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Aeterna Zentaris Reports Second Quarter 2010 Financial and Operating Results

^{Published on 2010-08-12 04:15:56 - Market Wire}
 

 Perifosine - April 5, 2010: Perifosine receives U.S. Food and Drug Administration ("FDA") Fast Track Designation for the Phase 3 X-PECT (Xeloda(R) + Perifosine Evaluation in Colorectal cancer Treatment) registration trial. - April 8, 2010: Initiation of the registration Phase 3 X-PECT study with perifosine. - April 15, 2010: Positive Scientific Advice from the European Medicines Agency ("EMA") for the Phase 3 program with perifosine in multiple myeloma. Therefore, the ongoing trial is expected to be sufficient for registration in Europe. - April 20, 2010: Presentations at the annual meeting of the American Association for Cancer Research ("AACR") in Washington, D.C. of preclinical data from a study sponsored by the National Institutes of Health with perifosine in oncology. - May 17, 2010: Publication of an article in the May 12, 2010 issue of the Journal of the National Cancer Institute, entitled "In Vitro and In Vivo Inhibition of Neuroblastoma Tumor Cell Growth by Akt Inhibitor Perifosine," demonstrating the single agent activity of perifosine in neuroblastoma tumor preclinical models. - June 7, 2010: Presentation at the American Society of Clinical Oncology ("ASCO") annual meeting of Phase 1 data on single agent perifosine in the treatment of recurrent pediatric solid tumors, including patients with advanced brain tumors and neuroblastoma. - June 8, 2010: Report at the ASCO annual meeting of Phase 2 results confirming a statistically significant improvement in both time to tumor progression and overall survival with perifosine, in combination with capecitabine (Xeloda(R)), in the treatment of advanced metastatic colorectal cancer. - June 29, 2010: EMA issues positive Scientific Advice for Phase 3 trial with perifosine in colorectal cancer. Therefore, the ongoing trial is expected to be sufficient for registration in Europe. AEZS-108 - May 6, 2010: Received orphan drug designation from the FDA for AEZS- 108, the Company's doxorubicin targeted conjugate compound, for the treatment of ovarian cancer. - May 12, 2010: Received approval from the FDA for the Company's Investigational New Drug ("IND") application for AEZS-108 in luteinizing hormone-releasing hormone ("LHRH") receptor-positive urothelial (bladder) cancer. - May 17, 2010: Received positive opinion for orphan medicinal product designation from the Committee for Orphan Medicinal Products of the EMA, for AEZS-108 for the treatment of ovarian cancer. - June 7, 2010: Presentation at ASCO's annual meeting of positive efficacy and safety data for AEZS-108 in ovarian cancer. - June 28, 2010: Announcement of a collaboration with Almac Group Ltd.'s ("Almac") Diagnostic division to develop a companion diagnostic for AEZS-108 in cancer. AEZS-130 (Solorel(TM)) - June 21, 2010: Presentation at the 92nd Annual Endocrine Society Meeting and Expo of positive data on AEZS-130, a ghrelin mimetic for diagnostic and therapeutic use. AEZS-131 and 132 - April 20, 2010: Presentations at AACR's annual meeting in Washington, D.C., of preclinical data on Erk inhibitor, AEZS-131, and on Erk/PI3K dual inhibitor, AEZS-132. Corporate developments - April 20, 2010: Completion of a $15.0 million registered direct offering with certain institutional investors. - April 23, 2010: Regained compliance with Nasdaq's minimum bid price listing requirement. - June 21, 2010: Completion of a $12.1 million registered direct offering with certain institutional investors. Subsequent to Quarter-End - July 8, 2010: Presentation at the 7th International Congress of Neuroendocrinology in Rouen, France, of a scientific poster entitled, "Use of the Orally Active Ghrelin Mimetic AEZS-130 as a Simple Test for the Diagnosis of Growth Hormone (GH) Deficiency (GHD) in adults (AGHD)". - July 14, 2010: Perifosine receives orphan drug designation by the FDA for the treatment of neuroblastoma, a cancer of the nervous system affecting mostly children and infants for which there are no FDA approved therapies. 

 Interim Consolidated Statements of Operations (in thousands, except for share and per share data) (unaudited) ------------------------------------------------------------------------- Three months ended Six months ended June 30, June 30, 2010 2009 2010 2009 ------------------------------------------------------------------------- ------------------------------------------------------------------------- $ $ $ $ Revenues Sales and royalties 5,165 5,427 10,881 10,398 License fees and other 419 2,952 1,125 4,092 ------------------------------------------------------------------------- 5,584 8,379 12,006 14,490 ------------------------------------------------------------------------- Operating expenses Cost of sales, excluding depreciation and amortization 4,415 4,545 9,032 8,239 Research and development costs, net of tax credits and grants 5,029 12,076 10,730 23,513 Selling, general and administrative expenses 3,129 3,102 5,921 6,656 Depreciation and amortization Property, plant and equipment 242 331 505 642 Intangible assets 358 563 747 1,120 ------------------------------------------------------------------------- 13,173 20,617 26,935 40,170 ------------------------------------------------------------------------- Loss from operations (7,589) (12,238) (14,929) (25,680) ------------------------------------------------------------------------- Other income (expenses) Interest income 31 118 89 272 Foreign exchange gain (loss) 3,108 (960) 4,510 (60) ------------------------------------------------------------------------- 3,139 (842) 4,599 212 ------------------------------------------------------------------------- Net loss for the period (4,450) (13,080) (10,330) (25,468) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Net loss per share Basic and diluted (0.06) (0.24) (0.15) (0.48) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Weighted average number of shares Basic and diluted 72,918,880 53,655,087 68,031,569 53,422,571 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Interim Consolidated Balance Sheet Information (in thousands) (unaudited) ------------------------------------------------------------------------- As at As at June 30, December 31, 2010 2009 ------------------------------------------------------------------------- ------------------------------------------------------------------------- $ $ Cash and cash equivalents 45,311 38,100 Accounts receivable and other current assets 9,325 10,913 Restricted cash 755 878 Property, plant and equipment 3,301 4,358 Other long-term assets 26,824 32,013 ------------------------------------------------------------------------- Total assets 85,516 86,262 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Accounts payable and other current liabilities 14,784 19,211 Current portion of long-term payable 56 57 Long-term payable 113 143 Non-financial long-term liabilities* 48,054 57,625 ------------------------------------------------------------------------- Total liabilities 63,007 77,036 Shareholders' equity 22,509 9,226 ------------------------------------------------------------------------- Total liabilities and shareholders' equity 85,516 86,262 ------------------------------------------------------------------------- ------------------------------------------------------------------------- * Comprised mainly of deferred revenues and employee future benefits.