Aeterna Zentaris Regains Compliance with NASDAQ $1.00 Minimum Bid Price Rule and Announces 2016 Corporate Objectives
December 08 2015 - 8:30AM
Business Wire
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”)
today announced that on December 7, 2015, NASDAQ notified the
Company that it has regained compliance with Rule 5450(a)(1), which
requires a minimum bid price of $1.00 for continued listing on the
NASDAQ Capital Market.
Commenting on the announcement, David A. Dodd, Chairman,
President and Chief Executive Officer of the Company, stated: “We
are pleased that we have been able to regain compliance with
NASDAQ's minimum bid price rule, because our NASDAQ listing is
important in maintaining liquidity in the trading of our common
shares.”
The Company also disclosed that at its annual end-of-year
meeting, its Board of Directors recently adopted the following
objectives for the Company in 2016:
- Zoptrex™: Completion of the pivotal
ZoptEC Phase 3 Clinical Trial – The objective is to complete the
ZoptEC Phase 3 study of Zoptrex™ during the third quarter of 2016
and to report top-line results of the study shortly thereafter. In
adopting this objective, the Board noted that the Company
disclosed, on October 13, 2015, that the independent Data and
Safety Monitoring Board recommended that the Company continue the
ZoptEC Phase 3 clinical study to its conclusion following a
comprehensive review of efficacy and safety data at 192 events. The
Board viewed this as a very encouraging development.
- Macrilen™: Completion of the
confirmatory Phase 3 Clinical Trial – The objective is to complete
the confirmatory Phase 3 clinical trial of Macrilen™ during the
fourth quarter of 2016 and to report top-line results within eight
weeks of completion.
- Commercial Operations: Addition of
another product to our commercial portfolio – The objective is to
acquire or in-license at least one product during 2016 and to
increase revenues from existing co-promotion arrangements.
- Financial Condition: Capital
structuring and strengthening – The objective is to further
strengthen the cash balance, while continuing to reduce burn rate.
The Board noted that over the past two years, the Company has
reduced its staff by over 50%, while significantly reducing its
operating burn rate, successfully progressing its commercial focus
and running two pivotal Phase 3 programs.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women’s health. We are engaged in drug
development activities and in the promotion of products for others.
The focus of our business development efforts is the acquisition of
licenses to products that are relevant to our therapeutic areas of
focus. We also intend to license out certain commercial rights of
internally developed products to licensees in territories where
such out-licensing would enable us to ensure development,
registration and launch of our product candidates. Our goal is to
become a growth-oriented specialty biopharmaceutical company by
pursuing successful development and commercialization of our
product portfolio, achieving successful commercial presence and
growth, while consistently delivering value to our shareholders,
employees and the medical providers and patients who will benefit
from our products. For more information, visit www.aezsinc.com.
About Zoptrex™
Zoptrex™ (zoptarelin doxorubicin), which was developed by Dr.
Andrew V. Schally, a recipient of the Nobel Prize, represents a new
targeting concept in oncology using a hybrid molecule composed of a
synthetic peptide carrier and a well-known chemotherapy agent,
doxorubicin. Zoptarelin doxorubicin is the first intravenous drug
in advanced clinical development that directs the chemotherapy
agent specifically to LHRH-receptor expressing tumors, which could
result in a more targeted treatment with less damage to healthy
tissue. The Company is currently conducting a ZoptEC
(Zoptarelin doxorubicin
in Endometrial Cancer) Phase 3 trial in
women with advanced, recurrent or metastatic endometrial cancer,
while zoptarelin doxorubicin is also in an investigator-initiated
Phase 2 trial in prostate cancer. Aeterna Zentaris owns the
worldwide rights to this compound except in China (including Hong
Kong and Macau) where rights have been out-licensed to Sinopharm
A-Think Pharmaceuticals, a subsidiary of Sinopharm, the largest
medical and healthcare group in China and on Fortune's Global 500
list. On April 16, 2015, the Company announced the filing of a
patent application intended to strengthen the exclusivity of
zoptarelin doxorubicin through a unique, significantly lower cost
in the manufacturing process.
About MacrilenTM
Macrilen™ (macimorelin), a ghrelin agonist, is a novel small
molecule that stimulates the secretion of growth hormone after the
patient drinks a solution containing the compound. If approved by
the FDA, Macrilen™ would be the first orally administered drug
indicated for the evaluation of AGHD. In the United States,
Macrilen™ is expected to be an alternative to the Insulin Tolerance
Test (“ITT”), which is considered to be the “gold standard” for
growth hormone secretion provocative tests but which requires
constant patient monitoring by a physician while the test is
administered intravenously and which is contra-indicated in
patients with seizure disorders, with cardiovascular disease and in
brain injured patients and elderly patients. MacrilenTM has been
granted orphan drug designation by the FDA for diagnosis of AGHD.
The Company owns the worldwide rights to this novel patented
compound.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the US Securities
Litigation Reform Act of 1995. Forward-looking statements may
include, but are not limited to statements preceded by, followed
by, or that include the words “expects,” “believes,” “intends,”
“anticipates,” and similar terms that relate to future events,
performance, or our results. Forward-looking statements involve
known and unknown risks and uncertainties that could cause the
Company's actual results to differ materially from those in the
forward looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue
R&D projects and clinical trials, the successful and timely
completion of clinical studies, the risk that safety and efficacy
data from any of our Phase 3 trials may not coincide with the data
analyses from previously reported Phase 1 and/or Phase 2 clinical
trials, the ability of the Company to efficiently commercialize one
or more of its products or product candidates, the ability of the
Company to take advantage of business opportunities in the
pharmaceutical industry, uncertainties related to the regulatory
process, the ability to protect our intellectual property, the
potential of liability arising from shareholder lawsuits and
general changes in economic conditions. Investors should consult
the Company's quarterly and annual filings with the Canadian and US
securities commissions for additional information on risks and
uncertainties relating to forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements. The Company does not undertake to update these
forward-looking statements. We disclaim any obligation to update
any such factors or to publicly announce the result of 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20151208005572/en/
Aeterna Zentaris Inc.Philip Theodore, 843-900-3223Senior Vice
Presidentptheodore@aezsinc.com
Aeterna Zentaris (NASDAQ:AEZS)
Historical Stock Chart
From Jul 2024 to Aug 2024
Aeterna Zentaris (NASDAQ:AEZS)
Historical Stock Chart
From Aug 2023 to Aug 2024