Full Press Release Details
Management s Discussion and
of Financial Condition and
Results of Operations
Highlights
On April 21, 2009, we
presented two posters on AEZS-126, a promising compound for clinical
intervention of the PI3K/ Akt pathway in human tumors, at the American
Association for Cancer Research ( AACR ) Annual Meeting in Denver, Colorado.
On April 22, 2009, we
presented a poster at the AACR which outlined Phase 1 results for our
orally-active tubulin and topoisomerase II inhibitor compound, AEZS-112, in
patients with advanced solid tumors or lymphoma, which may potentially provide
a new therapeutic approach for the treatment of cancer.
On April 29, 2009, we
announced that we had received notification from the Nasdaq Stock Market ( Nasdaq )
that we had regained compliance with Listing Rule 5450(a)(1) relating
to the maintenance of a minimum bid price.
presented results supporting the evaluation of our targeted cytotoxic peptide
conjugate compound, AEZS-108 (formerly AN-152), in prostate cancer at the
American Society of Clinical Oncology ( ASCO ) Annual Meeting, which was held
in Orlando, Florida.
announced that our partner, Keryx Biopharmaceuticals, Inc. ( Keryx )
presented, at the ASCO Annual Meeting, positive Phase 2 data on the clinical
activity of perifosine (KRX-0401), a PI3K/Akt pathway inhibitor compound for cancer, as a
treatment for advanced metastatic colon cancer and advanced renal cell
entered into an agreement with the administrators of Ardana Bioscience Limited
( Ardana ) to acquire all Ardana assets relating to AEZS-130 for $0.2 million.
disclosed results for our European multi-center Phase 2 trial in non-small cell
lung cancer with perifosine as radioenhancer.
On June 10, 2009, we
announced the initiation of the extension or our North American efficacy Phase
3 study with cetrorelix pamoate for the treatment of benign prostatic
hyperplasia ( BPH ), a benign enlargement of the prostate. This extension of
the study will be sponsored by sanofi-aventis, our partner for the US market.
On June 11, 2009, we
presented a poster on AEZS-130 at the annual meeting of the Endocrine Society,
reporting the first clinical data relating to the use of AEZS-130 as a simple
diagnostic test for adult growth hormone deficiency.
On June 15, 2009, we
announced that we would report data from the safety study of the Phase 3
program in BPH with cetrorelix ahead of schedule, moving that disclosure from
the fourth quarter of 2009 to the third quarter of 2009.
On June 23, 2009, we
completed a registered direct offering of US$10.0 million of units comprised of
common shares and common share purchase warrants to certain institutional
investors. We received net proceeds of approximately US$9.2 million after
deducting placement agent fees and other offering expenses.
Subsequent to Quarter-End
announced the publication in the renowned American scientific journal, Proceedings of the National Academy of Sciences, of new data
supporting the use of our ghrelin receptor antagonist compound, AEZS-123
(JMV2959), for the treatment of alcohol dependence that involves ghrelin.
On August 3, 2009, we
announced that our partner Keryx
reached an agreement with the U.S. Food and Drug Administration regarding a
Special Protocol Assessment on the design of a double-blind, placebo-controlled
Phase 3 trial with perifosine, in relapsed or relapsed/refractory multiple
myeloma patients previously treated with bortezomib (VELCADE ).
Introduction
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,
2009. In this MD&A, the Company , we ,
us , and our 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 for the
three-month and six-month periods ended on June 30, 2009 and 2008. Our consolidated financial
statements, reported in United States dollars ( US dollars ) have been prepared
in accordance with Canadian Generally Accepted Accounting Principles ( Canadian
GAAP ) for interim financial information, which differ in certain respects from
United States Generally Accepted Accounting Principles ( US GAAP ).
All amounts presented in this MD&A are in US dollars, except where
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 US Food and Drug
Administration, the Therapeutic Products Directorate of Health Canada or any
other organization responsible for enforcing regulations in the pharmaceutical
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 shares, or where it is
quite 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
provinces of Canada and is registered in the United States and is, therefore,