Full Press Release Details
Management s Discussion and Analysis of Financial Condition and Results
April 5, 2010: Perifosine receives U.S. Food and
Drug Administration ( FDA ) Fast Track
Designation for the Phase 3 X-PECT (Xeloda + Perifosine Evaluation in Colorectal
cancer Treatment) registration
April 8, 2010: Initiation of a Phase 3 registration trial with perifosine in refractory
advanced colorectal cancer.
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 in Washington, D.C., of preclinical data on Erk inhibitor,
AEZS-131, and on Erk/PI3K dual inhibitor, AEZS-132, as well as preclinical data
from a study sponsored by the National Institutes of Health with perifosine in
April 20, 2010: Completion of a US$15.0 million registered direct offering with
certain institutional investors.
April 23, 2010: Regained compliance with Nasdaq s minimum bid price listing requirement.
May 6, 2010: Received orphan drug designation from
the FDA for AEZS-108, our doxorubicin targeted conjugate compound, for the
treatment of ovarian cancer.
May 12, 2010: Received approval from the FDA for
our Investigational New Drug ( IND ) application for AEZS-108 in luteinizing
hormone-releasing hormone ( LHRH ) receptor-positive urothelial (bladder)
May 17, 2010: Received positive opinion for orphan medicinal product designation from the
Committee for Orphan Medicinal Products ( COMP ) of the EMA, for AEZS-108 for the treatment of ovarian cancer.
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 annual meeting of the American Society of Clinical
Oncology ( ASCO ) of positive efficacy and safety data for AEZS-108 in ovarian
June 7, 2010: Presentation at the 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 ), in the treatment of advanced metastatic
June 21, 2010: Presentation
at the 92nd Annual Endocrine Society ( ENDO ) Meeting and
Expo of positive data on AEZS-130, a ghrelin mimetic for diagnostic and
June 21, 2010: Completion of a US$12.1 million registered direct offering with certain institutional
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.
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.
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
The following Management s Discussion and Analysis ( MD&A ) provides a
review of the results of operations, financial condition and cash flows of
terna Zentaris Inc. for the three-month and six-month periods ended
June 30, 2010. In this MD&A,
the Company , we , us , our and the Group mean terna Zentaris Inc. and
its subsidiaries. This discussion should be read in conjunction with the
information contained in the Company s interim consolidated financial
statements and related notes thereto as at June 30, 2010 and for the
three-month and six-month periods ended June 30, 2010 and 2009. Our interim consolidated financial
statements have been prepared in accordance with Canadian generally accepted
accounting principles ( Canadian GAAP ) for financial information, which differ
in certain respects from United States generally accepted accounting principles
All amounts in this MD&A are presented in US dollars, except for
share, option and warrant data, per share and per warrant data and as otherwise
About Forward-Looking Statements
This document contains forward-looking
statements, which reflect our current expectations regarding future events.
Forward-looking statements may include words such as anticipate , believe , could ,
expect , goal , guidance , intend , may , objective , outlook , plan , seek ,
should , strive , target and will .
Forward-looking statements involve risks and
uncertainties, many of which are discussed in this MD&A. Results or
performance may differ significantly from expectations. For example, the
results of current clinical trials cannot be foreseen, nor can changes in
policy or actions taken by such regulatory authorities as the FDA, the EMA, the
Therapeutic Products Directorate of Health Canada or any other organization
responsible for enforcing regulations in the pharmaceutical industry.
Given these uncertainties and risk factors,
readers are cautioned not to place undue reliance on any forward-looking statements.
We disclaim any obligation to update any such factors or to publicly announce
any revisions to any of the forward-looking statements contained herein to
reflect future results, events or developments, unless required to do so by a
governmental authority or by applicable law.
About Material Information
This MD&A includes the information we
believe to be material to investors after considering all circumstances,
including potential market sensitivity. We consider information and disclosures
to be material if they result in, or would reasonably be expected to result in,
a significant change in the market price or value of our securities, or where
it is likely that a reasonable investor would consider the information and
disclosures to be important in making an investment decision.
Company is a reporting issuer under the securities legislation of all of the