| | | Geschrieben am 04-08-2011 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.
 --------------------------------------------------------------------------------
 
 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
 --------------------------------------------------------------------------------
 
 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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