EANS-News: AGENNIX AG
Agennix Reports Financial Results for Third Quarter and
First Nine Months of 2011
-------------------------------------------------------------------------------- Corporate news transmitted by euro adhoc. The issuer/originator is solely responsible for the content of this announcement. -------------------------------------------------------------------------------- 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 -------------------------------------------------------------------------------- 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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