equivalents, other current financial assets
and restricted cash totaled E 43.3 million (December 31, 2010: E 79.3 million).
Net cash burn for the nine months ended September 30, 2011, was E34.9 million
(September 30, 2010: E25.3 million) with net cash burn of E 11.5 million in the
first quarter, E 11.6 million in the second quarter and E 11.8 million in the
third quarter of 2011. The increase in net cash burn was mainly due to clinical
trial costs related to increased patient enrollment in the Phase III FORTIS-M
trial and the Phase II portion of 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 provided the following financial guidance for the remainder of 2011
and for 2012:
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
The Company expects R&D expenses for fiscal year 2011 to be higher than in 2010
due to increased talactoferrin clinical trial-related costs. During 2011,
patients continue to be treated in the Phase III FORTIS-M trial, and the OASIS
Phase II/III trial was initiated in June 2011. Agennix expects R&D expenses in
2012 to increase compared to 2011. The OASIS trial is expected to continue to
enroll patients, and Agennix expects to incur additional production and other
costs in preparation for a potential regulatory filing and commercial launch of
talactoferrin.
Administrative expenses
Administrative expenses for fiscal year 2011 are expected to be slightly higher
than for 2010 as the Company engages in certain critical pre-commercialization
activities. Administrative expenses are expected to increase in 2012 compared to
2011 because pre-commercialization activities are planned to increase as the
Company gets closer to a potential regulatory filing and commercial launch.
Cash position
Management believes that Agennix 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 from the FORTIS-M trial as well as the Phase II portion of
the OASIS trial, both expected in the second quarter of 2012, assuming no
significant changes to current projected timelines. This projected cash reach
also assumes that the E 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 part
of the OASIS trial.Management plans to raise additional funds through licensing
agreements and/or through equity or debt investments to fund the Company's
operations beyond the second half of 2012.
Talactoferrin update
The Company provided an update on its lead program, the oral immunotherapy,
talactoferrin.
Top-line data from Phase III FORTIS-M registration trial expected in the second
quarter of 2012. The Company tightened its guidance, indicating that it now
anticipates top-line data from the FORTIS-M trial in the second quarter of 2012.
The FORTIS-M trial is a randomized, double-blind, placebo-controlled study
evaluating talactoferrin plus best supportive care compared to placebo plus best
supportive care in non-small cell lung cancer patients whose disease has
progressed following two or more prior lines of therapy.
Forty-five percent of patients enrolled in Phase II part of OASIS Phase II/III
trial. Agennix provided an update on enrollment in its ongoing Phase II/III
OASIS trial in severe sepsis. As of October 31, 2011, 157 patients - or 45% of
the planned 350 patients - had been enrolled in the Phase II part of the OASIS
trial. The study was initiated at the end of June 2011. Top-line results are
now expected in the second quarter of 2012.
Enrollment expected to complete in NIH-sponsored Phase I/II study for nosocomial
infections in pre-term infants by year-end 2011.
Agennix also reported that enrollment in an NIH-sponsored Phase I/II trial
evaluating talactoferrin's potential to reduce the incidence of late-onset
infections in infants born prematurely is expected to complete by the end of
2011. Data are expected in mid-2012. Agennix does not currently 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, November 3rd at 9 AM ET/2 PM CET. The dial-in numbers for
the call are as follows:
Participants from Europe: 0049 (0)69 710445598
0044 (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 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 in a Phase II/III trial in severe sepsis. 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. 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. 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. 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(TM) 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 third quarter
and nine months ended September 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:
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, 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: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Hamburg, Düsseldorf, Hannover, München
language: English