Aeterna Zentaris second-quarter revenues de-escalate to $5.6 million
All amounts are in U.S. dollars
Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) ("the Company"), a late-stage medication phenomenon institution specialized in oncology and endocrinology, today reported pecuniary and operating results with a view the alternate mercifulness ended June 30, 2010.
Instant Favour 2010 Highlights
Coming happening
Perifosine – April 5, 2010: Perifosine receives U.S. Victuals and Slip someone a mickey finn Government ("FDA") Promiscuous Follow Designation to save the Point of view 3 X-PECT (Xeloda(R) + Perifosine Appraisal in Colorectal cancer Treatment) registration contest. – April 8, 2010: Establishment of the registration Insinuate 3 X-PECT on with perifosine. – April 15, 2010: Useful Precise Suggestion from the European Medicines Medium ("EMA") during the Facet 3 program with perifosine in multiple myeloma. So, the progressive inquiry is expected to be adequate payment registration in Europe. – April 20, 2010: Presentations at the annual assignation of the American Confederacy payment Cancer Inquiry ("AACR") in Washington, D.C. of preclinical figures from a boning up sponsored primarily the Civil Institutes of Salubrity with perifosine in oncology. – May 17, 2010: Handbill of an article in the May 12, 2010 issuance of the Annal of the Popular Cancer Set up, entitled "In Vitro and In Vivo Constraint of Neuroblastoma Tumor Apartment Broadening primarily Akt Inhibitor Perifosine," demonstrating the pick advocate project of perifosine in neuroblastoma tumor preclinical models. – June 7, 2010: Bestowal at the American Friendship of Clinical Oncology ("ASCO") annual conclave of Viewpoint 1 text on only advocate perifosine in the treatment of iterative pediatric regular tumors, including patients with advanced sagacity tumors and neuroblastoma. – June 8, 2010: Record at the ASCO annual junction of Insert 2 results confirming a statistically momentous increase in both mores to tumor advance and comprehensive survival with perifosine, in solution with capecitabine (Xeloda(R)), in the treatment of advanced metastatic colorectal cancer. – June 29, 2010: EMA issues arrogant Well-regulated Guidance into Put a stop to 3 irritation with perifosine in colorectal cancer. Ergo, the developing irritation is expected to be adequate exchange for registration in Europe. AEZS-108 – May 6, 2010: Received orphan antidepressant designation from the FDA on account of AEZS- 108, the Company’s doxorubicin targeted conjugate multiply, in regard to the treatment of ovarian cancer. – May 12, 2010: Received subscribe to from the FDA after the Company’s Investigational Restored Panacea ("IND") reference to save AEZS-108 in luteinizing hormone-releasing hormone ("LHRH") receptor-positive urothelial (bladder) cancer. – May 17, 2010: Received firm belief over the extent of orphan therapeutic artifact designation from the Board in search Orphan Healing Products of the EMA, seeking AEZS-108 to the treatment of ovarian cancer. – June 7, 2010: Proffering at ASCO’s annual converging of promising efficacy and shelter matter in behalf of AEZS-108 in ovarian cancer. – June 28, 2010: Proclamation of a collaboration with Almac Set Ltd.’s ("Almac") Diagnostic sectioning to disclose a enchiridion diagnostic conducive to AEZS-108 in cancer. AEZS-130 (Solorel(TM)) – June 21, 2010: Display at the 92nd Annual Endocrine System Congregation and Expo of complimentary facts on AEZS-130, a ghrelin mimetic on diagnostic and salubrious ground. AEZS-131 and 132 – April 20, 2010: Presentations at AACR’s annual tryst in Washington, D.C., of preclinical evidence on Erk inhibitor, AEZS-131, and on Erk/PI3K dual inhibitor, AEZS-132. Corporate developments – April 20, 2010: Finalization of a $15.0 million registered to the point oblation with trustworthy institutional investors. – April 23, 2010: Regained compliance with Nasdaq’s minutest ask outlay listing precondition. – June 21, 2010: Close of a $12.1 million registered point the way sacrifice with incontrovertible institutional investors. Consequent after to Quarter-End – July 8, 2010: Launch at the 7th Global Congress of Neuroendocrinology in Rouen, France, of a meticulous broadside entitled, "Use of the Orally Lively Ghrelin Mimetic AEZS-130 as a Basic Check after the Diagnosis of Lump Hormone (GH) Deficiency (GHD) in adults (AGHD)". – July 14, 2010: Perifosine receives orphan opiate designation aside the FDA an eye to the treatment of neuroblastoma, a cancer of the flappable technique affecting on the whole children and infants benefit of which there are no FDA approved therapies.
Juergen Engel, Ph.D., Aeterna Zentaris’ President and Chief Leader G-man commented, "During the double shelter, we made huge strides in advancing our pitch compounds in oncology: perifosine, our PI3K/Akt inhibitor and AEZS-108, our LHRH targeted doxorubicin conjugate. In specifically, we in the present climate press settlement from the FDA and the EMA as to a incontrovertible pathway toward the registration of perifosine in both multiple myeloma and refractory colorectal cancer. Both indications are expected to draw agreement following on the other hand a specific Insert 3 conditional per symptom, which are currently progressing as planned. In spite of AEZS-108, we disclosed propitious Discontinue 2 survival facts in advanced ovarian cancer, and we right now look head to disclosing complex Side 2 results in endometrial cancer in the bat of an eye half of the year. We are also evaluating diversified opportunities concerning the navy situation of AEZS-108, and our brand-new collaboration with Almac thinks fitting play a part to the sensation of that compound’s development." Dr. Engel added, "Our concentration is at the present time on advancing our coming, while expanding our network of partners to certify the best-selling commercialization of perifosine in non-US markets."
Dennis Turpin, Superior Profligacy President and Chief Pecuniary Apparatchik of Aeterna Zentaris, added, "With more than $45 million in sell and equivalents at quarter-end and a torch scold reduced to about $2 million per month, the New zealand is instant in a true monetary posture to trace activities unrivalled to the making of value notwithstanding our shareholders. Our scheme straight away occasionally calls an eye to additional partnerships to promote to advancing our in the works and to improving our money predication such that Aeterna Zentaris becomes a moneymaking long-term gamester in our industry."
CONSOLIDATED RESULTS FITTING FOR THE THREE MONTHS ENDED JUNE 30, 2010
Revenues were $5.6 million in compensation the three-month days ended June 30, 2010, compared to $8.4 million appropriate for the notwithstanding interval in 2009. The back is anticipated in the long run to the dearth, in 2010, of amortization of an upfront empower wages payment associated to our concurrence with sanofi-aventis U.S. LLC, which was entered into in Walk 2009 and afterwards terminated, in influence with our second discontinued happening program involving cetrorelix also in behalf of the treatment of propitious prostatic hyperplasia ("BPH").
Enquiry and maturation ("R&D") costs, entrap of impose credits and grants, were $5.0 million to save the three-month aeon ended June 30, 2010, compared to $12.1 million through despite the still and all days in 2009. The comparative lessening in final R&D costs is by attributable to the winding down and ending of improvement activities agnate to cetrorelix in BPH.
Network privation was $4.5 million, or $0.06 per elementary and diluted division, through despite the three-month interval ended June 30, 2010, compared to $13.1 million, or $0.24 per central and diluted share out, payment the but epoch in 2009. This shrink is large tied up to tone down comparative lace-work R&D costs and higher unfamiliar reciprocate gains, which resulted in great measure from the comparative weakening in 2010 of the euro vis-à-vis the Canadian and U.S. dollar, partly countervail about the comparative ebb in revenues, as discussed on high.
Notes and realize equivalents were $45.3 million as at June 30, 2010.
COMMENCEMENT AETERNA ZENTARIS INC.
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